Congenital Interventional Catheterization in ACHDSorajja P, Cabalka AK, Hagler DJ, Rihal CS J Am...

Donald J. Hagler, MD, FASCIProfessor of Pediatrics and Medicine

Mayo Clinic College of Medicine

Congenital Interventional Catheterization in ACHD

Friday, November 2, 12

Mayo Recent ExperienceACHD

Ø173 patients with ACHD studied 2011- mid 2012

Ø82 or 47% were interventional procedures excluding simple RV biopsy

ØMajority were ASDs(13) or PFO (35) device closure

Ø12 StentsØRotational 3D angiography and CT

correlations ave become more frequent2

Preop CT

Rotational 3D angiography

Melody Valve Percutaneous pulmonary valve implantation

Ø31 Pulmonary valve implants in 30 pts. Of these one pt also had TV replaced at the same procedure

ØAges 6-79 yearsØTOF, DORV, Truncus, PA/PS,TGA,

RossØ9 Homografts, 17 tissue prosthesesØ10 Tricuspid tissue prostheses

replacedØ8 Mitral tissue prostheses replaced 6

Paravalvular leaks2011-12

Ø46 patients with aortic or mitral leaksØAges 29-84 yearsØ Assessment of Percutaneous Catheter Treatmentof Paravalvular Prosthetic RegurgitationDonald J. Hagler, MD,† Allison K. Cabalka, MD,† Paul Sorajja, MD,* Frank Cetta, MD,† Sunil V. Mankad, MD,* Charles J. Bruce, MD,* Lawrence J. Sinak, MD,*Krishnaswamy Chandrasekaran, MD,* Charanjit S. Rihal, MD*JACC: Cardiovascular Imaging 2010; 3:88-91

Ø Long-Term Follow-Up of Percutaneous Repair of Paravalvular Prosthetic Regurgitation

Sorajja P, Cabalka AK, Hagler DJ, Rihal CSJ Am Coll Cardiol 2011; 58:2218-24

Paravalvular LeaksJACC 2011

Ø136 total -heart failure, hemolytic anemia

Ø126 patients enrolled in review with 154 defects

ØMean age 67 +/- 12 yrsØ11 pt - unsuccessful (8.7%)ØNo or mild residual 96 (66%)ØModerate residual 30 (24%)

Paravalvular LeaksØMedical follow up 11 monthsØ3 deaths and 2 strokes in first 30 daysØ29(23%) deaths during follow upØ20(15.8%) had subsequent cardiac

surgeryØ3 yr est survival was 64.5%Øcurrently most commonly use AVPII

§primarily to achieve flat ventricular and atrial disc and the body of the device filling the defect

Basic ApproachØFemoral venous accessØTranseptal sheath (St Jude Agilis steerable

sheath)ØCross defect with 0.035” extra support

angled Glide wire and telescoped catheter system (6Fr MP Guide, 5Fr MP diagnostic)

ØAdvance 6 Fr MP Guide through defect. If not possible can create an AV loop or use Ventricular puncture to snare if Aortic mechanical prosthesis

Ø Various catheters (up to 8 Fr Shuttle) to place AVP II

Imaging

3D TEE

ImagingSimultaneous multiple devices

72 Year Old Female

Referred for Catheter-based Closure of Large Mitral Paravalvular Leak and

associated LV psuedoaneurysm

History

ØAortic Stenosis/regurgitation, Mitral regurgitation, and tricuspid regurgitation

Ø2011 (elsewhere): S/P 21 mm St Jude AVR, 25 mm St Jude EPIC tissue MVR, Tricuspid annuloplasty ring/repair, MAZE procedure

ØStormy postop course, >90 day hospitalizationØOngoing CHF symptoms ØHemolytic anemiaØReferred for treatment of paravalvular leak

associated with pseudoaneurysm

Pre-Cath Imaging

Basic Approach

ØFemoral venous accessØTranseptal sheath (St Jude Agilis steerable

sheath)ØCross defect with 0.035” extra support

angled Glide wire and telescoped catheter system (6Fr MP Guide, 5Fr MP diagnostic)

ØEnter pseudoaneurysm and position guide wire; catheter to place AVP II

ØApproach paravalvular defect for definitive closure

Transeptal Puncture Guidance

Approach to Pseudoaneurysm

Extra-stiff Angled Glide WireFriday, November 2, 12

Pseudoaneurysm Closure: 10mm AVP II

Clot Formation in Pseudoaneurysm

Guide for Closure of Paravalve Leak

Glide Wire 6 FR Guide Cath

AVP IIIn

Pseudoaneurysm

Paravalvular Leak Closure: 12 mm AVP II

Case Resolution

ØOvernight hospitalizationØNo procedural complicationsØDyspnea significantly improved

overnightØEcho showed trivial periprosthetic

regurgitation§Stable bioprosthetic valve function§No effusion

Disclosure:Some slides courtesy of Medtronic Corporation Melody® Transcatheter Pulmonary Valve

Melody® and Ensemble® are registered trademarks of Medtronic, Inc.

Melody Valve Percutaneous pulmonary valve

implantation

Melody® Valve

ØBovine jugular venous valve segment

ØPlatinum-Iridium stent

Melody® Valve

ØBovine jugular venous valve segment

ØPlatinum-Iridium stent

Valve Design Rationale

ØUtilizes natural venous valve & vein wall segment

ØDeep coaptation provides competence across range of diameters & geometries

ØThin leaflets open & close under minimal pressure changes

ØVenous wall provides functionality of covered stent

Transcatheter Pulmonary Valve

Bonhoeffer P, et al. Lancet 2000

First Human Use

ØCircumferential RVOT conduit with > 16 mm diameter at time of original implantation

ØInner diameter < 22 mm

ØRegurgitant and/or stenotic lesions

•> moderate PR•RVOT mean gradient > 35-40 mmHg

Indications The Melody Valve FDA approved under HDE - 2010

Clinical History

Revised TPV (2003)

World Wide: >850 patients among >75 centers

2000 2002 2004 2006 2008

1st ImplantParis, France (2000)

CE Mark, Health Canada Approval (2006)

1st US Implant (2007)

Bonhoeffer Cohort(2003-05)

US Cohort (2007-08)

July 2009 FDA Circulatory System Devices Panel July 2009Full Panel Approval

Ø22 Fr crossing profileØRetractable sheath

Ensemble® Delivery System

ØBalloon-in-balloon catheter

Ø3 outer balloon diameters§ 18 mm§ 20 mm§ 22 mm

TPV Deployment

Safety ConsiderationsProcedural RisksØCoronary artery

compressionØConduit ruptureØDevice embolization

Device RisksØStent fractureØPulmonary

embolic complications

ØEndocarditis

20 yr old PA/VSDMelody® TPV Placement

“PS” velocity – 2 m/sec; Mean gradient 10 mmHgTR velocity 2.9 m/sec; RVSP 44 mmHg

PR eliminated and ΔRVSP = - 30 mmHg

Freedom From Stent FractureError bars are 95% confidence limits

Months 0 3 6 9 12 14N at risk 89 77 52 36 29 9N at risk 89 74 47 28 24 8

U.S. Study

Major All

6 months 12 Months

FF Major stent fracture 99% 91%FF All stent fracture 89% 77%

Type I Type II Type III Stent Fracture Examples

U.S. Study

Fragmentation with embolization:

One observed in U.S. Study

U.S. Study

Mayo Clinic PatientsØ32 procedures in 31 pts. age 6 - 79 years;

mean 27.7yrsØVarious lesions- TGA, PA, Ross, DORVØ9 homograft conduits; 2 contegra; 20

Tissue prosthesesØ2 Explanted - 1 coronary compression; 1

aortic erosion -stented homograftsØ1 pt -18 y/o at 6 mos had compressed

conduit - had Melody re-implantØAll currently have trivial or no pulmonary

regurgitation - 1 has 38 mm conduit gradient 50

Other implantsØ8 patients have had MV implant in a

tissue prothesisØ10 patients have had TV implant in a

tissue prosthesisØAll sucessful resultsØLargest was in 33 mm CE TV

prosthesisØMild Mod MR in one patient, rest had

trivial to no insufficiency

Stent Compression and FxØTwo 4110 Palmaz Stent and Melody

18 Y/O with DORV and contegra graft developed

obstruction in 6 mos

re-stented 4110 stents x 3

Two 4110 Palmaz Stents 22mm Melody valve

Lessons Learned

Lessons LearnedØWhen Gradient or RVSP increase during

follow up – suspect TPV fracture

ØFluoroscopy to detect minor stent fractures

ØOnce noted, ↑ frequency of echo F/U exams to assess for changes in gradient

ØPrestented or Bioprosthetic conduits have a ↓’d incidence of fracture

Ø“Repeat” TPV has been effective in relieving fracture related PS

ØLate performance of 2nd TPV is still to be determined

Conclusions

ØIntermediate term function of the Melody® TPV is good§ Improved PR, RVSP, RV dilation,

RVOT gradient, and NYHA class• Very little clinically important PR

§Recurrent PS is rare except in those with stent fractures• (Pre-stenting landing zone should

impact this favorably)

VSD Closure

Ø59 y/o male S/P AVR with 25 mm Carbomedics Aortic Mechanical prosthesis

ØS/P LIMA LAD bypass graftØS/P attempted surgical repair of VSDØDDD pacing system for CHB after AVRØResidual VSD with LV to RV/RA shunt

VSD Closure

Hemodynamics

SVC approach – ICE guidance

Transseptal with left Judkins

Wire snared into IVC

10 mm Amplatz VSD occluder

10 mm VSD

Post VSD closure

SummaryInterventional progress

ØInitally Balloon valvotomy, angioplasty, Vascular stents

ØClosure devices: ASD, PDA, VSDØParavalvular leak closures - AVPII, AVPIII

not yet available in US.ØPercutaneous Melody valve implant

§ Expanded to Tricuspid, MitralØNew smaller percutaneous, pulmonary

and aortic valve implants -14 FrenchØGreater use of CT and Rotational

Angiography and 3D EchocardiographyFriday, November 2, 12

THANK YOU

Congenital Interventional Catheterization in ACHDSorajja P, Cabalka AK, Hagler DJ, Rihal CS J Am...

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