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The State of TAVR -PARTNER: From Concept to Mortality Benefit

The State of TAVR -PARTNER: From Concept to Mortality Benefit. Jeffrey W. Moses , MD. Columbia University Medical Center Cardiovascular Research Foundation New York City. Presenter Disclosure Information for U Minn Grand Rounds;. Jeffrey W. Moses , M.D. Equity Relationship:

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The State of TAVR -PARTNER: From Concept to Mortality Benefit

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  1. The State of TAVR -PARTNER: From Concept to Mortality Benefit Jeffrey W. Moses , MD Columbia University Medical Center Cardiovascular Research Foundation New York City

  2. Presenter Disclosure Information forU Minn Grand Rounds; Jeffrey W. Moses , M.D. Equity Relationship: Claret

  3. At Least 30% of Patients with Severe Symptomatic AS are “Untreated”! Severe Symptomatic Aortic StenosisPercent of Cardiology Patients Treated AVR No AVR Under-treatment especially prevalent among patients managed by Primary Care physicians • Bouma B J et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999;82:143-148 • Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal2003;24:1231-1243 (*includes both Aortic Stenosis and Mitral Regurgitation patients) • Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation 2005 • Charlson E et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis2006;15:312-321

  4. Potential Patients for Transcatheter Aortic Valve Therapy SEVERE AORTIC STENOSIS BALLOON AORTIC VALVULOPLASTY PT. REFUSALS NOT REFERRED ? ASYMPTOMATIC There is an unmet clinical need! HIGH-RISK PATIENTS AORTIC VALVE REPLACEMENT SURGERY

  5. TAVR 2011 TechnologyReview

  6. Early Catheter-Based AV Designs The Davis valve (1965) The Andersen valve (1992)

  7. 1 3 2 Systole Diastole Alain Cibier Sketches (1990)

  8. Cribier-Edwards Device First generation – polyurethane • equine pericardial valve • stainless steel stent • 23mm and 26mm diameters • balloon-expandable • AVA = 1.7-1.9 cm2 Second generation – bovine pericardium PVT-Edwards Percutaneous Heart Valve

  9. Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis First Human Case Description Alain Cribier, MD; Helene Eltchaninoff, MD; Assaf Bash, PhD; Nicolas Borenstein, MD; Christophe Tron, MD; Fabrice Bauer, MD; Genevieve Derumeaux, MD; Frederic Anselme, MD; François Laborde, MD; Martin B. Leon, MD AHA; Nov, 2002 April 16, 2002 Dr. Alain CribierFirst-in-Man PIONEER Conclusions— Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement.

  10. Sapien XT + NovaFlex Delivery System 18 Fr profile

  11. Transcatheter AVR Trans-apical Access Route Transapical Transfemoral

  12. TAVR 2011 The PARTNER Trial

  13. Published on-line September 22, 2010@ NEJM.org and print October 21, 2010 On behalf of the Executive Committee, the Investigator Sites, and the courageous patients who participated in the PARTNER trial!

  14. PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients Inoperable High Risk N = 358 N = 699 2 Parallel Trials: Individually Powered ASSESSMENT: Transfemoral Access ASSESSMENT: Transfemoral Access Yes No Transapical (TA) Transfemoral (TF) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR AVR TA TAVR AVR TF TAVR Standard Therapy VS VS VS Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortalityand Repeat Hospitalization (Superiority) Primary Endpoint: All-Cause Mortality at 1 yr(Non-inferiority)

  15. Executive Committee Lars Svensson Craig Miller Murat Tuzcu Craig Smith Jeff Moses Marty Leon John Webb Michael Mack

  16. Transcatheter AVRHybrid OR-Cath Lab A unique collaborative experience!

  17. Inoperable: Patient Characteristics - 1

  18. Inoperable: Patient Characteristics - 2

  19. Standard Rx TAVI 1ryEndpt - All Cause Mortality • HR [95% CI] =0.54 [0.38, 0.78] • P (log rank) < 0.0001 All-cause mortality (%) Months

  20. 1ry Endpt - All Cause Mortality Standard Rx • ∆ at 1 yr = 20.0%NNT = 5.0 pts TAVI 50.7% All-cause mortality (%) 30.7% Months

  21. Clinical Outcomes at 30 Days & 1 Year

  22. Clinical Outcomes at 30 Days & 1 Year

  23. Percent TAVI Standard Rx TAVI Standard Rx TAVI Standard Rx TAVI Standard Rx Treatment Visit Baseline 30 Day 6 Month 1 Year NYHA Class Over TimeSurvivors • P = 0.68 • P < 0.0001 • P < 0.0001 • P < 0.0001 I II III IV

  24. PARTNER QOL Analyses TAVI not only adds years to life, but also, adds life to years!

  25. $100,000 per LY • Cost = $79,837 D LE = 1.59 years • ICER = $50,212/LYG $50,000 per LY Cost-Effectiveness of TAVR vs. Control Lifetime Results

  26. TAVR 2011 Main Outcomes: High Risk

  27. Primary Endpoint:All-Cause Mortality at 1 Year • HR [95% CI] =0.93 [0.71, 1.22] • P (log rank) = 0.62 0.5 TAVR AVR 0.4 26.8 0.3 24.2 0.2 0.1 0 0 6 12 18 24 No. at Risk Months TAVR AVR

  28. All-Cause MortalityTransfemoral (N=492) • HR [95% CI] =0.83 [0.60, 1.15] • P (log rank) = 0.25 26.4 22.2 No. at Risk Months TAVR AVR

  29. All-Cause MortalityTransapical (N=207) • HR [95% CI] =1.22 [0.75, 1.98] • P (log rank) = 0.41 29.0 27.9 No. at Risk Months TAVR AVR

  30. PARTNER 1A :30 Day Outcomes (AT) 15.4 P=0.09 P=0.045 10.9 9.5 8.7 8.2 7.6 7.0 5.4 2.5 3.7 4.4 1.4 TF AVR TF AVR TF AVR TA AVR TA AVR TA AVR Death Major Stroke Death Stroke Death Major Stroke Death Stroke Transfemoral Transapical 18 16 14 12 10 8 6 4 2 0

  31. NYHA Functional Class • P = 1.00 • P < 0.001 • P = 0.05 • P = 0.75 Patients Surviving, % Baseline 30 Days 6 Months 1 Year I II III IV

  32. Echo FindingsAortic Valve Gradients 80 Peak Gradient - AVR 70 Peak Gradient - TAVR Mean Gradient - AVR Mean Gradient - TAVR 60 50 40 Mean and Peak GradientAs-Treated Trial Arms (mmHg) 30 20 10 0 Baseline 30 Days 6 Months 1 Year TAVRn = 327 TAVRn = 287 TAVRn = 246 TAVRn = 227 AVRn = 159 AVRn = 301 AVRn = 231 AVRn = 170

  33. Paravalvular Aortic Regurgitation • P < 0.001 • P < 0.001 • P < 0.001 Patients, % 30 Days 6 Months 1 Year Severe None Trace Mild Moderate

  34. Surgery – The “PAST” TAVR – The “Future” TAVR - The FutureMy Rosey Prophecy In 5-10 years, most patients with severe AS requiring AVR will be treated using TAVR!

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