1. 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

2. 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

3. 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: , 2011

4. Patient selection
New Engl J Med 364: , 2011

6. 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

7. 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

8. 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

9. Freedom From Mortality & Reintervention
DMR MitraClip
DMR Surgery
FMR MitraClip
DMR Clip: % [92.7%, 99.3%]
DMR Surg: 91.8% [81.3%, 96.5%]
FMR Clip: % [69.1%, 91.3%]
FMR Surg: % [63.2%, 99.1%]
At 1 year
FMR Surgery
DMR Clip: % [77.7%, 95.2%]
DMR Surg: 85.9% [60.1%, 95.6%]
FMR Clip: % [31.6%, 79.4%] FMR Surg: % [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

10. Reduction in LV Volumes at 5 Years EVEREST II RCT

11. 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

12. 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

13. 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