1. Balloon-Expandable Transcatheter Valve System : OUS Data
Alec Vahanian, FESC, FRCP
Bichat Hospital, Paris
Put the title of french society of cardiology ,see with stephanie

2. Alec Vahanian, MD Honoraria: Valtech Edwards Lifesciences Medtronic,
Abbott

3. Cardiogenic shock, patient not amenable to surgical treatment
TAVI First in man
Cardiogenic shock, patient not amenable to surgical treatment
Alain Cribier, 16 April 2002 4 4

4. Major vascular access complications
Source Registry
2307 TAVI procedures (2009) in 37 centers
Edwards Sapien TF
(n=920) TA
(n=1387)
P-value
Age(yr)
82±7
81±7
<0.001
LogEuroscore(%)
23.9±14.2
27.6±16
Procedural success 93
92.2 ns
New pacemaker
6.7
7.1
Stroke
2.9
2.5
Major vascular access complications
11.3
2.0%
(Thomas M et al Circulation 2011;124:425-33)

5. Source Registry 1-YEAR SURVIVAL 95% 90% 85% 80% 75% 70% All TF TA
100%
95%
90%
85%
80%
75%
70%
All(N=2307)
Transfemoral(N=920)
Transapical(N=1387)
Survival
65%
60%
55%
Survival
30 Days
1 Year
All
90.5%
76.5% TF
92.5%
80.1% TA
89.1%
74.2%
50% 3 6 9 12 15 18 21 24
Time to Death (Months) 9
(Thomas M et al Circulation 2011;124:425-33)

6. European TAVI Registries
French registry
33 centers,
4042 consecutive pts
Belgian registry
18 centers,
600 consecutive pts
United Kingdom registry
26 centers
872 consecutive pts
German registry
22 centers
833 consecutive pts
Italian registry
14 centres
663 pts CoreValve

7. On behalf of the scientific committee and the investigators
FRANCE 2 :
FRench Aortic National Corevalve
and Edwards Registry
Martine Gilard and Marc Laskar
On behalf of the scientific committee and the investigators
P Donzeau-Gouge, K Chevreul, H Eltchaninoff, J Fajadet,
B Iung, P Leprince, A Leguerrier, M Lievre, A Prat, E Teiger
ESC Paris

8. FRANCE Registry All centers selected by the Ministry of Health
Registry co-ordinated by the French Societies
of Cardiology and Cardiac Surgery
Two models of THV used: Edwards Sapien (transfemoral and transapical approaches) and CoreValve (transfemoral and subclavian approaches)
Training and proctoring completed in all centers

9. FRANCE 2 Current enrollment 9 January 2012: 4 042pts
Inclusion / month = 132
Inclusion / month = 190

10. FRANCE 2
Interim analysis consecutive patients- 34 centres January 1, to October, 2011

11. FRANCE 2 Methods Clinical prospective and comprehensive registry
All events and values site recorded
No core lab
Patients followed up to 3 years by serial clinical and echo assessments and 5 years by clinical status
30 d
6 mos
1 yr
2 yrs
3 yrs
4 yrs
5 yrs

12. Inclusion criteria and Endpoints
FRANCE 2
Inclusion criteria and Endpoints
Inclusion criteria: All implanted patients
1- Severe aortic stenosis: E.O.A. < 0.6cm²/m²
2- Severe symptoms: dyspnea NYHA > 2
3- Patient at high surgical risk
(Log. EuroScore > 20%, STS > 10% or C-I to surgery)
Primary Endpoint:
30 day mortality, 6 month mortality, up to 5-y
Secondary Endpoints (up to 5-y):
M.A.C.E., hemodynamics, Q.O.L.

13. Valves and approaches used
FRANCE 2
Valves and approaches used
Valves
Approach TA TF SC
(5%)
(29%)
(66%)

14. FRANCE 2 Baseline Demographics and Risk Factors Age, y 82.7 ±7
Female, %
49.0 %
Previous MI, %
16.4 %
CAD, %
48 %
Previous CABG, %
18.2%
PAD, %
20.8%
Previous Stroke, %
10.0%
Dialysis, %
2.7%
Previous AVR
1.6%
Smoker, %
2,8 %
Hypertension, %
69.4 %
Diabetes, %
25.8 %
Dyslipidimia, %
48 %

15. FRANCE 2 Risk scores NYHA functional class L. Euroscore, % 21.9 ± 14
STS, %
14.4 ± 12
(26%)
(16%)
NYHA functional class
I - II
III - IV
25%
75 %

16. FRANCE 2 Baseline echocardiographic data Ao annulus (mm) 22.1 ± 2.1
Gradient (mm Hg)
48.1 ± 16.6
AVA (cm²)
0.7 ± 0.2
SPAP (mm Hg)
46.5 ± 15
Ejection fraction (%)
53.2 ± 14.1

17. FRANCE 2 Procedural characteristics (84%) 74.7% 15.3% 9.9%
(21%)
(12%)
General anesthesia, %
59 %
Per-procedure TEE, %
60.7 %
(84%)
74.7%
(67%)
Operative room
Cath-lab
Hybrid room

18. FRANCE 2 Implantation Success Device success rate: 96.9% TF TA SC
97.1
95.9
96.7
Definition: successful delivery and deployment of the valve

19. FRANCE 2 KM Mortality rate 30-day 6-month Total 293 9.7 % 474 18.6 %
528
24.0 %

20. FRANCE 2 KM Mortality rate Type of Valve 30-day 12-month Edwards 195
9.6%
352
24.0%
CoreValve 91
9.4%
168
23.7%
Edwards
CoreValve
L. Euroscore
22.2 ± 14.3
21.3 ± 14,3

21. FRANCE 2 KM Mortality rate Access Mortality TF Edwards TF CoreValve
TA Edwards
n=561
SC CoreValve
n=180
30-day
8.1%
9.3%
13.9%
10.1%
6-month
16.4%
18.8%
22.4%
22.7%
12month
20.7%
23.3%
32.3%
24.6%

22. Vascular complications Bleeding(+tamponade)
FRANCE 2
Major complications (30 days)
Total
N = 3195
Edwards
N= 2107
CoreValve
N=1043
Vascular complications
9.7%
10.7%
9.2%
New Pacemaker
15.6
11.5%
24.2%
Bleeding(+tamponade)
13.1%
11.4%
8.8%
Stroke
4.1%
3.8%
4.3%

23. Hemodynamics after implantation
FRANCE 2
Hemodynamics after implantation
Effective Valve Area (cm²)
Mean gradient (mmHg)

24. Aortic regurgitation (grade)
FRANCE 2
Aortic regurgitation (grade)
Grade 0-1
Grade 2
Grade 3
Central
Peri-prothethic

25. Functional Status (NYHA)
FRANCE 2
Functional Status (NYHA)

26. Predictive factors of 30-day, 6-month 1-year mortality
FRANCE 2
Predictive factors of 30-day, 6-month 1-year mortality
Over 20 risk factors were analyzed
Logistic Euroscore, NYHA functional class and TA approach were the only predictors of 30-day, 6-month and 1 year mortality by multivariate analysis

27. Procedural success (%)
Belgian TAVI Registry
Edwards
(n=303)
CoreValve
(n=297)
Total population
(n=600)
P-value
Age(yr)
83±6 ns
LVEF(%)
50±15
57±15
53±15
LogEuroscore(%)
29±15
24±15
26±16
Procedural success (%) 97 99 98 ns
New pacemaker(%) 4 23 14
0.0001
Stroke(%) 5
1-month Survival(%) 92 93
(Bosmans et al Inter Cardiovasc Thoracic Surgery 2011;12:762-67)

28. (Blackman. PCR London Valve Oct 2011.)
Outcomes in UK registry with different valves and access routes
Outcome
Edwards transfemoral, n=389
(%)
CoreValve transfemoral, n=706 p
Edwards transapical, n=409
CoreValve subclav., n=91
30-d mortality
4.3
5.2 NS
11.2
4.4
12-mo survival
84.5
80.8
0.453
74.5
75.4
New permanent pacemaker
6.2
21.6
<0.001
5.6
22.1
Aortic regurg. ≥ 2/4
8.4
13.4
0.015
6.4
9.5
(Blackman. PCR London Valve Oct 2011.)

29. Conclusions
The current European registries included over 5000 patients
They confirm the safety and efficacy of the Balloon expandable transcatheter valve systems
Improvements are expected due to better patient selection,management of the procedure and technology…..