1. Late breaking news in heart valve disease
C. Bouleti

5. Primary endpoint Device success (VARC definition)
Successful vascular access, delivery and deployment of the device
Correct position of the device
Aortic valve area > 1.2 cm2, mean aortic gradient < 20 mmHG or V max < 3 m/s, AR<3
Only 1 valve implanted in the proper anatomical location

10. Baseline patient characteristics

12. Baseline TTE

13. Procedural factors: valve size

14. Procedural details

15. Immediate results: AR

16. Primary endpoint: device success

18. Clinical outcome at 30 days

19. Clinical outcome at 30 days

21. JAMA

23. CoreValve US Pivotal Trial High Risk Results

24. CoreValve US Pivotal Trial
Primary Endpoint: All-cause mortality at 1 year 24
(Adams et al. N Engl J Med online March 29)

25. Study Device and Access Routes
4 valve sizes
(18-29 mm annular range)
Transfemoral
Subclavian
Direct Aortic
18Fr delivery system 25 25 25 25

26. Primary Endpoint: All-cause mortality at 1 year
Non-inferiority Testing: TAVR with the CoreValve prosthesis was non-inferior to SAVR for 1 year all-cause mortality with a 7.5% non-inferiority margin
Superiority Testing: If the primary endpoint was met at the one-sided 0.05 level, a subsequent test for superiority was performed at the one-sided 0.05 level 26

27. Hierarchical Testing of Secondary Endpoints
Δ mean gradient baseline to 1 year (non-inferior)
Δ effective orifice area baseline to 1 year (non-inferior)
Δ NYHA class baseline to 1 year (non-inferior)
Δ KCCQ baseline to 1 year (non-inferior)
Difference in MACCE* rate at hospital discharge or 30 days, whichever is later (superiority)
Δ SF-12 baseline to 30 days (inequality)
* Major adverse cardiovascular and cerebrovascular events, defined as a composite of all-cause mortality, myocardial infarction, all stroke, or aortic-valve reintervention 27

28. Participating Sites 28

29. Inclusion Criteria NYHA functional class II or greater
Severe aortic stenosis: AVA ≤ 0.8 cm2 or AVAI ≤ 0.5 cm2/m2 AND mean gradient > 40 mm Hg or peak velocity > 4 m/sec at rest or with dobutamine stress echocardiogram
Risk of death at 30 days after surgery was ≥ 15% and the risk of death or irreversible complications within 30 days was < 50%
Surgical risk assessment included consideration of STS Predicted Risk of Mortality estimate and other risk factors not captured in the STS risk model 29

30. Exclusion Criteria
Recent active GI bleed (< 3 mos), stroke (< 6 mos), or
MI (≤ 30 days)
Any interventional procedure with bare metal stents (< 30 days) and drug eluting stents (< 6 months)
Creatinine clearance < 20 mL/min
Significant untreated coronary artery disease
LVEF < 20%
Life expectancy < 1 year due to co-morbidities 30

31. Study Disposition

32. Baseline Demographics32

33. Baseline Demographics33

34. Primary Endpoint: 1 Year All-cause Mortality
ACC 2014
19.1%
4.5%
Surgical
14.2%
P = 0.04 for superiority
3.3%
Transcatheter 34

35. All Stroke 35

36. Hierarchical Testing of Secondary Endpoints
Δ mean gradient baseline to 1 year (non-inferior; P<0.001)
Δ effective orifice area baseline to 1 year (non-inferior; P<0.001)
Δ NYHA class baseline to 1 year (non-inferior; P<0.001)
Δ KCCQ baseline to 1 year (non-inferior; P=0.006)
Difference in MACCE rate at hospital discharge or 30 days, whichever is later (superiority; P=0.103)
Δ SF-12 baseline to 30 days (inequality; nominal P<0.001) 36

37. 1 Year MACCE 37

38. Other Endpoints 38

39. NYHA Class Survivors 39

40. Paravalvular Regurgitation40

41. Subgroup Analysis for 1 Year Mortality41

42. Subgroup Analysis for 1 Year Mortality42

43. Conclusion
We assessed the safety and effectiveness of TAVR with the CoreValve prosthesis compared to surgical valve replacement in symptomatic patients with severe aortic stenosis at increased surgical risk
One-year survival was superior in patients that underwent transcatheter replacement with CoreValve as compared with surgical AVR 43

44. DONC… Si SAPIEN XT > COREVALVE (CHOICE)
ET QUE COREVALVE > CHIRURGIE
(COREVALVE US PIVOTAL TRIAL)
ALORS ….

45. DONC…
…. SAPIEN > CHIRURGIE

46. DONC…
... SAPIEN > CHIRURGIE

47. All Cause Mortality in PARTNER A TAVI vs AVR
The primary analysis reveals no difference in mortality between TAVR and AVR with a hazard ratio of The two year KM estimates of mortality are 35% for AVR and 33.9% for TAVR.
(Kodali et al. NEJM 2012;366: )
Months 47

48. PARTNER-A: population
Mêmes critères d’inclusion (surface Ao, NYHA≥ 2, mortalité estimée à 30 jours >15%) Mais STS 12% versus 7% ES logistic 29% versus 18% pop à plus haut risque dans PARTNER

49. PARTNER-A: procedure
Voie d’abord: 30% de transapical Valve ancienne génération (Sapien)

50. PARTNER-A: stroke
Recueil retrospectif des stroke Vs Prospectif pour CoreValve trial Plus de stroke retrouvés (TAVI 6% et chir 3% dans PARTNER Vs 9% et 13% dans CoreValve Trial ) “When you look harder you find more”

51. Conclusion
La place importante du TAVI est confirmée par des études randomisées avec niveaux de preuve élevés En passe de donner de meilleurs résultats que la chirurgie ? Interprétation des études doit être prudente et attention aux comparaisons