Will TAVI replace the Replacement ? Hôpital Cardiothoracique Le TAVI remplacera t-il la chirurgie conventionnelle de la valve aortique ? Will TAVI replace the Replacement ? NO !!! Jean-François OBADIA Hôpital Cardiothoracique - LYON -

Affiliation/Financial Relationship Déclaration de Relations Professionnelles Disclosure Statement of Financial Interest J'ai actuellement, ou j'ai eu au cours des deux dernières années, une affiliation ou des intérêts financiers ou intérêts de tout ordre avec une société commerciale ou je reçois une rémunération ou des redevances ou des octrois de recherche d'une société commerciale : I currently have, or have had over the last two years, an affiliation or financial interests or interests of any order with a company or I receive compensation or fees or research grants with a commercial company : Affiliation/Financial Relationship List of companies > Grant/Research Support Boeringher > Consulting Fees/Honoraria Saint Jude Medical, Thoratec, Edwards > Major Stock Shareholder/Equity > Royalty Income > Ownership/Founder > Intellectual Property Rights Landanger, Delacroix-Chevalier > Other Financial Benefit Medtronic, Sorin

Will TAVI replace the Replacement ? Aortic Valve Disease

TAVI or RVAo Aortic Calcification  RA Aortic Valve Disease

TAVI or RVAo Bioprostheses Meca  Age < 65 y Aortic Calcification  RA Aortic Valve Disease

TAVI or RVAo Bioprostheses Surgical CI Meca  Age < 65 y Aortic Calcification  RA Aortic Valve Disease

Bioprostheses Per Abord ss cut. Mini-Thoraco Minithoraco Sternotomie Cutané cœur battant CEC CEC Ss Clav Apical Fem. Carotide Trans Ao Asc Suturless Bioprostheses Ready to implant Surgical CI Bioprostheses Meca  Age < 65 y Aortic Calcification  RA Aortic Valve Disease

Per Abord ss cut. Mini-Thoraco Minithoraco Sternotomie Cutané cœur battant CEC CEC Ss Clav Apical Fem. Carotide Trans Ao Asc Suturless Bioprostheses Ready to implant CI Surgical CI Bioprostheses Meca  Age < 65 y Aortic Calcification  RA Aortic Valve Disease

Equivalent Survival but : 1) Partner ? 2) Stroke 3) AR 4) Durability ? 68.0 43.3 Standard therapy TAVR Equivalent Survival but : 1) Partner ? 2) Stroke 3) AR 4) Durability ? 5) Cost *) AV Block 33.9 35.0 Death from any cause, ITT PARTNER 2y

1) Relevance of Partner ? * Randomization : The Dutch Cochrane instrument and the Jadad score (2/5) indicates a substantial risk of bias Cohort B  Group different (chance ?) Cohort A  ITT analysis (1,1% TAVI and 10,8% surg not selected) * Conflict of interest : 22 authors 1 employed by Edwards 1 member of the board 8 consistent remuneration 4 disclosed financial interest the deal reportedly also included to Mr. Leon the chance to earn an additional $1.5 million if the product achieved certain milestones, one of which related to the number of patients successfully treated

2) Stroke : Is self audit reliable ? Rothwell et al. Lancet 1995; 346:1623 Rothwell et al. Stoke 1996;27:260 surgery n=30 surgery (80% AVR) 41 new MRI signal in 47% of patients Knipp et al. Eur J Cardiothoracic Surg 2005;28:88 n=21 AVR 33 new MRI signal in 48% of patients Kahlert et al. Circulation 2010;121:870 n=60 TAVI 251 new MRI signal in 68% of patients Rodes-Cabau et al. JACC 2011;57:18 n=32 TAVI 115 new MRI signal in 84% of patients TAVI

2) Risk of Stroke Standard therapy TAVR PARTNER B PARTNER A Surgery 30 d 1.7 6.7 4.7 2.4 1 y 4.5 10.0 6.0 3.1 2 y 5.5 13.8 7.7 4.9 In the transcatheter heart valve population, patients who had a major stoke did not fare as well as those who did not have a stroke, and they had significantly higher mortality. France 2 4,1%

3) AR: Long term Impact ? X 3,6 PARTNER B PARTNER A Moderate to severe III / IV 30 days 1 Year p TAVI  12,2 % 6,8 % < 0.001 AoVR  0,9 % 1,9 % < 0.001 X 3,6

Italian registry (n=663): late death with AR ≥2+ 3) AR: Long term Impact ? France 2 = 1% 10% 40% 50% Italian registry (n=663): late death with AR ≥2+ OR 3.8 (IC 1.6-9.1) Tamburino et al. Circulation 2011;123:299 Kodali et al. NEJM 2012, in press

3) AR: Evaluation ? - color-flow doppler: « jets frequently excentric and irregular in shape » - vena contracta: « no validation of adding the vena contracta widths of multiple jets » - circumference of ring occupied by jet: « may overestimate… when multiple small jets » - Aortic regurgitant volume by 3D echo: « … has yet to be determined » - Secondary signs:

4) Long Term Durability

4) Long Term Durability

PARTNER A-type patient 5) Cost-effectiveness Reynolds et al. Circulation 2012, 125:1102 PARTNER group B PARTNER A-type patient PARTNER B-type patient 70 000€/QUALY PARTNER B Partner B -50 000$ /y of life gained -60 000$/QUALY gained Partner A - TAVI  43 600 € - Replacement  23 600 € HAS report, oct 2011 Neyt et al. KCE report, 2011

TAVI or AoVR Per-cutaneous Less invasive Pain Choice  Repair/Meca/Bio Fast-track Choice  Repair/Meca/Bio Stoke x 2 Aortic Regurgitation x 3,8 Cost

TAVI or RVAo in France Chir. (N) Chir + TAVI 2011 ? 2447 63 % 16 % 2010 14 030 2 % 1 500 128 % 11 % 2009 13 793 7 % 657 87 % 5 % 2008 12 832 350 3 % 2007 12 225 9 % ξ 2006 11 194 En l’état actuel des connaissances, la HAS recommande de limiter les indications des valves implantées par voie transcutanée aux patients contre-indiqués à la chirurgie après une évaluation en réunion multidisciplinaire et complète les critères d’éligibilité des centres implanteurs. En outre, la HAS insiste sur la nécessité d’informer le patient par écrit des incertitudes relatives à l’efficacité à moyen et long terme de la technique et de ses complications.

CONCLUSION TAVI or RVAo Worldwide, Qui décide ? France : - Partner B - Attention V in V et Frailty US : - FDA pour Partner B Germany : - Lander rules Belgique - No after KCE report Liban : - No Santé Médecins La guerre est une chose trop sérieuse pour la confier aux militaires