Debate: SAVR for Low-Risk Patients in 2017 is Obsolete AVR vs TAVI

Transcription

1 Debate: SAVR for Low-Risk Patients in 2017 is Obsolete AVR vs TAVI Joseph E. Bavaria, MD Roberts-Measey Professor of Surgery Vice Chair, Division of Cardiovascular Surgery University of Pennsylvania Immediate Past President-Society of Thoracic Surgeons (STS) STS/EACTS LatAm, Cartagena, Sept 2017

2 Penn Primary Investigator: Medtronic Surtavi Trial; Edwards Partner Trial(s); St. Jude/Abbott Portico Trial Chairman: STS/ACC TVT Steering Committee ( ) Co-Chairman: Institutional and Operator Requirements Writing Committee for STS/ACC (NCD) Previous Holder of Founders Equity in CardiAQ TMVI (Now Edwards)

3 Penn Primary Investigator: Medtronic Surtavi Trial; Edwards Partner Trial(s); St. Jude/Abbott Portico Trial Chairman: STS/ACC TVT Steering Committee ( ) Co-Chairman: Institutional and Operator Requirements Writing Committee for STS/ACC (NCD) Previous Holder of Founders Equity in CardiAQ TMVI (Now Edwards) I do BOTH AVR and TAVI

4 Theme of this talk: Data Driven and. The Data just keeps on Coming in!!!

5 Non-op (Extreme Risk) Patients STS score > 10 (mean 12)

6 All-cause mortality (%) All Cause Mortality EASY! DRAMATIC! And all TF Standard Rx TAVI at 1 yr = 20.0% NNT = 5.0 pts 50.7% 30.7% Months Numbers at Risk TAVI Standard Rx

7 Primary Endpoint: Iliofemoral CoreValve Trial SAME results as Partner Sapien TCT 2013 LBCT (JACC 2014) Extreme Risk Study Iliofemoral Pivotal 7

8 So.. Easy Decision! All Extreme Risk (STS > 10) Receive a TAVI

9 High Risk for Surgical AVR Patients STS score > 8

10 PARTNER Cohort A 1-Year outcomes published on-line June 5, NEJM.org and in print June 9, Year outcomes published on-line March 26, NEJM.org and print May 3, 2012

11 All-Cause Mortality All Patients 5-yr or Stroke (ITT) 100% 90% TAVR HR [95% CI] = SAVR 80% 1.09 [0.90, 1.31] 69.8% p (log rank) = % 60% 50% 62.9% 40% 30% 20% Error Bars Represent 10% 95% Confidence Limits 0% Months post Randomization All-Cause Mortality or Stroke No. at Risk TAVR SAVR

12 12 All-Cause Mortality or Major Stroke ACC 2014 Note: STS Partner A = 11.2 STS CoreValve HR = 7.4

13 Echocardiographic Findings (AT) Mean & Peak Gradients No. of Echos TAVR AVR

14 Concepts and Nuance from the Data

15 Subgroup Analyses of Treatment Effect All-Cause Mortality at 1 Year Subgroup TAVR (%) n=348 AVR (%) n=351 RR (95% CI) RR (95% CI) P-value for interaction Overall ( ) Age <85 > ( ) 1.03( ) 0.52 Sex Male Female ( ) 1.17( ) BMI <26 > ( ) 0.99( ) 0.66 STS score <11 >11 LV ejection fraction <55 > ( ) 0.92( ) 0.96( ) 1.01( ) TAVR better AVR better

16 16 Subgroup Analysis for 1 Year Mortality ACC 2014

17 Women do ESPECIALLY well with TAVI

18 So. Why TAVI trials into INTERMEDIATE RISK patients??

19 For all the Reasons explained. The High Risk trials all showed equivalence to AVR. It is the next logical step

20 So the Real Question is. Why NOT a New TAVI trial into INTERMEDIATE RISK patients??

21 Intermediate Risk Patients STS score > 3-4 to 8

22 P2 RCT Primary Endpoint (ITT) All-Cause Mortality or Disabling Stroke All-Cause Mortality or Disabling Stroke (%) % 6.1% Surgery TAVR AVG STS = % 14.5% HR [95% CI] = 0.89 [0.73, 1.09] p (log rank) = % 19.3% Months from Procedure Number at risk: Surgery TAVR

23 All-Cause Mortality (ACC 4/2017) All-Cause Mortality 30% 25% 20% 15% 10% 5% STS PROM 4.4/4.5% 30 Day SAVR 1.7% O:E 0.38 TAVR 2.2% O:E 0.50 TAVR 24 Months SAVR 95% CI for Difference 11.4% 11.6% -3.8, 3.3 No. at Risk SAVR TAVR 0% Months Post-Procedure

24 Surgical AVR vs TAVI Results of Partner/CoreValve Randomized Clinical Trial in Intermediate Risk patients (STS = 4-8) No Difference!! Presented at ACC April 2016 and 2017

25 Now Newer 3 rd Generation Valves??

26 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

27 Baseline Patient Characteristics S3i Patients (Intermediate Risk STS 4-8) Average STS = 5.3% (Median 5.2%) Average Age = 81.9yrs N = 1076

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

29 ACC 2017 Evolute Pro

30 A few problems must be solved with TAVI, especially for application into LOW RISK Patients But I think they will be solved!

31 Aortic Valve Insufficiency

32 Paravalvular Regurgitation (VI) 3-Class Grading Scheme 100% 80% 60% 40% P < P < Moderate 8.0% Mild 26.8% Moderate 0.6% Mild 3.5% Severe Moderate Mild None/Trace 20% 0% 35% had +1 or greater AI TAVR Surgery TAVR Surgery No. of echos 30 Days 2 Years TAVR Surgery

33 ACC 2017 CoreValve/Evolute ACC 2017, Michael J. Reardon 40% mild or greater AI

34 Paravalvular Leak: S3HR & S3i (Valve Implant Patients) 0.1% 4.2% in S3I Lots of Residual AI: Even with 3 rd generation S3 No. of Echos 1504

35 N=1,016 patients STS = 4.02

36 Peri-Procedural TAVI AI still exists but is improving steadily

37 Real World Data

38 TAVR and SAVR* Procedures In the TVT Registry and STS ACSD* 35,000 30,000 25,000 20,000 15,000 10,000 5, ,778 4,466 30,665 29,810 29,462 24,581 25,949 8,997 16, q1-3 TAVRs (TVT Registry) SAVRs (ACSD) * SAVR= isolated surgical aortic valve replacement; ACSD=Adult Cardiac Surgery Database Source: STS/ACC TVT Registry Database as of Jan 18, 2017; STS ACSD 2015 Annual Report 2017

39 Median STS Risk Score for all TAVR Procedures 7.2% 7.0% 6.8% 6.6% 6.4% 6.2% 6.0% 5.8% 7.1% 6.8% 6.7% STS Risk Score 6.3% Note: vertical scale accentuates trend. Why? Risk creep versus expanded indications versus identification of patients with other factors not included in STS score (frailty, etc)? Source: DCRI analysis, Sept 12, 2016

40 5.0% 4.0% 3.0% 2.0% 1.0% 0.0% TAVR: Catastrophic Procedure Details 3.4% 3.5% 1.1% 4.4% 2.7% 1.5% 2.7% 1.3% 1.4% 0.9% 0.9% 0.5% 0.7% q1-3 CPB req Convert to OHS Procedure Aborted Source: STS/ACC TVT Registry Database. 80,130 records as of Jan 18, 2017

41 The Near Future??: Treatment of Aortic Stenosis Low and Moderate Risk SAVR Partner 2A SURTAVI High Risk A TAVR or SAVR Inoper able B TAVR Inoperable C Utility Operative Risk 10-15% Operative Risk > 15% Futility Adapted from S. Kodali and M. Leon

42 So, Develop the Robust Heart Team and be Prepared. It will be best for Surgeons, Cardiologists, and Patients TAVR vs SAVR vs Cohort C?? Mitral, TV, and CAD??

43 So NOW the Real Question is. Why NOT a New TAVI trial into LOW RISK patients??

44 The PARTNER 3 Low Risk Trial Study Design Severe, Calcific Aortic Stenosis Patients at Low Operative Risk Heart team agrees the patient has low risk and STS < 4 Registries Assessment by Heart Team: Transfemoral access No Alternative Access TAVR Yes 1:1 Randomization TAVR (SAPIEN 3 valve) CT Imaging Sub-study Actigraphy/Quality of Life Sub-study Surgical AVR (surgical bioprosthetic valve) CT Imaging Sub-study Actigraphy/Quality of Life Sub-study Primary Endpoint: Composite of all-cause mortality, all stroke, and rehospitalization at 1 year post procedure. Follow-up: 30 day, 6 months, and annually through 10 years

45 The Reality I don t expect the results will be any different than in the past 10 years??

46 Questions?