EVEREST II 5 Year Report and Beyond Ted

EVEREST II 5 -Year Report and Beyond Ted Feldman, M. D. , MSCAI FACC FESC Evanston Hospital CRT Cardiovascular Research Technologies Washington D. C. February 18 -21 st, 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 Mitra. Clip N = 184 Surgery N = 95 p-value 67 66 ns Male 63% 66% ns History of CHF 91% 78% 0. 005 NYHA Functional Class III/IV 51% 47% ns Functional MR Etiology 26% 27% ns Coronary Artery Disease 47% 46% ns Prior Myocardial Infarction 22% 21% ns Previous Cardiovascular Surgery 22% 19% ns Atrial Fibrillation 34% 39% ns COPD (with or without home O 2) 15% ns Moderate to Severe Renal Disease 3% 2% ns Diabetes 8% 11% ns LV Ejection Fraction (mean), % 60 61 ns LV End Systolic Dimension (mean), cm 3. 7 3. 5 ns Characteristic Age (mean), years 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 Mitra. Clip (N=178) 93. 7% 92. 3% 1 year Proportion of Patients Surviving Surgery (N=80) 81. 2% 79. 0% 5 years Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years Mitra. Clip # At Risk 178 165 158 154 143 133 119 58 Surgery # At Risk 80 76 70 70 65 57 52 24

Kaplan-Meier Freedom From MV Surgery in Mitra. Clip Group or Re-operation in Surgery Group Surgery (N=80) Mitra. Clip (N=178) 78. 9% 97. 4% 1 year 74. 3% 92. 5% 5 years oportion of Patients Free From Surgery Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years Mitra. Clip # At Risk 178 136 128 125 117 109 98 45 Surgery # At Risk 80 75 69 68 63 54 49 21 EVEREST II RCT Deaths are censored

Kaplan-Meier Freedom From MV Surgery in Mitra. Clip Group or Re-operation in Surgery Group Surgery Mitra. Clip 97. 1% 98. 7% 1 year oportion of Patients Free From Surgery 91. 4% 93. 7% 5 years 6 -Month Landmark Analysis EVEREST II RCT

Freedom From Mortality & Reintervention DMR Mitra. Clip DMR Surgery DMR Clip: DMR Surg: FMR Clip: FMR Surg: FMR Surgery 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 9 8 RCT Surgery DMR 62 55 52 46 43 16 # At Risk Kaplan-Meier estimate FMR Mitra. Clip 97. 7% [92. 7%, 99. 3%] 91. 8% [81. 3%, 96. 5%] 83. 2% [69. 1%, 91. 3%] 93. 8% [63. 2%, 99. 1%] At 1 year DMR Clip: DMR Surg: FMR Clip: FMR Surg: 89. 4% [77. 7%, 95. 2%] 85. 9% [60. 1%, 95. 6%] 59. 7% [31. 6%, 79. 4%] 55. 0% [27. 2%, 76. 0%] At 5 years EVEREST II RCT

Reduction in LV Volumes at 5 Years EVEREST II RCT Decrease in Volume (ml) 60 Despite residual MR with Mitra. Clip… LV remodeling still persists after 5 years 50 Mitra. Clip Surgery 40 30 20 10 0 End-Diastolic Volume End-Systolic Volume

Septal Lateral Annular Dimensions EVEREST II RCT All Treated Patients - Mitra. Clip Group (N=178) Diastolic SLAD 5 5 4 4 3. 3 3 2 1 0 Baseline 5 Years Mean SLADdiast (cm) Mean SLADsyst (cm) Systolic SLAD 3. 9 Baseline 5 Years 3 2 1 0 Feldman T J Am Coll Cardiol 2015; 66: 2844– 54

EVEREST II REALISM Continued Access One-Year Outcomes in Primary MR Baseline Characteristics Age (mean ± SD) Male NYHA Functional Class III/IV Congestive Heart Failure Coronary Artery Disease Prior Myocardial Infarction Previous CABG Atrial Fibrillation Chronic Obstructive Pulmonary Disease Diabetes Moderate to Severe Renal Disease Cerebrovascular Disease STS Mortality Risk Core-Lab Assessed MR Grade ≥ 3+, (%) LV Ejection Fraction (mean ± SD) LV End Diastolic Volume (mean ± SD) Leaflet Flail Leaflet Prolapse High Risk DMR (N=189) 83 ± 9 years 56% 84% 96% 64% 22% 35% 74% 31% 25% 27% 23% 12. 6 ± 7. 0% 90% 60 ± 10% 124 ± 42 ml 51% 63% Non-High Risk DMR (N=185) 75 ± 12 years 54% 55% 77% 41% 10% 14% 53% 21% 13% 7% 10% 4. 8 ± 3. 0%* 91% 61 ± 7% 125 ± 41 ml 41% 85% ESC 2015

EVEREST II REALISM Continued Access One-Year Outcomes in Primary MR Freedom From MV Surgery Event (30 Days / 1 Year) Single Leaflet Device Attachment Through 1 Year High Risk DMR (N=189) Non-High Risk DMR (N=185) 0. 0% 4. 6% ESC 2015