Evolving and Expanding Indications for TAVR

Transcription

1 Evolving and Expanding Indications for TAVR Wilson Y. Szeto, MD Associate Professor of Surgery Surgical Director, Transcatheter Cardio-Aortic Therapies Associate Director, Thoracic Aortic Surgery Division of Cardiovascular Surgery University of Pennsylvania Medical Center Philadelphia, PA Penn Aortic Valve Repair Symposium Philadelphia 2015

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Grant/Research Support Consulting Fees/Honoraria Company Edwards Lifesciences, Medtronic, Vascutek, Sorin Microinterventional Device

3 A BREAKDOWN OF OUR 1,000 TAVR CASES PARTNER Trial (N=475) Nov Jan PARTNER 1 (n=185) 115 TF 70 TA PARTNER 2 Commercial TAVR Cases (N=518) 368 TF 150 Alternative Access 337 Sapien (65.1%) 95 Sapien XT (18.3%) 86 Corevalve (16.6%) P2A (n=39) 25 TF 1 TAO 13 TA P2B (n=140) 112 TF 4 TAO 24 TA Sapien 3 SURTAVI (N=7) 6 TF 1 Alternative Access High Risk (n= 45) 32 TF 3 TAO 10 TA Intermediate Risk (n=66) 60 TF 1TAO 5TA

4 U Penn AVR / TAVR Continues to Grow VOLUME Open AVR TAVR

5 Repair Heart Valve Team TAVR MIS Sutureless Hybrid

6 Patient Selection TAVR vs AVR Operable AS patients Low-Intermediate Risk High Risk Too Sick Inoperable II A A High Risk B Extreme Risk C 90% 10% %?

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8 The Heart Team Class I Patients with severe VHD should be evaluated by a multidisciplinary heart valve team when intervention is considered. (Level of Evidence: C)

9 Prohibitive Risk Class I TAVR is recommended in patients who meet an indication for AVR who have a prohibitive risk for surgical AVR and a predicted post-tavr survival greater than 12 months (Level of Evidence: B)

10 High Risk Class IIa TAVR is a reasonable alternative to surgical AVR in patients who meet an indication for AVR and who have high surgical risk for surgical AVR (Level of Evidence: B)

11 Kapadia, TCT 2014

12 All-Cause Mortality (ITT) Crossover Patients Censored at Crossover Standard Rx (n = 179) TAVR (n = 179) 80.9% 87.5% 93.6% All-Cause Mortality (%) 50.8% 30.7% 68.0% 43.0% 53.9% 64.1% HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < % Months * In an age and gender matched US population without comorbidities, the mortality at 5 years is 40.5%.

13 Mack, ACC 2015

14 All-Cause Mortality (ITT) All Patients HR [95% CI] = 1.04 [0.86, 1.24] p (log rank) = % 62.4% Error Bars Represent 95% Confidence Limits No. at Risk TAVR SAVR

15 Reardon, ACC 2015

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17 Expanding the Indications Practice Gaps Intermediate risk Significant MR / TR Valve in Valve Renal failure / Dialysis Bicuspid aortic valve Aortic Insufficiency

18 Low / Intermediate Risk Class I Surgical AVR is recommended in patients who meet an indication for AVR with low or intermediate surgical risk (Level of Evidence: A)

19 Intermediate Risk PARTNER II Enrollment completed SURTAVI Enrollment ongoing

20 Clinical and Echocardiographic Outcomes at 30 Days with the SAPIEN 3 TAVR System in Inoperable, High-Risk and Intermediate-Risk AS Patients Susheel Kodali, MD on behalf of The PARTNER Trial Investigators ACC 2015 San Diego March 15, 2015

21 Evolution of the Edwards Balloon-Expandable Transcatheter Valves Cribier- Edwards 2002 SAPIEN 2006 SAPIEN XT 2009 SAPIEN * Sheath compatibility for a 23 mm valve

22 The PARTNER II S3 Trial Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT by Heart Valve Team n = 1076 Patients Intermediate Risk Operable (PII S3i) SAPIEN 3 2 Single Arm Non-Randomized Historical-Controlled Studies High Risk Operable / Inoperable (PII S3HR) n = 583 Patients ASSESSMENT: Optimal Valve Delivery Access PII A SAVR PI A SAPIEN ASSESSMENT: Optimal Valve Delivery Access Transfemoral (TF) Transapical / Transaortic (TA/TAo) Transfemoral (TF) Transapical / Transaortic (TA/TAo) TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3 TF TAVR SAPIEN 3 TAA TAVR SAPIEN 3

23 Mortality and Stroke: S3HR At 30 Days (As Treated Patients) 100 All-Cause Mortality Cardiovascular 100 All Stroke Stroke Disabling % O:E = (STS 8.6%) S3HR % S3HR

24 Mortality and Stroke: S3i At 30 Days (As Treated Patients) 100 All-Cause Mortality Cardiovascular 100 All Stroke Stroke Disabling O:E = 0.21 (STS 5.3%) % % S3i S3i

25 Paravalvular Leak: S3HR & S3i (Valve Implant Patients) 0.1% No. of Echos 1504

26 Bicuspid Aortic Valve

27 Bicuspid Aortic Valve

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30 Bicuspid AV and TAVR Kochman et al, JACC, 2014

31 Aortic Insufficiency History of Homograft

32 JACC:CI 2014

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35 Impact of MR: TAVR vs AVR Barbanti et al, Circulation 2013

36 TAVR vs AVR/MVR McCarthy et al; Annals of Thorac Surg, 2014

37 TAVR: Dialysis vs Non Dialysis Medicare Study: 5000 patients McCarthy et al, STS 2015

38 TAVR vs AVR in Dialysis Propensity Matched 194 pts McCarthy et al, STS 2015

39 -1 to 1 Landing Zone Concept Endobentall Endo Arch Synergy TAVR/TEVAR

40 Transcatheter Mitral Therapies

41 Vital Components to a Successful Transcatheter Valve Program The Heart Team Penn Physicians: Cardiovascular Surgeons Interventional Cardiologists Echocardiologists CT anesthesiologists Outside Referring Physicians Hybrid OR Staff ICU Nurses Research Coordinators Sponsoring Company Patient Families Team Work

42 American Association for Thoracic Surgery Transcatheter Aortic Valve Replacement Writing Group Members Wilson Szeto, MD (Co-Chair) Kevin Greason, MD (Co-Chair) Samir Kapadia, MD (Co-Chair) William Brinkman, MD Ted Feldman, MD Thomas Gleason, MD Rebecca Hahn, MD Howard Herrmann, MD Hasah Jilaihawi, MD Neil Kleiman, M Susheel Kodali, MD Marty Leon, MD Raj Makkar, MD Hersh Maniar, MD D. Craig Miller, MD Jeff Popma, MD Michael Reardon, MD Craig Smith, MD Lars Svensson, MD Vinod Thourani, MD Murat Tuzcu, MD Mat Williams, MD