Jean-François OBADIA

Hôpital Cardiothoracique - LYON -

Will TAVI replace the Replacement ?NO !!!

Le TAVI remplacera t-il la chirurgie conventionnelle de la valve aortique ?

Déclaration de Relations ProfessionnellesDisclosure Statement of Financial

Interest

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 :

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 :

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

4

Aortic Valve Disease

Aortic Calcification RA

TAVI or RVAo

5

TAVI or RVAo

Aortic Valve Disease

Aortic Calcification RA

Meca Age < 65 y

Bioprostheses

Aortic Valve Disease

Aortic Calcification RA

Meca Age < 65 y

Surgical CI

Bioprostheses

TAVI or RVAo

Ready to implant

Aortic Valve Disease

Aortic Calcification RA

Meca Age < 65 y

Surgical CI

Bioprostheses

Per Abord ss cut. Mini-Thoraco Minithoraco SternotomieCutané cœur battant CEC CEC

Ss Clav ApicalFem. Carotide Trans Ao Asc Suturless Bioprostheses

Ready to implant

Aortic Valve Disease

Aortic Calcification RA

Meca Age < 65 y

Surgical CI

Bioprostheses

Per Abord ss cut. Mini-Thoraco Minithoraco SternotomieCutané cœur battant CEC CEC

Ss Clav ApicalFem. Carotide Trans Ao Asc Suturless Bioprostheses

CI

33.9

35.0

68.0

43.3

Standard therapy

TAVR

PARTNER 2y

Deat

h fr

om a

ny ca

use,

ITT Equivalent Survival but :

1) Partner ?2) Stroke3) AR4) 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

Rothwell et al. Lancet 1995; 346:1623Rothwell et al. Stoke 1996;27:260

surgeryn=30 surgery (80% AVR) 41 new MRI signal in 47% of patients

Knipp et al. Eur J Cardiothoracic Surg 2005;28:88

n=21 AVR33 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) Stroke : Is self audit reliable ?

2) Risk of Stroke

Standard therapy

TAVRPARTNER B

TAVR PARTNER A

Surgery

30 d 1.7 6.7 4.7 2.4

1 y 4.5 10.0 6.0 3.12 y 5.5 13.8 7.7 4.9

France 24,1%

Moderate to severe III / IV

30 days 1 Year pTAVI 12,2 % 6,8 % < 0.001AoVR 0,9 % 1,9 % < 0.001

3) AR: Long term Impact ?

30 days 2 years0%

10%20%30%40%50%60%70%80%90%

100%

moderate to severemildnone or trace

P=0.001

PARTNER B PARTNER A

unchanged46%

improved32%

worsened22%

X 3,6

Kodali et al. NEJM 2012, in press

10% 40%

50%

France 2 = 1%

Italian registry (n=663): late death with AR ≥2+ OR 3.8 (IC 1.6-9.1)

Tamburino et al. Circulation 2011;123:299

3) AR: Long term Impact ?

- 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:

3) AR: Evaluation ?

4) Long Term Durability

4) Long Term Durability

Neyt et al. KCE report, 2011

Partner B -50 000$ /y of life gained

-60 000$/QUALY gained

Reynolds et al. Circulation 2012, 125:1102

PARTNER group B

PARTNER B-type patient 70 000€/QUALY

PARTNER B

PARTNER A-type patient

HAS report, oct 2011

Partner A- TAVI 43 600 €- Replacement 23 600 €

5) Cost-effectiveness

Per-cutaneousLess invasivePainFast-track

Choice Repair/Meca/BioStoke x 2Aortic Regurgitation x 3,8Cost

TAVI or AoVR

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 3 %

2007 12 225 9 % ξ

2006 11 194 ξ

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.

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

La guerre est une chose trop sérieuse pour la confier aux militairesSantéMédecins