EVEREST II 5-Year Report and Beyond

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Presentation transcript:

EVEREST II 5-Year Report and Beyond Ted Feldman, M.D., MSCAI FACC FESC Evanston Hospital The MitraClip Workshop - Supported by an educational grant from Abbott (12:00 PM – 5:10 PM) CRT 2017 Track: CRT Valve & Structural The MitraClip Workshop (NON-CME) Session: Mitraclip: Show Me The Data (3:45 PM – 5:10 PM) Saturday, February 18, 2017 3:45 PM – 3:55 PM Room: Blue Pre-Function Room EVEREST II 5-Year Report and Beyond Your role: Presenter MitraClip: Show Me The Data 3:45 PM - 5:10 PM 3:45 PM Mitraclip: Show Me The DataModerator: William A. Gray, MD, FSCAI Moderator: Howard C. Herrmann, MD, FACC, MSCAI EVEREST II 5-Year Report and BeyondPresenter: Ted Feldman, MD, MSCAI 3:55 PM EVEREST REALISM Non-High-Risk CohortPresenter: Howard C. Herrmann, MD, FACC, MSCAI 4:05 PM MitraClip Outcomes from the STS TVT RegistryPresenter: Ted Feldman, MD, MSCAI 4:15 PM My Best Tips & Tricks to Have a Successful MitraClip ProcedurePresenter: Brijeshwar S. Maini, MD 4:25 PM Examples of When MitraClip FailedPresenter: Scott Lim, MD 4:35 PM A Case of MitraClipPresenter: Anita W. Asgar, MD, FACC 4:45 PM MitraClip: Next Generation Design AdvancesSpeaker: Sameer A. Gafoor, MD CRT Cardiovascular Research Technologies Washington D.C. February 18-21st, 2017

Ted Feldman MD, MSCAI FACC FESC Disclosure Information The following relationships exist: Grant support: Abbott, BSC, Cardiokinetics, Corvia, Edwards, WL Gore Consultant: Abbott, BSC, Edwards, WL Gore Stock Options: Mitralign Off label use of products and investigational devices will be discussed in this presentation

Baseline Characteristics EVEREST II RCT-Candidate for mitral valve surgery including CPB MitraClip N = 184 Surgery N = 95 p-value Age (mean), years 67 66 ns Male 63% 66% History of CHF 91% 78% 0.005 NYHA Functional Class III/IV 51% 47% Functional MR Etiology 26% 27% Coronary Artery Disease 46% Prior Myocardial Infarction 22% 21% Previous Cardiovascular Surgery 19% Atrial Fibrillation 34% 39% COPD (with or without home O2) 15% Moderate to Severe Renal Disease 3% 2% Diabetes 8% 11% LV Ejection Fraction (mean), % 60 61 LV End Systolic Dimension (mean), cm 3.7 3.5 New Engl J Med 364:1395-1406, 2011

Patient selection New Engl J Med 364:1395-1406, 2011

Kaplan-Meier Freedom From Mortality EVEREST II RCT MitraClip (N=178) Surgery (N=80) 93.7% 92.3% 1 year 81.2% 79.0% 5 years Proportion of Patients Surviving Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years MitraClip # At Risk 178 165 158 154 143 133 119 58 Surgery 80 76 70 65 57 52 24

Kaplan-Meier Freedom From MV Surgery in MitraClip Group or Re-operation in Surgery Group Surgery (N=80) MitraClip (N=178) 78.9% 97.4% 1 year 74.3% 92.5% 5 years Proportion of Patients Free From Surgery Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years MitraClip # At Risk 178 136 128 125 117 109 98 45 Surgery 80 75 69 68 63 54 49 21 EVEREST II RCT Deaths are censored

Kaplan-Meier Freedom From MV Surgery in MitraClip Group or Re-operation in Surgery Group 97.1% 98.7% 1 year 91.4% 93.7% 5 years Proportion of Patients Free From Surgery 6-Month Landmark Analysis EVEREST II RCT

Freedom From Mortality & Reintervention DMR MitraClip DMR Surgery FMR MitraClip DMR Clip: 97.7% [92.7%, 99.3%] DMR Surg: 91.8% [81.3%, 96.5%] FMR Clip: 83.2% [69.1%, 91.3%] FMR Surg: 93.8% [63.2%, 99.1%] At 1 year FMR Surgery DMR Clip: 89.4% [77.7%, 95.2%] DMR Surg: 85.9% [60.1%, 95.6%] FMR Clip: 59.7% [31.6%, 79.4%] FMR Surg: 55.0% [27.2%, 76.0%] At 5 years # At Risk Baseline 12 Months 24 Months 36 Months 48 Months 60 Months RCT Device FMR 48 39 33 31 26 9 RCT Device DMR 130 119 110 102 93 49 RCT Surgery FMR 18 15 13 11 8 RCT Surgery DMR 62 55 52 46 43 16 EVEREST II RCT Kaplan-Meier estimate

Reduction in LV Volumes at 5 Years EVEREST II RCT

Septal Lateral Annular Dimensions EVEREST II RCT All Treated Patients - MitraClip Group (N=178) Systolic SLAD Diastolic SLAD Mean SLADdiast (cm) Mean SLADsyst (cm) Baseline 5 Years Baseline 5 Years Feldman T J Am Coll Cardiol 2015;66:2844–54

EVEREST II REALISM Continued Access One-Year Outcomes in Primary MR Baseline Characteristics High Risk DMR (N=189) Non-High Risk DMR (N=185) Age (mean ± SD) 83 ± 9 years 75 ± 12 years Male 56% 54% NYHA Functional Class III/IV 84% 55% Congestive Heart Failure 96% 77% Coronary Artery Disease 64% 41% Prior Myocardial Infarction 22% 10% Previous CABG 35% 14% Atrial Fibrillation 74% 53% Chronic Obstructive Pulmonary Disease 31% 21% Diabetes 25% 13% Moderate to Severe Renal Disease 27% 7% Cerebrovascular Disease 23% STS Mortality Risk 12.6 ± 7.0% 4.8 ± 3.0%* Core-Lab Assessed MR Grade ≥3+, (%) 90% 91% LV Ejection Fraction (mean ± SD) 60 ± 10% 61 ± 7% LV End Diastolic Volume (mean ± SD) 124 ± 42 ml 125 ± 41 ml Leaflet Flail 51% Leaflet Prolapse 63% 85% ESC 2015

EVEREST II REALISM Continued Access One-Year Outcomes in Primary MR Freedom From MV Surgery Event (30 Days / 1 Year) High Risk DMR (N=189) Non-High Risk DMR (N=185) Single Leaflet Device Attachment Through 1 Year 0.0% 4.6% ESC 2015