Le TAVI remplacera til la chirurgie conventionnelle de

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

Déclaration de Relations Professionnelles Disclosure Statement of Financial Interest J'ai actuellement, ou j'ai eu au cours 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 4

TAVI or RVAo Bioprostheses Meca Age < 65 y Aortic Calcification RA Aortic Valve Disease 5

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

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

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

Death from any cause, ITT 68. 0 Standard therapy TAVR 43. 3 35. 0 33. 9 PARTNER 2 y Equivalent Survival but : 1) Partner ? 2) Stroke 3) AR 4) Durability ? 5) Cost *) AV Block

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

2) Risk of Stroke Standard therapy TAVR PARTNER B TAVR PARTNER A Surgery 30 d 1. 7 6. 7 4. 7 2. 4 1 y 2 y 4. 5 5. 5 10. 0 13. 8 6. 0 7. 7 3. 1 4. 9 France 2 4, 1%

3) AR: Long term Impact ? PARTNER B 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% PARTNER A Moderate to severe III / IV moderate to severe mild none or trace P=0. 001 30 days 1 Year p TAVI 12, 2 % 6, 8 % < 0. 001 Ao. VR 0, 9 % 1, 9 % < 0. 001 2 years worsened 22% unchanged 46% improved 32% X 3, 6

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 3 D echo: « … has yet to be determined » - Secondary signs:

4) Long Term Durability

4) Long Term Durability

5) Cost-effectiveness 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 Reynolds et al. Circulation 2012, 125: 1102 Partner A - TAVI 43 600 € - Replacement 23 600 € HAS report, oct 2011 Neyt et al. KCE report, 2011

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

TAVI or RVAo in France Chir. (N) Chir + TAVI (N) TAVI + 2011 ? ? 2447 63 % 16 % 2010 14 030 2% 1 500 128 % 11 % 2009 13 793 7% 657 87 % 5% 2008 12 832 5% 350 2007 12 225 9% ξ 2006 11 194 ξ 3% 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 s n i c é t e La guerre est une chose trop sérieuse pour la confier aux militaires d é San M