V. Riambau - endovascular.es · endovascular therapeutics with a daring look into the future. This...

CARDIOLOGIAINTERVENCIONISTA

Alfonso, F. (Madrid, España)Betriu, A. (Barcelona, España)Calabuig, J. (Pamplona, España)Cribier, A. (Rouen, Francia)Cubero, J. (Sevilla, España)Esplugas, E. (Barcelona, España)Fournier, J.A. (Sevilla, España)Goicolea, J. (Madrid, España)Hernández, T. (Madrid, España)Jiménez Cárcamo, J. (Miami, USA)Llovet, A. (Madrid, España)Macaya, C. (Madrid, España)Masotti, M. (Barcelona, España)Medina, A. (Las Palmas, España)Moris, C. (Oviedo, España)Nienaber, C. (Rostok, Germany)Pasadolos, J. (Vigo, España)Pey, J. (Madrid, España)Pico, F. (Murcia, España)Quininha, J. (Lisboa, Portugal)Ramee, S. (New Orleans, USA)Roubin, G.S. (New York, USA)Sáenz, M.E. (Costa Rica)Sancho Jaldón, J. (Cádiz, España)Serra, A. (Barcelona, España)Sobrino, N. (Madrid, España)Suárez de Lezo, J. (Córdoba, España)Wholey, M.H. (Pittsburg, USA)

MEC XXI Medical Education & Communication

Aribau, 237, Escalera B, 3º-1ª • 08021 BARCELONA (ESPAÑA)e-mail: [email protected]

Diseño y Maquetación: www.a2multimedia.comImprime: Romero Industria Gráfica, S.L.

S.V. 167-R-CM. Depósito Legal: M-41883-1997 • ISSN: 1138-4379

www.sociedadcela.com

V. RiambauHospital Clinic. Villarroel 08036 Barcelona, España

[email protected]

CIRUGIAVASCULAR

Álvarez-Tostado, J. (Cleveland, USA)Acín, F. (Getafe, España)Balcazar, J.E. (La Paz, Bolivia)Barrera, J. (Bogotá, Colombia)Bergeron, P. (Marseille, Francia)Blankensteijn, J. (Utrecht, The Netherlands)Botelho de Medeiros, D. (Lisboa, Portugal)Busquet, J. (París, Francia)Cao, P.G. (Perugia, Italia)Carpenter, J.P. (Philadelphia, USA)Caserta, G. (Sao Paulo, Brasil)Da Rocha, M.F.M. (Sao Paulo, Brasil)Díaz-Durán, C. (Veracruz, México)Doblas, M. (Toledo, España)Fajardo, D. (Bogotá, Colombia)Fernandes e Fernandes, J. (Lisboa, Portugal)Fernández-Fernández, J.C. (A Coruña)Fernández-Samos, R. (León, España)Ferreira, L.M. (Buenos Aires, Argentina)Ferreira, M. (Rio Janeiro, Brasil)Fillinger, J. (Lebanon, USA)Galvagni, P. (Floridanapolis, Brasil)García Colodro, J.M. (Lugo, España)García-Madrid, C. (Barcelona, España)Gastambide, C. (Montevideo, Uruguay)Greenberg, R.K. (Cleveland, USA)Gilling-Smith, G. (Liverpool, UK)Giossa, W. (Montevideo, Uruguay)Hussein, E.A. (Cairo, Egipto)Kramer, A. (Chile)La Mura, R. (Buenos Aires, Argentina)Lerut, P. (Lovaina, Bélgica)Makaroun, M.S. (Pitsburg, USA)Marticorena, J. (Lima, Perú)Martín Paredero, V. (Tarragona, España)Matsumura, J.S. (Chicago, USA)Mertens, R. (Chile)Moll, F. (Utrecht, The Netherlands)Mulet, J. (Barcelona, España)Murillo, I. (Monterrey, México)Peeters, P. (Bonheiden, Belgium)Pitty, F. (Panamá)Pontes, C. (Salvador de Bahía, Brasil)Poredos, P.I. (Ljubljana, Slovenia)Puech, P. (Brasil)Queral, L.. (Baltimore, USA)Ramírez, J.C. (Asunción, Praguay)Saldaña, G. (Monterrey, México)Sicar, G. (Saint Louis, U.S.A.)Schumaker, H. (Heidelberg, Germany)Urgnani, F. (Barcelona, España)Valdes, F. (Chile)Vaquero, C. (Valladolid, España)Verhoeven, E. (Groningen, The Netherlands)Von Ristow, A. (Río de Janeiro, Brasil)

J.A. Jiménez Cossío †

RADIOLOGIAINTERVENCIONISTA

Acitores, I. (Madrid, España)Blasco, J. (Barcelona, España)Bolia, A. (Leicester, UK)Canis, M. (Córdoba, España)Echenagusía, A. (Madrid, España)Felices, J.M. (Murcia, España)Ferral, H. (New Orleans, USA)Fraire, V. (Monterrey, México)Garzón, G. (Madrid, España)González-Tutor, A. (Santander, España)Gregorio, M.A. de (Zaragoza, España)Hernández Lezana, A. (Madrid, España)Hilario, J. (Zaragoza, España)Katzen, B. (Miami, USA)Lammer, J. (Viena, Austria)López Ibor, J. (Madrid, España)Macho, J. (Barcelona, España)Marini, M. (A Coruña, España)Martín Palanca, A. (Málaga, España)Martínez, F. (Las Palmas, España)Muñoz, J.J. (Málaga, España)Palmaz, J.C. (Sant Antonio, USA)Palmero, J. (Valencia, España)Pueyo, J. (Mallorca, España)Pulpeiro, J.R. (Lugo, España)Real, M.I. (Barcelona, España)Reekers, J. (Amsterdam, The Netherlands)Reyes, R. (Las Palmas, España)Rousseau, H. (Toulouse, Francia)Sánchez, J. (Madrid, España)Sancho, C. (Barcelona, España)Segarra, A. (Barcelona, España)Schönholz, C. (New Orleans, USA)Tagarro, A. (Madrid, España)Tobío, R. (Madrid, España)Urtasun, F. (Pamplona, España)Verdú, P. (Alicante, España)Viaño, J. (Madrid, España)Ybañez, F. (Madrid, España)Zubicoa, S. (Madrid, España)

Cerezo, M. (Buenos Aires Argentina)Criado, F. (Baltimore, USA)

Parodi, J.C. (Buenos Aires, Argentina)Dietrich, E.B. (Phoenix, AZ, USA)

Becquemin, J.P. (Creteil, France)Montañá, X. (Barcelona, España)

Gaines, P. (Sheffield, England)Egaña, J.M. (San Sebastián, España)

De Blas, M. (San Sebastián, España)Malina, M. (Malmo, Suecia)

Raithel, D. (Nüremberg, Germany)Veith, F. (New York, USA)

Espinosa, G. (Pamplona, España)García, G. (Medellín, Colombia)

Coordinador Científico de CELA

La información presentada en los artículos expresa únicamente la opinión personal de los autores siendoestos los responsables del contenido. Técnicas Endovasculares se publica 3 veces al año. Copyright © 1998.Ninguna de las partes de estas publicaciones puede reproducirse sin el previo consentimiento de la Editorial.

SUMARIO

3786Congresos

3790Normas de publicación

3785Novedades

3604Comunicaciones

3579Riambau, V.

E D I T O R I A L

COMUNICACIONES

3725Comunicaciones Orales

COMUNICACIONES ORALES

3731Comunicaciones

CASOS PROBLEMA

3747Posters

POSTERS

N O V E D A D E S D E S D E L A I N D U S T R I A

C O N G R E S O S

N O R M A S D E P U B L I C A C I Ó N

3582SITE 2011

P R O G R A M A

Una nueva edición del SITE nos espera en una nueva ubicación. Por motivoslogísticos hemos trasladado el escenario al Palacio de Congresos de Catalunya.Estamos convencidos que el SITE 2011 incrementará su calidad y confort con lanueva sede.

El programa científico, como siempre, será el centro de atención para todos losasistentes. Mantendremos nuestro compromiso de actualizar el conocimiento yexperiencia en terapéutica endovascular, con una mirada atrevida hacia el futuro.La nueva edición incluirá sesiones científicas dedicadas a revisar las futuras tecno-logías diagnósticas y terapéuticas, la actualidad en revascularización de extremida-des inferiores, controversias en el tratamiento endovascular de la aorta abdominaly torácica, ramas viscerales y troncos supraórticos.

Como novedad, además de las clásicas sesiones-competición dotadas con atracti-vos premios para la mejor presentación libre y al mejor póster, este año se añadeuna nueva sesión-competición para casos problema en terapéutica endovascularque contengan elementos educativos. Un jurado internacional y la propia audien-cia seleccionarán a los ganadores. Para dar más holgura al denso programa cientí-fico, también será novedad la disposición de una sala paralela al auditorio central,que durante toda una mañana revisará los aspectos más actuales, innovadores ycontrovertidos, relacionados con patología venosa, malformaciones arteriovenosasy accesos vasculares.

Al igual que en anteriores ediciones, no nos olvidaremos de los recién iniciadosofreciendo talleres endovasculares de realidad virtual que dispondrán de unárea destacada con agenda propia. Los simposios paralelos completarán el inten-so programa científico.

Como siempre, contaremos con un panel de ponentes de contrastada reputa-ción internacional y nacional. Todos ellos dispuestos a trasmitirnos información deextrema actualidad y asequibles a nuestros comentarios y preguntas. Como enediciones anteriores, uno de ellos será homenajeado por su especial contribuciónal desarrollo de las técnicas endovasculares. Pero mantendremos el secreto, por elmomento.

Una vez más, vuestra participación es crucial. Vuestras opiniones críticas y discu-siones pragmáticas enriquecerán las conclusiones del Simposio. Esperando podersaludaros personalmente en Barcelona.

3579

E D I T O R I A L

Dr. V. RiambauSITE Director

Symposium Co-Chairs: M. de Blas, J.M. Egaña, X. MontañáProgram Advisors: M. Castellá, G. Espinosa, C. García-Madrid, J. Macho, G. Mestres, M. SabatéScientific Committee: P. Gaines, F. Moll, J. Goicolea, E. Ros, S. Trimarchi

3581

A new Edition of SITE is waiting for us in a new location. For logistic reasons wehave moved the setting to the Palau de Congressos de Catalunya (the CataloniaCongress Palace). We are convinced that with this new venue SITE 2011 willenhance its quality and comfort.

The scientific programme, as always, will be the highlight for all those whoattend. We will maintain our promise to update knowledge and experience inendovascular therapeutics with a daring look into the future. This new edition willinclude scientific sessions dedicated to revising future diagnostic technologies andtherapies, the current news in lower limb revascularization, controversies in endo-vascular treatment of abdominal and thoracic aorta, visceral vessels and supra-aor-tic trunks.

As well as the classic competition-sessions offering interesting prizes for the bestoral free paper and best poster, this year we are adding the novelty of a newcompetition-session for challenging cases in endovascular therapeutics whichcontain educational elements. Moreover, both an international jury and theaudience will vote for the winners. To accommodate the dense scientific program-me this year we will also offer a room parallel to the plenary auditorium which,throughout an entire morning will be home to sessions that will review the mostcurrent, innovative and controversial aspects related to venous pathology, arterial-venous malformations and vascular accesses.

As in previous editions we won’t forget the recently recruited and will feature vir-tual reality endovascular workshops which will be set apart in a reserved areaand will have their own schedule. Finally, the parallel symposia will complete theintense scientific programme.

As always, we will have the pleasure of being able to count on a panel of expertspeakers of national and international repute. All of whom will bring cutting-edgeinformation as well as being open to our comments and queries. Once again, wewill pay tribute to one of our prestigious speakers for his/her outstanding contribu-tion to the development of endovascular techniques, but we will only reveal thesecret on the day.

Once again your participation is crucial. Your critical opinions and pragmatic dis-cussions will enrich the conclusions of the Symposium. Looking forward to gree-ting you personally in Barcelona.

E D I T O R I A L

Dr. V. RiambauSITE Director

Symposium Co-Chairs: M. de Blas, J.M. Egaña, X. MontañáProgram Advisors: M. Castellá, G. Espinosa, C. García-Madrid, J. Macho, G. Mestres, M. SabatéScientific Committee: P. Gaines, F. Moll, J. Goicolea, E. Ros, S. Trimarchi

3584

IX SITE Simposio Internacionalsobre Terapéutica Endovascular

4-7 Mayo 2009 • Barcelona (Spain)

08:00-20:00 h Montaje exhibición / Exhibit set up

10:30-11:30 h Inscripción / Registration

16:30-20.00 h Inscripción / Registration

17:30-19.00 h SIMPOSIOS SATÉLITE / SATELLITE SYMPOSIA

07:30-18.00 h Inscripción / Registration

07:55-08.00 h Bienvenida e introducción / Welcome and introduction

Controversia: La revascularización endovascular debe ser la primeraopción terapéutica en isquemia críticaControversy: Endovascular revascularization should be the first option forcritical limb ischemia08:00 h Pro D. Scheinert08:08 h Con H. Sillesen

Cómo recanalizar las lesiones TASC D del sector ilíaco: Material,métodos y trucosHow to recanalyze aorto-iliac TASC D lesions: Material, methods and triksM. Maynar

Cómo negociar con las oclusiones totales de femoral superficial: Material,métodos y trucosHow to deal with CTO in the superficial femoral: Material, methods andtriksJ. Bleyn

08:00-9:07 h

08:00-08:16 h

08:16-08:23 h

08:24-08:31 h

Sesión I / Session I:ENDOREVASCULARIZACIÓN DE EXTREMIDADES INFERIORES (I)LOWER LIMB ENDO-REVASCULARIZATION (I)

Moderador / Moderator: P. GainesPanelistas / Panelists: F. Vermassen, J. Palmero

Miércoles 4 de Mayo de 2011 / Wednesday, 4th May 2011

Jueves 5 de Mayo de 2011 / Thursday, 5th May 2011

Programa / Programme

3585

08:47-09:00 h Discusión / DiscussionComienza con / Starts with F. Gómez Palonés


Cómo recanalizar oclusiones totales de los troncos tibiales: Material,métodos y trucosHow to recanalyze total occlusions in tibial vessels: Material, methodsand triksD. Scheinert

Como recanalizar arcos plantares ocluidos: Material, métodos y trucosHow to recanalyze total occluded plantar vessels: Material, methodsM. Manzi

08:32-08:39 h

08:40-08:47 h

Visión coste-eficacia en el tratamiento endovascular de la isquemia críticaThe cost-effectiveness view for endovascular techniques in critical limbischemiaF. Vermassen

El beneficio de los balones impregnados con drogaThe benefits of drug eluting balloonsC. Rabbia

¿Son mejores los stents liberadores de droga en la femoral superficial?Are drug eluting stents in the SFA better?P. Peeters

Actualización sobre los stents bio-degradables para la revascularizaciónde las extremidades inferioresUpdate in bio-absorbable stents in lower limb revascularizationD. Scheinert

El concepto “outpatient” en el tratamiento endovascular de lasextremidades inferiores: Condiciones y cuidadosThe outpatient concept in endovascular treatment of lower limb:Conditions and cautionsJ. Bleyn

Como tratar las reestenosis intra-stent: Las mejores estrategias para unapermeabilidad más prolongadaHow to deal with instent restenosis: The best strategies for a longerpatencyJ. van den Berg

09:08-09:15 h

09:16-09:23 h

09:24-09:31 h

09:32-09:39 h

09:40-09:47 h

09:48-09:55 h

09:08-10:30 hSesión II / Session II:ENDO-REVASCULARIZACIÓN DE EXTREMIDADES INFERIORES (II)LOWER LIMB ENDO-REVASCULARIZATION (II)

Moderador / Moderator: P. PeetersPanelistas / Panelists: M. de Blas, J.R. March

Sistema electrónico de respuesta de la audiencia /Audience response system

Idioma oficial: Inglés y Español (traducción simultánea disponible) / OfficialLanguaje: English & Spanish (Simultaneous translation will be provided)

Mensajes para llevar a casa / Take home messages

09:00-09:05 h

09:05-09:07 h

3586


Vasos artificiales para determinación de las propiedades biofísicas denuevos dispositivos endovascularesBio physical property assessment of new endovascular devices in artificialvesselsM. Balcells

¿Qué es lo próximo en la tecnología de los stents?What is next in stent technology?J. Palmaz

Inhibición de la reestenosis sin compromiso de la reendotelizaciónInhibition of restenosis formation without compromising reendothelializationS. Nikol

Actualización sobre el stent multicapas en el tratamiento de aneurismasperiféricosUpdate on multilayer stents in peripheral aneurysmC. Rabbia

Introducción al análisis computacional para fluidos-sólidos-remodelación ensimulación cardiovascularIntroduction to computational analysis for fluid-solid-growth modeling in car-diovascular simulationsC.A. Figueroa

11:00-11:07 h

11:08-11:15 h

11:16-11:23 h

11:24-11:31 h

11:32-11:39 h

10:12-10:23 h Discusión / DiscussionComienza con / Starts with I. Blanes



Pausa café / Coffee breakDiscusión a pie de póster / Poster viewing and discussion

10:24-10:27 h

10:28-10:30 h

10:30-11:00 h

11:00-12:00 hSesión III / Session III:CIENCIA BÁSICA Y MÁS ALLÁ EN TERAPIA ENDOVASCULARBASIC SCIENCE AND BEYOND ON ENDOVASCULAR THERAPY

Moderador / Moderator: C. LiapisPanelistas / Panelists: J. van den Berg, J. Goicolea

Actualización en angiogénesis terapéutica en isquemia críticaUpdate in therapeutic angiogenesis in critical limb ischemiaS. Nikol

Importancia del tratamiento adyuvante en revascularización endovascularde las extremidades inferioresHow important is the coadjuvant pharmacological therapy in endovascularrevascularization in lower limbE. Puras

09:56-10:03 h

10:04-10:11 h

11:39-11:52 h Discusión / DiscussionComienza con / Starts with M. Miralles



11:52-11:57 h

11:57-12:00 h

TBDTBDTBDTBDTBDTBD


12:00-12:11 h12:12-12:23 h12:24-12:35 h12:36-12:47 h12:48-12:59 h13:00-13:11 h

13:12-13:20 h

SIMULATION WORKSHOP I (See specific program). Sala / Room H2

SESIONES DE CASOS PROBLEMA: C-1, C-2 (ver programa específico)CHALLENGING SESSIONS: C-1, C-2 (see specific program)

11:00-12:30 h

11:30-13:30 h

FORUM ENDOVENOSO: SESIONES EV-1, 2 Y 3 (ver programa específico)ENDOVENOUS FORUM: SESSIONS EV-1, 2 AND 3 (see specific program)

15:00-18:30 h

13:30-15:00 h COMIDAS SIMPOSIO / LUNCH SYMPOSIA

Comida Simposio I / Lunch Symposium I (MEDTRONIC)(Sala / Room Plenaria H3+J)Nuevas alternativas terapéuticas endovasculares: Una visión al futuroNew endovascular alternatives: A look into the future

Comida Simposio II / Lunch Symposium II (EV3)(Sala / Room A)

Comida Simposio III / Lunch Symposium III (ATRIUM, GRIFOLS)(Sala / Room H2)¿A qué retos se enfrentan en la región aórtica, ilíaca y renal?Which challenges do you face in the aortic, iliac and renal region?

Comida Simposio IV / Lunch Symposium IV (SIEMENS)(Sala / Room H1)

12:00-13:30 hSesión IV / Session IV:COMUNICACIONES ORALES (los 6 mejores abstracts)ENDOVENOUS FORUM (top 6 abstracts)(presentaciones de 8’ seguidas de 3’ de discusión) / (8’ talks followed by 3’ discussion)

Moderador / Moderator: E. RosPanelistas / Panelists: A. Mansilha, M. Cairols

15:00-17:00 hSesión V / Session V:NOVEDADES DESDE EL CORAZÓNNEWS FROM THE HEART

Moderador / Moderator: M. SabatéPanelistas / Panelists: J. Mulet, M. Castellá

3587


Evolución de los stents coronarios: De los BMS a los VRTCoronary stent evolution: From BMS to VRTS. Brugaletta

15:00-15:07 h

3588


Actualización en válvulas pulmonares percutáneasUpdate on transcatheter pulmonary valvesJ. Suárez

Actualidad sobre los dispositivos de cierre percutáneo transeptal y más alláUpdate on transeptal closure devices and beyondC. Nienaber

Actualización sobre la reparación percutánea de las fugas periprotésicasvalvularesUpdate on transcatheter perigraft endoleak repairE. García

Actualización sobre el cierre percutáneo del apéndice auricularUpdate on transcatheter atrial appendix closureA. Bethencourt

Nuevas técnicas en cardiopatías estructurales: Clips mitrales y más alláNew developments in structural cardiopathies: Mitral clips and beyondP. Denti

Válvulas autoexpandibles son preferibles para el abordaje percutáneoSelfexpandable valve is preferable for percutaneous approachC. Morís

Recambio valvular transcatéter: Diez años de historiaTen years history of transcatheter aortic valve replacementH. Eltchaninoff

El recambio valvular transapical es más seguro: Una perspectivade cirujanoTransapical aortic valve replacement is safer: A surgeon’s perspectiveA. Van Linden

Controversia: Es hora de extender las indicaciones de la TAVIControversy: It is time to expand indications for TAVI16:12 h Pro H. Eltchaninoff08:08 h Con J.L. Pomer

Discusión / DiscussionStarts with C. Barriuso



15:08-15:15 h

15:16-15:23 h

15:24-15:31 h

15:32-15:39 h

15:40-15:47 h

15:48-15:55 h

15:56-16:03 h

16:04-16:11 h

16:04-16:11 h

16:27-16:52 h

16:52-16:57 h

16:57-17:00 h



17:00-17:30 h

17:00-18:30 h

3589


¿Las conclusiones del estudio ASTRAL es el fin de la angioplastia renal?Do ASTRAL conclusions represent the end of RAS?C. Rabbia

Radiofrecuencia periarterial renal: Indicaciones, técnica y resultadosclínicos inicialesPeriarterial renal radiofrequency: Indications, technique and early clinicalresultsD. Id

Seguimiento con eco Doppler de los procedimientos endovascularesvisceralesSurveillance of visceral endovascular interventions by DuplexR. Gilabert

Los mejores consejos para el éxito clínico en angioplastia y stenting en laisquemia crónica del tronco celíaco y arteria mesentérica superiorThe best recommendations for a clinical success in angioplasty and sten-ting for chronic ischemia of celiac trunk and superior mesenteric arteriesC. Rabbia

Selección de paciente y de materiales en la reparación endovascular delos aneurismas visceralesPatient and device selection for endovascular repair of visceral aneurysmsand dissectionsJ. van den Berg

Angiografía con dióxido de carbono para procedimientos endovascularesabdominales en pacientes con insuficiencia renal crónicaCarbon dioxide angiography for endovascular abdominal procedures inpatients with chronic renal insufficiencyE. Criado

Discusión / DiscussionComienza con / Starts with A. Clará



17:30-17:37 h

17:38-17:45 h

17:46-17:53 h

17:54-18:01 h

18:02-18:09 h

18:10-18:17 h

18:17-18:26 h

18:26-18:29 h

18:29-18:30 h

17:30-18:30 h Sesión VI / Session VI:TEMAS CLAVE EN INTERVENCIONISMO VISCERALKEY POINTS IN VISCERAL INTERVENTIONS

Moderador / Moderator: J. PalmazPanelistas / Panelists: I. Lojo, D. Scheinert

SIMPOSIOS PARALELOSPARALLEL SYMPOSIA

REUNIÓN DE LA SCACVE. MESA REDONDA.Infecciones en Cirugía VascularSCACVE MEETING. PANEL DISCUSSION.Infections on vascular surgery

18:30-19:30 h

11:30-13:30 h

3590

Viernes 6 de Mayo de 2011 / Friday, 6th May 2011

08:00-09:30 hSesión VII / Session VII:TEMAS CLAVES EN TERAPÉUTICA ENDOVASCULAR EN TRONCOSSUPRAÓRTICOS (I)KEY POINTS ON ENDOVASCULAR TREATMENT IN SUPRAORTIC TRUNKS (I)

Moderador / Moderator: H. SillesenPanelistas / Panelists: S. Macdonald, M. Matas

Controversia: La recanalización endovascular debe ser la primeraopción terapéutica en las lexiones proximalesControversy: Endovascular recanalization should be the first optionfor proximal lesions08:00 h Pro C. Rabbia08:08 h Con H. Sillesen

Tratamiento endovascular del síndrome del opérculo torácico:Ventajas y limitacionesEndovascular repair in toracic outlet syndrome: Benefits and limitationsE. Criado

Consejos clave para evitar complicaciones en el tratamiento endovascularde las arterias vertebralesKey recommendations on endovascular techniques for vertebral arterylesionsJ. Macho

Revisión de la evidencia actual sobre CAS para pacientes sintomáticosCurrent evidences review on CAS for symptomatic patientG. Fraedrich

¿Deben los resultados del CREST animar a los defensores de CAS?Should CREST results encourage CAS defenders?F. Criado

La evidencia presente no afecta mi práctica en pacientes sintomáticosCurrent evidence does not affect my practice in symptomatic patientsP.G. Cao

Revisión de los ensayos recientes CAS (ICSS y CREST) y la interpretaciónde los intervencionistasReview recent CAS trials (ICSS and CREST) and give an interventionistsappraisal of themP. Gaines

No hay duda: La endarterectomía es la primera elección para pacientessintomáticos en el momento actualNo doubt: Endarterectomy is the first choice for symptomatic carotidstenosis nowadaysJ. Fernandes e Fernandes

Hoy pienso que si tuviera una estenosis sintomática de carótida preferiría...To my mind today: If i would have a symptomatic carotid stenosisI would prefer...F. Veith

08:00-08:15 h

08:16-08:23 h

08:24-08:31 h

08:32-08:39 h

08:40-08:47 h

08:48-08:55 h

08:56-09:03 h

09:04-09:11 h

09:12-09:19 h

Inscripción / Registration7:30-18:00 h

3591


10:30-11:45 hSesión VIII / Session VIII:TEMAS CLAVES EN TERAPÉUTICA ENDOVASCULAR EN TRONCOSSUPRAÓRTICOS (II)KEY POINTS ON ENDOVASCULAR TREATMENT IN SUPRAORTICTRUNKS (II)

Moderador / Moderator: G. BiasiPanelistas / Panelists: C. Liapis, F. Criado

Los actuales dispositivos de protección embólica no sonsuficientes todavíaCurrent embolic protective device are not yet enoughS. Macdonald

Implicaciones en las lesiones cerebrales: Endarterectomía vs CASThe brain injury implications: Endarterectomy vs CASL. Capoccia

El stenting carotídeo transcervical con flujo reverso reduce losfenómenos embolígenosTranscervical carotid stenting with carotid flow reversal reducesembolic eventsE. Criado

Actualización sobre el estudio ACST-2ACST-2 updateA. Halliday

Controversia: La estenosis asintomática de carótida superior al 70%debería ser tratada...Controversy: Carotid stenosis >70% shoul be treated...

Sólo farmacológicamentePharmacologically onlyA. Halliday

Farmacológicamente más CASPharmacologically plus CASC. Setacci

09:20-09:45 h

09:45-09:55 h

09:55-10:00 h

Discusión / DiscussionComienza con / Starts with C. Liapis



SESIONES DE CASOS PROBLEMA: C-3 (ver programa específico)CHALLENGING SESSIONS: C-3 (see specific program)


SIMULATION WORKSHOP II (See specific program). Sala / Room H2


09:00-10:00 h

10:00-10:30 h

11:00-12:30 h

12:30-13:30 h

10:30-10:37 h

10:38-10:45 h

10:46-10:53 h

10:54-11:01 h

11:02-11:30 h

11:02-11:09 h

11:10-11:17 h

3592


Faramacológicamente más endarterectomíaPharmacologically plus endarterectomyD. Raithel

Dependiendo de las características ultrasónicas de la placaAccording to the plaque ultrasound characteristicsG. Biasi

Desmenuzando el CRESTSpinning of CRESTF. Veith

¿Son las guías clínicas de la ESVS todavía válidas?Are ESVS guidelines on carotid intervention still valid?C. Liapis

Discusión / DiscussionComienza con / Starts with A. Giménez Gaibar



11:18-11:25 h

11:26-11:33 h

11:34-11:41 h

11:42-11:50 h

11:51-11:55 h

11:56-11:58 h

11:59-12:00 h

12:00-12:45 h Sesión IX / Session IX:NOVEDADES DESDE EL CEREBRONEWS FROM THE BRAIN

Moderador / Moderator: M. DoblasPanelistas / Panelists: C. A. Figueroa, L. Sanromán

Análisis computacional de la dinámica de fluidos de los aneurismascerebrales: Aplicaciones diagnósticas y terapéuticasComputational fluid dynamics of cerebral aneurysms: Diagnosticand therapeuticA. Frangi

Concepto de diversión de flujos: Stents en Y y stents divisores de flujoFlow diversion concept: Y stenting and flow divider stentsJ. Macho

Clasificación y cuantificación de aneurismas cerebrales a travésde la imagen computacionalImage-based computational modelling and quantification of cerebralaneurysmsA. Frangi

Nuevas herramientas en el tratamiento de aneurismas intracranealesNew devices in the intracraneal aneurysm treatmentJ. Macho

Discusión / DiscussionComienza con / Starts with J. Blasco



12:00-12:08 h

12:09-12:17 h

12:18-12:26 h

12:27-12:35 h

12:35-12:50 h

12:50-12:55 h

12:55-13:00 h

3593


13:00-13:30 h Sesión X / Session X:CEREMONIA DE HOMEHAJEHOMAGE CEREMONY

Chairmen: X. Montañá, V. RiambauIntroducción / Introduction: F. Criado

Conferencia plenaria: Propiedades del vino para la salud crdiovascularPlenary Lecture: Wine properties for cardiovascular healthJ. Palmaz

13:30-15:00 h COMIDAS SIMPOSIO / LUNCH SYMPOSIA

Comida Simposio V / Lunch Symposium V (GORE)(Sala / Room Plenaria H3+J)Avances en tratamientos endovascularesAdvances in endovascular treatments

Comida Simposio VI / Lunch Symposium VI (GRUPO CARDIVA)(Sala / Room A)Anaconda®: Presente y futuroExperiencia y novedades: La nueva endoprótesis fenestradaAnaconda®: Present and futureExperience and news: The new fenestraded endograft

Comida Simposio VII / Lunch Symposium VII (COOK)(Sala / Room H2)Novedades en Zenith AAA y TAADevelopments in Zenith AAA and TAA

15:00-16:30 h

15:00-15:07 h

15:08-15:15 h

15:16-15:23 h

15:24-15:31 h

Sesión XI / Session XI:TEMAS CLAVES SOBRE EVAR (I)KEY POINTS ON EVAR (I)

Moderador / Moderator: G. CoppiPanelistas / Panelists: A. García de la Torre, M. Makaroun

Qué debemos aprender de los últimos estudios aleatorizados:Lo que sigue para el futuro de la reparación de AAAWhat should we learn from the latest randomized trials: The next for thefuture of AAA repairR. Greenhalgh

¿Deberían ser repetidos los estudios EVAR, DREAM y OVER con la nuevatecnología y experiencia?Should EVAR, DREAM and OVER be re-edited with the new technology andexperience?I. Loftus

EVAR no está justificado para los pequeños aneurismas todavíaEVAR for small aneurysm is not yet justifiedP.G. Cao

EVAR para los AAA rotos: Actualización del estudio IMPROVEEVAR for rAAA: IMPROVE updateJ. Powell

3594


15:32-15:39 h

15:40-15:47 h

15:48-15:55 h

15:56-16:03 h

16:04-16:11 h

16:12-16:19 h

16:19-16:25 h

16:25-16:29 h

16:29-16:30 h

17:00-18:40 h

17:00-17:15 h

Sesión XII / Session XII:TEMAS CLAVE SOBRE EVAR (II)KEY POINTS ON EVAR (II)

Moderador / Moderator: R. GreenhalghPanelistas / Panelists: J. Maeso, M. Ferreira

Controversia: El abordaje totalmente percutáneo para EVAR es la mejortécnicaControversy: Total percutaneous approach for EVAR is the best way17:00 h Pro G. Torsello17:08 h Con J. Brunkwall

No es necesario ningún estudio sobre AAA rotos: La experiencia mundialacumulada ya es suficienteA trial about rAAA is not necessary: World accumulated experienceis enoughF. Veith

EVAR vs cirugía abierta para AAA rotos: Una revisión sistemáticaactualizadaEVAR vs open surgery for rAAA: An update systematic reviewM. van Sambeek

La influencia del estrés de pared en el crecimiento de los AAA y susbiomarcadoresThe influence of wall stress on AAA growth and biomarkersM. van Sambeek

Análisis dinámico de las imágenes y sus implicaciones en el tratamientoEVAR y su seguimientoDynamic imaging analysis and its implications in EVAR treatment andfollow-upF. Moll

Análisis computacional para investigar la estabilidad posicional de lasendoprótesis abdominalesA computational framework for investigating the positional stability ofabdominal endograftsC.A. Figueroa

Actualización sobre realidad virtual y robótica en la planificación ytratamiento de AAAVirtual reality and robotics update in AAA planning and treatmentN. Cheshire

Discusión / DiscussionComienza con / Starts with F. Gómez Palonés



SESIÓN DE PÓSTERES. Los mejores 6 pósteres (ver programa específico)POSTERS SESSIONS. The 6 best posters (see specific program)

Pausa Café / Coffee Break


16:30-17:00 h

16:30-17:00 h

17:00-18:30 h

3595


EVAR en mujeres: El género hace la diferenciaEVAR in women: Gender makes the differenceM. van Sambeek

Mejoras deseables de las endoprótesis para EVARDesired improvements for EVAR devicesM. Makaroun

La importancia de dispositivos de bajo perfil en EVARThe importance of low profile devices in EVART. Resch

Las endoprótesis fenestradas precargadas pueden simplificar elprocedimiento para los AAA yustarrenalesPre-loaded fenestrated devices can simplify the procedure forjustarenal AAAK. Ivancev

La mayoría de los AAA yusta o suprarrenales pueden ser tratados con latécnica de la chimenea: Trucos y consejosThe majority of justa and suprarenal AAA can be treated with chimneytechniques: Tricks and tipsA. Lobato

Utilidad de las endosuturas Aptus en EVARThe usefulness of Aptus endostapling for EVARJ.P. de Vries

¿Cómo tratar las endofugas tipo I en endoprótesis fenestradas?How to deal with type I endoleaks in fenestrated endografts?S. Haulon

Conversión abierta del EVAR: Trucos y consejosOpen conversion after EVAR: Tricks and tipsG. Coppi

Lo más relevante de las guías clínicas para AAA de la ESVSThe highlights from ESVS guidelines for AAA managementF. Moll

Discusión / DiscussionComienza con / Starts with S. Sultan



17:16-17:23 h

17:24-17:31 h

17:32-17:39 h

17:40-17:47 h

17:48-17:55 h

17:56-18:03 h

18:04-18:11 h

18:12-18:19 h

18:20-18:27 h

18:28-18:33 h

18:34-18:36 h

18:37-18:40 h


SIMPOSIOS PARALELOS / PARALELL SYMPOSIA

17:30-18:30 h

18:30-19:30 h

3596

Sábado 7 de Mayo de 2011 / Saturday, 7th May 2011

08:00-10:00 h

08:00-08:07 h

08:08-08:15 h

08:16-08:23 h

08:24-08:31 h

08:32-08:39 h

08:40-08:47 h

08:48-08:55 h

08:56-09:11 h

09:12-09:19 h

Sesión XIII / Session XIII:TEMAS CLAVE SOBRE TEVAR (I) (Presentaciones de 7’)KEY POINTS ON TEVAR (I) (7 min talks)

Moderador / Moderator: P. TaylorPanelistas / Panelists: G. Fraedrich, C. Paré

Todo lo que necesitamos saber de la historia natural de las diseccionestipo B asintomáticas: Implicaciones terapéuticasAll we need to know about the natural history of asymptomatic acutetype B dissection: Therapeutic implicationsS. Trimarchi

Todo lo que debemos saber sobre la historia natural de los PAU y IMH:Implicaciones terapéuticasAll we need to know about the natural history of PAU and IMH:Therapeutic implications A. Evangelista

Ecocardiograma transesofágico: La utilidad real en el diagnóstico y trata-miento de la disección tipo BTransesophageal echo cardiogram: The real usefulness in type B dissec-tion diagnosis and managementM. Azqueta

TC y RMN dinámicos: Para entender mejor los cambios morfológicos yhemodinámicos en la disección tipo BDynamic CT and MRI: To better understand morphologic changes andhemodynamics in type B dissectionF. Moll

Actualización sobre el estudio ADSORBADSORB updateJ. Brunkwall

Tratamiento con endoprótesis de la aorta ascendente: La nueva fronterapara la disección tipo A y más alláAscending aorta endografting: The next frontier for type A Standford dis-section and beyondI. Loftus

Trompa de elefante congelada para la disección tipo I de DeBakey:Dificultades y beneficiosFrozen elephant trunk for DeBakey type I dissection: Challengesand benefitsC.A. Mestres

Controversia: Las disecciones tipo B crónica son una buena indicaciónpara su reparación endovascularControversy: Chronic type B dissections are a good indication for endovas-cular repair08:56 h Pro C. Nienaber09:04 h Con H. Safi

Soluciones endovasculares para la luz falsa residual más allá del extremode la endoprótesisEndovascular solutions for residual false lumen beyond the stentgraft edgeF. Criado

3597


Limitaciones de las endoprótesis actuales para el tratamiento de lasdisecciones tipo B: ¿Cuán lejos de la endoprótesis ideal nos encontramos?Limitations of current endografts for type B dissection treatment: How fararre we from the ideal endografts?G. Melissano

¿Es todavía el tratamiento endovascular la primera elección para lostraumatismos aórticos agudos?Does thoracic endografting still remain the first option for acute trauma?M. Makaroun

Análisis computacional de la dinámica de flujos en el tratamiento y pronós-tico de las disecciones tipo BComputational analysis of flow dynamics in type B dissection managementand prognosisH. Rousseau

Discusión / DiscussionComienza con / Starts with V. Fernández-Valenzuela



Pausa Café / Coffee Break

09:20-09:27 h

09:28-09:35 h

09:36-09:43 h

09:43-09:52 h

09:53-09:58 h

09:58-10:00 h

10:00-10:30 h

10:30-12:00 h

10:30-10:37 h

10:38-10:45 h

10:46-10:53 h

10:54-11:01 h

Sesión XIV / Session XIV:TEMAS CLAVE SOBRE TEVAR (II)KEY POINTS ON TEVAR (II)

Moderador / Moderator: H. SafiPanelistas / Panelists: M. Josa, C. Vaquero

Anatomía y distensibilidad del arco: ¿Juega un papel en el tratamientoendovascular con endoprótesis?Arch anatomy and compliance: Does it play a role in endograftingtreatment?F. Moll

¿Cómo actúan las fuerzas de desplazamiento pulsátiles en lasendoprótesis torácicas?Pulsatile displacement forces acting on thoracic aortic endograftsC.A. Figueroa

Transposición de troncos supraórticos y tratamiento con endoprótesispara los aneurismas que comprometen el arco: Trucosy recomendacionesSupraortic debranching and endografting for aneurysms involving the arch:Tricks and tipsG. Melissano

Técnicas con chimeneas en el arco: Lo más simple y seguroChimney techniques in the arch: The simplest and safestF. Criado

3598


12:00-13:30 h

12:00-12:07 h

12:08-12:15 h

12:16-12:23 h

12:32-12:39 h

Sesión XV / Session XV:TEMAS CLAVE SOBRE TEVAR (III)KEY POINTS ON TEVAR (III)

Moderador / Moderator: F. CriadoPanelistas / Panelists: S. Sultan, G. Melissano

La cirugía abierta es la primera opción para los aneurismas toraco-abdominales: Pero, ¿hay espacio para el tratamiento endovascular?Open surgery is the first option for thoraco-abdominal aneurysm repair:But, is there any place for endovascular repair?H. Safi

Requerimientos para crear un centro de la aorta en EuropaRequirements to become an aortic center in EuropeM. Jacobs

Imagen para la anatomía de la médula espinal: ¿Es útil para la reparaciónde aneurismas toraco-abdominales?Spinal cord anatomy imaging: Is it useful for thoraco-abdominal aneurysmrepair by open or endovascular surgeryP. Matute

Tratamiento de las complicaciones neurológicas del TEVARTreatment of neurological complications in thoracic stentgraftingP. Taylor

Fenestración in situ en el arco aórtico: ¿Por qué no?In situ fenestration in the aortic arch: Why not?M. Malina

Reparación endovascular completa del arco: Las endoprótesis con ramaslo hacen fácilTotal endovascular repair of the arch: Branched endograft makes it easyK. Ivencev

Cómo solucionar los problemas de conformabilidad del arcoHow to solve the apposition problems in the archF. Cochennec

Cómo tratar las complicaciones y desastres del TEVAR: Técnicas ylecciones aprendidasManaging TEVAR complications and disasters: Techniques and lessonslearnP. Taylor

Predictores de morbilidad y mortalidad en el TEVARPredictors of morbidity and mortality on TEVARM. Makaroun

Discusión / DiscussionComienza con / Starts with J. Serrano


Mensajes para llevar a casa / Take home messagesRefrescos y café hasta las 12:30 / Refreshment nad coffee will be availableuntil 12:30

11:02-11:09 h

11:10-11:17 h

11:18-11:25 h

11:26-11:33 h

11:34-11:41 h

11:41-11:53 h

11:53-11:58 h

11:58-12:00 h

3599


Alternativas a la cirugía abierta para los aneurismas tóraco-abdominales:La controversia continúaAlternatives to open surgery for thoraco-abdominal aneurysms: The con-troversy continues

Abordaje combinado: Lo mejor y lo peorHybrid approach: The best and the worstN. Cheshire

Técnicas de chimenea y sandwich: Plan y resultados clínicosChimney and sandwich techniques: Planning and clinical resultsA. Lobato

Endoprótesis con ramas: Resultados clínicos y la nueva plataforma endepósitoBranched endografts: Clinical results and new off the shelf platformS. Haulon

Complicaciones y soluciones en casos complejos de TEVARtoracoabdominalComplications and solutions in complex thoraco-abdominal endograftingM. Ferreira

Discusión / DiscussionComienza con / Starts with G. Espinosa



12:40-13:03 h

12:40-12:47 h

12:48-12:55 h

12:56-13:03 h

13:04-13:11 h

13:12-13:25 h

13:25-13:29 h

13:29-13:30 h

13:30-14:00 h

14:00

Sesión XVI / Session XVI:CEREMONIA DE ENTREGA DE PREMIOSAWARDS CEREMONY

Moderador / Moderator: V. RiambauPanelistas / Panelists: X. Montañá, J.M. Egaña, M. de Blas

Competiton AwardsPremio GRIFOLS a la mejor Comunicación OralGRIFOLS Award to the best Oral Communication

Premio BOSTON SCIENTIFIC al mejor Caso ProblemaBOSTON SCIENTIFIC to the best Challenging Case

Premio AMPLATZER al mejor PósterAMPLATZER Award to the best Poster

CONCLUSIONES Y FIN DEL SIMPOSIOCONCLUSIONS AND ADJOURNMENTV. Riambau

3600

16:19-16:28 h Discusión / DiscussionComienza con / Starts with E. Roche

Ablación venosa con vapor: Técnica y resultadosVenous steam ablation: Technique and resultsR. Milleret

Ablación térmica segmentaria: Influencia de la energía liberada endiámetro de la VSIThermal segmental ablation: Influency of the supplied energy on the GSVdiameterC. García-Madrid

Nueva modalidad de ablación endovenosa: El sistema ClariVeinTM

A new endovenous ablation modality: The ClariVeinTM systemJ.P. de Vries

Escleroterapia con espuma: ¿Cómo evitar riesgos?Foam esclerotherapy: How to avoid risks?F. Fernández

Técnicas de ablación venosa para incompetencia de perforantes:Métodos y resultadosAblation techniques for perforator veins incompetence: Methods andresultsM. Whiteley

La ablación térmica es un método primitivo para el tratamiento del reflujovenoso superficialTermal ablation is a primitive way of managing superficial vein refluxS. Sultan

Evidencia médica en el tratamiento intervencionista de la insuficienciavenosa: Cirugía abierta, láser, radiofrecuencia, espuma, etc.Current evidence in venous insufficiency interventional treatment: Opensurgery, laser, rediofrequency, foam, etc.I. Loftus

Actualización sobre endo-reconstrucción valvular del sistema venosoprofundoUpdate on deep venous valve endo-reconstructionJ.P. de Vries

Síndrome de congestión pélvica: Diagnóstico y tratamiento endovascularPelvic congestion syndrome: Diagnosis and endovascular treatmentJ. Leal Monedero

Flebo-TC en el diagnóstico de insuficiencia venosa complejaFlebo-CT in complex venous insufficiency diagnosis and treatmentJ.F. Uhl

15:00-16:30 h

15:00-15:07 h

15:08-15:15 h

15:16-15:23 h

15:24-15:31 h

15:32-15:39 h

15:40-15:47 h

15:48-15:55 h

15:56-16:03 h

16:04-16:11 h

16:12-16:19 h

Sesión EV-I / Session EV-I:TRATAMIENTO ENDOVASCULAR DE LAS VARICESENDOVASCULAR TREATMENT OF VARICOUS VEINS

Moderador / Moderator: C. García-MadridPanelistas / Panelists: E. Puras, M. Whiteley


Fórum Endovenoso / Endovenous Forum

Mensajes para llevar a casa / Take home messagesPausa Café / Coffee BreakDISCUSIÓN A PIE DE PÓSTER / POSTER VIEWING AND DISCUSSION

16:28-16:30 h

16:30-17:00 h

3601


17:00-17:30 h Sesión EV-2 / Session EV-2:MALFORMACIONES ARTERIOVENOSASARTERIO-VENOUS MALFORMATIONS

Moderador / Moderator: P. ZamboniPanelistas / Panelists: R. Bofill, P. Gaines

Angiografía y RMN en el diagnóstico de las malformaciones vasculares¿Cómo mejorar su rendimiento?MRI and angiography in vascular malformation diagnosis: How yo improvetheir imaging definition?J. van den Berg

Flebo-TC en el diagnóstico de las malformaciones venosas congénitasFlebo-CT in congenital venous malformations diagnosisJ.F. Uhl

Novedades en el tratamiento endovascular de las malformacionesvascularesWhat is new in endovascular treatment of vascular malformations?B.B. Lee

Discusión / DiscussionComienza con / Starts with V. Martín ParederoMensajes para llevar a casa / Take home messages

17:00-17:07 h

17:08-17:15 h

17:16-17:23 h

17:23-17:29 h

17:29-17:30 h

17:30-18:30 h Sesión EV-3 / Session EV-3:MISCELÁNEA ENDOVENOSAENDOVENOUS MISCELLANEA

Moderador / Moderator: G. MestresPanelistas / Panelists: B.B. Lee, F. Lozano

Tratamiento endovascular de la esclerosis múltiple: Justificación y técnicaEndovascular treatment for multiple sclerosis: Rational and techniqueP. Zamboni

Tratamiento endovascular del acceso vascular en riesgo: Indicaciones,técnicas y resultados.Endovascular treatment for vascular access at risk: Indications, techniquesand resultsA. del Río

Cirugía venosa con láser de 1470 nm: Experiencias inicialesEndolaser vein surgery with the 1470 nm laser: Early experiencesC. Miquel

Tratamiento endovascular del síndrome de Budd-ChiariEndovascular treatment for Budd-Chiari syndromeB.B. Lee

Filtros de VCI: Ventajas de los nuevos diseñosInferior vena cava filters: Advantages of the new designsM. de Gregorio

Tratamiento quirúrgico y endovascular del síndrome de Pagett-SchroetterSurgical and endovascular treatment of Pagett-Schoetter syndromeP. Lozano

Discusión / DiscussionComienza con / Starts with J.R. EscuderoMensajes para llevar a casa / Take home messages

17:30-17:37 h

17:31-17:45 h

17:46-17:53 h

17:54-18:01 h

18:02-18:09 h

18:10-18:17 h

18:17-18:28 h

18:28-18:30 h

3602

11:30-12:30 hSesión C-I / Session C-I:CASOS PROBLEMAS EN EXTREMIDADES INFERIORESCHALLENGING CASES IN LOWER LIMBModerador / Moderator: I. Blanes, P. Gaines, F. Vermassen

12:30-13:30 hSesión C-2 / Session C-2:CASOS PROBLEMAS EN TRONCOS SUPRAÓRTICOSCHALLENGING CASES SUPRAORTIC TRUNKS AND CAROTIDSModerador / Moderator: S. Macdonald, J. Macho, G. Viasi

09:00-10:00 hSesión C-3 / Session C-3:CASOS PROBLEMAS EN EVAR Y TEVARCHALLENGING CASES IN EVAR AND TEVARModerador / Moderator: I. Loftus, J.Palmero, G. Espinosa

12:30-13:30 hSesión C-4 / Session C-4:CASOS PROBLEMAS EN INTERVENCIONISMO CARDÍACOCHALLENGING CASES IN CARDIAC INTERVENTIONISMModerador / Moderator: M. Castellà, M. Masotti, E. García

17:30-18:30 hSesión C-5 / Session C-5:CASOS PROBLEMAS MISCELÁNEAMISCELLANEOUS CHALLENGING CASES Moderador / Moderator: M. Malina, M. Maynar, M. Ferreira




Sesiones de Casos Problema / Challenging Case Sessions

TBDTBDTBDTBDTBDTBD

16:30-16:35 h16:35-16:40 h16:40-16:45 h16:45-16:50 h16:50-16:55 h16:55-17:00 h

16:30-17:00 hSESIÓN DE PÓSTERES (presentaciones de 3’ + 2’ de discusión)POSTER SESSION (3 min. presentations + 2 min. discussion)

Moderador / Moderator: J.M. Egaña, S. Sultan, J. Busquet

Sesión de Pósteres / Poster Session

3603

PONENTES / FACULTY

Universidad de Barcelona. Facultad de Medicina, Departament de Cirugia i Especialitats Quirúrgiques• Hospital Universitario Clínic Barcelona • International Society for Vascular Surgery

• Sociedad Iberoamericana de Información Científica • Sociedad C.E.L.A. • Capítulo Español de Flebología• CCE, Sociedad Española de Angiología y Cirugía Vascular • Sociedad Española de Radiología Vascular

Intervencionista • Fundación Teknon • Societat Catalana D’Angiologia i Cirugia Vascular.

AUSPICIADO POR: / ENDORSED BY:

Cook Medical • Medtronic • Boston Scientific • ev3 • Gore • Bolton Medical • Abbot Vascular • Bard• Biotronik • Grupo Cardiva • Cordis • GE Healthcare • Grifols • Jotec • Palex • Terumo

PATROCINADORES / SPONSORS

Azqueta, M. SpainBalcells, M. USABarriuso, C. SpainBethencourt, A. SpainBiasi, G. ItalyBlanes, I. SpainBlasco, J. SpainBleyn, J. BelgiumBofill, R. SpainBrugaletta, S. The NetherlandsBrunkwall, J. The NetherlandsBusquet, J. FranceCairols, M. SpainCao, P.G. ItalyCapoccia, L. ItalyCastellá, M. SpainCheshire, N. UKClará, A. SpainCochennec, F. FranceCoppi, G. ItalyCriado, E. USACriado, F. USADe Blas, M. SpainDe Gregorio, M. SpainDe Vries, J.P. The NetherlandsDel Río, A. SpainDenti, P. ItalyDoblas, M. SpainEgaña, J.M. SpainEltchaninoff, H. FranceEscudero, J.R. SpainEspinosa, J. SpainEvangelista, A. SpainFernandes, J. PortugalFernández, F. SpainFernández-Valenzuela, V. SpainFerreira, M. BrazilFigueroa, A. USAFraedrich, G. AustriaFrangi, A. SpainGaines, P. UK

García, C. SpainGarcía, E. SpainGarcía de la Torre, A. SpainGilabert, R. SpainGiménez Gaibar, A. SpainGoicolea, J. SpainGómez, F. SpainGreenhalgh, R. UKHalliday, A. UKHaulon, S. FranceId, D. GermanyIvancev, K. UKJacobs, M. The NetherlandsJosa, M. SpainLeal Monedero, J. SpainLee, B.B. USALiapis, C. GreeceLobato, A. BrazilLoftus, I. UKLojo, C. SpainLozano, P. SpainLozano, F. SpainMacho, J.M. SpainMacdonald, S. UKMaeso, J. SpainMakaroun, M. USAMalina, M. SwedenMansilha, A. PortugalManzi, M. ItalyMarch, J.R. SpainMartín Paredero, V. SpainMasotti, M. SpainMatas, M. SpainMatute, P. SpainMaynar, M. SpainMelissano, G. ItalyMestres, C.A. SpainMestres, G. SpainMillaret, R. FranceMiquel, C. SpainMiralles, M. Spain

Moll, F. The NetherlandsMontañá, X. SpainMorís, C. SpainMulet, J. SpainNienaber, C. The NetherlandsNikol, S. The NetherlandsPalmaz, J. USAPalmero, J. SpainParé, C. SpainPeeters, P. BelgiumPomar, J.L. SpainPowell, J. UKPuras, E. SpainRabbia, C. ItalyRaithel, D. GermanyResch, T. SwidenRiambau, V. SpainRoche, E. SpainRos, E. SpainRousseau, H. FranceSabaté, M. SpainSafi, H. USASan Román, L. SpainScheinert, D. GermanySerrano, J. SpainSetacci, C. ItalySillesen, H. DenmarkSuárez, J. SpainSultan, S. IrelandTaylor, P. UKTorsello, G. GermanyTrimarchi, S. ItalyUhl, J.P. Francevan den Berg, J. SwitzerlandVan Linden, A. GermanyVan Sambeek, M. The NetherlandsVaquero, C. SpainVeith, F. USAVermassen, F. BelgiumWhiteley, M.S. UKZamboni, P. Italy

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Critical limb ischemia (CLI) is a clinical conditionresulting from insufficient blood flow to the lowerlimb. Either rest pain and/or non-healingwounds/gangrene accompanies CLI. Anotherdefinition of CLI is when the systolic ankle pres-sure index is below 50 mmHg or below the toepressure is below 30 mmHg.

Traditionally, open surgery has been the option ofchoice for these patients since they most oftenwill present with long occlusions or multiplestenoses located somewhere between theinfrarenal aorta to the ankle. Treatment of arterialobstruction proximal to inguinal ligament is todaydominated by endovascular techniques and resultsare in most cases very good. Only in cases withsevere bilateral disease or unilateral occlusionfrom the aorta to the femoral artery may the pri-mary treatment choice be open surgery.

In case of good inflow to the femoral artery, butwith severe obstructive disease peripheral to thegroin, bypass surgery, especially using autologousvein, has been shown to be a good treatmentoption in patients with CLI. When no vein isavailable an artificial graft may be used. Again, incase of good inflow there will either a long occlu-sion of the femoral/popliteal artery or multiplestenoses/occlusions in order to cause CLI. Onlyone randomized controlled trial has testedwhether an open surgical or endovascular firstapproach benefits patients best with respect tosurvival without amputation – the BASIL trial. Inthis trial, patients with CLI, who was consideredtreatable with either open or endovascular surgerywere randomized to either of the 2 techniques asthe initial approach. The primary end-point wasneutral at 2 years, however, patients living morethan 2 years and those having bypass using autol-ogous vein did better than those who underwent

endovascular treatment.

The BASIL trial randomized patients almost 10years ago and especially endovascular techniqueshave improved during this time period. Neverballoons and stents have been marketed meanwhile.

For years, endovascular approaches have beentried as an alternative to classical open surgery;subintimal angioplasty in the superficial femoralartery being the first alternative to be introducedby Bolia et al (ref). This technique was reportedto have great immediate success rates and verygood efficacy in terms of preventing amputation(ref). However, the enthusiastic results reportedinitially could not be reproduced by other groups(ref). Endoluminal revascularization has beenfavored by the majority.

The result of endoluminal treatments for obstruc-tive disease has improved dramatically over thelast decades. High success rates are reported andmany uncontrolled series show good patency andlimb salvage rates. However, very often there isno control group simply because those suited forsurgery were operated and vice versa. Nonethe-less, in some regions there has been a shifttowards an endovascular treatment first approach.However, as in many other situations, the lack ofstrict evidence addressing the issue in question isnot the same of the current practice is the best.

References:

BASIL Trial Participants: Bypass versus angioplasty in severeischaemia of the leg (BASIL): multicentre, randomised con-trolled trial. Lancet 2005:166:1925-34

Norgren L, Hiatt WR, Dormandy JA, et al. TASC II: inter-society consensus for the management of peripheral arterialdisease (TASC II). Eur J Vasc Endovasc Surg 2007;33:S1

Sillesen, H.

Chairman, Dept. of Vascular Surgery. Rigshospitalet, University of Copenhagen, Denmark.

Endovascular revascularizationshould be first option for criticallimb ischemia

C O M U N I C A C I O N E S S I T E 2 0 1 1

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Las oclusiones del sector iliaco han sido ori-ginalmente tratadas mediante cirugía abiertay aptando en algunos, según criterio, me-diante bypass aorto-bifemoral.

Desde la aparición de la cirugía endovascu-lar y la evolución de los materiales usadospara estas técnicas, el método terapéuticoha ido cambiando hasta permitir que pa-cientes con un síndrome de Leriche puedanser recanalizados, con restauración del flujo,por métodos endovasculares con la posibili-dad de usar un implante bifurcado por me-dio de la cirugía endovascular.

Las primeras indicaciones de revasculariza-ción iliaca se hicieron mediante paso deguía y posterior dilatación, lo que llevaba a:

• Una oclusión temprana, dependiendo dela longitud de la iliaca,

• Embolia distal, debido a trombo dentrode la oclusión

• Rotura, sin disponer en aquella época, destents cubiertos.

Posteriormente la evolución nos llevó a larecanalización y colocación de stent prima-rio, con lo que se evitó los embolismos dis-tales.

Otra técnica, usada en esta evolución, ha si-do la fibrinólisis “in situ” para conseguir re-solver la oclusión desde el punto de vistatrombótico y delimitar el segmento a tratarlo que en un pequeño porcentaje de casosevita la colocación de stent. (ver. figuras).

En los casos de iliacas primitivas bilateral-

mente ocluidas, se comenzó el tratamientopor medio de stents descubiertos mediantela técnica “Kissing stenting”, que dejaba laparte proximal dentro de la aorta y la distalen las respectivas iliacas. No obstante exis-ten dos problemas para esta técnica:

• Competitividad de flujos, que puede lle-varnos a una reoclusión y que en el caso deusar stent cubiertos sería más útil el usar uncubierto y un descubierto.

• Muchos de estos pacientes son ateroma-tosos, no solo con lesiones del sector iliaco,sino de aorta distal por lo que la colocaciónsimplemente de stents en la bifurcación ilia-ca no solucionaría el problema a largo tiem-po.

Por ello si bien tradicionalmente estos pa-cientes han sido operados mediante un bi-furcado antes mencionado, en la actualidady mediante cirugía endovascular podemoshacer la corrección completa de aorta y bi-furcación iliaca, mediante una prótesis bi-furcada que en general precisará de materialque tenga flexibilidad y conformabilidad.

Material

Se precisa todo tipo de material endovascu-lar para resolver el problema de la oclusióniliaca.

• Aguja de punción e introductores.

• Guías con gran capacidad distal floppy, ti-po Bentson.

• Guías con capacidad de ser manipuladas yconducidas a través de oclusión (con torque).

Maynar, M.; Zander, T.; Gonzáles, G.; de ALba, L.; Rivero, O.

Universidad de las Palmas de Gran Canaria. Grupo HOSPITEN. Islas Canarias, España.

Cómo recanalizar las lesionesTASC D del sector ilíaco: material,métodos y trucos

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• Guías stiff para dar más soporte al avancede las prótesis a través de la lesión.

• Catéteres con agujeros laterales, que per-mitan la introducción de contraste sin extra-er la guía, para comprobar el lugar de revas-cularización.

• Catéteres con diferentes morfologías co-mo: multipropósito, jota o Simmons entreotros.

• Balones de angioplastia con diferentesdiámetros y longitudes.

• Sistemas de perfusión para lisis “in situ”.

• Stent descubiertos.

• Stent cubiertos para aquellos casos en losque aparezca una fuga.

• Endoprótesis bifurcada con característicasantes mencionadas.

• Un recuperador de cuerpos extraños.

M. Maynar ey al.- Cómo recanalizar las lesiones TASC D del sector ilíaco:material, métodos y trucos

Técnicas Endovasculares Vol.XIV. Núm. 1. Enero-Abril 2011; 3605-3608

Fig. 1. Se observa síndrome de Leriche con oclusiónde la aorta abdominal por debajo de la salida de la

arteria mesentérica inferior.

Fig. 2. Recanalización a nivel de bifurcación a. ilíaca dere-cha (interna/externa) y a nivel de la a. femoral común izq.La ilíaca interna izquierda se rellena a través de colaterales.

Fig. 3. Se observa completa permeabilidad del ejeaorto-ilíaco mediante tratamiento de fibrinólisis “in situ”

(urokinasa) y angioplastia.

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• Un sistema percutáneo de cierre, si no seha realizado disección arterial.

• Medicación adecuada pre, durante y posttratamiento: Antibioterapia, heparina, antia-gregación.

• Monitorización.

Métodos

En caso de no considerarse la introducciónde una prótesis bifurcada, se puede realizartodo el estudio de forma percutánea si biennuevos diseños permitirán hacerlo.

Las arterias iliacas pueden ser revasculariza-das de forma retrograda anterograda.

Con suficiente longitud permeable en el lu-gar de punción, se puede optar por punciónipsilateral y retrograda. En caso de no con-seguir conectar con la luz verdadera se pue-de recanalizar la obstrucción de forma ante-rograda a través de una punción contralate-ral y usando un catéter tipo “J”. En caso deconectar con la femoral común ipsilateral ala lesión se realiza una técnica de “throughand through” para la posteriordilatación/colocación de stent de la lesión.

En caso de ser oclusión bilateral, se puedetambién recanalizar por vía braquial usandocatéteres guías que facilitarán el posiciona-miento en el lugar de entrada de la obstruc-ción y darán soporte a las maniobras de re-canalización. Una vez pasada las obstruccio-nes se valorar: fibrinólisis, angioplastia, stentprimario, endoprótesis bifurcada o combi-nación.

En caso de la colocación de una endopróte-sis bifurcada, se realiza una arteriotomía unio bilateral. El cuerpo de la prótesis se avan-za a través de la arteriotomía mientras quela pata contralateral se puede colocar a tra-vés de una punción percutáneo o de una ar-teriotomía según las consideraciones deloperador. En casos aislados el diámetro delas arterias iliacas externas no permiten elavanza de una endoprótesis a pesar de unadilatación progresiva. En estos casos puedeser necesario un acceso iliaco retroperitone-al. La recanalización del orificio de la pata

contralateral puede ser de forma anterogra-da a través de un acceso braquial o desde laarteriotomía contralateral ya que general-mente se observa un colapso del orificio de-bido al calibre de la aorta.

Trucos

Ante toda recanalización TASC D, se preci-sa experiencia. El principal truco de estatécnica es creer y conocer que una prótesisbifurcada por técnica endovascular se puedeusar en aortas con síndrome de Leriche ysin lesión aneurismática.

En los casos de obstrucciones completas ysin obtener un pulso femoral palpable, un“road mapping” contralateral o a través delbrazo nos ayudará a la punción de la a. fe-moral común.

Debemos reconocer como se ha conseguidola revascularización: Luz principal o subinti-mal.

Es de máxima importancia conocer cuandose puede perforar la arteria, ya que estamosen un territorio retro-peritoneal, sin protec-ción a la fuga, y con la necesidad de serdiagnosticada inmediatamente para serocluida y evitar complicaciones que nospuedan llevar al fallecimiento del paciente.Para ello tendremos controlado la aproxi-mación a la lesión, tanto desde la aorta, co-mo desde la femoral común.

A través de un “through and through” fe-moro-femoral se puede dilatar la lesión des-de el acceso contralateral a la lesión. De estaforma – en caso de rotura del vaso – se dejael balón inflado (clampaje interno) mientrasa través del acceso femoral ipsilateral se in-troduce una prótesis cubierta.

Usaremos, en el comienzo, balones de pe-queño calibre (3-4 mm) para en caso de fu-ga, esta sea mínima, teniendo siempre pre-parado un stent cubierto, cuando las sospe-chas de posible rotura sean importantes, asaber: cronicidad de la lesión, calcificaciónsevera, múltiples colaterales y un dolor des-proporcionado cuando se usan los balonesde bajo calibre. En estos casos un stent cu-bierto primario puede ser una alternativa.



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Abstract

Neointimal hyperplasia is the most decisivefactor on results post-stenting in SFA.Stents themselves contribute to intimalhyperplasia in ways which are becomingmore predictable and potentially remediablein the near future. The applications of adrug coating on a stent surface, inhibits theinflammatory response and smooth musclecell proliferation in the vessel wall during acertain period and delays the process of inti-mal hyperplasia. Thus, drug-eluting stent(DES) technology was developed to pre-vent early thrombosis and late luminal lossto potentially improve long-term patencyrates. Because DES with active stent coat-ings have shown to be beneficial in thetreatment of coronary artery disease[1-3],

the applicability of these drug coatings forthe treatment of femoro-popliteal (FP)lesions has also been tested.

Favorable DES results have recentlybecome available with the Zilver® PTX™and STRIDES studies. But next to the clin-ical value of DES, also the cost for societyand health care systems have to be consid-ered. In this respect, a hypothetical cost cal-culation based on the data that is currentlyavailable learns us that DES, despite the factthat it works in the SFA, is not cost-effec-tive for implantation in de novo SFAlesions. Particularly in times of economicrecession, and already steeply rising health-care costs, ethical considerations have to bemade when implementing a high-cost treat-ment modality that does not improve the

La dilatación debe ser progresiva para evitarla rotura empezando con balones de bajocalibre hasta un diámetro que se considereadecuado.

En caso de oclusiones agudas con alto ries-go de pérdida de la extremidad por embo-lia, el stent primario recuperando el flujo ysin remover el trombo, puede darnos unasolución inmediata.

En los pacientes con la bifurcación iliacamuy cerrada y con gran cantidad de calcio,cuando usemos la ruta contralateral, nospodemos beneficiar de los introductores nocolapsables y que crean un tracto continuoy sin rozamiento al paso de los materiales.

BIBLIOGRAFÍA

Maynar M, Zander T, Qian Z, Rostagno R, Llorens R, ZeroloI, et al. Bifurcated endoprosthesis for treatment of aortoiliacocclusive lesions. J Endovasc Ther 2005;12(1):22-7.

Wholey MH, Maynar MA, Wholey MH, Pulido-Duque JM,Reyes R, Jarmolowski CR, et al. Comparison of thrombolytictherapy of lower-extremity acute, subacute, and chronic arte-rial occlusions. Cathet Cardiovasc Diagn 1998;44(2):159-69.

Reyes R, Maynar M, Lopera J, Ferral H, Górriz E, CarreiraJM, Castañeda-Zúñiga W. Treatment of chronic iliac artery oc-clusions with guide wire recanalization and primary stentplacement. J Vasc Interv Radiol. 1997 Nov-Dec;8(6):1049-55.

Peeters, P.

Department of Cardiovascular & Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium

Are drug eluting stents in theSFA better?

1.-

2.-

3.-



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clinical results after 1 year. It is our opinionthat DES will not be the treatment ofchoice in de novo SFA lesions, due to thecomparable results in TASC A&B lesionswith non-DES stent and in TASC C&Dlesions with bypass surgery.

However, DES might play an importantrole for treatment of in-stent restenosis and

in high-risk surgical patients, such as elderlypeople and diabetics, who present withTASC C or D FP lesions. It is clear that thisspecific patient subset will benefit from aminimally invasive approach that can offersatisfying results. In this respect, a random-ized trial in this patient subgroup is war-ranted comparing DES implantation versusother endovascular treatment modalities.

The problem of elastic recoil, flow-limitingdissection and residual stenosis in the treat-ment of superficial femoral artery diseasehas been resolved with stentin g, and byusing stents the primary technical result canbe optimized (this is especially of impor-tance in treating patients with critical limbischaemia).

However, restenosis is still major drawbackin all territories (especially SFA and BTK).PTA as stand-alone therapy will not workdue to the sponge-like behaviour of neo-intimal hyperplasia, leading to early recoil.Given the increasing number of stentsbeing used in the SFA/popliteal and to alesser extent BTK the problem of patientspresenting with in-stent restenosis willincrease in the future. Since an endovascularcommitment to patient has been made, andthe patient in general will be older and lessamenable to surgery when presenting withrestenosis, endovascular therapy should beconsidered as first line therapy.

Treatment options:• Stand-alone PTA• Debulking

• Rotational/orbital atherectomy• Directional atherectomy• Laser debulking• Debulking in combination with• DEB• Covered stents• Brachytherapy• Drug-eluting stents

In-stent restenosis should probably betreated at an early stage (even when patientis asymptomatic (cf. surveillance of surgicalbypass). Treatment of in-stent restenosis isalso less complex as compared to treatmentof a totally occluded stent.

Debulking is essential in treatment of in-stent restenosis. Currently only laser-debulking has been approved for treatmentof in-stent restenosis, although rotationaland directional atherectomy has beenapplied to treat in-stent restenosis as well.

Problem with these techniques is that stentintegrity can be hampered. Treatment of in-stent restenosis with laser debulking is feasi-ble and safe, but long-term results have tobe awaited.

Van den Berg, J.

How to deal with in-stent restenosis:the best strategies for a longer patency

P. Peeters.- Are drug eluting stents in the SFA better?Técnicas Endovasculares Vol.XIV. Núm. 1. Enero-Abril 2011; 3608-3609

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Results of the TAMARIS angiogenesisgene therapy trial

For angiogenesis gene therapy, mixedresults in phase I/II trials werde followedby a negative result in a very large phase IIItrial (TAMARIS).

The results of the Phase III TAMARIS trialevaluating the investigational angiogenictherapy NV1FGF (riferminogen pecaplas-mid) were presented at the American HeartAssociation scientific sessions November2010. The results of the phase III studydid not confirm the phase II study findingsand highlighted the complexity of thedevelopment of innovative biological com-pounds like NV1FGF in a challenging dis-ease such as critical limb ischemia. Despiterecent advances in surgical and vasculartechniques, a large number of patients suf-fering from this disease are not eligible forrevascularization procedures and face ampu-tation as their ultimate treatment option.

526 patients from 30 countries with CLIand skin lesions, unsuitable for standardrevascularization, were included in theTAMARIS trial. Disease characteristics aresimilar by geographic region. In addition,when patients reach the end stage disease,there does not seem to be a differencebetween patients with diabetes or without,with regards to the vascular disease.

The mechanism of action for NV1FGF wasproven in a phase I clinical trial whereNV1FGF was administered intramuscular(IM) which lead to local expression ofFGF1 in muscle cells of CLI patients whichpromotes local angiogenesis by stimulatingcell migration and cell growth and appearsto induce the formation of new blood vessel

networks (PM105 study, reference Baum-gartner, 2009). The TAMARIS trialhypothesis was that, local expression of theangiogenic growth factor FGF1 will trans-late into a meaningful clinical benefit, suchas prevention of amputation in CLIpatients. This hypothesis was based on apositive phase II finding (-63% reduction ofmajor amputation on the secondary end-point of TALISMAN study).

There was no difference in baseline demo-graphics between groups in the study (ran-domization was stratified by country anddiabetes status). Endpoints were appropri-ate, especially, amputation free survival is a“hard endpoint”, clinically meaningful inthis disease. An independent adjudicationcommittee adjudicated amputations andconfirmed that all major amputations in thetrial were justified showing the robustnessof the investigators judgment TAMARISwas well powered.

TAMARIS results did not confirm the pre-liminary efficacy findings that were observedin the phase II findings. These results con-firm the importance of conducting largephase III studies with innovative biologicalcompounds like NV1FGF, particularly in acomplex disease like critical limb ischemiawhere, despite recent advances in surgicaland vascular techniques, a large number ofpatients are not eligible for revascularizationprocedures and face amputation as theirultimate treatment option. The event rates (of major amputations anddeaths) within the trial were as expected inthe sample size assumptions, confirmingthat the trial was powered appropriately.

This demonstrates that large placebo-con-trolled randomized trials are a prerequesite

Nikol, S.

Update in therapeutic angiogenesisin critical limb ischemia

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to exclude statistical errors before a noveltherapy can be established and widely dis-tributed.

Overview of actual stem cell trials forperipheral artery disease

Stem cell therapy still has to prove any ben-efit in the treatment of peripheral arterialdisease. Until today published clinical trials

were too small, had too short follow-upperiods, in some cases unsuitable endpoints,were mostly uncontrolled and if they werecontrolled, then they were either not ran-domized or not blinded. The large numberof published pilot trials may suggest benefi-cial effects, yet, we are still far from anestablished new therapy. Most of these trialspublished to date are level 4 trials, few arelevel 1b or level 2 trials.

A lo largo de los últimos años hemos asisti-do a un progresivo cambio en la sistemáticade tratamiento de los pacientes con isque-mia de miembros inferiores (MMII), haciaterapias basadas en abordajes y dispositivosendovasculares. Lamentablemente los pro-gresos en estas terapias no se ha visto acom-pañado de estudios científicos prospectivosrelacionados con la aplicación y evaluaciónde las mejores terapias médicas (antitrom-bóticas, anticoagulantes o antiproliferativas)y por ello, hemos ido tomando los resulta-dos de la experiencia en Cardiología inter-vencionista, aplicando según arte muchasveces personal, estas terapias a los pacientestratados por isquemia de MMII. No existenconsensos universalmente aceptados para elmanejo de pacientes sometidos a tratamien-to de lesiones TASK A-D en los sectores ilí-aco femoral o popliteo distal. Por ello lasnecesidades actuales relacionadas con estas

terapias médicas obligan a responder dos ti-pos de preguntas:

A) Cuáles son las mejores terapias coad-yuvantes para mejorar el resultado delprocedimiento de revascularización?:

1. Tipo de terapia y dosis de fármacos antia-gregantes con los que un paciente debe sermanejado antes, durante y después de unprocedimiento de revascularización deMMII.

¿Cuánto tiempo debemos mantener estasterapias?

A pesar de la evidencia convincente que in-dica que el tratamiento antiagregante pla-quetario reduce la incidencia de episodiosvasculares en los pacientes con isquemia deMMII, es frecuente que exista un trata-

Puras, E

Importancia del tratamientoadyuvante en la revascularizaciónendovascular de las extremidadesinferiores

S. Nikol.- Update in therapeutic angiogenesis in critical limb ischemiaTécnicas Endovasculares Vol.XIV. Núm. 1. Enero-Abril 2011; 36010-3611

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E. Puras.-Importancia del tratamiento adyuvante en la revascularizaciónendovascular de las extremidades inferiores


miento insuficiente en los pacientes que su-fren este trastorno. Así, en el programaPARTNERS1, tan sólo un 54% de los pa-cientes con arteriopatía de MMII con enfer-medad conocida y un 33% de los que teníanarteriopatía de MMII de nuevo diagnósticorecibían un tratamiento antiagregante pla-quetario, en comparación con el 71% de lospacientes con accidentes cerebrovasculares.

En España los datos de un registro de pa-cientes atendidos en consulta de cirugía vas-cular demuestran que de los 928 pacientesincluidos inicialmente en el estudio y conantigüedad media de diagnóstico de la clau-dicación de 3,5 años, sólo el 43,8% recibíanantiagregantes plaquetarios, existiendo unporcentaje importante de pacientes que, apesar de haber sido diagnosticados, no setrataban correctamente2.

Muchas instituciones han adoptado el usode tienopiridinas (clopidogrel) en procesosde revascularización de MMII con coloca-ción de stents o endoprótesis.

El estudio CAPRIE3, demostró que el clo-pidogrel, tenía un efecto más beneficioso enlos 6452 pacientes incluidos con isquemiade MMII, con una disminución del riesgorelativo de estos eventos, del 23,8% (CI8,9-36,2; p= 0,0028) frente a la aspirina.

Los efectos beneficiosos de clopidogrel fue-ron especialmente evidentes en el subgrupode pacientes con isquemia de MMII y dia-betes Estos datos han guiado la recomenda-ción sobre el uso del clopidogrel en pacien-tes isquemia de MMII en las guías de laACC/AHA4 y de la ADA (AmericanDiabetes Association)5.

En la actualidad la terapia dual con aspirinay clopidogrel está aceptada como elStandard en el tratamiento6, tanto de la an-gioplastia carotídea con stent como en laangioplastia y stenting de arterias periféri-cas, si bien estos tratamientos no poseen es-tudios clínicos en los que basarse y sólo seaceptan como la extrapolación de los resul-tados en estudios coronarios como el CU-RE y el CREDO.

La duración óptima de esta terapia poststenting no está clara. Parece que al menos1 mes es recomendable, aunque la prácticaactual tiende a prolongar este tiempo enfunción del tipo de paciente y material utili-zado. A pesar de los efectos beneficiososasociados al tratamiento con clopidogrel enestos contextos de alto riesgo, las experien-cias clínicas y de laboratorio han permitidoidentificar algunas de sus limitaciones, lamás relevante de las cuales es la amplia va-riabilidad existente en la respuesta inhibito-ria plaquetaria. En esta variabilidad de larespuesta al clopidogrel se han involucradodiferentes factores clínicos, genéticos y celu-lares. En el momento actual no existe unconsenso aceptado sobre como manejar estasituación de “resistencia” al clopidogrel.Una opción válida puede ser la de incre-mentar las dosis tanto de carga inicial comode mantenimiento.

Diversos autores como Muller y cols.7, handemostrado que, una dosis de carga de600mg de clopidogrel, con una dosis demantenimiento de 150 mg. en combinacióncon aspirina resultó en una inhibición pla-quetaria mucho mayor que la dosis habi-tual de 300mg de carga y 75 mg. de mante-nimiento (p=0,01).

También nuevos inhibidores del los recep-tores de ADP, tales como el prasugrel, handemostrado tener menor variabilidad y sermás potente inhibidor plaquetario que clo-pidogrel, aunque con un claro incrementoen el riesgo de sangrado8. En estos momen-tos otros antagonistas de receptores deADP, tales como el ticagrelor o el cangrelorestán en fase de investigación clínica en pa-cientes sometidos a intervencionismo coro-nario, con el objeto de lograr una acciónantiplaquetaria mayor y más consistente9.

2. Dosis de Heparina que debe ser adminis-trada en el manejo endovascular de sectoresiliaco-femorales o popliteo- distal. Nivel deanticoagulación óptimo y control intrapro-cedimiento.

La medicación anticoagulante debe ser sus-pendida previamente a la realización de pro-

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cedimientos donde se desee una hemostasianormal. La vida media de la heparina nofraccionada permite volver a una situaciónde hemostasia normalizada después de cor-tos periodos de suspensión (2-3 horas des-pués de suspender una infusión continua).

Diferente es la situación con la Heparina debajo peso molecular (HBPM), que requiere12h de suspensión previa en dosis profilácti-cas y al menos 24h de suspensión si las dosiseran terapéuticas.

No existe una recomendación firme acercade la dosis a utilizar de heparina en los pro-cedimientos endovasculares. Las interven-ciones de alto riesgo (sector infrapoplíteo)pueden beneficiarse de administrar dosis de75 a 100 U/Kg, mientras que situacionesmenos complejas como una angioplastiailiaca sólo requieren dosis entre 25-50U/Kg.

Las HBPM aunque presentan perfiles de se-guridad y eficacia altos no han conseguidointroducirse en esta indicación terapéuticapor carecer de un método sencillo de con-trol de anticoagulación.

3.Conocimiento de nuevas medicacionesanticoagulantes, ¿mejoran el perfil de ries-go/beneficio de la heparina?

Al contrario que la inhibición indirecta de latrombina generada por la heparina los inhi-bidores directos son más específicos contrala trombina soluble o la ligada a trombo.

La bivaliridina, ha sido más extensamenteestudiada en procedimientos cardiológicosmostrando en muchos estudios una reduc-ción muy significativa del los end points demuerte, infarto o hemorragia mayor.

El estudio Approve10, demostró un alto ni-vel de eficacia y seguridad para la bivalirudi-na cuando se aplico como único anticoagu-lante en el tratamiento endovascular de pa-cientes con isquemia de MMII.

Su aplicación en práctica clínica no ha teni-do mucho éxito a pesar de este buen perfil

muy probablemente ligado a su elevadocoste económico.

Otras sustancias como el argatroban o la le-piridina carecen de estudios en revasculari-zación periférica.

4. Terapia antilipemiante con la que un pa-ciente debe ser dado de alta. ¿ Son precisasen todos los casos?

La hipercolesterolemia es un factor de ries-go modificable que a menudo no es tenidosuficientemente en cuenta en los procesosde revascularización endovascular de MMII.Las estatinas no sólo disminuyen el coleste-rol sino que también poseen un efecto an-tinflamatorio, antiproliferarivo, antitrombo-génico y mejoran la función endotelial. Portodo ello su prescripción es esencial en todoestos procesos de revascularizacion .

B ¿ Qué otras medicaciones son necesa-rias para disminuir el riesgo de eventoscardiovasculares futuros en pacientes tra-tados de isquemia de MMII?.

Los estudios epidemiológicos sobre los en-fermos con Enfermedad Arterial Oclusivade MMII, demuestran que en general, elpronóstico de la enfermedad con respecto ala extremidad es relativamente benigno, yaque sólo el 5% de los pacientes necesitaránintervenirse y sólo entre el 1 y 2% llegarán aprecisar una amputación mayor. Sin embar-go, el pronóstico vital de estos enfermos essignificativamente peor, con una mortalidada 5 años entre 2 y 3 veces superior a la deindividuos de la misma edad en la poblacióngeneral; las principales causas de muerte enla EAO son la isquemia miocárdica (50%) yel ictus cerebral (15%)11, 12, 13.

Existen diferentes tratamientos farmacológi-cos utilizados en pacientes con isquemia deMMII. El objetivo primario del tratamientoes doble: prevenir los episodios cardiovascu-lares futuros y adoptar medidas de preven-ción secundaria máxima mediante trata-miento antiagregante, deshabituación tabá-quica y tratamiento de la hipertensión, lahiperlipidemias y la diabetes mellitus13.



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BIBLIOGRAFÍA

Hirsch AT, Criqui MH, Treat-Jacobson D, et al..Peripheral ar-terial disease detection, awareness, and treatment in primarycare. JAMA. 2001 Sep 19;286(11):1317-24.Cancer S. Luján S., Puras E., et al. Arteriopatía periférica,tratamiento y cumplimiento (ARTYC) Angiología2003;55:217-227.The CAPRIE Steering Committee. A randomised, blinded, trialof clopidogrel versus aspirin in patients at risk of ischaemicevents. Lancet 1996; 348: 1329-39.Hirsch AT, Haskal ZJ, Hertzer NR, et al ACC/AHA Guidelinesfor the Management of Patients with Peripheral ArterialDisease (lower extremity, renal, mesenteric, and abdominalaortic): a collaborative report from the American Associationsfor Vascular Surgery/Society for Vascular Surgery, Society forCardiovascular Angiography and Interventions, Society forVascular Medicine and Biology, Society of InterventionalRadiology, and the ACC/AHA Task Force on PracticeGuidelines (writing committee to develop guidelines for themanagement of patients with peripheral arterial disease)—sum-mary of recommendations.American Association for VascularSurgery/Society for Vascular Surgery; Society forCardiovascular Angiography and Interventions; Society forVascular Medicine and Biology; Society of InterventionalRadiology; ACC/AHA Task Force on Practice Guidelines.JVasc Interv Radiol. 2006 Sep;17(9):1383-97

American Diabetes Association.Peripheral arterial disease inpeople with diabetes. Diabetes Care. 2003 Dec;26(12):3333-41.Chaturvedi S, Yadav JS. The role of antiplatelet therapy incarotid stenting for ischemic stroke prevention. Stroke. 2006Jun;37(6):1572-7.Müller I, Seyfarth M, Rüdiger S, et al. .Effect of a high load-ing dose of clopidogrel on platelet function in patients under-going coronary stent placement.Heart. 2001 Jan;85(1):92-3.Wiviott SD, Braunwald E, McCabe CH, et al. TRITON-TIMI38 Investigators Prasugrel versus clopidogrel in patients withacute coronary syndromes.N Engl J Med. 2007 Nov15;357(20):2001-15Serebruany VL Aspirin Dose and Ticagrelor Benefit in PLA-TO: Fact or Fiction?. Cardiology. 2011 Feb 8;117(4):280-283Allie DE, Hall P, Shammas NW, Safian R, Laird JR, YoungJJ, Virmani A. The Angiomax Peripheral Procedure Registryof Vascular Events Trial (APPROVE): in-hospital and 30-dayresults. J Invasive Cardiol. 2004 Nov;16(11):651-6.TransAtlantic Inter-Society Consensous (TASC).Management of peripheral arterial disease (PAD). J Vasc Surg2000; 31: 5-85.Dormandy J. Fate of the patient with chronic leg ischaemia. JCardiovasc Surg 1989; 30: 50-7.Dormandy J, Heeck L, Vig S. The natural history of claudica-tion: risk to life and limb. Semin Vasc Surg 1999; 12: 123-37.

There is increasing concern that the localdelivery of anti-proliferative drugs is accom-panied by thrombosis, a consequence of en-dothelial dysfunction and delayed restora-tion1 that lead to loss of vasoreactivity, highlevels of platelet aggregation1, and induc-tion of tissue factor expression3, 4. Sirolimus,for example, inhibits smooth muscle cell

(SMC) proliferation and intimal hyperplasiapresumably by effects on signaling withinthe mammalian target of rapamycin(mTOR) pathway5, 6. Prolonged exposure tosirolimus partially inhibits Akt activationand smooth muscle cell proliferation7. Butsirolimus also induces tissue factor expres-sion3,4 and dysfunction in endothelial cells

Martorell, J.1,2; Molins, J.J.2; García, A.2; Palmés, E.1,2; Bea, J.A.3; Edelman,E.1,4; Balcells, M.1,2

1. Massachusetts Institute of Technology (MIT), USA.2. Institut Químic de Sarrià (IQS). Ramón Llull University, Spain3. Universidad de Zaragoza, Spain4. Brigham and Women’s Hospital, USA

Biophysical property assesmentof new endovascular devices inartificial vessel

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J. Martorell et al.- Biophysical property assesment of new endovasculardevices in artificial vessel


(EC). Innovative in silico8, 9 and in vivo10, 11

studies have shown how drug tissue distri-bution after release correlates with the pat-tern of thrombosis, intimal hyperplasia,smooth muscle proliferation and inflamma-tion, but have not examined the impact onendothelial cells. EC are especially flow-sen-sitive and altered hemodynamics may dis-rupt endothelial health and vessel balance12.

We aimed to develop a tool to study andpredict device outcome after implantationin complex geometries. Computational mo-deling and tissue engineering of vessel-likestructures exposed to physiological flow re-gimes were used to study tissue factor dis-tribution along the arterial wall after stentdeployment, to map monocyte adhesion onstent struts and to describe mechanisms ofrepair after intervention.

A user-friendly Visual Basic® 2008 interface(cf. Fig 1A) was designed to create a modelof any realistic arterial bifurcation inCatia®.v5. The interface uses several Catiav5 workbenches available from Part Designfor solids, Generative Shape Design to pro-duce complex surfaces and CNC MachineTool Simulation to generate the code forCNC machine. The program, based onKolachalama et al.13 C code, has three diffe-rent applications: fluid dynamics simulation,mold design and scaffold’s direct 3D Printthat share the exact same geometry, whichis defined by 44 parameters divided inlengths, diameters, ratios and angles. Theprogram generates a macro able to designthe geometry to export an IGES file forflow simulations (cf. Fig 1B), four macrosto create molds (cf. Fig 1C) to manufacturethrough Computer Numeric Control

Fig. 1. A user friendly software platform (A) allows entering key geometric parameters of a given geometry and to model thegeometry for flow simulations (B), to cast molds of it (C) and to 3D print scaffolds.

(CNC) or one macro to export STL files(cf. Fig 1D) to manufacture the geometrywith a 3D printer able to photo-polymerizewith UV light the raw material.

Teflon manufactured as described above torecapitulate the exact lumen of a given bi-furcated geometry served as a negative tem-plate to produce polyurethane molds thatwere injected with liquid water soluble wax.Once solidified polydimethylsiloxane(PDMS, Dow Corning) was allowed to curearound the water soluble wax structure (Fig2A). In parallel, polyurethane acrylate scaf-folds were manufactured using 3D printing(Object) (Fig 2B). Prior to cell seeding, 3Dprinted scaffolds were extracted for 6h withtoluene in order to eliminate unreacted spe-cies that were proven toxic to cells.Thereafter, both PDMS-made and 3D prin-ted scaffolds were washed in 0.2% sodium

dodecyl sulphate solution for 20min, rinsedtwice with distilled water for 20min and ste-am sterilized. Scaffolds were coated with20g/ml fibronectin (Sigma) in PBS for2h, while rotating at 10rph at 370C.

Sequential layering of human aortic adven-titial fibroblasts, followed by application ofsmooth muscle cells and thereafter endot-helial cells followed produced a tri-layer ves-sel-like constructs (Fig 2C).

Vessel-like constructs were stented with 7-cell stainless steel NIR stents (3.5x16mm,Medinol) and kept under static conditionsor culture media perfused at a given flowregime in a perfusion bioreactor developedby Balcells et al14. Re-endothelization de-gree was measured 3 days after deploymentand flow exposure. At day 3 vessel-likeconstructs were exposed to freshly isolatedmonocytes for 24h and their effect on en-dothelial recovery quantified by fluorescen-ce imaging after DAPI staining of cell nu-clei. Tissue factor expression by smoothmuscle cells proximal and distal from thestented section was measured using mouseanti-Tissue Factor (American Diagnostica)diluted 1:50 in PBS-BSA and goat anti-mouse Alexa Fluor® 647 (1:100 in PBS-BSA) as secondary antibody.

Our system has enabled us to better unders-tand vascular response to altered flow regi-mes and injury provoked by stent deploy-ment. Tissue factor expression by vascularsmooth muscle cells exposed to oscillatoryflow conditions was 2.5-fold that measuredunder steady flow exposure. Endothelialcells among stent struts suffered extensivedenudation. After 3 and 4 days of exposureto physiological flow regime endothelialcells coverage was 6.2cell/mm2 and11.7cell/mm2, respectively. Adhesion ofmonocytes to the injured endothelium onday 3 significantly enhanced endothelialproliferation (99.7 cell/mm2 vs 11.7cell/mm2 when no monocytes were present).

Our flow system holds the potential to tracknot only tissue factor expression and re-en-dothelialization but up and down stream

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Fig. 2. Polydimethylsiloxane (A) and polyurethane acrylate(B) bifurcated scaffolds used to seed vascular cells layer-by-

layer. (C) SEM image of endothelial cells adhered to thescaffold surface.

signaling molecules and to identify criticalpathways and screening of different drugsthat interfere with them and its most effi-cient delivery mode.

REFERENCES

Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, LadichE, Kutys R, Skorija K, Gold HK, Virmani R. Pathology ofdrug-eluting stents in humans: delayed healing and late th-rombotic risk. J Am Coll Cardiol. 2006;48:193–202.Serruys PW, Kukreja N. Late stent thrombosis in drug-elu-ting stents: return of the “VB syndrome.” Nat Clin PractCardiovasc Med. 2006; 3:637.Steffel J, Latini RA, Akhmedov A, Zimmermann D,Zimmerling P, Luscher TF, Tanner FC. Rapamycin, but notFK-506, increases endothelial tissue factor expression: impli-cations for drug-eluting stent design. Circulation.2005;112:2002–2011.Camici GG, Steffel J, Amanovic I, Breitenstein A, BaldingerJ, Keller S, Luscher TF, Tanner FC. Rapamycin promotes ar-terial thrombosis in vivo: implications for everolimus and zo-tarolimus eluting stents. Eur Heart J.2010;31:236 –242.Jiang BH, Liu LZ. Role of mTOR in anticancer drug resistan-ce: perspectives for improved drug treatment. Drug ResistUpdat. 2008;11: 63–76.Zeng Z, Sarbassov dos D, Samudio IJ, Yee KW, MunsellMF, Ellen Jackson C, Giles FJ, Sabatini DM, Andreeff M,Konopleva M. Rapamycin derivatives reduce mTORC2 sig-naling and inhibit AKT activation in AML. Blood.2007;109:3509 –3512.

Sarbassov DD, Ali SM, Sengupta S, Sheen JH, Hsu PP,Bagley AF, Markhard AL, Sabatini DM. Prolonged rapamy-cin treatment inhibits mTORC2 assembly and Akt/PKB. MolCell. 2006;22:159 –168.Kolachalama VB, Tzafriri AR, Arifin DY, Edelman ER.Luminal flow patterns dictate arterial drug deposition in stent-based delivery. J Control Release. 2009;133:24 –30.Balakrishnan B, Dooley J, Kopia G, Edelman ER. Thrombuscauses fluctuations in arterial drug delivery from intravascularstents. J Control Release. 2008;131:173–180.Miyauchi K, Kasai T, Yokayama T, Aihara K, Kurata T,Kajimoto K, Okazaki S, Ishiyama H, Daida H. Effectivenessof statin-eluting stent on early inflammatory response and ne-ointimal thickness in a porcine coronary model. Circ J.2008;72:832– 838.Baker AB, Groothuis A, Jonas M, Ettenson DS, Shazly T,Zcharia E, Vlodavsky I, Seifert P, Edelman ER. Heparanasealters arterial structure, mechanics, and repair following endo-vascular stenting in mice. Circ Res.2009;104:380 –387.Garcia-Cardena G, Gimbrone MA Jr. Biomechanical modula-tion of endothelial phenotype: implications for health and di-sease. Handb Exp Pharmacol. 2006;79 –95.Kolachalama VB, Bressloff NW, Nair PB (2007). Mining da-ta from hemodynamic simulations via Bayesian emulation.BioMedical Engineering OnLine 2007, 6:47Balcells M, Martorell J, Olive C, Santacana M, Chitalia V,Cardoso A, Edelman ER. Smooth muscle cells orchestrate theendothelial cell response to flow and injury. Circulation 2010May; 121(20): 2192-9.

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Palmaz, J.

What is next in stent technology?:Enhanced endothelialization byengineered surface microtopography

Rationale

Endothelialization of prosthetic surfaces hasbeen recognized as an important factor inthe orderly healing of vascular implants.

Among the many important functions ofhealthy endothelium are resistance to cellu-lar adhesion molecules platelet and mo-

nocyte attachment. By colonizing a prosthe-tic surface, endothelial cells (EC) effectivelycompete with platelets and white cells forbinding sites on the protein matrix and setup mechanisms for inhibition of prolifera-tion, chemotaxis and migration of pro-in-flammatory cells, largely responsible for inti-mal build-up and eventual failure of vascularconduits.



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Endothelialization of prosthetic surfaces hasbeen attempted by various mechanisms, in-cluding seeding, grafting of adhesive pepti-des such as RGD and binding antibodies toCD-34, a receptor present on the surface ofcirculating progenitor endothelial cells.Although these attempts are laudable, vas-cular endothelium is abundant and quiteadapted to readily cover a surface providedthe right conditions are met. Minutes aftera gap on the endothelium layer is created,boundary EC change their phenotype andbecome migratory, sending filopodia and la-mellipodia on the leading edge pulling thecell out of their stationary binding. A for-ward motion is established by the cell ro-lling like a tumble-weed in the wind (theblood stream). Attachment receptors linkedto the cytoskeleton are expressed on theventral surface of the cell seeking a matingcontact with a complementary binding site(cellular adhesion molecule ligand). If at-tachment occurs, the cell pulls itself to thesite by contraction of the actin fiber bundleconnected to the receptor. This pulls thecell membrane and cytoplasm forward whileattachment sites are released on the trailingedge. The motion of the migrating EC isnot random as the cell is sensitive to topo-graphical features and seeking places withhigh concentration of binding sites.Although EC migration is largely in the di-rection of flow, it tends to deviate sidewaysin a zig-zag pattern as it seeks contact withother cells. Upon a cell collision, the migra-ting EC slows down temporarily (contactinhibition). If many collisions ensue, the ECprepares itself for change to a stationaryphenotype. Unimpeded, EC migrate relati-vely fast. Under normal flow shear the rateof migration is approximately one celllength per hour. Contact inhibition, topo-graphy sorting and tentative movementslows down EC migration on surfaces whichotherwise could have proper characteristicsfor endothelialization.

Since endothelialization can be considered acompetitive race for the surface with plate-lets and monocytes, faster EC coverage re-presents less opportunities for thrombusand intimal formation to form.

Surface engineering of prosthetic surfa-ces

By lap microphotography of cells migratingunder flow, it is evident that EC are sensiti-ve to linear surface features. Upon encoun-tering an edge commensurate with the sizeof the cell, EC will follow the edge at a spe-ed related to the orientation of the edge re-lative to the flow (maximal speed along theflow, minimal at 90 degree angle). EC mi-grating on a surface covered with parallelmicrogrooves do it at a rate more than dou-ble than on a flat and otherwise identicalsurface. From comparative studies we havedetermined the ideal groove shape, dimen-sions and interval for maximal response.Using laminar flow chambers with prescri-bed shear rate, we have found that the ECguidance effect of microgrooves is indepen-dent of the type of material. We found bio-logical effects other than cell movement andmigration. By focal adhesion kinase (FAK)assays, EC migrating on grooved surfaces(GS) expressed more FAK than those oncontrol flat surfaces. Likewise we found in-creased nitric oxide (NO) and proliferatingcell nuclear antigen (PCNA) on EC on GS.These findings suggest enhanced metabolicactivation of EC on GS probably triggeredby outside-inside signaling pathways invol-ving the adhesion and tubular apparatusmediating activation of the cyclin pathwayand DNA transcriptional initiation. In vivo,we confirmed the increased speed of endot-helialization on microgrooved carotid andcoronary stents and we found a correspon-ding decrease in intimal area and thicknessin response to placement of stents using apig injury model.

Conclusion

The rate of endothelialization of prostheticmaterials can be enhanced with resultingdecrease in intimal hyperplasia using micro-grooves on the blood-contacting surfaces.The creation of the microgrooves can beachieved using micro and nanotechnologiescompatible with current standards of vascu-lar prosthetic manufacturing.

J. Palmaz.- What is next in stent technology?: enhanced endothelializationby engineered surface microtopography


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BIBLIOGRAPHY

Maniotis A, Chen CS, Proc Natl Acad Sci USA1997;94:849Palmaz JC, Benson A, Sprague EA JVIR

1999;10:439Sprague EA, Luo J, Palmaz JC JLTEMI2000;10:97Simon C, Palmaz JC, Sprague EA. JLTEMI2000;10:127Sprague EU, Palmaz JC. JEVT 2005;12:594.

J. Palmaz.- What is next in stent technology?: enhanced endothelializationby engineered surface microtopography


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Nikol, S.

Inhibition of restenosis formationwithout compromisingreendothelialization

Percutaneous transluminal angioplasty isroutinely used revascularization techniquesfor patients with coronary or peripheralartery disease. Depending on the arteriallocation, more than 50% of patients under-going angioplasty may develop a renarrow-ing of the treated vessel, called restenosis,even following bare metal stent implanta-tion, in fewer cases even after drug-elutingstent implantation.

On the one hand, drug-eluting technolo-gies, both stent- and balloon-based havebeen developed successfully in the pastyears. However, such rather unselectivetechnologies to the arterial endotheliumalso lead to a delayed endothelial repair ofthe vessel wall, which affords long-termdual platelet inhibition at risk for acute orsubacute artery occlusions even after manymonths.

Alternatively, gene therapy emerged as apotential means for the prevention ofrestenosis for arteries. Gene modificationaims to produce a localized specific effect

on certain relevant cells and thus to reduceproliferation or matrix formation, however,without compromizing re-endothelializa-tion. The process of inflammation or cellproliferation, major players in restenosis,may be halted selectively at the extracellularlevel, which includes certain growth factors,or in cells themselves, where signal trans-duction leads to activation of the cell cycleand thus to cell division. Novel and morepotent vectors including liposomes are stillbeing developed for gene transfer whichmay improve the clinical potential of thisnovel strategy.

Also, certain catheters developed for localperivascular gene delivery appeared to beuseful avoiding systemic side effects to acertain extent. Using conventional drugssuch as paclitaxel, local adventitial applica-tions may inhibt restenosis without com-promizing endothelial repair.

Several approaches have reached clinicalevaluation in studies performed in the Unit-ed States and in Europe.

3620

Since the 1970s, we as a research communi-ty have come to appreciate the fundamentalimportance of biomechanical factors in reg-ulating normal vascular biology and physi-ology and similarly in impacting the pro-gression of many diseases as well as theirresponses to clinical intervention. In thespecific area of endovascular therapy, aorticneck dilation in response to excessive deviceoversizing is a clear example of maladaptionin response to changes in the biomechanicalenvironment of the aorta.

Although the factors regulating vascularadaptation clearly involve coupled effectsbetween the flowing blood, vascular wall,and perivascular tissues, that is,fluid–solid–solute interactions, research invascular biomechanics has traditionallyadvanced along separate lines – biofluidmechanics, biosolid mechanics, and bio-transport phenomena. There is, therefore, apressing need to move toward coupledproblem formulations and solutions.

Moreover, it is well known that most physi-ologic, pathophysiologic, and reparativeprocesses in the vasculature manifest overperiods of days to weeks, months, or evenyears. Yet, most attention in vascular bio-mechanics has focused on behaviors duringa cardiac cycle or, at best, at select timepoints during the progression of a disease

or response to a treatment or injury. Clear-ly, there is also a pressing need to under-stand better the underlying processes thatare responsible for the conspicuous changesin structure and function that occur overlong periods, changes that likewise dependstrongly on the biomechanics.

This work is motivated by these needs,indeed, the need for a new paradigm toaddress diverse biomechanical problems ofthe vasculature by accounting for coupledfluid–solid-transport over long periods ofvascular adaptation and maladaptation1.Hence, in this paper we show how compu-tations of complex fluid–solid interactions(FSI) during a cardiac cycle can be linked todetailed analyses of the solid mechanics ofthe vascular wall as well as descriptions ofthe kinetics of biological growth andremodeling (G&R) which can dependstrongly on solute transport. We refer tothis new approach as fluid–solid-growth(FSG) modeling. Toward this end, we buildprimarily on four separate advances by ourgroups: biomechanics of growth andremodeling2, a coupled momentum methodfor fluid–solid interactions during a cardiaccycle3, a theory of small on large for cou-pling biosolid and biofluid mechanicalmodels4, and improved approaches formodeling fluid boundary conditions incomplex vascular systems5.

Figueroa, A.C*; Taylor*, C.A.; Baek, S.**; Humphrey, J.D.***

*Department of Bioingineering, Stanford University, CA, USA***Department of Mechanical Engineering, Michigan Sate University, MI, USA***Department of Biomedical Engineering, Yale University, New Haven, CT, USA.

Introduction to computationalanalysis for fluid-solid-growthmodeling in cardiovascularsimulations

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A. Figueroa, et al.- Introduction to computational analysis for fluid-solid-growth modeling in cardiovascular simulations


The FSG framework utilizes a loose cou-pling between the short term FSI simula-tions and the long-term G&R simulations.This coupling is illustrated by the loopdepicted in Fig. 1. In this loop, at a giventime sn defined over long-time scales, theFSI analysis calculates hemodynamic loadsacting on the arterial wall during the cardiaccycle, extracts the mechanical stimuli thataffect vascular wall G&R, and then transfersthe information to the G&R formulation.The G&R analysis then simulates the evolu-tion of the arterial wall over multiple G&Rtime steps. The arterial wall is representedas a constrained mixture of amorphouselastin matrix, collagen fibers and smoothmuscle (see Fig. 2). When changes in vesselwall geometry and/or structure are signifi-cant, the loop returns to the FSI analysiswith updated information about the geom-etry, pre-stresses, and material properties.

In this study, we restrict our illustrativeresults to a simple situation – influence ofpressure-induced intramural stress and flow-induced wall shear stress on the evolutionof shape and properties of a basilar arteryfollowing an initial concentric loss of a por-tion of the elastin within the wall (see Fig.

3). Notwithstanding the complexity of theassociated biomechanical and biochemicalprocesses, which will certainly require fur-ther research to identify more completeconstitutive relations for the growth andremodelling kinetics, we submit that thesimple illustrative examples herein revealboth the need for and the great potential offluid–solid-growth modeling in basicresearch, industrial R&D, and clinical appli-cations.

REFERENCES

Figueroa CA, Baek S, Taylor CA, Humphrey JD. ComputerMethods in Applied Mechanics and Engineering 2009; 198:3583-3602.Baek S, Rajagopal KR, Humphrey JD. ASME Journal ofBiomedical Engineering 2006; 128: 142–149.Figueroa CA, Vignon-Clementel IE, Jansen KE, HughesTJR, Taylor CA. Computer Methods in Applied Mechanicsand Engineering 2006; 195: 5685-5706.Baek S, Gleason RL, Rajagopal KR, Humphrey JD. Comput-er Methods in Applied Mechanics and Engineering 2007;196: 3070–3078.Vignon-Clementel IE, Figueroa CA, Jansen KE, Taylor CA.Computer Methods in Applied Mechanics and Engineering2006; 195: 3776–3796.

Fig. 1. Iterative loop and information transferred in the coupling between the FSI and G&R parts of the FSG framework.

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A. Figueroa, et al.- Introduction to computational analysis for fluid-solid-growth modeling in cardiovascular simulations


Fig. 1. Arterial wall as a constrained mixture of amorphous elastin matrix, collagen fibers and smooth muscle.

Fig. 1. Schematic representation of the FSG problem considered. In the first stage of the analysis, we grow the artery until itreaches a homeostatic equilibrium at time sN. We then introduce an insult in the vessel wall that results in a local concentric

loss of the elastin matrix, and perform two different FSG simulations: in Case 1, the arterial growth and remodeling is mediat-ed by tensile stress only, whereas in Case 2, the growth is mediated by tensile and wall shear stress. For illustrative purposes,

we show the evolution of the linearized circumferential component of the stiffness A (left) and the vessel wall shear stress

(right) for each time step of the analysis.

3623

In 1964, Charles Theodore Dotter andMelvin P. Judkins described the first angio-plasty1 and thirteen years later, AndreasGruntzig performed the first balloon coro-nary angioplasty, that lead to the birth of anew specialty, called interventional cardio-logy1.

The “plain old balloon angioplasty” (PO-BA) was a pioneering treatment, whose suc-cess was hindered by the problems of acutevessel closure and restenosis3, 4. These pro-blems lead to the development of a secondrevolutionary treatment, the metallic coro-nary stent, which was first implanted bySigwart in 19865. Although the initial stentsproved to be effective as “bailout” devicesin cases of abrupt or threatened vessel clo-sure, thereby reducing rates of emergencycoronary artery bypass6, development wasultimately hampered by the risk of subacutethrombotic coronary artery occlusion (up to18% of cases within 2 weeks after implanta-tion)7. In addition, the use of these metallicdevices required the use of complex antico-agulation regimens, associated with increa-sed bleeding and prolonged hospitaliza-tion8. Overall, the early success and compli-cation rates seen with these initial coronarymetallic stents were not always competitivewith those of routine POBA9.

Coronary stenting only became a widely ac-cepted technique after the BENESTENT(Belgian Netherlands Stent) trial10 and theSTRESS (Stent Restenosis Study)11, indica-

ting that stenting was safe in the absence ofanticoagulation therapy with the use of dualantiplatelet therapy and/or adequate stentdeployment12, 13. By 1999, coronary stentingwas then performed in 84.2% of PCI proce-dure14. However, despite obvious advanta-ges, there were raised other concerns: an ia-trogenic problem emerged in the form onin-stent neointimal hyperplasia15.17. In parti-cular, the intrastent growth of scar tissue,which was the result of proliferation andmigration of vascular smooth muscle cells,directly linked to stent implantation, resul-ted in restenosis rate of 20-30%18. The at-tempts to minimize this in-stent neointimalhyperplasia and thereby reduce rates of re-peat revascularization lead to the develop-ment of another treatment, the drug-elu-ting stent (DES). The first human DES im-plant was performed by J. Eduardo Sousa inSao Paulo in December 1999 at the start ofthe 2 first-in-man studies recruiting a totalof 45 patients and reporting minimal in-stent neointimal proliferation through to12-month follow-up19-20. The dramatic re-duction of the restenosis rate with DES,compared with BMS, was the major drivingforce behind the exponential growth of PCIas a treatment for patients with coronary ar-tery disease21-23. In addition, as there was anincreased confidence to use PCI, DES useexpanded also to lesions subsets that wereonly previously considered suitable for co-ronary artery by-pass24-25.

In 2006 concerns were raised over the sa-fety profile of DES, resulting in an imme-

Brugaletta, S.

Thorax Institute, Department of Cardiology. Barcelona, Spain.Thoraxcenter Erasmus MC, Rotterdam, The Netherlands

Coronary stent evolution:from bare metal stent to vascularrestoration therapy

3624

S. Brugaletta.- Coronary stent evolution: from bare metal stent tovascular restoration therapy


diate world-wide downturn in their use26-27.However, these concerns proved a vital sti-mulus to focus research and have ultimatelylead to the development of newer stentsand improved safety, resulting in a resur-gence in the use of DES. While the initialcoronary stents were composed of 316Lstainless steel, radio-opaque and providingadequate radial strength, for the second ge-neration DES cobalt chromium, which ex-hibits superior radial strength and improvedradio-opacity, allowing for thinner stentstruts, was used28. Thinner struts also leadto a reduction in device profile and, hence,an improvement in stent deliverability tothe target lesion (Table 1).

Evidence from animal and human studiessuggested also that nonerodable polymerscan cause persistent arterial wall inflamma-tion and delayed vascular healing, both ofwhich may subsequently have a role in stentthrombosis and delayed restenosis29-31. Thesefindings accelerate the development of new

DES coated with biodegradable polymers,which offer the attractive combination ofcontrolled drug eluting in parallel with bio-degradation of the polymer into inert mo-nomers: once the biodegradation is comple-te, a bare metal stent remains, thereby redu-cing the long-term risks associated with thepresence of a permanent polymer32. In re-cent times, an extension of this concept hasbeen the development of DES completelyfree of polymer and of BMS coated in novelcoatings33 (Table 2).

Finally, completely biodegradable scaffoldhave been developed, which completely di-sappear once vascular healing has taken pla-ce (Table 3). The Abbott Vascular everoli-mus-eluting bioresorbable vascular scaffold(BVS) is the only drug-eluting bioresorba-ble scaffold currently undergoing clinicaltrials. The BVS has a backbone of poly-L-lactic acid, which is subsequently coatedwith a thin layer of a 1:1 mixture of anamorphous matrix of poly-D,L-lactide (PD-

STENT POLYMERDRUGMECHANISM

DRUG (concentration[u/cm2])

STRUTTHICKNESS (um)

RELEASE KINE-TICS 28 DAYS

METAL

Cypher

Taxus Express

Taxus Liberté

Endeavor

Xienve V

Sirolimus (140)

Paclitaxel (100)

Paclitaxel (100)

Zotarolimus (100)

Everolimus (100)

Inhibits mTOR,cytostatic

Microtubule inhi-bitor, cell cyclearrest in G0/G1and G2/M

Microtubule inhi-bitor, cell cyclearrest in G0/G1and G2/M



Polyethelyneco-vinyl acetateand poly-n-butylmethacrylate

Poly(styrene-b-isobutylene-b-styrene

Poly(styrene-b-isobutylene-b-styrene

Phosphorylcholi-ne

Polyvinylidenefluoride cohexa-fluoropropyleneand poly-n-butyl methacry-late

Stainless Steel

Stainless Steel

Stainless Steel

CobaltChromium

CobaltChromium

140

132

97

91

81

80%

<10%

<10%

95%

80%

TABLE III. BIORESORBABLE SCAFFOLDS TESTED IN HUMAN

LLA) and 8.2 g/mm of the antiproliferativedrug everolimus. The PDLLA enables con-trolled release of everolimus, such that 80%is eluted by 30 days. The first BVS devicehad a strut thickness of 150m and consistedof circumferential out-of-phase zigzaghoops, with struts linked directly togetheror by thin and straight connections. Thescaffold had to be kept stored below -20°Cto prevent physical aging of the polymer.The safety and feasibility of this BVS was as-sessed in 30 low-risk patients in theprospective, open-label, multicenter AB-SORB A study34-35: this study demonstratedan angiographic late loss of 0.44 mm, com-parable to values from the early DES stud-ies, and the clinical safety of the BVS withonly one ischemic driven major adverse

event (nonQ wave myocardial infarction)during the 42 month follow-up.36 The re-duction in hyper-echogenicity, the changein plaque composition on IVUS-VH, thedisappearance of the polymeric struts byOCT and the return of vasoactivity follow-ing administration of methylergometrinemaleate or acetylcholine were importantfindings, supporting the occurrence ofbioresorption and the concept of “vascularrestoration therapy”. Importantly, at 6-month, the late loss of this device represent-ed a combination of neointimal hyperplasiaand a reduction in scaffold area, a phenom-enon called late scaffold shrinkage. The latescaffold shrinkage, which occurs as a conse-quence of the loss of radial strength withbioresorption, represented a new phenome-non not previously observed with conven-tional metallic stents37, which leads to im-portant design modifications to the device.

The second-generation device, BVS 1.1,utilizes the same polymer, but a change inthe manufacturing process was made in or-der to maintain the mechanical integrity ofthe device up to 6 months. The new designhas in-phase zigzag hoops linked bybridges, which allow for a more consistentdrug application. From a practical perspec-tive, the scaffold can now be stored at roomtemperature. The BVS 1.1 is currently be-ing assessed in the ABSORB Cohort B trial,enrolled 101 patients. Currently, data fromthe 6-month follow-up showed a late lossconsiderably lower than that seen with theBVS 1.0 (0.19 mm) with strong reductionof the late shrinkage phenomenon3 8.Longer-term follow-up is ongoing. In thepipeline for the future is the pivotal non-in-feriority trial of the BVS vs. a metallicDES39.

In conclusion, it is easy to think that no sin-gle stent design and polymer type is suitablefor all patients and lesion types. With re-gards to this, a more individualized choiceof stent, taking into account patient’s (abili-ty to take long-term double antiplatelettherapy) and lesion’s (bifurcation, myocar-dial infarction, etc) characteristics, would be

3625



BIODEGRADABLE COATING

• Biomatrix/Nobori (abluminal poly-L-lactide)• Nevo (Reservoir Technology)• Supralimus• Axxess• XTENT• Excel• Elixir• Infinnium• JACTAX• Synergy• Combo• etc

POLYMER-FREE

• Yukon• Biofreedom• VESTAsyn (hydroxyapatite)• Amazonia Pax (crystallized PTX)• etc

STENT WITH NOVEL COATING

• Catania (Nano Thin Polyzene-F)• Tita-2-stent (titanium-nitride oxide)• Genous Bio-engineered R-stent (EPC capture CD34• etc

TABLE II. NEW STENTS WITH BIODEGRADABLEOR NOVEL COATING OR POLYMER-FREE

3626

an important factor influencing stent selec-tion.

The technology of the bioresorbable scaf-folds, which allows a “vascular restorationtherapy”, following their bioresorption, isalso of value and will grow in the nextyears.

REFERENCES

Dotter, C.T. & Judkins, M.P. Transluminal Treatment ofArteriosclerotic Obstruction. Description of a New Technicand a Preliminary Report of Its Application. Circulation 30,654-670 (1964).Gruntzig, A. Transluminal dilatation of coronary-artery steno-sis. Lancet 1, 263 (1978).3.Gruntzig, A.R., Senning, A. &Siegenthaler, W.E. Nonoperative dilatation of coronary-arterystenosis: percutaneous transluminal coronary angioplasty. NEngl J Med 301, 61-68 (1979).

SCAFFOLDS ABSORP-TION

PRODUCTS

DRUGELUTION

DESIGNSTRUTMATERIAL

COATINGMATERIAL

DEPLOY-MENT

TOTAL STRUTTHICKNESS

(STRUT+COATING)

DURATIONRADIAL

SUPPORT

ABSORPTIONTIME

Poly-L-lactic acid

Metalmagne-sium alloy



Poly-tyro-sine-deri-ved poly-carbonatepolymer

Polymersalicyla-te+linker

Poly-L-lactic acid

Poly-L-lactic acid

IgakiTamai

AMS-I

AMS-II

AMS-II

REVA

BTI

BVS 1.0

BVS 1.1

Nil

Nil

Nil

Nil

Nil

Salicylate+ differentlinke

Poly-D,L-lactide

Poly-D,L-lactide

Lactic acidCO2 andH2O

Not appli-cable

Not appli-cable

Not appli-cable

Aminoacid, etha-nol, CO2

SalycilateCO2 andH2O



Nil

Nil

Nil

Nil

Nil

Sirolimussalicylate

Everolimus

Everolimus

Selfexpandingwith hea-ted balloon

Balloon

Balloon

Balloon

Balloon

Balloon

Balloon

Balloon

6 mo

Days orweeks

Weeks

Weeks

3-6 mo

3 mo

Weeks

3 mo

2 y

<4 mo

>4 mo

>4 mo

2y

6 mo

2y

2y

170

165

125

125

200

200

156

156

Zig-zaghelicalcoils withstraightbridges

Sinusoidalin-phasehoops lin-ked bystraightbridges

Side andlook

Tube withlaser-cutvoids

Out ofphasesinusoidalhoops withstraightand directlinks

In-phasehoops withstraightlinks

TABLE I. FIRST AND SECOND GENERATION DRUG ELUTING STENT

1.-

2.-

3.-



3627



REFERENCES

de Feyter, P.J., de Jaegere, P.P. & Serruys, P.W. Incidence,predictors, and management of acute coronary occlusion aftercoronary angioplasty. Am Heart J 127, 643-651 (1994).Sigwart, U., Puel, J., Mirkovitch, V., Joffre, F. & Kappen-berger, L. Intravascular stents to prevent occlusion andrestenosis after transluminal angioplasty. N Engl J Med 316,701-706 (1987).Roubin, G.S., et al. Intracoronary stenting for acute andthreatened closure complicating percutaneous transluminalcoronary angioplasty. Circulation 85, 916-927 (1992).Serruys, P.W., et al. Angiographic follow-up after placementof a self-expanding coronary-artery stent. N Engl J Med 324,13-17 (1991)van Domburg, R.T., et al. Long term outcome after coronarystent implantation: a 10 year single centre experience of 1000patients. Heart 82 Suppl 2, II27-34 (1999).Garg, S. & Serruys, P.W. Coronary stents: current status. JAm Coll Cardiol 56, S1-42.Serruys, P.W., et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients withcoronary artery disease. Benestent Study Group. N Engl JMed 331, 489-495 (1994).Fischman, D.L., et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment ofcoronary artery disease. Stent Restenosis Study Investigators.N Engl J Med 331, 496-501 (1994).Schomig, A., et al. A randomized comparison of antiplateletand anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med 334, 1084-1089 (1996).Colombo, A., et al. Intracoronary stenting without anticoagu-lation accomplished with intravascular ultrasound guidance.Circulation 91, 1676-1688 (1995).Serruys, P.W., Kutryk, M.J. & Ong, A.T. Coronary-arterystents. N Engl J Med 354, 483-495 (2006).Karas, S.P., et al. Coronary intimal proliferation after ballooninjury and stenting in swine: an animal model of restenosis. JAm Coll Cardiol 20, 467-474 (1992).Gordon, P.C., et al. Mechanisms of restenosis and redilationwithin coronary stents—quantitative angiographic assess-ment. J Am Coll Cardiol 21, 1166-1174 (1993).Hoffmann, R., et al. Patterns and mechanisms of in-stentrestenosis. A serial intravascular ultrasound study. Circula-tion 94, 1247-1254 (1996).Moliterno, D.J. Healing Achilles—sirolimus versus paclitax-el. N Engl J Med 353, 724-727 (2005).Sousa, J.E., et al. Lack of neointimal proliferation afterimplantation of sirolimus-coated stents in human coronaryarteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 103,192-195 (2001).Sousa, J.E., et al. Sustained suppression of neointimal prolif-eration by sirolimus-eluting stents: one-year angiographic andintravascular ultrasound follow-up. Circulation 104, 2007-2011 (2001).Stettler, C., et al. Outcomes associated with drug-eluting andbare-metal stents: a collaborative network meta-analysis.Lancet 370, 937-948 (2007).Spaulding, C., Daemen, J., Boersma, E., Cutlip, D.E. & Ser-ruys, P.W. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 356, 989-997 (2007).Kastrati, A., et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 356,1030-1039 (2007).Seung, K.B., et al. Stents versus coronary-artery bypass graft-ing for left main coronary artery disease. N Engl J Med 358,1781-1792 (2008).Serruys, P.W., et al. Percutaneous coronary intervention ver-sus coronary-artery bypass grafting for severe coronary arterydisease. N Engl J Med 360, 961-972 (2009). 26.Nordmann,A.J., Briel, M. & Bucher, H.C. Mortality in randomized con-

trolled trials comparing drug-eluting vs. bare metal stents incoronary artery disease: a meta-analysis. Eur Heart J 27,2784-2814 (2006).Lagerqvist, B., et al. Long-term outcomes with drug-elutingstents versus bare-metal stents in Sweden. N Engl J Med 356,1009-1019 (2007).Kereiakes, D.J., et al. Usefulness of a cobalt chromium coro-nary stent alloy. Am J Cardiol 92, 463-466 (2003).Finn, A.V., et al. Pathological correlates of late drug-elutingstent thrombosis: strut coverage as a marker of endothelial-ization. Circulation 115, 2435-2441 (2007).Finn, A.V., et al. Vascular responses to drug eluting stents:importance of delayed healing. Arterioscler Thromb VascBiol 27, 1500-1510 (2007).Joner, M., et al. Pathology of drug-eluting stents in humans:delayed healing and late thrombotic risk. J Am Coll Cardiol48, 193-202 (2006).Niemela, K.O. Biodegradable coating for drug-elutingstents—more than a facelift? Eur Heart J 29, 1930-1931(2008).Garg, S. & Serruys, P.W. Coronary stents: looking forward. JAm Coll Cardiol 56, S43-78.Ormiston, J.A., et al. A bioabsorbable everolimus-elutingcoronary stent system for patients with single de-novo coro-nary artery lesions (ABSORB): a prospective open-label trial.Lancet 371, 899-907 (2008).Serruys, P.W., et al. A bioabsorbable everolimus-elutingcoronary stent system (ABSORB): 2-year outcomes andresults from multiple imaging methods. Lancet 373, 897-910(2009).Onuma, Y., et al. Three-year results of clinical follow-upafter a bioresorbable everolimus-eluting scaffold in patientswith de novo coronary artery disease: the ABSORB trial.EuroIntervention 6, 447-453.Tanimoto, S., et al. Late stent recoil of the bioabsorbableeverolimus-eluting coronary stent and its relationship withplaque morphology. J Am Coll Cardiol 52, 1616-1620(2008).Gomez-Lara, J., et al. A comparative assessment by opticalcoherence tomography of the performance of the first andsecond generation of the everolimus-eluting bioresorbablevascular scaffolds. Eur Heart J 32, 294-304.Onuma, Y., Ormiston, J. & Serruys, P.W. BioresorbableScaffold Technologies. Circ J.

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5.-

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8.-

9.-

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17.-

18.-

19.-

20.-

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3628

Mitral regurgitation (MR), is the mostprevalent valve disease in the western popu-lation(1-3). When MR is severe, freedom fromevents and life expectancy are reduced(2,4-6).According to guidelines, symptomatic pa-tients with severe MR should be submittedto surgery(7,8).

Euro Heart survey showed that up to 50%of symptomatic patients hospitalized withthe diagnosis of severe MR, are not referredto surgery due to the perceived risk of theprocedure (1). To reduce the invasiveness ofthe surgical approach, different types oftrans-catheter procedures are becomingavailable (table 1). The MitraClip proce-dure (Abbott Vascular Inc. Menlo Park,CA) is yet the only catheter based proce-dure available in clinical practice at the mo-ment. This device is designed to resemble atechnique originally introduced by Alfieri(9), the double orifice repair. This is a sur-gical method to treat MR that has beenused to treat either DMR (Degenerative )or FMR (Functional) (9-12) with excellent re-sults.

Indication and timing of intervention is acrucial step in the diagnostic-therapeuticpathway of patients with mitral regurgita-tion. Since Mitraclip is avaible selection be-tween surgical and interventional treatmentis an emerging clinical challenge. Overalldecision making is strongly influenced byanatomical and clinical factors (table 2).Generally, MitraClip is effective in treatingeither type II or IIIb dysfunction. On theother hand, type IIIa mitral dysfunction is acontraindication for the MitraClip proce-dure due to the risk of inducing mitralstenosis.

The Mitraclip device has been evaluated ina number of preclinical studies, registriesand in FDA approved clinical trials. (EVER-

EST trial, ACCESS-EU trial) (13-16).

Degenerative mitral regurgitation (DMR) isthe most common etiology of organic MRand the most common pathology treated bysurgeons according to Euroheart survey.Valve repair is the gold standard surgicaltreatment of chronic degenerative MR withmitral valve replacement being exceptionaltoday in high volume centers(17).When repairis successfully performed, functional recov-ery and life expectancy are restored and arecomparable to the general population.

Soon after the first in man experience(2003), the Endovascular Valve Edge-to-Edge REpair Study (EVEREST) was initiat-ed in the United States. Although the thistrial suggested that MitraClip is superior tosurgery in terms of safety and non-inferiorin terms of efficacy, the results are still notconvincing enough to advocate MitraCliptreatment in low risk patients with DMR.In our clinical practice patients with DMRaccounts for 19/62 pts (31%) treated withMitraClip. Despite the suboptimal MR re-duction in 20% of patients, clinical improve-ment was obtained in the majority of pa-tients, including those with residual MR.According to it, MitraClip therapy is indi-cated in those DMR patients with high sur-gical risk and ideal anatomy for clip implan-tation (according to EVEREST criteria). Inselected patients with high surgical risk andsuboptimal anatomical criteria the proce-dure can be undertaken, but realizing thatit could be unsuccessful or suboptimal.However, in these patients it is not uncom-mon to observe a significant improvementof symptoms even in case of sub-optimal re-sult (residual MR grade 2+ or 3-4+). Thismismatch between hemodynamic result andclinical benefit could be related to the inac-curacy of the current semiquantitativemethods of assessment of residual MR.

Denti, P.

Mitraclips and beyond

Differently from DMR, in FMR there arenot intrinsic valve lesions: MR is the effectof left ventricular dysfunction and deforma-tion. Surgical correction of FMR is usuallyobtained by simply over-reducing the annu-lar dimensions with undersized rings. The

addition of edge-to-edge suture to under-sized annuloplasty has been associated withincreased durability and reduced risk of re-current mitral regurgitation (18) This con-cept has been used as a background for theuse of MitraClip in FMR. Unfortunately,surgical treatment of FMR is associatedwith significant operative and 30 days mor-tality risk. Trans-catheter valve interventionslower the risk and carry the potential for anearlier approach, compared to surgery. Inour clinical practice patients with FMR ac-counts for 69% of all 62 patients treatedwith MitraClip. FMR is currently the mainindication for MitraClip for a variety of rea-sons. The procedure is technically less de-manding and it is offered to patients whoare often denied surgery, being the opera-tive risk of surgery well above 5% for de-pressed left ventricular function.

Since its introduction in Europe, data havebeen collected in the ACCESS post-marketregistry. The enrollment is ongoing andlimited data is available at the moment.Initial reports(19) suggest that risk profile ofpatients currently treated in Europe is dif-ferent from the patients enrolled in theEVEREST trial. Average Euroscore isaround 20%, and most patients have lowejection fraction and FMR. Also the risk ofthe procedure remains low (hospital mortal-ity 3%) despite most patients treated haveseverely depressed left ventricular function. Although the initial results of MitraClip arevery encouraging, we are left with severalopen issues. Little is known about durabili-ty, particularly in patients with suboptimalanatomy. These patients have not beenstudied in the EVEREST trial and the datafrom ACCESS, although useful for hypoth-esis generation, will not be as reliable asthose of the trial, since they are not core labadjudicated. Other issues include the feasi-bility of mitral repair at a later stage if recur-rent MR occurs, the clinical benefit inFMR, as well as the relative role ofMitraClip compared to the other heart fail-ure treatments (medical therapy, CRT, ven-tricular assist devices). But the most criticalissue at this moment, when evaluating therole of the percutaneous treatment of MR,

3629

P. Denti.- Mitraclips and beyondTécnicas Endovasculares Vol.XIV. Núm. 1. Enero-Abril 2011; 3628-3631

LEAFLET REPAIR

• MitraClip (Abbott Vascular)• Mobius (Edwards)• Neochord• Percu-Pro (leaflet spacer)• Thermocool (leaflet ablation)

CHINCHING DEVICES

• PS3 (Ample Medical)• I-Coapsys

DIRECT ANNULOPLASTY

• Mitralign• Guidant• Guided delivery systems• ValtechCardio - Cardioband • Millipede

RADIOFREQUENCY BASED REMODELING

• Q-care (Quantum Cor)†• ReCor

CORONARY SINUS ANNULOPLASTY

• Monarc (Edwards Lifesciences)• Percutaneous transvenous mitral annuloplasty

(PTMA) (Viacor)• Carillon - Cardiac Dimensions• St Jude

MITRAL VALVE REPLACEMENT

• Endovalve-Herrmann prosthesis(Right mini-thoracotomy)

• CardiaAQ (Transseptal)• Mitraltech (transseptal)• Medtronic (unknown)• Lutter prosthesis (Transapical)

TABLE I. PERCUTANEOUS DEVICES FORMITRAL VALVE REPAIR

3630


is that only MitraClip is available to correctMR in clinical practice. Due to the strictanatomical criteria, several patients cannotbe treated percutaneously at the moment.In particular the lack of a reliable annulo-plasty device is probably the most impor-tant limitation to the expansion of the per-cutaneous mitral valve intervention field.The addition of annuloplasty is associatedwith more durable surgical results(20). Whenpercutaneous annuloplasty will becomeavailable, most patients will becomeamenable to percutaneous interventions(from a pure anatomical standpoint). Butmore devices are under evaluation (Table1), and will further expand the indicationsfor transcatheter interventions. Neochordaeimplantation, as an example, will further ex-pand the reparability of complex myxoma-

tous valves with multiscallop disease. Alsonew devices for percutaneous ring implanta-tion are under evaluation. Finally, tran-scatheter mitral valve implantation will bedeveloped in the next future to completethe therapeutic portfolio, potentially ex-panding the indications to patients withrheumatic disease and to those with anato-my unsuitable for repair. There are still sev-eral obstacles to the development of a reli-able device for transcatheter mitral valve im-plantation. Compared to the aortic valve,the mitral valve anatomy is more complex,and far from a cylindrical geometry.Moreover, the larger size of the annuluscompared to the aortic valve prevents theuse of conventional stent technology.Anchoring of the implant is another chal-lenge, since radial force cannot be applied

EVEREST KEY INCLUSION CRITERIA

• Candidate for mitral valve repair or replacement surgery• Moderate to severe (3+) or severe (4+) chronic mitral valve regurgitation and symptomatic with LVEF >25% andLVID-s !55 mm or asymptomatic with 1 or more of the following:

-LVEF >25% to 60%-LVID-s "40 to 55 mm-New onset of atrial fibrillation-Pulmonary hypertension defined as pulmonary artery systolic pressure >50 mm Hg at rest or >60 mm Hgwith exercise.

EVEREST KEY EXCLUSION CRITERIA

• Recent myocardial infarction• Any interventional or surgical procedure within 30 days of the index procedure• Mitral valve orifice area <4 cm2

• Renal insufficiency, endocarditis, rheumatic heart disease• Previous mediastinal surgery in the first 27 patients

EVEREST KEY AUTOMATICAL CRITERIA

• Flail gap > 10 mm• Flail width < 15 mm• Coaptation deth < 11 mm• Coaptation length ! 2 mm

TABLE II.

Indications criteria for inclusion in the EVEREST I and II pivotal trials, from Feldman et al. JACC 2009.(16) LVEF = left ventricular ejection fraction; LVID-s= left ventricular internal diameter-systole.

3631


for the large dimensions of the valve andbecause a real annulus does not exist, nei-ther is usually calcified, as for the aorticvalve. Using radial force would be subopti-mal also due to the risk of impingement in-to the aortic valve. The anatomy of the mi-tral valve is totally asymmetric, therefore mi-tral implantation devices should be designedto accommodate this feature. In particular,the anterior leaflet of the mitral valve is di-rected towards the left ventricular outflowtract. A mitral implant should take care ofthe anterior leaflet and should not protrudein the outflow tract to avoid obstruction.Last but not least, if perivalvular leaks aretolerated in the aortic position, they will notbe acceptable in the mitral position, sincethey will be more hemodynamically signifi-cant and may induce severe hemolysis.

For all these reasons, it will be take a whilebefore mitral valve implantation will be-come available and will provide reliable re-sults. In the meanwhile, percutaneous mi-tral valve repair will evolve with the poten-tial to become a real alternative to surgery.

Conclusions

A relevant number of patients in need ofMR reduction do not undergo surgery be-cause of a high perioperative risk. To date,MitraClip therapy has only been assessed intrials where patients with a normal surgicalrisk and stringent valvular and ventricularsuitability criteria were enrolled. However,current practice suggests that higher risk pa-tients can be treated with reasonable riskprofile.

The procedure is quite predictable in pa-tients with favorable anatomy according tothe EVEREST criteria. In patients with sub-optimal anatomy, if the risk of surgery is toohigh, MitraClip is indicated, but at the costof higher risk of complications and with lesschance of a successful implant. The intro-duction of additional technologies will ex-pand the indications of percutaneous mitralinterventions, and will further improve thetherapeutic options for patients with MR.

REFERENCES

Mirabel M, Iung B, Baron G, et al. What are the characteris-tics of patients with severe, symptomatic, mitral regurgitationwho are denied surgery? European Heart Journal2007;28:1358-1365.Bursi F, Enriquez-Sarano M, Nkomo VT, et al. Heart Failureand Death After Myocardial Infarction in the Community:The Emerging Role of Mitral Regurgitation. Circulation2005;111:295-301.Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, ScottCG, Enriquez-Sarano M. Burden of valvular heart diseases: apopulation-based study. Lancet 2006;368:1005-1011.Ling LH, Enriquez-Sarano M, Seward JB, et al. Clinical out-come of mitral regurgitation due to flail leaflet. N Engl J Med1996;335:1417.Avierinos J-F, Gersh BJ, Melton LJ, III, et al. Natural Historyof Asymptomatic Mitral Valve Prolapse in the Community.Circulation 2002;106:1355-1361.Grigioni F, Enriquez-Sarano M, Zehr KJ, Bailey KR, TajikAJ. Ischemic Mitral Regurgitation : Long-Term Outcome andPrognostic Implications With Quantitative Doppler Assess-ment. Circulation 2001;103:1759-1764.Bonow RO, Carabello BA, Chatterjee K, et al. ACC/AHA2006 Guidelines for the Management of Patients With Valvu-lar Heart Disease: A Report of the American College of Car-diology/American Heart Association Task Force on PracticeGuidelines (Writing Committee to Revise the 1998 Guide-lines for the Management of Patients With Valvular HeartDisease): Developed in Collaboration With the Society ofCardiovascular Anesthesiologists: Endorsed by the Societyfor Cardiovascular Angiography and Interventions and theSociety of Thoracic Surgeons. Circulation 2006;114:e84-231.Vahanian A, Baumgartner H, Bax J, et al. Guidelines on themanagement of valvular heart disease. Eur Heart J2007;28:230-268.Fucci C, Sandrelli L, Pardini A, Torracca L, Ferrari M,Alfieri O. Improved results with mitral valve repair usingnew surgical techniques. Eur J Cardiothorac Surg1995;9:621-6 discuss 626-7.Alfieri O, Maisano F, De Bonis M, et al. The double-orificetechnique in mitral valve repair: a simple solution for com-plex problems. J Thorac Cardiovasc Surg 2001;122:674-81.Bhudia SK, McCarthy PM, Smedira NG, Lam BK,Rajeswaran J, Blackstone EH. Edge-to-edge (Alfieri) mitralrepair: results in diverse clinical settings. Ann Thorac Surg2004;77:1598-606.Maisano F, Torracca L, Oppizzi M, et al. The edge-to-edgetechnique: a simplified method to correct mitral insufficiency.Eur J Cardiothorac Surg 1998;13:240-5; discussion 245-6.Condado JA, Acquatella H, Rodriguez L, Whitlow P, Velez-Gimo M, St Goar FG. Percutaneous edge-to-edge mitralvalve repair: 2-year follow-up in the first human case.Catheter Cardiovasc Interv 2006;67:323-5.Feldman T, Kar S, Rinaldi M, et al. Percutaneous mitralrepair with the MitraClip system: safety and midterm durabil-ity in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol 2009;54:686-94.Feldman T. Endovascular valve edge-to-edge repair study(EVEREST II) randomized clinical trial: Primary safety andEfficacy endpoints. American College of Cardiology (ACC)Meeting, 14 March 2010, Atlanta, GA. 2010.Feldman T. EVEREST II Randomized Clinical Trial Update:Two Year Outcomes Degenerative vs Functional MR.EuroPCR Meeting, 25 May 2010, Paris. 2010.Gillinov AM, Cosgrove DM, Blackstone EH, et al. Durabilityof mitral valve repair for degenerative disease. J Thorac Car-diovasc Surg 1998;116:734-743.De Bonis M, Lapenna E, La Canna G, et al. Mitral valverepair for functional mitral regurgitation in end-stage dilatedcardiomyopathy: role of the” edge-to-edge” technique. Circu-lation 2005;112.Maisano F. Data from the European ACCESS registry: whatpatients have been treated in Europe. Transcatheter Cardio-vascular Therapeutics (TCT) Meeting, 21–25 September2010, Washington, DC. 2010.Maisano F, Caldarola A, Blasio A, De Bonis M, La Canna G,Alfieri O.Midterm results of edge-to-edge mitral valve repairwithout annuloplasty. J Thorac Cardiovasc Surg. 2003Dec;126(6):1987-97.

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The sympathetic nervous system via its ef-fect on the kidney maintains a key role inblood pressure regulation and in the patho-genesis of hypertension. In turn, the kidneyreceives a dense innervation of afferent sym-pathetic fibers allowing it to effectivelymodulate the sympathetic tone. Hence, thekidney can be both culprit and victim of in-creased sympathetic activity. In addition,conditions such as congestive heart failure,chronic renal failure or the metabolic syn-drome are associated with an increased sym-pathetic activity whether or not hyperten-sion is present.

On this account, both the sympathetic ner-vous system and the kidney were identifiedas potential therapeutic targets in the treat-ment of hypertension and other conditionsassociated with a high sympathetic tone.Initial investigations focused on surgical re-moval of the sympathetic trunk, unfortu-nately accompanied by operative mortalityand major side effects. More specific meth-ods of disrupting interactions between thesympathetic nervous system and the kidneyswere subsequently explored including theremoval of diseased kidneys and, more re-cently, minimally invasive severance of therenal sympathetic nerves. Currently, mosthypertensive patients can be treated by ef-fective antihypertensive drugs. Notwith-standing, a small group of hypertensive pa-tients remains suboptimally controlled de-spite identification of potential causes andappropriate treatment. In this group an ele-vated sympathetic tone may be a significantcontributor to treatment resistance and se-

lective renal sympathectomy may be benefi-cial.

The kidney regulates arterial pressure andvolume by pressure natriuresis. By this prin-ciple, changes in sodium and volume intakeare counterbalanced by adjustments intubular sodium reabsorption. Likewise,blood pressure changes mediated, for exam-ple, by variations in peripheral arterial resis-tance are counterbalanced by appropriatechanges in sodium reabsorption. Thismechanism is intrinsic to the kidney and oc-curs in the absence of extrinsic neurohor-monal influences. The feedback response isset such that the blood pressure will remainlargely unaffected by variations in sodiumand volume intake or by changes in periph-eral arterial resistance.

In addition, renal juxtaglomerular epith-eloid cells synthesize renin, the key enzymeof the renin-angiotensin-aldosterone cas-cade. It is released into the intravascularspace and interstitium by afferent arterioles.Renin converts angiotensinogen to an-giotensin I which is converted to an-giotensin II in the lungs and elsewhere.Angiotensin II is one of the most potent di-rect vasoconstrictors and, via enhancementof mineralocorticoid hormone productionsuch as aldosterone it stimulates renal tubu-lar sodium reabsorption thereby modifyingthe pressure natriuresis response.Furthermore, angiotensin II activates thesympathetic response by norepinephrine-re-uptake inhibition. The renin-angiotensin-al-dosterone system (RAAS) therefore influ-

Id, D.; Kaltenbach, B.; Wunderlich, N.; Sievert, H.

Cardiovascular Center, Frankfurt, Germany.

Periarterial renal radiofrequency:indications, technique and earlyclinical results

3633

D. Id, et al.- Periarterial renal radiofrrequency: indications,technique and early clinical results


ences vascular resistance, sodium balance,extracellular fluid volume and sympatheticactivity. The sympathetic nervous system isa major contributor to hypertension initia-tion and sustenance via its influence on re-nal blood flow, glomerular filtration rate,renin release, and urinary sodium and waterbalance regulation.

The kidney is innervated by a network ofpostganglionic sympathetic neurons arisingfrom the thoracic and lumbar spine.Likewise, it communicates with autonomiccenters in the central nervous system by af-ferent sympathetic neurons. Both efferentand afferent fibers enter and exit the kid-neys within the adventitia alongside the re-nal arteries.

Efferent renal sympathetic nerves releasenorepinephrine as the primary transmitterand innervate the preglomerular and post-glomerular vasculature, all elements of thejuxtaglomerular apparatus and virtually allsegments of the nephron in both corticaland medullo-papillary regions.

An increase in efferent renal sympatheticnerve activity causes renal vasoconstrictionwith subsequent reduction in renal bloodflow, renal tubular sodium reabsorption,renin release and thereby activation of therenin-angiotensin-aldosterone cascade, andrelease of catecholamines and other vasoac-tive substances all of which lead to a bloodpressure increase.

The activation of the above mechanisms ap-pears to be dependent on the intensity ofthe renal sympathetic nerve signal. It is important to recognize that the kidneysare richly innervated not only by sympathet-ic efferent fibers but also by sensory afferentfibers that communicate pressure and elec-trolyte changes to the central nervous sys-tem.

These afferent fibers originate in the kidney.The cell bodies are located in the dorsalroot ganglia and are connected via thespinal cord to the autonomic centers in thecentral nervous system (mainly within the

paraventral nucleus of the hypothalamus).They contain substance P, calcitonin gene-related peptide and adenosine as the prima-ry neurotransmitte. Furthermore, afferentfibers are coupled to the efferent sympa-thetic fibers of the contralateral kidney andthereby coordinate the excretory functionbetween the two kidneys through reno-re-nal reflexes. Signals are transmitted to thespinal cord and central nervous system viaafferent fibers located (together with the ef-ferent fibers) in the renal arterial wall.

Adverse conditions such as ischemia or hy-poxemia result in an increase in renal affer-ent nerve activity. Renal afferent nerve ac-tivity, on the other hand, by modulatingposterior hypothalamic activity, directly in-fluences overall sympathetic adrenergic dri-ve (to the kidneys and other highly inner-vated organs such as the heart and peripher-al vasculature).

The denervation of the renal sympatheticnerves was performed with a specifically de-signed catheter (Ardian Symplicity®Catheter), providing an insulated arch wireto position the electrode at the vessel walland an electrode on its tip connected to aradiofrequency generator. The radiofre-quency catheter was positioned into the re-nal artery via a 5 French guide catheter,both of which are generally deliveredthrough an 8 French renal guide catheter.Once the tip of the catheter was positionedappropriately at the renal artery wall ra-diofrequency was applied. The sympatheticnerves are particularly sensitive to radiofre-quency energy and at the energy levels ap-plied are disrupted without affecting thesurrounding tissue.

Prior to the procedure, anticoagulation wasinitiated and maintained aiming for an ACTbetween 250-200 seconds. Analgesics andnarcotics were routinely administered as theintended injury of renal afferent sympathet-ic nerves is invariably associated with diffuseabdominal discomfort. After access via thefemoral artery and confirmation of anatom-ic eligibility with renal angiography, the ra-diofrequency ablation catheter was inserted

3634



into each renal artery, and the radiofre-quency ablations of 8 watt or less lasting 2minutes each were applied to achieve atleast 5 ablations for an optimal result.Catheter tip temperature and impedancewere constantly monitored during the abla-tion procedure and delivery of the radiofre-quency was regulated according to a prede-termined algorithm. In case of reduced re-nal blood flow, catheter tip temperaturemay rise to greater than 75ºC due to a de-creased cooling effect of the blood causingautomatic deactivation of the radiofrequen-cy generator and thereby preventing dam-age to surrounding tissue. The energy de-livered was several magnitudes lower thanthat used for radiofrequency ablation of thepulmonary veins in patients with atrial fib-rillation. Upon completion and removal ofthe radiofrequency catheter, either manualcompression or closure devices were used toachieve hemostasis at the puncture site.After the procedure no specific medicationswere required and the previous antihyper-tensive regimen was continued. Treated pa-tients were usually discharged from hospitalthe following day. Periodic follow-up toone year with blood pressure reassessmentand determination of the number of antihy-pertensive medications was mandatory. Toexplore the feasibility, safety and efficacy of

selective renal sympathectomy via a ra-diofrequency catheter positioned into therenal arteries percutaneously, in 2007, thenon-randomized prospective SimplicityHTN-1 trial was initiated. Patients with re-sistant hypertension and suitable renalartery anatomy (bilateral single renal arter-ies with a minimal diameter and length of4mm and 20 mm respectively) were en-rolled. 138 patients were included andtreated as described above. At baseline, theaverage arterial office blood pressure was176/98 mmHg despite a mean of 5.0 anti-hypertensive drugs. The data of 138 pa-tients who underwent selective catheter-based sympathectomy with follow-up to 24months confirm the favorable blood pres-sure response and durability of the results(figure 1).

The Symplicity HTN-2 trial was an interna-tional, multi-center, prospective, random-ized, controlled study in patients with un-controlled hypertension. 106 patients wereenrolled from 24 investigational sites. Atbaseline, the randomized treatment andcontrol patients had similar high bloodpressures: 178/97 mmHg and 178/98mmHg, respectively, despite both receivingan average daily regimen of 5 antihyperten-sive medications. After six months, the aver-

Fig. 1. Results of office blood presure change after treatment with perairterial renal radiofrequency (Simplicity HTN-1 trial).

3635

age blood pressure of the renal denervationgroup was reduced to 146/85 mmHg,compared to an average blood pressure of179/98 mmHg for the control group (fig-ure 2 and 3).

The results of the multi-center prospective,randomized, controlled Symplicity HTN-2trial demonstrate that catheter-based renaldenervation is safe and results in substantialreductions of blood pressure in patients

with uncontrolled hypertension. These re-sults confirm the findings of the previouslypublished and presented results of the mul-ti-center, single-arm Symplicity HTN-1study, which demonstrated the longer termsafety and the durable benefit of catheter-based renal denervation. The trials foundthat the therapy has no serious device orprocedure-related events, no cardiovascularcomplications and no kidney-related com-plications.



Fig. 2. Results of office blood presure change after treatment with perairterial renal radiofrequency(n=49, Simplicity HTN-2 trial).

Fig. 3. Results of office blood presure changes in the control group (n=51,Simplicity HTN-2 trial).

3636

Visceral artery aneurysms represent a rareclinical entity. Once considered uncom-mon, they are now being diagnosed withincreasing frequency. This increasing inci-dence is caused by the more frequent use ofcomputed tomography (CT), magnetic re-sonance imaging, and ultrasound. Theseaneurysms are important to recognize be-cause up to 25% may be complicated byrupture, and the mortality rate after ruptureis between 25% and 70%, depending on thelocation of the aneurysm.

However, little is known about the naturalhistory and clinical presentation of visceralartery aneurysms and therefore controversystill exists regarding their treatment. Thedecision for intervention has to take intoaccount the size and the natural history ofthe lesion, the risk of rupture, which is highduring pregnancy, and the relative risk ofsurgical or endovascular intervention. Formost asymptomatic aneurysms, conservativetreatment is acceptable. For larger (>2 cmin diameter) aneurysms, aneurysms that de-monstrate growth, and symptomaticaneurysms treatment is advisable.Diagnostic radiology plays a major role inthe detection and characterization of visce-

ral artery aneurysms. Cross-sectional ima-ging can help exclude aneurysm rupture,which requires emergent treatment. CT an-giography or catheter angiography can cle-arly depict the aneurysm and help identifyother aortic, visceral, or peripheralaneurysms. Most important, radiologic exa-mination can help determine the adequacyof the collateral blood supply to the vascu-lar bed distal to the aneurysm, informationthat is essential prior to the initiation of en-dovascular treatment. Advances in endovas-cular therapy have allowed interventionaliststo contribute to the management of visceralartery aneurysms.

Coil embolization or covered stent place-ment as well as flow-diverting devices cannow be used to treat patients withaneurysms whose size or location wouldmake a surgical approach problematic, aswell as patients in whom surgery is conside-red to pose considerable risk. Surgical treat-ment can consist of aneurysm exclusion (li-gation), excision, or revascularization. Thispaper will discuss patient diagnostic work-up, and will give tips to properly select tre-atment modality and help in device selec-tion.

Van den Berg, J.

Ptient and device selection forendovascular repair of visceralaneurysms and dissections

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Renal dysfunction following EVAR andother interventional, abdominal proceduresis multi-factorial in origin. Iodinated con-trast agents used during transluminal inter-vention are likely a major factor in causingrenal dysfunction following EVAR. Thedeterioration in renal function after EVARrequires the use of methods that may redu-ce perioperative renal toxicity. Avoidingiodinated contrast agents in patients withpre-existing renal insufficiency or allergy toiodinated media, could reduce the risk ofdeterioration in renal function and allergicreactions to contrast during EVAR.

Carbon dioxide (CO2) is an extremely safenegative contrast agent, vastly under-utili-zed by vascular surgeons and other inter-ventionalists. Carbon dioxide is not neph-ro-toxic, is not allergenic, and when usedwith adequate digital subtraction angio-graphic technique provides excellent angio-graphic images of the abdominal aorta andits branches. Carbon dioxide has extremelylow viscosity (less than 400 times that ofiodinated contrast material), a unique pro-perty that allows effective injection of highvolume rates of carbon dioxide through

extremely small catheters, and virtual spacessuch as those existing between the compo-nents of coaxial transluminal devices. Ourexperience with CO2 for EVAR guidance inmore than 100 consecutive procedures,included 96 patients with mild to severereduction in glomerular filtration rate(GFR). Postoperatively, this group ofpatients did no experience any significantdecrease in the GFR, and had no increase indelayed endoleak detection or in require-ment for additional intervention. Our expe-rience suggests that CO2 guided EVAR istechnically feasible and safe, and does notproduce significant renal toxicity even inpatients with pre-existing renaldysfunction.

REFERENCESCriado E, Kabbani L, Cho K. Catheter-less Angiography forEndovascular Aortic Aneurysm Repair: A new application ofCarbon Dioxide as a Contrast Agent. J Vasc Surgery 2008;48:527-534.

Knipp BS, Escobar G, English S, Upchurch GR,Jr., Criado E.Endovascular Repair of Ruptured Aortic Aneurysms UsingCarbon Dioxide Contrast Angiography. Annals of VascularSurgery, 2010, in press.

Criado, E.

Professor of Surgery, University of Michigan, School of Medicine, Ann Arbor, Michigan, USA.

Carbon dioxide angiography forendovascular abdominalprocedures

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Proximal lesions of the supraortic vessels arerare compared to i.e. lesions of the carotidbulb/proximal internal carotid artery.However, access for open surgical revascu-larization of proximal arterial obstructionsometimes requires a major exposure.

Indications are important: asymptomaticocclusion should probably not be treatedno matter at which position. Non-hemi-spheric symptoms in a patient with proxi-mal obstruction of one or more of thecarotids/vertebrals should probably only be

treated if cerebral blood flow is compro-mised as evaluated by stimulation tests.

There are no good scientific data to supportwhether open surgical or endovascularapproach is first option for treatment ofproximal lesions of the supra-aortic vessels.However, given the morbidity associatedwith major exposure i.e. by sternum split,endovascular approach will often be attrac-tive. However, in some cases, i.e. occlusionof the left subclavian, open surgical repairremains a good first choice.

Sillesen, H.

Chairman, Dept. of Vascular Surgery, Rigshospitalet, University of Copenhagen, Denmark.

Endovascular recanalizationshould be first opinion forproximal lesions

Transluminal intervention has an importantrole in the management of patients withvascular compression at the thoracic outletas an adjunct to surgical decompression.During the last five years we have treated72 patients presenting with predominantly

arterial (34) or venous (38) compression atthe thoracic outlet. Among the arterial cas-es, 7 (21%) underwent catheter directed ar-terial thrombolysis and/or surgicalthrombectomy prior to thoracic outlet de-compression. All patients underwent arterial

Criado, E.; Young, K.; Bertha, B.; Baker, N.

Cardiovascular Center. University of Michigan. School of Medicine, Ann Arbor, Michigan, USA

Endovascular therapy in thoracicoutlet syndrome: Benefits andlimitations

Carotid Stenting Trialists’Collaboration (CSTC)

Recent randomized controlled trials com-paring carotid artery stenting (CAS) withendarterectomy (CEA) for the treatment ofsymptomatic carotid stenosis were not pow-ered to investigate differences in risks inspecific patient subgroups.

A pooled analysis of individual patient datafrom the Symptomatic Severe CarotidStenosis trial (EVA-3S), the Stent-ProtectedAngioplasty versus Carotid Endarterectomytrial (SPACE), and the International

Carotid Stenting Study (ICSS) was there-fore performed.

Individual data from all 3433 patients ran-domized and analyzed in these trials werepooled and analyzed with fixed-effect bino-mial regression models adjusted for sourcetrial. The primary outcome event was anystroke or death.

In the first 120 days after randomization(ITT analysis), the primary outcome eventoccurred in 153/1725 patients in the CASgroup (8 9%) compared with 99/1708 pa-tients in the CEA group (5 8%, risk ratio

Fraedrich, G.

Innsbruck

Current evidence review on CASfor symptomatic patient

3639

decompression with rib resection, with si-multaneous arterial reconstruction in 9(26%) cases. At three months to five yearsof follow-up, all decompressed arteries re-mained patent, and none required addition-al transluminal intervention or surgical revision.

Among the 38 patients with venous com-pression at the thoracic outlet, 37 presentedwith acute axillo-subclavian vein thrombosisand one with subclavian vein stenosis.

Twenty-eight patients (74%) underwentemergency catheter directed venous throm-bolysis one day to one year prior to surgicaldecompression of the thoracic outlet, while10 patients (26%) were initially treated withanticoagulation only.

The final, comprehensive treatment in allpatients was first rib resection with simulta-neous intraoperative, transluminal dilatationof the subclavian vein. Additional intraoper-ative mechanical/chemical, catheter direct-ed thrombolysis was required in 8 (21%) pa-tients. Immediate postoperative subclavianvein re-thrombosis occurred in 7 (18%) pa-tients. Additional catheter directed mechan-ical/chemical thrombolysis was successful intreating 6 of the 7 recurrent thromboses,with only one patient undergoing stentingof the subclavian vein. Following interven-tion, all patients were placed on Coumadintherapy for 6 months. Overall, the axillo-subclavian vein segment remained patent in37 (97%) patients, and no recurrent throm-boses were identified during the follow-upperiod.

E. Criado et al.- Endovascular therapy in thoracic outlet syndrome: benefits and limitations


3640

[RR] 1 53, 95% confidence interval [CI]1 20-1 95, p=0 0006; absolute risk differ-ence 3 2, 95% CI 1 4-4 9). Age was the on-ly subgroup variable which significantlymodified the treatment effect: in patients<70 years old (the median age), the 120-day stroke or death risk was 5 8% in CASand 5 7% in CEA (RR 1 01, CI 0 68-1 47);in patients 70 years or older, there was anestimated twofold increase in risk with CASover CEA (12 0% versus 5 9%, RR 2 04,1 48-2 82, interaction p=0 0053) (Figure).Patients who underwent CAS within twoweeks of their most recent clinical eventwere at an almost three times higher risk ofstroke and death (RR 2.7, CI 1.4-5.5)compared to CEA. (Carotid StentingTrialists’ Collaboration: Lancet2010;376:1062)

Endarterectomy was safer in the short-termthan stenting, because of an increased riskof stroke associated with stenting in patientsover the age of 70 years. Stenting should beavoided in older patients, but may be as safeas endarterectomy in younger patients.Determination of the efficacy and ultimatebalance between the two procedures re-quires further data on long-term stroke re-currence.

CSTC data compared to the CRESTfindings

The CSTC results should be put into thecontext of the latest published randomisedevidence from the Carotid RevascularisationEndarterectomy Versus Stenting Trial.CREST’s conclusion of a similar benefit be-tween both procedures was driven by theinclusion of even silent myocardial infarc-tion in the composite endpoints. When 30-day outcomes in symptomatic patients(n=1321) were analysed with regard to theendpoints of the European trials (periopera-tive stroke and death) CAS was associatedwith a doubling of the risk for these end-points (6.0% vs 3.2%, HR 1.9, CI 1.1-3.2).Corroborating the CSTC findings the pro-cedural risks following CAS were nearlyequivalent to CEA in patients < 70 years,

while CAS was significantly inferior to CEAin patients older than 70 years in CREST.(Brott T.G. et al: New Engl J Med2010;363:11)

Conclusion

In summarizing these actual meta-analysesincluding nearly 5000 symptomatic patientsit should be concluded that CEA is saferthan CAS, particularly in patients older than70 years. In younger patients CAS could beas safe as CEA, but this has to be shown instudies evaluating long-term restenosisrates. At present knowledge CEA should beconsidered the gold standard, including pa-tients younger than 70 years.

G. Fraedrich.- Current evidence review on CAS for symptomatic patientTécnicas Endovasculares Vol.XIV. Núm. 1. Enero-Abril 2011; 3639-3640

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Criado, F.

Should CREST results enourageCAS defenders?

The CREST Trial reflects the best of evi-dence-based Medicine. Both CAS and CEAperformed in an exemplary fashion, speak-ing –among other things – of the extremelyhigh quality operators involved on both thestenting and surgical arms of the study.

There is little doubt CEA emerged (again)as the superior form of therapy for themajority of patients. However, the truth betold, CAS also performed quite well, andreally better than most of us would haveanticipated.

We are left now with a situation that isclearly better than it was in the past as wehave at our disposal 2 valid and satisfactorytreatment options.

But care must be exercised at the timechoosing one versus the other modality,and we must resist the attempts at unfairinduction in one direction or the otherfrom various specialists who are clearly try-ing to spin the CREST results in a way thatappears most favorable from their biasedperspective and unique background.

Cao, P.

U.O.C. Chirurgia Vascolare, Ospedale S. Camilo-Forlanini, Roma, Italy.

Current evidence does not affect mypractice in symptomatic patients

ObjectivesThis study sought to evaluate long-termoutcomes of carotid stenting (CAS) versuscarotid endarterectomy (CEA) based onphysician-guided indications.

BackgroundThe issue regarding long-term outcome ofCAS versus CEA in patients with carotidstenosis is clinically relevant but remainsunsettled.

MethodsConsecutive patients (71% men, mean age71.3 years) treated by CEA (n=1,118) orCAS (n=1,084) after a training phase werereviewed. Selection of treatment was basedon better-suitability characteristics (mor-phology and clinical).

Data were adjusted with propensity scoreanalysis and stratified by symptoms, age,and sex.

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P. Cao.- Current evidence does not affect my practice insymptomatic patients


ResultsThirty-day stroke/death rates were similar:2.8% in CAS and 2.0% in CEA (p=0.27).The risk was higher in symptomatic (3.5%)versus asymptomatic (2.0%) patients(p=0.04) but without significant differencebetween CAS and CEA groups. Five-yearsurvival rates were 82.0% in CAS and 87.7%in CEA (p=0.05). Kaplan-Meier estimatesof the composite of any periproceduralstroke/death and ipsilateral stroke at 5years after the procedure were similar, in allpatients (4.7% vs. 3.7%; p=0.4) and the sub-groups of symptomatic (8.7% vs. 4.9%;p=0.7) and asymptomatic (2.5% vs. 3.3%;

p=0.2) patients in CEA versus CAS, respec-tively. Cox analysis, adjusted by propensityscore, identified statin treatment (p=0.016)and symptomatic disease (p=0.003) associ-ated with the composite end point. Therewere no sex- or age-related significant out-come differences.

ConclusionsWhen physicians use their clinical judgmentto select the appropriate technique forcarotid revascularization CAS can offer effi-cacy and durability comparable to CEAwith benefits persisting at 5 years.

Gaines, P.

Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom.

Review of the recent CAS trialsand an interventionistsappraisal of them

IntroductionThere are a some simple concepts associatedwith carotid artery disease. Stroke can bedevastating for the patient and burdens so-ciety with huge cost. The intention of treat-ing carotid artery disease is to prevent fu-ture stroke and stroke associated death us-ing a technique that minimises risk.Unfortunately different specialities havetheir own view of carotid artery interven-tion. Open surgery is considered to be anenjoyable, technically challenging proce-dure. Carotid stenting is seen as the cuttingedge of endovascular therapy. Both in thecorrect environment bring financial reward.Both are presented with learned interpreta-tion to suite the speaker. To help clarify

how carotid endarterectomy (CEA) andcarotid artery stenting (CAS) compare withregard to those outcomes that matter to thepatient, 2 large trials have recently beencompleted and published. I will present thebare results and then give my perspectiveon how the data may be viewed.

ICSSThis international multicentre trial ran-domised 1713 recently symptomatic pa-tients, with a culprit ipsilateral internalcarotid artery stenosis, to either CAS orCEA. The preliminary results have beenpublished and consider early outcomes to120 days. The headline outcome is that thethe risk of stroke, death or procedural MI

3643

P. Gaines.- Review of the recent CAS trials and an interventionistsappraisal of them


was significantly higher in the CAS group -8.5% vs 5.2% (HR 1.69, 1.16-2.45,p=0.006). As ever, the results require rathermore dissection.

What matters to the patient and society i.e.major stroke and death, were not different.The dominant feature that changed theoutcome was the incidence of non-disablingstroke and death. In all major studies otherthan ICSS the number of non-disablingstrokes was at least twice the number of dis-abling strokes (Figure 1). But not on theper-protocol analysis in ICSS. Whilst fol-lowing CEA there were 14 disabling strokes, there were only 11 non-disabling strokes.Surely ascertainment bias is the only reason-able cause.

Neither is everyone happy with the way thatthe results are presented. If the bottom lineis to be major stroke and death, then fine.However, to include non-disabling neuro-logical events is also sound, but lets includethem all including cranial nerve palsy. Theargument that palsies are not important be-cause most are not disabling is fine, but thatalso applies to non-disabling stroke (hencethe name). So, count them all, or countneither, but do not count only one of a col-lection of non-disabling neurological event.If the trial were to set the bottom line atcounting all bad events in the per-protocolanalysis to include; important outcomes(death and disabling stroke), all the rest of

the adverse neurological events (non- dis-abling stroke and cranial nerve palsy) andprocedural MI, and major haemorrhagicmajor complications then we have 71 out-comes in the CAS group and 102 in theCEA group. An outcome that favoursCAS.

Hidden too within the trial are some gems.The trial is biased because the process toCAS is more efficient than to CEA. Thismeant that the time to treatment is quickerfor CAS, which is to be applauded. Weknow that this means that the initial out-comes will be worse but over all morestrokes will be prevented. Which probablyexplains the catch up for stroke preventioneven in the flawed EVA 3S trial. Forwomen, those presenting with amaurosisfugax, and for the younger patient the out-comes as defined by ICSS are equivalent.And for high volume centres the outcomeswere the same for all patients. It remains amystery to me why CAS needs to demon-strate superiority over CEA when the bene-fits of a minimally invasive approach areclear to all well informed patients.

CRESTThis multi-centre study randomised 2502patients with carotid disease to CAS orCEA. The chosen primary end-point was acomposite one that combined stroke, MIand death from any cause during the peri-procedural period, or any ipsilateral stroke

NON-DISABLING STROKE DISABLING STROKE RATIO

4

19

21

65

24

17

150

2

17

8

20

10

13

70

2

1.1

2.6

3.25

2.4

1.3

2.14

EVA 3S

SPACE

CREST

NASCET 50-69%

NASCET 70-99%

ECST

AVERAGE

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P. Gaines.- Review of the recent CAS trials and an interventionistsappraisal of them


out to 4 years follow-up. There was no dif-ference. In addition, the equivalence oftreatment was true when only the sympto-matic patients were reviewed. I have heardcommentators suggest that what matters isdeath and stroke and therefore the differ-ence favours CEA. Yet those commentatorschose the end-point and subsequently wishto ignore it. MI does matter. A subsequentpaper from the CREST team shows that if apatient suffers an MI during treatment thentheir life expectancy is significantly reduced.

On a personal note it was nice to see thatthe Interventional Radiologists had the bestoutcomes in those treated by CAS.

ConclusionsCAS has outcomes at least as good as CEA.The option for both treatments should begiven to patients.

We should spend time identifying groups ofpatients who may benefit more from oneparticular intervention.

Veith, F.

To my mind today: if I had asymptomatic carotid stenosis I wouldprefer a carotid endarterectomy

Background: Carotid artery stenting(CAS) is considered by many as an alterna-tive to carotid endarterectomy (CEA) forthe management of carotid artery stenosis.However, recent trials demonstrated infe-rior results for CAS in symptomatic patientscompared with CEA. We reviewed the lite-rature to evaluate the appropriateness ofCAS for symptomatic carotid artery stenosisand to determine the pathogenetic mecha-nism(s) associated with stroke following thetreatment of such lesions. Based on this, wepropose steps to improve the results of CASfor the treatment of symptomatic carotidstenosis.

Methods: PubMed/Medline was searchedup to March 25, 2010 for studies investiga-ting the efficacy of CAS for the manage-ment of symptomatic carotid stenosis.Search terms used were “carotid artery sten-ting,” “symptomatic carotid artery steno-sis,” “carotid endarterectomy,” “stroke,”

“recurrent carotid stenosis,” and “long-term results” in various combinations.

Results: Current data suggest that CAS isnot equivalent to CEA for the treatment ofsymptomatic carotid stenosis. Differences incarotid plaque morphology and a higherincidence of microemboli and cerebrovascu-lar events during and after CAS comparedwith CEA may account for these inferiorresults.

Conclusions: Currently, most symptomaticpatients are inappropriate candidates forCAS. Improved CAS technology referableto stent design and embolic protection stra-tegies may alter this conclusion in the futu-re.

Reference: Paraskevas KI, Mikhailidis DP, Veith FJ. Mecha-nisms to explain the poor results of carotid artery stenting(CAS) in symptomatic patients to date and options to improveCAS outcomes. J Vasc Surg 2010;52:1367-75.

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Introduction Carotid endarterectomy (CEA) and stent-ing (CAS) are widely accepted revascular-ization procedures in carotid atheroscleroticdisease. Authors concern on neurologicalmorbidity following CEA or CAS is mainlyfocused on TIAs or strokes detectionwhereas subclinical brain injuries are merelyreported. The clinical impact of silent is-chemic lesions within brain areas withoutprimary motor, sensory, or linguistic func-tion is debated1. However cumulative bur-den of ischemic brain injuries can causeneuropsychological deficits or aggravatevascular dementia2. Microemboli are knownto initiate an inflammatory response andcause brain dysfunction demonstrated bycognitive impairment3. Cognitive functionis being increasingly recognized as an im-portant outcome measure that affects pa-tient well-being and functional status4.While subtle brain injuries occurring duringor after carotid revascularization procedurescan be detected by the use of Diffusion-Weighted Magnetic Resonance Imaging(DW-MRI), neuropsychometric tests(NPMTs) can be useful in evaluating neu-rocognitive decline, thus allowing compari-son between the two findings5-12.

Furthermore subclinical neurological is-chemic events can be detected by measur-ing serum markers of brain injury. A varietyof biochemical markers of brain injury havebeen described. Among them neuron-spe-cific enolase (NSE) and the calcium-bindingprotein S100 have been demonstrated tobe markers of stroke in animal models13-14and human patients15-17.

We performed a study to assess the relation-ship between serum levels of S100 andNSE and post-operative DW-MRI andMini-Mental State Examination (MMSE)score in two groups of patients submittedto carotid revascularization by CEA or CASand to compare MMSE scores and DW-MRI findings at follow-up evaluations.

Patients and methods:

Patient PopulationBetween April 2008 and April 2009 60consecutive asymptomatic patients under-going elective carotid revascularization wererecruited to participate in this prospectivestudy. Inclusion criteria were the presenceof a carotid stenosis "70% (ECST stenosisevaluation criteria) with no previous neuro-logical symptoms referred in past historyand the absence of a previous brain is-chemic lesion detected at DW-MRI.

Exclusion criteria for entering the studywere the presence of previous neurologicalsymptoms related to carotid disease referredin past history, previous ischemic lesions de-tected at DW-MRI, inability to give con-sent.

Patients were allocated in the two treatmentgroups according to clinical and anatomiccriteria. CEA was performed under loco-regionalcervical anaesthesia by standard surgicalprotocol in 32 cases. Shunt was used in12.5 % of cases. Patch angioplasty was per-formed in 78% of cases.

Capoccia, L.1,2; Sbarigia, E.1; Rizzo, A.1; Mansour, W.1; Speziale, F.1

1. Vascular Surgery Division, Department of Surgery “Paride Stefanini”, Políclínico Umberto I, “Sapienza”.University of Rome, Italy.2. Vascular Surgery Division, Department of Surgery, S. Pietro Hospital, Rome, Italy.

The brain injury implications:Endarterectomy vs CAS

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CAS was performed with local anesthesia in28 cases. FilterWire (Boston Scientific,Natick, MA, USA ) embolic protection de-vice and Wallstent (Boston Scientific,Natick, MA, USA) were used in all patients.Technical success was achieved in all cases. All patients underwent DW-MRI pre-ope-ratively and at 24 hours in the post-operati-ve period. In the present series no patientshowed ischemic lesions at pre-operativeDW-MRI.

Patients were assessed with Mini-MentalState Examination (MMSE) test before sur-gery, within 24 hours from interventionand at the 6 and 12-month follow-up visits. Venous blood samples were obtained foreach patient preoperatively (basal sample)and at 5 minute after declamping ICA orEPD retrieval, and 2, 6, 12 and 24 hoursafter the end of the procedure. S100 andNSE proteins were analyzed by the use ofautomated immunoluminometric assays(S100 Elecsys test, Roche DiagnosticsGmbH, Mannheim, Germany; ELSA-NSE,CIS bio international, Gif-sur-YvetteCedex, France).

We considered the variation in markers ofbrain injury (S100 e NSE) primarily in sub-jects (within variation) and then betweendifferent groups (between variation).Besides analysis on continuous markers val-ues we divided patients in each treatmentgroup according to the variation of markersencountered by comparing each value withbasal sample and 24-hour value with 12-hour value. We considered significant an in-crease of ±25% from the reference value.Results were subsequently stratified in sta-ble, increased or decreased in each patientand then analyzed as belonging to thesethree groups for between variation analysis.

Statistical AnalysisChi-square test, unpaired t-student test formultiple comparisons and Fisher exact test(95% Confidence Interval) were used to as-sess differences in demographic and clinicaldata, MMSE score, presence of new lesionson DW-MRI and serum biomarkers levelsbetween the two treatment groups.

Continuous values were expressed asmean±SD. The threshold for significancewas set at p<0.05.

ResultsThirty-two patients were submitted to CEAand 28 to CAS. No significant demographicand preoperative characteristics differencesbetween the two treatment groups were de-tected except for coronary artery diseaseand COPD. No mortality was observed inthe peri-operative period in both groups.One patient in the CAS group presented anischemic stroke 2 hours after the end of theprocedure, while being completely asymp-tomatic throughout the intervention(1.6%). In this patient postoperative DW-MRI showed two acute brain injury, ac-companied by a significant increase in neu-ro-markers starting from the 2-hours value.

All patients in the present series were sub-mitted to pre-operative DW-MRI with noischemic lesion detected. In 6 CAS patientsand 1 CEA patient new ischemic lesionswere detected at 24 hours post-operativeDW-MRI (21.4% vs 3%, p=0.03). All pa-tients were submitted to MMSE with amean pre-operative score of 26.1±3.46 and25.6±4.46 and post-operative score of25.6±3.27 and 22.9±4.54 in CEA and CASgroups respectively. Analysis within grouprevealed a significant decrease in MMSEscore in CAS group not observed in CEAgroup (p=0.045 and p=0.67 respectively).Analysis between group showed a signifi-cant decrease in post-operative score inCAS patients respect to CEA patients(p=0.03) with a >5 points decrease in 7CAS (25%) and 1 CEA (3%) patients. InCAS patients new lesions at DW-MRI weresignificantly associated with MMSE scoredecline greater than 5 points (p=0.001); inthose patients MMSE score was significant-ly decreased compared to patients with neg-ative post-operative DW-MRI (p<0.001).At six-months follow-up MMSE scoreshowed an improvement in CAS patientswith stable values in CEA group (meanscore 23.7±4.58 in CAS and 25.9±3.43 inCEA group; within and between groupanalysis p=ns). Twelve-month follow-up

L. Capoccia et al.- The brain injury implications: endarterectomy vs CASTécnicas Endovasculares Vol.XIV. Núm. 1. Enero-Abril 2011; 3645-3649

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evaluation was performed in 58 patients outof 60 (96.6%) by DW-MRI and MMSE.No clinical or subclinical brain lesion wasobserved in both groups. Patients present-ing new ischemic lesions at postoperativeDW-MRI showed lower MMSE scorescompared to CEA and CAS patients withno ischemic lesions (p=0.08).

Basal NSE and S100 levels were the samefor each group (p=ns). Analysis on continu-ous values after intervention in CAS groupshowed an increasing trend for all S100and NSE levels compared to basal value andfor 24-hours value compared to 12-hourslevel. This trend was not confirmed in CEApatients.

In CAS group S100 showed a "25% in-crease at 12-hours value respect to basal and24-hours respect to 12-hours values in 78and 82% of patients and NSE in 57 and71% of cases. In CEA group increases wererecorded in 44 and 50% of cases in S100and 53 and 34% in NSE.

Analysis between groups showed a signifi-cant number of CAS patients with increas-ing 24-hours values respect to 12-hours lev-el of S100 and NSE compared to CEA pa-tients (p=0.02).

All CAS patients with new lesions on post-operative DW-MRI and significant declinein post-operative MMSE score had a not-significant increase of 24 hours S100 valuecompared to basal value.

DiscussionIn the present series patients submitted toCAS presented more frequently postopera-tive subclinical brain lesions compared tothose submitted to CEA. Those lesions we-re detected with both DW-MRI andNPMTs combined with S100 and NSE le-vels evaluation. At 12-month MMSE eva-luation patients presenting postoperative si-lent ischemic lesions showed a persistentlylower score compared to patients with noischemic lesion detected.

At present DW-MRI is considered the gold

standard for very early brain ischemic chan-ges detection. It has been shown to be posi-tive within a few minutes after brain injurysince the DWI enhancement appears within5–10 minutes of the onset of neurologicalsymptoms and remains for up to two we-eks18. The increased signal detected on aDWI scan is given by cytotoxic edema thatfavors restriction to water diffusion. Thecombined images of perfusion and diffusiontechniques highlight the “mismatch” repre-sentative of the so-called “ischemic penum-bra”, the area capable of reperfusion by ex-pedite revascularization.

Subclinical brain injuries can also be detect-ed by the use of highly sensitive markers ofneuronal cell damage. Maximum levels ofS100 can be detected as early as 20 min-utes after brain injury and its estimated bio-logic half-life is about 2 hours19-20. Neuron-specific enolase (NSE) is a glycolytic en-zyme that is found mainly in the cytoplasmof neurons and cells of neuroendocrine ori-gin21. It has a molecular weight of 78 KDaand a biological half-life in serum of 20hours22-23.

Since subclinical brain injuries usually in-volve small brain areas, those areas could beresponsible for higher cortical functions.Cognitive functions can be evaluated by theuse of NeuroPsychoMetric Tests (NPMTs).They can also be useful in monitoring sub-clinical long-term effects of microemboliza-tion. The MMSE or Folstein test is a brief30-point questionnaire test that is used toscreen for cognitive impairment. It is com-monly used in medicine to screen for de-mentia12,24-25. It is also used to estimate theseverity of cognitive impairment at a givenpoint in time and to follow the course ofcognitive changes in an individual over ti-me, thus making it an effective way to do-cument an individual’s response to treat-ment. Recently some authors have considered ce-rebrovascular disease beyond the traditionalclinical endpoints of major motor and spe-ech strokes. The role of carotid emboli insilent stroke and their cognitive sequelaehas been addressed in a lot of studies and

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reviews2-4, 26-33. In their study Rapp et al.5 re-ported a series of 48 patients undergoing54 CAS procedures with excellent clinicaloutcomes but a concerning number of newlesions on DW-MRI. These subclinicalbrain injuries showed up in the ensuing 48hours, when transcranial Doppler studieshad confirmed an ongoing number of em-bolic events. In their review on carotid ath-erosclerosis and vascular cognitive decline,Dempsey et al.29 concluded that a linear re-lationship between the process of mechani-cally unstable areas of carotid plaques andcognitive decline suggests a contributoryrole for such a process in silent strokes. Rateof microembolization in different carotidrevascularization procedures has been com-pared in many studies and reviews. Zhou etal.29 found that the incidence of microem-boli detected by DW-MRI was significantlyhigher in a group of 68 patients submittedto CAS compared to a group of 100 pa-tients submitted to CEA (46.3% and 12%respectively). In their review Ghogawala etal.30 showed that CAS was associated with ahigher burden of microemboli compared toCEA. A substudy of the InternationalCarotid Stenting Study (ICSS)31 found thatabout three times more patients in the CASgroup than in the CEA group had new is-chemic lesions on DW-MRI on post-treat-ment scans.

A recent report by Gupta et al.34 on the in-cidence of microemboli in carotid revascu-larization found that flow-reversal filters inCAS were able to decrease that rate whencompared to distal embolic protection de-vices but the incidence was still higher thanin CEA patients.

In this small group of patients presentingwith subclinical brain lesions we were ableto demonstrate postoperative DW-MRI en-hancement together with increased levels ofneurobiomarkers (S100 and NSE) andMMSE score decline. The ability of combi-ned neurocognitive and biohumoral testscompared to DW-MRI to detect subclinicalbrain injuries should be proved in larger se-ries, because of its good reproducibility andlow costs35.

In our series all patients with new postope-rative enhancements in DWI presented nolesions at 12-month DW-MRI evaluationbut a persistently decreased MMSE score.This finding may be related to temporal(too late) and spatial (too small lesions) li-mits of DW-MRI while the neurocognitiveimpairment can still be detected by specifictests36.

If those findings will be confirmed in futurestudies, we will then derive some considera-tions:

1.- Carotid revascularization proceduresshould be evaluated and compared not onlyon the basis of death/stroke rates but alsoof microembolization rates.

2.- Microembolization effects may persistover time so adequate evaluation toolsshould be used.

3.- New easier and cheaper methods to per-form cognitive impairment evaluationshould be validated.

4.- Following the principle of no-harm, mi-croembolization should be avoided whene-ver possible since its consequences remainstill unknown.

REFERENCES

Martin KK, Wigginton JB, Babikian VL, Pochay VE, Crit-tenden MD, Rudolph JL. Intraoperative cerebral high-inten-sity transient signals and postoperative cognitive function: asystematic review. Am J Surg. 2009 Jan;197(1):55-63. Epub2008 Aug 23.Gossetti B, Gattuso R, Irace L, Faccenna F, Venosi S, Boz-zao L, Fiorelli M, Andreoli R, Gossetti C. Embolism to thebrain during carotid stenting and surgery. Acta Chir Belg.2007 Mar-Apr;107(2):151-4.Rapp JH, Pan XM, Neumann M, Hong M, Hollenbeck K, LiuJ. Microemboli composed of cholesterol crystals disrupt theblood-brain barrier and reduce cognition. Stroke. 2008Aug;39(8):2354-61.Lal BK. Cognitive function after carotid artery revasculariza-tion. Vasc Endovascular Surg. 2007 Feb-Mar;41(1):5-13.Rapp JH, Wakil L, Sawhney R, Pan XM, Yenari MA, Glas-tonbury C, et al. Subclinical embolization after carotid arterystenting: new lesions on diffusion-weighted magnetic reso-nance imaging occur postprocedure. J Vasc Surg 2007; 45:867-874.Heyer EJ, Adams DC, Solomon RA, Todd GJ, Quest DO,McMahon DJ, et al. Neuropsychometric changes in patientsafter carotid endarterectomy. Stroke 1998; 1110-1115.

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2.-

3.-

4.-

5.-

6.-

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REFERENCES

Wunderlich MT, Ebert AD, Kratz T, Goertler M, Jost S, Herr-mann M. Early neurobehavioral outcome after stroke is rela-ted to release of neurobiochemical markers of brain damage.Stroke 1999; 30: 1190-1195.Connolly ES, Winfree CJ, Rampersad A, Sharma R, MackWJ, Mocco J, et al. Serum S100B protein levels are correlatedwith subclinical neurocognitive declines after carotid endarte-rectomy. Neurosurgery 2001; 49: 1076-1083.Pearson S, Maddern G, Fitridge R. Cognitive performance inpatients after carotid endarterectomy. J Vasc Surg 2003; 38:1248-1253.Palombo D, Lucertini G, Mambrini S, Zettin M. Subtle cere-bral damage after shunting vs non shunting during carotidendarterectomy. Eur J Vasc Endovasc Surg 2007; 34: 546-551.Roh HG, Byun HS, Ryoo JW, Na DG, Moon WJ, Lee BB,Kim DI. Prospective analysis of cerebral infarction after caro-tid endarterectomy and carotid artery stent placement byusing diffusion-weighted imaging. AJNR Am J Neuroradiol.2005 Feb;26(2):376-84.Folstein MF, Folstein SE, McHugh PR. Mini-mental state. Apractical method for grading the cognitive state of patients forthe clinician. Journal of psychiatric research 1975; 12 :189‚Äì198.Barone FC, Clark RK, Price WJ, White RF, Feuerstein GZ,Storer BL, et al. Neuron-specific enolase increases in cerebraland systemic circulation following focal ischemia. Brain Res1993; 623: 77-82.Hardemark H-G, Ericsson N, Kotwica Z, Rundstrom G, Men-del-Hartvig I, Olsson Y, et al. S-100 protein and neuron-spe-cific enolase in CSF after experimental traumatic or focalischemic brain damage. J Neurosurg 1989; 71: 727-731.Persson L, Hardemark H-G, Gustafsson J, Rundstrom G,Mendel-Hartvig I, Esscher T, et al. S-100 protein and neuron-specific enolase in cerebrospinal fluid and serum: markers ofcell damage in human central nervous system. Stroke 1987;18: 911-918.Sindic CJM, Chalon MP, Cambiaso CL, Laterre EC, MassonPL. Assessment of damage to the central nervous system bydetermination of S-100 protein in the cerebrospinal fluid. JNeurol Neurosurg Psychiatry 1982; 45:1130-1135.Jonsson H, Johnsson P, Alling C, Backstrom M, Bergh C,Blomquist S, et al. S100beta after coronary artery surgery:release pattern, source of contamination, and relation to neu-ropsychometric outcome. Ann Thorac Surg 1999; 68: 2202-2208.Moseley ME, Cohen Y, Mintorovitch J, Chileuitt L, ShimizuH, Kucharczyk J, et al. Early detection of regional cerebralischemia in cats: comparison of diffusion-and T2-weightedMRI and spectroscopy. Magn Reson Med 1990; 14:330‚Äì346.Zimmer DB, Cornwall EH, Landar A, Song W. The S100protein family: history, function and expression. Brain ResBull 1995; 37: 417-429.Jonsson H, Johnsson P, Hoglund P, Alling C, Blomquist S.Elimination of S-100B and renal function after cardiac sur-gery. J Cardiothorac Vasc Anesth 2002; 14: 698-701.Jauch EC. Diagnosis of stroke: the use of serum markers. AdvEmerg Card Neurovasc Care 2002; 39‚Äì45.Cooper EH. Neuron-specific enolase. Int J Biol Markers1994; 9: 205-210.Ingebrigsten T, Romner B. Biochemical serum markers forbrain damage: a short review with emphasis on clinical utilityin mild head injury. Restorative Neurology and Neuroscience2003; 21: 171-176.Harrell LE, Marson D, Chatterjee A, Parrish JA. The SevereMini-Mental State Examination: a new neuropsychologic ins-trument for the bedside assessment of severely impairedpatients with Alzheimer disease. Alzheimer Dis AssocDisord. 2000 Jul-Sep;14(3):168-75.

Crum RM, Anthony JC, Bassett SS, Folstein MF. Population-based norms for the Mini-Mental State Examination by ageand educational level. JAMA 1993; 269: 2386‚Äì2391.Semplicini A, Maresca A, Sartori M, Cal L, Pessina AC.Hypertension and cerebrovascular diseases: a specific role ofvascular protection for the prevention of dementia. J Cardio-vasc Pharmacol. 2001 Nov;38 Suppl 2:S79-82.Leiendecker J, Hcker J, Meybohm P, Fudickar A, Bein B.Postoperative neurocognitive function and microembolusdetection in patients undergoing neck dissection: a pilotstudy. Eur J Anaesthesiol. 2010 May;27(5):417-24.Dempsey RJ, Vemuganti R, Varghese T, Hermann BP. Areview of carotid atherosclerosis and vascular cognitive decli-ne: a new understanding of the keys to symptomology. Neu-rosurgery. 2010 Aug;67(2):484-93.Zhou W, Dinishak D, Lane B, Hernandez-Boussard T, BechF, Rosen A. Long-term radiographic outcomes of microem-boli following carotid interventions. J Vasc Surg. 2009Dec;50(6):1314-9.Ghogawala Z, Westerveld M, Amin-Hanjani S. Cognitiveoutcomes after carotid revascularization: the role of cerebralemboli and hypoperfusion. Neurosurgery. 2008 Feb;62(2):385-95.Bonati LH, Jongen LM, Haller S, Flach HZ, Dobson J,Nederkoorn PJ, Macdonald S, Gaines PA, Waaijer A, StierliP, J§ger HR, Lyrer PA, Kappelle LJ, Wetzel SG, van derLugt A, Mali WP, Brown MM, van der Worp HB, EngelterST; ICSS-MRI study group. New ischaemic brain lesions onMRI after stenting or endarterectomy for symptomatic carotidstenosis: a substudy of the International Carotid StentingStudy (ICSS). Lancet Neurol. 2010 Apr;9(4):353-62.Falkensammer J, Oldenburg WA, Hendrzak AJ, NeuhauserB, Pedraza O, Ferman T, Klocker J, Biebl M, Hugl B, Mes-chia JF, Hakaim AG, Brott TG. Evaluation of subclinicalcerebral injury and neuropsychologic function in patientsundergoing carotid endarterectomy. Ann Vasc Surg. 2008Jul-Aug;22(4):497-504.Capoccia L, Speziale F, Gazzetti M, Mariani P, Rizzo A,Mansour W, Sbarigia E, Fiorani P. Comparative study oncarotid revascularization (endarterectomy vs stenting) usingmarkers of cellular brain injury, neuropsychometric tests, anddiffusion-weighted magnetic resonance imaging. J Vasc Surg.2010 Mar;51(3):584-91.Gupta N, Corriere MA, Dodson TF, Chaikof EL, BeaulieuRJ, Reeves JG, Salam AA, Kasirajan K.The incidence of microemboli to the brain is less with endar-terectomy than with percutaneous revascularization with dis-tal filters or flow reversal. J Vasc Surg. 2011 Feb;53(2):316-22.Hauth EA, Jansen C, Drescher R, Schwartz M, Forsting M,Jaeger HJ, et al. MR and clinical follow-up of diffusion-weighted cerebral lesions after carotid artery stenting. Am JNeuroradiol 2005; 26: 2336-2341.Debette S, Markus HS. The clinical importance of white mat-ter hyperintensities on brain magnetic resonance imaging:systematic review and meta-analysis. BMJ. 2010 Jul26;341:c3666.

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The embolic risk during carotid stenting(CAS) is influenced by the access techniqueand cerebral protection methods utilized inthe procedure. Embolic phenomena duringtransfemoral carotid stenting occur univer-sally due to instrumentation of the arch andproximal supra-aortic trunks, and crossingof the carotid lesion without protection, aswell as during stent deployment. In addi-tion, the use of distal filter protection de-vices has never been shown to reduce theembolic risk during CAS. The transcervicalapproach with carotid flow reversal for pro-tection for CAS can eliminate the embolicrisk of the transfemoral approach with distalfilter protection.

The advantage of transcervical CAS isdemonstrated by the lower incidence ofmiddle cerebral artery TCD-detected em-bolic signals during the procedure, and amajor reduction in the post-procedural inci-dence of ischemic brain infarcts detected bydiffusion weighted MRI, when compared totransfemoral stenting with distal filter pro-tection. The aadvantages of trancervicalCAS with carotid flow reversal are clinicallydemonstrated by a remarkably low rate ofneurological adverse events, even in the oc-togenarian population.

The endoluminal treatment of carotid dis-ease has gained popularity during the lastfew years, thanks to technological advancesand increasing experience with this tech-nique. In 1996, Theron et al1 described arather sophisticated technique for translu-

minal CAS and reported a rather large ex-perience with excellent initial results.During the last 2 decades it has become ap-parent that embolic events are very com-mon during transfemoral carotid arterystenting not only at the experimental lev-el,2,3 but also in vivo4,5. The critical stepsduring carotid artery stenting that are par-ticularly likely to produce embolization areduring access of the guidewires andcatheters into the aortic arch and supra-artictrunks, the advancement of the guidingcatheter or sheath into the common carotidartery, crossing of the stenotic lesion withthe guide wire, and balloon inflation andstent deployment2,6.

These well known embologenic phenomenaprompted the development of several pro-tection methods to avoid embolization dur-ing carotid CAS. Distal cerebral protectiondevices involve either and occlusion balloondistal to the lesion that prevent forwardflow in the carotid or a filter placed distal tolesion that would theoretically capture em-bolic debris. Proximal protection devices re-ly on flow cessation through the carotidartery during the intervention or flow rever-sal in the internal carotid artery. Both sys-tems aim to avoid migration of embolic ma-terial into the carotid territory during theintervention.

Distal filter protection has become the mostpopular protection method, and in generalconsists of polymeric membranes with poresranging in diameter from 80 to 200 mi-

Criado, E.

Professor of Surgery. University of Michigan. School of Medicine, Ann Arbor, Michigan, USA

Transcervical carotid stentingwith carotid flow reversal reducesembolic events

3651

crons attached to an expandable metallicframe that allows filter deployment andwithdrawal distal to the lesion. Distal filtershave the advantage to preserve antegradeflow in the carotid artery and allow angio-graphic injections throughout the interven-tion. However, they present seriousdisadvantages, such as the lack of protectionduring crossing of the stenotic lesion, ratherlarge profiles that make lesion crossing notonly difficult but hazardous, allowing smallparticles to migrate through the pores ofthe filter, or passage of even larger particlesaround the filter and into the distal cerebralcirculation. In addition, filters may becomethrombosed or clogged by large amounts ofdebris that may occasionally be producedduring the intervention. In addition, filtersdo not allow the physician to choosewhichever guide wire seems more appropri-ate for the procedure.

Distal filters although may allow angiogra-phy during the procedure certainly restrictthe amount of carotid blood flow becauseof the small size of the pores. Most distalfilter protection devices require significantnumber of technical steps that may prolongthe duration of the procedure7,8.

Distal balloon occlusion devices have theadvantage of offering a rather low crossingprofile that indeed prevent the passage ofany particles into the distal circulation whilethe balloon is inflated.

However, they may allow embolization oftrapped particulate matter as soon as theballoon is deflated. They also require cross-ing of the lesion without protection, arather a hazardous maneuver. In addition,flow remains interrupted into the internalcarotid artery and the distal internal carotidartery may be traumatized or become spas-tic during inflation. Another limitation ofdistal occlusion devices is the inability toconduct angiography during the procedure.They may provide incomplete occlusion intortuous or large carotid arteries, or pro-duce intolerance to the carotid occlusion, oroccasional production of arrhythmias duringballoon inflation7,10.

Proximal protection methods include twosystems that occlude the common carotidand external carotid arteries. The MoMa(Invatec, Rocandalle, Italy) applies occlu-sion to the common carotid artery and withan additional balloon the external carotidartery thereby arrest inflow into the internalcarotid artery. This method has been asso-ciated with cerebral intolerance rates of 6 to8%1 1. The other proximal protectionmethod designed by Parodi12, known As theParodi Anti Embolism System (PAES),(Arterial Medical Science, San Francisco,California, USA) is currently under develop-ment and allows flow reversal from the in-ternal carotid artery into the femoral veinwith an interposed filter to avoid paradoxi-cal embolization of potential embolic mate-rial.

Both proximal protection systems have themajor advantage that they do not requirecrossing of the stenotic lesion without pro-tection. They do not preclude the use ofadditional distal protection should there bea need for them, such as in the “seat beltand airbag technique”,13 where all the em-bolic particles, regardless of the size may berecovered. The disadvantage of distal flowinterruption during protection is a certaindegree of intolerance, and that they requirerather large sheath diameters that need tobe negotiated through the femoral-iliac ar-teries and into the supra aortic trunks. Thismaneuver in the presence of diseased archesor torturous trunks may be associated withsignificant embolization during access andcatheter placement.

In 2004, we described14 a transcervical ap-proach with cerebral flow reversal estab-lished between the common carotid arteryand the jugular vein. This technique is donethrough a minimal incision at the base ofthe neck that allows control of the commoncarotid artery. This transcervical approachavoids all the technical difficulties and risksinherent to the use of protection devices de-ployed through a transfemoral route.

The transcervical approach for carotid arterystenting with carotid flow reversals has a

E. Criado.- Transcervical carotid stenting with carotid flow reversalreduces embolic events


3652



number of important advantages over otherpreviously described protection methods.It avoids crossing of stenotic lesions with-out cerebral protection. Although thisproblem is also avoided with transfemoralproximal protection methods. TranscervicalCAS does not require negotiation of theaortic arch or aortic trunks that may berisky in many cases and certainly always em-boligenic. In addition, in the octogenarianpopulation were the prevalence of the cal-cific atherosclerotic arch lesions and tortu-ous anatomy in the arch and trunks is wellknown provides an additional advantage byavoiding the embolic risk. This risk is illus-trated by the initial experience of theCREST15 trial that reported a 12% perioper-ative stroke rate in octogenarian comparedto 3% in younger patients. In a similar wayLamb16 reported an 11% stroke rate in octo-genarian patients compared to 1% strokerates for patients under 80 years of age, andKastrup17 encountered a significantly higherneurological complication rate in patientsolder than 75 years compared to theyounger population. Roubin18 et al in aprospective study of 5 years observed thatage greater than 80 years was a strong pre-dictor of perioperative complications andlate stroke. Strikingly, Alvarez et al19 usingour technique with transcervical carotidartery stenting with carotid flow reversalobserved a lack of increased complicationsin octogenarians compared to younger pa-tients, and actually documented a strokerate comparable to that obtained withcarotid endarterectomy in octogenarians.

The flow reversal time required during tran-scervical carotid artery stenting averagesfrom 15 to 21 minutes,20,21 and the meantotal procedure time ranges from 50 to 70minutes. Procedural times associated with avery low rate of intolerance of less than 3%.Transcervical carotid artery stenting avoidsany potential complications associated withthe transfemoral puncture and negotiationof the iliac vessels. Complications relatedto this particular approach may be as highas 14%.22 During transfemoral CAS micro-embolic signals have been routinely en-countered in the middle cerebral artery as

documented by transcranial Doppler ultra-sound. Interestingly, the systematic use ofdistal filter protection for CAS was support-ed in a 2004 consensus document, pub-lished in the Journal of Vascular Surgery,without offering any clear evidence to sup-port there use23. Prior to it, several uncon-trolled studies suggested a reduction inneurologic events with the use of distal fil-ters. However, the only randomizedprospective trial comparing transfemoralCAS with distal filter protection againstcarotid stenting without protection failed toshow any reduction in the number of microembolic events or in the number of newembolic lesions in the ipsilateral hemisphereusing diffusion weighted magnetic reso-nance imaging (DW-MRI)24. In addition,the comparison of distal filter protectionwith other systems of cerebral protectionhas shown in several occasions that the useof distal filters increases the number of mi-cro embolic signals detected in the middlecerebral artery detected by transcranialDoppler ultrasound25,26.

Animal studies have established that parti-cles greater than 50 microns are capableproducing ischemic cerebral lesions27. Sincemost size pores in the currently available fil-ters range between 100 and 120 microns, itis not surprising to find a significant num-ber of ischemic lesions following CAS withdistal filter protection. The clinical rele-vance of new ischemic lesions detected byDW-MRI is not known, but there is an in-creasing concern with their likely relation-ship with long term psychometric deteriora-tion and later development of dementia anddecline in cognitive functions, as it occursin patients with multiple laccunar infarcts orwith multiple white matter ischemic le-sions28.

The most likely cause of all these new hyperintense ischemic lesions detected followingcarotid stenting is embolization of throm-botic material or atherosclerotic plaque dur-ing the procedure, since the micro air bub-bles that may be injected during the proce-dure are normally absorbed. Althoughwhen air bubbles occlude capillaries, the

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distal perfusion impairment may cause en-dothelial damage with an inflammatory re-sponse that may lead to cerebral tissue in-jury and perhaps the development of minorcerebral symptomotology29.

The majority of the new ischemic lesionsfollowing CAS are found on the side ipsilat-eral to the carotid intervention, which sug-gests that the manipulation of the ipsilateralcarotid access and stent delivery may be re-lated with a high incidence of symptomaticneurologic events30.Interestingly, between19 and 32% of patients undergoing trans-femoral CAS may show evidence of em-bolization into the hemisphere contralateralto the treated side, most likely secondary tothe manipulation of the aortic arch andsupra aortic trunks24,31.

The occurrence of neurological symptoma-tology following embolization is related tothe location of the new ischemic lesions andon the total number and volume of the le-sions30, as well as the size of the embolicparticles. In this regard Rapp32 demonstrat-ed experimentally that embolic particlesgreater than 200 microns produce neuronalischemia compared to smaller particles.

The use of carotid flow reversal diminishesthe number microbolic signals as detectedby transcranial doppler24, which may actual-ly drop to zero as Parodi12 and Ribo21,33 sug-gested. In addition, carotid flow reversalduring CAS significantly reduces the num-ber of new ischemic lesions as detected byDW-MRI34. This is supported by our un-published experience with 31 patients inwhom a prospective, blinded evaluation ofDW-MRI detected embolic signals follow-ing transcervical CAS was remarkably lowerthan that reported in the literature fortransfemoral CAS.

The experience with transcervical CAS islimited, however all published studies haveshown a remarkably low rate of major ad-verse events despite of the technique beingin its infancy. In conclusion, carotid flowreversal using a transcervical approach forcarotid artery stenting produces a significant

reduction in the embolic signals and the de-velopment of new ischemic lesions in thebrain. It is likely that a reduction in is-chemic infarction following CAS is benefi-cial to the patient, most likely by reducingthe long-term incidence of dementia andother long term neurological deterioration.Transcervical carotid artery stenting avoidsarch and supra aortic trunk manipulation,thereby reducing potential embolic phe-nomena from these arteries and more im-portantly avoids the need to cross the lesionbefore the protection is in place.

All these advantages make the transcervicalapproach to carotid stenting an excellent al-ternative for all high risk patients such asoctogenarians, those with unfavorableanatomy or with contraindications for atransfemoral approach. Transcervicalcarotid stenting with carotid flow reversal isextremely safe and may be the procedure ofchoice in many cases.

SELECTED REFERENCES

Criado E, Doblas M, Fontcuberta J, Orgaz A, Flores A.Transcervical Carotid Artery Angioplasty and Stenting withCarotid Flow Reversal: Surgical Technique. Annals of Vas-cular Surgery 2004;18:257-261.Criado E, Doblas M, Fontcuberta J, Orgaz A, Flores A,Lopez P, and Wall P. Carotid angioplasty with internalcarotid artery flow reversal is well tolerated in the awakepatient. Journal of Vascular Surgery, 2004;40:92-97.Criado E, Doblas M, Fontcuberta J, Orgaz A, Flores A, WallLP, Gasparis A, Lopez P, Strachan J. Transcervical carotidangioplasty with internal carotid artery flow reversal: Feasi-bility and preliminary results. Journal of Vascular Surgery,2004;40:476-83Lo C, Doblas M, Criado E. Advantages and indications oftranscervical carotid artery stenting. J Cardiovasc Surg (Tori-no), 2005 Jun;46(3):229-39.Criado E, Fontcuberta J, Orgaz A, Flores A, Doblas M. Tran-scervical carotid stenting with carotid artery flow reversal:Three year follow up of 103 stents. J Vasc Surgery2007;46:864-9.Alvarez B, Ribo M, Maeso J, Quintana M, Alvarez-Sabin J,Matas M. Transcervical carotid stenting with flow reversal issafe in octogenarians: a preliminary safety study. J VascSurg. 2008;47(1):96-100.Flores A, Doblas M, Criado E. Transcervical Carotid ArteryStenting with Flow Reversal Eliminates Emboli during Stent-ing: Why Does it Work and what are the Advantages withthis Approach. J Cardiovasc Surg, Dec 2009; 50: 745-9.Leal JI, Orgaz A, Fontcuberta J, Flores A, Doblas M, Garcia-Benassi JM, Lane B, Loh C, Criado E. A Prospective Evalua-tion of Cerebral Infarction following Transcervical CarotidStenting with Carotid Flow Reversal. European Journal ofVascular and Endovascular Surgery, 2010; 39:661-666.

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REFERENCES

Theron JG, Payelle GG, Coskun O, Huet HF, Guimaraens L.Carotid artery stenosis: treatment with protected balloon angio-plasty and stent placement. Radiology. 1996;201(3):627-636.Coggia M, Goeau-Brissonniere O, Duval JL, Leschi JP, LetortM, Nagel MD. Embolic risk of the different stages of carotidbifurcation balloon angioplasty: an experimental study. J VascSurg. 2000;31(3):550-557.Rapp JH, Pan XM, Yu B, Swanson RA, Higashida RT, Simp-son P, Saloner D. Cerebral ischemia and infarction fromatheroemboli <100 microm in Size. Stroke. 2003;34(8):1976-1980.Jordan WD, Jr., Voellinger DC, Doblar DD, Plyushcheva NP,Fisher WS, McDowell HA. Microemboli detected by transcra-nial Doppler monitoring in patients during carotid angioplastyversus carotid endarterectomy. Cardiovasc Surg. 1999;7(1):33-38.Ohki T, Marin ML, Lyon RT, Berdejo GL, Soundararajan K,Ohki M, Yuan JG, Faries PL, Wain RA, Sanchez LA, SuggsWD, Veith FJ. Ex vivo human carotid artery bifurcation stent-ing: correlation of lesion characteristics with embolic potential.J Vasc Surg. 1998;27(3):463-471.Al-Mubarak N, Roubin GS, Vitek JJ, Iyer SS, New G, LeonMB. Effect of the distal-balloon protection system onmicroembolization during carotid stenting. Circulation.2001;104(17):1999-2002.Ohki T, Veith FJ. Critical analysis of distal protection devices.Semin Vasc Surg. 2003;16(4):317-325.Yadav JS. Embolic protection devices: methods, techniques,and data. Tech Vasc Interv Radiol. 2004;7(4):190-193.Bosiers M, Deloose K, Verbist J, Peeters P. What practical fac-tors guide the choice of stent and protection device duringcarotid angioplasty? Eur J Vasc Endovasc Surg.2008;35(6):637-643.Eskandari MK. Cerebral embolic protection. Semin Vasc Surg.2005;18(2):95-100.Uflacker R, Brothers T. Filling of the aneurysmal sac withDEAC-glucosamine in an animal model of abdominal aorticaneurysm following stent-graft repair. J Cardiovasc Surg (Tori-no). 2006;47(4):425-436.Parodi JC, La Mura R, Ferreira LM, Mendez MV, CersosimoH, Schonholz C, Garelli G. Initial evaluation of carotid angio-plasty and stenting with three different cerebral protectiondevices. J Vasc Surg. 2000;32(6):1127-1136.Parodi JC, Schonholz C, Ferreira LM, Mendaro E, Ohki T.“Seat belt and air bag” technique for cerebral protection duringcarotid stenting. J Endovasc Ther. 2002;9(1):20-24.Criado E, Doblas M, Fontcuberta J, Orgaz A, Flores A. Tran-scervical carotid artery angioplasty and stenting with carotidflow reversal: surgical technique. Ann Vasc Surg.2004;18(2):257-261.Hobson RW, 2nd, Howard VJ, Roubin GS, Brott TG, FergusonRD, Popma JJ, Graham DL, Howard G. Carotid artery stentingis associated with increased complications in octogenarians:30-day stroke and death rates in the CREST lead-in phase. JVasc Surg. 2004;40(6):1106-1111.Lam RC, Lin SC, DeRubertis B, Hynecek R, Kent KC, FariesPL. The impact of increasing age on anatomic factors affectingcarotid angioplasty and stenting. J Vasc Surg. 2007;45(5):875-880.Kastrup A, Schulz JB, Raygrotzki S, Groschel K, Ernemann U.Comparison of angioplasty and stenting with cerebral protec-tion versus endarterectomy for treatment of internal carotidartery stenosis in elderly patients. J Vasc Surg.2004;40(5):945-951.Roubin GS, New G, Iyer SS, Vitek JJ, Al-Mubarak N, LiuMW, Yadav J, Gomez C, Kuntz RE. Immediate and late clini-cal outcomes of carotid artery stenting in patients with sympto-matic and asymptomatic carotid artery stenosis: a 5-yearprospective analysis. Circulation. 2001;103(4):532-537.Alvarez B, Ribo M, Maeso J, Quintana M, Alvarez-Sabin J,

Matas M. Transcervical carotid stenting with flow reversal issafe in octogenarians: a preliminary safety study. J Vasc Surg.2008;47(1):96-100.Criado E, Fontcuberta J, Orgaz A, Flores A, Doblas M. Tran-scervical carotid stenting with carotid artery flow reversal: 3-year follow-up of 103 stents. J Vasc Surg. 2007;46(5):864-869.Ribo M, Molina CA, Alvarez B, Rubiera M, Alvarez-Sabin J,Matas M. Transcranial Doppler monitoring of transcervicalcarotid stenting with flow reversal protection: a novel carotidrevascularization technique. Stroke. 2006;37(11):2846-2849.Castillo-Sang M, Tsang AW, Almaroof B, Cireddu J, Sferra J,Zelenock GB, Engoren M, Kasper G. Femoral Artery Compli-cations after Cardiac Catheterization: A Study of Patient Pro-file. Ann Vasc Surg. 2009.Ouriel K, Yadav J, Green RM. Standards of practice: carotidangioplasty and stenting. J Vasc Surg. 2004;39(4):916-917.Barbato JE, Dillavou E, Horowitz MB, Jovin TG, Kanal E,David S, Makaroun MS. A randomized trial of carotid arterystenting with and without cerebral protection. J Vasc Surg.2008;47(4):760-765.Schmidt A, Diederich KW, Scheinert S, Braunlich S, Olen-burger T, Biamino G, Schuler G, Scheinert D. Effect of twodifferent neuroprotection systems on microembolization duringcarotid artery stenting. J Am Coll Cardiol. 2004;44(10):1966-1969.Rubartelli P, Brusa G, Arrigo A, Abbadessa F, Giachero C,Vischi M, Ricca MM, Ottonello GA. Transcranial Dopplermonitoring during stenting of the carotid bifurcation: evalua-tion of two different distal protection devices in preventingembolization. J Endovasc Ther. 2006;13(4):436-442.Marcus ML, Heistad DD, Ehrhardt JC, Abboud FM. Total andregional cerebral blood flow measurement with 7-10-, 15-, 25-,and 50-mum microspheres. J Appl Physiol. 1976;40(4):501-507.Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ,Breteler MM. Silent brain infarcts and the risk of dementia andcognitive decline. N Engl J Med. 2003;348(13):1215-1222.Skjelland M, Krohg-Sorensen K, Tennoe B, Bakke SJ, BrucherR, Russell D. Cerebral microemboli and brain injury duringcarotid artery endarterectomy and stenting. Stroke.2009;40(1):230-234.Flach HZ, Ouhlous M, Hendriks JM, Van Sambeek MR, Veen-land JF, Koudstaal PJ, Van Dijk LC, Van Der Lugt A. Cerebralischemia after carotid intervention. J Endovasc Ther.2004;11(3):251-257.Pinero P, Gonzalez A, Mayol A, Martinez E, Gonzalez-MarcosJR, Boza F, Cayuela A, Gil-Peralta A. Silent ischemia afterneuroprotected percutaneous carotid stenting: a diffusion-weighted MRI study. AJNR Am J Neuroradiol.2006;27(6):1338-1345.Rapp JH, Pan XM, Sharp FR, Shah DM, Wille GA, Velez PM,Troyer A, Higashida RT, Saloner D. Atheroemboli to the brain:size threshold for causing acute neuronal cell death. J VascSurg. 2000;32(1):68-76.Matas M, Alvarez B, Ribo M, Molina C, Maeso J, Alvarez-Sabin J. Transcervical carotid stenting with flow reversal pro-tection: experience in high-risk patients. J Vasc Surg.2007;46(1):49-54.Rabe K, Sugita J, Godel H, Sievert H. Flow-reversal device forcerebral protection during carotid artery stenting—acute andlong-term results. J Interv Cardiol. 2006;19(1):55-62.Pipinos, II, Johanning JM, Pham CN, Soundararajan K, LynchTG. Transcervical approach with protective flow reversal forcarotid angioplasty and stenting. J Endovasc Ther.2005;12(4):446-453.Lin JC, Kolvenbach RR, Pinter L. Protected carotid arterystenting and angioplasty via transfemoral versus transcervicalapproaches. Vasc Endovascular Surg. 2005;39(6):499-503.Faraglia V, Palombo G, Stella N, Rizzo L, Taurino M, BozzaoA. Cerebral embolization during transcervical carotid stentingwith flow reversal: a diffusion-weighted magnetic resonancestudy. Ann Vasc Surg. 2009;23(4):429-435.



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IntroductionACST-1 (1993-2008) randomised 3120asymptomatic patients requiring treatmentsfor carotid artery stenosis into two arms: 1)best medical treatment only and 2) bestmedical treatment with “immediate”carotid endarterectomy (CEA). The fiveyear results provided evidence that CEA in-volved a small (~3%) but definite peri-pro-cedural risk of stroke or death, a substantial(~3% vs ~12%) reduction in the subsequentstroke rate over the next 5 years and hencea net reduction (~6% vs ~12%) in the overall5-year risk of stroke or peri-proceduraldeath. In 2010 the 10 year results werepublished which indicated the benefit wasretained and that allocation to immediateCEA almost halved the non-perioperativestroke rate over the next 10 years.Therefore ACST-1 provided evidence thatimmediate intervention by CEA with bestmedical therapy was superior to best med-ical therapy alone and has resulted inchanges in clinical practice.

Carotid artery stenting (CAS) is now beingused to treat carotid artery stenosis and pre-vious comparative trials of symptomatic pa-tients have shown CEA to be the preferen-tial treatment. However, worldwide 70%of CAS are performed on asymptomatic pa-tients therefore further investigation intothis cohort is required. The CREST trialrecruited 1181 asymptomatic patients andresults suggest that both procedures arecomparable (N Engl J Med 2010;363:11-

23.: Stenting versus Endarterectomy forTreatment of Carotid-Artery Stenosis, T.G.Brott et al, CREST Investigators).However, a much larger scale clinical trial isneeded to fully assess CAS versus CEA inasymptomatic patients and ACST-2 hasbeen designed to meet this need.

ACST-2 is a large, simple, randomised trialof CEA versus CAS for stroke prevention.The trial has been designed to minimisecollaborators’ workload, making it easy tointegrate into normal medical routine. Theprimary objective is to compare the peri-procedural risks (myocardial infarction[MI], stroke and death within the firstmonth after the intervention in attempted),and the long-term prevention of stroke (upto 5 or more years), particularly disabling orfatal strokes. Secondary objectives: Datamay enable some types of patients to beidentified in which one or other procedureis clearly preferable. As part of a health eco-nomic evaluation, procedural costs, stroke-related healthcare costs and quality of lifewill be assessed for a subset of patients.

MethodsBefore joining the trial, each operator sub-mits a track record documenting their expe-rience (a minimum of 25 CEA or CAS,mostly performed in the last two years) giv-ing stroke and non-stroke deaths within 1month of the procedure. In general, theoperators should have <8% stroke and death

Halliday, A.; Hayter, E.; Carver, T

on behalf of the ACST-2 collaborators

Carotid stenting vs Surgery inasymptomatic patients: update ofthe ACST-2 Trial

3656

rate for symptomatic patients and <4% riskfor asymptomatic patients. Each centremust have a collaborating neurologist (orstroke physician), vascular surgeon andstenting interventionalist (radiologist, cardi-ologist, surgeon or physician with specialisttraining in carotid stenting). They will bejointly responsible for patient recruitment,treatment and follow-up. A centre may beorganised between colleagues in neighbour-ing hospitals.

All patients in the trial should be on opti-mum medical treatment, however still re-quire intervention. To be eligibility for thetrial, the patient must not have not sufferedany ipsilateral symptoms for six months andhave had no previous procedure performedon the side. If the patient has undergoneany previous coronary procedures (egCABG) they must wait 30 days before par-ticipating in the trial (be outside the peri-procedural period for any previous treat-ment). All eligible patients should be of-fered the trial, and if interested they arethen assessed by MRA or CTA to ensurethey are anatomically suitable for both pro-cedures. Written consent is required andafter a short call to the randomisation unitan allocation of treatment group( eitherCEA or CAS) is obtained. The procedure

should be carried out following normal rou-tine practice. The patient should be seen fora 30 day post procedure followed up.Thereafter the patient is followed up annu-ally by postal questionnaire.

ResultsTo date 288 operators have submitted trackrecords for blinded review by an indepen-dent management committee. 254 from 26countries have currently been approved.Some remaining operators have been ad-vised to obtain further experience. Theprocedural experience of our operators isshown below.

Currently 79 centres from 23 countries canrandomise into the trial and another 28centres are in the process of obtainingethics.

ConclusionCEA is a well established procedure in thetreatment of carotid stenosis. Experience inCAS is increasing as evident in the publica-tions of country registries, national guide-lines, and the CREST results. There is in-sufficient evidence to determine the besttreatment for asymptomatic patients. Alarge randomised trial is required to answerthe question, therefore ACST-2 has been

A. Halliday et al.- Carotid stenting vs surgery in asymptomatic patients:update of the ACST-2 trial


PROCEDURAL EXPERIENCE

APPROVED CLINICIANS

CAS CEA CAS CEA

PROCEDURE COMBINED EXPERIENCE MEDIAN EXPERIENCE

69

118

67

254

77,215

11,384

7,666

19,050

28,283

29,882

58,165

60

59

100

124

CAS only

CEA only

CAS and CEA

Total combined

Total combinedExperience for allProcedures

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A. Halliday et al.- Carotid stenting vs surgery in asymptomatic patients:update of the ACST-2 trial


designed to provide evidence needed forthe treatment of asymptomatic carotidartery stenosis.

The ACST-2 aims to recruit 5000 patientsas this will provide generalisable results andproviding reliable level 1 evidence on whichcohort of patients may benefit from CEAand CAS procedures.

If you are UNCERTAIN, randomise andbe CERTAIN that the trial will provide theanswer.

The ACST-2 is still recruiting centres. Forfurther information on the trial, please con-tact [email protected] or visit our websiteat www.acst.org.uk .

Sillesen, H.

Chairman, Dept. of Vascular Surgery, Rigshospitalet, University of Copenhagen, Denmark.

Asymptomatic carotid stenosisshould be treated pharmacologicallyalone

Risk of recurrent ischemic events in patientswith symptomatic carotid artery stenosis iswell established to be high. Based on theclassic trials NASCET and ECST the esti-mated 3 year risk of stroke or death was 20-30%. Carotid endarterectomy became anevidence based treatment modality in theearly 1990’ies in case of stenosis exceeding50% diameter reduction and ipsilateralsymptoms. Later, re-analyses of the datafrom these trials (NASCET and ECST)showed that age, sex and time since indexevent were important predictors of a secondevent – much like in patients with coronaryartery disease.

Specific trials to show the benefit of phar-macologic agents in patients with carotidstenosis with respect to hard clinical end-points has not been conducted so for. Anti-platelet agents and lipid-lowering drugs arerecommended today based on secondaryanalyses of trials with designed to show

effects primarily in other or patient groupsor in trials with surrogate end-points.

Similar in patients with asymptomaticstenosis, trials showing the benefit of med-ical treatment have never been conducted.Two trials have shown statistically signifi-cant benefit from carotid endarterectomy inpatients randomized before introduction oftoday’s medical therapy and risk factorreduction! Latest, the ECST published 10year results showing a persistent benefit ofendarterectomy, however, the benefit wasobtained on the early years of the trial whenneither of the treatment groups were treat-ed according to today’s recommendations.In fact, the survival curves are parallel in thelater years indicating that all benefit wasfrom before all patients were treated as rec-ommended today!

The risk of ipsilateral stroke and death hasdeclined in patients with asymptomatic

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carotid stenosis, in fact, just as stroke risk ingeneral has declined in the western world.In the latest studies, the annual risk is below1% per year – much less than in the 2 trialscomparing endarterectomy to medical treat-ment; in both trials the annual risk of strokeor death exceeded 2% in the non-surgicallytreated groups.

Therefore, it is pertinent to argue that trialsof the past, conducted in symptomatic aswell as in asymptomatic patients are outdat-ed! With an annual risk of less than 1% peryear and a perioperative risk of interventionof 2-5% it will not be possible to show ben-efit in a trial undertaken comparing bestmedical treatment and carotid endarterecto-my.

Carotid stenting has never been proven toreduce the risk of ipsilateral stroke. In trialscomparing carotid endarterectomy to stent-ing in symptomatic patients meta-analysesclearly show inferiority of carotid stenting.No specific trials have been conducted incase of asymptomatic carotid diseasealthough asymptomatic cases have beenincluded in some trials. However, onlywhen end-points such as coronary infarc-tion (also asymptomatic) have been includ-ed some data show equality. However, thesame trials did not consider asymptomaticbrain infarction which has been shown tobe much more common after carotid stent-ing.

In conclusion, with today’s effective med-ical preventive therapy, invasive treatmentfor asymptomatic carotid stenosis is notwarranted.

REFERENCES

Halliday A, Harrison M, Hayter E, et al. AsymptomaticCarotid Surgery Trial (ACST) Collaborative Group. 10-yearstroke prevention after successful carotid endarterectomy forasymptomatic stenosis (ACST-1): a multicentre randomisedtrial. Lancet. 2010 Sep 25;376(9746):1074-84.Carotid Stenting Trialists’ Collaboration, Bonati LH, DobsonJ, Algra A et al. Short-term outcome after stenting versusendarterectomy for symptomatic carotid stenosis: a pre-planned meta-analysis of individual patient data. Lancet. 2010Sep 25;376(9746):1062-73. Epub 2010 Sep 15.

Liapis CD, Bell PF, Mikhailidis DP et al; ESVS GuidlinesCollaborators: ESVS guidelines ESVS Guidelines: section A- prevention in patients with carotid artery stenosis. CurrVasc Pharmacol. 2010 Sep;8(5):673-81.Sillesen H, Amarenco P, Hennerici MG, et al.: Atorvastatinreduces the risk of cardiovascular events in patients withcarotid atherosclerosis. A Secondary Analysis of the StrokePrevention by Aggressive Reduction in Cholesterol Levels(SPARCL) trial. Stroke 2008, 39:3297‚Äì3302.Markus HS, Droste SW, Kaps M et al: Dual AntiplateletTherapy With Clopidogrel and Aspirin in SymptomaticCarotid Stenosis Evaluated Using Doppler Embolic SignalDetection. The Clopidogrel and Aspirin for Reduction ofEmboli in Symptomatic Carotid Stenosis (CARESS) Trial.Circulation. 2005;111:2233-2240European Carotid Surgery Trialists‚Äô Collaborative Group.Randomised trial of endarterectomy for recently symptomaticcarotid stenosis: final results in the MRC European CarotidSurgery Trial (ECST). Lancet. 1998;351:1379‚ Äì1387.North American Symptomatic Carotid Endarterectomy TrialCollaborators. Beneficial effect of carotid endarterectomy insymptomatic patients with high-grade stenosis. N Engl JMed. 1991;325:450‚Äì453.Spence JD, Coates V, Li H et al: Effects of Intensive MedicalTherapy on Microemboli and Cardiovascular Risk in Asymp-tomatic Carotid Stenosis. Arch Neurol. 2010;67(2):180-186Goessens BMB, Visseren FLJ, Kappelle LJ et al: Asympto-matic Carotid Artery Stenosis and the Risk of New VascularEvents in Patients With Manifest Arterial Disease. TheSMART Study. Stroke 2007;38:1470-5.Marquardt L, Geraghty OC, Mehta Z, Rothwell PM. Lowrisk of ipsilateral stroke in patients with asymptomaticcarotid stenosis on best medical treatment: a prospective,population-based study. Stroke 2010;41:e11-7.Abbott AL. Medical (nonsurgical) intervention alone is nowbest for prevention of stroke associated with asymptomaticsevere carotid stenosis: results of a systematic review andanalysis. Stroke 2009;40:e573-83.Naylor R and Bell PRF: Treatment of Asymptomatic CarotidDisease with Stenting: Con. Semin Vasc Surg 2008; 21:100-107.P M Rothwell, M Eliasziw, S A Gutnikov, C P Warlow, H JM Barnett, for the Carotid Endarterectomy Trialists Collabo-ration: Endarterectomy for symptomatic carotid stenosis inrelation to clinical subgroups and timing of surgery. Lancet2004; 363: 915‚Äì24

H. Sillesen.- Asymptomatic carotid stenosis should be treatedpharmacologically alone


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In Western countries, stroke is the thirdleading cause of death and is the most com-mon cause of permanent disability. A steno-sis of the internal carotid artery may be re-sponsible for 10% to 20% of all strokes ortransient ischemic attacks (TIA).

Carotid artery stenting (CAS) has emergedas a useful, potentially less-invasive alterna-tive to carotid endarterectomy (CEA) and isone of the most controversial procedures inthe era of modern medicine.

The two most referenced trials in the cur-rent clinical decision-making process forcarotid stenosis are the North AmericanSymptomatic Carotid Endarterectomy Trial(NASCET) and the Asymptomatic CarotidAtherosclerosis Study (ACAS), that con-cluded there was a clear benefit to CEA inpatients with symptomatic and asympto-matic carotid occlusive disease, definingwhich patient population, which patientsand what degree of stenosis would benefitfrom CEA.

In current clinical practice, CAS hasemerged as a viable alternative for patientswho are deemed at high risk for surgery orpoor candidates for CEA, which is still con-sidered the standard of care.

This is demonstrated by some trials, butsome Authors suggest that the 30-day and1-year risk of death, stroke, or MI withCAS is equivalent to that with CEA insymptomatic and asymptomatic patients

with the same degree of carotid stenosiswithout considering surgical risk.

The critical safety objective of carotid bifur-cation prophylactic intervention is theavoidance of stroke, in particular, disablingstroke.

On the basis of several studies, CEA is gen-erally considered the standard therapy forsevere carotid artery disease.

In the last years the scientific world havebeen concentrated on CAS investigation.There is no general agreement whether itshould be accepted as an alternative methodto CEA. This controversy is caused by thelack of large randomized trials comparingendarterectomy to stenting particularly innon-high risk patients. If we look at theLiterature we can find a wider interest forpatient at high-risk treated with CAS butonly in the recent years attention moved topatient with a low-standard risk.

There is certainty: on the basis of the cur-rent evidence, CAS with cerebral protec-tion, in the hands of experienced Operatorsshould be considered equal (if not superior)to CEA in high-risk patient. Despite thefact that the immediate peri-procedural andin-hospital results are encouraging, we areaware that embolic protection devices (in alltheir forms) allowed Operators to protectthe procedure but unfortunately did not af-fect late embolic events.

Setacci, C.; Sirignano, P.; Setacci, F.; Chisci, E.; de Donato, G.

Department of Surgery, Vascular and Endovascular Surgery Unit. University of Siena, Italy.

Asymptomatic carotid stenosis>70% should be treated:Pharmacologycally plus CAS

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Our experience with CAS started 11 yearsago. Initially we made a precise patient se-lection and we focused endovascular treat-ment to patient with anatomical complexsituations (hostile necks, deleterious necksurgery with tracheostomy, secondary inter-ventions after endarterectomy, cervical ra-diotherapy, carotid stenosis after radiother-apy, frozen neck, large and short neck withhigh bifurcation, carotid bypass stenosis) orwith poor clinical conditions where surgeryoffers worse results (controlateral occlu-sions, deficient Willis‚Äô circle, severe coro-nary diseases, neurological deficit, heart fail-ure or pending coronary revascularization,low life expectancy due to tumours, or oldage) [so called: High-risk patient].

Year after year of experience with CAS, ourlearning curve was optimized and the re-sults obtained supported our conviction tooffer CAS as the first-choice to a patientwith severe carotid stenosis.

At the moment we relatively contraindicat-ed to CAS these kind of patient:

- Patient with floating thrombus in internalcarotid artery or common carotid artery.

- Patient very young (40-60 years) if theyare at standard risk for CEA (ASA ‚!2).

Long-term stroke prevention in our treatedpatients is the hallmark of successful carotidintervention. The 1-year and 3-years rate ofipsilateral stroke for CAS in this review arerespectively 2.92 %, 7.23%, similar withthose of the CEA arm 2.93%, 6.20% (p val-ue not significant).

Several Studies, comparing both techniquesrevealed equality of stenting and surgery,taking MI into account as an endpoint,high-risk patients benefit more from CAS.In our experience we lack to demonstratedifferences statistically significant for MIs at30 day between the two groups (p=0,16).

On the basis of our results we can demon-strated with facts and not with fictions, that

if we used specific devices applied to specificlesions and/or anatomies (‚Äútailored‚ÄùCAS strategy) the endovascular procedurecan be successful with a very low percent-age, but not without complications. The‚Äútailored‚Äù CAS strategy bases its ratio-nale mostly on deep knowledge of patientclinical status, vascular anatomy, carotidplaque characteristics and complexity. Webelieve that the pathological conditionshave to matched to the technical features ofthe materials at disposition of the Operator. An another important factor is that the BestMedical Treatment during the last years isbettering and nowadays is not equal at allto that of 20-25 years ago (the NASCET‚Äúera‚Äù). We have now more differentfamilies of drugs to fight hypertension, dis-lipidemia, ischemic cardiopathy and dia-betes. For example, there is a convincingevidence that clopidogrel, a new generationof anti-platelet anti-aggregation drug, usedwidely for CAS, in addition to aspirin re-duces the risk of myocardial infarction.

The medical therapy and in the future mol-ecular and gene therapy will be extremelyimportant to the cardiovascular patient.

We strongly believe that the treatment ofsevere carotid stenosis must be successfullymanaged by skilled Operators in high-vol-ume centers. These can be only centers ofVascular Surgery, because the VascularSurgeon knows very well the pathology, theanatomy, the haemodynamic of the bloodand the correlation with Echo-duplex find-ings and the lesion characteristics. Thisjoined with a correct patient and lesionanalysis could indicate and not force, theright intervention to the single, selected pa-tient (‚Äútailored‚Äù procedure). A ‚Äútai-lored‚Äù procedure can be possible if theoperator knows completely both the proce-dures with a precedent exhaustive learning-curve. The vascular surgeon can completelycome up to all patient‚Äôs requests.

Our real world study demonstrated anequivalence between CAS and CEA and inparticular a superiority of CAS to CEA for

C. Setacci et al.- Asymptomatic carotid stenosis >70% should be treated:pharmacologically plus CAS


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high-risk patients. We can strongly affirmthat an accurate learning-curve for CAS ismandatory to obtain optimal results.

Our standard of care, has become to treatas first option with CAS and we indicateCEA only with younger people, particularhypoechoic lesion at Duplex. Nowadays wecan offer both CEA and CAS to the patientwith the same peacefulness and conscious-ness.

However the literature lack of evidence tosupport our consideration, others trials andregisters will be necessary, but we don‚Äôtforget that the medical science is continu-ously evolving and maybe the randomizedlarge trials with their strict protocols cannot follow on time the advancement oftechnique, materials and devices. We needfor more dynamic studies but now we cannot do without randomized trials.

Raithel, D.; Wu, Z.; Qu, L.

Asymptomatic carotid stenosis>70%: endarterectomy andpharmacology

C. Setacci et al.- Asymptomatic carotid stenosis >70% should be treated:pharmacologically plus CAS


Background:

In Europe, at least one million people havesevere carotid stenosis. Patients with severecarotid artery stenosis are 3 times morelikely to suffer fatal or disabling ischaemicstroke compared with the general popula-tion. What is the best treatment for asymp-tomatic severe carotid artery stenosis(ASCAS)? We conducted a literature reviewin order to get consensus guidelines for tre-atment of ASCAS.

Methods:

We have undertaken a comprehensivereview of the published literature dealingwith the ASCAS, found out evidence-basedanswers to this questions and made a sum-mary.

Results:

Guidelines from American heart associa-tion, American academy of neurology andEuropean society of vascular surgery recom-mended that CEA can reduce future strokerate for ASCAS patients if the perioperativecomplication rate is kept low (< 3%). Gui-delines from Society for vascular surgeryand other clinical trials recommended CEAplus best medical therapy (BMT), if theperioperative risk is low. In the first asymp-tomatic carotid surgery trial (ACST-1),3120 patients were randomised betweenimmediate CEA plus medical therapy anddelayed CEA plus medical therapy. The 10-year results showed stroke risks were 4.1%versus 10.0% at 5 years and 10.8% versus16.9% at 10 years, excluding perioperativeevents and non-stroke mortality. 62 versus104 had a disabling or fatal stroke, and 37

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versus 84 had a non-disabling stroke. Com-bining perioperative events and strokes, netrisks were 6.9% versus 10.9% at 5 years and13.4% versus 17.9% at 10 years. Many stu-dies have all indicated that antiplateletagents and statins have made repair as muchas 50% safer. One meta-analysis of randomi-sed trials of statins in combination withother preventive strategies, including165792 individuals, showed that each 1mmol/L (39 mg/dL) decrease in LDLcholesterol equates to a reduction in relativerisk for stroke of 21·1% (p=0·009). Alt-hough four published trials of CEA versusCAS and the lead-in phase of the CarotidRevascularisation Endarterectomy versusStent Trial (CREST) have included someasymptomatic patients, no large trial has

specifically set out to compare CAS andCEA in asymptomatic patients. ACST-2aims to compare CEA with CAS in asymp-tomatic patients and provide clinicians withrobust evidence as to which (if either) inter-vention is least hazardous and which canprovide best long-term stroke reductionbenefit.

Conclusion:

CEA plus BMT is currently the best way totreat most ASCAS, if the patients are care-fully selected and the surgery is performedby surgeons with procedural morbidity andmortality rates of less than 3%.

D. Raithel et al.- Asymptomatic carotid stenosis >70%: endarterectomyand pharmacology


The treatment of asymptomatic carotid ste-nosis is still controversial after more than 15years of randomized trials and divergingopinions about the best solution betweenthe surgical option, carotid endarterectomy(CEA), or the endovascular procedure, ca-rotid stenting (CAS).

Today, more than 50% of the interventionson carotid stenosis worldwide are perfor-

med on asymptomatic patients. The benefitin stroke reduction coming from theAsymptomatic Carotid Surgery Trial(ACST) study for the treatment of asymp-tomatic patients is considerable: CEA hal-ved the net 5-year stroke risk from about12% to about 6%1. But, outside trials, inap-propriate selection of patients or poor qua-lity procedures could neutralize such bene-fits.

Froio, A.; Rossi, L.; Biasi, G.M.

Asymptomatic carotid stenosis>70%: Treatment should beconsidered according to the plaquecharacteristics

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A. Froio et al.- Symptomatic carotid stenosis >70%: treatment should be con-sidered according to the plaque characteristics


The endovascular approach to carotid ste-nosis with CAS has been proposed for yearsbut never really had the power to replaceCEA: in 2009, the Cochrane Collaborativereview stated that CEA still has to be consi-dered the treatment of choice for carotidstenosis2.

The latest data from the CREST study sho-wed that CAS or CEA, if randomly perfor-med on asymptomatic patients, have similarrates for periprocedural stroke, death andsubsequent ipsilateral stroke and myocardialinfarction, although the incidence of peri-procedural stroke was lower in the CEAgroup rather than the CAS group whereasmyocardial infarction rates were higher forthe CEA group3. On January 2011, theCirculatory System Panel of the Food andDrug Administration in the US voted in fa-vor of an expanded indication for the RXAcculink Carotid Stent System (Abbott,Abbott Park, IL), stating the benefits of ca-rotid stenting in patients at standard risk foradverse events from endarterectomy out-weigh the risks4.

In 2006, we stated that CAS and CEA arenot equivalent and should not be alternati-vely proposed in the same way to every pa-tient. Moreover, the selection of asympto-matic candidates for any carotid procedurebased on the degree of stenosis alone doesnot identify correctly the real risk presentedby the patient. We therefore described thatthe treatment of carotid stenosis should betailored upon peculiar characteristics ofeach patient, such as comorbidities, vascularanatomy features and plaquemorphology5.

Plaque morphology plays an important rolein order to identify asymptomatic patientsat high risk of cerebral infarction, and the-refore select the best treatment option.

For the first time, in 2009 the ESVSGuidelines for the treatment of carotid ste-nosis underlined that plaque morphologyshould be assessed before any invasive treat-ment6.

Carotid plaques are not always the same.Differences in macroscopic and microscopicappearance are clear to those who performsurgery of the carotid bifurcation; differentplaques are associated with different beha-viours allowing us to divide plaques withlow and high embolic power (vulnerableplaques).

Several morphological features can be asses-sed by modern imaging techniques such asultrasound, CEUS, Angio-CT and PET inorder to characterize the vulnerable plaque.One of the most common predictors of re-current events is plaque echolucency, obtai-ned by duplex scanning.

Echography, assessed according to theGray-Weale/Geroulakos classification7-8 canreliably identify areas rich of echoes (hype-rechoic or echogenic) and areas with fewechoes (hypoechoic or echolucent).

Several independent authors discovered thatecholucent plaques are associated with amuch greater embolization rate rather thanechogenic plaques, a higher grade of futureneurological events and an increased pre-sence of plaque macrophages9-15.

In conclusion, plaque echolucency reflects ahistological “unstable” composition madeby lipids, a thinner fibrous cap, hemorrha-gic core, neovascularization and inflamma-tory markers.

The carotid echographic evaluation has be-en improved with the introduction of acomputer-assisted objective grading of theechogenicity of the plaques, the GSM16-18.

The GSM measures plaque echogenicity, aquantitative index of the echoes registeredfrom the plaque. Low GSM plaques genera-te a higher number of embolic particles fo-llowing CAS19.

There is evidence of a direct correlationbetween the number of particles generatedduring CAS and the incidence of new clini-

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cal and subclinical lesions on magnetic reso-nance imaging and the risk of stroke duringthe endovascular procedure20,21.

With the Imaging in Carotid Angioplastyand Risk of Stroke (ICAROS) study, an in-ternational multicenter registry that collec-ted 418 CAS cases from 11 centers, we eva-luate the relationship between the echoge-nicity of carotid plaque, as measured byGSM, and the risk of stroke during CAS inorder to obtain a better selection of candi-dates for CAS22,23.

An echographic evaluation of carotid pla-que with GSM measurement was made pre-procedurally. The onset of neurological de-ficits during the procedure and the postpro-cedural period (30 days) was recorded. TheGSM value in complicated patients was sig-nificantly lower than in uncomplicated ca-ses, both in the stroke (p<0.005) and thestroke plus TIA (p<0.005) subsets. A recei-ver operating characteristic curve was usedto choose the best GSM cutoff value: themost successful threshold was 25. The pre-valence of a GSM value <25 (echolucentplaques) was high: 37% (155 of 418 pa-tients). Eleven (7.1%) of the 155 patientswith GSM !25 had a stroke compared to 4(1.5%) of 263 patients with GSM >25(p=0.005)22.

Further evidence derives from many worksthat showed that echolucent carotid pla-ques (with low GSM values) have a higherincidence of a positive brain computed to-mography for ischemic lesions, a conditionrelated to neurological impairment and de-mentia, elevated serum levels of triglyceri-de-rich lipoproteins and lower levels ofhigh-density lipoprotein cholesterol(HDL), higher inflammatory markers (se-rum interleukin-6 and C-reactive protein),and a faster plaque progression24-33.

The combination of contrast agents to tra-ditional ultrasonography (Contrast-Enhanced Ultrasonography, CEUS) is cu-rrently emerging as a new diagnostic tool invascular medicine. CEUS has the potential

to identify carotid plaque neovasculariza-tion, an index of plaque vulnerability.Carotid neovascularization assessed byCEUS is significantly associated with onsetof neurological symptoms, the presence ofipsilateral embolic lesion on pre-operativebrain CT, a thinner fibrous cap, greater in-flammatory infiltrate in carotid plaque spe-cimens34.

Within the new emerging imaging modali-ties of plaque morphology, positron emis-sion tomography (PET) of atherosclerosiswith the use of [18F]- fluorodeoxyglucose(FDG), in which glucose metabolism wit-hin plaques can be assessed with high sensi-tivity, has been identified as a diagnosticmethod and for risk stratification35-37. HighFDG uptake in carotid artery plaques is as-sociated with presence of macrophages andmolecular gene up-regulation of enzymesknown to degrade the cellular matrix ofvulnerable plaques38-40. Because of that,FDG PET depicts inflammation in atheros-clerotic carotid lesions and this finding iscorrelated with echolucent plaques.

Conclusion Indications for treatment withCAS or CEA are essential in order to per-form safe and tailored procedures.

Selection of candidates for CAS or CEAshould be based on vascular anatomical fea-tures, comorbidities, and plaque morpho-logy; in the near future, the use of new ima-ging techniques (GSM; CEUS; PET) andvascular biomarkers will select asymptoma-tic patients with the higher benefit fromsurgery or carotid stenting.

The GSM index allows the detection andstratification of vulnerable plaques inasymptomatic patients; A low GSM value isnot an absolute contraindication to CAS,but an index related to a higher risk for theprocedure. Echographic evaluation of caro-tid plaque through the GSM should there-fore always be included in the planning ofany clinical trial on the endovascular treat-ment of carotid lesions.



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REFERENCES

Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, etalMRC Asymptomatic Carotid Surgery Trial (ACST)Collaborative Group. Prevention of disabling and fatal strokes bysuccessful carotid endarterectomy in patients without recent neu-rological symptoms: randomised controlled trial. Lancet2004;363:1491e502.Ederle J, Featherstone RL, Brown MM. Percutaneous translumi-nal angioplasty and stenting for carotid artery stenosis. CochraneDatabase Syst Rev 2007;4:CD000515.doi:10.1002/14651858.CD000515.pub3.Brott TG, Hobson RW II, Howard G, Roubin GS, Clark WM,Brooks W, Mackey A, Hill MD, Leimgruber PP, Sheffet AJ,Howard VJ, Moore WS, Voeks JH, Hopkins LN, Cutlip DE,Cohen DJ, Popma JJ, Ferguson RD, Cohen SN, Blackshear JL,Silver FL, Mohr JP, Lal BK, Meschia JF; Crest investigators.Stenting versus endarterectomy for treatment of carotid-artery ste-nosis. N Engl J Med. 2010;363:11‚-23.Abbott. FDA advisory committee votes favorably on expandingthe indication for Abbott’s carotid stent system to include patientsat standard surgical risk [press release]. January 26, 2011Biasi GM, Froio A, Deleo G, Lavitrano M. Indication for carotidendarterectomy versus carotid stenting for the prevention of brainembolization from carotid artery plaques: in search of consensus.J Endovasc Ther 2006;13:578‚-591.Liapis CD, Bell PR, Mikhailidis D, Sivenius J, Nicolaides A,Fernandes E, Fernandes J, Biasi G, Norgren L. ESVS guidelines.Invasive treatment for carotid stenosis: indications, techniques.Eur J Vasc Endovasc Surg 2009;37:1-19.Geroulakos G, Ramaswami G, Nicolaides A, et al.Characterization of symptomatic and asymptomatic carotid pla-ques using high-resolution real-time ultrasonography. Br J Surg.1993;80:1274-1277.78 in search of consensusGray-Weale AC, Graham JC, Burnett JR, et al. Carotid artery at-heroma: comparison of preoperative B-mode ultrasound appearan-ce with carotid endarterectomy specimen pathology. J CardiovascSurg (Torino). 1988;29:Liapis CD, Kakisis JD, Kostakis AG. Carotid stenosis: factors af-fecting symptomatology. Stroke. 2001;32:2782-2786.676-681.Gronholdt ML, Nordestgaard BG, SchroederTV, et al. Ultrasonicecholucent carotid plaques predict future strokes. Circulation.2001;104:68-73.Mathiesen EB, Bonaa KH, Joakimsen O. Echolucent plaques areassociated with high risk of ischemic cerebrovascular events incarotid stenosis: the Tromso study. Circulation. 2001;103:2171-2175Polak JF, Shemanski L, O‚ÄôLeary DH, et al. Hypoechoic plaqueat US of the carotid artery: an independent risk factor for incidentstroke in adults aged 65 years or older. Cardiovascular HealthStudy. Radiology. 1998;208:649-654.Nicolaides AN, Kakkos SK, Griffin M, et al. Effect of image nor-malization on carotid plaque classification and the risk of ipsilate-ral hemispheric ischemic events: results from the asymptomaticcarotid stenosis and risk of stroke study. Vascular. 2005;13:211-221.Gronholdt ML, Nordestgaard BG, Bentzon J, et al. Macrophagesare associated with lipid-rich carotid artery plaques, echolucencyon B-modeAndrew N. Nicolaides, Stavros K. Kakkos, Efthyvoulos Kyriacouet al. Asymptomatic internal carotid artery stenosis and cerebro-vascular risk stratification J Vasc Surg. 2010 Dec;52(6):1486-1496Biasi GM, Mingazzini PM, Baronio L, et al. Carotid plaque cha-racterization using digital image processing and its potential in fu-ture studies of carotid endarterectomy and angioplasty. JEndovasc Surg. 1998;5:240-246.Biasi GM, Sampaolo A, Mingazzini P, et al.Computer analysis ofultrasonic plaque echolucency in identifying high risk carotid bi-furcationlesions. Eur J Vasc Endovasc Surg. 1999;17:476‚Äì479.el-Barghouty N, Geroulakos G, Nicolaides A,et al. Computer-as-sisted carotid plaque characterisation.Eur J Vasc Endovasc Surg.1995;9:389-393.Henry M, Henry I, Klonaris C, et al. Benefits ofcerebral protec-

tion during carotid stentingwith the PercuSurge GuardWire sys-tem: midterm results. J Endovasc Ther. 2002;9:1-13.Ackerstaff RG, Jansen C, Moll FL, et al. The significance of mi-croemboli detection bymeans of transcranial Doppler ultrasono-graphymonitoring in carotid endarterectomy. J Vasc Surg.1995;21:963-969.Tubler T, Schluter M, Dirsch O, et al. Balloonprotected carotid ar-tery stenting: relationshipof periprocedural neurological compli-cations with the size of particulate debris. Circulation.2001;104:2791-2796.Biasi GM, Froio A, Diethrich EB, et al. Carotidplaque echolu-cency increases the risk ofstroke in carotid stenting: the Imagingin CarotidAngioplasty and Risk of Stroke (ICAROS) study.Circulation. 2004;110:756-762.Biasi GM, Ferrari SA, Nicolaides AN, et al. The ICAROS re-gistry of carotid artery stenting. Imaging in Carotid Angioplastiesand Risk of Stroke. J Endovasc Ther. 2001;8:46-52.Jaeger HJ, Mathias KD, Hauth E, et al. Cerebralischemia detectedwith diffusion-weighted MR imaging after stent implantation inthecarotid artery. AJNR Am J Neuroradiol. 2002;23:200-207.Flach HZ, Ouhlous M, Hendriks JM, et al. Cerebral ischemia aftercarotid intervention. J Endovasc Ther. 2004;11:251-257.Schluter M, Tubler T, Steffens JC, et al. Focal ischemia of thebrain after neuroprotected carotid artery stenting. J Am CollCardiol. 2003;42:1007-1013.Wolf O, Heider P, Heinz M, et al. Microembolic signals detectedby transcranial Doppler sonography during carotid endarterec-tomy and correlation with serial diffusion-weighted imaging.Stroke. 2004;35:e373-375.Liebetrau M, Steen B, Hamann GF, et al. Silent and symptomaticinfarcts on cranial computerized tomography in relation to demen-tia and mortality: a population-based study in 85-year-old sub-jects. Stroke. 2004;35:1816-1820.Vermeer SE, Prins ND, den Heijer T, et al. Silent brain infarctsand the risk of dementia and cognitive decline. N Engl J Med.2003;348:1215-222.Mathiesen EB, Bonaa KH, Joakimsen O. Low levels of high-den-sity lipoprotein cholesterol are associated with echolucent carotidartery plaques: the Tromso study. Stroke. 2001;32:1960-965.Gronholdt ML, Nordestgaard BG, Nielsen TG, et al. Echolucentcarotid artery plaques are associated with elevated levels of fas-ting and postprandial triglyceride-rich lipoproteins.Stroke.1996;27:2166-2172.Yamagami H, Kitagawa K, Nagai Y, et al. Higher levels of inter-leukin-6 are associated with lower echogenicity of carotid arteryplaques. Stroke. 2004;35:677-681.Johnsen SH, Mathiesen EB, Fosse E, et al. Elevated high-densitylipoprotein cholesterol levels are protective against plaque pro-gression: a follow-up study of 1952 persons with carotid atheros-clerosis the Tromso study. Circulation. 2005;112:498-504.G.L.. Faggioli, R. Pini, R.. Mauro, G.. Pasquinelli, S.. Fittipaldi,et al. Identification of Carotid -òVulnerable Plaque‚Äô byContrast-enhanced Ultrasonography: Correlation with PlaqueHistology, Symptoms and Cerebral Computed TomographyEuropean Journal of Vascular and EndovascularSurgery, Volume 41, Issue 2, Pages 238-248Basu S, Zhuang H, Torigian DA, Rosenbaum J, Chen W, Alavi A.Functional imaging of inflammatory diseases using nuclear medi-cine techniques. Semin Nucl Med 2009;39:124-45.Warburton L, Gillard J. Functional imaging of carotid atheroma-tous plaques. J Neuroimaging 2006;16:293-301.Vallabhajosula S, Fuster V. Atherosclerosis:imaging techniquesand theevolving role of nuclear medicine. J Nucl Med1997;38:1788-96.Rudd JHF, Warburton EA, Fryer TD, et al. Imaging atherosclero-tic plaque inflammation with [18F]-fluorodeoxyglucose positronemission tomography. Circulation 2002;105: 2708-11.Graebe M, Pedersen SF, Borgwardt L, Hjgaard L, Sillesen H,Kj¶r A. Molecular pathology in vulnerable carotid plaques: co-rrelation with [18]- fluorodeoxyglucose positron emission tomo-graphy (FDG PET). Eur J VascEndovasc Surg 2009;37:714-21.Tawakol A, Migrino RQ, Bashian GG,et al. In vivo 18F-fluorode-oxyglucose positron emission tomography imaging provides a no-ninvasive measure of carotid plaque inflammation in patients. JAm Coll Cardiol 2006;48:1818-24.



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Level I evidence founded on well conduct-ed randomized controlled trials is supposedto be the holy grail of scientific data onwhich to base good medical practice. Therecent CREST trial (Carotid Revasculariza-tion Endarterectomy versus Stent Trial)comparing the outcomes of carotid stenting(CAS) and carotid endarterectomy (CEA),is one such study that was designed andconducted in exemplary fashion. It hasattracted a great deal of attention andshould be part of a solid and definitive basisfor determining medical practice.

Yet when its findings have been presented,the conclusions differ greatly depending onthe underlying bias of the presenter. If avascular specialist with a bias toward CEAinterprets the CREST findings, the lowerstroke and death rate for CEA justifies theconclusion that CEA is superior and shouldbe used preferentially to treat patientsrequiring an invasive procedure for acarotid stenosis. On the other hand, if avascular specialist with a bias toward CAS isinterpreting CREST findings, he or she willregard them as definitive and will concludethat the equivalent and low overall compos-ite (death, stroke and myocardial infarction)adverse event rates for the two proceduresjustifies the widespread and increased use ofCAS to treat patients with symptomatic andasymptomatic carotid stenosis.

All should recognize the extent to whichthe results of CREST are being spun andthat the truth lies somewhere in betweenthese two diametrically opposed views.Moreover, all should realize that the truesignificance of CREST awaits a carefulanalysis and sub-analysis of the trial’sdetailed results, some of which have yet to

be fully revealed in peer reviewed publica-tions.

Before determining how CREST shouldinfluence practice patterns and utilization ofCEA and CAS, we need to see the datarelating to the costs for the two procedures.More importantly we need to appreciatethat minor strokes and mild myocardialinfarctions (MIs) are not equivalent (asCREST might imply). This non-equiva-lence is borne out by the greater late dis-ability suffered by those who had adverseevents after CAS than after CEA in CREST.This difference is the result of a minorstroke’s residual brain damage, which cancause subtle problems not reflected in evena careful neurological exam. We alsoshould appreciate that, although there weremore cranial nerve injuries (CNIs) afterCEA, most of these were minor and tran-sient. Although some have equated CNIsto strokes, the latter may leave patients withlasting brain dysfunction and mood changeseven though there is no apparent residualmotor or sensory loss. We also still need toknow what were the exact effect of age, sexand other factors on the incidence ofstroke, myocardial infarction and deathrates after the two procedures?

In addition, we must consider that CREST,even though it was well designed and con-ducted, has its flaws. The techniques usedfor CAS are already outdated. For example,flow reversal and cessation methods forcerebral embolic protection, already clearlyshown to be useful in some circumstances,were never employed. So the case could bemade that current CAS results would bebetter than they were in CREST. More-over, even better CAS technology like

Veith, J.

Vascular Surgery. Cleveland Clinic Foundation. Cleveland. USA.

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membrane-covered stents are on the hori-zon and may well further improve CASresults. Off- setting these possibilities, theCAS operators in CREST were unusuallyvetted and skilled. This raise the question:will the CAS results in CREST be general-izable if the procedure is widely adopted byvascular specialists at large? Populationbased studies suggest that CAS will havesubstantially higher adverse event rates thanthose in CREST.

Another issue with CREST is that it includ-ed both symptomatic and asymptomaticpatients. This clearly reduces the power ofthe trial, and prevented the substantiallylarger number of major strokes and deathsafter CAS in symptomatic patients fromachieving statistical significance. There isalso the issue that the periproceduralantiplatelet regimen for CAS patients wasmore intensive than for CEA patients. Thiscould account in part at least for the lowerMI rate after CAS than CEA.

Finally in the asymptomatic patient cohort,the nagging possibility remains that currentbest medical therapy, particularly with highdose statins which were not used inCREST, could produce equal or better out-comes than both CEA and CAS, since thestroke rate in such medically treatedpatients only ranges between 0.4% and 0.8%per year. This possibility will remain untilappropriate prospective trials such asSPACE II, ECST-2 and TACIT, whichcompare both CEA and CAS to best med-ical treatment, are completed. The comple-tion of these trials will take many years, andTACIT has yet to be funded.

So how should we cut through the spin sur-rounding CREST and use the trial to helpus as soon as possible? We should await itscomplete publication and the analyses andsub-analyses of the data contained in thesearticles. We should recognize the intrinsicflaws even in this well conducted trial andview it in the perspective of other random-ized prospective trials which also have theirflaws. ICSS is particularly relevant in thisregard since it was conducted entirely in

symptomatic patients. Although the experi-ence of the CAS operators in this trial canbe criticized, the incidence of strokes andsilent brain defects on diffusion weightedMRI was clearly and significantly greaterafter CAS than CEA.

Most importantly we should demand othertrials in this interesting and extremely con-troversial area where bias leads to “spin-ning” of results. These other trials are sore-ly needed to evaluate evolvingimprovements in patient selection and tech-nology for CAS and to compare both CASand CEA with best medical therapy inasymptomatic patients. Other work isneeded to develop methods to detect vul-nerable but asymptomatic plaques at highrisk of causing a stroke so they can be treat-ed invasively without subjecting large num-bers of patients with low risk plaques tounneeded procedures at a great monetarycost to society.

Although CREST is an important trial, wemust remember that no trial is perfect,definitive or of timeless value. Beware thespinning that purports to make it so – inany direction.

REFERENCES

Brott TG, Hobson RW 2nd, Howard G, et al; CRESTInvestigators. Stenting versus endarterectomy for treat-ment of carotid artery stenosis. N Engl J Med2010;363:11–23.Paraskevas KI, Mikhailidis DP, Nicolaides AN, VeithFJ.Interpreting the Carotid Revascularization Endarterecto-my versus Stent Trial (CREST): Additional Trials AreNeeded. VASCULAR 2010;18: 247-249.International Carotid Stenting Study investigators, EderleJ, Dobson J, Featherstone RL, et al. Carotid artery stent-ing compared with endarterectomy in patients with symp-tomatic carotid stenosis (International Carotid StentingStudy): an interim analysis of a randomised controlledtrial. Lancet 2010;375:985–97.

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In April 2009, the European Society forVascular Surgery published clinical practiceguidelines for the invasive treatment ofcarotid disease1. Today, after 2 years ofendovascular progress and accumulation ofknowledge, the question that is raised iswhether these guidelines are still valid.

Invasive treatment recommendation 2.Carotid artery stenting (CAS) in sympto-matic patients

The available level I evidence suggests thatfor symptomatic patients, surgery is cur-rently the best option [A].

The recommendation was based on a meta-analysis by The Cochrane Collaboration ofeight randomised trials comparing carotidendarterectomy (CEA) with CAS(CAVATAS, Kentucky, Leicester, Wall-stent, SAPPHIRE, EVA-3S, SPACE andBACASS) showing that surgery is associat-ed with lower stroke and death rate within30 days of treatment (OR: 1.39, 95% CI:1.05-1.84, p=0.02)2. The results of twomore trials were published thereafter, bothof which lending further support to theESVS recommendation. The ICSS trialshowed that the risk of any stroke or deathwithin 120 days of randomization washigher in the stenting group than in theendarterectomy group (8.5% vs 4.7%, OR1.86, 1.26-2.74)3. Similarly, in the sub-group analysis of the symptomatic patientsin the CREST trial, the peri-proceduralstroke or death rate was 6.0% in the stent-ing group vs 3.2% in the endarterectomygroup (OR 1.89, 1.11-3.21, P=0.02)4. Atrend towards a higher rate of myocardial

infarction in the group of symptomaticpatients undergoing CEA did not reach sta-tistical significance (1% in the CAS group vs2.3% in the CEA group, OR 0.4, 0.18-1.11, P=0.08).

Mid-term stroke prevention after suc-cessful CAS is similar to CEA [A].

The recommendation was based on themid-term outcomes of EVA-3S andSPACE5,6.

In accordance with these data, the results ofthe CREST trial showed that, after theperiprocedural period, the incidence of ipsi-lateral stroke was similarly low with carotidartery stenting and with carotid endarterec-tomy (2.0% and 2.4%, respectively; P =0.85)4. Because the life expectancy of thepatients included in CREST was 15 yearsafter the procedure, outcomes are beingassessed out to 10 years and are awaited.

CAS should be offered to symptomaticpatients, if they are at high risk forCEA, in high volume centres with docu-mented low peri-procedural stroke anddeath rates or inside an RCT [C].

The recommendation was based on expertsopinion with the term “high risk for CEA”referring mainly to adverse vascular andlocal anatomic features. Today, there is stillinsufficient evidence to support a wide-spread change in clinical practice away fromthese strict indications for CAS.

Invasive treatment recommendation 3. CASin asymptomatic patients

Kakisis, J.D.; Liapis, C.

Department of Vascular Surgery, Athens University Medical School, Attikon University, Athens, Greece.

Are ESVS guidelines on carotidintervention still valid?

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Meanwhile, it is advisable to offer CASin asymptomatic patients only in high-volume centres with documented lo peri-procedural stroke and death rates orwithin well-conducted clinical trials[C].

The recommendation was based on the factthat data on asymptomatic patients werevery weak, coming only from one small ran-domised trial, comprising only 85 patients7,and a subgroup analysis of the SAPPHIREtrial, which was not prespecified8. Bothstudies showed that CAS and CEA areequally effective in preventing stroke anddeath in asymptomatic patients.

Today, there is increasing evidence that therate of stroke and death does not differ sig-nificantly in asymptomatic patients under-going carotid artery stenting and thoseundergoing carotid endarterectomy, since asubgroup analysis from the CREST trialshowed that the rate of peri-proceduralstroke or death was 2.5% in CAS vs 1.4% inCEA (OR 1.88, 0.79-4.42, P=0.15)4. Nostatistically significant difference was alsofound in the rate of myocardial infarction(1.2% vs 2.2%, OR 0.55, 0.22-1.38,P=0.2), in the rate of any periproceduralstroke (2.5% vs 1.4%, OR 1.88, 0.79-4.42,P=0.15) or in the rate of the composite pri-mary end point (any periprocedural stroke,myocardial infarction or death: 3.5% vs3.6%, OR 1.02, 0.55-1.86, P=0.96)4.

On the other hand, there is growing evi-dence that rates of ipsilateral and any-terri-tory stroke with medical intervention alonehave fallen significantly since the mid-1980s, with recent estimates overlappingthose of patients who underwent CEA inrandomized trials9, 10. The average annualrisk of ipsilateral stroke in asymptomaticpatients with >50% stenosis was >3% in1985, but has fallen to approximately 0,5%in 20089. Given this new evidence, currentvascular disease medical intervention alonemay now be best for stroke prevention asso-ciated with asymptomatic severe carotidstenosis. Until the results of the SPACE-2,

TACIT and ACT I studies are available, itwould be prudent to stick with the ESVSguideline and offer CAS in asymptomaticpatients only in centers of excellence orwithin well-conducted randomized con-trolled trials.

Invasive treatment recommendation 4.Treatment options influenced by medical co-morbidities

For asymptomatic patients at ‘extreme-ly’ high risk (several medical comorbidi-ties at the same time), best medicaltreatment might be the best optioninstead of invasive intervention [C].

CAS should not be offered to asympto-matic ‘high-risk’ patients if the peri-interventional complication rate is >3%[C].

There is still no indication from the litera-ture that a ‘high risk’ for surgery patient isalso at ‘high risk’ for stroke if medicallytreated. Therefore, a peri-interventionalstroke or death risk of >3% in ‘high-risk forsurgery’ patients with asymptomatic carotidstenosis cannot be accepted.

CAS is associated to higher risk ofembolisation in octogenarians [B]. CEAis performed in octogenarians withoutincreased risk of embolisation and withan acceptable rate of neurological andcardiac complications [C].

The recommendation was based on severalpapers demonstrating that octogenariansundergoing CAS are at higher risk thannonoctogenarians for peri-procedural com-plications, including neurological eventsand death11,12. The recommendation wasstrengthened by the findings of the CRESTtrial detecting an interaction between ageand treatment efficacy, with a crossover atan age of approximately 70 years; carotid-artery stenting tended to show greater effi-cacy at younger ages, and carotidendarterectomy at older ages4. Mechanismsunderlying the increased risk with CAS in

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very elderly patients probably include vascu-lar tortuosity and severe vascular calcifica-tion, leading to an increased risk of cerebralembolization in this group of patients4.

Invasive treatment recommendation 13.Improving the CAS outcome Cerebral protec-tion devices are probably beneficial [C].

The recommendation was based on a sys-tematic review of all studies reporting onthe incidence of CAS complications thatwere published between 1990 and 200213,as well as on a subsequent report by theGlobal Carotid Artery Stent Registry docu-menting a 5.3-5.5% rate of stroke and deathin cases performed without protection,compared with 1.8-2.2% in cases performedwith cerebral protection14.

A randomised study of CAS with or with-out a distal cerebral protection filter, pub-lished before the ESVS guidelines, hadshown that, contrary to the initial expecta-tions, new MRI lesions developed in 72% ofthe cerebral protection group comparedwith 44% in the no cerebral protectiongroup (p=0.09)15. Most of these lesionswere silent, with the stroke rate being equalin the two groups (11%). The major limita-tion of this study was the small number ofcases included (36 stenting procedures in35 patients), which was due to the reluc-tance of the patients to participate in astudy with no cerebral protection group.

Interestingly, the findings of this study wererecently duplicated by another randomizedtrial, which showed that filter-protectedCAS is associated with an increase in newlesions on diffusion-weighted magnetic res-onance imaging (29% vs 18%) and signifi-cantly higher rates of total and particulatemicroembolisation on transcranial doppler(426.5 and 251.3 vs 165.2 and 92, respec-tively) than unprotected CAS16. This studywas also very small (30 patients) and thedifferences in MRI lesions did not reachstatistical significance. Larger studies areclearly warranted, though recruiting forsuch studies is expected to be very difficult,due to the already established, widespread

belief that, as the ESVS recommendationstates, “cerebral protection devices areprobably of benefit”.

This belief is also reinforced by the findingsof the most recent systematic review com-paring stroke outcomes in protected andunprotected CAS17. The review included134 articles reporting on 12,263 protectedCAS patients and 11,198 unprotected CASpatients. Using pooled analysis, the relativerisk (RR) for stroke was 0.62 (95% CI 0.54to 0.72) in favor of protected CAS. Sub-group analysis revealed a significant benefitfor protected CAS in both symptomatic(RR 0.67; 95% CI 0.52 to 0.56) andasymptomatic (RR 0.61; 95% CI 0.41 to0.90) patients (p<0.05).

REFERENCES

Liapis CD, Bell PR, Mikhailidis D, Sivenius J, Nicolaides A,Fernandes e Fernandes J, Biasi G, Norgren L; ESVS Guide-lines Collaborators. ESVS guidelines. Invasive treatment forcarotid stenosis: indications, techniques. Eur J VascEndovasc Surg. 2009;37(4 Suppl):1-19.Ederle J, Featherstone RL, Brown MM. Percutaneous translu-minal angioplasty and stenting for carotid artery stenosis.Cochrane Database Syst Rev 2007;4: CD000515. doi10.1002/14651858. CD000515. pub3.International Carotid Stenting Study investigators, Ederle J,Dobson J, Featherstone RL, Bonati LH, van der Worp HB, deBorst GJ, Lo TH, Gaines P, Dorman PJ, Macdonald S, LyrerPA, Hendriks JM, McCollum C, Nederkoorn PJ, Brown MM.Carotid artery stenting compared with endarterectomy inpatients with symptomatic carotid stenosis (InternationalCarotid Stenting Study): an interim analysis of a randomisedcontrolled trial. Lancet 2010;375:985-997.Brott TG, Hobson RW 2nd, Howard G, Roubin GS, ClarkWM, Brooks W, Mackey A, Hill MD, Leimgruber PP, Shef-fet AJ, Howard VJ, Moore WS, Voeks JH, Hopkins LN, Cut-lip DE, Cohen DJ, Popma JJ, Ferguson RD, Cohen SN,Blackshear JL, Silver FL, Mohr JP, Lal BK, Meschia JF;CREST Investigators. Stenting versus endarterectomy fortreatment of carotid-artery stenosis. N Engl J Med2010;363:11-23.Mas JL, Trinquart L, Leys D, Albucher JF, Rousseau H,Viguier A, et al. EVA-3S investigators. Endarterectomy Ver-sus Angioplasty in Patients with Symptomatic Severe CarotidStenosis (EVA-3S) trial: results up to 4 years from a ran-domised, multicentre trial. Lancet Neurol 2008;7:885-92.Eckstein HH, Ringleb P, Allenberg JR, Berger J, FraedrichG, Hacke W, et al. Results of the Stent-Protected Angioplastyversus Carotid Endarterectomy (SPACE) study to treat symp-tomatic stenoses at 2 years: a multinational, prospective, ran-domised trial. Lancet Neurol 2008;7:893-902.Brooks WH, McClure RR, Jones MR, Coleman TL, BreathittL. Carotid angioplasty and stenting versus carotid endarterec-tomy for treatment of asymptomatic carotid stenosis: a ran-domized trial in a community hospital. Neurosurgery2004;54:318-25.SAPPHIRE Investigators (Stenting and Angioplasty withProtection in Patients at High Risk for Endarterectomy).


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REFERENCES

Protected carotid-artery stenting versus endarterectomy inhigh-risk patients. N Engl J Med 2004;351:1493-501.Abbott AL. Medical (nonsurgical) intervention alone is nowbest for prevention of stroke associated with asymptomaticsevere carotid stenosis: results of a systematic review andanalysis. Stroke 2009;40:e573-83.Naylor AR, Gaines PA, Rothwell PM. Who benefits mostfrom intervention for asymptomatic carotid stenosis: patientsor professionals? Eur J Vasc Endovasc Surg 2009;37:625-32.Hobson 2nd RW, Howard VJ, Roubin GS, Brott TG, Fergu-son RD, Popma JJ, et al. CREST Investigators. Carotid arterystenting is associated with increased complications in octoge-narians: 30-day stroke and death rates in the CREST lead-inphase. J Vasc Surg 2004;40:1106-11.Stanziale SF, Marone LK, Boules TN, Brimmeier JA, Hill K,Makaroun MS, et al. Carotid artery stenting in octogenariansis associated with increased adverse outcomes. J Vasc Surg2006;43:297-304.

Kastrup A, Gröschel K, Krapf H, Brehm BR, Dichgans J,Schulz JB. Early outcome of carotid angioplasty and stent-ingwith and without cerebral protection devices: a systematicreview of the literature. Stroke 2003;34:813-9.Wholey MH, Al-Mubarek N, Wholey MH. Updated reviewof the global carotid artery stent registry. Catheter CardiovascInterv 2003;60:259-66.Barbato JE, Dillavou E, Horowitz MB, Jovin TG, Kanal E,David S, et al. A randomized trial of carotid artery stentingwith and without cerebral protection. J Vasc Surg2008;47:760-5.Macdonald S, Evans DH, Griffiths PD, McKevitt FM, Ven-ables GS, Cleveland TJ, Gaines PA. Filter-protected versusunprotected carotid artery stenting: a randomised trial. Cere-brovasc Dis 2010;29:282-9.Garg N, Karagiorgos N, Pisimisis GT, Sohal DP, Longo GM,Johanning JM, Lynch TG, Pipinos II. Cerebral protectiondevices reduce periprocedural strokes during carotid angio-plasty and stenting: a systematic review of the current litera-ture. J Endovasc Ther 2009;16:412-27.


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The appearance of flow diverting stents(FD) heralds a new tool in the treatment offusiform aneurysms (FA) and wide-necksaccular aneurysms (SA). These were noweither problematic to treat or consideredintractable, which in many cases meant thatvessel occlusion was the only treatmentoption. The objective of a FD is to securethe remodelling of the artery and the redis-tribution of flow, allowing progressiveexclusion and resulting in the thrombosis ofthe aneurysm, while maintaining permeabil-ity in healthy branches covered by the stentkeeping permeable1-6. They are self-expand-ing tight-mesh stents, and therefore presenthigh-metal surface area coverage1. There are2 options on the market, the Pipeline(ev3/Chestnut Medical, Menlo Park, Cali-fornia) which comprises 48 braided strandsof cobalt chromium and platinum which,when expanded, offers a metal coverage ofapproximately 30% to 35% of the total sur-face area 1. The second FD available is the

Silk (Balt, Montmorency, France), of simi-lar manufacture but using of nickel-titani-um and platinum, and providing a metalcoverage of 35% to 55% of the surface area4.To date, they have been described in limit-ed series, mainly in the treatment ofuncomplicated aneurysms, and show apromising future1-6. In the past year, articlesof isolated cases have also been published inwhich the indications have been extendedto small aneurysms (< 2mm) treated in 3patients with FD 35, 24 and 10 days after asubarachnoid haemorrhage (SAH), also inan acute case of a patient with SAH sec-ondary to the rupture of a blood blister-likeaneurysm8, and in the treatment of amycotic aneurysm of the cavernous carotidartery in a 10-year-old girl9. Despite beingrelatively new technique, we should be con-versant with the new characteristics, eitherfor optimal treatment planning or beingaware of potential FD-specific complica-tions.

Macho, J.M.; Blasco, J.; San Romásm, L.; Tomasello, A.; López, A.

Flow diversion concept: stentingand flow divider stents

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REFERENCES

Nelson PK, Lylyk P, Szikora I, Wetzel SG, Wanke I,Fiorella D. The pipeline embolization device for theintracranial treatment of aneurysms trial. AJNR Am J Neu-roradiol. 2010Lubicz B, Collignon L, Raphaeli G, Pruvo JP, Bruneau M,De Witte O, Leclerc X. Flow-diverter stent for the endovas-cular treatment of intracranial aneurysms: A prospectivestudy in 29 patients with 34 aneurysms. Stroke.2010;41:2247-2253Lylyk P, Miranda C, Ceratto R, Ferrario A, Scrivano E,Luna HR, Berez AL, Tran Q, Nelson PK, Fiorella D. Cura-tive endovascular reconstruction of cerebral aneurysms withthe pipeline embolization device: The buenos aires experi-ence. Neurosurgery. 2009;64:632-642; discussion 642-633;quiz N636Kulcsar Z, Ernemann U, Wetzel SG, Bock A, Goericke S,Panagiotopoulos V, Forsting M, Ruefenacht DA, Wanke I.High-profile flow diverter (silk) implantation in the basilarartery: Efficacy in the treatment of aneurysms and the roleof the perforators. Stroke. 2010;41:1690-1696Szikora I, Berentei Z, Kulcsar Z, Marosfoi M, Vajda ZS,Lee W, Berez A, Nelson PK. Treatment of intracranialaneurysms by functional reconstruction of the parent artery:The budapest experience with the pipeline embolizationdevice. AJNR Am J Neuroradiol. 2010;31:1139-1147Byrne JV, Beltechi R, Yarnold JA, Birks J, Kamran M.Early experience in the treatment of intra-cranial aneurysmsby endovascular flow diversion: A multicentre prospectivestudy. PLoS One. 2010;5Kulcsar Z, Wetzel SG, Augsburger L, Gruber A, Wanke I,Rufenacht DA. Effect of flow diversion treatment on verysmall ruptured aneurysms. Neurosurgery. 2010;67:789-793Rasskazoff S, Silvaggio J, Brouwer PA, Kaufmann A, Nis-tor A, Iancu D. Endovascular treatment of a ruptured bloodblister-like aneurysm with a flow-diverting stent. IntervNeuroradiol. 2010;16:255-258Appelboom G, Kadri K, Hassan F, Leclerc X. Infectiousaneurysm of the cavernous carotid artery in a child treatedwith a new-generation of flow-diverting stent graft: Casereport. Neurosurgery. 2010;66:E623-624; discussion E624O'Kelly C J, Krings T, Fiorella D, Marotta TR. A novelgrading scale for the angiographic assessment of intracra-nial aneurysms treated using flow diverting stents. IntervNeuroradiol. 2010;16:133-137van Rooij WJ, Sluzewski M. Perforator infarction afterplacement of a pipeline flow-diverting stent for an unrup-tured a1 aneurysm. AJNR Am J Neuroradiol. 2010;31:E43-44S. William Stavropoulos M, Sridhar R. Charagundla M,PhD. Imaging techniques for detection and management ofendoleaks after endovascular aortic aneurysm repair1. Radi-ology. Volume 243: Number 3—June 2007Turowski B, Macht S, Kulcsar Z, Hanggi D, Stummer W.Early fatal hemorrhage after endovascular cerebralaneurysm treatment with a flow diverter (silk-stent) : Do weneed to rethink our concepts? Neuroradiology. 2010Cebral JR, Mut F, Raschi M, Scrivano E, Ceratto R, LylykP, Putman CM. Aneurysm rupture following treatment withflow-diverting stents: Computational hemodynamics analy-sis of treatment. AJNR Am J Neuroradiol. 2010Kulcsar Z, Houdart E, Bonafé A, Parker G, Millar J, God-dard AJP, Renowden S, l GG, Turowski B, Mitchell K,Gray F, Rodriguez M, Berg Rvd, Gruber A, Desal H,Wanke I, fenacht DAR. Intra-aneurysmal thrombosis as apossible cause of delayed aneurysm rupture after flow-diversion treatment. American Journal of Neuroradiology.2010Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, CloftHJ. A second-generation, endoluminal, flow-disruptingdevice for treatment of saccular aneurysms. AJNR Am JNeuroradiol. 2009;30:1153-1158.

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Fig. 1. 3D MIP reconstruction showing a fusiform aneurysm at thesupraclinoid rigth internal carotid (RICA).

Fig. 2. Stent mesh at the (RICA), just at the end of the procedure.

Fig. 3. 3D angiographic reconstruction showing a complete aneurysmocclusion with moderate intrastent stenosis at the 3 month follow up.

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Wine is a pleasant and healthy beveragewhose salutary properties have been recog-nized in ancient times. In recent years therehas been an emphasis on the health promo-ting aspects of wine in a variety of condi-tions which created a consumption increasein the US. In Europe, time-honored winedrinking has never been challenged alt-hough the conviction on its benefit hasbeen recently reinforced by the FrenchParadox.

Basic chemistry of wine

Wine is a live liquid. If we could perfectlyseal wine in a vessel it will invariably turn tovinegar if we wait long enough. The reasonis the presence of peroxide generators inwine like phenol turning into quinone bythe presence of PPO and other enzymes.Fortunately PPO has a pKa about 9-10,making the forward reaction quite slowunder the normally acid wine environmentof 3.5-4. Free oxygen radicals oxidize manysubstrates in wine, like ethyl alcohol to ace-taldehyde and further to acetic acid (vina-ger).

This concept helps understand the increa-sing chemical complexity of wine with timeknown as the “wine multiplication effect”.As alcohol oxidizes to aldehyde and carbo-xic acid spontaneous combinations of alco-hol, aldehyde and acid produces esters, ace-tal and hemiacetals. If we consider thatthere is more than ten alcohols in wine it iseasily seen how hundreds of new chemicalsare generated with time, increasing thechemical complexity of wine.

A few of the known “wine factoids” havechemical explanations. One of them is “bot-

tle shock” or the loss of flavor soon afterbottling. Wine that has been protectedfrom air during barrel aging, is suddenlyexposed to air-and oxygen- during bottlingcausing a rapid generation of acetaldehydewhich is blamed for the flavor loss. Withtime, the acetaldehyde is converted to ace-tic acid and the flavors return. Three alter-natives to deal with this are: prevent agita-tion and air exposure during bottling, agethe bottled wine for a year before release oradd sulfur dioxide to the wine to turn thealdehyde into hyposulfite, a flavorless subs-tance.

Corkiness is caused by TCA or trichloroani-sole, an incredibly flavorful substance(detectable at 1 ppb) produced by a moldnaturally occurring in cork and wood. Themold cannot be avoided but since it needschlorine to make the nasty substance, Cl istotally avoided in the wine industry, there-fore minimizing this problem. Althoughmany of us have returned bottles to a sadsommelier because of corkiness, fewer trulyrecognize the flavor: Burnt charcoal,moldy, medicinal, wet cement. Another fac-toid is related to red wine headache. Thishas been blamed to intolerance to sulfitesor allergies to red wine phenols. Morerecently it has been associated to biogenicamines like histamine and tyramine, knownto produce headache, flushing, nausea andgeneral discomfort. These substances areproduced by slow growing bacteria inwine, introduced by poor sanitation in itsprocessing. Modern wine facilities producefar cleaner (bacteria free) wines than 50years ago.

Of importance to doctors, particularly whendealing with patients on low sodium diets,is the fact that wine is actually sodium poor

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(!100 mg/lt) and potassium rich ("1000mg/lt). Among the anions of interest,phosphate is in relatively large concentra-tion at 300mg/lt and sulfates (the reasonfor the label warning in wines) at around800 mg/lt. Phosphates are naturally occu-rring in the grape while sulfates are largelyintroduced by processing in the field andlater in the winery. Many randomizationstudies have proven that sulfite intoleranceactually does not have a rational basis.Many people who claim sulfite intolerancewith wine do not have the same effect whenexposed to dried fruits, having many timesthe concentration of sulfites of wine.

Tannins are important chemicals becausethey are responsible for the astringency andcolor, two important characteristics of wine,particularly red wine. Also, some of them(flavonoids) are known as the health mole-cules, quite relevant these days. Tanninsaccount for about 800 mg/lt in reds andare responsible for astringency and mouthfeel, giving wine taste persistence andbody. Tannins are polymers of gallic andellagic acid and catechins. As the nameimplies they tan (bind irreversibly to pro-teins causing denaturation). They bind irre-versibly to proteins of the mucosal lining ofthe mouth and tongue producing theastringency feeling and the persistenceeffect. The longer the tanning polymer, themore effective it is in binding mucosal pro-teins. Since polymerization of tannins is atime-dependent effect, it is possible thatolder red wines produce longer, moreintense mouth feel because of the moreeffective binding to the mucosa and tastebuds. This fact is the basis for the carefulhandling of old wines and red wine in gene-ral, avoiding the disruption of the delicatelong tannin polymer chains. This is also thebasis for gravity flow in wine making, repla-cing mechanical pumps to move winearound.

Biological effects of wine

Resveratrol is among several flavonoids inwine. It has been recognized to prolong the

life span of Saccharomyces Cereviseae, theyeast used for grape fermentation. This isachieved by inhibition of cell apoptoticmechanisms. It is interesting that this mole-cule in the grape promotes fermentation bysupporting life in a saprophyte organismpresent in the grape skin. Further, it hasbeen found to increase SIR-2 activity, aprotein deacetylase with anti-apoptotic pro-perties. For this reason molecules like resve-ratrol are called sirtuins. Interestingly, Res-veratrol as a molecule is quite similar to thesynthetic estrogen diethylethilbestrol(DES). In live animals, resveratrol increasesthe life span of mice on a high calorie dietby improving many altered metabolic path-ways resulting from high calorie consump-tion, like insulin resistance.

In recent years there has been an emphasison the neuroprotective effects of sirtuins. Ina mouse model of Alzheimers’s disease,consumption of wine instead of water bythese animals slowed down the progressionof the disease, improved neuromuscularfunction and significantly decreased thefocal deposits of amyloid beta protein intheir brains. This and other studies are thebasis for the prudent use of red wine in theprevention of progression of a variety ofneurodegenerative disorders such as seniledementia, Parkinson’s disease and Alzhei-mer’s disease.

A population study published in the NewEngland J of Medicine in 2005, olderwomen drinking moderate amounts of alco-hol had better cognitive functions andmemory that those not drinking.

The most resounding effect of red wine hasbeen its cardiovascular benefit. My favoritepublication is a French study in Circulation2002, describing the effect of wine con-sumption in victims of myocardial infarc-tion. Of 437 survivors of AMI followed for4 years for mayor acute cardiovascular end-points (MACE), there was a 59% reductionin those who drunk 2 wine glasses/day and52% reduction in those drinking 4 glas-ses/day compared to abstainers.

J. Palmaz.- Wine in healthTécnicas Endovasculares Vol.XIV. Núm. 1. Enero-Abril 2011; 3673-3676

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More recently wine has been proven tohave an effect against weight increase inwomen. In another population studypublished in Arch of Intern Med 2010, theweight of 20,000 women averaging 39 yrsof age were follow up for 13 yrs. There wasan inverse correlation between alcohol con-sumption and weight gain with those con-suming "30gr/day (2-3 glasses wine/day)having the least weight increase.

Flavors in wine:

Several defined chemicals are known to givewine specific flavors. Terpenoids are respon-sible for floral aromas, damascenone forfruity aromas while pyrazines give vegetati-ve aromas. Some of these substances areused in the food industry as additives butwine being a natural product should notreceive any flavor enhancing chemicals. Ofnote is the buttery flavor in white wine, par-ticularly chardonnay given by diacetyl. Thischemical is a byproduct of malo-lactic fer-mentation, a common procedure aimed atdecreasing tart flavors in wine produced bymalic acid. Its conversion into lactic acidsoftens the wine acid and gives a roundmouth feel. Further, diacetyl adds a butterytaste that is pronounced in certain Califor-nia chardonnays. Diacetyl used as artificialbutter flavor for pop-corn has been recogni-zed as potentially harmful for workers inha-ling it in large amounts for a long time toproduce a form of obliterative bronchiolitisknown as pop-corn lung.

The chemical nature of wine remains largelyunknown and is should be regarded as acomplex natural substance not to be mani-pulated beyond the traditional ways. Alt-hough wine tasting should be defined by acombination of the four basic tastes ofsweet, sour, salty and bitter (umami, themeety flavor can be included as a fifth basictaste) it involves smell. The wine aroma feelcouples with flavor and mouth feel to give acomplex perception of flavor, scent and tex-ture that goes beyond description by simplewords. A useful way to identify flavors is tocompare them with known flavors in our

memory and use them as descriptors. Oneway to help identify those flavors is thearoma wheel from UC Davis, Ann Noble.The wheel has general descriptors in thecenter, multiplying by more defined des-criptors in the periphery, such that a fruityflavor can be identified as tropical and furt-her into pineapple.

Wood, an important determinant of qua-lity

Wine aging in contact with wood is animportant because it adds complexity andfinesse to the basic fruity components ofwine. It is also the largest value added towine manufacture and something that defi-nes its quality and price. Wine exposure towood (particularly certain types of oak)adds tannins and complex carbohydrateslike ramnose and arabinose. The mostexpensive way to do this is by barrel aging.Barrels are expensive and yield wood flavorsin only a fraction of the wood thickness.

They also allow for certain amount of eva-poration and perhaps oxygen and gasexchange with the surrounding air. Barrelaging is quite old and yet the effects onwine are not completely understood,beyond the fact that it is the best way to ageand finish wine before bottling. Alternative,less expensive ways to impart wood flavorsto wine are wood staves, cubes, chips andsaw dust. Unfortunately, the immersion ofthese forms of wood products in the winehave the potential for contamination withmachine oils and dust. An even less desira-ble form of adding wood flavors is concen-trated fluids resulting from boiling wood.These are added to the wine. As easilyunderstood, the wood finish of wine is amatter of price and quality that shouldmake us think twice before drinking cheapwine!

The wine lingo

One puzzling consequence of the complexi-ties of assessing wine by using language is

3676

that there are not enough specific words todescribe wine taste. This has brought a sortof wine jargon where qualities are describedby words not easily understood by the uni-nitiated.

For example, a mouth feel can be round,sharp or thick or angular and the flavorsforward, assertive, layered, balanced, bright,etc.

Importantly,

“Wine is one of the most civilized things inthe world and one of the natural things ofthe world that has been brought to the gre-atest perfection, and it offers a greater rangefor enjoyment and appreciation than, pos-sibly, any other thing which may be purcha-sed”

Death in the afternoon. Ernest Heminway1899-1961

Clinical Trial Data

The early results of the EVAR-11, DREAM2

and OVER3 trials were consistent and con-vincing. (Table 1) 30-day mortality is atleast a factor of 3 times greater followingopen surgery (OR) than endovascular repair(EVR). Despite this, sceptics cite concernsabout the long term durability. They alsochallenge EVR based on cost effectiveness.EVAR-1 did report a higher post-operativecomplication rate within 4 years in the EVRgroup [41% EVR vs. 9% OR p<0.0001].

The DREAM trial reported operative mor-tality of 4.6% [95% CI 2-8.9] for OR and1.2% for EVR [95% CI 0.1-4.2] with meanfollow up to 22 months. Similar early post-operative benefits were reported in the

OVER study, but the survival advantagewas not sustained beyond 2 years (mortality7.0% EVR vs. 9.8% OR p=0.13).

More recently the results up to 10-yearsfollowing the start of the EVAR-1 trial havebeen published4.These show no differencein all-cause or aneurysm-related mortality.The study describes the high rate of graftrelated complications and additive costs ofre-interventions.

EVR should be re-evaluated, but not justbecause of the long term results of the ran-domised trials. EVR outcomes haveimproved significantly since the original tri-als were performed. The reasons for this aremultifactorial. EVR is the driver forimproved peri-operative outcomes in AAA


Loftus, I.

St. George’s Vascular Institute, London, UK.

Should EVAR, DREAM andOVER be re-edited with the newtechnology and experience?

3677

surgery, and has allowed a greater numberof patients with large AAA to be treatedwho would previously have had no thera-peutic option.

Principal Limitations of the Clinical Tri-als

Current devices have superseded many ofthe older generation of endovascular grafts.Although the long-term in-vivo durabilityof the newer endografts is yet to be estab-lished it is likely that they will prove moredurable and lead to less complications bothin the short and long term.

Secondly, EVAR-1 was initiated when EVRwas in its infancy; there was limited under-standing of EVR, and many centres hadlimited experience. The trial began 3 yearsbefore reporting standards for graft relatedcomplications. No core-lab was establishedfor consistent unbiased reporting. The unitsrecruiting patients qualified having per-formed a minimum of 20 cases; it havesince suggested that centres should haveperformed 55-60 cases. There is also now aclear documented relationship between theoutcomes from aneurysm repair and hospi-tal volume.

A further limitation regarding the trial datais the interpretation of readmission, reinter-vention and complication rates. EVAR-1demonstrated significantly greater reinter-vention rates in the EVR group. Thesecomplications, being vascular specific wererelatively simple to identify and record. Theprincipal complications following open

repair are not vascular specific and are morelikely to lead to readmission under non-vas-cular specialists, and may be under-report-ed.

EVAR-1 concluded that EVR was morecostly. The cost calculation was based on arequirement for 3 computed tomography[CT] scans in the first post-operative year,followed by annual surveillance CT imag-ing. This intensive surveillance is notrequired and many units now recommendprimary follow-up with Duplex ultrasound5.Some are now suggesting that duplex isunnecessary in the majority of cases andthat targeted higher risk cohorts might beidentifiable from risk modelling. This wouldbring the overall cost down significantly.There is an accruing body of evidence thatre-intervention rates are less than describedin EVAR-1. A contemporary large seriesdemonstrated a 7.4% re-intervention rate atmedian 2.5 years follow-up6. In 553 EVRpatients at St George’s, 12.5% required re-interventions at 3 years7.

Intraoperative problems are now betterrecognised and corrected, reducing reinter-vention rates. There may also have been adegree of over-intervention in the earlydays; with time we have developed a greaterunderstanding of those problems that canmanaged conservatively, such as type-2endoleaks. The majority of re-interventionsare now performed using endovascularmeans, with no impact on aneurysm-relatedor actuarial 5-year survival8. This was notthe case in EVAR-1 where 3.2% of patientsreceived secondary interventions for a type

I. Loftus.- Should EVAR, DREAM and OVER be re-edited with the newtechnology and experience?


N=STUDY EVR MORTALITY OR MORTALITY P-VALUE

1082

351

881

1.7%

1.2%

0.5%

4.7%

4.6%

3%

0.009

0.10

0.004

EVAR-1

DREAM

OVER

TABLE 1. 30-day mortality from the randomised trials.

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II endoleak and significant proportion ofsecondary interventions required opensurgery with inherent increased risk.

Lastly, it should be noted that the originalEVAR-1 study was only powered for analy-sis to 3.3 years. The continued follow-upprovides a unique data-set, but should beinterpreted in the same manner as any post-hoc analysis. Therefore, while the long-term findings of EVAR-1 are both interest-ing and valuable, they should be interpretedin light of the wealth of other evidence sup-porting the wider adoption of EVR.

Registry data for elective EVR (Table 2)

The prompt identification of a need forlong-term data on the safety and efficacy ofEVR led to the establishment of a series ofprospective registries. The largest of these isEUROSTAR. Similar registries were estab-lished world-wide; the RETA registry wascreated in the U.K., and the LIFELINEregistry in the U.S.A.

EUROSTAR has presented outcomes for30-day and long-term [8 year] mortality(2.3% and 9.5% respectively)9. Adverseevents were experienced in 11.1% butaneurysm rupture [0.5%] and device migra-

tion [1.8%] were rare. 9% required late re-intervention. The first generations of endo-graft were characterized by excellent earlyresults but poor durability. The latest datashow significant improvements in all out-come measures, most importantly, thoserelating to durability10.

The RETA registry published long-term‘first generation’ outcome data prior to theEVAR-1 trial [1996-2000]. Despite 25%considered unfit for OR, the 30-day mor-tality was 5.8%11. Conversion rates and mor-tality fell with time, reflecting better patientselection, advances in stent-graft design,and improved mentoring. The Lifeline reg-istry, showed similar improvements in out-come measures with time12.

Registry evidence for OR outcomes is avail-able from the UK National Vascular Data-base (NVD). The 30-day mortality rate of6.8% improved to 5.2% in 2009, with con-temporaneous 1.9% mortality for EVR. TheNVD also showed an increased uptake ofEVR from 29% of cases in 2006 to 44% in200913. ‘Swedvasc’ has reported increaseduptake of EVR with an associated increasein overall improvement in peri-operativeoutcomes14.

PERIOD OF DATACOLLECTION

REGISTRY N= 30-DAY MORTALITY REINTERVENTIONS

1996-2006

1998-2004

1996-2000

2000-2005

1999-2004

8345

2664

1000

1064

4545

2.3%

1.7%

5.8%

2.5%

6.8%

19.2%

22%

62%

-

-

EVR

EUROSTAR

LIFELINE

RETA

SWEDVASC

OR

NVD

TABLE 2. Registry data regarding outcomes following AAA.

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Conclusion

EVR should be re-evaluated, but not just asa consequence of the randomised trials,which suggest no difference between ORand EVR in long term all-cause mortality.Clinicians’ expertise, understanding and thetechnology have progressed significantlysince the establishment of the trials, suchthat the results, though valuable, may nottranslate to modern practice. The evidence-base now demonstrates that best practice inAAA management is in specialist vascularcentres, performing high volume surgeryoffering EVR to all patients who are mor-phologically suitable.

REFERENCES

Endovascular aneurysm repair versus open repair in patientswith abdominal aortic aneurysm (EVAR trial 1): randomisedcontrolled trial. Lancet 2005;365(9478): 2179-2186.Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sam-beek MR, Balm R et al. A randomized trial comparing con-ventional and endovascular repair of abdominal aorticaneurysms. N Engl J Med 2004;351(16): 1607-1618.Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT, Jr.,Matsumura JS, Kohler TR et al. Outcomes followingendovascular vs open repair of abdominal aortic aneurysm: arandomized trial. JAMA 2009;302(14): 1535-1542.

Greenhalgh RM, Brown LC, Powell JT, Thompson SG,Epstein D, Sculpher MJ. Endovascular versus open repair ofabdominal aortic aneurysm. N Engl J Med 2010;362(20):1863-1871.Nordon IM, Karthikesalingam A, Hinchliffe RJ, Holt PJ,Loftus IM, Thompson MM. Secondary interventions follow-ing endovascular aneurysm repair (EVAR) and the enduringvalue of graft surveillance. Eur J Vasc Endovasc Surg2010;39(5): 547-554.Black SA, Carrell TW, Bell RE, Waltham M, Reidy J, TaylorPR. Long-term surveillance with computed tomography afterendovascular aneurysm repair may not be justified. Br J Surg2009;96(11): 1280-1283.Karthikesalingam A, Holt PJ, Hinchliffe RJ, Nordon IM,Loftus IM, Thompson MM. Risk of reintervention afterendovascular aortic aneurysm repair. Br J Surg 2010;97(5):657-663.Conrad MF, Adams AB, Guest JM, Paruchuri V, BrewsterDC, LaMuraglia GM et al. Secondary intervention afterendovascular abdominal aortic aneurysm repair. Ann Surg2009;250(3): 383-389.Chambers D, Epstein D, Walker S, Fayter D, Paton F, WrightK et al. Endovascular stents for abdominal aortic aneurysms:a systematic review and economic model. Health TechnolAssess 2009;13(48): 1-189, 215-318, iii.Harris PL, Buth J. An update on the important findings fromthe EUROSTAR EVAR registry. Vascular 2004;12(1): 33-38.Thomas SM, Beard JD, Ireland M, Ayers S. Results from theprospective registry of endovascular treatment of abdominalaortic aneurysms (RETA): mid term results to five years. EurJ Vasc Endovasc Surg 2005;29(6): 563-570.Lifeline registry of endovascular aneurysm repair: long-termprimary outcome measures. J Vasc Surg 2005;42(1): 1-10.Lees T, Stansby G, Baker S, Mitchell D, Holt PJ, Taylor P etal. The National Vascular Database 2009. London; 2009.Wanhainen A, Bylund N, Bjorck M. Outcome after abdomi-nal aortic aneurysm repair in Sweden 1994-2005. Br J Surg2008;95(5): 564-570.

4.-

5.-

6.-

7.-

8.-

9.-

10.-

11.-

12.-

13.-

14.-

1.-

2.-

3.-

Cao, P.

U.O.C. Chirurgia Vascolare, Ospedale S. Camilo-Forlanini, Roma, Italy.

EVAR for small aneurysm is not yetjustified

Background

Randomised trials have failed to demon-strate benefit from early surgical repair ofsmall abdominal aortic aneurysm (AAA)compared with surveillance. This studyaimed to compare results after endovascularaortic aneurysm repair (EVAR) or surveil-lance in AAA<5.5 cm.

Methods

Patients (50-79 years) with AAA of 4.1-5.4cm were randomly assigned, in a 1:1 ratio,to receive immediate EVAR or surveillanceby ultrasound and computed tomography(CT) and repair only after a defined thresh-old (diameter" 5.5 cm, enlargement >1 cm/year, symptoms) was achieved. The main

3680

endpoint was all-cause mortality. Recruit-ment is closed; results at a median follow-upof 32.4 months are here reported.

Results

Between 2004 and 2008, 360 patients(early EVAR = 182; surveillance = 178)were enrolled. One perioperative death afterEVAR and two late ruptures (both in thesurveillance group) occurred. At 54 months,there was no significant difference in themain end-point rate [hazard ratio (HR)0.76; 95% confidence interval (CI) 0.30-1.93; p=0.6] with Kaplan-Meier estimatesof all-cause mortality of 14.5% in the EVARand 10.1% in the surveillance group.Aneurysm- related mortality, aneurysm rup-ture and major morbidity rates were similar.Kaplan-Meier estimates of aneurysms

growth"5mm at 36 months were 8.4% inthe EVAR group and 67.5% in the surveil-lance group (HR 10.49; 95% CI 6.88-15.96; p < 0.01). For aneurysms under sur-veillance, the probability of delayed repairwas 59.7% at 36 months (84.5% at 54months). The probability of receiving openrepair at 36 months for EVAR feasibilityloss was 16.4%.

Conclusions

Mortality and rupture rates in AAA <5.5 cmare low and no clear advantage was shownbetween early or delayed EVAR strategy.However, within 36 months, three out ofevery five small aneurysms under surveil-lance might grow to require repair and oneout of every six might lose feasibility forEVAR.

P. Cao.- EVAR for small aneurysm is not yet justifiedTécnicas Endovasculares Vol.XIV. Núm. 1. Enero-Abril 2011; 3679-3680

BackgroundSystematic reviews have suggested a survivaladvantage for patients with rupturedabdominal aortic aneurysm (AAA), who aremanaged by endovascular repair. Thesereviews are based mainly on single centreexperiences of selected patients althoughmore recently they have been complement-ed by an exploratory analysis of the USMedicare data base. The problem with allthese data is that they are confounded bypatient and centre selection. For any wide-

spread strategy to improve the outcome ofpatients with ruptured AAA (whethernational as in the UK National Health Ser-vice or insurance company based), we needto know whether endovascular treatmentshould be available to ALL patients withruptured AAA. If so, there will need to bechanges in the way in which care for rup-tured aneurysm is delivered through policyand management changes. Increasingly weneed to be able to show that any new clini-cal strategy not only improves patient-spe-

Powell, J.T.

Vascular Surgery Research Group. Imperial College at Charing Cross, London.

Endovascular repair for rupturedabdominal aortic aneurysm:update from the IMPROVE trial

3681

J.T. Powell.- Endovascular repair for ruptured abdominal aortic aneurysm:update from the IMPROVE trial


cific outcomes but also is cost-effective.Initial estimations, based on highly selectedpatients, suggests that endovascular repairof ruptured AAA might be cost-effective.

How should new technologies and newcare pathways be evaluated for translationinto clinical practice? The IDEAL statement(Lancet 2009;374:1089-1112) states thatthere should be no surgical innovationwithout evaluation and recommends the 5steps, Innovation, Development, Explo-ration, Assessment and Long-term followup: Randomised Controlled Trials are thegold standard for the assessment phase.

The cornerstone of Assessment is the ran-domized controlled trial. The applicationfor the IDEAL standards to the repair ofruptured AAA are shown in Table 1. Thereare 3 trials in progress for ruptured AAA.The Amsterdam AJAX trial which has near-ly completed its recruitment of 120 patientsstarted first. This trial, like its sister Paris-based French trial, ECAR, is taking a con-servative approach. They ask the question asto whether in haemodynamically stablepatients who are anatomically suitable forEVAR whether 30-day operative mortalityis lower after EVAR than open repair.Patients are randomized after assessment byCT scan and haemodynamic monitoring.The IMPROVE trial in the UK has at itsheart a different question: does a strategyof endovascular repair whenever possible

improve 30-day survival of all patients withruptured AAA? This trial poses questionsdirectly relevant to the delivery of clinicalservices and requires more patients, 600, toshow an advantage for endovascular repair(Figure 1). The IMPROVE trial needs awide contributory base (many hospitalacross the UK) to have generalisable find-ings.

Objective of the IMPROVE trialTo determine whether a policy of endovas-cular repair improves the survival of allpatients with ruptured AAA.

MethodsA randomized controlled trial, IMPROVE(ISRCTN 48334791) will randomizepatients with a clinical diagnosis of rupturedAAA, made in hospital, either to immediateCT scan and endovascular repair wheneveranatomically suitable (endovascular first), orto open repair, with CT scan being optional(normal care), The trial is set on a back-ground of guidelines for emergency care,CT scanning and anaesthesia, which incor-porate the protocol of permissive hypoten-sion. Recruitment started in late 2009 and600 patients are required to show a 14%survival benefit at 30 days (primary out-come) for the endovascular first policy.

Secondary outcomes include 24h, in-hospi-tal and 1 year survival, complications, costs,quality of life and cost-effectiveness.

IDEAL PHASE DESCRIPTION CITATION

First case described

Protocols developed&associatedproblems described in a few centres

Pilot randomised trialsExploratory analysis of registries

Randomised controlled trials(AJAX, ECAR, IMPROVE)

To 10 years using registries & othersources

Yusuf et al. 1994

Mayer et al 2009Verhoeven et al 2008

Hinchliffe et al 2006Egorova et al 2008

AJAX, IMPROVE Trialists2006, 2009

Innovation

Development

Exploration

Assessment

Long-term follow up

TABLE 1. Application of IDEAL statement to the use of endovascular repair for ruptured AAA.

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J.T. Powell.- Endovascular repair for ruptured abdominal aortic aneurysm:update from the IMPROVE trial


ProgressWe are one third of our way to targetrecruitment and the Data Monitoring andEthical Committee have no safety concerns.The trial has stimulated the uptake ofendovascular repair for ruptures throughoutthe UK and we now have 21 centres activelyrecruiting patients. The patients being ran-domized have very large aneurysms, median7.8cm and no small aneurysms (<5.5cm)have presented. Our recruitment targetremains very challenging in a time when theincidence of ruptured AAA appears to bedecreasing rapidly.

DiscussionThis is a “real life” trial that will answer thefundamental relevant clinical dilemma,

namely, do patients who present with rup-tured aneurysm derive benefit from treat-ment in a system, which offers a preferentialstrategy of endovascular repair? The trialaddresses whether the anticipated reducedmortality and morbidity associated withendovascular repair offsets the relativelygreater ease of access, speed and lower ini-tial costs of conventional surgery. This issueis pivotal to future patient care and provi-sion of services.

AcknowledgementsThe IMPROVE trial is funded by theNational Institute for Health ResearchHealth Technology Assessment Programmein the UK. The views expressed here arethose of the applicants.

Fig. 1. Design of the IMPROVE trial.

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This presentation reviews the history ofand experience with endovascular repair(EVAR) of ruptured abdominal aorticaneurysms (RAAAs). It also addresses thequestion whether or not a randomized con-trolled trial (RCT) comparing EVAR withopen repair (OR) for RAAA is needed.

Many single center reports, meta-analysesand population-based studies have shown asubstantially lower 30-day mortality forEVAR than OR in the RAAA setting.However, it is possible that this difference isdue to patient selection with OR beingsometimes used in higher risk patients thanEVAR. In addition, some comparative tri-als have failed to find better mortality out-comes after EVAR than after OR. For thisreason RCTs have been proposed.

A recently completed review (2009) of thecollected world experience with EVAR forRAAAs included data from 13 centers inwhich EVAR was used to treat almost allRAAAs in patients with suitable anatomy ir-respective of hemodynamic status or riskstatus. In these centers the 30-day mortali-ty for EVAR treatment was 19.7% while 30-day mortality for OR was 36.3% (p <.0001). Several treatment strategies, ad-juncts and technical factors were felt to beimportant in achieving this lower mortalityfor EVAR. These included use of a stan-dardized RAAA protocol and adequateEVAR experience, fluid restriction and hy-potensive hemostasis, appropriate tech-niques for achieving supra-celiac aortic bal-loon control and use of such control only

when necessary, early detection and appro-priate treatment of abdominal compartmentsyndrome, and use of EVAR in the treat-ment of the worst risk patients.

Because of these results in the 13 centers,none of which would participate in a RCTof EVAR versus OR for RAAAs and be-cause of logistical and ethical considera-tions, it is concluded that a RCT is notneeded to validate the preferential use ofEVAR to treat RAAAs in patients with suit-able anatomy for the procedure.

REFERENCES

Veith FJ, Lachat M, Mayer,D et al: Collected world and sin-gle center experience with endovascular treatment of rup-tured abdominal aortic aneurysms. Ann Surg 2009;250:818-824.Veith FJ, Powell JT, Hinchliffe RJ. Is a randomized trialnecessary to determine whether endovascular repair is thepreferred management strategy in patients with ruptured ab-dominal aortic aneurysms. J Vasv Surg 2010;52:1087-1093.

Veith, F.

A randomized trial of EVAR vs OR forrAAA is not necessary: accumulatedworld experience is enough

1.-

2.-

3684

Mortality in patients with a ruptured ab-dominal aortic aneurysm (AAA) treatedwith open surgery remains high. Among pa-tients who arrive in the hospital alive andundergo open surgery, the reported mortal-ity rates varied between 32% and 70% (aver-age 50%) and the morbidity rates between30% and 50%.

Advantages and disadvantages of endovas-cular repair over open surgery exist.Important advantages of endovascular re-pair are potential avoidance of general anes-thesia and minimization of invasiveness.During endovascular repair the aorta is notclamped and blood loss is considerably lessthan with open surgery.

Several studies have demonstrated a reduc-tion in mortality and morbidity rates of en-dovascular repair compared with conven-tional open surgery in patients with rup-tured AAAs. Most of these studies, howev-er, included hemodynamically unstable pa-tients in the open surgery group, whereas inthe endovascular group mostly hemody-namically stable patients were included.

In a systematic review of the literature weidentified all studies comparing open surgi-cal treatment and EVAR for ruptured AAA.The pooled 30-day mortality was 22%(95%-confidence interval (CI) 16–29%) forendovascular repair and 38% (95%-CI32–45%) for open surgery. The crude oddsratio for the 30-day mortality for endovas-cular repair compared to open surgery was0.45 (95%-CI 0.28–0.72). After adjustmentfor patients’ hemodynamic condition, theodds ratio was 0.67 (95%-CI 0.31–1.44).

In a 4-year period we evaluated the resultsof 94 consecutive patients with a rupturedAAA that were referred a teriairy referralcenter in the Netherlands. Thirty-nine pa-tients were excluded from the analysis be-cause of supra-renal clamping (N=26), AAAof unknown origin (N=2) or patient uncon-scious and therefore too unstable to under-go CTA.

Fifty-five patients were available for analysis,26 patient received endovascular treatmentand 29 patients received conventional opensurgery.

Mortality and systemic complications weresimilar in both groups.

Patients treated with an endovascular inter-vention required less blood transfusion,shorter ICU stay and a shorter hospital stay.Despite the body of evidence currently ex-isting about outcome of EVAR versus opensurgical repair of patients with a rupturedAAA EVAR, still controversy exist aboutthe superiority of EVAR.

In a recent Cochrane review the authorscame to the following conclusion: “There isno high quality evidence to support the useof EVAR in the treatment of RAAA.However, evidence from prospective con-trolled studies without randomisation,prospective studies, and retrospective caseseries suggest that EVAR is feasible in se-lected patients, with outcomes comparableto best conventional open surgical repair forthe treatment of RAAA .”

This controversy can only be overcome with

van Sambeek, M.; Visser, J.J.

Catharina Hospital Eindhoven, The Netherlands.

EVAR vs open surgery for rAAA:an update systematic review

3685

level 1 evidence from properly poweredrandomized controlled trials. Debatable canbe if these randomized controlled trialsshould evaluate the results of EVAR versusopen surgical repair only in patients suitablefor EVAR or that a trial design randomiz-ing all patients with a ruptured AAA be-tween open surgery versus a strategy thatincludes EVAR if suitable.

REFERENCES

Bown MJ, Sutton AJ, Bell PR, Sayers RD. A meta-analysisof 50 years of ruptured abdominal aortic aneurysm repair. BrJ Surg 2002; 89:714-730.Bown MJ, Cooper NJ, Sutton AJ, et al. The post-operativemortality of ruptured abdominal aortic aneurysm repair. Eur JVasc Endovasc Surg 2004; 27:65-74.Vaddineni SK, Russo GC, Patterson MA, Taylor SM, JordanWD, Jr. Ruptured abdominal aortic aneurysm: a retrospective

assessment of open versus endovascular repair. Ann VascSurg 2005; 19:782-786.Kapma MR, Verhoeven EL, Tielliu IF, et al. Endovasculartreatment of acute abdominal aortic aneurysm with a bifurcat-ed stentgraft. Eur J Vasc Endovasc Surg 2005; 29:510-515.Peppelenbosch N, Yilmaz N, van Marrewijk C, et al.Emergency treatment of acute symptomatic or ruptured ab-dominal aortic aneurysm. Outcome of a prospective intent-to-treat by EVAR protocol. Eur J Vasc Endovasc Surg 2003;26:303-310.Greco G, Egorova N, Anderson PL, et al. Outcomes of en-dovascular treatment of ruptured abdominal aortic aneurysms.J Vasc Surg 2006; 43:453-459.Visser JJ, van Sambeek MR, Hamza TH, Hunink MG, BoschJL.Ruptured abdominal aortic aneurysms: endovascular repairversus open surgery--systematic review.Radiology. 2007;245:122-9. Moore R, Nutley M, Cina CS, et al. Improved survival afterintroduction of an emergency endovascular therapy protocolfor ruptured abdominal aortic aneurysms. J Vasc Surg2007;45:443-450.Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin DW.Endovascular treatment for ruptured abdominal aorticaneurysm. Cochrane Database of Systematic Reviews 2007,Issue 1. Art. No.: CD005261. DOI: 10.1002/14651858.CD005261. pub2

M. van Sambeek et al.- EVAR vs open surgery for rAAA:an update systematic review


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Growth rate of an AAA is generally definedas the change in maximum aortic diameterover a certain time period. Previous studiesindicate that AAA growth rate increaseswith the diameter of the AAA.

However, this growth rate is not identicalfor all AAA’s, as some AAA’s remain stablefor a considerable period of time, while oth-ers show a strong increase in diameter overa short period. Also, some AAA’s tend togrow discontinuously, with alternating peri-ods of growth and non-growth.

Recently, multiple studies have focused onpatient- specific AAA wall stress analyses.

Peak wall stress was found to be significant-ly higher for patients with symptomatic orruptured AAA’s than for asymptomaticaneurysms. However, in these studies, therelation between wall stress and AAAgrowth rate was not investigated. Withincreasing wall stress, more damage mayoccur in the AAA wall, leading to degenera-tion of the wall and expansion of theaneurysm. Wall stress may thus have aprominent role in aneurysm growth andcomputing AAA wall stress may lead to apredictive model for AAA growth rate.

Circulating biomarkers are believed toreflect inflammation and degeneration in

van Sambeek, M.; Speelman, L.


Influence of wallstress on AAAgrowth and biomarkers

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the AAA wall. Matrix metal- loproteinase-9(MMP-9) is involved in the breakdown ofthe extracellular matrix and a higher plasmaMMP-9 concentration was associated withAAA presence. Additionally, MMP-9 signif-icantly correlated with AAA growth rate.

We hypothesized that in AAA’s with highwall stress, relative to the diameter, the wallis more extensively damaged and degenerat-ed than average. This could be reflected byincreased AAA growth rate and up- ordown regulation of specific biomarkers. Theresults of our study showed that a relativemedium or high wall stress could be associ-ated with a higher growth rate, which wassignificant between the medium and lowwall stress group, and close to significantbetween the high and low wall stressgroups. Although the average levels ofMMP-9 and hs-CRP showed an increasingtrend for increasing relative wall stress,none of the MMP-9, TIMP-1, a1-AT andhs-CRP concentrations were significantlydifferent between the stress groups. Theaverage concentration of hs-CRP in themedium and high stress groups exceeded 3mg/L, which was previously identified asthreshold level between average and higherrelative risk for future vascular events. Thegrowth rate in these groups was also higherthan for the low stress group. A positiverelation between MMP-9 concentrationand AAA growth rate was found, but nocorrelation between absolute AAA wallstress and biomarkers could be identified.

Between the biomarkers mutually, a posi-tive correlation was found between hs-CRPand MMP-9 possibly reflecting the fact thatboth biomarkers respond to AAA relatedevents; namely inflammation and matrixdegradation. Furthermore, TIMP-1 wasnegatively correlated with MMP-9. Nor-mally, TIMP-1 regulates the activity ofMMP-9. This regulation may be disturbedin patients with AAA, resulting in a lowerTIMP-1 concentration for higher MMP-9levels. TIMP-1 and a1-AT were also nega-tively correlated. The pathophysiologicalmeaning is not clear, but it was previously

postulated that both MMP-9 and a1-ATpositively correlated with AAA growth.However, in the current study, only MMP-9 showed a positive correlation with AAAgrowth.

Conclusion

To our knowledge, this is the first studythat combines both circulating biomarkerinformation and wall stress informationwith the prospective growth rate of AAA’s.A relative medium or high wall stress wasassociated with a higher growth rate com-pared to a relative low wall stress. TheMMP-9 plasma concentration positivelycorrelated to AAA growth rate. No correla-tion was found between absolute or relativewall stress and biomarker concentrationsanalyzed in this study, although the averageconcentrations of MMP-9 and hs-CRPshowed an increase for higher relative wallstress. Further analysis is warranted to verifythe relation between AAA wall stress,growth rate and biomarker concentrations.

REFERENCES

L. Speelman, F.A. Hellenthal, B. Pulinx, E.M.H. Bosboom,M. Breeuwer, M.R. van Sambeek, F.N. van de Vosse, M.J.Jacobs, W.K.W.H. Wodzig, G.W.H. Schurink. The Influenceof Wall Stress on AAA Growth and Biomarkers. Eur J VascEndovasc Surg 2010;39:410-416.Stonebridge PA, Draper T, Kelman J, Howlett J, Allan PL,Prescott R, et al. Growth rate of infrarenal aortic aneurysms.Eur J Vasc Endovasc Surg 1996;11:70-73.Vega de Ceniga M, Gomez R, Estallo L, de la Fuente N,Viviens B, Barba A. Analysis of expansion patterns in 4-4.9cm abdominal aortic aneurysms. Ann Vasc Surg 2008;22:37-44.Fillinger MF, Raghavan ML, Marra SP, Cronenwett JL,Kennedy FE. In vivo analysis of mechanical wall stress andabdominal aortic aneurysm rupture risk. J Vasc Surg2002;36:589-597.Golledge J, Tsao PS, Dalman RL, Norman PE. Circulatingmarkers of abdominal aortic aneurysm presence and progres-sion. Circulation 2008;118:2382-2392.

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Endovascular repair has greatly reduced theperioperative morbidity and mortality ofabdominal aortic aneurysm repair comparedto open surgeries1.

However, endovascular stent-grafts areexposed to a number of clinical complica-tions, such as endograft migration (i.e., lossof positional stability), stent fractures andendoleaks (i.e., persistence of blood flowinto the aneurysm sac after device place-ment).

These complications may result in life-threatening and costly events such asaneurysm growth, rupture, need for sec-ondary procedures, and constant follow-upwith imaging studies.

Understanding the biomechanical environ-ment experienced by endografts in-vivo is acritical factor in improving their perfor-mance2. In this work, we combine compu-tational solid mechanics and computationalfluid dynamics tools with patient-specificclinical and imaging data to characterize theperformance of abdominal endografts in-vivo. We propose a Finite Element framework toevaluate the positional stability of stent-grafts deployed in realistic models of theabdominal and thoracic aorta.

This framework consists of several blocks(see Fig. 1): Analysis of the vessel wall pre-

stress; deployment of the stent-graft; deriva-tion of the CFD loads, and analysis of thefixation between the device and the aorticwall.

We will discuss the computational chal-lenges of each of the steps highlightedabove and provide examples of how differ-ent geometric factors affect the positionalstability of the device.

REFERENCES

Zarins CK, Bloch DA, Crabtree T. Journal of VascularSurgery 2003; 38(6): 1264-1272.Figueroa CA, Zarins CK. Biomechanics and Mechanobiolo-gy of Aneurysms 2011. Springer-Verlag series on Studies inMechanobiology, Tissue Engineering and Biomaterials.

Figueroa, A.*; Prasad, A.*; Zarins, C.**

*Department of Bioengineering, Stanford University, Stanford, CA, USA**Department of Surgery, Stanford University, Stanford, CA, USA

A computational framework forinvestigating the positionalstability of abdominal endografts

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For both elective and ruptured AAA repair,an increasing number of studies looked atinfluence of gender on operative mortality.In logistic regression analysis, a majority of

these studies showed that gender was anindependent predictor of higher treatmentmortality in both elective and rupturedAAA repair. The results of these studies

A. Figueroa et al.- A computational framework for investigating the positio-nal stability of abdominal endografts


Fig. 1. Main building blocks of the framework proposed to evaluate the stability of abdominal aortic stent-grafts:Starting with a computer model of the abdominal aorta of the patient (1), a pre-stress analysis of arterial wall is performed

to define the internal stresses of the vessel wall corresponding to the pressure recorded at the time of the imaging study (2).Then, a multi-body (i.e., stent and graft) device is fitted into the abdominal aorta considering the proximal and distal fixationlengths and device oversizing (3). Once the device is deployed, a Computational Fluid Dynamics (CFD) analysis is performed

to obtain the loads exerted by blood flow on the device (4). Lastly, a fixation analysis (5) examines the frictional stabilitybetween the device and the aortic wall at the proximal and distal fixation zones.

van Sambeek, M.; Grootenboer, N.


EVAR in women: gender makesthe difference

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reported odds ratios for treatment mortalityranging from 1.34-1.60 for electivelyrepaired AAAs and 1.21-3.00 for rupturedAAAs, indicating that women may have anup to three times higher treatment mortali-ty than men after AAA repair. Other studiesperforming logistic regression analysis,however, did not find a significant oddsratio for gender. In addition, many studieson treatment results of AAA repair did notspecifically focus on gender. Therefore, cur-rently it is unclear whether treatment mor-tality is different for women versus men.

Before we reconsider treatment guidelines itis essential to get insight into whether treat-ment outcomes differ between men andwomen. The impact of gender on treatmentmortality may be different for elective ver-sus ruptured aneurysms. Also, treatmentmortality of men and women may be differ-ent for open versus endovascularly repairedAAAs. As AAA anatomy is a major selectioncriteria for EVAR and women have beenreported to have a poorer anatomical suit-ability compared to men it is important toevaluate whether treatment mortality is dif-ferent for men and women in these groups.

A total of 2264 articles were identified fromthe literature search . On the basis of titleand abstract, 873 articles were retrieved infull and, of these, 62 met our inclusion cri-teria. The primary reason for exclusion wasthe lack of gender stratification whenreporting mortality. Review of the referencelist of each article did not lead to any addi-tional articles being included. Of the 62included articles, 27 reported on electiveopen repair, 21 on elective endovascularrepair, 26 on ruptured open repair, and onestudy ruptured on endovascular repair.

The total number of patients of all includedarticles was 517,064; 404,045 men and113,019 women respectively. The propor-tion of women varied from 13% in the elec-tive endovascular repair group to 22% in theelective open repair group. On average,women were older than men in all groupsbut not significantly. The largest differencein age was seen in the ruptured open repair

group where women were on average 5years older than men. (77.7 years vs. 72.1years).

For the elective open repair group, 30-daymortality was 6.7% for women and 4.4% formen. The unadjusted odds ratio for mortal-ity for women vs. men was 1.58 (95%CI1.14-2.2). After adjustment for age theodds ratio for women was 1.51 (95%CI1.06-2.14).

For the elective endovascular group, treat-ment mortality was 4.8% for women and1.8% for men. The unadjusted odds ratiofor women was 2.51 (95%CI 1.72-3.69).After adjustment for age and AAA diameterthe odds ratio for women was 2.41 (95%CI1.65-3.53) (After adjustment for age onlythe odds ratio for women was 2.41 (95%CI1.49-3.88).

For the ruptured open repair group, treat-ment mortality was 50.8% for women and40.9% for men. The unadjusted odds ratiofor women was 1.49 (95%CI 1.16-1.91).After adjustment for age the odds ratio forwomen was 1.24 (95%CI 0.94-1.64).

Only one study was found for rupturedendovascular repair. Treatment mortalitywas 14.3% for women and 44% for men.

Stratified data on complications was notavailable for the elective open and rupturedopen repair groups. Stratified data was avail-able for the elective endovascular repairgroup showing higher rates for womencompared to men of conversion and/oraborted procedure (11% women vs. 2%men) and endoleaks (17% women vs. 9%men).

Possible mechanisms could lead to worsetreatment mortality of women compared tomen. The most important factors being theabsolute treatment criteria for repair, theendovascular devices not specificallydesigned for women and the reducedawareness and thus diagnosis of cardiovas-cular and therefore also abdominal aorticaneurysm disease in women compared to

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men. Even though it has been suggested totreat women with an AAA at smaller diame-ters than men it is still common practice totreat both sexes at an AAA diameter of5.5cm. Seeing that on average, the normalaortic diameter of a woman is smaller thanthat of a man; by the time it has reached5.5cm it has undergone a bigger relativeincrease in diameter. By using this absolutetreatment threshold, women could be in alater stage of atherosclerotic disease whenthey undergo surgery leading to worse out-come.

Women have poorer anatomical suitabilitycompared to men for endovascularaneurysm repair (EVAR) which we also sawin our study by the higher abortion/con-version rates in women compared to men.Endovascular devices have not been specifi-cally designed for women yet, which possi-bly also plays a role in their worse outcomein this group. Again the aorta and accessarteries are on average smaller in womenthan men making EVAR in women moredifficult than in men.

The most probable explanation for thehigher treatment mortality of women com-pared to men, however, might be that car-diovascular disease as a whole, and thus alsoabdominal aortic aneurysm is under recog-nized in women. This leads to an array ofproblems such as delayed diagnosis andintervention but also to less primary andsecondary preventive measures such as car-diovascular medication and life style adjust-ments. Better awareness of these issuescould lead to a better treatment outcome inwomen with abdominal aortic disease.

REFERENCES

Norman PE, Powell JT. Andominal aortic aneurysm: theprognosis in women is worse than in men. Circulation2007;115:2865-2869.Grootenboer N, Bosch JL, Hendriks JM, van SambeekMRHM. Epidemiology, aetiology, risk of rupture and treat-ment of abdominal aortic aneurysms: does sex matter. Eur JVas Enodvasc Surg 2009;38:278-284. Grootenboer N, van Sambeek MRHM, Arends LR, HendriksJM, Hunink MG, Bosch JL.Systematic review and meta-analysis of sex differences in outcome after intervention forabdominal aortic aneurysm.Br J Surg. 2010;97:1169-1179.

M. van Sambeek et al.- EVAR in women: gender makes the differenceTécnicas Endovasculares Vol.XIV. Núm. 1. Enero-Abril 2011; 3688-3690

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Introduction

Initial designs for endovascular aorticaneurysm repair (EVAR) were limited to in-fra-renal abdominal aortic aneurysms withan adequate sealing zone below the renalarteries for the proximal component of the

stent, usually more than 15mm of non-an-gulated, thrombus-free neck. More recentlystandard infra-renal EVAR devices havebeen modified to incorporate fenestrationsthrough which small diameter coveredstents may be delivered allowing incorpora-tion of the aortic visceral segment into the

Morgan-Rowe, L.; Simring, D.; Cross, J.; Harrison, S.; Harris, P.;Ivancev, K.

UCLH Multi-disciplinary endovascular team University College Hospital, London.

Fenestrated endovascularaneurysm repair with apre-loaded wire

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L. Morgan-Rowe et al.- Fenestrated endovascular aneurysm repairwith a pre-loaded wire


proximal sealing zone (FEVAR). Prior tothe development of FEVAR, patients withjuxta-renal aortic aneurysms had only theoption of open surgical repair though casereports of infra-renal EVAR with “chim-neys” for the renal arteries provided a limit-ed alternative. A contemporary series ofopen repair of juxta-renal aneurysms carrieda peri-procedure mortality of 2.9%1, howev-er morbidity can be considerable. Morethan a third of patients may develop acuterenal impairment, with over 3% requiringdialysis. It has been shown in previous stud-ies that EVAR carries substantially im-proved mortality rates2, as compared with

open repair of infra-renal aneurysms. Thedevelopment of fenestrated endovasculargrafts has made this survival benefit avail-able to patients with juxta-renal aneurysms.

Thus far evidence for FEVAR relies only onpublished case series. Nordon et al3 com-pared FEVAR (8 studies with a total of 368patients) with open repair (12 studies witha total of 1164 patients). They found a1.4% versus 3.6% 30 day mortality in favourof FEVAR. A further analysis by theOntario Health Technology4 compared 5FEVAR studies with 7 open studies giving a1.8% versus 3.1% 30 day mortality in favourof FEVAR and a 12.8% versus 23.7% latemortality in favour of FEVAR.

Performing FEVAR can be lengthy andtechnically challenging. The cannulation ofthe fenestrations and subsequently the vis-ceral arteries can be difficult and time con-suming and renal dysfunction is a commoncomplication5.

Furthermore, the procedure requires largesheaths to be inserted into both access ar-teries. This increases the risk for arterial dis-section, limb ischaemia and reperfusion in-jury. The patient is also exposed to signifi-cant doses of radiation, with increased fluo-roscopy times. The use of pre-loaded wiresaiding in the cannulation of fenestrationsand subsequently viscera is an innovationdesigned to tackle these challenges.

Fenestrated grafts with pre-loaded wires:Technique

Fenestrated grafts can be custom made tohave a double length 0.014” nitinol wireloaded through a port on the device han-dle. The wire passes out through the push-er, into the graft lumen at its distal end andout through a fenestration. It then loopsover the top-cap to the other side of thegraft, through the graft fabric and back into the contralateral fenestration (Fig 1),where it follows a path back down the lu-men and out through a port on the handle(Fig 2).

Fig. 1. The wire (thin arrows) passes from within the stent-graft, out through a fenestration (thick arrow), over the topcap, back in through the opposite fenestration and down

the stent-graft again.

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The graft is delivered via the trans-femoralroute until it is safely docked in the iliac ar-terial system. A sheath with a maximum di-ameter of 6F and ideally 90cm in length isthen advanced over one end of the pre-loaded wire until resistance is felt. Anothersheath is inserted over the other end of thewire. Clips may be placed on the ends ofthe wires and pulled gently to stiffen thewire and allow easier passage. Once bothsheaths are in place, the graft is advanced tothe visceral segment and orientated and de-ployed in the usual fashion. The 6F sheathsare then advanced over the pre-loadedwires. Once the sheath dilators have passedthrough their fenestrations, they should bebenched and the sheath should be advancedto the level of the lower margin of the fen-estration. The dilators can then be re-moved. A separate puncture in the valve of each 6Fsheath is made, and an 0.035” hydrophilicwire is advanced through a Curly Q (CookMedical, Bloomington, IN) 4F catheter.The curve on the catheter allows for vari-able angulation to be achieved at the levelof the fenestration, and each viscera is can-nulated in turn (Fig 3).



Fig. 2. The Preloaded wires and their entry into the handle of the stent-graft.

Fig. 3. The Curly Q catheter has a tight curve (upperimage) allowing for variable directionality within the

fenestration (lower image)

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The pre-loaded wire must then be removedby withdrawing the wire via the side port, asneither sheath may be advanced into thevisceral artery proper with the wire in place.

Once the preloaded wire is withdrawn, thesheaths are advanced into over dilators orballoons and the procedure is continued asfor a standard FEVAR.

Advantages

The purpose of the pre-loaded wire is to fa-cilitate more rapid cannulation of the fenes-trations and subsequent cannulation of thevisceral vessels.

This serves to decrease the operating timewhich has significant benefits; there is re-duced physiological stress from lengthygeneral anaesthesia, reduced blood lossfrom the exposed arteries and leakage fromsheaths, reduced exposure to ionising radia-tion and reduced ischaemic time for thelimbs.

The wires themselves serve as stabilising“reins” and when tension is applied, as withany through-wire, the sheaths on them willtrack more easily and buckle less.

Another advantage is the obviation of theneed for a large contralateral sheath to beinserted for visceral artery cannulation. Thesheaths for the target vessels are inserted in-to ports in the graft main body, which istypically 20F. On the contralateral limbtherefore, it may only be necessary to inserta 5F sheath for control angiography, and anadditional 6F - 7F sheath for the remainingvisceral vessel(s), for example the SMA orthe coeliac artery.

By having an uninhibited iliac system onone side, internal iliac and femoral arterypatency is maintained and the risk of pelvicand limb ischaemia and reperfusion injury isreduced. In those patients with limited ac-cess such as unilateral occluded iliac arteries:this allows the use FEVAR without havingto expose or recannalise the occluded sidefor visceral cannulation.

Limitations

One limitation in the design of the pre-loaded FEVAR system is the restricted sizeof the sheaths that can be used for visceralvessel cannulation. At present, this is a max-imum of 6F in diameter as this is the largestsize that can fit through the device. Thelargest V12 (Atrium Medical, NH, USA)covered stent that can be accommodated bya 6F sheath is 6mm by 22mm and thereforeif a target visceral vessel required a coveredstent greater than this, the use of a pre-loaded system would not be suitable. Anyflaring of the Atrium is limited to a 9mmballoon for the same reason. Similarly, onlytwo sheaths can be inserted and if morethan two visceral vessels need to be incor-porated into the graft there is a requirementfor separate sheaths for these vessels, usuallydelivered via the contralateral iliac system.

Another consideration is the additionalsteps and technical challenges that the useof the pre-loaded wire incorporates into theprocedure. Clearly, this technology is in itsinfancy and problems can arise in the deliv-ery of the graft. In the tortuous aneurysm,graft twisting may make advancement ofstents, balloons and catheters through the6F sheaths difficult. Similarly, the pre-loaded wire may become trapped within thetop-cap and become difficult or impossibleto remove.

Case Report

An eighty year old man was referred fortreatment of his 62mm juxta-renal abdomi-nal aortic aneurysm, with no adequate prox-imal seal for a standard EVAR. The rightrenal artery arose just 5mm below the ori-gin of the superior mesenteric artery(SMA), and the left renal artery was just be-low this.

A custom made graft with fenestrations forthe right and left renal arteries and the SMAproduced, with a preloaded wire for cannu-lation of the renal arteries. The deploymentsequence was as described above (See Fig4A-4D).



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Summary

The evolution of endovascular aneurysm re-pair to include fenestrations and branchesfor visceral vessels has opened the benefitsof this minimally invasive technique to agroup of patients for whom open surgerywas previously the only treatment option.

These procedures do require refinementand ongoing development in order to max-imise their benefit.

The innovation of using preloaded wires tofacilitate rapid cannulation of target vesselfenestrations is one such refinement. Itserves to decrease the operating time, thusreducing the physiological stress of generalanaesthesia, reducing the exposure to ionis-ing radiation and reducing blood loss andlimb ischaemic time. The presence of thepreloaded wire and consequent passage of

the sheaths via the main body means thaton the contralateral limb smaller sheathsneed only be inserted, thereby further re-ducing the risk of limb ischaemia.

REFERENCES

Jongkind V, Yeung KK, Akkersdijk GJ et al. Juxtarenalaortic aneurysm repair. J Vasc Surg. 2010 Sep;52(3):760-7. The United Kingdom EVAR Trial Investigators.Endovascular versus Open Repair of Abdominal AorticAneurysm. N Engl J Med 2010; 362:1863-1871 May20, 2010Nordon IM, Hinchliffe RJ, Holt PJ et al. Modern treat-ment of juxtarenal abdominal aortic aneurysms with fen-estrated endografting and open repair--a systematic revi-ew. Eur J Vasc Endovasc Surg. 2009 Jul;38(1):35-41.Secretariat MA. Fenestrated endovascular grafts for therepair of juxtarenal aortic aneurysms: an evidence-basedanalysis. Ontario Health Technology Assessment Series.2008;9(4).Haddad F, Greenberg RK, Walker E, Nally J, O'Neill S,Kolin G, et al. Fenestrated endovascular grafting: Therenal side of the story. J Vasc Surg. 2005 Feb;41(2):181-90.

Fig. 4. A: The stent graft is partially deployed with the renal fenestrations (arrows) orientated to face the arteriesB: The preloaded wire (thin arrow) facilitates passage of the sheath and catheter (thick arrow) to the right renal artery

C: The preloaded wire has been removed and an Atrium V12 stent has been deployed (arrow)D: Completion angiogram demonstrating satisfactory filling of the visceral vessels.

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Introduction

One of the drawbacks of endovascular ab-dominal aneurysm repair (EVAR) is the oc-currence of proximal migration which canresult into type IA endoleaks. The incidenceof type I endoleaks increases with difficultproximal landing zones like short and angu-lated necks. Type I endoleaks have been as-sociated with abdominal aneurysm rupturepost-EVAR1. Occasionaly, some type I en-doleaks might seal during follow-up.However, even if sealing has occurred theprevious type I endoleak may have fatal con-sequences because systemic blood pressurecan be transmitted through the clot.

As the need for reinterventions post-EVAR(REVAR) has been associated with substan-tial morbidity and mortality, proximal mi-gration and type IA endoleaks remain anarea of concern and have to be overcomeand/ or prevented2.

Most follow-up schedules post-EVAR in-clude the use of computed tomography(CT) scans at 1 month and 12 months. Ifno complications are seen at the one-year-CT-scan, yearly follow-up with duplex ultra-sound and plane X-ray has been recom-mended3. However, in obese patients prop-er duplex scanning of the abdominal aortamay not be feasible and CT-scans or mag-netic resonance arteriographies are stillneeded, with their potential contrast relatedcomplications. Furthermore, in patientswith poor overlap of the endograft compo-nents or endotension frequent CT-scans arerecommended. The impact of these repeat-ed follow-up visits must not be underesti-

mated regarding a patient’s well being.

More reliable and secure fixation of endo-grafts to the aortic wall may decrease theoccurrence of proximal migration, type IAendoleaks, and the need for yearly follow-up.

The use of endostaples is a new fixationtechnique completely independent of theendograft itself. It might enable the vascularsurgeon to determine the extent and loca-tion of fixation, which simulates the processof suturing during open surgery. We evalu-ated the feasibility of the use of AptusEndoStaples during REVAR to solve mi-grated endografts with or without addition-ally type IA endoleaks.

Technique

The EndoStapler system (AptusT M

Endosystems, Inc, Sunnyvale, CA, USA)consists of a steerable guiding catheter withobturator (figure 1), which can be used viaopen or percutaneous femoral access as pre-ferred. When the top of the deflectable en-doguide sheath has been positioned at thelevel of the proximal part of the endograftthe obturator is removed. The endoguidehas a steerable deflecting tip for precise po-sitioning, perpendicular to the graft material(figure 2). The electronically-controlledEndoStaple applier (with one preloadedEndoStaple) is then advanced into the en-doguide, and proper apposition to the graftmaterial is ensured (bulging of the endo-graft under fluoroscopy). Subsequently theEndoStaple (figure 3) is skrewed into the

de Vries, J.P.

Head Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.

The use of Aptus EndoStaplesduring REVAR, a feasibility study

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J.P. de Vries.- The use of aptus endoStaples during REVARa feasibility study


endograft and aortic wall. The leading edgeis sharpened to allow passage through thegraft and into the vessel wall. The last coilof the helix is folded back on itself, ensur-ing that it can not pass through the fabricof the graft. It has been advised to implantat least 4 EndoStaples for proper fixation ofthe endograft4.

Patients

In a six-months-period 4 patients withproximal migrated endografts or proximaltype I endoleaks were treated with proximalextender cuffs and the use of AptusEndoStaples. Computed tomography (CT)scans were performed 3-months post-proce-durally.The four patients (3 men, age 71 + 6 years)needed revision for proximal migration(n=2) and/or proximal type I endoleaks(n=2) post-EVAR. In all patients, the pri-mary endograft (AneuRx n=2, Endurantn=1, Talent n=1) was first fixated with anaverage of 4 endostaples to the aortic wall.After endostapling of the primary endograft

to the aortic wall, a proximal cuff was in-serted with the proximal part of the fabricjust below the lowermost renal artery. Theproximal cuffs (Endurant n=3, Aptus n=1)were also fixated with endostaples to theprimary endograft and/or aortic wall. Atcompletion angiography 1 patient (with aprimary huge proximal type I endoleak) stillsuffered from this leak and a juxtarenal selfexpandable bare stent had to be implanted.At 3-months CT-scans no proximal type Ior type III endoleaks were seen, nor furtherproximal migration was noticed. No en-dostapling related complications were diag-nosed.

Discussion

Secondary interventions to treat proximalmigration and type IA endoleaks can bechallenging. Less invasive options, like theendovascular implantation of an extendercuff as sole treatment is not recommendedbecause of the high risk of persistent migra-tion of the primary endograft, which will

Fig. 1. The deflectable sheath specifically designed for the endostaple delivery.Fig. 2. Fluoroscopy of implantation of an endostaple in the proximal part of an Aptus endograft.

Fig. 3. The Aptus EndoStaple.

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J.P. de Vries.- The use of aptus endoStaples during REVARa feasibility study


lead to type III endoleaks between cuff andprimary endograft during follow-up. Moreinvasive techniques, like unilateral endo-grafts and fem-fem crossover bypass grafts,laparoscopic banding, or even conversionmight be necessary.

With the introduction of endostaples a mi-grated endograft can be secured to the aor-tic wall and the cuffs can be fixated to theprimary endograft, like we did in the afore-mentioned 4 patients. This patient seriesshowed the feasibility of the use of theAptusTM EndoStapling system for its use insecondary interventions of proximally mi-grated endografts. Endostapling of the de-vice in combination with implantation of aproximal extender cuff makes sense and willminimize the risk of future type III en-doleaks between cuff and endograft.Besides, it secures the proximal part of theendograft to the aortic wall. The use ofEndoStaples enables the surgeon an en-

dovascularly equivalent of a sutured anasto-mosis.

We will continue with this technique, andstart with a European EndoStapling registryto increase the number of patients withlong-term follow-up.

REFERENCES

Fransen GA, Vallabhaneni SR, Van Marrewijk CJ, LaheijRJ, Harris PL, Buth J. Rupture of infra-renal aorticaneurysm after endovascular repair: a series from EU-ROSTAR registry. Eur J Vasc Endovasc Surg 2003;26:487-93.Sampram ES, Karafa MT, Mascha EJ, Clair DG, GreenbergRK, Lyden SP, et al. Nature, frequency, and predictors ofsecondary procedures after endovascular repair of abdominalaortic aneurysm. J Vasc Surg 2003;37:930-7Moll FL, Powell JT, Fraedrich G, Verzini F, Haulon S,Waltham M, et al. Management of abdominal aorticaneurysms: clinical practice guidelines of the EuropeanSociety for Vascular Surgery. Eur J Vasc Endovasc Surg2011;41:S1-S58.Deaton DH, Mehta M, Kasirajan K, Chaikof E, Farber M,Glickman MH, et al. The phase I multicenter trial (STAPLE-I) of the Aptus Endovascular Repair System: results at 6months and 1 year. J Vasc Surg 2009;49:851-8.

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Trimarchi, S.*; van Keulen, J.**; van Herwaarden, J.**; Jonker, F.***;Verhagen, J.M.***; Rampoldi, V.*; Moll, F.**; Mushs, B.****;

*Políclinico San Donato IRCSS, Cardiovascular Center E. Malan, University of Milano, Milan, Italy.**Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, the Netherlands.***Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.****Section of Vascular Surgery, Yale University School of Medicine, New Haven, Connecticut, USA.

All we need to know about the naturalhistory of asymptomatic acute type Bdissection: therapeutic implications

Acute aortic dissection is a challenging andlethal disease with high in-hospital andfollow-up mortality rates. Dissections con-fined to the descending aorta (Type B) havebetter in-hospital survival compared withthose involving the ascending aorta1.However, unlike type A dissection, the

majority of patients with TB-AAD are trea-ted with medical therapy alone. Surgery orendovascular treatment is reserved forpatients with complications such as rupture,enlarging aneurysm, retrograde dissection,malperfusion syndromes or refractory painand/or hypertension2. In-hospital outcomes

3698

are generally acceptable in patients withuncomplicated TB-AAD, with up to 90% ofpatients surviving to hospital discharge afterreceiving effective antihypertensive the-rapy3,4. Short-term and long-term prognosisafter discharge from the hospital remain lessclear. In IRAD recent analysis, 1 in 4patients discharged from the hospital alivewere dead at 3 years, which exceeds thecumulative incidence of mortality in otherdiseases such as coronary artery disease,moderate chronic obstructive pulmonarydisease, and stage II colon cancer5,6. Inother experiences, the long-term prognosisof these patients managed medically, waseven far less optimistic, with mortality ratesas high as 48-82% after 5 years3, 7-9.

A large amount of the long-term mortalityis caused by aorta-related complications, asaortic rupture or extension of the dissec-tion10, which can develop despite adequateantihypertensive treatment11-13. Neverthe-less, preventive open repair in all asympto-matic type B dissections patients is associa-ted with a mortality rate around 30%12-14.Recently, endovascular repair is showingbetter outcomes when compared with opensurgery, but preventive treatment withstentgrafts in asymptomatic patients doesnot seem to improve their mid-term outco-me12-15.

In acute and subacute uncomplicated B dis-sected patients, early predictors of a suc-cessful medical management versus thenecessity of an early intervention mighthelp in optimizing their management.However, actually these predictors are scar-ce and it is largely unknown which asymp-tomatic patients could benefit more froman early intervention, or require closerfollow-up. Imaging studies suggest thatthrombosis of the false lumen has beneficialprognostic value while a patent false lumenpredicts poor outcomes16-20. The impact of apartially thrombosed false lumen (the con-current presence of partial laminar flow andpartial thrombosis) on clinical outcomes hasbeen studied within IRAD. In TB-AADpatients it resulted associated with increasedsurgical mortality14, and among those TB-AAD patients discharged alive, a partiallythrombosed false lumen on imaging resul-ted an independent predictor of increasedmortality after adjusting for age, genderand type of in-hospital treatment13. In thisIRAD cohort, the risk of death in patientswith a partial false lumen thrombosis wasincreased by a factor 2.7 in comparisonwith patients with a completely patent falselumen.13 Due to the observational charac-teristics of the IRAD registry, the exactcause of the increased mortality in patientswith partial false lumen thrombosis remai-

S. Trimarchi et al.- All we need to know about the natural history of asymp-tomatic acute type B dissection: therapeutic implications


Fig. 1. Presence of post- dissected dilation at the level of the upper descending aorta presenting with partial lumen thrombosis. Fig. 1B. MRI shows increasing aortic diameter after one year.

March 2009 March 2010

3699

ned unclear. Formation of a partial throm-bus may occlude distal reentry tears of thefalse lumen (“sac formation”), leading toincreased pressure in the false lumen. Thismay subsequently lead to increased walltension, which may elevate the risk of aorticexpansion, re-dissection and rupture andwould thus explain the increased mortalityseen in these patients13. In addition, it hasbeen suggested that patients with a partiallythrombosed false lumen might suffer from ahigher risk on aortic rupture due to hypoxiaof the arterial wall adjacent to the throm-bus13, similarly to what has been describedearlier in patients with an abdominal aorticaneurysm20,21.

However, a study by Sueyoshi and collea-gues, focused on the aortic growth ratesand thrombosis of the false lumen, did notconfirm these findings23. In their analysis,the dissected aorta showed the fastest meangrowth rate in case of a patent false lumen(4.9mm/year), followed by a partiallythrombosed false lumen (4.0mm/year),while dissected aortas with a completelythrombosed false lumen decreased in dia-meter on average (-0.2mm/year). In thepartially thrombosed false lumen group,dissected aortas with a “sac formation type”showed a significantly increased growth ratecompared to those with a non-sac forma-tion type23. Our group of research, inclu-ding University of Utrecht, the Nederland,University of Rotterdam, the Nederland,Yale University, USA, and Policlinico SanDonato IRCCS, Italy, is actually developingsome projects focused on the evaluation ofvariables that might help to determine therisk of the dissected aorta to expand withconsequent morbidity and mortality. Loo-king into the role of partial lumen throm-bosis, our preliminary results showed thataortic segments of patients affected by par-tial false lumen thrombosis appeared toexpand more frequently during follow-upwhen compared to patients with completethrombosis or a patent false lumen. Theincreased frequency of aortic expansion incase of a partially thrombosed false lumenmay lead to an elevated risk of rupture anddissection, which could explain the increa-

sed mortality, as seen in the IRAD registry.In addition, a trend towards increased aor-tic expansion was observed as well forpatients with hypertension, aorticaneurysm, tobacco history, larger initialaortic diameter and smoking, similarlycorrelated to increased aortic growth inpatients with abdominal aortic aneurysm(AAA)24-26. Although careful follow-up maybe warranted in all TB-AAD patients andadditional data needs in order to validatesome observations, those patients presen-ting with partial false lumen thrombosismight be beneficial from a prophylacticendovascular treatment.

REFERENCES

Hagan PG, Nienaber CA, Isselbacher EM, Bruckman D, Karavite DJ, Russman PL, et al. The International Registry ofAcute Aortic Dissection (IRAD): new insights into an old disease. JAMA 2000 Feb 16;283(7):897-903.Elefteriades JA, Hartleroad J, Gusberg RJ, Salazar AM, Black HR, Kopf GS, et al. Long-term experience with descen-ding aortic dissection: the complication-specific approach. Ann Thorac Surg 1992 Jan;53(1):11-20.Elefteriades JA, Lovoulos CJ, Coady MA, Tellides G, Kopf GS, Rizzo JA. Management of descending aortic dissec-tion. Ann Thorac Surg 1999 Jun;67(6):2002-5.Suzuki T, Mehta RH, Ince H, Nagai R, Sakomura Y, Weber F, et al. Clinical profiles and outcomes of acute type Baortic dissection in the current era: lessons from the International Registry of Aortic Dissection (IRAD). Circulation2003 Sep 9;108 Suppl 1:II312-II317.Tsai TT, Fattori R, Trimarchi S, Isselbacher E, Myrmel T, Evangelista A, et al. Long-term survival in patients presen-ting with type B acute aortic dissection: insights from the International Registry of Acute Aortic Dissection. Circula-tion 2006 Nov 21;114(21):2226-31.Tsai TT, Evangelista A, Nienaber CA, Trimarchi S, Sechtem U, Fattori R, et al. Long-term survival in patients presen-ting with type A acute aortic dissection: insights from the International Registry of Acute Aortic Dissection (IRAD).Circulation 2006 Jul 4;114(1 Suppl):I350-I356.Estrera AL, Miller CC, III, Safi HJ et al. Outcomes of medical management of acute type B aortic dissection. Circula-tion 2006; 114:I384-I389.Erbel R, Alfonso F, Boileau C et al. Diagnosis and management of aortic dissection. Eur Heart J 2001; 22:1642-1681.Nienaber CA, Eagle KA. Aortic dissection: new frontiers in diagnosis and management: Part II: therapeutic manage-ment and follow-up. Circulation 2003; 108:772-778.Gysi J, Schaffner T, Mohacsi P et al. Early and late outcome of operated and non-operated acute dissection of the des-cending aorta. Eur J Cardiothorac Surg 1997; 11:1163-1169.Bastos Goncalves F, Metz R, Hendriks JM et al. Decision-making in type-B dissection: current evidence and futureperspectives. J Cardiovasc Surg (Torino) 2010; 51:657-667.Fattori R, Tsai TT, Myrmel T et al. Complicated acute type B dissection: is surgery still the best option?: a report fromthe International Registry of Acute Aortic Dissection. JACC Cardiovasc Interv 2008; 1:395-402.Tsai TT, Fattori R, Trimarchi S et al. Long-term survival in patients presenting with type B acute aortic dissection:insights from the International Registry of Acute Aortic Dissection. Circulation 2006; 114:2226-2231.Trimarchi S, Nienaber CA, Rampoldi V et al. Role and results of surgery in acute type B aortic dissection: insightsfrom the International Registry of Acute Aortic Dissection (IRAD). Circulation 2006; 114:I357-I364.Nienaber CA, Rousseau H, Eggebrecht H et al. Randomized comparison of strategies for type B aortic dissection: theINvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation 2009; 120:2519-2528.Erbel R, Oelert H, Meyer J, Puth M, Mohr-Katoly S, Hausmann D, et al. Effect of medical and surgical therapy onaortic dissection evaluated by transesophageal echocardiography. Implications for prognosis and therapy. The Europe-an Cooperative Study Group on Echocardiography. Circulation 1993 May;87(5):1604-15.Bernard Y, Zimmermann H, Chocron S, Litzler JF, Kastler B, Etievent JP, et al. False lumen patency as a predictor oflate outcome in aortic dissection. Am J Cardiol 2001 Jun 15;87(12):1378-82.Mohr-Kahaly S, Erbel R, Rennollet H, Wittlich N, Drexler M, Oelert H, et al. Ambulatory follow-up of aortic dissec-tion by transesophageal two-dimensional and color-coded Doppler echocardiography. Circulation 1989 Jul;80(1):24-33.Golledge J, Eagle KA. Acute aortic dissection. Lancet 2008 Jul 5;372(9632):55-66.Sueyoshi E, Sakamoto I, Hayashi K, Yamaguchi T, Imada T. Growth rate of aortic diameter in patients with type Baortic dissection during the chronic phase. Circulation 2004 Sep 14;110(11 Suppl 1):II256-II261.Kazi M, Thyberg J, Religa P et al. Influence of intraluminal thrombus on structural and cellular composition of abdo-minal aortic aneurysm wall. J Vasc Surg 2003; 38:1283-1292.Satta J, Laara E, Juvonen T. Intraluminal thrombus predicts rupture of an abdominal aortic aneurysm. J Vasc Surg1996; 23:737-739.Sueyoshi E, Sakamoto I, Uetani M. Growth rate of affected aorta in patients with type B partially closed aortic dissec-tion. Ann Thorac Surg 2009 Oct;88(4):1251-7.Brady AR, Thompson SG, Fowkes FG, Greenhalgh RM, Powell JT. Abdominal aortic aneurysm expansion: risk fac-tors and time intervals for surveillance. Circulation 2004 Jul 6;110(1):16-21.MacSweeney ST, Ellis M, Worrell PC, Greenhalgh RM, Powell JT. Smoking and growth rate of small abdominal aor-tic aneurysms. Lancet 1994 Sep 3;344(8923):651-2.Schlosser FJ, Tangelder MJ, Verhagen HJ, van der Heijden GJ, Muhs BE, van der GY, et al. Growth predictors andprognosis of small abdominal aortic aneurysms. J Vasc Surg 2008 Jun;47(6):1127-33.

S. Trimarchi et al.- All we need to know about the natural history of asymp-tomatic acute type B dissection: therapeutic implications


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La ecocardiografía transesofágica (ETE) esuna de las técnicas disponibles junto a laaortografía (angio), la tomografía axialcomputerizada (TAC) y la resonancia mag-nética (RM) para el estudio de la aorta. Engeneral todas las técnicas, adecuadamenteaplicadas e interpretadas, tienen una buenaprecisión diagnóstica, si bien demuestransuperioridad, unas en relación a otras, endeterminados aspectos (tabla I).

Una de las limitaciones de la ETE es la im-posibilidad de explorar la aorta en toda suextensión, más allá del nivel gástrico; asimis-mo las ramas arteriales y las estructuras pa-ra-aórticas no son visualizadas adecuada-

mente. Por el contrario la información en-doluminal es excelente, punto de especialrelevancia en los casos de disección aórtica,permitiendo visualizar la puerta de entrada,el tamaño, la situación en relación al origende la arteria subclavia izquierda (ASI) (figu-ra 1) y la presencia de re-entradas a lo largode la aorta torácica descendente. Ademásproporciona una exacta identificación de lafalsa luz y la situación hemodinámica de lamisma con la ayuda del Doppler y la admi-nistración de ecocontraste. La presencia deuna puerta de entrada de grandes dimensio-nes junto a una falsa luz sin las reentradasdistales suficientes para reconducir el flujosanguineo a la luz verdadera, provoca una

Azqueta, M.

Ecocardiograma transesofágico: lautilidad real en el diagnóstico ytratamiento de la disección tipo B

ETE TAC RM ANGIO

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Extensión

Puerta entrada

Puntos domunicación

Trombosis FL

Afectación de los TSA

Afectación ramas abdominales

Disponibilidad (quiróf.)

Accesibilidad del eje aorta/femoral

TABLE 1.

3701

M. Azqueta.- Ecocardiograma transesofágico: la utilidad real en el diagnósti-co y tratamiento de la disección tipo B


alta presurización de la falsa luz y un mayorriesgo de dilatación y rotura en el segui-miento.

Otra de las ventajas del ETE es su disponi-bilidad en quirófano y por tanto, junto alequipo de radiología, permite contribuir a lamonitorización del proceso de implante delas endoprótesis y cuya finalidad es :

conseguir el cierre de la puertade entrada y redireccionar elflujo a la luz verdadera despre-surizar la falsa luz y así mejo-rar la perfusión de las ramasproducir la trombosis de la fal-sa luz y el remodelado poste-rior del vaso y prevenir la dila-tación aórtica y la rotura pos-terior.

La identificación de la falsa luzdurante el proceso del implan-te es de vital importancia parala correcta posición de la en-doprótesis y su posterior des-pliegue. Los criterios que per-miten diferenciar la verdaderade la falsa luz son :la falsa luz es mayor que laverdadera, excepto en el iniciode la disección.

el flujo en la falsa luz es en ge-neral más lento que el de laverdadera.

la luz verdadera se expande ensístole (con un retraso debidoa la distancia de la aorta toráci-ca respecto al corazón). En loscasos de una disección crónica,con un colgajo ya muy engro-sado y rígido, estos cambiospueden desaparecer.

La ETE permite de forma in-mediata valorar el éxito del se-llado de la falsa luz al detectarun proceso de trombosis en suinterior a lo largo de toda laextensión de la endoprótesis(figura 2). En general la trom-

bosis es sólo parcial a nivel de la aorta abdo-minal que mantiene un cierto flujo por lasre-entradas distales.

En resumen, la monitorización permite eva-luar los siguientes pasos : posición adecuada de la guía posición ade-cuada de la endoprótesis en relación a lapuerta de entrada desplegamiento completo

Fig. 1. A – la forma mas frecuente es una puerta de entrada principaljunto al origen de la arteria subclavia izquierda, lo que condiciona una zona

de anclaje proximal más corta y en ocasiones la necesidad de protegerpreviamente parte de los troncos supraaórticos.

B – puerta de entrada mas distal.

Fig. 2. Plano transversal de la aorta torácica descendente con una endo-prótesis desplegada adecuadamente (flecha) y en la parte derecha la falsa

luz (FL) trombosada. LV, luz verdadera.

3702

M. Azqueta.- Ecocardiograma transesofágico: la utilidad real en el diagnósti-co y tratamiento de la disección tipo B


de la endoprótesis ausencia de migración dela endoprótesis confirmar la trombosis de lafalsa luz y detección de posibles “leaks”.

A diferencia de la imagen que proporcionala radiología la ETE no aporta una visióncompleta, global, de la endoprótesis en elespacio; se trata de planos tomográficos conuna precisa información de la estructuras

analizadas pero sólo en el pla-no del corte, no de lo queocurre fuera del mismo. Estalimitación aplica tanto a la vi-sualización completa de lasguías, como de de la propiaestructura de la endoprótesis.Para obviar en parte este pro-blema se deben combinarconstantemente planos orto-gonales, lo que mejora la in-formación al disponer de cor-te longitudinales de la estruc-tura aórtica. La introducciónde la técnica en 3D pareceque permitirá en el futuro,una vez superadas la limita-ciones actuales en relación asu baja resolución, suplir las

limitaciones antes comentadas de la técnica2D (figura nº 3).

En resumen: la ETE permite un adecuadodiagnóstico de la disección tipo B y es uneficaz complemento de la radiología en lamonitorización de los implantes de las en-doprótesis en la aorta torácica.

Introduction

Endovascular techniques have revolution-ized the treatment of pathology affectingthe descending thoracic aorta (TEVR), withdemonstrable reduction in both mortality

and morbidity in conditions with diversepathologies. It may be argued that endovas-cular repair of the thoracic aorta is now thefirst line therapy for complicated acute TypeB dissections, descending thoracicaneurysms and thoracic transactions.

Loftus, I.M.

St. Georges’s Vascular Institute, London, UK.

Ascending aorta-endografting: thenext frontier for type A Stanforddissection and beyond

Fig. 3. Imagen tridimensional de la parte distal de una endoprótesis.

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I.M. Loftus.- Ascending aorta-endografting: the next frontier for type AStanford dissection and beyond


With the success of TEVR, new applicationshave been sought for this technology. Onearea of potential interest is the ascendingaorta. Several pathologies may be candidatesfor endovascular treatment including isolat-

ed ascending aortic aneurysms, cannulationsite false aneurysms and some Type A dis-sections. Around two thirds of all dissec-tions affect the ascending aorta (Figure 1).

Challenges of the Ascending Aorta

The anatomical and physiological challengesto endovascular therapy of the ascendingaorta remain formidable and include:• Proximal fixation close to the aortic valveand coronary ostia• Distal fixation which may impinge on theinnominate artery• Curvature of the distal ascending aortaSizing discrepancies in pathological condi-tions• Haemodynamic forces in this arterial seg-ment• Potential for fatal retrograde dissectionDespite these difficulties, endovascular de-velopment may offer a therapeutic modalityfor cases of surgically untreatable Type Adissection (Figure 2). Selective studies havedemonstrated that up to 30% of patientswith Type A dissection are unable to under-go surgical treatment1,2. The mortality inthese cases is high at around 1% per hour or80% in all. Endovascular therapy may be apossible alternative. Furthermore, the mor-tality from open surgery for type A dissec-tions is high in most centres, with mostpublished series demonstrating a periopera-tive mortality of over 20%. Approximately50% of Type A dissections occur 2cm ormore distal to the coronary ostia and thesepatients might derive some benefit fromcoverage of the primary entry tear.

A number of case reports have demonstrat-ed the feasibility of type A dissection en-dovascular repair, some of which have in-corporated simultaneous stenting of thecoronary ostia 3,4,5. Currently the evidence islimited to small case series with limited longterm follow up. The extension of endovas-cular techniques in to the ascending aorta isnow a reality but demands design modifica-tions to existing devices. In the last year agraft has been developed (Cook Medical)for compassionate use in the ascending aor-ta. The nitinol based stent graft has features

Fig. 1. Acute Type A Stanford Dissection extending into thedescending thoracic aorta.

Fig. 2. Successful deployment of an ascending thoracicstent graft.

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I.M. Loftus.- Ascending aorta-endografting: the next frontier for type AStanford dissection and beyond


specifically designed for use in this challeng-ing anatomy:

A delivery system capable of delivering thestent to the ascending aorta from a femoralroute. This is a hydrophilic coated 100cmflexor system (16-20 French).A soft flexible tip capable of atraumatic en-try to the left ventricleStable delivery with accurate placementLength and diameter compatible with theascending aorta. The stent graft is availablein diameters from 28-46mm diameter andis 85mm long (covered component 65mmwith a bare proximal and distal stent).

The design and applicability of this devicewill be demonstrated. It should be reiterat-ed that this device is not currently approvedfor commercial use.

Summary

Currently intervention rates for acute typeA Stanford dissection are too low, and con-

servative management confers extremelyhigh mortality rates. Open surgery, whilefeasible in over two thirds of cases, has aperi-operative mortality of over 20%. Wenow have proof of concept with regard toendovascular repair and a stent graft specifi-cally designed for purpose. It could be ar-gued that an endovascular approach can on-ly improve current results for type A repairbut careful audit and follow up will be re-quired as the technique is developed.

REFERENCES

Swee W, Dake MD. Endovascular management of thoracicdissections. Circulation 2008;117:1460-73.Hagan PG, Nienaber CA, Isselbacher EM et al. IRAD: newinsights into an old disease. JAMA 2000;283:897-903.Senay S, Alhan C, Toraman F et al. Endovascular stent grafttreatment of type A dissection: case report and review of lit-erature. Eur J Vasc Endovasc Surg 2007;34:457-60.Zhang H, Li M, Jin W and Wang Z. Endoluminal and surgi-cal treatment for the management of Stanford Type A aorticdissection. Eur J Cardiothor Surg 2004;26:857-9.Zimpfer D, Czerny M, Kettenbach J et al. Treatment of acutetype A dissection by percutaneous endovascular stent graftplacement. Ann Thor Surg 2006;82:747-9.

The fate of the FL after stent-graft inter-vention for aortic dissection is a major pointof concern, and a highly controversial anddebatable issue. It relates of course to thetreatment of patients presenting with typeIIIb aortic dissection where the dissectionprocess extends well below the diaphragm,and often down into the iliac arteries.

The discussion in this area will be impactedby a number of important issues, such as

Indications for stent-graft intervention inaortic dissection, acute vs, chronic;

Extent of stent-graft coverage/relining ofthe true lumen (TL);

Criado, F.

Endovascular solutions for theresidual false lumen (FL) beyondthe distal edge of the stent-graft

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The objectives for stent-grafting of degen-erative aneurysms are clear-cut (exclusion ofthe aneurismal sac from the circulation,depressurization of the sac, prevention ofrupture) and the stent-grafts have beenspecifically designed for these purposes. Onthe other hand, the goals of stent-graftingfor the treatment of dissections are less defi-nite and specific and devices are generallyused off-label.

The primary goal in the treatment of type Bdissections is to close the proximal entrytear. Any commercially available stent-graftcould be used for this purpose, howeverthere are some specific concerns that shouldbe considered for the choice of the device: 1) retrograde dissection: this potentiallyfatal complication could be more commonwith the use of proximal bare stents,hooks/barbs, high radial force devices,excessively oversized (> 10%) devices

2) rupture of the intimal lamella at the dis-tal end of the stent graft producing a newentry tear: this may be due to the significantdiameter difference between the proximallanding zone in the undiseased aorta andthe true lumen where the stent-graft landsdistally. This problem may be addressedwith tapered stent-grafts or using a smallerstent-graft placed distally to protect theintima-media layers that for the wall of thetrue lumen of the dissected aorta beforeplacing the proximal stent-graft that willcover the intimal tear.

Other goals may include:1) closure of additional entry tears: thesemay be treated with supplementary stentgrafts or in selected cases with plugs or car-diac septal closure devices that come fromdifferent manufacturers. Diagnosis of thesetears is crucial; trans-oesophageal ultra-sonography is our preferred diagnostic tool.

Melissano, G.; Bertoglio, L.; Tshomba, Y.; Chiesa, R.

Department of Vascular Surgery - “Vita-Saluite” University-IRCCS San Raffaele. Milano, Italy.

Limitations of current endografts fortype B dissection treatment. How farare we from the ideal endograft?

F. Criado.- Endovascular solutions for the residual false lumen beyondthe distal edge of the stent-graft


Significance and morbid potential of con-tinuing flow in the FL beyond the loweredge of the stent-graft repair in the chest;

Possible indications for the PETTICOAT-type repair as an effort to obliterate the FLwell beyond the stent-graft repair in thechest;

Adjunctive maneuvers to obliterate the FLsuch as plugs, coils/glue, and stent-grafts;

Data on long-term outcome when the dis-tal FL remains patent.

3706

G. Melissano et al.- Limitations of current endografts fortype B dissection treatment.


The decision to treat additional distal tearsin the thoraco-abdominal aorta should beweighted against a possible increase risk ofspinal cord ischemia.

2) treatment of collapsed aortic true lumen:if the true lumen is still collapsed afterplacement of the proximal stent graft inthe aorta, specific aortic stents that may besafely positioned also over the origin of theaortic branches may be used.

3) treatment of end-organ malperfusion:single malperfused branches may be treatedwith stents to address the different potentialcauses of malperfusion.

4) proximal perfusion of the false-lumenfrom the left subclavian artery: may beobserved from either collaterals or from a

carotid-subclavian by-pass if this is per-formed. It may be addressed percutaneouslywith plugs.

Aortic remodelling and even healing hasbeen observed especially with early treat-ment of acute dissections however in manycases, while the stent-grafts eliminates theproximal perfusion of the false lumen thatundergoes thrombosis in the thoracic por-tion, the distal thoraco-abdominal andabdominal portions of the false lumen areoften still perfused from secondary smallertears located at these levels. Expansion ofthe true lumen and shrinkage of the falselumen are desirable results, however, stabili-ty over time of the overall aortic diameterwith good organs and limbs perfusion arealso considered satisfactory outcomes.

Computational technology provides a pow-erful tool to probe the biomechanicalbehavior of arteries and other componentsof the cardiovascular system. It combinessynergistically with medical imaging tech-nologies to provide information that is oth-erwise difficult (or impossible) to get, and itenables us to study how mechanical forces

may induce arterial disease, helps in design-ing better vascular devices, and may oneday be routinely used for therapeutic plan-ning.

In this paper we report a new imagingbased tool for the hemodynamic analysis ofthe vascular system, particularly focused on

Rousseau, H.*; Moreno, R.*; El Aassar, O.*; Midulla, M.*; Chau, M.****;Marcheix, B.**; Negre-Salvayre, A.*; Nicoud, F.***

**Department of Radiology, Rangueil University Hospital, Toulouse, France** Department of Cardiovascular Surgery, Rangueil University Hospital, Toulouse, France***University Montpellier II –CNRS UMR 5149 I3M, CC 051, Montpellier, France****ASA, Advanced Solutions Accelerator, Montpellier, France

Computational analysis of flowdynamics in type B dissectionmanagement and prognosis

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H. Rousseau et al.- Computational analysis of flow dynamics in type B dis-section management and prognosis


aortic dissection and the evaluation of thethoracic endovascular aortic repair(TEVAR). This novel method is based onthe CFD technology combined withdynamic and functional MRI.

Methods

- Image acquisition: MRI protocol

Using a 1.5 T MR scanner with ECG-syn-chronization, a routine contrast enhancedT1-Full Field Echo sequence is performedon sagittal-oblique planes, parallel to theaortic arch. Multi-Slice 2D MR Cine Imag-ing (b-SSFP), using the same orientation ofthe angio-MR, is also performed. Usually30 slices (600 cine images), acquired in 6apneas, are sufficient to cover the wholeaortic geometry. 2D Phase-Contrast (PC)sequences, orthogonal to the vessel’s axis,provided the velocity inlet profiles at theascending, descending aorta and supra-aor-tic vessels.

- Image data processing

Static geometry extraction is performedwith a 3D Level Set algorithm (Matlab 7.6,the MathWorks, Inc). A “native” computa-tional grid is obtained by the discretizationof this geometry (Amira 4.1, TGS, MercuryComputer Systems, USA). Wall movementsare imposed to the “native” grid accordingto the cine acquisitions (b-SSFP), by meansof a “non linear transformation field” in-house algorithm (Matlab 7.6, the Math-Works, Inc). The flow simulations are per-formed using the finite volume (FV)method, as implemented in the AVBP 6.0Navier-Stokes solver (CERFACS,Toulouse, FR).

- CFD features

Blood is assumed to be a homogeneousnewtonian fluid with a dynamic viscosityapproximated as 4 cPoi and a density of1050 kg/m3.The FV method used in thecode solves the full Navier–Stokes equation,governing the flow, by an efficient explicitAlgebraic Lagrangian Eulerian (ALE) for-mulation, which allows to impose the tetra-

hedral moving grid within the cardiac cycles(uncoupled). The CFD application provideanatomical images which are plotted as vir-tual 4D models by a CFD and numericalsimulation visualization freeware software(Paraview Kitware Inc., USA). This uses aquantitative color-coded scale to representthe results of the analysis of the blood flowcomponents; velocity (cm/sec), vorticity (s-1) and pressure gradients (mmHg) as wellas the parameters relative to the aortic wall;compliance and wall shear stress (Pa).

Results & Discussion

Currently, there is no validated techniqueavailable for quantifying the individual riskof rupture for a TAA or a dissection. Thedecision to electively repair a thoracic aorticdisease is widely based on the “maximumdiameter criterion”; i.e., when theaneurysm reaches a certain size (typically 6or 6.5 cm), it is thought that the risk ofrupture warrants its repair. However, thiscriterion is only a general rule-of-thumband is unreliable. Actually, the ‘simplified’Law of Laplace (with only axial diameter)cannot explain why different patients initial-ly presenting with equivalent maximumdiameters, have different rates of diameterprogression afterwards.

While it is generally accepted that hemody-namics plays a major role in the initiation,acute propagation, and chronic develop-ment of dissections, nevertheless, the exactmechanism of formation and developmentof dissections is yet not well understood.Moreover, there is considerable uncertaintyabout the critical diameter of rupture of thefalse lumen and how to treat false lumenaneurysms. For all above-mentioned rea-sons, there is a certain need for the develop-ment of new methods capable of providingreliable quantitative prediction of the risk ofrupture of dissections on a patient-specificbasis in contrary to the currently adopted“one-criterion-fits-all” approach.

In the literature, the use of CFD for simu-lating the in-vivo behavior of vascular struc-tures has been reported for the abdominaland thoracic aorta evaluation, derived from

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CT scan or MRI. All these investigations,though, apply the numerical computationmethod in steady state conditions withinsimplified models, mainly because of thelack of reproducibility of the in-vivodynamic conditions related to the aorticwall displacement over the cardiac cycle.

Modern equipment and imaging techniquesbased on the intrinsic sensitivity of MRI toflow and motion offer the possibility ofacquiring spatially registered functionalinformation simultaneously with morpho-logical data within a single study. Charac-terizing the dynamic components of bloodflow and cardiovascular function can pro-vide insights into normal and pathologicalphysiology, and considerable progress inthis field has been made in recent years.

The objective of this paper is to demon-strate that CFD results provide a reliable

technique for the qualitative and quantita-tive assessment and visualization of bloodflow in the aorta. Different applications ofthis functional information can be useful forthe therapeutic decision making for dissec-tions as well as the selection and follow upof stent grafts.

Our multidisciplinary team has developed adedicated method to build, based ondynamic and functional MR examinations,patient-specific geometric data and bound-ary conditions for unsteady CFD runs withvariable meshes valid over the cardiaccycles, and has finally created color coded4D-CFD virtual models for each patient.To our knowledge, our project is the firstto apply the CFD to in-vivo images derivedfrom a dynamic study of the thoracic aorta.After in vitro validation, the method hasbeen tested for the evaluation of differentdiseases (aneurysms, dissections, PU andIMH) before and after TEVAR implanta-tion.

As a whole, quantitative evaluation strate-gies to assess flow rates, wall shear stressand vorticity is obtained in order to developand apply objective diagnostic criteria forthe description of vascular pathologies.Computational technology enables us tosimulate and quantify this biomechanicalenvironment in otherwise inaccessible loca-tions. Such techniques, in conjunction withappropriately designed experiments, arehelping us better understand the linksbetween biomechanics and arterial diseases.Furthermore, the post processing virtual4D modeling represent theoretically animportant purpose for future investigationson the aortic dissection, in order to developan imaging based method for planning theinterventional strategies (use of stent-graftsto cover the entry tears, creation of fenes-trations of the intimal flaps) that are actual-ly being performed on empirical basis.Finally, computing, in conjunction withsuitable experimental data, can be impor-tant by helping us understand the complexrelationship between biomechanics anddevice failure and by aiding in design ofbetter devices while shortening design cycletime.

J.F. Nistal.- El tratamiento de los aneurismas toracoabdominalesdebería ser abierto

Técnicas Endovasculares Vol.XII. Núm. 1. Enero-Abril 2009; 2850-2852

Fig. 1. Example of an imaging based method for planningthe endovascular management of a type dissection:In this case we simulate the use of a stent-graft (panel A/2)to cover the proximal entry tears. Quantitative and dyna-mic evaluation of wall shear stress, flow rates, and vorticity(panel D/E) is obtained in order to apply objective diagnos-tic and therapeutic criteria.

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Endovascular treatment for thoracic aorticdisease has developed significantly in thelast 15 years. The pioneering work of Dakeand colleagues1 began in the mid-90s; now,tens of thousands of procedures are per-formed yearly in the US alone. Thoracicaneurysms and aortic dissections constitutethe majority of clinical cases. Although theshort- and midterm outcomes of endovas-cular procedures have been favorable com-pared to open surgical repair, the risks ofaneurysm enlargement, endoleaks, endo-graft collapse, and migration demand costly

periodic screenings of the patient. More-over, a number of investigators haveexpressed concern regarding the long-termdurability and outcomes following thoracicendografting2-5.

The unique anatomical and biomechanicalenvironment of the thoracic aorta (i.e.,large motion, highly pulsatile flow) posessignificant challenges to the long-term suc-cess of endografts. A deeper understandingof the forces experienced by endografts invivo is required to improve their perfor-

Figueroa, A.*; Zarins, Ch.**

*Deaprtment of Bioengineering. Stanford University, Stanford, CA, USA.*Deaprtment of Surgery. Stanford University, Stanford, CA, USA.

Pulsatile displacement forces actingon thoracic aortic endografts

Fig. 2. Flow and pressure waveforms in selected vessels obtained in the CFD analysis of a proximal descendingthoracic aortic aneurysm model.

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mance and long-term durability. While thedisplacement force (DF) acting on aorticendografts has been assumed to be in thedownward direction of blood flow, recentstudies in the abdominal aorta have shownthat sideways displacement of endografts inthe aneurysm sac is a predictor of lateadverse events6,7. In-vitro experimentalstudies8, 9 as well as theoretical and compu-tational studies10 have been conducted toinvestigate the magnitude of loads actingon thoracic endografts, their resistance todislodgment, as well as their stability andmovement. However, in all cases, the stud-ies failed to either reproduce the complexanatomical configuration of the aorta andendograft or the highly pulsatile bloodflow, pressure, and wall dynamics of thethoracic aorta. The purpose of this investi-gation is to study the magnitude and direc-tion of pulsatile displacement forces actingon realistic models of thoracic aortic endo-grafts built from image data using computa-tional fluid dynamics (CFD) techniques

(see Figure 1)11. We investigate the impactthat different factors, such as device loca-tion, size, elevated pressure and elevatedflow have on the forces experienced by theendograft.

REFERENCES

Dake MD, Miller DC, Semba CP, et al. New England Journalof Medicine 1994; 331:1729-1734.Matsumura JS, Cambria RP, Dake MD, et al. Journal of Vas-cular Surgery 2008; 47:247-257.Leurs LJ, Bell R, Degrieck Y, et al. Journal of VascularSurgery 2004;40:670-680.Ricco JB, Cau J, Marchand C, et al. Journal of Thoracic andCardiovascular Surgery 2006;131:131-137.Bavaria JE, Appoo JJ, Makaroun MS, et al. Journal of Tho-racic and Cardiovascular Surgery 2007;133:369-377.Rafii BY, Abilez OJ, Benharash P, et al. Journal of Endovas-cular Therapy 2008; 15:335-343.Figueroa CA, Taylor CA, Yeh V, et al. Journal of Endovas-cular Therapy 2009; 16:284-294.Veerapen R, Dorandeu A, Serre I, et al. Journal of Endovas-cular Therapy 2003; 10:1101-1109.Liffman K, Sutalo ID, Lawrence-Brown MM, et al. Journalof Endovascular Therapy 2006; 13:51-61. Lam S, Fung G, Cheng S, et al. Medical and Biological Engi-neering and Computing 2008;46:1129-1138.Figueroa, Taylor CA, Chiou AJ, et al. Journal of Endovascu-lar Therapy 2009;16:350-358.

IntroductionStroke is a major source of concern afterhybrid aortic arch repair. The aim of thisstudy is to analyse the results of hybridrepair of aortic disease involving the archand incidence of stroke to possibly identify

strategies to avoid this devastating compli-cation.

MethodsIn the last decade, 361 patients receivedTEVAR at our Institution; in 131 cases the

Melissano, G.; Bertoglio, L.; Kahlberg, A.; Tshomba, Y.; Civilini, E.; Chiesa, R.


Supraaortic debranching andendografting for aneurysmsinvolving the arch. Tricks and tips

A. Figueroa.- Pulsatile displacement forces acting on thoracic aortic endografts


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aortic arch was involved (112 degenerativeaneurysms, 19 dissections). “Zone 0”patients (29) received supra-aortic arteriesde-branching through sternotomy, includ-ing the left subclavian artery (LSA) in 3cases. “Zone 1” patients (30) receivedextra-anatomic revascularization of the leftcommon carotid artery and the LSA in 7cases. In “Zone 2” patients (72) the LSAwas revascularized selectively in 59 cases. Aone-stage procedure was performed in 124cases and the LSA was ligated or occludedwith a plug in 47 cases before stent-graft(SG) deployment.

ResultsInitial clinical success, mortality and spinalcord ischemia in TEVAR patients with orwithout arch involvement were respectively:87.8% vs. 93.1%, 4.6% vs. 2.7% and 1.5% vs.3.7%. Patients with arch involvement had astroke rate of 3.1% vs. 1.1% in patientswithout (P=NS). The stroke rate was 10.3%

(P<0.02) in “Zone 0”, 0% in “Zone 1”,and 1.4% in “Zone 2”. Three strokes werecerebellar and one hemispheric, all fatal andassociated with multi-organ embolization.The scans showed severe atheroma and/orthrombus in the arch in all cases. Stroke wasobserved in patients with (3.4%) or without(2.7%) LSA revascularization, however itwas never observed in patients in whom theLSA was occluded before SG deploymentand in 4.7% of patients in whom it waspatent at the time of SG deployment.

ConclusionsStroke after TEVAR is not infrequent espe-cially when the arch is involved. Its origin ismostly embolic and possibly related toendovascular manipulation. Better patientselection together with a strategy to reduceembolization such as occlusion of supra-aortic trunks before SG deployment mayplay a beneficial role.

Chimney grafts (stents) have emerged as avery useful and widely applicable adjunctivetechnique to preserve aortic arch branchesduring TEVAR.

The appeal of the technique relates to itsavailability and off-the-shelf nature, the factthat a percutaneous approach is often possi-ble, and its apparent effectiveness and suc-cess in achieving the intended goal of pre-

serving normal blood flow into one ormore arch branches.

The chimney technique has long been con-sidered as a bail-out or rescue approach –and this is appropriate. However, rapidlygrowing experience and reported resultswould appear to suggest that envisioning alarger role may be reasonable.

Criado, F.

Chimney techniques in the arch:simplest and safest

G. Melissano et al.- Supraaortic debranghing and endografting for aneurysmsinvolving the arch. Tricks and tips


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Introduction

Traditionally, arch replacement has involveda median sternotomy or thoracotomy andgraft implantation with or without an ele-phant trunk for descending thoracic aorticdisease. Thoracic stent-graft placement afterde-branching of the great vessels avoids car-dio-pulmonary bypass, but a thoracotomy isoften required and this still carries signifi-cant morbidity. A new device for totalendovascular arch replacement has recentlybeen introduced, a modification of theexisting basic structure of the TX2 thoracicstent-graft (Cook Medical, Bloomington,In.).

Current state of open surgery

Since the first series of arch replacements in19751 significant advances have been madein open aortic arch surgery. The introduc-tion of profound hypothermic circulatoryarrest (PHCA) and retrograde cerebral per-fusion (RCP) improve operative morbidityand mortality with the best outcomes inthose undergoing selective antegrade cere-bral perfusion (SACP). Not surprisingly,those undergoing elective repair fare betterthan emergent cases and operative mortalityand stroke rates of 2.7% and 5.4% can beachieved2. Using SACP, moderate HCArather than PHCA may be used withoutincreasing stroke rates, with benefit gainedfrom less coagulopathy and blood loss3.Patients greater than 80 years, traditionallyat highest risk, can be treated with safely

with these techniques with a mortality ratereported of 4.5%4.

More extensive aortic arch disease mayrequire the use of an “elephant trunk” fordealing with the descending thoracic aortaas a staged procedure. Not completing thesecond stage has been a common problemnoted in a number of large series and thisraises the spectre of a larger single-stageopen approach. This, however is associatedwith greater morbidity and mortality5.

One solution to this problem has been theuse of a frozen elephant trunk, which incor-porates the use of a stent-graft placed retro-grade into the descending thoracic aorta asa way of creating a single-stage procedurewithout further open surgical exposure,with short and long-term results arefavourable when compared with standardelephant trunk procedures6.

Current state of Endovascular ArchSurgery

Chimney graftsRetrograde positioning of a chimney stentgraft to preserve antegrade innominateartery flow is a relatively straightforwardtechnique but a Type 1 endoleak may becreated in the gutters around the chimney7.The long-term durability of this techniquehas not been established, and the interac-tion of different materials in this positioncreates some uncertainty. Chimney grafts

Simring, D.; Morgan-Rowe, L.; Hague, J.; Raja, J.; Harris, P.; Ivancev, K.

UCLH Multi-disciplinary endovascular team University College Hospital, London.

Total endovascular repair of thearch: branched endograftingmakes it easy

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D. Simring et al.- Total endovascular repair of the arch: branched endografting makes it easy


have therefore a role in emergent situations,but unpredictability limits its application inthe elective setting.

In-situ fenestrationThe use of in-situ fenestrations has beendescribed for preservation of the left subcla-vian artery but can be used for establishingantegrade perfusion of the innominate andleft subclavian arteries8. After temporarybypass to the arch vessels is performed thestent-graft covers the origins of these archvessels; a retrograde perforation of thestent-graft is then performed. This fenestra-tion is dilated until a further stent graft canbe delivered9. A complete haemostatic sealcan usually be achieved but again its dura-bility in this hostile environment is yet to bedetermined. Refinements of this approachin the future may include the use of laser,which has been successfully used for leftsubclavian artery revascularisation10.

Hybrid RepairHybrid aortic arch repair is well describedand has good short and long term results11.This technique utilises a thoracic stent-graftwith extra-anatomic bypass from theascending aorta to maintain flow in the archvessels avoiding the need for cardio-pul-monary bypass, though a thoracotomy anda reasonable length of good ascending aortais still needed.

Branched arch device

Current configurations and technicalnotesThe current design of the branched archdevice is based on a stent-graft delivered viathe transfemoral route. This fully custom-made device (Cook Medical, Perth, Aus-tralia) incorporates two internalised sleevesfor the innominate and left carotid brancheswith large funnel openings to facilitate ret-rograde cannulation (Fig 1a).

The graft is mounted on a pre-curved can-nula (and pre-curved sheath), which con-forms in a reliable fashion to the curvatureof the arch. In addition the stent graft is

mounted onto the cannula with a spiraltrigger wire wound round the cannula, andas such the funnels are reliably delivered tothe outer curvature of the arch facilitatingorientation (Figs 1b).

Trigger wires secure “pro-form” alignmentof the first two sealing stents into thecurved portion of the ascending aorta. Theportion of the graft containing the openingsof the internalised sleeves (the funnels) isreduced in diameter which allows continuedantegrade cerebral blood flow through thegraft during deployment and prior to com-pletion with the innominate and carotidbranches. Diameter reducing ties attachedto trigger wires are also a standard feature.Multiple gold markers outline the funnels.(Fig 1c).

A surgical conduit is placed to the rightsubclavian artery and a left carotid-subcla-vian bypass is performed. A radio-opaquetipped sheath marks the innominate arteryorigin. Once the stent-graft has been intro-duced via the transfemoral route its longitu-dinal position can be ascertained relative tothe innominate artery, with the funnel goldmarkers fully proximal to the innominateorifice. The graft is then unsheathed underrapid overpacing to minimize aortic move-ment and reduce wind-socking. All triggerwires are then removed apart from the wiresecuring the distal stent graft. Both sleevesare retrogradely cannulated and a bridgingstent graft is then positioned from the rightsubclavian conduit preserving the innomi-nate artery bifurcation. The left carotidbridging stent graft is then brought in fromthe ipsilateral brachial artery. The origin ofthe left subclavian artery may be embolizedfrom this access to prevent a Type 2Endoleak.

Case Description

An 81 year old male patient presented witha 73mm saccular aneurysm of the arch asso-ciated with a hoarse voice. Severe respirato-ry disease precluded open arch replacementor debranching via a sternotomy. A bovineorigin of the innominate and left carotid

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Fig. 1.1a. External view of stent-graft showing funnelorifices and internalised sleeves (arrows).1b. Trigger wire wound around the central can-nula (arrows).1c. Diameter reducing ties and the pre-curvedcannula (arrows).

Fig. 2. 2a Pre operative surface shaded image of the aortic arch showing the saccular aneurysm (arrow)and bovine origin of innominate and left common carotid arteries

2b Cook Medical custom-made stent-graft plan.

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arteries without an adequate seal distallyprecluded placement of a standard thoracicstent-graft (Fig 2a) and therefore a custom-made stent graft (Cook Medical, Perth,WA) incorporating the internalised sleevedesign was used.

The stent-graft was constructed with twoproximal sealing stents 46mm in diameterfor an ascending aortic diameter of 41mm.Note in the graft plan that the peaks of theproximal 6 internal stainless steel stentsalign with the peaks of subsequent stent;this confers increased rigidity of this portionof the stent graft, and allows for a rigidrhomboidal configuration of the funnel ori-fices (Fig 2b).

The case was performed under generalanaesthesia following the placement of aspinal drain and temporary pacing wiresfrom the left femoral vein. A 10mm Dacronconduit to the right subclavian artery andan 8mm Dacron left carotid to left subcla-vian artery bypass graft were performed. Viaa right femoral artery cutdown, a wire wasadvanced to the aortic arch and through theaortic valve into the left ventricle. This wasexchanged for a pre-curved stiff wire whichwas coiled in the heart.

Over this stiff wire, the graft was advanceduntil the nose cone was just through theaortic valve, though remaining above thesino-tubular junction. The gold markers

showing the funnel positions could beclearly seen (Fig 3a). A 30cm 6 Frenchsheath was placed in the innominate arteryvia the right subclavian conduit and posi-tioned to mark the orifice of the vessel.

The main stent-graft was deployed duringrapid overpacing with the proximal triggerwire released and pro-form deployed. Theproximal internal sleeve was then cannulat-ed via the 6F sheath and a Zenith Flex aor-tic limb (Cook Medical, Perth, WA) wasdeployed preserving the innominate arterybifurcation (Fig 3b).

The second funnel was then cannulatedfrom the left brachial artery and a 13.5mmFluency (CR Bard Inc, Surrey, UK) stent-graft was deployed. The left sublavian arterywas then cannulated and an Amplatzoccluder (AGA Medical, Plymouth, Minn)was placed at its origin to prevent retro-grade flow from the bypass into theaneurysm (Fig 3c).

Discussion

While there are clear advantages in avoidinga full thoracotomy or cardiac bypass, long-term performance is untested as only ahandful of cases have been performed. Fur-thermore the device is limited to treatmentof arch disease and significant pathologiesin the ascending aorta (Ishimaru Zone 0)will require alternative approaches.



Fig. 2. 3a Angiogram demonstrating stent-graft ready to deploy; the sleeve markers are easily seenon the outer curve of the graft (arrow) 3b Main stent-graft deployed with innominate artery stent-graft in place

3c Completion angiogram demonstrating flow through both arch branches and exclusion of the aneurysm. The origin of theleft subclavian artery has been embolised (arrow)

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In the two-branch format, a left carotid-subclavian bypass is still required for preser-vation of the left vertebral artery thoughmodifications are in progress for placementof a third left subclavian artery sleeve toovercome this though this clearly adds tothe endovascular complexity of the case.Even with this modification, a surgical cut-down to the neck vessels is required forbranch delivery.

One considered alternative is a minithora-cotomy with trans-ventricular antegradecannulation, pre-loaded wires, and ante-grade delivery of the branch stent-grafts tothe sleeves with potential reduction instroke risk and cranial nerve injury.

This also permits snaring of a through wirefor easier passage of the main stent-graftespecially in the tortuous arch, and withhighly accurate deployment. As furthergraft refinements are made and experiencegrows with the device, more meaning com-parisons with current accepted treatmentswill be possible.

REFERENCES

Griepp RB, Stinson EB, Hollingswoth et al. Prostheticreplacement of the aortic arch J Thoracic Cardiovasc Surg1975; 70; 1051-63Sundt TM, Orszulak TA, Cook DJ et al. Improving results ofarch replacement Ann Thorac Surg 2008; 86: 787-796Minatoya K, Ogino H, Matsuda H et al. Evolving selectivecerebral perfusion for aortic arch replacement: high flow ratewith moderate hypothermic circulatory arrest Ann ThoracSurg 2008; 86: 1827-32Minatoya K, Ogino H, Matsuda H et al. Is conventional archsurgery justifiable in octogenarians? J Thorac CardiovascSurg 2010; 139(3): 641-5Svensson LG, Kim KH, Blackstone EH et al. Elephant trunkprocedure; newer indications and uses Ann Thorac Surg2004; 78: 109-16Uchida N, Katayama A, Tamura K et al. Long-term resultsof the frozen elephant trunk technique for extended aorticarch disease. Euro J Cardiothorac Surg 2010; 37: 1338-45Sugiura K, Sonesson B, Akesson M et al. The applicabilityof chimney grafts in the aortic arch J Cardiovasc Surg 2009;50(4):475-81.Sonneson B, Resch B, Allers M, Malina M. Endovasculartotal aortic arch replacement by in situ stent graft fenestra-tion technique. J Vasc Surg: 2009; 49(6):1589-91McWilliams RG, Fearn SJ, Harris PL et al. Retrograde fenes-tration of endoluminal grafts from target vessels:feasibility,technique, and potential usage. J Endovasc Ther2003; 10(5): 946-52.J . Murphy EH, Dimaio JM, Dean W et al. Endovascularrepair of acute traumatic thoracic aortic transection withlaser-assisted in-situ fenestration of a stent-graft covering theleft subclavian artery. J Endovasc Ther. 2009; 16(4): 457-63Koullias GJ, Wheatley GH. State of the Art hybrid proce-dures for the aortic arch: a meta-analysis Ann Thorac Surg2010; 90: 698-97.



Introduction

Endovascular repair of the thoracic aorta isnot straightforward and there are many pit-falls for the unwary. This chapter discusses

problems that can occur during thoracicendovascular aortic repair and ways to avoidand treat them. The neurological complica-tions of stroke and paraplegia are dealt within another chapter.

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Clough, R.*; Taylor, P.**

*NIHR BRC Clinical Training Fellow. **Professor of Vascular Surgery Department of Vascular Surgery. NIHR Comprehensive Biomedical Research Centre of Guy’s andSt Thomas’ NHS Foundation Trust and King’s College London, and King’s Health Partners

Managing TEVAR complicationsand disasters: techniques andlessons learn

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R. Clough et al.- Managing TEVAR complications and disasters: techniques and lessons learn


ImagingMultislice CT scan is routinely used toimage from the vertebral and carotid arter-ies cranially to the femoral arteries caudally,assessing the full length of the thoracic andabdominal aorta and the iliac arteries. Soft-ware programmes which perform 3Dreconstruction of the aorta, including cen-tre line of flow, are important in both diag-nosing and planning endovascular treat-ment and in the follow up of patients (1,2). In dissection multiple aortic branches canbe compromised by the false lumen, andidentification of the primary entry tear isessential. Additional imaging techniquessuch as magnetic resonance imaging, digitalsubtraction angiography and intravascularultrasound may help in identifying sec-ondary entry tears. Multiple aneurysms cancoexist synchronously especially when theyare caused by infection and so imaging theentire aorta is important.

Imaging of the iliac and femoral vessels ismandatory as the large size of the sheaths(up to 24 French) require vessels to have aminimum diameter of 8mm. Diseasedfemoral arteries may require endarterecto-my and patch angioplasty if a large stenoticplaque is disrupted by the device.

In elective patients a duplex examination ofthe carotid, vertebral and subclavian arteriesshould be performed if the arch vessels areto be deliberatedly covered. In the emer-gency situation this may not always be pos-sible, and intraoperative angiography can beused to identify arterial disease. Reductionin flow of a dominant left vertebral arterymay result in a posterior circulation strokeand the left subclavian may give rise to acoronary graft using the left internal mam-mary artery.

AccessConduits are required in about 5-17% ofpatients, usually women (3). Diseased arter-ies with focal stenoses may require angio-plasty prior to insertion of the device. Serialintroduction of dilators with increasingdiameters may open stenosed arteries andthe small pliant arteries of adolescents suffi-

ciently to allow passage of the device. Rup-ture of iliac arteries can occur when a largesheath is pushed forcibly through small cal-cified tortuous arteries usually associatedwith a sudden give. When the sheath isremoved, the blood pressure usually fallsprecipitously as the patient exsanguinates.This can be controlled immediately by rein-serting the sheath if the wire has not beenremoved. An occlusion balloon can also beplaced above the site of injury and inflatedto control haemorrhage. This can also beintroduced into the infrarenal aorta usingthe contralateral femoral artery if wire posi-tion has been lost. The balloon requires along sheath to hold it in position as the ris-ing blood pressure will force it distally. Theruptured iliac artery can be treated by acovered stent, but this may not be possibleif there has been complete transaction ofthe vessel. Open access via a retroperi-toneal approach can be performed, thearteries oversewn and a polyester graftsutured in place. Occasionally the iliacarteries are so badly damaged that in situreconstruction is not possible. Oversewingthe proximal artery and revascularisationwith a femorofemoral cross over graft maybe the only option.

DevicesAll current devices have idiosyncrasies withwhich the user must be familiar. Devicerelated complications will increase if manytypes of device are used in a unit so that allinterventionalists may not have completedtheir learning curve. Usually two differentdevices can cope with most thoracic pathol-ogy. Certain devices have a longitudinalsupport which has to be orientated correct-ly to the outer curve. Others require a bareproximal stent to safely deploy the deviceand prevent the stent turning back on itself.Some can be safely deployed proximal tothe final landing position and moved distal-ly, others can only be moved proximally.Hooks, barbs and anchors can also dictatewhich direction the device can safely bemoved. Most devices are now held to theintroducing system during deployment toallow accurate positioning. The releasemechanism is different for each system and

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familiarity with the technique is essential.Problems of release need an action planbefore they occur. It is possible to impartenergy to any device in very tortuous aortasby keeping tension on it which can generateenough force to move it substantially awayfrom its intended position.

The devices are usually deployed with a stiffguide wire which takes the racing line intortuous vessels. Deployment in the archcan be affected by the wire taking a positionon the inner curvature. The device will tendto move distally on deployment if not heldin position by the introducer. In a tortuousaorta the haemodymanic forces on thedevice will tend to force it to migrate to theouter wall of a large aneurysm. It is there-fore very important to allow sufficient over-lap of devices to prevent complete disloca-tion resulting in a type III endoleak. Serialfollow up imaging is important to deter-mine the position of the device within largeaneurysms and to judge the degree of over-lap of devices.

PositioningDevices which cause complete aortic occlu-sion during deployment cause very highblood pressures forcing the device distally.Hypotensive agents can be used to reduceblood pressure, cardiac arrest with adeno-sine can be used but overpacing the heart isthe most popular (4).

The use of a femoral to brachial wire canhelp straighten a tortuous aorta and canhelp position a device in the proximal aorticarch. A catheter should cover the brachialwire into the aortic lumen to preventcheesewiring the origin of the vessel. Theuse of a right brachial wire may increase therisk of stroke in some patients.

ComplianceThoracic devices were developed from pro-totypes used to treat the infrarenal aorta,and they cope well in straight parts of theaorta. This does not apply to the aortic archwhere very few devices are able to copewith the inner curvature. The rigidity ofsome devices with excellent column

strength ensures that they stand proud ofthe inner curvature. Haemodynamic forcescause device collapse resulting in aorticocclusion which can be fatal (5,6). Recentlythe Proform from Cook and the cTAGfrom Gore have been introduced to accom-modate the curvature of the aortic arch.

Inadvertent occlusion of branch vessels:Debranching the arch vessels using extra-anatomic grafts allows arch pathology to betreated but there is evidence that the risk ofstroke increases with the number of vesselsoccluded (7,8) Occasionally this happensinadvertently and serious consequences mayfollow including stroke and paraplegia.These can be recognised immediately if theprocedure is under regional anaesthesia butwill be delayed by general anaesthesia.Reduction in cerebral blood flow may onlybecome clinically apparent when balloondilatation causes stenosis of an arch vessel.Decreasing levels of consciousness are asso-ciated with a reduction in blood pressuremeasured by an arterial line in the corre-sponding radial artery. Urgent revascularisa-tion must be performed if the neurologicaldeficit is to be reversed. Brachial accessshould be quickly performed either percuta-neously with the aid of an ultrasound scansurgically. A wire and catheter is passed intothe aortic arch and a stent applied acrossthe origin of the vessel where it is compro-mised by the stent graft.

The right brachial artery can be used toopen up the origin of the brachiocephalicartery, and the left brachial artery can beused to open the origin of the left subcla-vian artery and even the left commoncarotid artery in the presence of a carotidsubclavian graft. This may be necessary if acoronary graft using the left internal mam-mary artery graft has been covered. Sternalwires are an important sign of previouscoronary revascularisation. Cardiac dysrhythmias may be caused by theguide wire passing through the aortic valveand entering the left ventricle. The wireshould be pulled back through the aorticvalve which cures the problem immediately.



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DissectionToo much oversizing of the device inpatients with dissection can result in devicecollapse and in conversion of a type B into atype A dissection (9,10). This is a disasterwhich requires immediate surgical conver-sion to prevent death from the conse-quences of myocardial ischaemia, aorticvalve dysfunction and cardiac tamponade.Balloon dilatation should also be avoided inacute dissections for similar reasons.Devices with bare stents or with hooks andbarbs should probably be avoided in dissec-tion.

Inadvertent stenting from the true into thefalse lumen can occur with complex dissec-tions with numerous lumens and may haveserious consequences. If there is any doubtabout the position of the wire it should beremoved and catheter angiography per-formed to confirm its position in the truelumen. If it is in the false lumen it shouldbe withdrawn and re-advanced. Intravascu-lar ultrasound is invaluable but is not widelyavailable. Similarly transoesophageal ECHOcan be used to confirm wire position.The TXD device is a bare stent which canopen the distal lumen and compromisedbranches in acute dissection but needs arandomised clinical trial to prove its effica-cy. (11) However we have had one deathassociated with use of this device. The pri-mary entry tear covered with a device sizedto the proximal un-dissected aorta and aTXD was deployed which successfully revas-cularised the visceral and renal vessels. TheTXD excluded the false lumen in the distalthoracic aorta, but remodelling of the truelumen at the lower end of the covereddevice allowed continued perfusion of thefalse lumen. The patient died at 48 hoursand post mortem confirmed rupture of thefalse lumen opposite the entry tear.

EmbolisationPatients with a large amount of free floatingthrombus in the aorta are at risk of massiveembolisation. This may cause ischaemia ofthe spinal cord, bowels and limbs. Emer-gency open embolectomy can be performedof the mesenteric vessels and those to the

limbs, but paraplegia is usually irreversible.If massive it is usually fatal but small embolican respond to infusions of vasodilatorssuch as iloprost.

Stent outside a stentThis occurs when guidewire position hasbeen lost after deployment of a proximaldevice. The wire is repositioned outside theexisting device and in a large aneurysm asecond device will pass easily alongside thefirst and can be maldeployed outside theproximal device. The wire should be with-drawn and reinserted within the proximalstent where its correct position can be con-firmed by angiography. A second device canthen be deployed crushing the maldeployedstent into the aneurysm sac.

SummaryEndovascular repair of the thoracic aorta isnot without risk. Some problems can beanticipated and avoided while others mayrequire emergency correction by eitherendovascular or open surgical techniques.Good imaging, planning and familiaritywith the endovascular device are importantin reducing complications.

REFERENCES

Gotway MB, Dawn SK. Thoracic aorta imaging with multislice CT. Radiologic Clinics ofNorth America 2003; 41: 521-543Greenberg RK, Secor JL, Painter T. Computer tomography assessment of thoracic aorticpathology. Seminars in Vascular Surgery. 2004; 17: 166-72Bell R, Taylor P. Open procedures to acquire aortic access for endoluminal grafting In:Branchereau A, Jacobs M Eds. Hybrid Vascular Procedures. Oxford. Blackwell PublishingLtd; 2004:107-113 Nienaber CA, Kische S, Renders TC et al. Rapid pacing for better placement: comparison oftechniques for precise deployment of endografts in the thoracic aorta. J Endovasc Ther 2007;14: 506-12Muhs BE, Balm R, White GH et al. Anatomic factors associated with acute endograft col-lapse after Gore TAG treatment of thoracic aortic dissection or traumatic rupture. J VascSurg 2007; 45: 655-61Rodd CD, Desigan S, Hamady MS et al. Salvage options after stent collapse in the thoracicaorta. J Vasc Surg 2007; 46; 780-5Bell R, Taylor P. Endovascular and hybrid procedures for aortic arch aneurysms. In:Branchereau A, Jacobs M Eds. Vascular Procedures in the Elderly Patient. Oxford. ParisConsultants Ltd. 2006:57-64Melissano G, Bertoglio L, Civilini E et al. Results of thoracic endovascular grafting in dif-ferent aortic segments. J Endovasc Ther 2007; 14: 150-7Eggebrecht H, Nienaber CA, Neuhauser M, Baumgart D, Kische S, Schmermund A et al.Endovascular stent-graft placement in aortic dissection: a meta-analysis. Eur Heart J 2006;27 (4): 489-98Eggebrecht J, Thompson MM, Rousseau H, Czerny M, Lonn L, Metha RH et al. Retrogradeascending aortic dissection during or after thoracic aortic stent graft placement. Circulation2009; 120: S276-81.Mossop PJ, McLachlan CS, Amutkotuwa SA et al. Staged endovascular treatment for com-plicated type B aortic dissection. Natl Clin Pract Cardiovasc Med 2005; 2: 316-321

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Despite the different advances and animproved understanding of Spinal cord(SC) anatomy and pathogenesis of SCischemia, debilitating postoperative para-paresis or paraplegia rate are still not negli-gible after open and endovascular proce-dure for thoracic or thoracoabdominalpathology treatment.

Single study have demonstrated the role ofdifferent anatomical variables in the patho-genesis of SCI, most of them related to SCvascular supply.

Knowledge of the spinal cord (SC) vascularsupply is important in patients undergoingprocedures that involve the thoracic andthoraco-abdominal aorta. However, the SCvasculature has a complex anatomy, andteaching is often based only on anatomicalsketches with highly variable accuracy; his-torically, this has required a “leap of faith”on the part of aortic surgeons.

Fortunately, this “leap of faith” is no longernecessary given recent breakthroughs inimaging technologies and post-processingsoftware. Imaging methods have expandedthe non-invasive diagnostic ability to deter-mine a patient’s spinal cord vascular pat-tern, particularly in detecting the presenceand location of the artery of Adamkiewicz.

CT is the imaging modality of choice formost patients with thoracic and thoraco-abdominal aortic disease, proving especially

useful in the determination of feasibility andplanning of endovascular treatment: thusthe data set required for our analysis ofspinal cord vascular anatomy is alreadyavailable. We have concentrated our effortson CT angiography, which offers particular-ly excellent imaging capabilities with state-of-the-art multidetector scanners.

Knowledge of the principal anatomical fea-tures of the SC blood supply of individualpatients undergoing open or endovascularthoraco-abdominal procedures has severalpotential benefits.

For open surgery, analysis of the SC vascu-lature could tell us the aortic region thatfeeds the Adamkiewicz artery and thusneeds to be reimplanted. For endovascularprocedures, we can determine whether thestent graft will cover the Adamkiewiczartery, thus avoiding unnecessary coverage.CT data can also be used to stratify risk ofspinal cord ischemia and guide the selectiveuse of spinal cord injury prevention strate-gies.

Melissano, G.; Bertoglio, L.; Civilini, E.; Tshomba, Y.; Rinaldi, E.; Mascia, D.; Chiesa, R.


Spinal cord anatomy imaging.Is it useful for thoraco-abdominalaneurysm repair?

Clough, R.*; Taylor, P.**

*NIHR BRC Clinical Training Fellow. **Professor of Vascular Surgery Department of Vascular Surgery. NIHR Comprehensive Biomedical Research Centre of Guy’s andSt Thomas’ NHS Foundation Trust and King’s College London, and King’s Health Partners

Treatment of neurologicalcomplications in thoracic stentgrafting

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IntroductionEndovascular repair is now considered to bethe first option to treat many thoracic aorticpathologies in spite of limited evidence forits use1,2. There are no randomised con-trolled trials comparing endovascular withopen surgery for thoracic aortic interven-tion. The current evidence base is from reg-istries and large cohort studies which showreduced mortality and morbidity rates whencompared to conventional open surgical re-pair3,4. Endovascular thoracic repair is asso-ciated with neurological complications suchas stroke and paraplegia each affecting up to10% of patients5-11. This chapter looks at thetreatment of patients with stroke and para-plegia during endovascular thoracic aorticprocedures.

Treatment of strokeStroke is a devastating complication of tho-racic endovascular aortic repair and is themajor cause of death from endovascularthoracic aortic repair in our experience. Allthe strokes are due to infarction and noneare secondary to cerebral haemorrhage.Excessive drainage of cerebrospinal fluidused to treat paraplegia after thoracic en-dovascular repair can cause subdural haem-orrhage so care must be taken not to drainmore than 20-30ml of CSF per hour. Thefirst manifestation of an intraoperativestroke is a sudden unexplained increase inblood pressure which is the body’s physio-logical response to an ischaemic cerebral in-sult. Magnetic resonance diffusion-weighted

and CT perfusion imaging can identify theischaemic penumbra, which is an area of re-versible ischaemia surrounding the cerebralinfarct12,13. Acute neurological degenerationdescribes the increase in the size of the cere-bral infarction due to the non-viability ofthe penumbra14. Clearly elevation of bloodpressure is a useful response to cerebral is-chaemia which helps to perfuse the penum-bra and therefore it should not be treatedaggressively with hypotensive medication.Early revascularisation of this area may helpto reduce the size of the infarct and reducethe neurological deficit.

Cerebral angiography may not show anydeficit in the cerebral circulation in whichcase treatment can only be supportive. Thisincludes tight control of the blood glucose,prophylaxis for thromboembolic events withcompression stockings and low molecularweight heparin, hydration with intravenousfluids, nutrition via a fine bore nasogastricfeeding tube and urinary catheterisation tomonitor the urine output. Early assessmentof the neurological deficit and appropriatetreatment includes physiotherapy, speechtherapy, occupational therapy, psychologyand psychiatry.

However if the cerebral angiogram showsocclusion of the middle cerebral artery thennew techniques are available to revascularisethe ischaemic penumbra in the acute sce-nario. Chemical thrombectomy can beachieved with either intravenous (iv) or

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catheter-directed recombinant tissue plas-minogen activator (tPA)1 5 , 1 6. In thePROACT II trial complete flow in the mid-dle cerebral artery was restored in 66% ofpatients17. However in the perioperative sit-uation thrombolysis increases the risk ofbleeding from the surgical wounds. Newdevices are approved which mechanically re-move thrombus and restore arterial patencywhich require full heparinsation. These in-clude the Merci retriever, which acts like acorkscrew to remove thrombus, and thePenumbra aspiration catheter where a prox-imal olive is used to physically draw thethrombus back into a catheter which hascontinuous negative pressure to aspirate thedebris. Both of these techniques can restorevessel patency in up to 80% of patients18,19.However these devices can only be used forthe middle cerebral artery, so catheter di-rected thrombolysis may need to be used inconjunction with these techniques to opensmaller distal arteries. Some encouragingcase reports of immediate treatment of em-bolic stroke have shown excellent clinicalimprovement. However, larger studieshave shown that although arterial patencycan be restored the clinical results havebeen disappointing. This may be related tothe length of time taken to revascularise theischaemic tissue. The necessary neuroradio-logical expertise required to perform thesehighly skilled procedures may not be imme-diately available on site.

If the patient has had deliberate occlusionof the left subclavian artery by the devicewith no revascularisation procedure, thenconsideration can be given to performingan urgent carotid subclavian bypass if thepatient has a stroke. In our series the high-est incidence of stroke was in patients whohad this clinical scenario. Prevention ismuch better than cure and we now have avery low threshold for performing prophy-lactic carotid subclavian bypass in patientswho have planned occlusion of the left sub-clavian artery by the device. Clearly right toleft carotid carotid bypass should be per-formed with deliberate occlusion of the ori-gin of the left common carotid artery.Likewise, revascularisation from the ascend-

ing aorta is necessary if all of the arch ves-sels are deliberately covered. Prophylacticcarotid endarterectomy can be performed ifthere are bilateral severe carotid stenoses,but there is no evidence to support thiscourse of action.

Survivors of stroke frequently have longterm disabilities which require extensive in-patient rehabilitation and continued long-term support when they return home.

Treatment of paraplegiaThe incidence of spinal cord ischaemia dur-ing thoracic endovascular repair is reportedto range from 0-10% with a figure ofaround 5% for larger series1o,11, 20-25. In pa-tients with aneurysms, the Gore Tag pivotaltrial reported an incidence of 3% in a seriesof 139 patients and the clinical trial for theTX2 device showed an overall incidence of6%5,6. Others have demonstrated an inci-dence of 4% in a series of 326 with mixedpathology and in the EUROSTAR Registrythe incidence was 2.5% and was increasedfour-fold with coverage of the left subcla-vian artery7,21.

Co-existing infra-renal pathology or a previ-ous aortic repair may reduce a substantialproportion of the collateral network supply-ing the spinal cord and increases the risk ofparaplegia with thoracic endovascular re-pair. The contribution of the internal iliacartery to the distal spinal cord may be im-portant and angioplasty of ostial stenosesmay permanently reverse paraplegia2 5.Longer endoluminal devices occlude moreintercostal arteries and have been shown tobe associated with an increased incidence ofparaplegia26,27.

It is very important that a CSF drain is in-serted immediately when the diagnosis ofparaplegia is made. No delay should occurfor imaging to try to confirm the diagnosisas this inevitably increases the duration ofischaemia to the spinal cord and may con-vert a potentially reversible deficit into apermanent one. The beneficial effect of re-ducing CSF pressure far outweighs the un-certainty of the underlying pathology. The

R. Clough et al.- Treatment of neurological complications in thoracic stent grafting


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CSF drain should be kept at 12 cm of wa-ter/saline above the spinal column and nomore than 20-30 ml of CSF should bedrained per hour as the risk of subduralhaemorrhage increases with excessivedrainage. The drain should be clamped ifthis volume is exceeded and released thenext hour. If the neurological deficit is notreversed with this protocol the systemicpressure can be elevated and the CSF pres-sure reduced to 10cm of saline. There is noclinical benefit in reducing the CSF pres-sure below this level. The drain is kept infor 3 days after which it is clamped for fourhours. If the neurological deficit continuesto be reversed at this time the drain is re-moved. Recurrence of paraplegia on clamp-ing suggests that the perfusion of the cordis inadequate. Angioplasty of any stenosis ofthe internal iliac or subclavian arteriesshould be undertaken and carotid subcla-vian bypass can be performed if the left sub-clavian is deliberately covered withoutrevascularisation. Failure of the spinal drainto reverse paraplegia despite adequate sys-temic blood pressure suggests that the drainis not therapeutic and it should be removedto avoid complications such as infection anddural fistula.

Permanent paraplegia requires a prolongedstay in a neurorehabilitation centre.Physiotherapy to build upper limb strengthto enable wheelchair use should be com-menced early. Intermittent urinary catheter-isation may be required but some patientsrequire permanent urinary catheters whichcan be placed suprapubically ortransurethrally. In the long term patientsusually find that they can control their bow-el movements, but a permanent colostomycan help some patients. Building work tomake their home suitable for wheelchair ac-cess may need to be undertaken, and somewill require to be rehoused. The long termprognosis for patients suffering permanentparaplegia following thoracic endograftingis poor.

SummaryNeurological complications of thoracic en-doluminal repair remain an important risk

with an incidence of stroke and paraplegiaeach affecting up to 10% of patients.

Certain patients can be identified who areat high risk of neurological complications.Consideration can then be given to prophy-lactic measures such as revascularisation ofthe left subclavian artery when it is deliber-ately covered, for stroke, and CSF drainagefor paraplegia in patients who require along device and those with a previous in-frarenal repair.

Removal of thrombus from the cerebral cir-culation in patients with stroke improvesthe arterial patency but the clinical resultsremain disappointing and the necessary ra-diological expertise may not be readilyavailable. Cerebrospinal fluid drainage canreverse paraplegia if it is performed as soonas the clinical signs are apparent before anyimaging is undertaken.

Patients with permanent neurologicaldeficits may require long term accommoda-tion in neurorehabilitation centres. Thosepatients who are able to return home willrequire long term support and may neverachieve full independence.

REFERENCES

Cho JS, Haider SE, Makaroun MS. Endovascular therapy ofthoracic aneurysms: Gore TAG trial results. Semin VascSurg. 2006 Mar;19(1):18-24.Fattori R, Nienaber CA, Rousseau H, Beregi JP, Heijmen R,Grabenwoger M, et al. Results of endovascular repair of thethoracic aorta with the Talent Thoracic stent graft: the TalentThoracic Retrospective Registry. J Thorac Cardiovasc Surg.2006 Aug;132(2):332-9.Bavaria JE, Appoo JJ, Makaroun MS, Verter J, Yu ZF,Mitchell RS. Endovascular stent grafting versus open surgi-cal repair of descending thoracic aortic aneurysms in low-risk patients: a multicenter comparative trial. J ThoracCardiovasc Surg. 2007 Feb;133(2):369-77.Makaroun MS, Dillavou ED, Wheatley GH, Cambria RP.Five-year results of endovascular treatment with the GoreTAG device compared with open repair of thoracic aorticaneurysms. J Vasc Surg. 2008 May;47(5):912-8.Makaroun MS, Dillavou ED, Kee ST, Sicard G, Chaikof E,Bavaria J, et al. Endovascular treatment of thoracic aorticaneurysms: results of the phase II multicenter trial of theGORE TAG thoracic endoprosthesis. J Vasc Surg. 2005Jan;41(1):1-9.Matsumura JS, Cambria RP, Dake MD, Moore RD,Svensson LG, Snyder S. International controlled clinical trialof thoracic endovascular aneurysm repair with the ZenithTX2 endovascular graft: 1-year results. J Vasc Surg. 2008Feb;47(2):247-57; discussion 57.Buth J, Harris PL, Hobo R, van Eps R, Cuypers P, Duijm

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REFERENCES

L, et al. Neurologic complications associated with endovas-cular repair of thoracic aortic pathology: Incidence and riskfactors. a study from the European Collaborators onStent/Graft Techniques for Aortic Aneurysm Repair (EU-ROSTAR) registry. J Vasc Surg. 2007 Dec;46(6):1103-10;discussion 10-1.Amabile P, Grisoli D, Giorgi R, Bartoli JM, Piquet P.Incidence and determinants of spinal cord ischaemia in stent-graft repair of the thoracic aorta. Eur J Vasc Endovasc Surg.2008 Apr;35(4):455-61.Dake MD, Miller DC, Mitchell RS, Semba CP, Moore KA,Sakai T. The “first generation” of endovascular stent-graftsfor patients with aneurysms of the descending thoracic aorta.J Thorac Cardiovasc Surg. 1998 Nov;116(5):689-703; dis-cussion -4.Mitchell RS, Miller DC, Dake MD, Semba CP, Moore KA,Sakai T. Thoracic aortic aneurysm repair with an endovascu-lar stent graft: the “first generation”. Ann Thorac Surg. 1999Jun;67(6):1971-4; discussion 9-80.Bergeron P, De Chaumaray T, Gay J, Douillez V.Endovascular treatment of thoracic aortic aneurysms. JCardiovasc Surg (Torino). 2003 Jun;44(3):349-61.Tong DC, Yenari MA, Albers GW, O’Brien M, Marks MP,Moseley ME. Correlation of perfusion- and diffusion-weighted MRI with NIHSS score in acute (<6.5 hour) is-chemic stroke. Neurology. 1998 Apr;50(4):864-70.Murphy BD, Fox AJ, Lee DH, Sahlas DJ, Black SE, HoganMJ, et al. Identification of penumbra and infarct in acute is-chemic stroke using computed tomography perfusion-de-rived blood flow and blood volume measurements. Stroke.2006 Jul;37(7):1771-7.Thanvi B, Treadwell S, Robinson T. Early neurological dete-rioration in acute ischaemic stroke: predictors, mechanismsand management. Postgrad Med J. 2008 Aug;84(994):412-7Tissue plasminogen activator for acute ischemic stroke. TheNational Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med. 1995 Dec14;333(24):1581-7.Barnwell SL, Clark WM, Nguyen TT, O’Neill OR, WynnML, Coull BM. Safety and efficacy of delayed intraarterialurokinase therapy with mechanical clot disruption for throm-boembolic stroke. AJNR Am J Neuroradiol. 1994Nov;15(10):1817-22.

Furlan A, Higashida R, Wechsler L, Gent M, Rowley H,Kase C, et al. Intra-arterial prourokinase for acute ischemicstroke. The PROACT II study: a randomized controlled trial.Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999Dec 1;282(21):2003-11.Smith WS, Sung G, Saver J, Budzik R, Duckwiler G,Liebeskind DS, et al. Mechanical thrombectomy for acute is-chemic stroke: final results of the Multi MERCI trial. Stroke.2008 Apr;39(4):1205-12.The penumbra pivotal stroke trial: safety and effectiveness ofa new generation of mechanical devices for clot removal inintracranial large vessel occlusive disease. Stroke. 2009Aug;40(8):2761-8.Greenberg RK, Lu Q, Roselli EE, Svensson LG, Moon MC,Hernandez AV, et al. Contemporary analysis of descendingthoracic and thoracoabdominal aneurysm repair: a compari-son of endovascular and open techniques. Circulation. 2008Aug 19;118(8):808-17.Feezor RJ, Martin TD, Hess PJ, Jr., Daniels MJ, Beaver TM,Klodell CT, et al. Extent of aortic coverage and incidence ofspinal cord ischemia after thoracic endovascular aneurysmrepair. Ann Thorac Surg. 2008 Dec;86(6):1809-14; discus-sionAxisa BM, Loftus IM, Fishwick G, Spyt T, Bell PR.Endovascular repair of an innominate artery false aneurysmfollowing blunt trauma. J Endovasc Ther. 2000 Jun;7(3):245-50.Bell RE, Reidy JF. Endovascular treatment of thoracic aorticdisease. Heart. 2003 Aug;89(8):823-4.Clough RE, Black SA, Lyons OT, Zayed HA, Bell RE,Carrell T, et al. Is endovascular repair of mycotic aorticaneurysms a durable treatment option? Eur J Vasc EndovascSurg. 2009 Apr;37(4):407-12.Bajwa A, Davis M, Moawad M, Taylor PR. Paraplegia fol-lowing elective endovascular repair of abdominal aorticaneurysm: reversal with cerebrospinal fluid drainag e. Eur JVasc Endovasc Surg. 2008 Jan;35(1):46-8.Matsuda H, Fukuda T, Iritani O, Nakazawa T, Tanaka H,Sasaki H, et al. Spinal cord injury is not negligible afterTEVAR for lower descending aorta. Eur J Vasc EndovascSurg. 2010 Feb;39(2):179-86.Bicknell CD, Riga CV, Wolfe JH. Prevention of paraplegiaduring thoracoabdominal aortic aneurysm repair. Eur J VascEndovasc Surg. 2009 Jun;37(6):654-60.



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PurposeTo assess the pullout force (POF) of bridg-ing stent-grafts in an aortic and iliac branchgraft.

MethodsPOF of Viabahn or Fluency with (Fluen-cy+Zilver) and without a Zilver stent wasmeasured when deployed into a Zenith tho-racoabdominal cuff-bearing stent-graft.POF of Atrium i-Cast, Viabahn, Fluency,and Fluency+Zilver was measured whendeployed into an iliac bifurcated graft. Atleast ten trials were performed for eachstent in air at room temperature.

ResultsThe median POF (standard deviation; datarange) required to dislodge each stent fromthe 6 mm diameter renal branch was: 1.89N (0.33 N; 1.65-2.5 N) for 7 mm diameterViabahn, 1.17 N (0.28 N; 0.68-1.57 N) for7 mm Fluency, and 2.08 N (0.32 N; 1.59-

2.62 N) for 7 mm Fluency with a support-ing 8 mm Zilver stent (p < 0.001). For the8 mm celiac branch, POF was 2.79 N (0.66N; 2.31-4.16 N), 1.74 N (0.14 N; 1.51-1.91 N), and 2.73 N (0.56 N; 1.9-3.61 N)for 9 mm Viabahn, 9 mm Fluency, and 9mm Fluency with a 10 mm Zilver stent,respectively (p<0.001). For the 8 mm inter-nal iliac branch, POF was 3.53 N (0.74 N;2.55-4.72 N) for 9 mm Atrium i-Cast, 3.82N (0.32 N; 3.29-4.45 N) for 9 mmViabahn, 2.32 N (0.29 N; 1.63-2.64 N) for9 mm Fluency, and 2.61 N (0.60 N; 1.65-3.63 N) for 9 mm Fluency with a 10 mmZilver stent (p<0.001).

ConclusionThere are significant differences in POFbetween different stent-grafts.

Key Words: bridging stent-graft, pulloutforce, branched-graft.

Tan, KT; Grenville, J.; TSE, L.; Rajan, D.; Lindsay, T.

Toronto General Hospital, University Toronto.

Bridging stent-graft pullout forceanalysis in branch EVAR

C O M U N I C A C I O N E S O R A L E S S I T E 2 0 1 1

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IntroductionAccurate measurement of native anatomy isrequired to plan devices for fenestratedendovascular aneurysm repair (fEVAR).Measurements are however, subject to interand intra-observer variability, creating thepossibility of errors and thus mismatchbetween the native anatomy and the stent-graft configuration. The aim of this study was to examine theeffect of mismatch between fenestratedstent-grafts and native anatomy on proximalseal.

MethodsA 36mm proximal main-body incorporatingtwo fenestrations and a scallop wasdeployed according to a standard protocolwithin a series of phantoms depicting vis-ceral aorta. One phantom was producedwith perfect alignment between the visceralvessels and fenestrations. Six additionalphantoms were created with incrementalmismatch in both the circumferential (n=3)and longitudinal position of the renal ves-sels (n=3).Qualitative assessment of appositionbetween the seal zone of the phantom andthe stent-graft fabric was made by visual

inspection and radiography. The degree ofstent-graft distortion and misalignment ofthe scallop in relation to the superiormesenteric artery (SMA) as a result of stent-graft/phantom mismatch was also assessed.

ResultsFabric to lumen apposition (seal) was main-tained in all phantoms. A circumferentialdiscrepancy of 30 degrees did not result inscallop misalignment. Partial SMA shutter-ing was observed with a 45 degree and adiscrepancy of 60 degrees resulted in com-plete shuttering with partial shuttering ofthe renal arteries. Attempts to correct shut-tering of the SMA with a balloon expand-able stent resulted in partial crushing of thestent. In the longitudinal direction, discrep-ancies in vessel separation between -5 and8mm were tolerated without compromisingtarget vessel patency.

ConclusionsFenestrated stent-grafts appear to tolerateconsiderable mismatch with aortic anatomywithout compromising seal. Additional fac-tors such as the effect of mismatch upondeployment and durability of target-vesselstents merit further study.

Oshin, O.***; How, T.**; Brennan, J.*; Fisher, R.*; McWilliams, R*; Vallabhaneni, S R.*

*Royal Liverpool Hospital; **University of Liverpool;****Royal Liverpool Hospital/University of Liverpool

The effect of mismatch betweennative anatomy of visceral aorta anddesign of fenestrated stent-graft

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IntroductionAdvanced endovascular procedures requirea high degree of skill with a long learningcurve. We aimed to identify differentialincreases in endovascular skill acquisition innovices using conventional(CC), manually-steerable(MSC) and robotic endovascularcatheters(RC).

Materials/Methods10 novices cannulated all vessels within aCT-reconstructed pulsatile-flow arch phan-tom in the Simulated Endovascular Suite.Subjects were randomly assigned to con-ventional/manually-steerable/robotic tech-niques as the first procedure undertaken.The operators repeated the task weekly for5 weeks. Quantitative (cannulation times,wire/catheter tip movements, vessel wall-hits) and qualitative metrics (validated rat-ing scale (IC3ST)) were compared.

ResultsSubjects exhibited statistically significantimprovement when comparing initial tofinal performance for total procedure timesand catheter tip movements with all

catheter types. Sequential non-parametriccomparisons identified learning-curveplateau levels at weeks 2 or 3(RCs, MSCs),and at week 4(CCs) for the majority ofmetrics. There were significantly fewercatheter-tip movements using advancedcatheter technology after training (Week 5:CC 74 IQR(59-89) versus MSC 62 (44-81);p=0.028, and RC 33 (28-44); p=0.012). RCs virtually eliminated wall hits atthe arch (CC 29(28-76) versus RC 8(6-9);p= 0.005), and produced significantly high-er overall performance-scores (p<0.02).

ConclusionAdvanced endovascular catheters, althoughmore intricate, do not seem to take longerto master and in some areas offer clearadvantages with regards to positional con-trol, at a faster rate. RCs seem to be themost intuitive and advanced skill acquisi-tion occurs with minimal training. Roboticendovascular technology may have a signifi-cantly shorter path to proficiency allowingan increased number of trainees to attemptmore complex endovascular procedures ear-lier and with a greater degree of safety.

Normahani, P.; Riga, C.V.; Cochennec, F.; Chadha, P..; Hamady, M.;Bicknell, C.D.; Cheshire, N.J.W.

Imperial College London.

Advanced catheter technology:is the answer to overcoming thelong learning curve in complexendovascular procedures?

3728

IntroductionIn-stent re-occlusion is a frequent complica-tion of endovascular stenting, especially inthe superficial femoral artery (SFA). Theoptions to treat in-stent occlusion areendovacular or open surgery intervention.Endovascular treatment is the less invasiveoption, (that means passage through theoccluded stent and re-dilatation the lesion),but in some cases crossing the occludedstent is very difficult. We propose a newtechnique for long in-stent SFA occlusionrecanalization, after antegrade failures.

PurposeA prospective study protocol were proposedon January 2010 and it was approved bythe ethics committee of our hospital. Theobjectives were evaluate the safety andreproducibility of the MAPACE Technique,in cases of long SFA in-stent occlusionrevascularization.

Methods and MaterialFrom January to December 2010, weenrolled all patients whose presented Criti-cal Limb ischemia or claudication intermit-tens, previously underwent to endovasculartreatment and stenting of the SFA. Patientswere hospitalized in our Foot and Ankleclinic and presented at admission with diag-nosis of in-stent occlusion by imagingscreening (Doppler US or Angio-CT), clas-sified as TASC C-D class. By antegrade ipsi-lateral access in a Common Femoral Artery,we positioned a 5F 10 cm sheath and thediagnostic angiography was performed to

confirm the in-stent re-stenosis/occlusion.After several unsuccessful antegradeattempts to engage the occluded stentproximal edge, with patient in supine posi-tion, the ipsilateral Hunter’s channel areawas prepared for puncture and retrogradedirect in-stent puncture performed(“MAPACE” Technique), followed by ret-rogradelly intra-stent wiring and antegradelong balloon angioplasty and haemostasis.

Results18 patients (11 males and 7 females, meanage 74,3 ± 9 years) were enrolled. In 12cases (66,6%) endovascular recanalizationwas reached by antegrade access, crossingthe occluded stent and re-dilatation of thelesion. In 6 cases (33,3%), after severalunsuccessful antegrade attempts to engageand cross the occluded stent, patientsunderwent to “MAPACE” technique. Weobtain the success of the procedure in allpatient treated by MAPACE Technique,without procedural or peri-procedural com-plications, such as haemorrhage, acutethrombosis or distal embolism. There wereno post-procedural complications, such ashaematoma in the in-stent puncture site.

Conclusion“MAPACE” technique is a useful and safetyalternative to treat a very important per-centage of cases with in-stent restenosis/occlusion in SFA, after several failedattempts to engage and cross the occludedstent.

Palena, L.M.; Cester, G.; Manzi, M.

Policlínico Abano Terme.

Endovascular treatment of in-stentstenosis/occlusion: new techniquefor recanalization of long SFAre-stenosis (“MAPACE technique”)

3729

IntroductionPatient-specific simulated rehearsal (PsR) ofa carotid artery stenting procedure (CAS)allows incorporation of patient-specific CTdata into the simulation software, enablingthe interventionalist to rehearse the case onan endovascular simulator prior to the pro-cedure on the actual patient. This studyaimed to evaluate whether PsR of a CASprocedure can enhance the operative per-formance compared to a virtual reality (VR)generic CAS warm-up procedure or nopreparation at all.

Material and MethodsParticipants were trained in CAS during a10 session cognitive and technical VRcourse. Thereafter, in a randomizedcrossover study, each participant performeda patient-specific CAS case 3 times on thesimulator, preceded by 3 different tasks: aPsR, a generic VR case or no preparation atall (control). Technical performances wereassessed using simulator-based dexteritymetrics and expert-based video ratingsusing generic endovascular and procedurespecific rating scales for CAS.

ResultsTwenty junior residents (surgery, cardiolo-gy, radiology) were recruited. Trainingplateaus were observed after 10 sessions forall participants. PsR was significantly betterthan generic warm-up and no warm-up fortotal procedure time (16.3±0.6 vs.19.7±1.0 vs. 20.9±1.1 min, p=0.001) andfluoroscopy time (9.3±0.1 vs. 11.2±0.6 vs.11.2±0.5 min, p=0.022) but did not influ-ence the amount of contrast volume or thenumber of roadmaps used during the ‘real’case. PsR was significantly better at enhanc-ing the quality of the CAS performance asmeasured by the expert-based ratings (score28 vs. 25 vs.25, p=0.020).

ConclusionsPatient-specific simulated rehearsal of aCAS procedure significantly improves theoperative performance, compared to ageneric VR warm-up or no warm-up at all.This technology may improve outcome andreduce complications for patients undergo-ing CAS in the clinical setting.

Willaert, W.*; Aggarwal, R.**; Van Herzeele, I.*; Vermassen, F.*;Cheshire, N.**

*Ghent University Hospital; **Imperial College London, St. Mary’s Hospital, London.

Simulated patient-specific rehearsalis more effective in preparinginterventionalists for the carotidartery stenting procedure than apreoperative generic warm-up

3730

ObjetivoComparar la efectividad de la revasculariza-ción en pacientes en isquemia crítica some-tidos a procedimientos quirúrgicos distalesabiertos (by-pass distal ) o endovasculares(angioplastia con o sin stent) en función delangiosoma reperfundido.

Pacientes y métodosEstudio retrospectivo 2006-2009 de 106pacientes con isquemia crítica con pulso po-plíteo sin distales, tratada mediante procedi-miento quirúrgico o endovascular. Edadmedia 73,93 (35-90), Varon:Mujer: 3:1.88% de diabéticos. 58% de fumadores. 16%de pacientes en insuficiencia renal crónica.

Se seleccionaron finalmente 92 casos de is-quemia grado 5 ó 6 Rutherford clasificadossegún el angiosoma lesionado que fue: TA(40), TP (42) y peronea (10).

Los procedimientos fueron codificados co-mo “revascularización directa” (RD) si elvaso tratado perfundía el angiosoma lesio-nado y como ”revascularización indirecta”(RI) si correspondía a otro angiosoma. Secomparó la tasa de salvación de extremidaden función del vaso diana y el procedimien-to. También se estudio la tasa de cicatriza-ción de amputación menor.

ResultadosSeguimiento medio 18,63 meses (3-39). Seregistraron 52 angioplastias distales y 40 ci-rugías de by-pass distal. 50 casos de RD y42 casos de RI con una tasa de salvamientode extremidad de 85% frente a 55%(p<0,01). No hubo diferencias de salvaciónde extremidad entre procedimientos quirúr-gicos o endovasculares (73% frente a 75%).La revascularización directa consigue lasmismas tasas de salvamiento de extremidadmediante cirugía abierta que Endovascular(85%-85%). En la revascularización indirec-ta el salvamiento de la extremidad mediantetécnica endovascular es del 63% frente a so-lo 44% de la cirugía de by-pass ( no sig.)También se analizan los resultados en cuan-to a la cicatrización efectiva de las heri-das/amputación menor siendo mejor la tasade curación de heridas en RD.

ConclusionesLa revascularización del angiosoma específi-co sobre el que asienta la lesión isquémicase asocia a una menor tasa de amputación.Los procedimientos endovasculares ofrecenresultados de salvamento de extremidadcomparables con los procedimientos quirúr-gicos. En caso de no poder hacer una revas-cularización directa la cirugía endovascularofrece mayores tasas de salvamiento de laextremidad.

Linares Palomino, J.P.**; Asensio Garcia, R.*; Vera Arroyo, B.*;Lozano Alonso, S.*; Guillen Fernández, M.*; Ros Díe, E.**

*Hospital Universitario San Cecilio**Hospital Universitario San Cecilio. Universidad de Granada.

Comparación entre cirugía distaly endovascular en la revasculariza-ción de ejes distales en isquemiacrítica en relación al vaso tratadoy al angiosoma lesionado

3731

Introduction

Endovascular stent graft placement has emerged as a minimal-ly invasive alternative to open surgery for the treatment of aor-tic aneurysms and dissections. There are few reports of stentgraft infections and aorto enteric fistula after endovascular tho-racic aortic aneurysm repair; and first multicentric study (Italiansurvey) showed incidence of about 2%.

Case Report

We present you the case of 69 years old, male patient, whowas admitted to our hospital due to dysphagia and chest dis-comfort. By means of chest radiography and MultisliceComputed Tomography (MSCT), posttraumatic thoracicaneurysm of 65 mm in diameter was revealed. Patient wassuccessfully treated by endovascular stent graft implantationusing 12 % of oversize. Postoperative recovery was uneventfuland he was discharged after control MSCT showed completeexclusion of the aneurysm. Nine months later he was admittedto regional hospital with severe chest pain in left hemi thoraxand arm refractory on analgesic therapy. Inflammatory para-meters were normal but thin inflammatory periaortic layer wasevident on CT images. Patient was treated with symptomatictherapy and three weeks later sent to our hospital with same

symptoms and additional haematemesis and inflammatorysyndrome, while blood culture test was positive on CandidaAlbicans. MSCT showed collection between stent graft andesophagus with thin layers of gas. Gastroendoscopy was per-formed, and visible blood jet at the 28th cm from incisive teethwas visualized. Blackmoor sonda was used to control hemor-rhage temporarily. Surgical treatment was performed in collab-oration of two teams (esophageal and vascular surgical team).In condition of partial femoro-femoral extracorporal bypass(ECBP), we performed left thoracotomy through 4th intercostalspace, resection of thoracic aorta and explantation of the stentgraft, followed by in situ reconstruction by using Dacron graft.Follows esophagectomy, midline laparotomy, and omentoplastyof Dacron graft, then nutritive gastrostoma and cervical je-junostoma were constructed.

After almost four weeks of slow respiratory recovery with sev-eral evacuations of 500-1000 ml of pleural effusion (positive onCandida albicans), patient finally developed hemoptisia. ControlMSCT revealed aorto bronchial fistula at the level of proximalanastomosis and left principal bronchus. According to patientgeneral condition we decided to perform endovascular treat-ment with implantation of another aortic cuff of 26 mm and pa-tient respiratory function recovered slowly, as was further gen-eral recovery. He was discharged to regional center

Koncar, I.**; Cvetkovic, S.**; Ilic, N.**; Dragas, M.**; Pesko, P.*; Davidovic, L.**

*Clinic for Oesophageal Surgery, Serbian Clinical Center**Clinic for Vascular and Endovascular Surgery, Serbian Clinical Center

A patient with aortoesophageal and aortobronchial fistula after TEVAR

C H A L L E N G I N G C A S E S S I T E 2 0 1 1

Paciente de 66 años, hipertensión arterial, fibrilación auricularpermanente. Anemia de difícil tratamiento. Disección aguda deaorta tipo A intervenida en 2007 con colocación de tubo valvu-lado de Dacron de 26 mm. Accidentes cerebrovasculares is-quémicos en 2007.

Episodios de dolor torácico de características atípicas. Se lediagnostica disección de aorta torácica descendente tratadacon colocación de prótesis endovascular 32 x 200 mm Relay®

(Bolton), en 01/2010. Por aumento progresivo del diámetroaórtico se realiza colocación de endoprótesis de aorta abdomi-

Espinosa, G.; Grochowicz, L.; Lucena, F.; Alegre, F.; Olavide, I.; Bilbao, I.; Pascual, J.I.

Clinica Universidad de Navarra. Spain

Disección de aorta toraco-abdominal tratada conautotrasplante renal e implante de endoprótesisfenestrada

3732

nal 28 x 16 x 16 mm Talent® (Medtronic), en 03/2010. En esteprocedimiento también se realizó angioplastia + stent 5 x 12mm de arteria renal izquierda.

En el seguimiento clínico se sigue observando fuga persistenteal nivel torácico y periprotésica a nivel abdominal, de difícil lo-calización y con mayor expansión del saco aneurismático. Serealiza estudio Angiográfico y de eco-Doppler intra-vascularque localiza la fuga en nivel de la arteria renal izquierda.También se observa endofuga tipo I en la fijación aórtica de laendoprótesis abdominal. Se realiza implante de cuff aórtico, destent recubierto Advanta® (Atrium) en arteria renal izquierda yse cateteriza la falsa luz con inyección de 20ml de Tissucol®

(Baxter).A pesar de los procedimientos realizados, en el estudio de an-gio-TAC de control se observa persistencia de la fuga del me-dio de contraste e importante derrame pleural bilateral.

La paciente presenta un deterioro físico y debilidad marcada.Anemización leve y progresiva. Se decide implantar endopróte-sis fenestrada excluyendo el riñón izquierdo y consecuente-mente también el origen de la renal derecha.

En 06/2010 se realiza autotrasplante renal derecho en fosa ilí-aca derecha como paso previo a colocación de endoprótesisfenestrada.

Finalmente se implanta endoprótesis fenestrada Relay (Bolton)uniendo la endoprótesis torácica con la endoprótesis abdomi-nal + colocación de stent en inicio del tronco celíaco + emboli-zación de arteria renal izquierda, el 13/07/2010.

La paciente evolucionó de forma favorable y en el angio-TACde control a los seis meses evidenciamos completa exclusióndel falso lumen.

Introduction

The need of re-intervention after endograft implantation occursin up to 35% of cases, regardless of the type of endograft orendoleak. We report 2 cases of sacotomy due to a persistenttype II endoleak.

Material and Methods

In January 2011, we observed two cases of persistent en-doleak. The first 87-year old patient underwent endovascularaneurysm repair about 2 year before by means of a suprarenaldevice (Medtronic Endurant). A CT scan performed in emer-gency revealed a type II endoleak from lumbar arteries, an 8cm abdominal aortic aneurysm and a pelvic haematoma. Thesecond one was a 80-year old male with a previous implanta-tion (2007) of a suprarenal aortic endograft (Medtronic Talent),treated over the years, for a persistent type II endoleak by mul-tiple (4) endovascular procedures, by means of coils and glue.

Both patients were submitted to open conversion with aneuris-mal sac opening, endograft exposure without cross-clampingand suture-ligation of bleeding lumbar vessels and sacrale me-dia within the sac. The endograft sealing was confirmed by theabsence of bleeding from the aortic neck or from iliac arteries.

Results

No postoperative complications were recorded in both patients.At hospital discharge a CT scan confirmed the successful sur-gical approach by absence of endoleak.

Conclusion

Open surgical repair of failed EVAR can be performed in select-ed cases with preservation of the endograft, without worseningmorbitity and mortality also if carried out in patients considered“unfit” for surgery.

Gattuso, R.; Castiglione, A.; Faccenna, F.; Alunno, A.; Felli, Marco M.G.; Venosi, S.

Policlinico Umberto I - "Sapienza" Università di Roma. Italy

Two cases of surgical open conversion withendograft preservation (sacotomy) in patientswith persistent type II endoleak

3733

Ulcerative lesions of the thoracic aorta as a source of thrombusthat produce distal acute ischemia is rare. Embolization ofnon-floating or floating thrombus generated in these lesions isreported in 12% and 75% respectively.

The recommended treatment for these lesions is medical (anti-coagulant, thrombilysis), surgical (thrombectomy, thromboen-darterectomy, prosthetic replacement) with high morbidity orendovascular treatment.

ObjectiveDuring the endovascular treatment of these lesions is easy to

detach the thrombus of the thoracic aorta,for this reason theuse of a distal protection system could be indicated. We present a patient with thoracic aortic ulcers with multipleinjuries and floating thrombus, with two major previous embol-ic events. Male 59 years.Two multiple embolic episodes (Iliac, femoral,popliteal)

CT SCAN: Floating thrombus in the thoracic aorta. Transesophageal echocardiography: Penetrating aortic ulcersand floating thrombus at different levels.

Anticoagulant therapy was performed and a GORE TAG endo-prosthesis was implanted and distal embolization preventionwas performed with a half-open stent in the supraceliac aortaas a filter.

When the stent was removed embolic material was found thathad been detached from the contact with the wire guide(Observed by Transesophageal echocardiography ).

ConclusionFor the treatment of floating thrombus in thoracic aorta, tem-porary placement of a stent as a filter in supraceliac aortaseems a useful technique to prevent distal embolization duringthe implant of a endoprosthesis.

Fernández Noya, J.**; Villaverde Rodríguez, J.*; Serramito Veiga, I.*;Martínez Pérez, M.*; Vega Fernández, Marino, J.*

*Hospital Clínico Universitario; **Hospital Clínico Universitario.

Prevention of distal embolization in the endolu-minal treatment of thoracic aortic lesions

A 76 years old lady, ASA IV, was presented with 6.3cm thora-co-abdominal aortic aneurysm Crawford Type II.

Hybird repair with de-branching followed by TEVAR/EVAR wereexcluded because of the co morbidities and high mortality rateof the procedure. Her TAA Aneurysm was not suitable to bemanaged by branched or fenestrated grafts.

The patient had her multi-layered stent covering the wholeaneurysm and all visceral vessels. 1 day post operatively herduplex scan showed the Aorta is 2.46 in the mid-distal ab-

domen with no obvious aortic sac visualized and no obviousendoleak. She was discharged home on second postoperativeday well. Follow up CTA Aorta showed all the visceral branchesare patent with good flow. Maximum aortic diameter shrunk to4cm.

Multilayered stents may divulge a resolution in such complexthoraco-abdominal aneurysm. Treating the aneurysm sacrather than excluding it may be the future management oppor-tunity.

Hamada, N.; McVeigh, T.; Tawfick, W.; Sultan, S.

Western Vascular Institute, Department of Vascular & Endovascular Surgery, University CollegeHospital, Galway, Ireland

Disruptive Endovascular Technology with Multila-yer Stent as A therapeutic option in the Manage-ment of Thoraco Abdominal Aortic Aneurysm

3734

IntroductionIn emergency, sometimes surgeons have to be creative and touse, not very consensual solutions. Availability of stentgrafts isa frequent limitation for urgent endovascular aortic aneurysmrepair (rEVAR). Moreover, taylored devices are expensive andwaiting time before production may be significant, limiting theiruse in daily practice.

Case presentationThe authors report a case of a 77 year-old Caucasian malewith prior history of multiple laparotomies and abdominal ra-diotherapy due to rectal cancer, presenting at the emergencydepartment with abdominal pain. The Computed TomographyAngiography (CTA) revealed an infra-renal abdominal aorticaneurysm (AAA) with contained rupture and hostile proximalneck anatomy (4 cm in diameter).

An emergent EVAR procedure was performed by combining athoracic (Valiant® Medtronic) and an abdominal bifurcated en-dograft (Endurant® Medtronic). The procedure was uneventfuland the patient was discharged on the 10th post-operative day.There were no clinical complications during follow-up (8months). There were no endoleaks, migration or stengraftfadigue at 1 and 6 months.

DiscussionEmergency situations sometimes require creative solutions. Inthis case a thoracic endograft was used as a proximal cuff toovercome the absence of adequate proximal size of off-the-shelf abdominal endografts, in order to treat a symptomaticAAA. Although sub-optimal, this proved to be an effective solu-tion with satisfactory mid-term results.

Grewal, P.; Chikkanna, G.; Aylwin, C.; D'Souza, R.; Davis, M.; Davies, N.; Hamilton, G.

Royal Free Hampstead NHS Trust

Juxta-renal AAA anatomically difficult for EVAR,Requiring a combined branch and doublefenestrations

IntroductionThe management of ruptured thoracoabdominal aneurysm ischallenging for surgeons due to the high mortality and morbidi-ty associated even after successful complex open repair. Theendovascular alternative in aneurysms that involve visceral andrenal arteries necessitate the use of branched stent-grafts thatare neither practical nor available for use in the emergencysetting. We present a case of a ruptured suprarrenal aneurysmsuccessfully treated by combining “endo-branching chimneys”and a thoracic stent-graft.

CaseA 74 year old woman was transferred to our institution inshock due to the rupture of an aneurysm extending from theceliac axis to the renal arteries. Open surgical repair was con-sidered futile. In the angiography suite a pigtail catheter was

placed percutaneously in the ascending aorta via the righthumeral artery. The celiac axis and the superior mesentericartery were cannulated through and open left axilary acces andsimilarly both renal arteries were cannulated through the leftcommon femoral artery. Four Viabahn (W.L Gore) stent-graftswere serially deployed in all the branches except the right renalartery, in which complete deployment was not technically pos-sible. Next, a Valiant Thoracic (Medtronic) was placed in theaorta via the right femoral artery to exclude the aneurysm.Finally, a mid line laparotomy for hemoperitoneum evacuationwas performed.

The postoperative period was complicated with renal failure,spontaneous spleenic ruptured requiring splenectomy. The pa-tient developed respiratory and urinary tract infection as wellas rectal ulceration with haemorrhage. There follow a slow res-

Gallardo Pedrajas, F.; Caeiro, S.; Franco, F.; Perez Lopez, R.; Cao, I.; Marini, M.); Diaz, M.

CHU A Coruña. Spain

Succesful endovascular treatment of a rupturedsuprarenal aneurysm

3735

piratory but the patient was finally discharge after an overall108 postoperative day. At seven months follow up theaneurysm remains excluded with the visceral and renal endo-branches patent.

ConsiderationFrom the technical point of view the main concern is the com-plete exclusion of the aneurysm without type I endoleaks whilea proper perfusion to the visceral branches is achieved. In thisrespect some aspects deserves attention:• Overlapping..• Length. “• Aneurysm morphology. • Oversizing. • Deployment.

Although it seems a very feasible technique we should alsotake into account that the high standard requirements in thepostoperative support as well as the economic burden associ-ated make reasonable that these procedures be conducted incenters of excellence.

ConclusionsThis case shows how the “off- label” use of an otherwise com-mon endovascular stock allows the successful treatment of in-creasingly more complex aneurysms even those which visceralbranch involvement and rupture. Nevertheless, the experienceis still limited and the uncertainty about the long term out-comes make that we have to await further information to reallyappreciate the role of this technique.

IntroducciónLa reparación quirúrgica de los aneurismas tóraco-abdomi-nales presenta altos índices de morbimoratlidad perioperatoria.Esta situación se agrava en caso de precisarse reinterven-ciones o en pacientes de alto riesgo quirúrgico. El tratamientode esta patología mediante prótesis preformadas con ramaspuede ser una alternativa válida y segura en este tipo de pa-cientes.

Objetivos y MétodosPresentar un caso de tratamiento endovascular con ramas co-mo alternativa a tratamiento quirúrgico en paciente joven conhistoria de múltiples reintervenciones por enfermedad aórticadegenerativa polianeurismática, con implicación de ramas vis-cerales en el episodio actual.

Resumen del CasoPaciente varón de 45 años de raza negra sin antecedentesmédicos de interés, diagnosticado de aneurisma de arteriasubclavia izquierda y aorta torácica-abdominal tipo I deCrawford, con screening negativo para enfermedades delcolágeno. Fué tratado en Abril de 2000 realizándose derivación

carótido-subclavia y exclusión de aneurisma torácico medianteendoprótesis, enrasada en D2. Se precisó canulación iliacaizquierda mediante prótesis de Dacron para la introducción deldispositivo. A los 3 meses, en un segundo tiempo, se realizóinterposición de injerto protésico tóraco-abdominal con anasto-mosis distal en pico de flauta englobando todas las arteriasviscerales, más revascularización de 2 intercostales medianteextensión protésica. Dicha intervención se realizó bajó circu-lación extracorporación con canulación a través de vasosfemorales derechos. La evolución postoperatoria fue satisfac-toria, dándose al paciente de alta a los 9 días de la interven-ción.

El paciente mantuvo seguimiento en consultas externas concontrol angiográfico mediante TC anual. A los nueve años deseguimiento es diagnosticado de degeneración aneurismáticaen zona anastomótica distal de 54 mm de diámetro mayor conimplicación de todos los troncos viscerales y aorta infrarenal li-bre de enfermedad, decidiéndose actitud expectante. Se solic-itó nuevo control mediante angioTC a los 6 meses, objetiván-dose crecimiento del saco aneurismático de 10 mm, por lo quese propone al paciente para intervención.

Rodríguez Carvajal, R.; Cruz Guzman, L.; Flores Ramírez, C.; Navarro Méndez, J.M.;Mestres Alomar, G.; Garcia Madrid, C.; Riambau Alonso, V.

Hospital Clínic de Barcelona. Spain

Tratamiento endovascular con ramas comoúltimo paso en paciente con aneurismatoraco-abdominal secundario a polianeurismosisdegenerativa

3736

Como tratamiento de elección, se optó por exclusión de la de-generación aneurismática distal mediante endoprótesis prefor-mada con ramas.

Como primer paso, se realizó un test de oclusión del TroncoCelíaco que confirmó la presencia de circulación retrógradaprocedente de la arteria Mesentérica superior, permitiendo laembolización del mismo con el fin de evitar endofugas tipo II.Se indicó colocación perioperatoria de drenaje de líquido ce-faloraquídeo como sistema de protección espinal. Medianteacceso quirúrgico femoral izquierdo y axilar derecho, se im-plantó la endoprótesis preformada revascularizando mesen-térica superior y ambas renales utilizando stents recubiertoscon refuerzo posterior mediante stents convencionales autoex-pandibles.

Con control angiográfico satisfactorio y excelente evoluciónpostoperatoria, el paciente fue dado de alta a los 4 días de laintervención.

ConclusiónLos resultados de la reparación endovascular con prótesis pre-formadas con ramas en aneurismas tóraco-abdominales sonexcelentes a corto plazo en la literatura, reduciendo de formasignificativa el impacto quirúrgico en los pacientes comparadocon la cirugía abierta. Esta técnica puede ser de elección enpacientes con alto riesgo quirúrgico o procedimientos quirúrgi-cos previos que aumenten el riesgo ante la necesidad denuevas reintervenciones. A pesar de todo, aún no se disponede evidencia sobre la durabilidad y viabilidad de estos proced-imientos a largo plazo.

Introduction

In emergency, sometimes surgeons have to be creative and touse, not very consensual solutions. Availability of stentgrafts isa frequent limitation for urgent endovascular aortic aneurysmrepair (rEVAR). Moreover, taylored devices are expensive andwaiting time before production may be significant, limiting theiruse in daily practice.

Case Presentation

The authors report a case of a 77 year-old Caucasian malewith prior history of multiple laparotomies and abdominal ra-diotherapy due to rectal cancer, presenting at the emergencydepartment with abdominal pain. The Computed TomographyAngiography (CTA) revealed an infra-renal abdominal aorticaneurysm (AAA) with contained rupture and hostile proximalneck anatomy (4 cm in diameter).

An emergent EVAR procedure was performed by combining athoracic (Valiant® Medtronic) and an abdominal bifurcated en-dograft (Endurant® Medtronic). The procedure was uneventfuland the patient was discharged on the 10th post-operative day.There were no clinical complications during follow-up (8months). There were no endoleaks, migration or stengraftfadigue at 1 and 6 months.

Discussion

Emergency situations sometimes require creative solutions. Inthis case a thoracic endograft was used as a proximal cuff toovercome the absence of adequate proximal size of off-the-shelf abdominal endografts, in order to treat a symptomaticAAA. Although sub-optimal, this proved to be an effective solu-tion with satisfactory mid-term results.

Alves, G.; Vasconcelos, L.; Gonçalves, F.; Rodrigues, H.; Ferreira, M.; Castro, J.;Capitão, L.

Hospital Santa Marta

Challenging rEVAR

3737

Objective

To describe an unusual sequence of catastrophic complicationsafter endovascular repair of an abdominal aortic aneurysm in ayoung patient.

Methods & Results

A 51-year-old man presented in extremis with severe bilaterallower limb ischaemia due to thrombosis of a bifurcated endo-graft (Endurant). This had been implanted 4 months earlier atanother unit. The patient, being sexually active, had opted foran endovascular approach to minimize post-operative erectiledysfunction. Plain x-ray showed the left limb of the endograftto be kinked. He underwent thrombectomy, restoration of theright limb flow and fem-fem crossover Dacron bypass. After astormy spell in ICU, he gradually improved with moderate rightfoot drop due to prolonged ischaemia. Unfortunately, the

Dacron graft became infected, he suffered anastomotic haem-orrhage and the prosthesis had to be removed. Recanalizationof the occluded left iliac limb had been achieved this time andthe problem area was relined with an Excluder limb. Bothfemoral arteriotomies had been closed with vein patches.Unfortunately, numerous bleeding episodes followed from bothgroins necessitating exclusion and obturator bypass from theexternal iliac to the distal superficial femoral artery. He was fi-nally discharged home after 3 months and several procedures.He remains well 10 months later.

Conclusions

Although minimally invasive, endovascular repair is still a majorprocedure with potentially serious complications both in theshort and in the long-term. This should be borne in mind whenoffering the repair to relatively young patients.

Karkos, C.; Karamanos, D.; Papadimitriou, D.; Giagtzidis, I.; Kalogirou, T.;Gerasimidis, T.

Hippocrateion General Hospital,Aristotle University of Thessaloniki,Greece

The "dark side" of endovascular abdominalaortic aneurysm repair

Introduction

In last decade, high number of interventional procedures forthe treatment of cardiovascular diseases was associated to agrowing rate of vascular access complications, especially inthe femoral discrict.

Endovascular management of this complications by using stentgraft can be a valid alternative to surgery in high-risk patientsfor general or local conditions.

Objectives

Aim of our study is to demonstrate feasibility and safety ofViabahn-assisted exclusion of iatrogenic femoral pseudoa-neurysms in presence of well-defined demographic andanatomical conditions.

Material used

From January 2008 to January 2010 we observed in our insti-

Accrocca, F.; Siani, A.; Antonelli, R.; Giordano, A.; Marcucci, G.

S.Paolo Hospital

Initial experience in Viabahn-assisted exclusionof iatrogenic femoral pseudoaneurism

3738

tute 7 patients (mean age 81.3) presenting femoral pseudoa-neurysms, post-catheterization in 6 cases and post-surgery inone case. In four cases pseudoaneurysm involved commonfemoral artery and in three cases superficial femoral artery wasdilated. Mean pseudoaneurysm sac diameter was 2.9 cm.Patients were all asymptomatic but a patient suffering forfemoral groin infection. We deployed 7 Viabahn stent grafts atlevel of the origin of femoral pseudoaneurysm, accurately pre-serving patency of deep femoral artery in all cases.

Methodology usedWe retrospectevely analyzed the results of our not randomizedseries of patients.

Results of the studyA technical succes was achieved in all cases, with a completeexclusion of femoral pseudoaneurysms in all cases. In one case

we observed a leg ischaemia due to an acute occlusion ofstent-graft and an open repair and removal of stent graft wascarried out with restoration of blood flow.

At one month follow-up stent grafts were all patent with a sig-nificative reduction of sac diameter. No rupture of femoralpseudoaneurysms was observed and symptomatic patientshowed a progressive disappearance of groin infection.

Conclusions of the studyViabahn-assisted exclusion can be a minimally invasive alter-native in the treatment of femoral pseudoaneurysms. This op-tion still remains helpful in old high-risk patients and inpseudoaneurysms originating from common femoral or superfi-cial femoral artery, with care in preserving patency of the deepfemoral artery.

Los pseudoaneurismas de arteria poplítea tras artroscopia derodilla son extremadamente raros, suponen un cuadro de difícilresolución en el momento agudo, añadiendo un problemagrave a unos pacientes que suelen tener las arterias sanas ysin patología vascular previa. El manejo quirúrgico precisaabordar una zona de la arteria poplítea de difícil acceso, salvoen decúbito prono, con una rotura arterial y un gran hematomaasociado o ligar la arteria poplítea proximal y distal a la lesión yposteriormente revascularizar mediante un by-pass, la existen-cia de una fístula arteriovenosa (FAV) dificulta todavía más lasolución.

El tratamiento endovascular es una alternativa sugerente conpocas reseñas en la literatura. Presentamos nuestra experien-cia con dos casos de pseudoaneurisma de arteria poplítea anivel de 2ª porción tras meniscectomia artroscópica tratadosde forma endovascular.

Material y métodos: Analizamos el manejo de dos pacientescon pseudoaneurisma de arteria poplítea tras meniscectomiapor artroscopia. Mujer de 44 años con obesidad mórbida y quea los 10 días de la intervención acude a nuestro hospital poruna tumoración pulsátil en hueco popliteo de 47x45 mm. dediámetro asociada a thrill y disnea de pequeños esfuerzos, elíndice tobillo/brazo es de 0’67, se observa la existencia de una(FAV) de alto flujo.

Varón de 59 años que no es trasladado de otro hospital a los 4días de intervenirse de menisco con un gran hematoma enmuslo y pantorrilla y un pseudoaneurisma de 57x56mm. dediámetro. En ambos se les colocó un stent de nitinol forrado dePTFE (Viabahn®) de 6x100 mm. y de 6x50 mm. respectiva-mente.

Resultados: Se consiguió la exclusión del pseudoaneurismaen ambos casos así como el cierre de la (FAV) cediendo la dis-nea. El otro paciente preciso la realización de fasciotomías yevacuación del hematoma. No hubo complicaciones ulteriores,estando permeables ambas reparaciones y asintomáticos a los14 y 8 meses.

La dificultad de canalización con la guía de la porción distal dela arteria poplítea en el caso de la (FAV) tras múltiples intentospor el alto flujo, fue solventada con el abordaje de la arteria pe-dia a través de la que se pasó una guía de 0’014” que fuecazada con un lazo.

Conclusiones: Los stents de nitinol forrados tipo (Viabahn®)son una alternativa eficaz para tratar las complicaciones ia-trogénicas de la arteria poplítea. La canalización retrógada yposterior lazado de la guía permite solventar la dificultad deatravesar la lesión de forma anterógrada.

Adeba Vallina, E.; Garcia de la Torre, A.; Garcia Pandavenes, M.; DominguezFolgado, R.; Fernandez Fernandez, M.; Alvarez García, L.; González Gay, M.

Hospital Universitario Central de Asturias HUCA

Tratamiento endovascular de lospseudoaneurismas iatrogénicos postartroscopia de arteria poplítea

3739

Introducción

El tratamiento endovascular del pie y de las arterias tibialestiene, actualmente, una reconocida y significativa utilidad. Enlos utimos aos el numero de tratamientos destinados al sal-vataje de la pierna y del pie, en particular en pacientes diabeti-cos, aumenta continuamente.

En casos seleccionados, el tratamiento endovascular del piepuede ser muy dificultoso, debido a la presencia de calcifica-ciones vasculares, que limitan y reducen las opciones tecni-cas.En estos casos, los caminos convencionales para revascu-larizar el pie y las arterias tibiales, pueden no ser practicablesy el encontrar rutas alternativas puede ser la unica solución.

Caso

Mujer de 56 aos, con diagnosis de Critical Limb Ischemia yarteriopatia obstructiva cronica, con vasos calcificados. Unprimer intento de revascularisación endovascular habia sidoineficaz.

La paciente presentaba diabetes de tipo I, dislipidemia y car-diopatia isquemica, como factores de riesgo.

La concentración de oxígeno transcutanea (TcpO2) a nivel delpie era de 13 mmhg y lesion III C seg. TUC a nivel del I dedo yel resultado de amputación del IV y V dedo.

El estudio angiográfico, precedente al tratamiento, demostrabaestenosis múltiples de la arteria femoral superficial y de la ar-teria poplitea. A nivel de la trifurcación tibial resultaba perme-able solo la arteria tibial posterior, la arteria interosea pre-sentaba múltiples estenosis, la arteria tibial anterior estaba ob-struida. A nivel del pie era permeable la arteria plantar medialy ramos tarsales.

Durante el tratamineto se cateterizó la arteria interosea y atraves de un ramo perforante profundo se cateterizó la arcadaprofunda (que conecta la arteria plantar medial con un ramotarsal dorsal) y desde allì se cateterizó en forma retrograda laarteria tibial anterior. Al final del intervento resultaban perme-ables la tres arterias tibiales y la arcada profunda, desde lacual originaba un ramo tarsal que llegaba al LOOP y revascu-larizaba las arterias digitales.

Comentarios

Se trata de un caso complejo, que se presentaba con vasosmuy calcificados y con el resto de una guìa a nivel del originde la arteria pedidia, como resultado de un intervento anterior.Se trataba de un verdadero intervento de salvataje del pie.

Es un caso didactico, que pone en evidencia la existencia decaminos alternativos para la revascularisación del pie y de lapierna, y la posibilidad de cateterizarlos y dilatarlos, aumen-tando el flujo de sangre al pie y a los dedos. Durante el pro-cedimiento se combinaron distintas tecnicas, útiles a la revas-cularisación extrema. Se obtuvo un resultato excelente, conpermeabilidad de todas las arterias tibiales y excelente flujopara el pie y los dedos.

Conclusiones

En casos de revascularisación extrema, es posible cateterizarla arca profunda del pie, sea para revascularizar en formaretrógrada, un vaso tibial, sea para revascularizar el pie, per-mitiendo de aumentar el flujo de sangre hacia el LOOP y losdedos, a traves de caminos secundarios.

Palena, L.; Cester, G.; Manzi, M.

Policlinico Abano Terme.

Revascularisación Endovascular del Pie y de lasArterias Tibiales a Traves de Caminos Alternati-vos, Utilizando la arcada Profunda del Pie

3740

CASO PROBLEMA: Paciente de 24 años que sufre herida in-cisa por arma blanca en cara anterior de pierna derecha que,tras 22 días de evolución, presenta dolor a nivel gemelar condesarrollo de masa hiperpulsatil. Se realizan ecodoppler yAngioTAC que confirma la existencia de pseudoaneurisma(PSA) de grandes dimensiones (5 cm) en origen de arteria per-onea.

INTRODUCCIÓN: No existen muchos casos publicados sobre eltratamiento adecuado para la resolución de traumatismos vas-culares que producen pseudoaneurismas de troncos distalesde miembros inferiores.

OBJETIVOS: Comunicar un caso complicado de traumatismovascular con intento de resolución endovascular y el desenlacefinal en cirugía abierta para la reparación completa.

MATERIAL UTILIZADOS: Embolización parcial con coils dediferentes diámetros en saco aneurismático.

MÉTODOS UTILIZADOS: Se realizó arteriografía diagnóstica yterapéutica con intento de embolización del PSA con múltiplescoils sin que se consiguiera la trombosis completa del mismo.En ecodoppler de control a las 24 horas se aprecia el PSA de-pendiente de la arteria peronea de 5 cm permeable con coils

en su interior y colección hemática intramuscular por posiblerotura del mismo.

RESULTADOS DEL ESTUDIO: Ante el fracaso del procedimien-to endovascular se decidió cirugía con abordaje de 3ª porciónpoplítea y control del tronco tibioperoneo, procediéndose a laapertura del PSA con evacuación de abundante trombo, restoshemáticos y diez coils metálicos, apreciándose punto san-grante en cara posterior de la bifurcación del tronco tibiopero-neo en origen de la arteria peronea que se suturó con puntossueltos de monofilamento del 6/0. Fue dado de alta en 8 díascon pulsos distales conservados en MID y sin clínica de sín-drome de ciático poplíteo externo CPE habiendo iniciado ladeambulación.

CONCLUSIONES DEL ESTUDIO: Consideramos que la cirugíaabierta sigue siendo la técnica de elección para reparar le-siones traumáticas de las arterias distales de miembros inferi-ores y, en ocasiones, es una técnica de rescate ante el fracasode las técnicas endovasculares.

Es muy importante tanto la elección de la técnica como el ma-terial a utilizar para asegurar el éxito del tratamiento endovas-cular. No existe clara evidencia sobre la idoneidad deltratamiento endovascular para la reparación de los trauma-tismos vasculares en miembros inferiores.

Martín Cañuelo, J.; Craven-Bartle Coll, A.; Rodríguez Piñero, M.; Alcalde López, J.;Laínez Rube, R.; Evangelista Sánchez, E.; López Atehortúa, J.

Hospital Universitario Puerta del Mar, Cádiz, Spain.

Traumatismo de troncos distales de miembrosinferiores. ¿Tratamiento de elecciónendovascular o abierto?

Venous malformations (VMs) are the most common form ofcongenital vascular malformations (CVMs) and comprise some80% of those presenting for therapy. They are low-flow lesionsaffecting the venous system as inborn errors throughout thebody.

We present a 14 year-old male patient complained ofswelling and deformity on his right leg since birth was admit-ted to our hospital. He also suffered heaviness, cosmetic andfunctional impairment in his leg. Physical examination had re-vealed no abnormality (bruit, thrill, hyperpigmentation or big

Demirkan, A.**; Bengisun, U.**; Cetinkaya, A.**; Yorubulut, M.*

*Primer Imaging Center; **Ankara University, School of Medicine.

Treatment of a congenital vascular malformationwith endovenous laser and foam sclerotherapy

3741

varicose veins) except a congenital venous malformation (CVM)which was located on the lateral side of the cruris and the dor-sal side of the foot like a buffalo hump. Duplex US showedmultiple malformed venous vessels with a trunk between 8-20mm in diameter. All deep veins and arteries of the lower ex-tremity were normal in size and function. There were no evi-dence of arterio-venous (AV) malformation. MR-angiographyconfirmed venous malformation (VM) of the right leg with nor-mal superficial and deep venous system including iliac veinsand inferior vena cava (IVC).

Lymphoscintigraphy showed an atypical lymphedema of theleg along the VM. Lymphatic transport function and clearancewere normal except dermal backflow below the right knee.Duplex US and T2 image of MR showed that the VM locateddeep enough to perform endovascular approach by laser. Itwas decided that the patient was suitable for the endovasculartreatment. Under general and tumescent anesthesia, truncularVM was successfully lasered by 980 nm diode laser (radialfiber, 14 W, mean energy delivery 130 J/cm along a 28cm segment).

The patient had an uneventful postoperative course and hewas discharged at the postoperative 6th hour. In the following

days Duplex US revealed that the proximal segment of the VMwas completely obliterated but the distal ! segment was par-tially obliterated possibly due to the larger branches.

Then two sessions of foam sclerotherapy under US guidancewere performed by 1% and 2% polidocanol respectively toobliterate the existing side branches.

The patient was advised to wear compression stockings afterthe operation. In the follow-up visit it was observed that he hadno pain due to venous stasis and all major truncular veins wereoblıterated except some small branches.

Diagnosis, characterisation and preoperative anatomic evalua-tion of congenital VMs are essential for the effective manage-ment.

Endovascular exclusion of congenital VMs can be done with ahigh degree of technical success, low morbidity, and shorthospital stay in selected patients.

A 59 year old gentleman with bilateral high grade carotidstenosis and previous laryngeal carcinoma and neck radiother-apy presented with recurrent right amaurosis fugax 6 weekspreviously and a single left cortical TIA one week previously.

On carotid Doppler the right ICA stenosis was 90%, the left70%; both lesions were hypoechoic. MRA confirmed theDoppler findings and demonstrated a bovine type I arch.

The plan was to stent both carotid lesions.

The right sided lesion was technically more straightforward butless clinically urgent (on account of it giving rise to ocularsymptoms six week ago, albeit recurrent). The left sided lesionhad given rise to a cortical event one week ago and was clini-cally more urgent but technically more challenging.

The decision was made to stent the right first and the left 24hours later, both with proximal protection/endovascular clamp-ing. The rationale was that we did not want to perform a slight-ly more lengthy procedure on flow arrest on the left carotidwith a critical stenosis in the right ICA.

The procedures were carried out according to plan with use ofthe Piton guiding catheter (Medtronic Invatec), which utilises awire bridge to prevent catheter prolapse whilst catheterisingrecurrent or bovine type arches to facilitate stenting of the leftsided lesion.

The case highlights complex clinical and technical decisionmaking plus use of a new guiding catheter designed for diffi-cult carotid access.

Macdonald, S.

Freeman Hospital.

Which Side First And How? Carotid ComplexCases session

3742

Endovascular repair continues to pose a formidable technicalchallenge in aneurysm, dissection and proximal type I endoleakinvolving the aortic arch. While covering the aortic arch by thestent-graft to obtain better seal, maintaining blood flow to thevital supra-aortic branches is difficult. We present a new en-dovascular procedure: double-chimney technology.

A 36 year old woman, who had underwent a complicated de-scending aortic dissection repair, presented a severe sec-ondary type I endoleak. First of the procedures, the bilateralcommon carotid arteries(CCA) were exposed, and a sheath wasplaced in a retrograde fashion respectively. Through thesheaths, two guidewires were advanced into the ascendingaorta. An SINUS stent was delivered in advance, with a shortsegment protruding into the aortic arch lumen and extending

distally into the proximal left CCA. Subsequently, a RELAYstent-graft was introduced from the aortic approach until theproximal fabric edge was adjacent to the innominate artery.The endograft repair was completed with complete coverage ofthe orifices of the innominate artery and the left CCA. The sec-ond SINUS stent was then introduced and deployed to open achannel for flow to the innominate artery. A follow-up CTA per-formed 1 year indicated no proximal endoleak with completethrombosis of the thoracic aortic false lumen, as well as freeflow into the innominate and left carotid arteries.

The double-chimney technology might offer a new option to si-multaneously preserve the innominate artery and the leftcarotid artery for total reconstruction of the aortic arch.

Feng, R.; Wei, X.; Zhao, Z.; Jing, Z.

Changhai Hospital, Second Military Medical University

Double-chimney Technology Treating SecondaryType I Endoleak after Endovascular Repair forComplicated Thoracic Aortic Dissection

Objetivo: Presentar un paciente joven con severa patologíapost-rádica de troncos supraórticos, que determinó unaisquemia cerebral manifestada principalmente por síndromeisquémico ocular bilateral y convulsiones generalizadas queobligan al paciente a permanecer en reposo absoluto. Tratadomediante stenting de arteria carótida primitiva izquierda, únicoeje supraórtico permeable.

Reporte del caso: Hombre de 42 años, con severa patologíapost-rádica de troncos supraórticos y de cayado aórtico quepresentó un síndrome isquémico ocular bilateral asociado aconvulsiones generalizadas y claudicación invalidante demiembros superiores a predominio derecho. El dúplex ultra-sonográfico de 4 vasos de cuello y la angiografía digital decayado aórtico y troncos supraórticos evidenciaron unaoclusión completa de tronco braquiocefálico, carótida primitivae interna derecha y arteria subclavia derecha prevertebral.Estenosis filiforme de arteria subclavia izquierda y estenosis de

90% en el ostium de carótida primitiva izquierda. Dadas lasgroseras deformaciones torácicas que hacen un tórax inabord-able quirúrgicamente y un cayado aórtico anatómicamentehostil con alto poder embolígeno, se decide revascularizaciónde miembro superior derecho mediante un bypass protésicofemoroaxilar derecho y a posteriori, implante de stent ex-pandible por balón en el ostium de la carótida primitiva izquier-da por vía retrograda a través de abordaje quirúrgico de caróti-da primitiva en cuello.

Excelente evolución clínica con regresión completa de su sin-tomatología cerebral y ocular. A los 6 meses el paciente per-manece asintomático retomando su vida social y laboral.

Conclusiones: El tratamiento endovascular de la patologíasupraórtica por vía retrógrada constituye una buena opcióncuando existe un alto riesgo de complicaciones a través delcayado aórtico.

Corradi Viola, D.; Amorin Cendan, M.R.

Circulo Católico de Uruguay

Tratamiento endovascular por vía retrograda dela isquemia cerebral debida a patología severa detroncos supra aorticos

3743

A 78 year old patient was referred to our clinic for the treat-ment of a large (10cm) saccular aneurysm of the right subcla-vian artery causing increasing dyspnoea due to compression ofthe trachea. The patient was an ex-smoker, suffered from hy-pertension and had a history of a groin hernia repair. Minimalinvasive endovascular treatment was planned because of hisage and general condition.

Access was challenging but achieved through dual approach(right common femoral artery and right brachial artery) using a

snare. A Viabahn 8/100 was first inserted though the groin, butbecause of tortuosity of the proximal subclavian artery, had do

be inserted and deployed via brachial access. Unfortunately,the olive of the delivery device got stuck and could not be re-trieved... so the delivery device was pushed forward after beingcut at the brachial side and eventually retrieved via by thesheath in the right groin. A completion angiogram after postdi-lation showed a correct position of the stent-graft with exclu-sion of the aneurysm without any evidence for an endoleak.

Bouckenooghe, I.**; Van Herzeele, I.**; Derom, A.*; De Ryck, F.**; Vermassen, F.**

*Ziekenhuis Zeeuws-Vlaanderen; **UZ Gent, Belgium.

Cutting the Viabahn, and the aneurysm...Endovascular treatment: is it always it?

Introduction: Up to date, carotid artery stenting is indicated inselected cases, in high volume center. Authors report the caseof carotid artery stenting complicated by the failure of the em-bolic protection system.

Clinical Case: a 83 yrs-old man was admitted because a lefthemispheric TIA. Duplex scan showed a 95% left internalcarotid artery stenosis, 15 mm of length, and the occlusion ofthe controlateral internal carotid. The cerebral CT was nega-tive. It was addressed to left internal carotid artery stenting.The supraortic arteriography shoved, a long plaque with criticalstenosis of the left internal carotid artery and confirmed theocclusion of the controlateral internal carotid. The distal inter-nal carotid artery was smoothly kinked. Because the tightstenosis of the left carotid artery, for enabling the passage ofthe embolic protection system, it was performed a predilata-tion with a 2 x 20 mm ballon, inflated at 8 atm, for just fewseconds. Then it was deploied the embolic protection system(FilterWire EZ – Boston-Scientific®) at the level of distal internalcarotid artery. Because the kinked course of the distal carotid,the stenting was performed by the delivery of an Rx Akkulink®

(Abbott-Vascular) 7-10x40 mm, at the level of the carotidstenosis, followed by postdilatation with a 5,5-20 mm ballon,

with a successful recanalization. The next step was the re-trieval of the embolic protection system; but once the basketwas reloaded in the retrieval sheat, at the passage of the de-vice over the stent, the soft tip was engaged between the stentstruts; during the up and down movement of the retrievalsheat, in the aim to disengage the soft tip, this last detachedfrom the device and was jammed between the struts. At thispoint the tip was lost without any possibility of retrieval. Then itwas decided to embed the tip into the arterial wall. In this aimwe released a second Rx Akkulink®, 7-10x30 mm, stent overthe first. The second stent allowed the steady locking of thelost tip between the two stent without any blood flow impair-ment.

The patients did well and he was discarged at 3rd day.

Conclusion: Less invasive carotid artery stenting can replacethromboendarterectomy in high risk, selected patients.Nonetheless it is a skill-requiring procedure and must be per-formed in high volume cases center, in complementary surgi-cal and radiologic vascular enviroment, with the avalilability ofthe different materials you can need for the procedure.

La Barbera, G.*; Vallone, M.**; La Marca, G.*; Cassaro, L.*; Dario Mamhoud, Parsaei,D.M.*; Ferro, G.*

*Vascular Sugery Unit; **Interventional Radiology

Embolic protection system failure during internalcarotid artery stenting. Case report

3744

The postoperative course was complicated by a stroke and in-creasing stridor and dyspnoea. AngioCT showed a successfullyexcluded subclavian aneurysm but an enlargement of theaneurysm caused by perforation and hematoma in theaneurysm wall during the procedure, leading to increased com-pression of the trachea and atelectasis of the right lung.Elective intubation and right posterolateral thoracotomy were

performed to drain the large saccular aneurysm and theaneurismal wall was closed. Weaning was prolonged but suc-cessfully.

Post-hoc… should we have chosen a safer and less invasivetreatment?

Introduction

Spontaneous rupture of a non-aneurysmal abdominal aorta is arare, life-threatening event. It is due to penetrating atheroscle-rotic ulcer, dissection, inflammation, infection, trauma or neo-plasia. Few vascular specialists have accumulated enough ex-perience in dealing with these pathologies. We describe theendovascular management of two such patients.

Methods and Results

Case 1: A 77-year-old man was admitted to a peripheral hospi-tal with a 3-day history of abdominal pain and fever one monthfollowing a myocardial infarction. Abdominal CT revealed a col-lection in the left psoas muscle which was misdiagnosed as anabscess and was treated conservatively.

Three days later, the patient deteriorated, became hypotensiveand his haemoglobin dropped to 7.1 g/dl. Repeat CT docu-mented a contained ruptured of abdominal aorta involving itsbifurcation and the left common iliac artery. He was transferredto our unit for definitive management. On arrival he was in hy-povolaemic shock and underwent emergency endovascular re-pair using a bifurcated endograft (Excluder, Gore). He had aslow but uneventful recovery and was discharged home on the14th day.

Follow-up CT at 6 weeks confirmed successful relining of theruptured segment without contrast extravasation and decreaseof the retroperitoneal haematoma. Reviewing his films, a spinalosteophyte was detected to be located exactly opposite the

perforated left common iliac artery. There was no sign of infec-tion and the perforation seemed to have been caused by theosteophyte.

Case 2: A 69-year-old man was admitted with lumbar pain andsevere hypertension. CT angiography revealed spontaneousrupture of a heavily calcified, non-aneurysmal visceral aorta.

The rupture involved the superior mesenteric artery which ap-peared to be occluded and extended from just below the celiactrunk down to the right renal artery. He was transferred to ourunit and was treated by emergency endovascular implantationof an aortic cuff (23 x 33 mm, Excluder, Gore) along with stentgrafting of the right renal artery (6 mm x 10 cm, Viabhan, Gore)using the periscope technique.

Final angiography showed the celiac artery not to be patentand, as a result, its origin was catheterized and the vessel wassalvaged by deploying a 9 x 40 mm balloon-expandable stent.The exact aetiology of the rupture could not be confirmed, butit was presumed to be related to the heavily calcified aorticwall. The patient had an uneventful recovery. Follow-up CT at 1month revealed no endoleak and the patient was symptom-free.

Conclusions

Spontaneous rupture of a non-aneurysmal abdominal aorta is arare and potentially fatal condition. Endovascular repair ap-pears to be a useful option for such challenging cases.

Giagtzidis, I.; Karkos, C.; Karamanos, D.; Papadimitriou, D.; Papazoglou, K.;Gerasimidis, T.

Aristotle University of Thessaloniki, Hippocratio Hospital, Thessaloniki, Greece.

Eendovascular management of abdominalaortic rupture

3745

El síndrome aórtico agudo es una entidad que agrupa una seriede patologías de la aórta torácica que incluye el hematomaaórtico, la úlcera aórtica penetrante y la disección aórtica.Cada una de ellas independiente pero a su vez interrela-cionadas.

Hasta hace poco tiempo el diagnóstico se basaba exclusiva-mente en la imagen de la Tomografía Axial Computerizada y laecografía transesofágica. La TAC presenta el problema de laradiación, el contraste y el ser una prueba estática lo que nosimpide determinar si alteracines hemodinámicas como la dis-ección estática o dinámica de diferente pronóstico y tratamien-to. La Ecografía transesofágica nos permite determinar conbastante exactitud las características e incluso determinar anteque entidad del síndrome aórtico nos encontramos si bien nopuede ver más allá del tronco celiaco lo que nos impide deter-minar con exactitud si existen problemas y de que tipo con re-specto a la aorta a nivel visceral e infrarrenal. Precisa además

de colaboración-sedación del paciente y el disponer de per-sonal muy entrenado y experimentado

El ultrasonido intravascular (IVUS) una cada vez más en auge yusada herramienta diagnóstica, nos permite ver con exactitudtoda la aorta desde el cayado aórtico a la iliaca externa.Permitiéndonos determinar no sólo, ante que patología nos en-contramos, sino distinguir si es una afectación estática odinámica. Nos permite tomar medidas precisas a la hora deltratamiento endovascular si se necesitara, así como, tomar laactitud terapeútica quirurgica o endovascular más adecuada.Se realiza con anestesia local, incluso en la propia cama delpaciente si bien, precisa de curva de aprendizaje

Presentamos un video demostrativo de cada una de las enti-dades que componen el síndrome aórtico agudo poniendo enclaro la utilidad del IVUS en el diagnóstico preciso.

Flores Herrero, A.; Orgaz Perez-Grueso, A.; Fontcuberta Garcia, J.; Gil Sales, J.;Leal, I.; Rodriguez, R.; Doblas Dominguez, M.

Hospital Virgen De La Salud, Toledo, España

IVUS y síndrome aortico agudo

Superior vena cava (SVC) stenting can provide rapid sympto-matic relief in most patients with superior vena cava syndrome(SVCS). Stenting may also be indicated in cancer patients inwhom radiation induced SVCS. Patients with entrappedcatheters in superior vena cava is a particular challenge be-cause little is known about the incidence and clinical outcome.

A 64 year-old male patient with symptoms of SVCS includingfacial edema, cyanosis and respiratory distress admitted to ourhospital. Three years ago, he had been treated for inoperablebronchial carcinoma with chemo-radiotherapy. Endovascular

therapy with balloon angioplasty/stenting of the SVCS hadbeen performed in another hospital 6 months ago. MR-venog-raphy of the SVC revealed the high grade in-stent restenosiswhere the previous stent was deployed. The patient wasscheduled for balloon angioplasty and re-stenting. During theangioplasty procedure the balloon bursted and the ballooncatheter get entrapped by the previously placed stent in supe-rior vena cava. After failed interventions for retrieval of theburst balloon catheter, following day we performed a mediansternotomy and explored the region where the balloon catheterwas still present and realized that the tumour and radiotherapy

Demirkan, A.; Cetinkaya, A.; Cetinkanat, G.; Sanlidilek, U.; Gungor, A.; Bengisun, U.Ankara University School Of Medicine.

Entrapped balloon angioplasty catheter in stentrestenosis of superior vena cava

3746

caused severe fibrosis in the mediastinum. The ballooncatheter could be removed incompletely from the SVC via rightupper extremity and a remnant of balloon catheter left in theSVC. Then a bypass between the right atrium and the left in-nominate vein was performed with a 10-mm Dacron® graft.

The patient was discharged at the 7th day without complicationand symptoms free. He received a combination of aspirin andclopidogrel postoperatively. The post operative 3 week timewas uneventful and the patient did not required further reinter-vention for signs of SVCS.

The risk of further traumatizing the superior vena cava byforcefully removing the foreign body should be considered.Small fragments may be left within the superior vena cava likein our case with SVCS but open by-pass surgery is the only al-ternative way to relief SVCS if endovascular treatment hasfailed. The success of surgery is possibly determined primarilyby the clinical status of the patient before the operation.Intraoperative decisions about removing or leaving in situ thecatheter remnants or stents should depend upon the locationand size of the fragment.

A 76 Yr old male was admitted to a hospital in after feeling un-well. His investigations revealed a low haemoglobin, thrombo-cytopaenia and a possible leaking abdominal aortic aneurysm..CT scan on admission showed a juxta-renal AAA with a para-aortic mass, reported in Cyprus as a possible rupture. The pa-tient self-discharged and flew back to England. On arrival thepatient presented to our institution. The CT was re-reported asan AAA with a para-aortic mass suggestive of a soft tissuemass or abscess.

On CT angiogram the neck diameter at the renal arteries was35mm. The renal arteries origins were at the same level at 11o’clock and 2 o’clock positions. The SMA origin was at 12 o’-clock 5mm above the renal arteries. This made planning a fen-estrated EVAR a challenging option.

He developed impaired renal function a day after his CT scan,which has remained elevated since. He was assessed by aConsultant Anaesthetist to be unfit for open surgery.

MRA confirmed the findings of a AAA and demonstrated a fluidcollection with septations and fluid levels in the para-aorticarea with vertebral erosions. A diagnosis of chordoma, giantcell tumour and abscess were suggested. CT guided aspirationof this mass/collection yielded some serosanguinous collectionwhich was sterile. He was started on steroids.

Repeat scan in 6 months later showed a significant reduction inthe retroperitoneal mass but the L2 and L3 vertebral bodies

showed scalloping giving a suspicion of Tuberculosis.Investigations failed to prove this.

Seven months post-presentation he presented with acceleratedhypertension, acute confusional state and acute renal failure.Investigations with CT head, MRI brain, MAG3 scan and MRI ofKidneys failed to show any cause for his acute presentation. Herecovered but was discharged with chronic renal impairment.

Currently his AAA is 8cm on CT scan. He then presented withshortness of breath on exertion and was diagnosed on V/Qscan to have multiple PE’s and treated with anticoagulation. Hehad started to develop weakness in his legs.

Due to his renal impairment a mixture of CO2 and contrast wasused for the procedure. A Cook main body 38x140mm was de-ployed with two renal fenestrations, stented with an Atrium7x22mm stents. A downward branch was stented into the SMAusing a Fluency 9x60mm stent. The main body was then ex-tended with a 24x80mm tube graft. Below this a 24mm bifur-cated body was deployed, with a contra-lateral body of 81mm.The contra-lateral limb was extended with a 73x24mm and theipsi-lateral was extended with a 56x20mm.

A good radiographic appearance was obtained. No evidence ofan endoleak. Flow maintained into the SMA, both renal arteriesand the common iliac arteries. A follow up CT scan has con-firmed patent target vessels and no presence of an endoleak.

Grewal, P.; Chikkanna, G.; Aylwin, C.; D'Souza, R.; Davis, M.; Davies, N.;Hamilton, G.

Royal Free Hampstead NHS Trust.

Juxta-renal AAA anatomically difficult for EVAR,Requiring a combined branch and doublefenestrations

3747

Purpose: To report a salvage maneuver for accidental cover-age of both renal arteries during endovascular aneurysm repair(EVAR) of an infrarenal aortic aneurysm (AAA) and survey oursurgical colleagues in the UK for their use of this bypass proce-dure.

Methods: A 74-year-old woman who had an EVAR complicatedby renal failure secondary to malposition of the stent-graft un-derwent successful delayed renal revascularization with hepa-torenal and splenorenal bypasses. This case prompted a litera-ture review and preparation of an online 6-part questionnaireregarding the incidence and management of renal impairmentfollowing EVAR. The survey invitation was sent to all listedmembers of the Vascular Society of Great Britain and Ireland.

Results: Responses from 68 (10.5%) of the 650 vascular sur-geons invited to participate in the survey were analyzed. Thecombined experience of those who completed the survey was>1500 EVAR procedures per annum. Forty percent (27/68) of

the respondents had experienced a case of bilateral renalartery occlusion during EVAR. Two thirds (67%, 18/27) of thesesurgeons stated a preference for revascularizing the kidneysendovascularly, 7 surgeons would convert to open repair, 1surgeon favored iliorenal bypass, and another suggestedsplenorenal bypass. Following intervention, 15 (56%) of 27surgeons achieved revascularization that resulted in a return tobaseline serum creatinine, 7 (26%) achieved partial recovery ofthe patient’s serum creatinine, 3 (11%) had a patient on per-manent dialysis, and 2 (7%) had patients who died (after openrepair and endovascular procedure, respectively).

Conclusion: Bilateral renal artery occlusion caused by malpo-sition of a stent-graft is probably underreported. If revascular-ization of the kidneys by endovascular techniques fails, there isno consensus as to the optimal approach. Hepato-spleno-renalbypass can provide a good functional result in this situation.Delayed revascularization should be considered if the kidneysshow concentration of imaging contrast.

Hamish, M.; Geroulakos, G.

Imperial College London

Hepato-Spleno-Renal Bypass for AbdominalAortic Aneurysm

P Ó S T E R S S I T E 2 0 1 1

IntroductionsType II endoleaks are the most common “complication” afterEVAR. Their incidence is various in the many series reportedand their significance and treatment have been long debated. Itseems to be generally agreed that the treatment of type II en-doleaks is recommended in case of growth of aneurysm dia-meter.

ObjectivesThe purpose of this study is to evaluate if the routinely intra-sac embolization with coils and fibrin glue during EVAR is a sa-

fe and effective procedure to reduce the incidence of type IIendoleaks and the incidence of re-intervention after EVAR.

Material and methodsFrom January 2009 to August 2010 63 patients underwentEVAR, emergency procedure are not considered here. 42 pa-tients have been treated in 2009 without sac embolization(group A) while, from January 2010, 21 patients underwentEVAR + routine intra sac embolization at the end of the endo-vascular procedure (Group B): 20 of these patients have beentreated by intra sac positioning of coils (19 cases Tornado® and

Menegolo, M.*; Frigatti, P.**; Antonello, M**; Morelli, I.**; Scrivere, P.**; Grego, F.**

*Clinic of vascular and Endovascular Surgery; **Clinic of vascular and Endovascular Surgery.

Prevention of type II endoleaks by colils and fibringlue embolization of the aneurysmatic sac

3748

1 case Balt®), 17 patients were treated also with injections offibrin glue (TissueColl®), 1 patients had only coils and one onlyfibrin glue. All patients underwent a 30 days postoperative CTscan.

ResultsThe 30 days the incidence of type II endoleaks in Group A was14.3% (6 cases) and in group B was 4.8% (1 case). In Group Bno adjunctive surgical procedure were needing and no type Iendoleaks were observed.

ConclusionsThe sac embolization with coils and fibrine glue at the time ofendograft placement seems to be a safe procedure for preven-tion of type II endoleaks. Considering that literature reports aglobal incidence of re-operation for type II endoleaks of 55%,seen the reductions of incidence of type II endoleak after thisprocedure, we can estimate a reduction of re-interventions ofabout 5.3% with a relevant cost saving for the national healthsystem. Moreover, the absence of type I (A or B) endoleaks inall the cases treated seems to confirm the effectiveness of thetechnique also in the stabilization of the sac giving high fixationto the endograft.

A 51 year old female with previous head and neck radiotherapyfor nasopharyngeal carcinoma presented with right hemispher-ic TIA. She had bilateral > 90% high grade long segment ulcer-ated carotid bifurcation lesions. On CT there was low densitymaterial packing both carotid bulbs and hypoechoic plaque bi-laterally on Doppler ultrasound.

She was treated (by placement of a right carotid stent) withinone week of index symptom with flow reversal embolic protec-tion plus the NAV6 EmboShield filter.

There are a number of technical aspects of this case thatshould generate discussion: the requirement for pre- and post-

dilatation in cases like this, management of flow reversal intol-erance, the most appropriate stent design given the patient’shistory, advancement of the filter retrieval system through thestent to the base of the filter whilst on flow reversal followed bycessation of flow reversal (allowing the stent to be “washedthrough” into the filter before filter retrieval). Lastly, the lengthof time that these patients need to be on dual antiplatelets giv-en the potentially different healing paradigms in patients withradiotherapy lesions compared with patients with de novo ath-erosclerosis.

Macdonald, S.

Freeman Hospital.

Complex Cases (carotid) - "Belt and Braces"

Introduction Variations in vascular anatomy of the aortic arch and great ves-sels are not uncommon and influence planning and treatmentof thoraco-abdominal aortic aneurysm (TAAA).

ReportWe report a case of TAAA secondary to aneurismal degenera-tion of Chronic Type B dissection. The complicating featurewas an aberrant origin of the right subclavian artery from the

descending aorta, distal to the origin of the left subclavianartery.

Discussion TEVAR with Boston Relay NBSTM thoracic stent graft was per-formed successfully to treat the aneurysm. Synchronouscarotid subclavian bypass was undertaken to reduce risk ofspinal and vertebro-basilar ischaemia. The technical consider-ations are discussed.

Kappadath , Sreevalsan K.**; Bhutia, S.G.*; Stansby , G.**

*Northern Vascular Centre, Freeman Hospital; **Northern Vascular Centre, Freeman Hospital

Synchronous Bilateral Carotid- SubclavianBypass and TEVAR to Treat TAAA Complicated byAberrant Origin of Right Subclavian Artery

3749

ObjectiveWe assessed the safety and efficacy of modified endovenouslaser treatment (ELT) of the saphenous vein combined with asurgical strategy for treatment of deep venous insufficiency inthe lower extremity, based on experience.

MethodsSince September 2007 to June 2010, 831 ELT procedures ha-ve been performed (great and small Saphenous vein and extra-Saphenous veins) using a diode laser 980 nm wavelength(LASEmaR1000-Eufoton, Italy) by a kit that includes optical fi-bers of 600 micron and 400 micron fibers for small extra-Saphenous veins (KIT INVE, Eufoton, Italy). Local Echo-guidedanesthesia have performed in all cases. Laser power is variableregarding veins diameter from 6 to 12 watts settled in semi-continuous mode and the energy supplied is personalized tomorphologic vein characteristics: 50-80J/cm for vein diameterof 1,5-3,5 mm; 80-100J/cm for vein diameter of 3,5-6 mm;100-140J/cm for vein diameter of 6-8; up to 140J for vein over8 mm of diameter. Power is personalized to echographyc veinpatterns (diameter, wall thickness, anatomic deep). In the 82%of all patients other techniques have been associated.

ResultsAll cases (100%) presented the subjective symptomatology’sfading, with an objective improvement of symptomatology after1 month of the operation.

3 months after operation, 99.9% of all cases presented a com-plete occlusion of vein treated, and in the 0.01% of cases hasbeen detected an early recanalization of Saphenous vein (initiallearning curve only). At 6 months after operation has been de-tected a recanalization of Saphenous vein in the 1.5% of 145operated patients. At 12 months after operation has been de-tected a long regurgitation without usual relapses in the 0.46%of 32 operated patients. No major complications occurred. OneDVT (0.0012%) occurred. Local transient paraesthesia at theankle and midcalf level occurred in 5 patients (0,006%). In the74% of patients we observed that vein treated disappear after6 months.

ConclusionsThe endovenous laser treatment (ELT) of Saphenous and extra-Saphenous veins is a minimally invasive surgical intervention,that is performable by a Day-Surgery ever under ultra-soundguide and by a topical anesthesia. It can ensure good clinicaland aesthetic results by a short time of convalescence. The la-ser treatment efficacy is linked to the standardization of pre-operative and operative clinical procedures. Interventions mustbe standardized for the part that pertains to the methodology,but it must be personalized to the patient’s vein. Combinedtechniques if indicated permit to obtain the best results and thebest satisfaction of patient.

Keywords: vein, laser, elt, evlt, elves, endovenous, varices, in-sufficiency

Baraldi, C.**; Carelli, M.**; Rinaldi, F.*

*Carmona Clinic; **Tricarico Clinic. Department of Vascular and Endovascular Surgery, Tricarico Clinic, Belvedere Marittimo, Italy

Modified Endovenous laser treatment (ELT) oflower limbs? varicose veins: our experiences

Acute renal thrombosis is an emergent pathology that is at pre-sent underdiagnosed due to the unclear onset of symptoms.Endovascular treatment consists of revascularization, which iscurrently acheived by use of a stent.

We report the case of a 68-year-old male who presented acuterenal failure and was referred to our unit for revascularizationof the right renal artery, that had shown signs of acute throm-bosis in an emergent CT scan.

Burrel, M.; Barrufet, M.; Oliveira, R.; Montañá, X.; Real, M.I.; Riambau, V.

Hospital Clínic. Barcelona. Spain

Stent dislodgement during revascularization ofacute renal artery thrombosis

3750

IntroducciónEl carcinoma de células renales o hipernefroma representaaproximadamente el 3% de las neoplasias diagnosticadas cadaaño, y representan más de 95000 muertes al año en el mundooccidental. La embolización de la arteria renal preoperatoriacomo tratamiento concomitante a nefrectomía ha demostradoser útil en la reducción de su morbimortalidad a lo largo de losaños. La realización de esta técnica junto a nefrectomía en unmismo acto quirúrgico conserva las ventajas del tratamientoreduciendo considerablemente la morbimortalidad asociada.

ObjetivosAnalizar los resultados de la embolización arterial renal condispositivo Amplatzer vs coils como procedimiento concomi-tante a nefrectomía en hipernefromas.

Métodos/PacientesEn 10 pacientes se realizó embolización de la arteria renal con-comitante a nefrectomía por hipernefromas. El procedimientofue realizado por un cirujano vascular en un quirófano conven-cional con un arco radiológico en C móvil.

En todos los casos se utilizó dispositivo Amplatzer para la em-bolización. En 4casos,se precisó la inyección de 2cc de trombi-na intracatéter posterior al implante.

La oclusión completa de la arteria renal se confirmó medianteangiografía intraoperatoria en todos los casos. Se analizarondatos demográficos como la edad y el tamaño del tumor. Se

analizaron a su vez los tiempos quirúrgicos, la morbimortalidadperi/postoperatoria, las perdidas sanguíneas, las necesidadestransfusionales y el deterioro de la función renal postoperato-ria. Se compararon los datos obtenidos con una muestra simi-lar obtenida en la bibliografía donde la embolización se realizócon coils. En análisis estadístico se realizó mediante tests noparamétricos. La significación estadística se estableció conp<0.05.

ResultadosPara la embolización con Amplatzer, el tiempo quirúrgico glob-al fue de 122,30min., incluyendo embolización y resección tu-moral. Se perdió una media de 316,5ml de sangre por pa-ciente, precisando dos pacientes transfusión de dos concentra-dos de hematíes. No existió mortalidad intra/periopeartoria.Dos pacientes precisaron vigilancia intensiva durante 24horas.

El tiempo de hospitalización medio fue de 5,8días. Ningún pa-ciente presentó deterioro de su función renal al alta. En elanálisis estdístico, se objetivaron diferencias significativas enel tamaño del tumor y el tiempo quirúrgico global a favor de laembolización con Amplatzer.

ConclusionesLa embolización renal concomitante a nefrectomía en hiperne-fromas, es una técnica accesible y con muy baja morbimortali-dad. La embolización mediante dispositivo Amplatzer presentaresultados similares a la embolización con coils, mejorandosignificativamente los tiempos quirúrgicos.

Rodríguez Carvajal, R.; Leal Lorenzo, J.I.; Peinado Cebrián, F.J.; Vicente Jiménez, S.;Flores Herrero, Á.; Orgaz Pérez-Grueso, A.; Doblas Domínguez, M.

Hospital Virgen de la Salud.

Embolización renal mediante dispositivoAmplatzer vs coils como tratamientoconcomitante a nefrectomía en hipernefroma renal

We followed our usual approach, which is percutaneous punc-ture of the right femoral artery. Selective catheterization wasvery difficult due to a marked angulation of the renal artery inrelation to the aorta. Due to this, we were unable to place along introducer sheath into the renal artery so as to performselective angiographies and ensure an exact deployment of thestent. Once the stent was placed, angiography showed that itsdislodgement was too proximal in the renal artery ostium, aswell as a persistent occlusion of the vessel together with riskof migration of the stent into the aorta. After repeated failed at-tempts to catheterize the stent through both femoral andbrachial approaches, we decided to retrieve the stent. This wasachieved using an angiographic snare and a long introducer

sheath through the femoral access. The patient presented noclinical complications related to the procedure, although in theend the right renal artery could not be revascularized.

Our case shows that an adequate planning of treatment is es-sential for a successful outcome of the procedure. Accessthrough the brachial artery would probably have avoided all ofthese technical complications. Nonetheless, we were able tosuccessfully retrieve the stent using a snare and introduce itinto the sheath; Awareness of this strategy is worthwhile incases of dislodgement or migration of small diameter stents.

3751

Paciente varón de 45 años de edad que ingresa en nuestrohospital con el diagnóstico de insuficiencia renal aguda secun-dario a hipertensión maligna.

En las pruebas complementarias se detecta una disección aór-tica desde una arteria subclavia derecha aberrante retroe-sofágica, hasta las arterias iliacas.

Se realiza by-pass carótido subclavio bilateral y cobertura de laentrada de la disección con endoprótesis TAG (Gore)31x150mm y un stent autoexpandible en iliaca común izquier-da. El paciente presenta mejoría de la función renal y controlde su tensión arterial.

En el TAC de control a los 15 días del postoperatorio presentadesplazamiento distal de la endoprótesis con reperfusión de la

luz falsa desde la entrada proximal y disección retrógrada queafecta a carótida derecha.Se decide realizar un by-pass desde la aorta ascendente a am-bas carótidas para realizar extensión proximal de la endopróte-sis.

Tras la derivación de ambas carótidas se colocan dos prótesisValiant (Medtronic), una distal cónica 34-30mm a nivel decayado aórtico y otra proximal 40-36mm a nivel de aorta as-cendente. En la liberación de la endoprótesis proximal se pro-duce malposicionamiento del primer stent con semiobstrucciónde la luz aórtica.

La mala colocación de la endoprótesis se corrige medianteparada circulatoria, arteriotomía de aorta ascendente y recolo-cación del stent.

Sánchez Abuín, J.; Fernández Fernández, J.C.; Rodriguez Saenz de Buruaga, V.; Garcia Familiar, A.; Egaña Barrenetxea, J.M.; De Blas Bravo, M.

Hospital Donostia

Disección aórtica. ¿La resolveremos algún dia?

Introducción. Los pacientes con Síndrome de Marfan sonpropensos a la dilatación y ruptura aórtica. La reconstrucciónde la raiz aórtica y la aorta descendente ha generado pacientescon mayor supervivencia que presentan expansión de la disec-ción distal aórtica. Este caso clínico propone una correcciónhíbrida para los Marfan con esta patología.

Objetivos. Presentar el tratamiento y evolución de un pacientecon Síndrome de Marfan y Disección Aórtica Crónica tipo B.

Material y método. Un varón de 40 años, con historia previade derivación Bentall , desrramado de troncos supraaórticos ycorrección de cayado y aorta descendente con doble stengraft,se presentó por dilatación de la luz falsa abdominal.

Se realizó una reparación aórtica total en dos etapas; revascu-larización subclavia izquierda inicial seguida de sustitución deaorta infrarrenal por injerto de Dacron cónico-recto, devascu-

larización visceral aórtica e implante de stengrafts desde stent-graft torácico previo a injerto de Dacron actual.

Resultados. En el postoperatorio inmediato se evidenció fugaIb en la unión de los injertos endovasculares y la reconstruc-ción Dacron que se empleó como leak inducido para permitirla completa recuperación sin déficit neurológicos. En el sexto mes presentó un cuadro isquémico intestinal conrespuesta a tratamiento médico.En el octavo mes de su seguimiento el paciente realiza vidaambulatoria y se encuentra a la espera de compensaciónmedular para interrupción de leak distal.

Conclusiones. La reconstrucción aórtica de los pacientes conSíndrome de Marfan precisa un seguimiento cercano. Las téc-nicas híbridas parecen una alternativa segura a corto y medioplazo para estos pacientes. La aparición de complicacionesneurológicas pueden revertirse con endoleaks inducidos .

Fernandez Fernandez, J.C.; Sanchez Abuin, J.; Rodriguez Sanz de Buroaga, V.; Gar-cia Familiar, A.; De Blas Bravo, M.; Egaña Barrenetxea, J.M.

Hospital Donostia

Reparación Híbrida de Disección Aórtica CrónicaTipo B en paciente con Síndrome de Marfan

3752

Introduction. The aberrant right subclavian artery (ARSA) isone of the most common anomaly of the aortic arch, with anincidence rate of 0.5-2. The ARSA can often become aneuris-matic. In the majority of these cases, patients are asympto-matic and the diagnosis is occasional. Difficulty swallowingsolids (“dysphagia lusoria”) may gradually develop8,9.Episodes of thromboembolism and rupture have been reportedwith high mortality rate 5 . Due to the anomalous anatomy,there is no one ideal standardized management of ARSAaneurysms (ARSAA). Objectives: We report a case of ARSAA,successfully treated with an hybrid approach.

Material and Method. A 72-year-old male patient with historyof hypertension, dysphagia, emerged 3 years earlier was re-ferred to our unit for a ARSAA. The patient complained a sud-den onset of dysphonia. he experienced An acute chest painradiating to the back was experienced three months earlier.The computed tomography scan (CT-scan) showed theanomalous origin of the supra-aortic vessel, including a bovineaortic arch, a regular left subclavian artery (LSA) and a hugeARSAA (5.1 cm in maximum diameter - fig.1). The aneurysmcaused an esophagus compression. Due to the anomalousanatomy, we avoided the surgical treatment. A staged hybrid

Robaldo, A.; Ferrero, E.; Ferri, M.; Viazzo, A.; Robaldo, A.; Carbonatto, P.; Nessi, F.

Mauriziano Umberto I Hospital - Turin - Italy

Hybrid repair of aneurysm of the aberrant rightsubclavian artery: a challenging case

Objective. Acute liver failure is a life-threatening emergencywith a poor survival. We report a rare clinical case of acutethromboembolic occlusion of the celiac axis and superiormesenteric artery in which endovascular recanalization usingpercutaneous balloon expandable stent was carried out suc-cessfully.

Case Report. A 67-year-old man was admitted to our vasculardepartment proceeding from other hospital with the diagnosisof acute liver failure by occlusion of the celiac trunk and supe-rior mesenteric artery. Twelve hours earlier, the patient under-went a right nephrectomy due to a hypernephroma. His pastmedical history was significant for arterial hypertension, atrialfibrillation and congestive heart failure. No signs of peritonitiswere found on physical examination, but a leukocytosis (14580x 103 /µL) with a critical alteration of hepatic enzymes (AST4337 U/L, ALT 2190 U/L, LDH 10170 U/L), and severe coagula-tion disorder (INR 3.73, Quick 28%, aPTT 59 seconds) was pre-sent. Contrast-enhanced abdominal computed tomography(CT) showed filling of contrast only in the inferior mesentericartery. Because of the patient’s poor condition and the majorsurgery performed the previous day, an endovascular approach

was decided. He was successfully managed by a femoral andbrachial access and the use of a percutaneous balloon expand-able stent placed in both visceral arteries. The patient im-proved markedly in the immediate postoperative period and alaparotomy was not necessary. He was discharged with oralanticoagulation and 100 mg of AAS daily. He remains symp-toms-free, and a CT-scan has showed patency of both stentssix months after the procedure.

Conclusions. Acute liver failure by ischemia is an extremelyrare condition that occurs when at least the celiac axis and thesuperior mesenteric artery is occluded avoiding the supple-mentary perfusion by collateral pathways. Endovascular tech-niques may be the treatment of choice in patients with no signsof peritonitis (bowel ischemia) and high operative risk. This ap-proach keeps away from aortic clamping and surgical controlof visceral arteries. The primary stent placement by balloon ex-pandable decreases the risk of distal embolization. Accordingto the literature, this seems to be the first clinical case of acombined acute thromboembolic occlusion of the CA and theSMA treated successfully with stenting.

San Norberto García, E.; González Fajardo, J.A.; Gutiérrez Alonso, V.; Chehayeb Morán,J.; Taylor, J.; Cenizo, N.; Vaquero, C.

Hospital Clínico Universitario de Valladolid (1)

Percutaneous treatment of acute mesentericischemia and liver failure

3753

Introducción: La fístula aorto-esofágica, está descripta comouna grave complicación de TEVAR. Generalmente se presentacomo una verdadera urgencia quirúrgica y el tratamiento concirugía abierta es habitualmente fatal.

Material y Método: Presentamos 2 casos en los cuales se im-plantaron Endoprótesis en el Arco Aórtico por diferentes pa-tologías (Disección Aórtica Tipo B en el primero y TransecciónAórtica post traumático en el segundo). La Fístula Aorto-es-ofágica se manifestó entre el primer y cinco años post im-plante.Tratamiento: La táctica quirúrgica fue la misma en ambos ca-sos. Cirugía Híbrida: By pass desde la Aorta Ascendente a losTroncos Supraaórticos e Implante de endoprótesis cubriendotodo el Cayado Aórtico excluyendo la fístula Aorto-esofágica.En un caso se Implantó una Endoprótesis intraesofágica.

Resultados: Un paciente falleció a las 72 horas post cirugía.La causa estuvo dada por un Taponamiento Cardíaco, productode la desinserción de la anastomosis del By Pass a losTroncos Supra aórticos provocada por el Stent descubierto dela Endoprótesis sobre dicha anastomosis.

El otro paciente se encuentra asintomático y de alta medica,bajo control.

Conclusiones

• La fístula Aorto esofágica puede presentarse como una com-plicación “tardía” post Implante de una Endoprótesis en el Arcoaórtico.

• El sitio de lesión fue en el piso del Cayado Aórtico en amboscasos.

• El seguimiento por imágenes debe ser estricto ya que unamodificación en la estructura metálica de la Endoprótesispuede indicar el inicio de ésta grave complicación.

• La “Cirugía Híbrida” fue para nosotros la indicada, con so-brevida inmediata.

• Recomendamos el uso de Endoprótesis con Stent cubiertoproximal para evitar el decúbito del Stent libre sobre la anasto-mosis del By Pass a los Troncos supraaórticos

Girela, G.; Bertoni, H.; de la Vega, A.; Quiroga, J.M.; Otero, A.; Barbosa, F.

Instituto Cardiovascular sel Sur - Cipolletti-Río Negro, Argentina.

Fístula aorto-esofágica. complicación tardía postimplante de endoprótesis en el arco aórtico.Tratamiento quirúrgico

treatment (surgical and endovascular repair) without thoracoto-my was perfomed. Through a bilateral supraclavicular ap-proach, a left carotid to the right subclavian bypass (CSB) with6 mm polytetrafluoroethylene (PTFE) prosthesis was per-formed.

A 10F sheath introducer was inserted through a surgicalfemoral access, whereas a 6F sheath introducer was percuta-neously placed controlaterally. A 12x7mm Amplatzer iliac plug(AGA Medical,Golden Valley,MN,USA) was inserted through the10F sheath and placed at the origin of the ARSA.

Another Amplatzer iliac plug (10x7mm) through the 10F sheathwas placed at the origin of the LSA. The Bolton Relay ThoracicStent-Graft (TEVAR) (38x34x150mm; Bolton MedicalInc.,Sunrise,Fla,USA) was introduced via the right CFA on abackup Maier guidewire.

During TEVAR, a controlled hypotension ( 50 mmHg) was in-duced by using the rapid ventricular pacing (RVP) technique.The intraoperative angiography control confirmed the correct

position of the device, the patency both of the common carotidarteries and of the CSB with a good perfusion of the vertebralarteries.

Results Postoperatively, we observed the Claude BernardHorner syndrome on the right eye. The patient was dischargedon the fourth post-operative day in good general condition witha complete recovery of the neurological symptoms.

The CT scan follow-up, performed at 1, 3, 8, 12, 24 and 36months, showed the technical success of the TEVAR, the com-plete ARSAA exclusion and the good perfusion of all supra-aor-tic trunks including the carotid-subclavian bypass (fig.2). Atclinical follow-up, symptoms of dysphonia disappeared.

Conclusion In case of appropriate anatomy the ARSAA can besuccessfully treated with the hybrid treatment (surgical and en-dovascular approach). We reckon that this minimally invasivetechnique avoid thoracotomy and could be the treatment ofchoice in high-risk patients.

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Cruz Guzman, L.; Flores, C.; Navarro, J.; Riambau, V.

Hospital Clínico Provincial (1)

Disección aórtica retrógrada tipo A posterior almanejo endovascular de la disección aóticatipo B crónica

Objetivo: De acuerdo con la literatura, en los aneurismas deaorta abdominal infra-renales, la longitud del cuello aórticoproximal para poder asentar una prótesis stent – graft no de-bería de ser menor a 10 mm. A pesar de esto, en nuestra prác-tica clínica del tratamiento de aneurismas infra-renales, elcuello proximal puede ser menor a 10 mm. Por lo tanto nuestroobjetivo es validar el riesgo de endoleaks, si los hubiera, en eltratamiento de aneurismas infra-renales con cuello corto o sincuello, utilizando una prótesis SETA balón expandible, stent-graft.

Material y Método: Fueron 101 pacientes que presentaban unaneurisma de aorta abdominal infra-renal, con un cuello proxi-mal menor a 10 mm. de longitud, en los que se les coloco unaprótesis SETA, stent-graft, en un periodo de tiempo comprendi-do entre noviembre del 2000 y diciembre de 2010. La efectivi-

dad de nuestro procedimiento fue evaluado mediante TC multi-corte a los 30 días y anualmente post procedimiento. Fuerontratados 86 pacientes con un dispositivo bifurcado y los 15restantes con un aorto-monoiliaco.

Resultados: En cuellos mayores de 3 mm. no se observaronendoleaks. Solo se observaron cuatro endoleaks, en cuellosmenores a 3 mm, inmediatamente después del procedimiento.Un paciente que presentó una ruptura del aneurisma, muriópor falla multi orgánica posteriormente, y un paciente requiriócirugía abierta. Otros dos pacientes que presentaron endoleaksse perdieron en el seguimiento a largo plazo.Conclusión: En cuellos mayores a 3 mm de longitud, la prótesisSETA, balón expandible stent-graft, es un dispositivo seguro yno demostró presentar endoleaks en el seguimiento a largoplazo.

Introducción.

Las técnicas endovasculares han emergido como una alternati-va para el manejo de la patología aórtica, con las cuales se hanobtenido tasas bajas de morbilidad y mortalidad que ha dis-minuido las estancias hospitalarias y en unidades de terapiaintensiva. Sin embargo existen complicaciones relacionadascon el procedimiento, una de las cuales es la Disección AórticaRetrograda tipo A que a pesar de su relativa baja incidencia,tiene una alta mortalidad.Objetivos y MétodosEl siguiente reporte presenta una disección aórtica retrógradatipo A como complicación de una colocación de una endo-prótesis torácica por una disección aórtica tipo B crónica.

Mediante la revisión de la literatura disponible se detallarán lasposibles causas predisponentes y las medidas preventivas paraevitarla.

Resumen del casoPaciente varón de 60 años con antecedentes de hipertensiónarterial de difícil manejo, cefaleas frecuentes y con diagnósticode Disección Aórtica Tipo B crónica.

Se le practicó derivación carótido-sublclavia izquierdo y colo-cación de endoprótesis aórtica tipo Relay NBS PLUS (BoltonMedical, Sunrise, FL) 38 x 34 x 200mm y Oclusión subclaviaizquierdo con Amplatzer (AGA Medical Corp. Plymouth, MN),obteniéndose un resultado angiográfico satisfactorio.

Girela, G.**; Bertoni, H.**; Bui, B.***; Sapoval, M.*; Barbosa, F.**; Barone, H.**

*Hôpital Européen Georges Pompidou;**Instituto Cardiovascular del Sur; Sherbrooke Hospital/InterventionalRadiology, ***Sherbrooke, QC/CA

Cuan corto puede ser el cuello proximal aórtico enun Aneurisma de Aorta Abdominal, cuando estratado con una prótesis SETA balón expandible

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Cinco días después presentó paro cardiorespiratorio sin pró-dromos. Se documentó derrame pericárdico de aspecto fibri-noso en la ecocardiografía, y a pesar de maniobras falleció.

Se confirmó por necropsia el diagnóstico taponamiento cardia-co secundario a disección aórtica retrógrada tipo A.

DiscusiónLa disección retrógrada aórtica tipo A es una complicaciónpoco frecuente después de la colocación de una endoprótesistorácica, con una incidencia variable entre 1 y 6,4%. Sin em-bargo se asocia a elevados índices de mortalidad que han sidoreportados cercanos al 50%.

Dicha complicación puede presentarse de forma variable en eltiempo desde las primeras horas posteriores al procedimiento

hasta varios meses después. Además la sintomatología es di-versa y algunos casos pueden ser asintomáticos. Las causasetiológicas que se han propuesto pueden relacionarse con elprocedimiento, el dispositivo colocado o con progresión naturalde la enfermedad, especialmente cuando se asocia a Síndromede Marfan.

ConclusiónLa disección retrógrada aórtica tipo A es una complicación po-tencialmente letal posterior a la terapia endovascular en laspatologías de la aorta torácica, sobre todo en los casos de dis-ección tipo B. Sus causas son diversas por lo que se debe ten-er atención especial sobre las características anatómicas delpaciente y las propias al dispositivo seleccionado. Además esimportante el protocolo de seguimiento, por su variable tiempode presentación.

IntroductionIt is reported that 1.65% of lower limb varicose veins are asso-ciated with ovarian vein insufficiency (OVI). Ovarian varices oc-cur in 10% of the general population of women, and maycause pelvic congestion syndrome (PCS). However, articles ofOVI or PCS in Japan are very few and there are only severalcase reports.

ObjectiveTo report our cases with OVI who were presented with leg vari-cose veins, and compare prevalence with previous literatures.Material and Method: 809 legs of 733 patients (511 females)with varicose veins were treated between April 2007 andDecember 2010. All patients were investigated with Duplexscan. Enhanced pelvic CT scan was performed when clinical orultrasound scanning suggested PCS, which is suspected byvarices at the thighs, buttocks, and vulva, and presence of epi-gastric or pudendal veins reflux. The symptoms of PCS, suchas pelvic pain, perineum discomfort, dyspareunia and dysuriawere also carefully questioned. If dilatation of ovarian veins orparauterin varices were seen on CT scan, patient underwentselective pelvic phlebography and diagnosed as PCS by visual-ization of ovarian or internal iliac veins insufficiency. A pres-sure gradient between left renal vein and inferior vena cavawas measured at the same time to identify nutcracker syn-drome and pressure gradient >3mmHg was considered signifi-cant.

ResultFour women (0.78%) had left-OVI but there was no patient withnutcracker syndrome. Two patients underwent coil emboliza-

tion of the left ovarian vein. Another two cases were followedconservatively because they had hardly any symptoms of PCS.[Case 1] A 43-year-old Gravida 3 Para 3 woman had been suf-fering from edema and pain of right crus and ankle. It is aggra-vated by menstrual period and reticular veins were seen atright lateral thigh and crus. Duplex scan showed no reflux atgreat and short saphenous veins but muscular deep vein inthigh.

Foam sclerotherapy for reticular veins did not reduce hersymptoms. Left-OVI was seen by selective pelvic phlebographyand she underwent coil embolization of the left ovarian vein.The ankle pain and edema has been improved for 6 months.[Case 2] A 64-year-old Gravida 3 Para3 woman was presentedwith varicose veins at upper posterior thigh and crus of the leftleg. She also had been suffering from chronic discomfort oflower abdomen and urinary frequency. There was no reflux atSFJ but great saphenous vein (GSV) from an external pudendalvein on Duplex scan. Left-OVI was detected in selective pelvicphlebography. Coil embolization of the left ovarian vein fol-lowed by foam sclerotherapy for the vulval varices and the se-lective GSV stripping was performed. The patient is free fromdiscomfort of lower abdomen and leg varicose veins after thetreatment for three years.

ConclusionPrevalence of OVI in our series was lower than other report. OVIis not very common as a cause of lower limb varicose veins butcan lead atypical symptoms which would not be improved byordinary treatment for leg varicose veins. Coil embolization ofthe ovarian vein was safe and effective for OVI.

Fujita, S.*; Kume, H.*; Sato, S.*; Kishino, M.**; Iwai, T.*

*Tsukuba Vascular Center; **Tokyo Medical and Dental University.

Ovarian vein insufficiency associated with legvaricose veins: an experience of single institutionin Japan

3756

Chimney grafts appear to be a good alternative to fenestratedgrafts in cases of abdominal aortic aneurysms with unfit necks.Technically it is a complex endovascular procedure, and carefulplanning is essential to the success of the procedure.

We report the case of a 72-year-old male who was admittedfor an elective endovascular repair of the abdominal aorta. TheCT scan had shown a short neck, and a chimney graft using acovered stent for the renal artery was the treatment chosen toexclude the aneurysmal sac. We first catheterized the left renalartery using a guidewire and angiographic catheter, whichproved to be unstable since we lost the renal catheterizationduring the endograft deployment. Before endograft dilation with

a balloon-catheter and after multiple attempts we were able toplace the guidewire between the graft and the aortic wall andfinally catheterize the left renal artery. A covered stent wasplaced in the renal artery and peristaltism of the excretory renalsystem was observed, as complete patency of the artery wasonce again achieved.

This case shows that, although difficult, it is possible to re-catheterize the renal arteries after accidental occlusion duringEVAR. Efforts should be made to revascularize because of theimportant clinical impact that a renal artery obstruction repre-sents.

Burrel, M.; Barrufet, M.; Oliveira, R.; Teixidor, M.; Montañá, X.; Riambau, V.

Hospital Clínic. Barcelona. Spain

Incidental renal artery occlusion duringdeployment of a planned chimney abdominalaortic endograft

IntroducciónLos aneurismas de la arteria esplénica son infrecuentes (0.04-0.8%) siendo mas prevalentes en mujeres que en hombres,con una relación de 4:1, El 80% cursan de forma asintomáticaaunque hasta un 10% pueden debutar con una rotura y una el-evada tasa de mortalidad.

ObjetivosExponer el manejo endovascular como tratamiento de una ro-tura de un aneurisma de arteria esplénica a propósito de uncaso.

Material utilizado Varón de 59 años con antecedentes de hipertensión arterial yfumador ocasional. Ingresa en urgencias por dolor abdominalintenso, mareo, sudoración profusa y pérdida de conocimiento.

A su llegada presenta una TA de 70/40.En el angio-TC se objetiva un aneurisma de arteria esplénicade 10x9, 5cm, con líquido libre perihepático, periesplénico yen ambas gotieras paracólicas. En la sala de angiografía se lepractica un estudio selectivo, vía femoral derecha, de la arte-ria esplénica objetivándose un gran aneurisma sacular depen-diente de la misma.

Método utilizadoSe coloca un introductor de 5F y 55cms de longitud (Cook) quese avanza hasta el interior del saco aneurismático. Gracias a laimagen 3D del TC se logra orientar catéter y guía para alcan-zar el cabo distal del saco y colocarlos en la arteria eferente.Esta se emboliza mediante la utilización de 1 Amplatzer Plug 4(9-avpo38-008) y el uso de 2 coils tornado (Cook). Para em-bolizar el saco, dado su gran tamaño, se emplea la funda

Ganzarain Valiente, L.; Rodriguez Saenz de Buruaga, V.; De Blas Bravo, M.; EgañaBarrenechea, J.M.

Hospital Donostia.

Tratamiento endovascular de aneurisma dearteria esplénica roto

3757

teflonada de una guía recta de 150cm de alma móvil, retirandocompletamente ésta y empujando la funda con suero a pre-sión. Se emplean 3 guías en total. Proximalmente se embolizala artería aferente con un Amplatzer Plug II (9-avp2-010) y eluso de 2 coils tornado. En el control angiográfico se objetivaexclusión completa del saco sin presencia de fugas en su inte-rior.

Resultados del estudioEl postoperatorio transcurre sin incidencias. En el TC realizadoal alta se objetivan pequeños infartos esplénicos sin reper-cusión clínica y ausencia de paso de contraste al saco. En elTC de control a los 4 meses, no se aprecian cambios.

Conclusión del estudioLa mortalidad de un aneurisma de arteria esplénica roto esmuy elevada (75%). Clásicamente el tratamiento de urgencia

es quirúrgico con resección del aneurisma acompañado o node esplenectomía con una mortalidad en torno al 40%. Eltratamiento endovascular es cada vez más aceptado como al-ternativa para los aneurismas de arteria esplénica mediante eluso de coils o el empleo de stent recubiertos. Aunque existenpocas referencias del tratamiento endovascular de estosaneurismas rotos, pensamos que es una buena alternativa porsu baja morbi-mortalidad. Además, dado que se conserva lacirculación colateral del bazo, el infarto esplénico es parcialconservando así su función disminuyendo el riesgo de sepsispor neumococo y meningococo.

En el caso descrito, el uso del Amplatzer nos parece un méto-do efectivo para embolizar la arteria esplénica sin riesgo demigración de coils. El empleo de la funda teflonada de unaguía de alma móvil en una aneurisma de grandes proporcionespuede resultar un método eficaz para favorecer la trombosisdel saco.

IntroducciónAproximadamente un 20-50% de los pacientes con un aneuris-ma de aorta abdominal (AAA), que no son candidatos para unacirugía abierta, no tienen un anatomía favorable para los dis-positivos convencionales disponibles para la reparación en-dovascular de los mismos (EVAR). El cuello aórtico proximal esuno de los factores limitantes y representa el indicador másimportante para el éxito o fracaso de esta técnica.

Caso ClínicoVarón de 66 años con antecedentes de HTA, DMNID, hiperco-lesterolemia, exfumador, cardiopatía isquémica sin revascu-larización coronaria, insuficiencia renal leve (Creatinina:1,4mg/dl), bloqueo auriculo-ventricular de primer grado, bociomultinodular y claudicación intermitente glútea en el miembroinferior derecho a corta distancia.

A la exploración presentaba pulso femoral izquierdo conausencia de femoral derecho, poplíteos y distales bilaterales,así como un abdomen muy globuloso con discreta hiperpul-satilidad.

En el AngioTAC abdominal y de miembros inferiores se eviden-ciaba un AAA yuxtarrenal bilobulado de 6.3 cm de diámetrocon una marcada ateromatosis calcificada en toda la aorta e il-iacas, una estenosis significativa en la arteria iliaca externaderecha (IED) y el resto de ejes arteriales permeables.

En la radiografía de tórax se apreciaba un ensanchamiento delmediastino superior y signos de broncopatía crónica, realizán-dose TAC de tórax que informaba de elongación de la aortatorácica y bocio multinodular.

Por las comorbilidades del paciente y un riesgo anestésico ASAIV, se descartó la opción de una cirugía abierta y se planteó eltratamiento endovascular del AAA como única opción; altratarse de un aneurisma yuxtarrenal, se discutieron como op-ciones terapéuticas una endoprótesis fenestrada o una EVARen chimenea, decidiéndonos por esta última por la disponibili-dad inmediata de los dispositivos necesarios así como por sumenor coste económico.

Se realizó la exclusión endovascular en técnica de chimenea,bajo anestesia general, mediante una endoprótesis bifurcadaEndurant (Medtronic®) de 36x16x145 mm, utilizándose comovía de acceso la femoral derecha tras angioplastia de IED conbalón de 7mm, stents recubiertos expandibles con balón enambas arterias renales ADVANTA (6x38 y 7x38 mm) (vías arte-rias humerales), tres extensiones a iliacas comunes y stent au-toexpandible en IED (8x40 mm) al finalizar el procedimiento.

El paciente fue dado de alta de la Unidad de ReanimaciónPostquirúrgica en menos de 24 horas y no precisó transfu-siones; a la exploración pulsos femorales, poplíteos y tibialposterior derecho presentes. La radiografía abdominal de con-

Craven-Bartle Coll, A.; Conejero Gómez, R.; Rodriguez Piñero, M.; Doiz Artazcoz, E.;Arribas Aguilar, F.; García Turrillo, E.; Martín Cañuelo, J.

Hospital Universitario Puerta del Mar (Cádiz)

Reparación endovascular de aneurisma de aortayuxtarenal mediante la técnica en chimenea a lasdos arterias renales

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PURPOSE/AIM OF THE EXHIBIT1.- To introduce the different strategies available in the man-agement of complex thoracoabdominal aortic diseases.

2.- To illustrate the ability of multidetector CT with MPR, MIPand VR reconstructions to improve the readers’ understandingof the grafts and it’s relationship to normal arterial branches.

CONTENTS1.- Define thoracic, thoracoabdominal and abdominal aorticaneurysms with complex anatomy

2.- Describe techniques of management of complex aortic dis-eases: • Hybrid repair: combined surgical and endovascular strategies• Complex endovascular techniques

- Fenestrated endografting- Branched endografting

3.- Illustrate imaging findings using helical CT angiography ofthe different techniques described above: Normal findings in-cluding localization of the surgical and stent grafts in relationto the arterial branches

CONCLUSIONS/ SUMMERYKnowledge of endovascular techniques, including hybrid re-pair, of complex aortic diseases is crucial for radiologists toprovide the referring clinician information to determine appro-priate clinical care.

MDCT, including vascular reformations, is the diagnostic testchoice for treatment assessment.

Teixidor, M.; Burrel, M.; Barrufet, M.; Real, M.I.; Montana , X.; Riambau, V.

Hospital Clinic Barcelona

Postprocedure CT evaluation of endovascularand hybrid repair of complex aortic aneurysms:a pictorial review

trol confirmaba un buen posicionamiento de las endoprótesis,siendo dado de alta con función renal conservada (Creatinina:1,7 mg/dl).

En el AngioTAC al mes, no se evidenciaban endofugas estandolos stents renales permeables; la función renal se manteníaestable (Creatinina: 1,7 mg/dl).

ConclusionesEn nuestra experiencia esta técnica es una alternativa en AAAcon zonas de anclaje proximales desfavorables, cuellos aórti-cos cortos o con una excesiva angulación, permitiendo ademásutilizar dispositivos convencionales de rápida disponibilidad ysin elevado coste económico.

Objetivos: El objetivo de este trabajo es relatar la experienciaen tratamiento endovascular de aneurisma de aorta abdominalen pacientes con ramas arteriales renales accesorias.

Material y métodos: En el periodo de febrero de 2008 hastadiciembre de 2010 se intervinieron 8 varones, portadores deAAA, mediante implante de endoprótesis con oclusión inten-

Grochowicz, L.**; Dzieciuchowicz, L.*; Lavilla Royo, F.**; Arbizu Lostao, J.**; Hernández Argüello, M.**; Espinosa, G.**

*Hospital Universitario Poznan; **Clínica Universitaria.Departamento de Cirugía Vascular. Clínica Universidad de Navarra. Pamplona. España.

Función renal en pacientes con AAA tratadosmediante endoprótesis con oclusiónintencionada de rama renal accesoria.

cionada de al menos una de las ramas arteriales renales acce-sorias. La edad media fue 72 (63-84) años. Ninguno de los pa-cientes tenía un aclaramiento de creatinina (según fórmulaMDRD-4) menor de 55 ml/min/1.73 mE2. Antes del proced-imiento se valoró por gammagrafía la posible repercusión de laoclusión de la rama accesoria sobre la función renal. Se reco-gieron datos referentes a función renal antes y a los 1, 3, 10,30 y 90 días después de la intervención.

Resultados: No hubo fallecimientos y ningún paciente requirióhemodiálisis durante el periodo de seguimiento. En el postop-eratorio inmediato 4 pacientes presentaron un cuadro de dolorleve en flanco abdominal que cedió con analgésicos. En el pre-operatorio ningún paciente presentaba insuficiencia renal sig-nificativa (estadio mayor de 2 según clasificación DOQI). Se

produjo incremento de los niveles de creatinina entre lasprimeras 24 y 72 horas siguientes a la intervención, con de-scenso posterior en todos los pacientes, salvo en un caso. Alos 30 y 90 días todos presentaron niveles de creatinina enplasma semejantes a los basales.

No se observaron endofugas dependientes de las arterias re-nales ocluidas por la endoprótesis.

Conclusiones: El implante de endoprótesis con oclusión inten-cionada de ramas arteriales renales es una posible opción ter-apéutica en el tratamiento de AAA, con bajo riesgo para la fun-ción renal. La gammagrafía renal es importante en la valo-ración preoperatoria.

IntroductionCurrently stent grafts for the thoracic aortic aneurysm exclu-sion are the covered stent grafts, which require a large deliverysheath for delivery and the grafts do not incorporate into aorticwall. Amplatzer Thoracic Graft (ATG) is designed with the fea-tures of low profile, recapturable, repositionable and integra-tion of the aortic wall.

ObjectivesTo evaluate ATG for the exclusion of aneurysms in a swinemodel under Good Laboratory Practice (GLP) conditions.

Material usedThoracic Aortic Aneurysms (TAA) were surgically created in 18swine (58.2-87.6 kg) using a fusiform Dacron graft. ATG is aself-expanding tubular prosthesis consisting of two nitinol andtwo polyester layers of braid. It was mounted into a deliverycatheter with a lock mechanism allowing fully recapture andreposition of the graft during implant. The graft was anchoredat the proximal landing zone of the aneurysm with a folded andsmooth nitinol braid edge.

Methodology usedAbout 2 weeks after the model creation, the graft was implant-ed using a 12F sheath. Angiography was performed to monitorthe exclusion of the aneurysm. Pressure measurements wereperformed above, in the middle of and below the graft, respec-tively. Animals were followed up at 1 week, 1 month, 3 monthsand 6 months, and afterwards euthanized for pathology exami-nation.

Results of the studyThe maximal diameter of the aneurysm was 30-36 mm(32.3±1.7 mm). The length of the aneurysm was 40-60 mm(47.9±4.9 mm). The diameter of aorta nearby the aneurysmwas 15-19 mm (16.8±1.3 mm). The diameter of the graft usedin this study was 18-21 mm (18.9±1.1 mm). Graft implanta-tion was technically successful in all 18 cases. Recapture andreposition of the graft were tried at 10 implants without any is-sues. Aneurysm exclusion rates by angiography and ultrasoundwere 83.3% after implant, 94.4% at 1 week, and 100% at 1month, 3 months and 6 months. All implanted grafts remainedstable in the implanted position throughout the course of thestudy. Three animals were out from the study after 1 week fol-low up. Two of the three animals died at day 8 from ileus/duo-denal rupture and bleeding gastric ulcer respectively; the otheranimal was euthanized at day 14 because of lameness andhealth concerns. Although increased joint fluid was observed,the brain was normal microscopically and the exact cause forthe lameness remained unclear. One animal was sudden deathwhen feeding. Pathology demonstrated generally optimal heal-ing of the grafted aorta and aneurysm characterized by inclu-sion of the graft in organized, maturing and stable neointima.All the aneurysms were full excluded and filled by organizedthrombus.

Conclusions of the studyEndovascular exclusion of TAA was achieved using a novelmetal/fabric hybrid graft in an animal model. The ATG offersthe advantages of low-profile introduction, reposition / recap-tureability and incorporation into aortic wall with neointimalcoverage of the graft surface for aneurysm exclusion.

Gu, X.; Zhao, C.; Russo, P.; Heidner, M.; Oslund, J.AGA Medical Corporation

Exclusion of thoracic aorta aneurysm using theAmplatzer thoracic graft: preclinical evaluationin a large swine model

3759

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Introduction. Benefits of endovascular aneurysm repair havebeen published in several reports. The Zenith endograft is athird-generation device that is widely used for EVAR.

Objective. The aim of this study is to present our single-centerresults of the Cook Zenith endograft after a mean follow-up of66.4 months.

Material and Methodology. Between September 1998 andOctober 2003, 143 patients underwent elective endovascularaneurysm repair using the Cook Zenith endograft. Data fromthese patients were reviewed from a prospective database inOctober 2008. Primary outcome measures were overall sur-vival, intervention-free survival, and freedom from aneurysmrupture. Secondary outcome measures were early and latepostoperative complications, including endoleaks.

Results of the study. Mean follow-up was 66.4 months.Overall survival was 72.1% at 5 years and 63.8% at 8 years.

There were no reinterventions-related deaths. Six patients hadlate aneurysm rupture, which was fatal in three. Freedom fromaneurysm rupture was 98.1% at 5 years and 91.0% at 8 years.Late complications occurred throughout the follow-up period,with a tendency for aneurysm rupture and surgical conversionto occur at a later stage in follow-up period. Aneurysm sac en-largement during follow-up was associated with late aneurysmrupture and with need for reintervention.

Conclusion of the study. Elective EVAR using the Cook Zenithendograft provides excellent results through a mean follow-upof >5 years.

There is a low aneurysm-related mortality and an acceptablerate of postoperative complications and reinterventions. Theoccurrence of late complications throughout the follow-up peri-od stresses the need for continued postoperative surveillancein EVAR patients.(Accepted for publication J Vasc Surg 2011)

Houthoofd , S.

University Hospital Gasthuisberg Leuven.

Endovascular abdominal aneurysm repair usingthe Cook Zenith Graft. A single center experience

INTRODUCCIÓNLas lesiones radionecróticas a nivel de los troncos supra-aórti-cos (TSA) son extremadamente raras. Su tratamiento, debido ala dificultad de acceso quirúrgico, la gran fibrosis producidapor la radiación y la proximidad de importantes estructurasvasculo-nerviosas susceptibles de ser lesionadas, supone unreto para el cirujano vascular.

OBJETIVOPresentamos dos casos de lesión radioterápica de la arteria in-nominada con sangrado agudo y alto riesgo quirúrgico, quefueron tratados satisfactoriamente mediante colocación de en-doprótesis.

CASOS CLÍNICOSSe trata de dos pacientes que acudieron a urgencias por pre-sentar un sangrado activo por radionecrosis: la primera, a nivelde hemotórax izquierdo después de mastectomía y radioter-apia para el tratamiento de cáncer de mama; la segunda, através de una fístula cutánea sangrante a nivel esternal comosecuela del tratamiento quirúrgico y radioterápico por cáncerde tiroides. La arteriografía intraoperatoria realizada por pun-ción femoral, mostró en ambos casos la existencia de unpseudoaneurisma en el origen del tronco braquiocefálico.Mediante abordaje quirúrgico de carótida común derecha secolocó una endoprótesis Wallgraft (Boston Scientific) por víaretrógrada, logrando la exclusión del pseudoaneurisma y la es-

Cenizo, N.; González, J.A.; Salvador, R.; Gastambide, V.; Gutiérrez, V.; Vaquero, C.;Martín, M.

Hospital Clínico Universitario de Valladolid

Lesión radionecrótica a nivel de la arteriainnominada

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tabilización hemodinámica de las pacientes. La oclusión delorigen de la arteria subclavia derecha fue bien tolerada y nopresentó repercusión clínica posterior.

Una paciente permaneció asintomática, con remisión de lalesión en angio-TAC de control a los 6 meses de evolución.

La otra, por el contrario, presentó un cuadro de mediastinitis alos 3 meses de seguimiento a través de la fístula cutánea queno respondió a antibioterapia, falleciendo a pesar del selladocompleto del pseudoaneurisma.

CONCLUSIÓNAunque las lesiones vasculares actínicas suelen ser esteno-oclusivas, se presentan dos excepcionales casos de pseudoa-neurisma por radionecrosis de los TSA. Las técnicas endovas-culares, en comparación con la cirugía convencional, permitenun rápido diagnóstico y tratamiento de este tipo de lesiones,mejorando la morbi-mortalidad asociada al tratamiento quirúr-gico y logrando el manejo óptimo del paciente en una situaciónvital crítica. La evolución a largo plazo, sin embargo, dependede la progresión de la enfermedad y de sus complicacionesclínicas.

IntroduccionDesde sus primeras aplicaciones, la PTA de las arterias tibialesy del pie se ha demostrado tecnicamente posible y segura. La patologia polidistrectual, generalmente presente en los pa-cientes diabeticos, hace si que el tratamiento endovascularsea complejo, con necesidad de revascularisación a distintosniveles del árbol vascular arterioso.

Actualmente el mayor desafío es vencer la re-estenosis de losvasos tratados mediante PTA. La solución podria estar en losnuevos materiale disponibiles, en particular en los balones lib-eradores de farmaco, que deberian garantizar la disminuciónde las re-estenosis, mejorando la permeabilidad de las arteriastratadas.

CasoPaciente de 70 aos, sexo masculino, con diagnosis de CriticalLimb Ischemia y arteriopatia polidistrectual de la pierna y delpie, precedentemente sometido a tratamiento endovasccular anivel de la arteria femoral superficial, con implante de multi-ples stents.

El paciente presentaba diabetes de tipo II, hipertensión arte-riosa y dislipidemia, como factores de riesgo.

La concentración de oxígeno transcutanea (TcpO2) a nivel delpie era de 7 mmhg y el paciente presentaba dehiscencia sobreamputación del cuarto dedo (lesion III D seg. TUC).

El estudio angiográfico, precedente al tratamiento, demostrabaobstrucción de la arteria femoral superficial con reabitación dela arteria poplitea, obstrucción de los tres vasos tibiales al ori-gen y reabitación de la arteria tibial posterior. A nivel del pie

permeabilidad de las arterias plantares y del tracto proximal dela arteria pedidea, obstruida la arcada pedalico-plantare.

Durante el tratamineto fueron dilatadas la arteria femoral su-perficial, la poplitea, las arterias tibiales, la arteria plantar lat-eral, la pedidea y la arcata pedalico-plantar, utilizando el balonliberador de farmaco a este último nivel.

ComentariosLa situación inicial imponia el tratamiento completo de todo elárbol arterioso de la pierna y del pie, incluida la arcada pedali-co-plantar. Durante el procedimiento se decidió de utilizar unbalon liberador de farmaco en la arcada, con el objetivo de au-mentar el run-off de las arterias digitale, incrementando el flujosanguìneo hacia los dedos y mejorando la permeabilidad de lasarterias tibiales en el tiempo.

El procedimiento fue realizado con multiples guias, combinan-do distintas tecnicas (recanalizacion subintimal, pedal-plantarLOOP technique, etc), en un verdadero tratamiento de Limband Foot Salvage, obteniendo un resultato excelente, con per-meabilidad de todas las arterias de la pierna y del pie,restableciendo el flujo sanguineo hacia todos los dedos.

ConclusionesEl caso demuestra que es posible el tratamiento endovascular,en casos extremamente complejos, combinando distintas tec-nicas y distintos materiales. Los balones liberadores de farma-co representan una alternativa en la batalla contra la re-es-tenosis. En los casos con patologia muy extendida, visto queactualmente no es posible tratar todos los vasos comprometi-dos, utilizar esta tecnologia distalmente podria garantizar unrun-off adecuado y de consecuencia mejorar la permeabilidadde las arterias a monte, mejorando a su vez el flujo distal.


Policlinico Abano terme.

Tratamiento Endovascular en caso de arteriopa-tia polidistrectual de la pierna y de las arteriasdel pie, con utilizo de DEB a nivel del LOOP.

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IntroduccionLa re-obstrucción es una complicación frecuente del posizion-amento de stent, en el tratamiento endovascular, en particulara nivel de la Arteria Femoral Superficial. Las opciones terapeu-ticas son la cirugia vascular o el tratamiento endovascular. Eltratameitno endovascular es la opción menos agresiva, pero enla mayor parte de los casos resulta dificultoso atravesar elstent obstruido. Proponemos un caso tratado con acceso en-dovascular, poniendo en practica una nueva tecnica dedicadaa la revascularización de el stent obstruido (MAPACETechnique).

CasoPaciente de 57 aos, sexo femenino, con diagnosis di CLI. Elpaciente habia sido precedentemente sometido a tratamientoendovascular a nivel de AFS, con implante de multiples stents,el estudio Eco-colordoppler demostraba obstrucción de losstent anteriormente implantados. Los factores de riesgo eranDiabetes tipo II, hipertensión arteriosa, dislipidemia y cardiopa-tia isquemica. El paciente no presentaba lesiones ulceradas alpie pero presentaba claudicatio intermitens a 50 metros. El es-tudio angiografico, precedente al tratamiento, demostraba ob-strucción de la arteria femoral superficial con reabitación de laarteria poplitea y rotura de los stents anteriormente implanta-dos.

A nivel de los vasos tibiales la arteria tibial anterior y posterioreestaban obstruidas, la arteria interosea se presentaba obstrui-da al tracto proximal y permeable el tracto distal. A nivel del

pie los ramos perforantes de la arteria interosea revascularisa-ban la arteria plantar lateral y un ramo tarsal.

Despues de numerosos intentos, infaustos, de cruzar el stentobstruido a traves del accesso anterogrado a nivel de la arteriafemoral común, se decidió de crear un accesso retrogrado, di-recto a nivel del tracto distal del stent, con recanalización delstent, rendez-vous, posicionamiento de una guia en direcciondel flujo y revascularización de la arteria Poplitea e de la arteriainterosea, con excelente resultado final.

ComentariosRestablecer el flujo sanguineo en los casos con stents obstrui-dos puede resultar muy dificultoso, sobre todo en los casos deobstrucción cronica. La alternativa es realizar una recanal-ización subintimal, que comporta implantar un nuevo stent(doble stent), con el claro riesgo de re-obstrucción. Esta nuevatecnica, “MAPACE Tecnique” permite de realizar la revascular-ización de o de los stent obstruidos, a nivel de la arteriafemoral superficial, sin aumentar significativamente el tiempodel tratamiento, evitando el implante de nuevos stents.No se verificaron complicaciones durante o post-tratamiento(trombosis aguda, embolia o hematoma).

ConclusionesLa tecnica “MAPACE” es una segura y efectiva alternativa parael tratamiento de revascularización de los stent obstruidos, de-spues de numerosos intentos fallidos de cruzar a traves delstent con el accesso anterógrado.


Policlinico Abano terme (1)

Nueva técnica para tratar la obstruccionintra-stent a nivel de la arteria femoralsuperficial (¿MAPACE Technique?), enpaciente diabético, con diagnosis de CLI

Introduction: Iliac Aneurisms aren’t so frequent, but most of-ten they present ruptured and in this case they are burdenedwith high postoperative mortality rate that’s higher in case ofhypogastric aneurisms.

A 57-yrs-old man was urgently admitted because an abdomi-nal pain lasting more than 24 hours. At the physical examina-tion there was an abdominal tenderness, with hypotension andlow haemoglobin.

La Barbera, G.*; Vallone, M.**; La Marca, G.*; La Rosa, G.*; Valentino, F.*; Ferro, G.*

*Vascular Surgery Unit; **Interventional Radiology

Endovascular urgent treatment of ruptured bilateral iliac aneurysm

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Clinical case: The patient had a significant medical history, ofterminal chronic renal insufficiency, chronic obstructive pul-monary disease, coronary disease already grafted, cirrhosis,arterial hypertension, and known iliac artery aneurysm.

The patient underwent an aortic graft 11 yrs before because anabdominal aortic aneurysm. The 5 yrs MR-angiographyshowed the regular patency of the graft but also the presenceof around 3 cm bilateral hypogastric aneurysm, Confirmed byarteriography.

The urgent abdominal CT performed at the admission showedthe bilateral hypogastric aneurysms of which the one of rightwas dominant with 9 cm diameter, presenting a contained rup-ture. Considering the comorbidities and because the pt wasstable, it was decided to treat him by endovascular procedure.We emploied an ANACONDA® endograft.

The arteriographic control showed a type 1 leak because theleft hypogastric aneurysm wasm’t covered, so we overcame it

by a Zenith extension leg of the same daiàmider but the arteri-ography showed the persistence of the leak although reduced;we considered it as cause of an inefficient sealing at the levelof the overlapping zone between the left leg and the extension;so we performed the ballooning of this area with the resolutionof the leak. The anterograde arteriography showed the patencyof the endograft although the presence of a leak type 3 at thelevel of the overlapping zone between the body and the left legthat we fixed with another Cook limb extension of the same di-ameter.The pt did well and he was discharged after 5 days. The 1month post-EVAR abdominal CT confirmed the regular attitudeand patency of the graft with occlusion of the hypogastricaneurysm.

Conclusion: The surgical treatment of ruptured hypogastricaneurisms, because the anatomic location, is a complex act,burdened with high mortality rate. Up to date the endovascularapproach can be considered the first line treatment of rupturedhypogastric aneurisms

Introduction: EVAR decreased overall morbidity and mortalityassociated with Abdominal Aortic Aneurysm (AAA), but not allthe patients are regularly fit for EVAR because complexanatomic features.

Objectives: Authors prospectively compare results of EVARtreatment in complicated and normal AAA. End point: postoper-ative major complications (acute limb ischemia, end stage re-nal insufficiency, infections, stroke,paraplegia) and mortality,matched with preoperative variable.

Material used: From January 2005 to December 2010, 109pts (100 men and 9 women) underwent EVAR treatment. Weconsidered as complicated AAA: aortic anastomotic AAA (4pts), more than 7 cm of diameter (17 pts), class C - D - E AAA(22 pts), an aortic and/or iliac angulation more than 60° (23pts) and an associated iliac aneurysm (17 pts).

Methodology used: Continous variables were evaluated by tStudent test and categorical variables by 2 test. We com-pared Group 1 (complex AAA) 48 pts and Group 2 (normal AAA)61 pts.

Result of the study: The mean age was 72.4 yrs (range: 51 –87) (DS:7.1). Group 1 mean age was higher (74.8 vs 70.6)p<0.05. Group 1 had older pts (58% vs 32%) p<0.005, more cardiac pts (88%vs 80%) p=ns, the AAA was more than 6 cm (48% vs 16%) p<0.005,more branch graft occlusion (6.5% vs 5%) p=ns, more leaks (10.5% vs6.5%) p=ns, more hybrid procedure (15% vs 3%) p<0.05, more techni-

cal pitfalls (8.5% vs 6.5%) p=ns, more aorto-uniliac graft (10.5% vs 5%)p=ns and higher mortality (4.5% vs 3.5%) p=ns. Higher postoperative major complication rate was found in:

Group 1 young pts (15% vs 3.5%) p=ns, than Group 2 (12% vs 11%)p=ns, Group 2 big AAA (20% vs 10%) p=ns, than Group 1 (9% vs 8%) p=ns,Group 1 cardiopatic pts, (17% vs 7%) p=ns, than Group 2 (8% vs 12%)p=ns,Group 1 aorto-uniliac graft (40% vs 5 %) p<0.01, than Group 2 (0% vs12%) p=ns,Group 2 hybrid procedures (50% vs 10%) p<0.05, than in Group 1 (14%vs 7%) p=ns, higher postoperative mortality rate was found in Group 1 young pts (15% vs 0%) p<0.05, than Group2 (5% vs 0%) p=ns,Group 1 little AAA (12% vs 5%) p=ns than Group2 (4% vs 0%) p=ns,Group 1 cardiopatic pts, (17% vs 2.5%) p=ns, than Group 2 (0% vs 4%)p=ns,Group 1 aorto-uniliac graft pts (20% vs 5%) p=ns, than Group 2 (0% vs4%) p=ns,Group 1 hybrid procedures (14% vs 5%) p=ns, than in Group 2 (0% vs3.5%) p=ns,During the FU, we obtained 98% cumulative survival rate at 5yrs in Group 1, and 86% at 9 yrs in group 2.

Conclusion of the study: Pts with Complex AAA are signifi-cantly older, with bigger AAA and require more hybrid proce-dures.

Complex AAA postoperative major complication rate is only af-fected by the aorto-uniliac graft while postoperative mortalityrate is affected by younger age. EVAR in complex anatomicfeatures is a skill.

La Barbera, G.*; Vallone, M.**; La Marca, G.*; Ferro, G.*; Mirabella, D.*; Tutone, G.*

Vascular Surgery Unit (1); Interventional Radiology (2)

Is it worth the EVAR treatment in complicatedabdominal aortic aneurysm ?

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Objetivos: Describir los resultados iniciales de los primeros 40pacientes con Aneurisma de Aorta Abdominal (AAA) tratadoscon la endoprótesis Aorfix® (Lombard) en nuestro centro.

Material y métodos: De Junio-2007 a Enero-2011 fueron in-tervenidos 40 pacientes (2 mujeres), de edad media 71,33años (55-87), con HTA (83,3%), dislipemia (63,3%), cardiopatíaisquémica (40%) e insuficiencia renal (30%) como principalesproblemas asociados. Todos presentaban un AAA infrarrenalquirúrgico que cumplía con los requisitos para la técnica en-dovascular. De ellos, 18 presentaban aneurisma de 1 ó 2 ilía-cas y 8 una angulación mayor de 45°. La anestesia fueraquídea (73,3%). El acceso vascular fue la disección femoralbilateral. El tiempo medio quirúrgico fue de 77,5 minutos (45-190). En 13 casos fue preciso emplear extensiones distales y 2necesitaron extensiones proximales.

Resultados: En 4 casos se detectó una endofuga inicial, 2 tipoII y 2 tipo IV. En un caso fue preciso reparar una rotura de arte-ria ilíaca externa. Se produjo una disección Stanford B aguda

retrógada hasta subclavia izquierda, tras balonear la endo-prótesis, con una endofuga tipo Ia por llenado de la falsa luz enel saco. Se reparó mediante una endoprótesis torácica (Relay,Bolton) y un Stent aórtico XL (Jotec) entre ambas prótesis, quesolucionó ambos problemas.

Tras un seguimiento medio de 17,3 meses (1-38), el 86% pre-sentan una trombosis del saco, de ellos, en el 92,3% hay unareducción significativa del diámetro aneurismático.

Tres pacientes presentan una endofuga tipo II sin complica-ciones. Se ha reintervenido un paciente por endofuga tipo Ibmediante extensión ilíaca. Un paciente ha fallecido por causaajena al aneurisma. No hubo complicaciones en los casos an-gulados.

Conclusiones: Aorfix® tiene un comportamiento igual debueno que el resto de dispositivos en casos convencionales. Suflexibilidad y adaptabilidad permiten abordar cuellos muy an-gulados con resultados esperanzadores.

García Martín, I.; Tascón, V.; Fernández Divar, J.; Pontón Cortina, A.; Jordá Lope, J.;Bustamante, M.; Revuelta Soba, J.

Hospital Universitario Marqués de Valdecilla (1)

Experiencia inicial con la endoprótesis Aorfix.Resultados de lo 40 primeros pacientes

INTRODUCCIÓN: Hasta hace muy poco la cirugía era la únicaopción terapéutica en el tratamiento de patología en el arcoaórtico, asociándose a cada procedimiento tasas de morbimor-talidad nada despreciables. La combinación con técnicas en-dovasculares, llevadas a cabo por equipos multidisciplinares,se presenta como una alternativa válida logrando buenos re-sultados en el tratamiento de malformaciones complejas de ar-co aórtico.

OBJETIVOS: Describir y analizar la técnica adoptada en la res-olución de una malformación infrecuente del arco aórtico me-

diante la combinación de cirugía convencional y técnicas en-dovasculares llevada a cabo en nuestro hospital.

MATERIAL Y MÉTODO: Paciente varón de 73 años, exfumador,diabético, dislipémico y cardiópata filiado, que, tras dos añosde evolución consulta por tos irritativa “incurable” y ronquera.Se realiza una aortografía torácica que revela una variante dela normalidad en el origen de troncos supraaórticos consistenteen: primer tronco común que se bifurca en A. Carótida derechae izquierda, seguido del origen de A. Subclavia izquierda (ASI),y pegado a ella, salida en cara medial del arco de A. Subclavia

Fernandez-Divar, J.A.; Garcia, I.; Jorda, J.; Sarralde, J.A.; Pontón, A.; Tascón, V.;Revuelta, J.M.

Hospital Universitario Marqués de Valdecilla.

Tratamiento híbrido de malformaciones en elarco aórtico. A propósito de un caso

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derecha (ASD) aneurismática en segmento proximal, que cruzahasta llegar a hemicuerpo derecho. Tras el diagnóstico, se re-aliza bajo anestesia general en un quirófano híbrido la im-plantación endovascular de prótesis Aórtica Relay Plus®(36x145mm) provocando la oclusión intencionada de ASD, jun-to a bypass subclavio-subclavio con injerto de Dacron® anilla-do (8mm) y ligadura de ASD aneurismática. No se dan compli-caciones intraoperatorias. Finalmente, se comprueba medi-ante angiografía la exclusión de la anomalía y el buen fun-cionamiento del bypass ASD-ASI.

RESULTADOS: Tras 5 días de postoperatorio el paciente es da-do de alta con pulsos distales positivos en ambas EESS, conlas heridas en proceso de cicatrización y sin tos irritativa nironquera. Un mes tras el procedimiento, permanece asin-tomático y en el TAC de control no se objetivan endofugas.

CONCLUSIONES: El aneurisma de arteria subclavia es unaidentidad infrecuente y con una expresión clínica muy escasa,

que cuando existe, produce disfagia por compresión o biendisfonía o ronquera por parálisis del nervio laríngeo recurrente.La prueba complementaria de elección para su diagnóstico esla arteriografía, ya que, además de descartar la existencia deaneurismas a otro nivel, sirve para evidenciar el eventual ori-gen anómalo de la arteria subclavia afecta. Hasta hace poco, laúnica posibilidad era el tratamiento exclusivamente quirúrgico,lo que suponía altas tasas de morbimortalidad asociadas alprocedimiento.

En la última década, el manejo terapéutico de esta afección haexperimentado un notable avance. El creciente interés que de-spiertan las técnicas endovasculares y la formación de equiposmultidisciplinares suponen una alternativa válida y efectivafrente a la cirugía aislada, consiguiendo muy buenos resulta-dos con una disminución considerable de las complicaciones yentrando a formar parte del arsenal terapéutico del quedisponemos para resolver malformaciones complejas en el ar-co aórtico.

INTRODUCTION: Carotid artery stenting (CAS) is a technicallydemanding procedure with a risk of causing strokes. A scoringsystem based on anatomic criteria has been developed by ex-perts to facilitate appropriate case selection for CAS. Recentadvancements in simulation science also permit case evalua-tion through patient-specific simulated rehearsal (PsR), by in-corporation of DICOM datasets into the simulation software.This enables the interventionalist to rehearse the case on anendovascular simulator prior to the procedure on the actual pa-tient. This study aimed to validate the expert derived scoringsystem using the PsR technology and to evaluate whether pa-tient cases of varying difficulty, graded according to the scoringsystem, influence performance parameters.

MATERIALS: Novice interventionalists were recruited into thestudy. Three patient cases of varying difficulty were selectedout of a database, according to the scoring system (maximumscore of 9). One case was considered easy (score :< 4.9), oneintermediate (5.0-5.9) and one difficult (> 7.0). These real pa-tient cases were incorporated into the simulation software andhardware after 3D levelset segmentation of the CT datasets.

METHODS: All novice interventionalists were pretrained in theCAS procedure by standardized cognitive and technical trainingsessions. Following training, each participant performed thepatient-specific CAS cases on a high fidelity simulator in a ran-domized order. Technical performance was assessed usingsimulator-based dexterity metrics. The quality of the procedure

was assessed by expert-based video ratings using the globalrating scale (GRS) and the procedure specific rating scale(PSRS) for CAS.

RESULTS: Twenty novice interventionalists were enrolled. Theinterventionalists took significantly more time to perform thedifficult CAS case (median 31.6 vs. 19.7 vs. 14.6min,p<0.0001) in comparison to the intermediate and easy case;more fluoroscopy (20.7 vs. 12.1 vs. 8.2min, p<0.0001), con-trast volume (56.5 vs. 51.5 vs. 50.0ml, p=0.0060) androadmaps were used (10 vs. 9 vs. 9, p=0.0040). Furthermorethe total time needed to catheterize the CCA (2.8 vs. 7.0 vs.15.8 min, p<0.0001) and to catheterize the ICA (1.3 vs. 1.1vs.1.7 min, p=0.0020) increased significantly with increasingcase severity. The quality of the performance, as measured byexpert-based ratings, declined significantly as the cases be-came more difficult for both the GRS (median scores 30 vs. 27vs. 25 p<0.0001) and also the PSRS (median scores 24 vs. 22vs. 19, p<0.0001).

CONCLUSION: The Delphi derived anatomic scoring system forCAS can adequately predict the difficulty of a CAS procedure asmeasured by patient-specific rehearsal on an endovascularsimulator. This scoring system, with or without the additionaluse of PsR, can guide novice interventionalists in selecting ap-propriate patients for CAS. This may reduce the perioperativestroke risk and improve patient safety.

Willaert, W.***; Cheshire, N.*; Aggarwal, R.*; Van Herzeele, I.***; Macdonald, S.**;Vermassen, F.***

*Imperial College London, St. Mary's Hospital; **Freeman Hospital; ***Ghent University Hospital.

Towards Safer Carotid Artery Stenting: Validationof the Scoring System for Anatomic Suitability forCAS with Simulated Procedure Rehearsal.

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Objetivos: Mostrar la utilidad y polivalencia del Stent aórticoXL (Jotec) en 3 diferentes situaciones que se pueden presen-tar cuando se emplean técnicas endovasculares para eltratamiento de la patología aórtica.

Material y métodos: Caso1: paciente de 71 años que presen-ta Aneurisma de Aorta Abdominal (AAA) al que se le implantóendoprótesis aorto-biilíaca (Jotec). En la angiografía de controlse evidenció endofuga tipo Ia persistente tras remodelado conbalón. Se implantó Stent XL desde aorta diafragmática hastabifurcación protésica.

Caso 2: paciente mujer de 73 años con AAA que tras implantarendoprótesis Aorfix (Lombard), presentó disección Stanford Bretrógrada hasta subclavia izquierda, además de endofuga tipoI por llenado de falsa luz en el saco. Tras implantar una endo-prótesis torácica (Relay, Bolton), se colocó un Stent XL entreambas prótesis, colapsando la falsa luz y eliminando la en-dofuga.

Caso 3: Paciente de 72 años que presenta una disecciónStanford B crónica desde subclavia izquierda hasta femoralcomún derecha. Tras presentar agudización con dolor lumbar yaneurisma de la falsa luz, es tratado mediante endoprótesistorácica (Jotec) y 2 Stent XL en la aorta abdominal, desde laprótesis torácica hasta la bifurcación en ilíacas, consiguiendola trombosis de la falsa luz a nivel torácico y minimizando elllenado a nivel abdominal.

Resultados: En los sucesivos controles, los casos 1 y 2 pre-sentan trombosis del saco aneurismático sin complicaciones yen el caso 3 únicamente se aprecia un leve llenado de la falsaluz abdominal, sin crecimiento en el diámetro, estando el pa-ciente asintomático.

Conclusiones: El Stent aórtico XL es una herramienta útil en eltratamiento de las disecciones aórticas y de las complica-ciones del tratamiento endovascular de los aneurismas de laaorta abdominal.

Tascón Quevedo, V.; García Martín, I.; Fernández Divar, J.A.; Pontón Cortina, A.;Jordá Lope, J.; Bustamante, M.; Revuelta Soba, J.M.

Hospital Universitario Marqués de Valdecilla.

Utilidad del stent aórtico XL en el tratamientoendovascular de la patología aórtica

INTRODUCCIÓN: El tratamiento endovascular del aneurisma deaorta abdominal reduce la agresión quirúrgica, con disminu-ción de la morbilidad y mortalidad perioperatoria, pero aún seestán dilucidando sus resultados y complicaciones a largo pla-zo. El seguimiento resulta fundamental en los pacientessometidos a este tipo de cirugía, principalmente de cara a ladetección de endofugas.

OBJETIVOS: Analizar los resultados del tratamiento deaneurismas de aorta abdominal mediante implante de endo-prótesis de forma electiva a los cinco años de seguimiento.

MATERIAL Y MÉTODOS: Se recogieron los pacientes inter-venidos de forma programada entre enero de 2001 y febrerode 2006: 81 pacientes, el 100% varones, con una edad mediade 71 años (rango entre 51 y 86). Se llevó a cabo un análisisretrospectivo de morbi-mortalidad perioperatoria, estanciahospitalaria, mortalidad global, endofugas y reintervencionesen un período de 5 años tras la cirugía.

RESULTADOS: El éxito técnico inicial fue del 95%, con im-plante de dispositivos bifurcados en el 75% d los pacientes,25% aorto-monoilíacas y 2% de reconversiones de bifurcada a

Vera Arroyo, B.; Asensio García, R.; Linares Palomino, J.P.; Lozano Alonso, S.; Guillén Fernández, M.; Ros Díe, E.

Hospital Universitario San Cecilio, Granada.

Tratamiento endovascular del aneurisma deaorta abdominal, seguimiento a los 5 años

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aorto-monoilíaca. La estancia en UVI fue de 1,3 días y en plan-ta 4,4. La morbilidad perioperatoria global fue del 11%. A los 5años se produjo un 10% de pérdidas para el seguimiento, y un33% de mortalidad, fundamentalmente a expensas de neo-plasias y causa cardiovascular, con 2 éxitus relacionados conel aneurisma. En cuanto a complicaciones, la más frecuentefue la existencia de endofugas, un 23% de los pacientes segui-

dos, con predominancia de las tipo 2 (70%) y un 9% de rein-tervenciones durante el seguimiento.

CONCLUSIONES:El tratamiento endovascular del aneurisma de aorta aporta ennuestra experiencia buenos resultados, con un porcentaje bajode reintervenciones y complicaciones a largo plazo.

IntroducciónLa embolización cerebral durante el stenting carotídeo consti-tuye una importante fuente de complicaciones neuroisquémi-cas perioperatorias siendo hoy en día la neuroprotección unstandard de uso en el intervencionismo carotídeo.

ObjetivosValorar la incidencia de aparición de nuevas lesionesisquémicas cerebrales tras el stenting carotídeo, comparandola neuroprotección con flujo reverso transcervical frente alabordaje transfemoral con filtro distal.

Material utilizadoEn un periodo de 22 meses, 64 pacientes consecutivos diag-nosticados de estenosis carotídea significativa tras estudio ul-trasonográfico fueron tratados mediante angioplastia y stentcarotídeo, siendo secuencialmente asignados a dos grupos detratamiento: acceso transcervical con flujo reverso (n=31) yabordaje transfemoral con filtro distal ( n=33).

Métodos utilizadosAdemás de la monitorización clínica, en todos los casos se re-alizó una Resonancia Magnética Nuclear (RMN) de difusión-perfusión dentro de las 24 horas anteriores y posteriores a lacirugía.

Ambas secuencias de imágenes fueron comparadas de formaciega e independiente por un neuroradiólogo no implicado enel estudio, siendo cualquier nueva señal hiperintensa en la se-cuencia de difusión perfusión interpretada como una lesiónpostoperatoria isquémica. Todos los pacientes fueron revisa-dos clínica y ultrasonográficamente a los 30 días, 6 meses y 1año.

Resultados del estudio44 de los 64 individuos reclutados ( 69%) fueron consideradossintomáticos en el momento del diagnóstico, sin encontrarsediferencias significativas entre los grupos transcervical / trans-femoral en la distribución de esta característica (p = 0,748) nide ninguna otra variable epidemiológica basal.

No se observaron eventos neurológicos durante las interven-ciones, en el postoperatorio inmediato, ni en el seguimiento enninguno de los dos grupos, permaneciendo todos los pa-cientes sin fluctuaciones en su estado neurológico. En la com-paración de las secuencias de difusión perfusión pre y postop-eratorias se encontraron nuevas lesiones en 4 de los 31 pa-cientes del grupo transcervical (12,9 %) y en 11 del grupotransfemoral (36,3%), todas ellas asintomáticas, siendo estosresultados estadísticamente significativos (p=0,03) a un nivelde significación del 5%. En el análisis multivariante, la edad (Riesgo Relativo – RR- 1,022, p<0,001) el estado síntomatico(RR 4,109, p <0,001) y el tipo de stent empleado (celda abiertafrente cerrada, RR 2,021, p<0,04) se comportaron como fac-tores de riesgo independiente de embolización en el grupotransfemoral y no en el transcervical.

Conclusiones del estudioLos resultados de este estudio sugieren de manera firme laexistencia de diferencias significativas en la tasa de em-bolización aguda asintomática perioperatoria detectada medi-ante estudios de difusión cerebral entre el stenting carotídeotransfemoral con dispositivo de protección embólica distal y elabordaje transcervical con flujo reverso, pudiendo ser éste últi-mo una alternativa terapéutica más segura en pacientes espe-cialmente susceptibles como los grupos sintomáticos y deedad avanzada.

Leal Lorenzo, J.I.; Rodriguez J Peinado, R.; Vicente C Salgado, S.; Gil A Flores, J.;Fontcuberta A Orgaz, J.; G Benassi E Criado, J.; Doblas Domínguez, M.

Hospital Virgen de la Salud.

Valoración prospectiva de los eventos embólicoscerebrales en el stenting carotídeo:flujo reverso transcervical vs abordajetransfemoral con filtro distal

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Human Immunodeficiency Virus (HIV) associated vasculitis is arare but important complication of HIV infection with potentiallydisastrous complications. Improvements in antiretroviral ther-apies and prolonged survival of HIV positive patients has meantthat increased consideration is being given to the long term se-quelae of HIV infection including cardiovascular complications.We report the case of a sixty-seven years old gentleman whowas admitted to our services with spontaneous contained rup-ture of the suprarenal abdominal aorta as a side effect of ac-celerated atherosclroisis from antiretroviral therapies. Hisbackground medical history was significant for hypertensioncomplicated by hypertensive nephropathy. On routine screen-ing his VDRL serology was positive, thus a diagnosis of late la-tent syphilis was made and a course of benzylpenicillin com-menced. He was negative for both Hepatitis B and C.

This man had recently been diagnosed with HIV-1 and wasfound to have been infected with treponema pallidum. It wasthus decided to proceed with an endovascular repair. Accesswas achieved via bilateral groin incisions and a left brachial in-cision. The aortic main body graft comprised a MedtronictalentTM aortic graft (30mm x 30mm x 28mm). The right renalartery ‘chimney graft’ was a gore viabahnTM endoprosthesis(8mmx 50mm x 120mm) deployed via the left brachial artery.

The patient recovered well in the immediate post-operative pe-riod and was recommenced on antiretroviral therapy on thefirst post-operative day inspite we advised the infection controlto stop his antiretroviral medications but our request was de-clined.

Follow-up CT scan demonstrated that the aortic stent was in agood position with complete patency of the right renal arteryHistopathology of arterial wall specimen’s demonstratedchronic inflammatory changes within the adventitia consistentwith aortitis.

Two months later, however, he required emergency readmis-sion and repeat CT angiogram confirmed recurrent rupture be-low the previous stent. The decision was made to reattemptendovascular intervention, involving placement of two furtherendologix stents (25mm x 25mm x 55mm and 34 x 34 x 80mm) overlapping with the previous stent. He recovered wellfrom this procedure and remained stable. His postoperative du-plex scan on 3rd postoperative day did not show any endoleak.On day five postoperatively, this gentleman had a further hy-potensive episode and following discussion with the patientand his partner the decision was made that he would not be forfurther intervention. He passed away two days later.

Sultan, S.; Dover, M.; Tawfick, W.

Western Vascular Institute, University Hospital Galway, Ireland.

Spontaneous Aortic Rupture due to Human Immu-nodeficiency Virus Associated Vasculitis: A Case IWish I Hadn’t Done

Lower limb monoplegia is an extremely rare presentation thoa-co-abdominal aortic aneurysms.A 70 year old female who pre-sented with a persistent right lower limb monoplegia. Followingexamination it was thought that this lady had anterior spinalartery syndrome after a MRI spine was undertaken which dis-played a 8.5 cm Crawford type II thoracoabdominal aortic

aneurysm (TAAA). After staged hybrid procedure she had com-plete exclusion of her TAAA and full resolution of her monople-gia.

This case depicts the ever challenging representations ofTAAA.

Sultan, S.; Waters, P.; Hamada, N.; Tawfick, W.

Western Vascular Institute, University College Hospital Galway, Galway, Ireland.

Subacute anterior spinal cord ischaemia withLower limb monoplegia. A Clinical dilemma ofa challenging scenario

Acute aortic syndrome is a devastating diagnosis with highmorbidity and mortality rates. AAS includes aortic dissection,intramural haematoma, penetrating atherosclerotic ulcer, trau-matic transection or a thoracic aneurysm that has become un-

stable. We convey our early experience in management of AAS.

33 TEVAR procedures were performed for 31 patients (13 fe-males: 18 Males) over a period of 36 months of which six were

Sultan, S.*; Waters, P.*; Hamada, N.*; Tubassam, M.*; Hynes, N.**; Tawfick, W.*

Western Vascular Institute, Department of Vascular & Endovascular Surgery, University College Hospital,Galway, Ireland.*: The Galway Clinic, Doughiska, Dublin Road, Galway, Ireland**

Thoracic abdominal endovascular aneurysm repair(TEVAR) in the management of Acute Aortic Syndro-me (AAS). An early experience with de-branching,chimney techniques and Multi-Layer stenting.

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Indications for Emergency CEA are Litigious as acute carotidocclusion natural history without Surgery is Atrocious. Menaceof CEA is Significantly Higher in Patients who are NeurologicallyUnstable.

Our aim is to conciliate Emergency CEA clinical success andefficacy in plummeting morbidity and mortality. CompositePrimary Endpoints are Stroke/Death .Secondary endpoints arefive year stroke free and survival free rate.

Between October 2002- October 2008, 1847 patients wereevaluated with carotid stenosis>60%.The Predicted Probabilityof Receiving CEA; SCAD (300)Vs CTIAs (45) Vs SIE (14) wasTabulated for All Patients by Using Multiple LogisticRegressions to Control for Co-morbidity and Anatomical High-risk Factors .We Used Propensity Scoring To Adjust ForBaseline Characteristics and Selection Bias By Matching Co-variables. Fast Track Clear Pathway for Symptomatic CADPatients Permitted us to Identify, Triage and Manage in a ShortTime Frame.

Mean Age was Similar Between SCAD, 68.6years; CTIAs, 69.1,p>0.05 but SIE patients were younger (67.2 years) than SCAD(p<0.01) or CTIAS (p<0.05) Groups .Co-morbidity SeverityScore were Similar Between SCAD/CTAIs but Higher for SIE(p>0.05).

Total Stroke was 1.1% and Total Death was 0.8%.CombinedStroke / Death was 1.9% but 7% in SIE.

5-Year Stroke Free Survival for SCAD;87.9% +/- 3.53%,CTIAs;93.3% +/- 8.05% (p=0.818),SIE;92.9% +/- 11.07%(p=0.184) . 5-year Intervention Free Survival for SCAD;87% +/-3.65%, CTIAs: 91.1% +/- 9.66% (p=0.889),SIE: 92.9% +/-11.07% (p=0.23).

Crescendo TIAs are managed by CEA within 24 Hours. Patientsthat occlude under observation should be explored. OnlySelected Patients are considered for Emergency CEA andIndicated if it propounds Improved Outcomes over MedicalTreatment.

Sultan, S.*; Pillay, K.*; Tawfick, W.*; Hynes, N.*; Sherif S.*,**, Kamsilla P.* ,Wael T.*; Niamh H.*,**

Western Vascular Institute, Department of Vascular & Endovascular Surgery, University College Hospital,Galway, Ireland. *The Galway Clinic, Doughiska, Dublin Road, Galway, Ireland**

Carotid artery endarterectomy (CEA) for symptoma-tic carotid artery disease (SCAD), crescendo tran-sient ischemic attacks (CTIAS) stroke in evolution(SIE): indications and Results: a 5-Year experience.

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emergencies. The mean age was 64.6 years. 17 patients wereASA Grade III or more with 3 patients with ASA grade Ve.

Risk factors were hypertension (n=20) followed by hypercho-lesterolaemia (n= 17), smoking (n=14) and ischaemic heartdisease (n=9). 17 procedures were for thoracic abdominalaneurysms type three, 7 thoraco-abdominal aneurysms typefour, 4 aortic dissection Type B, 1 infantile adult aortic coarcta-tion and 2 spontaneous supra visceral aortic ruptures.

Seven patients underwent a one/ two stage hybrid debranchingof visceral vessels followed by TEVAR. Fourteen patients un-derwent chimney or Snorkel Endografting of Subclavian or re-nal vessels. Two patients underwent multilayered stenting forthoraco-abdominal aneurysms with visceral involvement. Onepatient had a CPS stent for infantile adult coarctation.

Primary endpoints were 6% mortalities within 30 days for thetwo acute emergencies of which one was a HIV patient withsyphilitic aneurysm. 30 day morbidity was one acute tubularnecrosis and one lower respiratory tract infection. Aneurysm free survival time was 19months. No patients devel-oped aneurysm rupture, paraplegia or stroke. Four cases of en-doleak were witnessed however no aneurysm expansion wasexperienced. Two patients experienced distal graft migrationand required re-intervention.

We display from our experience that minimal invasive tech-niques with TEVAR and debranching, chimney or snorkel graft-ing of visceral vessels is safe, prudent and economically viable.The development of multilayered stenting technique looks everpromising for future management of complex aortic patholo-gies.

Our endeavor is to contrast clinical and technical outcome ofBIF vs AUI in high risk EVAR patients.

From 2002 to 2007, 82 high-risk patients underwent electiveEVAR (BIF, n=52 [63.4%]; AUI, n=30[36.6%]). Mean Age 74yrs(BIF vs AUI, p=0.835), Male% (BIF vs AUI, 86.5%vs76.7%,p=0.260) and Mean Aneurysm Diameter (BIF vs AUI:5.4cmvs5.3cm, p=0.514).

The predicted probability of receiving AUI was tabulated for allpatients by using multiple logistic regressions to control forSVS co-morbidity and anatomical severity scores. We usedpropensity scoring to adjust for baseline characteristics andselection bias by matching co-variables, creating a pseudo-randomized control design. Primary endpoints were 30-daymortality, 4-year survival and 4-year intervention free survival. Mean Proximal Endograft diameter was significantly lower withBIF (29.3 vs 30.9, p=0.031). Mean number of devices usedwas similar (3.0vs3.4, p=0.165).

BIF and AUI had similar 30-day mortality (1.9%vs0%,p=0.453), 4-year all-cause survival (72.1%vs74.0%, p=0.882,

h=0.92 [95%CI=0.30-2.78]) and 4-yr Aneurysm-relatedSurvival (98.1%vs100%, p=0.448). There was no graft migra-tion or structural failure. There was no intervention required forType II (23.1%vs36.7%, p=0.191). 4-yr Limb thrombosis Rate(7.6% vs 10%, p=0.723) and 4-yr Intervention-free survival(BIF 89.8% vs AUI 85.9%, p=0.612, h=0.71 [95%CI=0.18-2.76]) were similar. 4 year Fem-Fem cross over patency rate is92.6% [95%CI=75.6%-98.6%].

There were no significant differences in procedure time, meanblood units and change in estimated glomerular filtration ratebetween groups (p>0.05). Length of Stay/HDU (4.2 vs. 7.4p=0.021/ 0.87 vs. 1.2days, p=0.656) were similarly low, withthe majority of patients discharged directly home (BIF vs AUI:92%vs80%, p=0.103).

By using propensity scoring for the primary endpoints, the pro-portions of AUI patients were equal to BIF for all levels of prob-ability and were unchanged as the probability of AUI increased. We established at 4 years that clinical and technical outcomeswere not compromised with AUI compared to BIF in this high-risk cohort.

Hynes, N.(1, 2); Sultan, S.(1, 2)

Western Vascular Institute, Department of Vascular & Endovascular Surgery, University College Hospital,Galway, Ireland (1)Department of Vascular & Endovascular Surgery, Galway Clinic, Dublin Road, Doughis-ka, Galway, Ireland(2)

Aorto-Uni-iliac Vs Bifurcated EndovascularAortic Repair: Technical Success, SecondaryIntervention Rate and Quality-adjusted costanalysis

Aim: The aim of this prospective study is to describe the roleof endovascular surgery in the management of CAVUS.

Methods: Between July 2004 and August 2007, out of 345revascularisation, 17 patients ( 6 males:11 females) werefound with CAVUS and were offered one stage managementwith angioplasty /stenting along with level two dissection andSFJ ligation. Mean age is 74.3( range 54-87) and ulcer dura-tion ranged from 6 months to 23 years. All but 1 wereRutherford category 5 and 14 patients were in TASC C and D.Patients were followed at 6week, 3,6,12, 18 months.

Results: 19 legs were treated in this study. 50% had angio-plasty and stenting. All patients had Saphenofemoral ligations.Preoperative mean ABI'S were 0.60(Range 0.42-0.86) which

increased to mean 0.81 in the postoperative period. The meanincrease in absolute pressures was 18.3mmHg and the meanincrease in digital pressures was 0.20. Ulcers healed withinmean 5.4 months in 14(82%) patients. Technical and devicesuccess was achieved in all but one patient. There was onemortality at 6 month. No patient had minor or major amputa-tion. TLR was necessary in 2 patients and TER was performedin 3 patients. 3 patients were lost to follow-up at 18months.The sustained haemodynamic improvement wasachieved with ABI improvement of 0.15 in rest of the patients.

Conclusion: Endovascular surgery for revascularisation alongwith sapheno-femoral ligation is an alternatine to the lengthybypass procedures in the high risk aged patients with lessmorbidity and mortality with good long term results.

Tubassam, M.(1); Sultan, S.(1, 2)

Department of Vascular & Endovascular Surgery, Western Vascular Institute, National University of Ireland,Galway (1) Galway Clinic, Doughiska, Galway (2).

Combined Arterial And Venous Lower Limb Chro-nic Ulceration (CAVUS). An 8 years longitudinalobservational study in a tertiary referral centre.

Objective: to report our experience with combined simultane-ous descending thoracic aortic stent-graft and abdominal aor-tic open repair by mini-invasive left subcostal transperitonealapproach and fast-track program.

Methods: three patients affected by thoracic and abdominalaortic pathologies with hig risk for open thoracoabdominal re-pair, were considered to be eligible for combined endovascularand open minimally invasive surgical repair. All patients wereaffected by infra-renal aorto-iliac aneurysm and they first un-derwent open surgical repair by means of aorto-bifemoral by-pass with left subcostal minilaparotomy. Simultaneously com-

mercially available endografts were inserted throught a limb ofthe aorto-bifemoral graft with standardized endovascular tech-nique. In one patient the esclusion of the left subclavian arterywas needed but was unnecessary its revascularization due tothe back bilateral hypogastric revascularization. In the othertwo cases a descending thoracic stent graft escluded success-ful the descending thoracic aortic aneurysm. A lumbardrainage was put in each patients.

Our multidisciplinary approach consisted furthermore inepidural anaesthesia-analgesia and postoperative early reha-bilitation by early feeding and ambulation.

Cassatella, R.; Brustia, P.; Renghi, A.; Guzzardi, G.; Fossaceca, R.; Gramaglia, L.Service of Vascular Surgery Maggiore Hospital Novara. Italy.

Simultaneus endovascular thoracic aorticaneurysm exclusion and open mini-invasiveabdominal aortic aneurysm repair.

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Results: stent-graft deployment was technically successful inall cases after minimally invasive aortic open repair. No spinalcord ischemia and no endoleaks was observed . Patients weredischarged homeward in 4th (2 of them) and 5th (the third ofthem) day after surgery.

Conclusion: conventional endovascular thoracic aortic repairin simultaneous combination with minimally invasive abdomi-nal aortic open surgical repair and a multidisciplinary ap-proach, including, stress free anaesthesia and enforced earlyfeeding and ambulation, is safe and speeds up recovery aftercomplex elective surgical procedures.

EvR for CLI should be complemented by non-invasive imagingmodalities for arterial mapping. DUAM can precisely discrimi-nate between echolucency due to thrombus vs atheroscleroticocclusion.

Our endeavour is to appraise DUAM as the exclusive imagingmodality when planning for CLI EvR. Primary endpoint is sensi-tivity and specificity of DUAM, compared to MRA or DSA.Secondary endpoints were procedural, hemodynamic, clinicaloutcomes, Cost-effectiveness and amputation free survival.

DUAM was the sole pre-operative mapping modality. MRA wasonly used where DUAM was inconclusive due to heavy calcifi-cation.

From 2002 to 2009, 3490patients were referred with peripher-al vascular disease. 483patients underwent revascularisationfor TASC C/D lesions (EvR:n=310; BS:n=173).

DUAM displayed 97%sensitivity and 98%specificity in identify-ing lesions requiring intervention. MRA was utilized in 62 pa-tients (12.8%) with 82% specificity. DUAM accurately identifiedthe total number of target lesions for revascularisation (TLR)

however MRA overestimated it. The expenditure of DUAM islower than both DSA and MRA.

Of 421procedures based on DUAM, immediate clinical im-provement was comparable between EvR and bypasssurgery(BS), with improvement to Rutherford category 3 or less98% in EvR and 97% in BS(P=0.71). 6-year freedom from bi-nary re-stenosis was 72.8%EvR and 65.3%BS(P=0.7001,hr=1.10,95%CI=[-0.69to1.74]). 6-year AmputationFree Survival was 72.9%EvR and 71.2%BS(P=0.9765,hr=0.95,95%CI=[-0.60to1.51]).

Comparing procedures performed based on DUAM to thosebased on MRA, 6-year binary re-stenosis was 69% for DUAMprocedures Vs 57% for MRA procedures (P=0.02,hr=0.255,95%CI=[0.09-0.71]).

DUAM is an outstanding pre-operative imaging tool and epito-mizes a minimally invasive modality to road-map EvR for CLIand offers precise consecutive data with hemodynamic out-come and limb salvage superior to EvR based on MRA. We be-lieve that DUAM is economically proficient, primary modalityfor managing patients with CLI.

Sultan, S.(1,2); Tawfick, W.(1)

Western Vascular Institute, Department of Vascular & Endovascular Surgery, University College Hospital,Galway, Ireland (1) The Galway Clinic, Doughiska, Dublin Road, Galway, Ireland (2))

Technical Superiority and Clinical Excellenceof Duplex Ultrasound Arterial Mapping (DUAM)vs Magnetic Resonance Angiogram (MRA),as the sole imaging modality in Bypass Surgery(BS) and Endovascular Revascularisation (EvR)For Critical lower ischemia (CLI) patients. 6 years Comparative Study in a tertiary referralvascular centre.

Introduction: Acute abdominal aorta occlusion – thrombosis isa rare, life threatening condition due to high mortality rates andchallenging management. Objectives: To show a succesufullyendovascular treatment of life threatening condition – throm-bosis of infrarenal abdominal aorta. To draw attention of ne-cessity of guidelines for peripheral and aortic catheter-directedfibrinolytic therapy.

Material and methods: A 54 years old man with a long historyof claudication intermittens in both lower extremities presentedto the emergency department, complaining of sudden onset (2hour before) of paresthesias in both legs and followed severepain in left leg. The computer tomography angiography (CTA)was performed, where trombosis of distal portion of abdominalaorta, iliac and left superfitial femoral arteries were presented.A decision was made to perform catheter-directed intraaortaltrombolytic therapy.

Intra-aortal (intra-trombus) fibrynolytic therapy through radialaccess was started with alteplase 10 mg/h (with bolus 10mgbefore). After therapy patient complained of more severe pain

in left leg In the followed digital subtraction angiography con-trol established recanalization of abdominal aorta and on leftside severe iliac artery stenosis, complete thrombosis offemoral superfitial artery and weak visualization of crural ar-teries. Left femoral artery was recanalized and 2 self-expand-able stents were implanted. In result there were renewed flowin femoral and infrapopliteal arteries. Decision was made tocontinue more fibrynolytic therapy with the same regime( al-teplase 10 mg/h). In post-thrombolytic DSA control (after 24hours) there were renewed arterial flow in left leg and leftcommon iliac artery stenosis was corrected.

Results: The patient was discharge from hospital in third dayafter thrombolytic therapy without any clinical ischaemicsymptoms in both legs.

Conclusion: Catheter-direct thrombolysis is a good option forendovascular treatment of acute infrarenal aorta thrombosiswith a narrow indications, good alternative to open surgery,with short recovery curve. There is a necessity for more inves-tigations in this field.

Ivanova, P.**; Rudnicka, S.**; Ponomarjova, S.**; Zvirgzdins, V.**; Barkans, A.*

*Riga East University Hospital; **Riga East University Hospital

Catheter-directed thrombolytic therapy for acuteinfrarenal abdominal aorta thrombosis based onchronical peripheral arterial disease

EVAR patients are thought to be at higher risk for cancer thanopen repair (OR), due to exposure to high doses of irradiationintra-operatively and CTA scan follow-up.

We aim to quantify metachronous malignancy following EVARor open repair (OR). Primary endpoint is development of malig-

nancy following AAA-repair, and malignancy/cardiovascular re-lated mortality. Secondary endpoints are prevalence of previ-ous, or synchronous malignancy, irradiation exposure and allcause survival.

Between 2002 and 2010, 2973 patients were reviewed with a

Sultan, S.(1,2); Tawfick, W.(1)

Western Vascular Institute, Department of Vascular & Endovascular Surgery, University College Hospital,Galway, Ireland (1) The Galway Clinic, Doughiska, Dublin Road, Galway, Ireland (2))

Prevalence of Malignancies post AAA repair:an eight years comparable longitudinal study ofEVAR vs Open Repair in a tertiary referraluniversity vascular centre

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A mid to long term experience of clinical efficacyand cost per quality-adjusted. Life years withpararenal endovascular aortic repair (PEVAR)without fenestration for para-renal AAAcompared with open surgical repair.

diagnosis of AAA. 409patients underwent AAA repair(267:EVARs, 142:OR). Pre-operative and follow up CTA and X-Ray radiation doses, as well as intra-operative EVAR radiationexposure were calculated and analysed.

Mean radiation exposure during EVAR was 11.4minutes, com-pared to 4.8minutes in OR patients who required some form ofendovascular re-intervention (P=0.021). Mean intra-operativeradiation dosage was 19236.28mGycm2, in contrast to7125.13mGycm2 in OR patients (P=0.006). Total radiationdosage including CTA and X-Ray was 81.37msv in EVAR and36.71msv in OR(P<0.001).

43 EVAR patients had malignancy VS 25 OR patients.Metachronous malignancy transpired in 3% of EVAR and 5.6%of OR(P=0.027). No metachronous malignancies occurred inpatients requiring endovascular re-intervention.

At 8years, all cause survival was 62%. 60% in patients withmalignancies and 69% in non-malignant (P=0.276). In malig-nant-EVARs, mortalities were 56%cardiovascular related,

33%malignancy related. In non-malignant-EVARs, mortalitieswere 62%cardiovascular related and 38%other causes.

In OR, all cause survival was 61%. 64%in malignant-OR and60%in non-malignant(P=0.107). In malignant-OR, mortalitieswere 56%cardiovascular related 22%malignancy related. Innon-malignant OR, 72% were cardiovascular related .

At 8years, median survival in EVAR patients was 37months formalignant and 46months for non-malignant patients(P=0.162,HR=1.639,95%CI=0.652to7.331). In OR patients,median survival was 35months in malignant and 43months innon-malignant patients (P=0.179,HR=1.957,95%CI=0.704to14.139).

EVAR is not an independent risk factor for post-AAA repair ma-lignancies. EVAR and OR had identical all cause survival at 8years inspite higher secondary intervention in the EVAR arm.Cardiovascular burden is more treacherous than any neoplasticpathology.

EVAR affords more propitious peri-operative and long-termsurvival than Open Surgical Repair (OSR). However, up to 70%of AAAs are anatomically incompatible with EVAR.

We aim to gauge the feasibility of applying commercially-avail-able endografts to pararenal aneurysms compared with OSR.Primary endpoints were aneurysm-related survival and costper Quality-Adjusted–Life-Years (QALY)..From 2002-2009, 1868 patients with pararenal AAA were in-vestigated. 118 had intervention and were described by con-sultant radiologists as ‘unsuitable for EVAR’. 66 had OSR and52 had Pararenal EVAR (PEVAR).

PEVAR patients were older (74.3yrs vs. 70.8 yrs, p=0.014) withhigher mean SVS co-morbidity severity scores (p=0.0001).

All procedures were within 14 days of diagnosis. Meananeurysm diameter was larger in OSR (OSR 6.6cm vs. PEVAR5.9cm, p=0.010). For PEVAR 83% of endografts were34mm/36mm.

3-year aneurysm-related survival was significantly higher withPEVAR (100% vs. OSR (92.4%+/-4.37%), p=0.045). PEVARprovided an incremental cost-effectiveness ratio of #129,586saved per QALY gained.

3-year freedom from secondary intervention (PEVAR 83.4% vsOSR 95.5%, P=0.301) and all-cause survival (PEVAR 57.1%vs. OSR 84.8%, p=0.195) were similar.

30-day morbidity halved with PEVAR (15% vs. 30%, p=0.059).Length of hospital stay (p=0.0007) was lower and number ofpatients fit for discharge to their home (p=0.006) higher withPEVAR.

PEVAR granted our patients longer Q-TWiST and SuperiorFreedom from MACE up to three years. Despite 3-year survivalrate of 57%, PEVAR is cost-effective and offered as Endo-bail-ing for patients living on borrowed time, abolishes the socio-economic catastrophe of managing a rupture PAAA.

Sultan, S.(1,2); Hynes, N.(1,2)

Western Vascular Institute, Department of Vascular and Endovascular Surgery, University College HospitalGalway, Newcastle road, Galway, Ireland (1) Department of Vascular and Endovascular Surgery, GalwayClinic, Ireland (2)

The purpose of this study is to appraise the incidence of CINand to compare the effect of IOCM and LOCM on renal func-tion/CKD during follow up in patient who underwent EvR.Primary endpoints: serum creatinine and incidence of CIN.Secondary endpoints: incidence of CKD in patients with normalrenal function preoperative.

Contrast media used were, Omnipaque 647mg/ml(Dec2003–Sept2005) and Visipaque 270mg/ml(Oct2005–Dec2008). Creatinine obtained preoperative, postop-erative at Day0-3, 30days, 3months, 6months and 12months.

315 patients underwent EvR of which 262 patients were in-cluded. Number of patients received Omnipaque / Visipaquewere 68/194. 142 were male. Mean age was 74.81 +/- 9.303in Omnipaque vs 72.08 +/-11.866 in Visipaque.

There is significant difference in the effect of renal function by

the types of contrast used over 12 months period, p= 0.03. InOmnipaque group, mean GFR significantly decreases at3months (62.56 +/- 26.89) and 12months (63.67 +/-22.74). InVisipaque group, mean GFR increases at 3months (64.07 +/-27.67) and 12months (67.17 +/- 30.99). The latter showed im-provement on renal function after 6 months.

Mean GFR significantly decreases with age regardless of con-trast type used, p=0.004.

30 patients had re-intervention within 12 months. One patientrequired subsequent haemodialysis for CIN and no CKD on fol-low up thereafter.

There is no significant incidence of CIN/CKD in 12 months fol-low up. Different types of contrast use have a significant im-pact on renal function over time. Use of IOCM is not nephro-toxic and enhances renal function compared to LOCM.

Sultan, S.(1,2); Chua, BoonYih (1); Hamada, N.(1)

Western Vascular Institute (1)Department of Vascular and Endovascular Surgery, Western Vascular Institute, University College HospitalGalway (1) Department of Vascular and Endovascular Surgery, Galway Clinic, Galway, Ireland (2)

Contrast induced nephropathy and chronic kidneydisease (CIN/CKD) as a consequence of utilising nonionic iso-osmolar contrast media (IOCM) vs low-osmolar contrast media (LOCM) following lowerextremity endovascular revascularisation (EvR): A 5years parallel group observational study.

Purpose: To report a 5-year observational parallel group studycomparing the effectiveness of subintimal angioplasty (SIA) tobypass grafting (BG) for treatment of TASC II type C/D lesions

in the lower limb arteries of patients with critical limb ischemia(CLI).

Sultan, Sherif (1); Hynes, Niamh (1)

Western Vascular Institute, Department of Vascular & Endovascular Surgery, UniversityCollege Hospital, and The Galway Clinic, Doughiska, Galway, Ireland. (1)

Five-year irish trial of CLI patients with TASC II typeC/D lesions undergoing subintimal angioplasty orbypass surgery based on plaque echolucency

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The rational use of renal artery stentingin renovascular hypertension therapy:a single center experience

Methods: Of 1076 patients referred with PVD from 2002 to2007, 206 SIAs in 190 patients (104 women; mean age 73613years) and 128 bypass grafts in 119 patients (77 men; meanage 70614 years) were enrolled in the study. All patients hadRutherford classification 4–6 ischemia manifested as rest painand/or tissue loss. Primary endpoints were (1) survival freefrom amputation and (2) sustained clinical improvement [+2Rutherford category and/ or ABI increase 0.15 without targetlesion revascularization (TLR)]. Secondary end points were ma-jor adverse events (MAE), the binary restenosis rate, freedomfrom TLR, and a special quality-adjusted life year (QALY) end-point (Q-TWiST) that incorporated both length and quality of lifeto evaluate treatments. A cost analysis was performed.

Results: At 5 years, clinical improvement was sustained in82.8% of the SIA group versus 68.2% of the BG patients(p50.106). Five-year all-cause survival was similar for SIA(78.6%) and BG (80.1%; p=0.734), as was amputation-free

survival (SIA 72.9% versus BG 71.2%;p=0.976).Hyperfibrinogenemia (p=0.009) and C-reactive protein(p=0.019) had negative effects on survival without amputation.Five-year freedom from binary restenosis rates were 72.8% forSIA versus 65.3% for BG (p=0.700). While the 5-year freedomfrom TLR rates (SIA 85.9% versus BS 72.1%, p=0.262) werenot statistically significant, the risk of MAE (p<0.002) andlength of hospital stay (p<0.0001) were significantly reduced.Q-TWiST significantly improved (p<0.001) and cost-per-QALY(SIA J5663 versus BG J9172, p<0.002) was reduced with SIA.The 5-year risk of re-intervention (p>0.05) and mean numberof procedures (p=0.078) were similar.

Conclusion: Five-year freedom from MAE was enhanced by20% in the SIA group, withsubstantial cost reduction and betterQ-TWiST. SIA is a minimally invasive technique thatexpandsamputation-free and symptom-free survival. SIA is poised tobring about a paradigm shift in the management of CLI.

Introduction: Endovascular surgery in renal artery stenosis isnow the treatment of choice.

Objectives: Our aim is to evaluate the improvement in bloodpressure and renal function of patients undergoing renal stent-ing.

Material used: Fifty-two patients were submitted to renalstenting for steno-obstructive lesions. Fifty-five stents wereimplanted in 52 patients (3 bilateral).

Methodology used: Preoperative study consisted of: contrast-enhanced ultrasound, dynamic renal scintigraphy and comput-ed tomography angiography. In all cases, renal artery stenosiswas hemodinamically significant and greater than 75%. All pa-tients received 300 mg clopidogrel the day before the proce-dure, followed by clopidogrel 75 mg / day associated with ASA100 mg / day for 6-12 months, then ASA 100 mg indefinitely.The follow-up (6 and 60 months) was performed by means ofcontrasted-enhanced ultrasound and if a restenosis was dis-covered, an Angio-CT scan was performed.

Results of the study: Reduction in blood pressure in the earlystages (3-6 months) was observed in 31 patients (59.6%). In

25 of this group (80.6%), a return to preoperative values ofblood pressure within 12 months was registered. A reductionin creatinine values less than 1.4 mg / dl was reached in 36patients (69.2%), while in 10 (19.2%) remained unchangedand in the remaining six (11.6%) worsened.

The primary patency was 84 .6% at 2 years and assisted atprimary level of 94.2% at 5 years.

Conclusions of the study: Renal stenting is a safe procedurewith a low rate of peri-operative complications and with an as-sisted primary patency rate close to 95% in our experience.

In this study, there was no immediate deterioration of renalfunction during follow-up but there was a 69.2% improvementin itself.

In our opinion, the poor results obtained for the improvementof blood pressure need to be investigated with controlledprospective trials.

In this experience, there is a good result concerning the recov-ery and / or improvement in renal function; while there is onlya temporary benefit in blood pressure control.

Gattuso, R.; Irace, L.; Felli, Marco Maria G.; Alunno, A.; Castiglione, A.; Malaj, A.;Gossetti, B.

Università La Sapienza

INTRODUCCIÓN:

La fístula aortoentérica secundaria es una entidad poco fre-cuente, de gran morbilidad y mortalidad, y alto riesgo quirúrgi-co. El abordaje endovascular simplifica en tratamiento inicial,aunque existen dudas sobre su eficacia a largo plazo.Presentamos dos casos de tratamiento endovascular del FAEsecundaria, uno como tratamiento único y otro como soluciónprovisional

CASO 1:

Varón, 83 años. 24 años antes by-pass aorto-bifemoral, doslaparotomías posteriores (colitis isquémica, colostomía dedescarga), eventración e implante de malla abdominal.Presenta hemorragias digestivas bajas, con importante anem-ización (Hb 6,6 g/dl) sin encontrarse punto hemorrágico en en-doscopia digestiva alta ni colonoscopia.

En angio-TAC se evidencia reacción inflamatoria periprotésicaalrededor del by-pass, en relación con cuarta porción duode-nal, con alta sospecha de FAE secundaria. Se evidencia fugade contraste desde el by-pass a tubo digestivo mediante arte-riografía intraopertoria procediéndose a implantar endopróte-sis aorto-monoilíaca derecha y by-pass fémoro-femoralderecha-izquierda.

En el postoperatorio inmediato se somete al paciente a reposointestinal y nutrición parenteral durante 2 semanas evolucionade forma favorable, sin nuevos episodios hemorrágicos. Es da-do de alta con tratamiento antibiótico vía oral (ciprofloxacino500 mg/12h y metronidazol 250 mg/8h) a largo plazo. Alta almes del episodio y seguimiento a los 6 meses libre de nuevashemorragias y TC con fibrosis en la zona de la FAE.

CASO 2:

Varón, 72 años. 10 años antes by-pass aorto-biferomal por pa-tología aneurismática infrarrenal.

Debuta con hemorragia digestiva alta, sin hallazgos en la en-doscopia. En angio-TAC se aprecian cambios inflamatoriosperiaórticos en relación con 3ª-4ª porción de duodeno y burbu-jas periprotésicas, llegando al diagnóstico de FAE.

En un primer tiempo quirúrgico se implanta endoprótesis aor-to-monilíaca derecha con by-pass cruzado fémoro-femoralderecha-izquierda. Mediante laparotomía subcostal se localiza

el orificio fistuloso en duodeno y se lleva a cabo reparación yepiplopastia. El paciente es mantenido con antibioterapia deamplio espectro (ertapenem 1g/24h y daptomicina 10mg/kg/d).

Tras 2 meses de tratamiento antibiótico y ante la persistenciade infección demostrada mediante TAC y gammagrafía, en unsegundo tiempo quirúrgico se realiza by-pass axilo-femoralderecho con anastomosis distal sobre el fémoro-femoral, ymediante abordaje retoperitoneal explante del material protési-co aórtico previo, incluida la endoprótesis, y ligadura de aortae ilíacas con refuerzo del muñón aórtico con fascia lata.

El paciente es dado de alta al mes sin tratamiento antibiótico

CONCLUSIONES:

El tratamiento endovascular mediante implante de endopróte-sis es una opción a tener en cuenta en el tratamiento de laFAE, y según las características del paciente puede suponer laresolución definitiva del cuadro, o proporcionar una mejoríasuficiente para estabilizar al paciente y llevar a cabo cirugíaabierta exerética con posterioridad.

Vera Arroyo, B.; Linares Palomino, J.; Asensio García, R.; Salmerón Febres, L.;Ramos Gutiérrez, V.; Ros Díe, E.

Hospital Universitario San Cecilio, Granada.

Tratamiento endovascular en fístula aorto entéricasecundaria: solución definitiva o puente a laresolución abierta

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Endovascular revascularisation (EvR) is the current gold stan-dard and first line of therapy for Critical Limb Ischaemia (CLI).However, despite the advances of EvR, there is still concernabout its capability for treating complex Tibial lesions. Thisstudy aims to compare outcomes with Cool Excimer LaserAssisted Angioplasty (CELA) Vs Tibial Balloon Angioplasty (TBA)in patients with CLI, TASC DE. The primary endpoints areSustained Clinical Improvement and amputation-free survival(AFS). Secondary endpoints are binary restenosis, TargetLesion Revascularisation (TLR), Target ExtremityRevascularisation (TER), all-cause survival and survival freefrom Major Adverse Events (MAE).

Pivotal Observational Analogy Congregate Proportional Analysisover 48 months.

From June05 - December08, 1406 patients were referred withPVD, 372 had CLI. 56 patients underwent 65 EvRs for tibialTASC DE; 35 using TBA and 30 using CELA. All interventionwas done using Pre-operative Duplex Ultrasound. Patientswere on a Statin, Aspirin, Clopidogrel and anti-hypertensivetherapy. All patients were Rutherford Category 4-6 with meanage 69 years (48-96yrs) and all had comparable demograph-ics, vascular-related risk factors and runoff grading.

Technical Success was 80% for CELA Vs 74% for TBA(p=0.278). Technical outcomes were independent of proce-dure, stent placement, multilevel interventions, and adjunctiveprocedures. Improvement to Rutherford Category !3 occurredin 80% of CELA Vs 66% of TBA (p=0.048) with hemodynamicSuccess in 90% of CELA Vs 71% of TBA (p=0.041).

At four years the rate of sustained clinical improvement wasenhanced with CELA (73.3%) compared to TBA (65.7%), al-though this did not quite reach statistical significance.(P=0.409, Hazard ratio (HR) =0.67, 95% CI [0.27 – 1.72]). 4year limb salvage rates (93.3% Vs 88.5%, P=0.482, HR=0.56,95%CI [0.11-2.78]) were also improved with CELA

4-year freedom from TLR was significantly augmented withCELA (93.3%) in comparison to TBA (65.7%). (P=0.0053, HR=

0.219, 95% CI = [0.0752 – 0.637] (Figure 3) At four years free-dom from binary restenosis was also substantially improvedwith CELA (76.6%) when compared with TBA (54.2%) but wasjust shy of statistical significance. (P=0.0699, HR=0.45, 95%CI [0.19 – 1.07]). Four-year freedom from TER remained supe-rior with CELA (90% vs. 80%, P=0.256, HR= 0.49, 95% CI=[0.14 – 1.69]) Furthermore the rate of revascularisation per-formed due to progress of arteriosclerosis at 4 years. (Obtainedby subtraction of TLR from TER rates) was significantly re-duced with CELA (P= 0.005, HR= 0.132, 95% CI = [0.032 –0.551]). 4 years freedom from MAE was significantly morelikely with CELA. (P= 0.02, HR= 0.367, 95% CI= [0.157 –0.859]).

CELA patients had a substantial improvement in quality of lifeat 4 years with a Q-TWiST of 9.72months compared to TBA pa-tients (7.5 months, P=0.078). Mean cost per primary proce-dure; mean cost including follow-up; and mean total cost wereall substantially reduced with CELA compared to TBA, with aincremental cost effectiveness ratio of #7,209.27 per QALYgained in favor of CELA.

Prospective Clinical Prelude showed that ostial lesions withpoor distal run off have a reduced prospect of distal embolisa-tion. Furthermore, CELA ameliorated PTA, if used primarily ininstances where the wire can cross but not the Balloon. Initiallycompromised endeavors’ at Crural PTA can be treated suc-cessfully with redo PTA without spoiling subsequent attemptsat bypass grafting.

Tibial EvR bestows Exceptional Outcome in CLI TASC DE .BothCELA & TBA enhance Anatomical, Clinical and TechnicalSuccess Rates in Complex Tibial Vessel Lesions. However,CELA has superior freedom from binary restenosis, freedomfrom TLR and Survival free from MAE, with improved Q-TWiSTbetter QALY and cost-effectiveness.

Sultan, S.; Tawfick, W.; Hynes, N.

Western Vascular Institute

Cool excimer laser assisted angioplasty (CELA) vstibial balloon angioplasty (TBA) in management ofinfragenicular tibial arterial occlusion incritical lower limb lschaemia (CLI) TASC DE.A pivotal observational analogy congregateproportional analysis over 48 months “Six L Trial”

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We aim to conciliate CAST, CEA and OMT in high-risk sympto-matic patients. Primary endpoints were stroke, myocardial in-farction or death. Secondary endpoints were cost per QALY, re-intervention rate, and patency.

From Oct01- Oct08, 847 patients were evaluated with carotidstenosis>60%. The Predicted Probability of receiving CEA,CAST, or OMT was tabulated for all patients using multiple lo-gistic regressions, controlling for co-morbidity and anatomicalfactors.

Propensity scoring was used to adjust for baseline characteris-tics and selection bias by matching co-variables, creating apseudo-randomized control design. From 306 CEA, 39 CASTand 275 OMT, we matched 55 CEA, 34 CAS and 67 OMT bypropensity score. 19 (6.3%) had bilateral interventions. Co-morbidity Severity Score were similar between groups (p>0.05) All interventions were performed within 14 days of initial pre-sentation. Mean age was similar between CEA and CAST(68.6years vs 70.6years, p>0.05) but OMT patients were older(75.4 years) than CEA (p<0.01) or CAST (p<0.05). Duplex ultra-sound was the sole preoperative imaging modality used toquantify plaque-morphology and stenosis.Following intervention, 5-year stroke-free rate was99.1%(95%CI 99.6-99.9%), stroke-free survival was90.6%(95%CI 85.9%-93.9%) and primary patency was94.6%(95%CI 90.5%-97.0%). 5-year stroke-free survival wassignificantly improved with CEA (90.6%) compared to OMT(44.3%, p<0.0001).

Cox-proportional hazards ratio showed age >80years(p<0.001), female gender (p<0.04) and echolucent plaque ma-

terial (p<0.01) were associated with reduced stroke-free sur-vival.

Q-TWiST and cost per QALY were comparable but in favor ofCEA over CAST (p>0.05) and were significantly improved withCEA compared to OMT (p<0.0001) and CAST (p<0.001).

OMT does not prevent future stroke in patients with severecarotid artery disease. Indications for CAST are limited; tech-nology is immature and strict selection criteria should apply.CEA remains the gold standard in suitable patients with recent-ly symptomatic carotid artery stenosis with superior 5-yearstroke-free survival compared to CAST or OMT.

Sultan, S.(1,2); Hynes, N.(1,2)

Western Vascular Institute, Department of Vascular and Endovascular Surgery, University College HospitalGalway, Department of Vascular and Endovascular Surgery, Galway Clinic, Ireland (2)

Fast track carotid surgery is the gold standardfor high-risk (HRP) carotid artery intervention:five year cost-effectiveness and quality strokefree survival comparison between carotidendarterectomy (CEA), carotid angioplasty andstenting technique (CAST) and optimal medicaltherapy (OMT) in symptomatic patients at a uni-versity vascular centre with appraisal of thecontemporary prose

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INTRODUCCIONPresentamos el caso de un paciente con dos reintervencionessecundarias luego de 11 años de seguimiento de un primerimplante de endoprotesis de aorta torácica

REPORTE DEL CASOVarón de 75 años, hipertenso y dislipidemico. Por diagnósticode aneurisma de aorta torácica descendente con trombo in-trarterial se le realizó implante de dos endoprotesis aórtica so-lapadas Talent 42 x 120 y por evidencia de endofuga tipo 1distal se procedió a cubrir con otra extensión Talent 44 x 90mm al cabo de 1 semana. En el transcurso de 6 años se ob-servó degeneración aneurismática del resto de la aorta toráci-ca (9 cm) abdominal (57 mm) ambas iliacas (5 cm bilateral) ehipogastricas. El paciente rechazó la cirugía abierta y fue rec-hazado para tratamiento endovascular para prótesis con ramaspor angulación de aorta torácica, angulación iliacas y aneuris-ma de ambas hipogastricas; sin embargo, por aparición deendofuga tipo III se procedió a implante de otra endoprotesisBolton Relay 44 x 200. A los 11 años de seguimiento, asin-tomático, se evidenció aumento del saco aneurismático distal(98 mm) con fuga periprotésica distal con progresión de en-fermedad aortica dado por aumento de los diámetros en launión toracoabdominal (68 x 64 mm) con ulcera intramural es-table y progresión del aneurisma infrarenal. Luego de 1 sem-ana, ingresó a urgencias por dolor torácico de 3 horas de

evolución asociado a disnea y nauseas con ECG y Troponinasnormales y tomografía que mostró endofuga distal con crec-imiento del saco hasta 105 mm sin evidencia de rotura. Se re-alizó de forma urgente tratamiento endovascular, con ex-clusión de endofuga distal con dos extensiones (Bolton Relay44 x 44 y 46 x 46). A las 24 horas durante permanencia enUCI, luego de extubado y sin drogas vasoactivas presenta dis-nea súbita e hipotensión arterial con evidencia de derramepleural izquierdo masivo. Luego de reintubación y múltiplestransfusiones se realizó nueva tomografía que mostró aumentode saco aneurismático torácico con evidencia de sangrado re-ciente, efecto de masa importante sobre aurícula y pulmónizquierdo, con diámetro máximo de 136 x 111 y endofuga dis-tal. Finalmente el paciente falleció 18 horas posteriores. La au-topsia confirmó los hallazgos de aneurisma torácico de 12 cmy fuga periprotésica con material coagulado reciente y hemo-tórax, así como aneurisma aorta abdominal y de ambas iliacascon marcada trombosis intramural de todos los aneurismas

COMENTARIOSLa evolución degenerativa aneurismática de la aorta toraco-abdominal representa un reto por la dificultad para sureparación tanto abierta como endovascular en ocasiones ir-reparables. Los estudios de necropsia son imprescindiblespara avanzar en el conocimiento y tratamiento de la patologíade la aorta

Navarro, J.; Flores, C.; Cruz, L.; Ramírez, R.; Riambau, V.

Hospital Clinic i Provincial.

Degeneración aneurismática de aortatoraco-abdominal e ilíacas: ¿No reparable?

Introducción: Los pseudoaneurismas de arteria glútea superi-or o inferior son excepcionales y la mayoría secundarios a untraumatismo pélvico, cirugía ortopédica o lesiones penetrantesen región glútea.

Material y Método.Caso clínico: Varón de 73 años, con antecedente de abscesoperianal con fascitis necrotizante, drenado quirúrgicamente 2meses antes, que presenta dolor y masa púlsatil en regiónglútea izquierda. Se realiza TC abdominal urgente que eviden-cia pseudoaneurisma de arteria glútea superior izquierda de9,3 * 4,7 cm diámetros máximos. Procedemos a la inyección

de trombina ecoguiada en interior de saco, consiguiéndose latrombosis del mismo en control ecográfico inmediato.

Resultados: A los dos meses el paciente presenta de nuevocuadro de dolor y tumoración a nivel de glúteo, observándose,por ecografía, reaparición de pseudoaneurisma arteria glúteasuperior izquierda.

Decidimos realizar tratamiento combinado endovascular, conembolización mediante liberación de coils, e inyección trombi-na ecoguiada. En arteriografía intraoperatoria y ecografía decontrol se observa trombosis completa de saco aneurismático.

Serramito, I.; Fernández, J.; Senin, E.; Martínez, M.

Complejo Hospitalario Universitario de Santiago de Compostela

Pseudoaneurisma de arteria glútea superior

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INTRODUCTION: To prospective analyze the sequelae of the intentional left sub-clavian artery (LSA) coverage during emergent thoracic en-dovascular aortic repair (TEVAR) for post-traumatic injuries.

METHODS: To assess the functional status of the left arm the followingtests were performed: clinical evaluation (temperature, pres-ence or absence of radial pulse, motility), brachial pressure andduplex scan. At 1-3 and 6 months these examinations were re-peated including a functional test and a questionnaire. Duringthe follow-up an angio-CT was performed at 1-3-6-12 monthand thereafter early.

RESULTS:From January 2005 to June 2011 31 patients underwentTEVAR for traumatic rupture of the thoracic aorta. Mean agewas 35 yrs. In 4 cases (12.9%) the LSA coverage was partial.

Two patients (6.4%) died in the postoperative period for associ-ated hepatic and cerebral trauma. No signs of left arm is-chemia, vertebral insufficiency, strokes, or paraplegia were ob-served. The duplex scan examination revealed in 27 patients(87.1%) a reperfusion of the left arm through the vertebralartery. At follow-up (mean 30 months, range 4-66), only onepatient (3.7%) showed an impairment of left arm function (is-chemic pain after 2.5 minutes of arm exercise), without anyimpediment in his normal life activity at the questionnaire. Nosigns of endoleaks or graft migrations were observed at the an-gio-CT.

CONCLUSIONS:LSA coverage during TEVAR for traumatic aortic injuries seemsa feasible and safe solution to extend endograft landing zone,without an adjunctive risk of paraplegia, stroke or left arm is-chemia. Further larger studies are required to confirm those re-sults.

Conclusiones: En este caso, al carecer de un antecedentetraumático, es lógico pensar en un origen yatrogénico por eldrenaje quirúrgico por la fascitis necrotizante. El diagnóstico loconfirma la ecografía aunque preferimos realizar TC abdominalpara precisar diámetros y relación con estructuras vecinas. En

cuanto al tratamiento, creemos que la embolización delaneurisma ó inyección de trombina son de elección frente altratamiento quirúrgico aunque debe enfatizarse la necesidadde un control posterior periódico por la posibilidad de reperme-abilización del mismo.

Antonello, M.; Maturi, C.; Menegolo, M.; Frigatti, P.; Grego, F.

University of Padua.

TEVAR with intentional coverage of the leftsubclavian artery for traumatic injuries ofthoracic aorta: results of a prospective study

Paciente 77 años de edad del paciente, hipertensión arterial,dislipemia, cardiopatía isquémica, insuficiencia renal, enfer-medad de Alzheimer y aneurisma de la aorta toraco-abdominalde 58 mm de diámetro diagnosticado en julio de 2008. En di-ciembre de 2008 debido a un aumento del diámetro de aortatorácica hasta 67mm, fue sugerido un tratamiento con unaprótesis endovascular ramificada por compromiso de troncosviscerales.

En octubre de 2009, el paciente fue ingresado de urgencia porun dolor pleurítico de 4 días de duración, sin fiebre. En placade tórax se observo un derrame pleural importante. Suoximetría basal fue de 91%. La sospecha de infección hizocomenzar el tratamiento antibiótico.

Posteriormente, en Angio-TC se obsevó un aneurisma de 86mm toraco-abdominal con derrame pleural derecho de gran

Espinosa, G.; Grochowicz, L.; Olavide, I.; Felipe, L.; Landecho, M.; Alegre, F.

Clinica Universidad de Navarra

Ruptura de aneurisma de aorta toraco-abdominal tra-tada con inversión de endoprótesis por vía trans-axilar

Técnica mixta (láser endovenoso y esclerosis conespuma) para el tratamiento de las varices C2dependientes de la vena safena interna incompetente.Descripción de la técnica, análisis de los resultados y del grado de satisfacción de los pacientes

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Thoraco-abdominal dissection with involvementof the Supra-Aortic Trunks

densidad, que podría corresponder a un hemotórax debido a laruptura del aneurisma.

A causa de la condición clínica del paciente decidimos tratar laruptura por vía endovascular, con dos endoprótesis Relay®(Bolton) guiada por ecografía transesofágica y radioscopia. Laprimera endoprótesis (38 mm) fue implantada en la aorta torá-cica descendente a través de un abordaje femoral y la segunda(46 mm), por vía axilar. A causa de falta de cuello distal, la en-doprótesis fue implantada justo por encima de la arteria

mesentérica superior con oclusión intencional del tronco celiaco.Durante la arteriografía de control se observó una estenosiscrítica de la arteria mesentérica superior, que se decidió tratarmediante angioplastia que se complicó con disección que serequirió un implante de stent.

Al día siguiente, se realizo un drenaje cerrado del tórax dere-cho con cánula de Yankauer y drenaje pleural. Se drena 2.500cc de sangre. El paciente se mantuvo en la UCI durante 5 díascon buena evolución. La función renal se mantuvo estable.

Fifty-five-years old patient with high blood pressure, requiring3 different drugs, sought medical attention due to oppressivethoracic pain, radiating to back. There was a widening of themediastinum in plain x-ray. A dissection of thoraco-abdominalaorta was observed in Angio-CT besides a huge descendingaorta aneurysm (80 mm of diameter). A big perforation of dis-section in descending thoracic aorta was noted with a retro-grade dissection till the aortic arch.

We decided to treat this dissection with implant of an endo-prothesis in the descending thoracic aorta by femoral ap-proach. The prothesis was a Relay (Bolton®) of 38 mm of di-ameter.

A retrograde flow till the aortic arch was observed during thepost-surgery control Angio-CT although the correct manage-ment of the intimal lesion of the descending thoracic aorta withthrombosis of the aneurysm sac.

Doppler echocardiography and transesophageal Doppler diag-nosed a proximal entry point of dissection. After the thoroughrevision of the Angio-CT, the entry point was localized in theorigin of the brachiocephalic trunk. We decided to implant 2covered stents by retrograde approach bilaterally.

The placement was performed under general anesthesia. Theaccess of the left carotid artery was made by punction and aplacement of 7F introductor, on the right side it was made byopen access. A stent Atrium 8 x 40 mm was implanted by theleft side and a stent graf Viaban (Gore®) 12 x 8 mm was im-planted in the right side.

The patient recovered in a very favorable way without any kindof neurological deficit. In the post-surgery Angio-CT a verygood result was observed of the procedure, with total thrombo-sis of the aneurysm sac.

Espinosa, G.; Grochowicz, L.; Olavide, I.

Clinica Universidad de Navarra.

INTRODUCCION: En la literatura (Min, Anastasio, Proebstle) ex-isten referencias de series de pacientes tratados con láser en-dovenoso para corregir el reflujo de la vena safena interna y

cierre permanente del eje, con un éxito cercano al 99%. Elcierre del eje safeno interno con esclerosis con espuma ecogu-iada, técnica novel por evitar el uso de un quirófano, ha

Sánchez, Á.; Leal, J.; de Abajo, J.; Chocrón, A.; Gallo, P.

Hospital Rúber Internacional.

Introducción: El manejo endovascular de las complicacioneslocalizadas en el territorio aórtico en pacientes portadores desíndrome de Marfan aún es controvertido. El presente casomuestra la posibilidad de reparar disecciones aórticas en-dovascularmente en este tipo de patología compleja.

Caso. Mujer de 38 años, diagnosticada de Síndrome deMarfan, con disección aórtica tipo B de Stanford. Con dos nive-les de disección, el proximal limitado a la aorta descendente.El distal de aorta infrarenal hasta arteria iliaca común izquier-da, con re-entrada en esta zona. Con asociación de aneuris-mas en aorta torácica e infrarenal. Se procedió a la colo-cación de endoprótesis torácica Bolton Relay NBS 28x204con despliegue distal desde el origen de arteria subclaviahasta la aorta a nivel diafragmático. En angiografía de controlhubo adecuado resultado final, colapsando la luz falsa. Tresmeses después, se trató el segmento de aorta abdominal me-diante la colocación de endoprótesis Gore Excluder de23x14x12. En arteriografía de control aún se observó persis-tencia de reentrada en bifurcación de arteria iliaca comúnizquierda. Al segundo año se encontró por AngioTC nueva en-trada y dilatación de 6mm en el extremo distal de la endo-prótesis torácica. Además de permeabilidad de la reentrada enarteria iliaca común izquierda. Se trató con extensión del com-ponente torácico con una endoprótesis Bolton 28x24 hasta elnivel supra-celiaco y una endoprótesis multicapa 6x60 a nivelde bifurcación de iliaca común izquierda.

Comentario. Paciente con Síndrome de Marfan que presentóuna doble disección de aorta tipo B tratada endovascularmenteen diferentes niveles. Las indicaciones para la terapia en-dovascular aún no se han definido completamente para la dis-ección aórtica. En el subgrupo de pacientes con síndrome deMarfan aún son mas inciertas. Sin embargo ante los resultadosque ofrece el tratamiento farmacológico, con tasas de mortali-dad de 30-50 % a 5 años y una expansión del falso lumen de20-50 % a 4 años, la opción de terapia endovascular ha idosuperando las expectativas iniciales. Sus resultados a corto ymediano plazo como la mortalidad tardía de 1.5% en faseaguda y de 4.8% en fase crónica la ha hecho una opción vi-able. A pesar de esto, las complicaciones tras una reparaciónendovascular como la que se presentó en este caso continúanoriginando temas a resolver. Tal complicación en la aorta torá-cica ha sido considerada un fenómeno de nueva entrada en lazona de anclaje distal secundaria. Debida a una mayor fuerzaradial del extremo distal de la endoprótesis torácica aplicadasobre un flap mas frágil en comparación a la zona proximal.

Conclusión. El tratamiento endovascular en pacientes conSíndrome de Marfan y disección aórtica es aplicable. Puederetrasar la cirugía abierta y requiere un seguimiento muy es-trecho para tratar sus complicaciones.

Si tuviera que tratar un caso similar usted que terapia apli-caría?

Flores, C.; Cruz, L.; Navarro, J.; Riambau, V. (1); Rodriguez, R.Hospital Clinic i Provincial de Barcelona España

Doble disección aórtica en paciente con síndromede Marfan: Abordaje endovascular

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demostrado que el eje safeno tiene un porcentaje de reapertu-ra de entre el 30 y 40% (meta-análisis de Van den Enden L, yotras publicaciones), además de los efectos sistémicos no des-preciables de la espuma, que distan de hacerla la técnica ide-al. Sin embargo múltiples publicaciones afirman que la escle-roterapia con espuma de venas C2 se constituye cada día co-mo técnica perfecta para reemplazar las flebectomías que serealizan complementarias al stripping o tratamiento con en-doláser de la vena safena interna.

OBJETIVOS: Describir los detalles técnicos de la técnica(tratamiento en quirófano de la vena safena interna con láserendovenoso y sesiones semanales de escleroterapia con es-puma de colaterales C2, empezando a la semana postoperato-ria) Analizar los resultados de aceptación por parte del pa-ciente (CIVIQ 2 pre-operaotorio y post-operatorio, cuestionariode satisfacción del paciente, que incluye la necesidad de técni-cas anestésicas menos cruentas) y tabular el seguimientoclínico en el tiempo y con ecodoppler de la evolución.

MATERIAL Y MÉTODOS: Entre noviembre de 2009 y diciembrede 2010, en el Hospital Rúber Internacional de Madrid, se harealizado el tratamiento con la técnica descrita a 79 pacientes,recogiendo la información mediante varios formularios (VCSS,CIVIQ 2 pre- y post-operatorio, encuesta de satisfacción del

paciente a los 14 días siguientes al post-operatorio y revi-siones periódicas tanto clínicas como por ecodoppler: 7, 14,30, 90 y180 días). Los resultados se tabularon en una base dedatos para obtener resultados estadísticos aplicables a lamuestra.

RESULTADOS: Los pacientes no experimentaron complica-ciones graves como trombosis venosa profunda o embolia pul-monar. Existió muy baja incidencia de complicaciones menorescomo hematomas, equimosis, trombosis, induración de latrayectoria de la safena, parestesias y dolor. La tabulación dedatos demuestra una muy buena aceptación de la técnica porparte de los pacientes y un eficiente tratamiento que semantiene en el tiempo en el cierre de la safena tratada conláser y de las varices C2 tratadas con esclerosis con espuma ypor último, una positiva mejoría en su calidad de vida con buenresultado estético como valor añadido.

CONCLUSIONES: En la serie descrita, se comprueba que esuna técnica mínimamente invasiva, que aprovecha las fort-alezas del láser endovenoso y de la esclerosis con espuma,con muy baja morbilidad postoperatoria y que permite un rápi-do regreso de los pacientes a la vida normal, mejorando positi-vamente su calidad de vida. Los resultados se mantienen através de su seguimiento en el tiempo.

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INTRODUCCIÓN

El tratamiento endovascular habitual de los aneurismas aórti-cos torácicos que implican a la arteria subclavia izquierda,conllevan la obliteración de la misma por el implante de la en-doprótesis en su ostium, asegurando así el correcto selladodel aneurisma.

OBJETIVOS

Presentamos la técnica quirúrgica endovascular de tratamientode los aneurismas de aorta torácica yuxta subclavios, preser-vando la permeabilidad de la arteria subclavia izquierda.

CASO CLÍNICO

Varón de 63 años, con antecedente único de hipercoles-terolemia. Diagnosticado mediante TC tóraco-abdominal, en elcontexto de estudio de disfonía de meses de evolución, de unaneurisma sacular a nivel del cayado de la aorta y un AAA in-frarenal.

A la exploración física se objetiva masa abdominal pulsátil, sinotros hallazgos a destacar.

Ante el diagnóstico de pseudoaneurisma del cayado de la aortapor úlcera penetrante aórtica, se decide el implante de una en-doprótesis de aorta torácica. Al tratarse de un caso sin cuelloproximal, y para así evitar la realización de un bypass carótido-subclavio que aumenta la morbi-mortalidad, se decide el im-plante de la endoprótesis de aorta torácica “custom made”tipo Relay® de 36 mm de diámetro. Se introduce la prótesis através de arteriotomía en arteria femoral izquierda. Se com-prueba al finalizar la intervención la correcta exclusión delaneurisma y permeabilidad completa de la arteria subclaviaizquierda.

Realizamos un TC torácico de control tras el primer mes queconfirma la permeabilidad de los troncos supraaórticos, sin ob-jetivar fugas de contraste y con una reducción del sacoaneurismático de 14 mm.

RESULTADOS DEL ESTUDIOActualmente las guías clínicas indican, de modo obligatorio, larevascularización de la subclavia, teniendo como opciones elbypass carótido-subclavio con el aumento de la morbi-mortali-dad que esto supone, o el implante de una endoprótesis deaorta torácica con “scallop” proximal. Esta técnica permite lapreservación del flujo de la arteria subclavia sin necesidad deotras técnicas adicionales.

Jiménez Olivera, M. A.; López de la Franca Beltran, B.; Esteban Gracia, C.; MartorellLossius, A.; Lisbona Sabater, C.; Lerma Roig, R.; Callejas Pérez, J.M.

Hospital Universitario Germans Trias i Pujol.

Preservación de la arteria subclavia izquierdamediante el implante de una endoprótesis torácicacon Scallop proximal por aneurisma yuxta subclavio

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Como resultado de la integración de los datos de los estudios clínicos, ev3, con su historia en el diseño de stents inno-vadores, lanza al mercado una nueva malla mejorada para el Stent de Femoral Superficial, llamado EverFlex+.

La mejora fundamental radica en que este stent posee una mayor resistencia a la fractura, hasta catorce veces mayor.Esto se ha conseguido mediante un nuevo diseño, que ahora es mecánicamente más equilibrado y hace que el stentreparta su fatiga axial (cuando el stent sufre elongación); por ello, se disminuyen los “puntos calientes” que contribu-yen a la fractura, y así, de esta manera, se reducen las restenosis asociadas a fracturas.

Durante los ensayos con stents elongados, el stent Everflex+ de 6 mm, resistió 9 ciclos más sin romperse (la mediapara todos los diámteros es de 5,5 ciclos más de resistencia frente a la fractura). Y todo esto, unido a que mantiene lamisma fuerza radial y flexibilidad que su predecesor, hacen del stent Everflex+ el primer stent de 3ª generación parala femoral superficial.

El nuevo Stent EverFlex+ conserva el sistema EX.P.R.T exclusivo de toda la familia PROTÉGÉ. Gracias a este sistema,se evita el salto o liberación prematura del stent, lo cual le confiere una liberación precisa.

El stent Everflex +, al igual que el anterior “EverFlex”, dispone de una amplia gama de medidas; longitudes de 20 a200 mm, y diámetros de 5 a 8 mm, todas ellas compatibles con introductor de 6F.

N O V E D A D E S D E S D E L A I N D U S T R I A

ev3 lanza el Nuevo stent de Femoralsuperficial EVERFLEX+

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4-7 May, 2011

Barcelona, SpainIX INTERNATIONAL SYMPOSIUM ONENDOVASCULAR THERAPEUTICS

Web site: site2011.atlantacongress.org

7-11 May, 2011

Philadelphia, PA91ST ANNUAL MEETING OF THE AMERICANASSOCIATION FOR THORACIC SURGERY

www.aats.org/annualmeetingPhone: (978) 927-8330

11-14 May, 2011

Noordwijkerhout, The Netherlands6TH INTERNATIONAL SYMPOSIUM ON THEDIABETIC FOOT

www.diabeticfoot.nlPhone: +31 (0)88 0898100Fax: +31 (0)88 0898109Email: [email protected]

12-13 May, 2011

New York, NYINNOVATIONS AND PRACTICALAPPLICATIONS IN VASCULAR SURGERY 2011

www.nyp.org/vascularContact: Jessica ScullyPhone: (201) 346-7007Fax: (201) 346-7011Email: [email protected]

12-14 May 2011

Miami Beach, FL9TH INTERVENTIONAL VEIN CONGRESS (IVC)

www.ivcmiami.comPhone: (888) 334-7495Email: [email protected]

17-20 May 2011

Paris, FranceEUROPCR

www.europcr.comFax: +33 5 34 45 26 46Email: [email protected]

1-4 June 2011

New Orleans, LA12TH ANNUAL NEW CARDIOVASCULARHORIZONS

www.newcvhorizons.comContact: Dana Rigdon, CMPPhone: (337) 993-7977 begin_of_the_skype_highlighting(337) 993-7977 end_of_the_skype_highlightingFax: (337) 993-7922Email: [email protected]

2-4 June 2011

Boston, MASVM 22ND ANNUAL SCIENTIFIC SESSIONS

www.vascularmed.orgPhone: (847) 480-2961 begin_of_the_skype_highlighting(847) 480-2961 end_of_the_skype_highlighting

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15-18 June, 2011

New York, NYLIVE SYMPOSIUM OF COMPLEX CORONARY &VASCULAR CASES 2011

www.cccsymposium.orgPhone: (425) 788-9060 begin_of_the_skype_highlighting(425) 788-9060 end_of_the_skype_highlighting

16-19 June, 2011

Chicago, IL2011 VASCULAR ANNUAL MEETING

www.vascularweb.orgPhone: (312) 541-0567 begin_of_the_skype_highlighting(312) 541-0567 end_of_the_skype_highlighting

26-30 June, 2011

Orlando, FLCOMPLEX CARDIOVASCULAR CATHETERTHERAPEUTICS (C3)

www.c3conference.net

3-5 August, 2011

Santiago, ChileSOLACI’11

www.solacicongress.comEmail: [email protected]

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12-13 August 2011

Chicago, ILAMPUTATION MANAGEMENT & PREVENTIONSYMPOSIUM

Phone: (305) 279-2263 begin_of_the_skype_highlighting(305) 279-2263 end_of_the_skype_highlightingEmail: [email protected]

25-26 August 2011

Tokyo, JapanJAPAN ENDOVASCULAR SYMPOSIUM

www.japanendovascular.comEmail: [email protected]

8-30 September 2011

Portoroz, CroatiaESVS VENOUS WORKSHOP

This workshop will be open forregistration on 1 May 2011

11 September 2011

HungaryESVS VASCULAR ACCESS WORKSHOP

This workshop will be open forregistration on 1 May 2011

22-25 September 2011

Athens, GreeceEUROPEAN SOCIETY FOR VASCULAR SURGERY25TH ANNUAL MEETING

Megaron Conference Centre

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La redacción de TÉCNICASENDOVASCULARES (TE) considerará para supublicación aquellos trabajos relacionados con laterapéutica endovascular. Las secciones que com-pone la revista son:

• Editorial• Trabajos originales• Revisiones• Casos clínicos• Imágenes endovasculares• Notas técnicas• Zona catastrófica• Novedades desde la industria• Cartas al Director• Bolsa de Trabajo e intercambio profesional• Congresos

EDITORIAL

Se asignará por invitación desde la redacción deTE.

TRABAJOS ORIGINALES

Se consideran trabajos originales aquellos que nohayan sido publicados en otros medios de comuni-cación escrita médica. Deberán constar de la es-tructura siguiente:

• Resumen en Español y Abstract en Inglés(máximo 250 palabras)

• Introducción• Material y Métodos• Resultados• Discusión y conclusiones• Referencias Bibliográficas

Importante:

Cada uno de los apartados anteriores iniciará pági-na. En la primera página deberá figurar el títulocompleto, los autores, el centro de trabajo, la per-sona de contacto para la correspondencia con sudirección postal y e-mail, la sección a la que va diri-gida y la fecha de envío. Asimismo deberá confec-cionar un título corto y facilitar palabras clave (mí-nimo de 3 y máximo de 6).

El manuscrito se redactará con letras de tamaño12 (preferiblemente tipo Times, Arial o Courier),con interlineado doble y con las páginas numera-das. El idioma deberá ser Español o Inglés.

Referencias Bibliográficas: Se numerarán segúnaparición correlativa en el texto. Para la citación delos trabajos se utilizarán las normas que aparecendetalladas en ‘Uniform Requeriments forManuscripts Submitted to Biomedical Journals’,NEJM 1997; 336:309-316.

A modo de ejemplo:Artículo: Kioka Y, Tanabe A, Kotani Y, Yamada N,Nakahama M, Ueda T, et al. Review of coronary ar-tery disease in patients with infrarenal abdominalaortic aneurysm. Circ J 2002;66(12):1110-2

Capítulo de Libro: Coselli JS, Buket S, Crawford ES.Thoracic Aortic Aneurysms. En: Haimovici H, AscerE, Hollier LH, Strandness DE, Towne JB, eds.Vascular Surgery. Cambridge (USA), BlackwellScience, 1996; 759-785

Figuras: Las figuras irán numeradas (números ára-bes) correlativamente según aparición en el texto.Se aceptará un máximo de 5. Las imágenes debe-rán indicar su orientación. Las figuras en color sereproducirán del mismo modo si su interés lo haceimprescindible. De modo contrario, se reproduci-rán en escala de grises. Se adjuntará en páginaaparte los pies de figura. Si las figuras van digitali-zadas deberán presentarse en formato jpg a 300ppp, a 10 x 15 cms.

Tablas: Las Tablas se numerarán con números ro-manos correlativos según su orden de aparición enel texto. Se aceptará hasta un máximo de 5 tablaspor trabajo. Cada tabla deberá identificarse con unbreve texto explicativo.

REVISIONES

Se aceptarán para su valoración aquellos trabajosde revisión que por su actualidad o controversiasusciten la atención de los especialistas relaciona-dos con las terapéuticas endovasculares. Se po-drán solicitar explícitamente desde la redacción obien someter libremente según iniciativa de sus au-tores. Deberán seguir las mismas normas de redac-ción y presentación que aparecen para los trabajosoriginales. No obstante, su estructuración deberácontemplar:

• Resumen (Español) y abstract (Inglés)• Introducción• Desarrollo• Conclusiones• Referencias Bibliográficas

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CASOS CLÍNICOS

Se aceptarán para su valoración los casos clínicossingulares y originales. Seguirán las normas de re-dacción ya mencionadas en apartados anteriores.Si bien su estructuración deberá ser:

• Resumen (Español) y Abstract (Inglés)máximo de 150 palabras

• Caso• Referencias Bibliográficas (máximo de 5)• Las Figuras estarán limitadas a tres como

máximo.

IMÁGENES ENDOVASCULARES

Se aceptarán para su valoración aquellas imágenesrelacionadas con las terapéuticas endovascularesque por su singularidad sean merecedoras de supublicación. Se acompañarán de texto (máximo100 palabras) y referencias bibliográficas si se con-sidera necesario en un máximo de dos. Sólo seaceptarán dos figuras.

NOTAS TÉCNICAS

Se aceptarán para su valoración aquellas modifica-ciones o innovaciones técnicas que se considerende interés para los profesionales relacionados conlas terapéuticas endovasculares. Se ilustrarán conun máximo de tres figuras y un texto máximo de500 palabras. Se podrá acompañar de 5 referen-cias bibliográficas.

ZONA CATASTRÓFICA

Se aceptará para su valoración aquellas situacioneso procedimientos que condujeron a complicacio-nes singulares, resueltas o no satisfactoriamente,pero que de la experiencia se pueda derivar unaenseñanza de interés para los profesionales relacio-nados con las terapéuticas endovasculares. Se se-guirán las recomendaciones reflejadas en el apar-tado de ‘casos clínicos’.

NOVEDADES DESDE LA INDUSTRIA

Los profesionales de la industria podrán disponerde un espacio que permitirá dar a conocer nuevosproyectos o productos a través de esta sección. Seaceptarán para su valoración textos (máximo 500palabras) y figuras (máximo de tres) para este co-metido. Se dará preferencia a las publicacionesprocedentes de las industrias colaboradoras habi-tuales de TE.

CARTAS AL DIRECTOR

En esta sección se dará cabida a todas las cartasque en la redacción se reciban a modo de suge-rencia, crítica o comentario del fondo y forma deTE.

BOLSA DE TRABAJO E INTERCAMBIO PROFESIONAL

Este espacio se reservará para anunciar oportuni-dades de trabajo o de formación en el campo dela terapéutica endovascular. El DepartamentoComercial de TE convendrá con el anunciante, elcoste de su anuncio.

CONGRESOS

Se incluirán todos aquellos acontecimientos cientí-ficos, congresos, reuniones, jornadas, simposios,etc,, que por su interés merezcan ser anunciados alos profesionales relacionados con terapéuticas en-dovasculares. Su anuncio estará libre de cargo.

Todos los manuscritos, copia impresa y en so-porte informático, deberán ser dirigidos a:

TÉCNICAS ENDOVASCULARESAribau, 237. Escalera B 3º-1ª, 08021 Barcelona

O directamente por correo electrónicoe-mail: [email protected]

Nota: El comité de redacción se reserva el derechode rechazar aquellos trabajos o informaciones queno cumplan con las normas aquí expuestas o no seconsideren de relevanciapara su publicación en TE.Asimismo, desde el comitéde redacción se propon-drán modificaciones nece-sarias a los trabajos que seconsideren oportunos. Elcomité de redacción secompromete a dar cumpli-da respuesta a todos los au-tores en el plazo de quincedías desde su recepción enla redacción.

¡Revise su manuscrito yconfirme su adecuación alas normas que aquí figu-ran antes de enviarlo a laredacción de TE!

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‘TÉCNICAS ENDOVASCULARES’ (TE) willconsider for publication original articles related toendovascular therapy. The appropriate sections inthe journal are:

• Editorial• Original articles• Reviews • Case Reports• Endovascular Images• Technical Notes• Complications/Catastrophies• News from Industry• Letters to the Editor• Bag of Work and Professional Exchange• Congress’ Agenda

CONDITIONS OF PUBLICATION

A covering letter must accompany all articles andshould be signed by all authors. The first namedauthor will be responsible for ensuring that all aut-hors have seen and approved the manuscript.Each author should have participated sufficiently inthe article to take public responsibility for the con-tent.

Articles will be accepted on the understanding thatthe work has not been submitted for publicationelsewhere. Exclusive copyright in the paper andillustrations shall be assigned to the publisher.

Articles involving human or animal investigationswill be accepted on the understanding that thework has been approved by local ethical committe-es.

The articles should conform to the “UniformRequirements for Manuscripts submitted toBiomedical Journals” NEJM 1997:336(4); 309-315.

EDITORIALS

These will be by invitation from the Editorial Board.

ORIGINAL ARTICLES

Language can be Spanish or English and shouldconform to the following structure:• Title Page• Abstract and key words• Introduction • Material and Methods (including a description ofthe statistics)

• Results• Discussion and Conclusions• Acknowledgements • References• Tables • Legends for Illustration

Each of the above sections should begin on a newpage. The title page should include the title of thearticle, the authors and affiliations, the name, ad-dress and e-mail contact of the author responsiblefor correspondence and requests for reprints, thecategory for which the manuscript is being submit-ted, the source of any support or funding and ashort title (running head). The second pageshould contain the abstract, which should not ex-ceed 200 words and should accurately reflect thecontent of the body of the article. 3 to 6 keywords are required. Each table should be on a se-parate page. Illustrations should be no larger than203 x 254mm.

The manuscript should preferably be typed on A4paper with 25mm margins in Times New Roman,Ariel or Courier New fonts, size 12, lines should bedouble spaced with numbered pages. Languagemay be Spanish or English.

References should be cited in the Vancouver Styleand should be numbered in the text consecutivelyby Superscript. References should be listed in nu-merical order at the end of the article. The first 6authors should be listed followed by et al.Examples of a perfect style of reference are:

Article: Kioka AND, Tanabe TO, Kotani AND,Yamade N, Nakahama M, Ueda T, et al. Review ofcoronary artery disease in patients with infrarenalabdominal aortic aneurysm. Circ J2002;66(12):1110-2.

Book Chapter: Coselli JS, Buket S, Crawford is.Thoracic Aortic Aneurysms. In : Haimovici H, AscerAND, Hollier LH, Strandness OF, Towne JB, eds.Vascular Surgery. Cambridge, Blackwell Science,1996; 759-785.

Figures should be consecutively numbered as theyappear in the text, each on a separate page. Amaximum of 5 will be accepted. The reverse sideof any illustration should indicate its orientation.Colour figures will only be accepted if they are in-dispensable, otherwise they will be reproduced inblack and white.

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Tables should be consecutively numbered as theyappear in the text. Up to 5 will be accepted.

Both figures and tables should have appropriate le-gends.

REVIEWS

The submission of review articles that address to-pics of current interest or controversy are encoura-ged. The structure of the article will be dependentupon the subject that they review, but a possibleformat would be:

• Abstract in English or Spanish• Introduction• Main text• Conclusions• References

CASE REPORTS

These should be brief (not exceeding 500 words)and follow the following structure:

• Abstract • Case Report• Discussion• References (maximum of five)• Figures and tables (minimum of three)

ENDOVASCULAR IMAGES

Striking endovascular images will be accepted forpublication, they should be short with text limitedto 100 words and up to 2 references. Only 2 figu-res will be accepted.

TECHNICAL NOTES

Therapeutic innovations or interesting technicalmodifications will be considered for publication.They should be short with a maximum of 500words, 3 figures and up to 5 references.

COMPLICATIONS/CATASTROPHIES

The Journal will accept for publication short casesthat involve complications that have a well-focusedlearning point for the readers. The case should bestructured as “case reports”.

NEWS FROM INDUSTRY

Industry will have space to focus on new productsor projects. The articles should have a maximumof 3 figures and 500 words. Preference will be gi-ven to those companies collaborating withTécnicas Endovasculares.

LETTERS TO THE EDITOR

Correspondence that focuses upon subjects of in-terests to the readership will be considered for pu-blication.

BAG OF WORK AND PROFESSIONALEXCHANGE

There will be an opportunity to advertise work op-portunities and teaching programmes relating tothe field of endovascular therapy. There will be afinancial charge for this facility.

CONGRESS AGENDA

This section will be available to advertise congres-ses, meetings, workshops etc that have relevanceto the field of endovascular therapy. There will beno charge.

CORRESPONDENCE

All manuscripts should be formatted asdetailed above, and presen-ted on A4 paper (210 x297mm) on one side of thepaper only with double spa-cing and 3cm margins. Ifpossible the entire manus-cript can be sent on a diskto:

XXI MECAribau, 237. Stairway B 3o-1a, 08021 Barcelona or e-mailed to:[email protected]@a2multimedia.com

If electronic submission is notpossible please forward 3 co-pies by post.

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Nº Suscriptor

Dirección de Envío

B o l e t í n d e S u s c r i p c i ó n

A ñ o 2 0 1 1

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Cheque nominativo que adjunto

Domiciliación bancariaTécnicas Endovasculares

Aribau, 237. Escalera B 3º-1ª08021 BARCELONA (ESPAÑA)

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V. Riambau - endovascular.es · endovascular therapeutics with a daring look into the future. This...

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Transcript of V. Riambau - endovascular.es · endovascular therapeutics with a daring look into the future. This...