Transcript Jean-Francois Obadia - Cardiologie

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 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
4
TAVI or RVAo
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
Abord ss cut.
Cutané
Fem.
Ss Clav
Carotide
Mini-Thoraco
cœur battant
Apical
Trans Ao Asc
Minithoraco
CEC
Suturless
Sternotomie
CEC
Bioprostheses
Surgical CI
Ready to implant
Bioprostheses
Meca  Age < 65 y
Aortic Calcification  RA
Aortic Valve Disease
Per
Abord ss cut.
Cutané
Fem.
Ss Clav
Carotide
Mini-Thoraco
cœur battant
Apical
Trans Ao Asc
Minithoraco
CEC
Suturless
Sternotomie
CEC
Bioprostheses
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 2y
Equivalent Survival but :
1) Partner ?
2) Stroke
3) AR
4) Durability ?
5) Cost
*) AV Block
KCE Reports 163
TAVI: an updated HTA
21
1) Relevance of Partner ?
Consequently, an under-representation of those patients in the TAVI subgroup leads to
an under-estimation of complications.
* Randomization
: The Dutch Cochrane instrument and the Jadad score (2/5)
Clinical feeling
indicates a substantial risk of bias
*
Obviously, clinical feeling should not play a role in the randomisation process. However,
• Cohort B  Group different (chance ?)
if concealment of allocation was not adequate –which cannot be excluded from the
• Cohort
 ITTnot
analysis
(1,1% TAVI
paper
and Acould
be clarified
by and
our 10,8%
inquirysurg
of not
theselected)
sponsor –the clinical feeling of
investigators
may have played a role.
Conflictparticipating
of interest
: 22 authors
2.3.5
• 1 employedAccess
by Edwards
Continued
study
• 1 member of the board
Data related to the randomised Continued Access Cohort B subgroup were presented
• 8 consistent remuneration
by the sponsor at the July 20, 2011 FDA meeting and results are depicted in Figure 4.11
• 4 disclosed
financial
interestmortality in the Continued Access control group is more
These
data show
that 1-year
• the
deal as
reportedly
also
to Mr.
Leon of
thethe
chance
to earn
an additional
than
twice
high than
in included
the control
group
pivotal
Cohort
B (50.7%$1.5
vs. million
21.6%)if the
product
(Table
9). achieved certain milestones, one of which related to the number of patients
successfully treated
Table 9. Pivotal and Continued Access study results
PIVOTAL COHORT B
CONTINUED ACCESS
TAVI
STANDARD
TAVI
STANDARD
11.2±5.8
12.1±6.1
12,1±6,7
13,3±6,9
179
179
41
49
26.4±17.2
30.4±19.1
27,5±17,7
32,8±21,2
30-day mort.
5,0%
2,8%
4 (9,8)
1 (2,1)
1-yr. mort.
30,7%
50,7%
34,3%
21,6%
STS score
N
Logistic EuroSCORE
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
1y
2y
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
30 days 1 Year
TAVI  12,2 %
6,8 %
AoVR  0,9 % 1,9 %
p
< 0.001
< 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 3D 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 AoVR
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
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
La guerre est une chose trop sérieuse pour la confier aux militaires