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Jean-François OBADIA

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.

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Jean-François OBADIA

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

  2. Déclaration de Relations ProfessionnellesDisclosureStatement 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 twoyears, an affiliation or financialinterests or interests of anyorderwith a company or I receive compensation or fees or researchgrantswith a commercial company :

  3. Will TAVI replace the Replacement ? Aortic Valve Disease

  4. TAVI or RVAo Aortic Calcification  RA Aortic Valve Disease

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

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

  7. Ready to implant Per Abord sscut. Mini-Thoraco MinithoracoSternotomie Cutané cœur battant CEC CEC Ss Clav Apical Fem. Carotide TransAoAscSuturlessBioprostheses Surgical CI Bioprostheses Meca Age < 65 y Aortic Calcification  RA Aortic Valve Disease

  8. Ready to implant Per Abord sscut. Mini-Thoraco MinithoracoSternotomie Cutané cœur battant CEC CEC Ss Clav Apical Fem. Carotide TransAoAscSuturlessBioprostheses CI Surgical CI Bioprostheses Meca Age < 65 y Aortic Calcification  RA Aortic Valve Disease

  9. 68.0 Equivalent Survival but : 1) Partner ? 2) Stroke 3) AR 4) Durability ? 5) Cost *) AV Block Standard therapy 43.3 Deathfromany cause, ITT TAVR 35.0 33.9 PARTNER 2y

  10. 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

  11. 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 Rodes-Cabau et al. JACC 2011;57:18 Rothwell et al. Lancet 1995; 346:1623 Rothwell et al. Stoke 1996;27:260 Knipp et al. Eur J CardiothoracicSurg 2005;28:88 Kahlertet al. Circulation 2010;121:870

  12. 2) Risk of Stroke France 2 4,1%

  13. 3) AR: Long term Impact ? PARTNER B PARTNER A P=0.001 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

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

  15. 3) AR: Evaluation ? - color-flow doppler: « jets frequentlyexcentric and irregular in shape » - vena contracta: « no validation of adding the vena contracta widths of multiple jets » - circumference of ring occupied by jet: « mayoverestimate… when multiple small jets » - Aorticregurgitant volume by 3D echo: « … has yet to bedetermined » - Secondarysigns:

  16. 4) Long Term Durability

  17. 4) Long Term Durability

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

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

  20. TAVI or RVAo in France 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.

  21. CONCLUSIONTAVI 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 Médecins Santé La guerre estune chose trop sérieuse pour la confier aux militaires

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