Cardiologia interventistica nelle

cardiopatie strutturali

Prof. Francesco Romeo

Universita’ degli Studi di Roma “Tor Vergata”

Genova 13/11/2015

Interventional cardiology has moved from

time it was important to stress:

“How to do”

“When and to whom”

CORONARY ARTERY DISEASE

Where is Interventional Cardiology going?

Come si può trattare

un’emergenza trombotica?

Per anni la trombolisi è stato il trattamento di scelta

nei pazienti con infarto miocardico acuto ottenendo

una significativa riduzione della mortalità in fase

acuta.

L’introduzione nell’ultimo decennio dell’angioplastica

primaria ha posto il problema di un corretto iter

terapeutico che permettesse di utilizzare nella

sequenza migliore entrambe le metodiche sfruttando i

vantaggi di entrambe

PCI in CAD is Here to Stay

•DES vs BMS nello STEMI •Culptit lesion o rivascolarizzazione completa •TC / patologia trivasale •Stent diretto o tromboaspirazione •Trattamento dei pazienti anziani •Trombolisi:quando farla?a chi farla?quando eseguire una PCI dopo una trombolisi “efficace” •No Reflow •Trattamento delle biforcazioni •Come trattare al meglio lo shock cardiogeno

PROBLEMI APERTI:

Congenital Heart Disease

Mitral Stenosis

Left Atrial Appendage

Percutaneous Closure of Para-prosthetic Leak

Aortic Stenosis

Mitral Regurgitation

Heart Failure Devices

Structural Cardiology

The new frontier of interventional cardiology

Homograft – 1962

Porcine valve – 1965

Pericardial tissue valve – 1969

First CoreValve Transcatheter AVR

by Retrograde Approach

Laborde, Lal, Grube – July 12, 2004

First PVT Transcatheter AVR

by Antegrade Approach

Alain Cribier – 2002

Mechanical heart valve – 1962 Chirurgica

Endovascolare

1960 2002 1970 2004 2006

First CoreValve PURE Percutaneous

AVR – Serruys, DeJaegere, Laborde

October 12, 2006

First Edwards/PVT Transapical Beating

Heart AVR – Webb, Lichtenstein

November 29, 2005

First CoreValve Percutaneous AVR

WITHOUT cardiac assist or pacing

Grube, Gerckens – November 6, 2006

Storia della Sostituzione Valvolare

Aortica

Treatment of high surgical risk patients has been modified with the introduction of TAVI

Storia Naturale

7 GP Ussia GP Ussia

Braunwald E. Aortic stenosis.

Circulation 1968

“Surgical intervention should be performed promptly once even …minor symptoms occur”

Andersen, a cardiologist at Aarhus University

Hospital, Denmark, recalls the interventional

meeting he attended in February 1989 in the

USA: "I was sitting in the auditorium listening

to Julio Palmaz describing his experience of

using coronary stents in dogs, when I

suddenly thought ‘why not make the stents

larger and place a biological valve inside.’"

1989 Henning Rud Andersen, the

inventor of TAVI

April 16, 2002: First human case

description trans-catheter aortic valve

Epidemiology

10 GP Ussia

Class I Symptomatic Severe Aortic Stenosis

Severe Aortic Stenosis in patients who undergoes other cardiac surgery (CABG, mitral valve repair …)

Asymptomatic Severe Aortic Stenosis with left ventricular disfunction ( EF<50%)

GP Ussia

• Diagnosis of Aortic Valve Stenosis

• Cardiac surgery risk and life expectancy – STS score/ log EuroScore – Comorbidities: liver chirrosis, porcelain aorta, cachexia,

hostile thorax, respratory insufficiency (FEV1<1 liter), pulmonary hypertension (PAPS>60 mmHg)

• Feasibility assessment of TAVI and exclusion criteria

Which Patient?

Transcatheter Valve implantation for pts

with aortic stenosis: a position statement

from EACTS-ESC-EAPCI

European Heart Journal 2008

- Left ventricular hypertrophy; - Left ventricular dilatation; - Diastolic dysfunction; - Preoperative 6 min walk test; - Hypoalbuminemia /poor nutritional status; - Anaemia; - Morbid obesity; - Right ventricular dysfunction..

- Frailty; - Active endocarditis; - Active cancer; - Low-flow low-gradient AS

- Porcelain aorta, - Previous chest wall radiation; - Hepatic failure; - Chest wall malformation;

G.P. Ussia

Echocardiogram

Aortography

Angio CT scan

Patient assessment

CT Scan Examination Annulus 23.7 x 30.5 mm

Sinus 33. 7mm

Perimeter 82.3 mm

Accesso Arteria Femorale Comune

Access Alternative

Accesso Arteria Succlavia/ascellare prossimale

Direct Aortic Surgical Technique

• Additional approach for those patients who are not candidates for either femoral or subclavian access options.

• Familiar access through a mini-sternotomy or mini-thoracotomy

• No pericardial dissection or direct heart muscle manipulation.

Bruschi G, et al. Direct Aortic Access Through Right Minithoracotomy for Implantation of Self-Expanding Aortic Bioprosthesis Valves 1

1J Brushi G, De Marco F, Fratto P, Oreglia J, Colombo P, Botta L, Klugmann S, Martinelli L. Alternative approaches for trans-catheter self-expanding aortic bioprosthetic valves implantation: single-center experience. Euro J Cardio-Thoracic Surg. 2011; 39: e151-e158.

Prognostic factor of long term death

• Procedural complications

• Chronic kidney disease

• COPD

• Frailty

• Atrial Fibrillation

Most frequent Complications

• Implant failure

• Paravalvular leak

• Major vascular complications

• Atrio-ventricular block

• Left and right ventricular perforation

• Cerebrovascular accident

Current Generation device

Medtronic CoreValve Edwards-Lifesciences

>50,000 patients treated thru 2012 in >500 interventional

centers outside the U.S.!

Optimal positioning

Indications for aortic valve replacement in aortic stenosis

ESC/EACTS GUIDELINES 2012

Accepted Date: 4

March 2015

Eltchaninoff H. London Valve 2014

EVOLUT R (Medtronic)

EVOLUT R (Medtronic)

Corevalve & Edwards

• 150.000 impianti

• 800 centri nel mondo

• Trial randomizzati ( Partner A, Corevalve US trial)

• Registri (ADVANCE, SOURCE, TCVT pilot, Registri Nazionali: UK, FRANCE 1 & 2, GARY …)

• Linee guida ESC 2012, ACC/AHA 2013

• FDA

Nuove Indicazioni

TAV in SAV for degenerated

bioprosthesis

Insufficienza Aortica

ACURATE neo™ & ACURATE TF™ Delivery System

The surgical repair or replacement of the mitral valve is the gold standard in severe treatment of the IM. Without surgical treatment the prognosis of patients with IM and heart failure is poor.

IM isolata (n=877)

IM <3+ (n=347)

IM severa (n=540)

Asintomatici n=144

Sintomatici n=396

Intervento CCH n=203 (51%)

No Intervento n=193 (49%)

Actual management of IM in the “real world”

da Euro Heart Survey

Mirabel. Eur Heart J 2007

No Intervento CCH n=193 (49%)

• disfunzione VS

• NYHA IV

• etiologia non ischemica

• età avanzata

• ↑ indice di Charlson per comorbidità

• IM grado 3+

Concept: Percutaneous Mitral Valve Repair

• Double-orifice suture technique developed by Prof. Ottavio Alfieri

• First published results in 1998 illustrated proven benefit

• Suggested procedure best suited for minimally invasive approach

• Dr. Fred St. Goar, interventional cardiologist had patient successfully treated with edge-to-edge surgery

• Conceived several ideas for percutaneous valve repair

• Founded Evalve 1999 to develop device to treat valvular disease

Human S/P Surgical Alfieri

Circulation 2002;106:e173

eValve Clip repair in porcine heart (6 mos post)

Circulation 2003;108 (supp IV):493

Edge-to-Edge Technique

MitraClip System

• Percutaneous repair of the MV

• Beating heart procedure

• Real time MR assessment

• Allow for repositioning of the device

Procedural Overview

Procedural Overview

Procedural Overview

Procedural Overview

Procedural Overview

Worldwide Clinical Experience

• Over 10,500 patients have been treated with the MitraClip Therapy

worldwide.1

– 75% are considered high risk* for mitral valve surgery

– 67% have functional mitral regurgitation (MR)

– 96% Implant Rate

• The use of the MitraClip is supported by a rigorous clinical trial program.1

– 50% are considered high risk* for mitral valve surgery

– 60% have functional MR

1. Data as of September 2013.Source: Abbott Vascular

* Determination of high surgical risk based on: logistic EuroSCORE ≥ 20%, or STS calculated mortality ≥ 12%, or pre-specified high surgical risk co-morbidities specified in EVEREST II High

Risk Study protocol.

FDA Approval

N Engl J Med 2011;364:1395–1406

MR Severity Functional Status

MitraClip therapy reduces functional Mitral regurgitation in patients with endstage heart failure and marked LV disfunction and entails clinical benefit at 6 months

Circulation. 2013;127:1018-1027

MitraClip in Specific Patient Populations

Patient groups in which significant clinical benefits have been reported:

– Severe Heart Failure, despite optimal medical therapy1

– CRT non-responders2

– Severe LV dysfunction refractory to medical therapy3

– Degenerative MR, declined for surgery4

– Bivalvular Disease: Severe Aortic Stenosis and Mitral Regurgitation5

1. Franzen et al. MitraClip Therapy In Patients With End-Stage Systolic Heart Failure. Eur J Heart Failure. 2011; 13: 569-576.

2. Auricchio et al. Correction of Mitral Regurgitation in Nonresponders To Cardiac Resynchronization Therapy By MitraClip Improves Symptoms And Promotes Reverse Remodeling. JACC 2011; 58: 2183-2189.

3. Franzen O, Baldus S, Rudolph V, et al. Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: Emphasis on adverse valve morphology and severe left ventricular dysfunction.

Eur Heart J. 2010; 31:1373-1381

4. Reichenspurner, H. et al. Clinical Outcomes through 12 months in patients with Degenerative Mitral Regurgitation treated with the MitraClip device in the ACCESS-Europe Phase I trial. Eur J Cardiothoracic

Surgery. 2013: July 17. [Epub ahead of print]

5. Rudolph V, Schirmer J, Franzen O, Schlüter M, Seiffert M, Treede H, Reichenspurner H, Blankenberg S, Baldus S. Bivalvular transcatheter treatment of high-surgical-risk patients with coexisting severe aortic

stenosis and significant mitral regurgitation. Int J Cardiol. 2013; 167(3):716-2

Confirmation of MR severity (3+ or 4+) and symptoms

Analysis of surgical risk (STS-score >10%; LogES>20%;

adjunctive criteria not included in the scores)

Evaluation of life expectancy (>1 y)

Assessment of the procedure feasibility and any

controindication to percutaneous treatment

Patient Selection

Sufficient leaflet tissue for mechanical coaptation

Non-rheumatic valve morphology

Non-endocarditic valve morphology

Absence of severe calcification

AVM > 4.0 cm2

FUNCTIONAL MR

• Coaptation depth ≤ 11mm

• Coaptation length ≥ 2mm

DEGENERATIVE MR

• Flail gap ≤10mm

• Flail width ≤ 15mm

Key Anatomic Elegibility Criteria EVEREST Trial

Pregi

Basso rischio di complicanze intraprocedurali

Successo procedurale immediato

Monitoraggio ETE in tempo reale con ↓ complicanze

Possibilità di ripetere impianti sino al migliore possibile

• Curva apprendimento lunga

• Rischio di intrappolamento nelle corde tendinee in caso di ripetute manovre

• Prognosi invariata nelle funzionali in scompenso cardiaco avanzato

Difetti

Pregi

IM funzionali: stabilizzazione clinica, riduzione dei ricoveri per scompenso

miglioramento qualità della vita

IM degenerative con rotture di corde complicate ma ottimo outcome clinico

Miglioramento quadro clinico e classe NYHA

• IM degenerative mixomatose complesse con risultato subottimale (manca anuloplastica)

• Recidiva di insufficienza mitralica ad un mese

• Costo del dispositivo

• Rimborso variabile da regione a regione

Difetti

The CardiAQ Transcatheter Mitral Valve

CAUTION: Investigational device, limited by Federal (or United States) law to investigational use. Exclusively for Clinical

Investigation. Not approved for sale in any country.

• ONE VALVE, MULTIPLE DELIVERY SYSTEMS

TS – Transseptal approach

TA – Transapical approach

• UNIQUE ANCHORING MECHANISM

Preserves chords and utilizes native leaflets

Promotes load distribution among annulus, leaflets and

chords

• DESIGNED TO PROMOTE PHYSIOLOGIC FLOW

Eliminate mitral regurgitation

Supra-annular position and tapered outflow to minimize

risk of LVOT obstruction

Intra-annular sealing skirt to minimize PV leak

Open frame cells to promote atrial flow

The CardiAQ Transcatheter Mitral Valve

CardiAQ Percutaneous

• Minimizes risk of LVOT obstruction even in the

presence of an acute aorto-mitral angle

• Left atrium easily accommodates atrial profile

The CardiAQ Transcatheter Mitral Valve Supra-annular Position

• Patients treated with aorto-mitral angle 50.5° to 80.9°

• No LVOT obstruction

TA-001: 80.9° TA-002: 68.5° TA-003: 50.5° TF-001: 60.0°

The CardiAQ Transcatheter Mitral Valve Supra-annular Position

• Designed to minimize paravalvular leak

• Animal studies demonstrate intra-annular sealing

and no paravalvular leak

The CardiAQ Transcatheter Mitral Valve Intra-annular Sealing Skirt

1 2 3

Transseptal

Transapical

Leaflet Capture Valve Expansion Valve Release

The CardiAQ TMVR Procedure One Valve, Multiple Delivery Systems

CardiaQ: 2° GEN

• Sistema ancoraggio atraumatico – Punte delle ancore imbottite

– Spazio aperto tra le punte delle ancore atriali e ventricolari

– Ridotta pressione sub-annulare delle punte ventricolari

– Migliore distribuzione del carico tra annulus e corde

CardiaQ

•Paziente di 72 anni , insufficienza mitralica severa, classe NYHA 3 •Approvazione Comitato Etico per uso compassionevole

25 marzo 2015 – Università di Roma “Tor Vergata”

TRANSAPICALE

TRANSAPICALE

18 giugno – Università di Roma “Tor Vergata”

TRANSFEMORALE

TRANSFEMORALE

TRANSFEMORALE

TRANSFEMORALE

Conclusioni

• La mitraclip è indicata

– nella IM primaria nei pazienti ad alto rischio cardiochirurgico

– Nella IM secondaria sintomatica

• Nella IM secondaria puo essere utilizzata come bridge al trapianto cardiaco quando la comparsa della IM peggiora il quadro di compenso emodinamico

Conclusioni

• L’intervento di riparazione transcatetere dell’insufficienza mitralica secondaria interrompe il circolo vizioso dello scompenso

• Migliora la qualità della vita del paziente riducendo il numero di scompensi cardiaci

• Non si hanno ancora dati controllati sulla sopravvivenza possiamo ipotizzare che – nelle IM secondaria alla CMPD la storia naturale della

cardiopatia non venga modificata

– Nelle forme secondarie a cardiopatia ischemica il corretto timing possa ridurre la mortalità a lungo termine

GRAZIE

Trans-Catheter Valve Treatment long-term Registry EURObservational Research Programme