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Transcatheter Aortic Valve Implantation: Current Clinical Update

Transcatheter Aortic Valve Implantation: Current Clinical Update. Dr Martyn Thomas Director of Cardiac Services Guys and St Thomas NHS Foundation Trust A Member of Kings Health Partners London. Available systems: Edwards (TA and TF) and Corevalve . Current Indications.

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Transcatheter Aortic Valve Implantation: Current Clinical Update

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  1. Transcatheter Aortic Valve Implantation:Current Clinical Update Dr Martyn Thomas Director of Cardiac Services Guys and St Thomas NHS Foundation Trust A Member of Kings Health Partners London

  2. Available systems: Edwards (TA and TF) and Corevalve.

  3. Current Indications The Edwards SAPIEN transcatheter heart valve is indicated for use in patients with symptomatic aortic stenosis (aortic valve area <0.8 cm2) requiring aortic valve replacement who have high risk for operative mortality, or are “non-operable”, as determined by one of the following risk assessments: 1) Logistic EuroSCORE >20% or 2) STS Score>10

  4. Inclusion Criteria (from 18F safety & efficacy study) Aortic valve area: < 1 cm2 (<0.6 cm2/m2) Aortic valve annulus diameter: ≥ 20 mm and ≤ 27 mm Ascending aorta: ≤ 43 mm Iliac/femoral vessel diameter: ≥ 6 mm AND 5a. Age ≥ 75 yrs OR 5c. Age ≥ 65 yrs and 1-2 comorbidities 5b. Logistic ES ≥ 15% OR

  5. Aortic Valve Replacement First PVT animal implantation A. Cribier First Corevalve animal implantation JC. Laborde Homograft – 1962 Transvascular Mechanical heart valve – 1962 Porcine valve – 1965 First Edwards/PVT Transapical Beating Heart AVR Webb, Lichtenstein – Nov 29, 2005 Pericardial tissue valve – 1969 1960 1970 2006 2000 2001 2002 2004 First PVT Transcatheter AVR by Antegrade Approach Alain Cribier - 2002 First CoreValve PERCUTANEOUS AVR by Retrograde Approach – Oct 12, 2006 Serruys, DeJaegere, Laborde Surgery First CoreValve Transcatheter AVR by Retrograde Approach Laborde, Lal, Grube – July 12, 2004

  6. Edwards SAPIEN™ THV Most recentclinicalResults. Randomized Control Feasibility Post-Market First-in-Man Procedural success in humans Demonstrate “reasonable” safety & effectiveness Effectiveness vs. control (AVR & medical therapy) Evaluate transition to commercial use Procedural success & clinical outcomes RECAST REVIVE REVIVE I REVIVAL I SOURCE PARTNER IDE REVIVE II REVIVAL II IDE TRAVERCE PARTNER EU > 1500 Patients treated with Edwards Valve

  7. PARTNER EU TF: Procedure Outcomes Patients Planned n = 60 Implant aborted n = 6 Patients Implanted n = 54 Vascular access (n = 3) Unsucessfull BAV (n=2) Active endocarditis (n=1) Successful Implants* n = 52 Implant failures n = 2 96.3% Ventricular embolization (n = 1) Aortic embolization (n=1) 23 mm SAPIEN valve N=25 26 mm SAPIEN valve N=27 *Implant success = Successful device delivery and deployment resulting in an AVA>0.9cm² with AI <2+

  8. THV Learning CurvePercent Successful Implant %

  9. PARTNER EU TFVascular Events 15%

  10. PARTNER EU TF: primary safety outcome.Freedom from death at 6 months. Freedom from death at 6M = 90%

  11. PARTNER EU TFFreedom from Stroke Freedom from Stroke at 6 Mo = 95%

  12. PARTNER EU TF: Efficacy endpointsNYHA Class

  13. PARTNER EU TF: Efficacy endpointsParavalvular Leak

  14. SOURCE Registry Post CE Mark Commercial Experience • Purpose • Evaluate the transition to commercial clinical use under controlled market release conditions with a prescribed training and proctor program • Objective • Multicenter, observational collection of acute and early (30d) procedural success and short term (1 yr)clinical performance outcomes

  15. The SOURCE Registry & SAPIEN™ THV Commercial Experience Acute Procedural Success • Transfemoral  • Success 96.9% (n=254) • Transapical  • Success 94.9% (n=316) Procedural Success definition used by Sponsor to assess training success in new commercial sites Defined as successful valve deployment and delivery system removal, AVA > 0.9 cm2 and AR ≤ 2.

  16. The SOURCE Registry Procedural Complications Transfemoral

  17. The SOURCE Registry Procedural Complications Transapical

  18. The SOURCE Registry30 Day Results: Trans-femoral *Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion)

  19. The SOURCE Registry (TA)30 Day Results *Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion)

  20. THV Learning Curve: TFPercent Successful Implant %

  21. Pooled Transfemoral TAVIAll Cause Mortality 93.6% 90% Source Partner Months Post Procedure

  22. Post CE Mark Cumulative 18F ReValving PAVR Procedures CoreValve Self-Expanding ReValving™ SystemTechnological Progress > 1600 Cases Generation 1 25F Generation 2 21F 14 patients 2004-2005 Generation 3 18F 65 patients** 2005-2006 124 patients 2006-2007 ** including 10 in feasibility study and 2 ReDo 2007 2008 Updated 01-October-2008: ~100 sites in 20 countries The Corevalve Aortic Valve Replacement Personnal contribution as Proctor Before CE mark : N = 123 Registry period : N = 495

  23. ProceduralResults 21F S&E 18F S&E 18F EE Site reported data only in the case of registry & not monitored

  24. PAVR Cases Post CE Mark 24

  25. Procedural Results In-Training (N = 809) Certified (N = 456) Both (N = 1265) 25

  26. Procedural Complications* Site reported data only in the case of registry & not monitored *Multiple events in same patients = data not cumulative

  27. ≤ 30-Day Adverse Events* Site reported data only in the case of registry & not monitored * Multiple events in same patients = data not cumulative † Includes 4 deaths where cause is not known

  28. Paired NYHA Comparison Baseline to 30-Day Follow-up

  29. Right Subclavian 1 Left Subclavian 26 Trans aorta * 2 Transapical * 5 Transfemoral approach 362 PAVR by Femoral vs Subclavian Access Personnal contribution as Proctor Registry period 04/01/08 - 30/09/08 N = 397 * Out of the Registry

  30. ASSESSMENT: Operability No Yes n=350 pts Cohort B n= up to 690 pts Cohort A Total n= 1040 ASSESSMENT: Transfemoral Access ASSESSMENT: Transfemoral Access No Yes No Yes Cohort A TA Powered to be Pooled with TF Cohort A TF Powered Independently 1:1 Randomization Not in Study 1:1 Randomization 1:1 Randomization Trans apical AVR Control Trans femoral Medical Management Control Trans femoral AVR Control VS VS VS Primary Endpoint: All Cause Mortality (Superiority) Primary Endpoint: All Cause Mortality(Non-inferiority) The PARTNER IDE Trial Co-principal Investigators:Martin B. Leon, MD Interventional CardiologyCraig Smith, MD, Cardiac SurgeonColumbia University Population: High Risk/Non-Operable Symptomatic, Critical Calcific Aortic Stenosis Two Trials: Individually Powered Cohorts(Cohorts A & B)

  31. Conclusions (Personal) • Primary success rate is improving and training can “limit” the learning curve of a TAVI device. • Patient selection remains a “learning” curve. Technical success but a non-cardiac death at 1 year with not be cost effective. • The trans-apical approach is very simple BUT requires a minithoracotomy. • The transfemoral approach is technically more difficult but has advantages if the peripheral complication rate can be minimised. • This is a major technology breakthrough.............what, where, why and when remain the questions!!

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