1. Comparison of EVEREST II High Surgical Risk and Continued Access High Surgical Risk Patient Cohorts 1 Year Preliminary Results
Michael Rinaldi, Saibal Kar, Scott Lim, Ted Feldman, and the EVEREST II Investigators
SCAI 2011
Baltimore, MD

2. Disclosures
Consulting Fees/Honoraria
Abbott Vascular

3. Percutaneous Mitral Valve Repair
MitraClip® System

4. MitraClip Therapy Worldwide Clinical Experience
Over 3,000 patients have been treated with the MitraClip device worldwide:
75% are considered high risk* for mitral valve surgery
67% have functional mitral regurgitation (MR)
1,453 patients have been enrolled in prospective clinical trials worldwide:
50% are considered high risk* for mitral valve surgery
60% have functional MR
Estimates of worldwide clinical experience as of March 31, 2011
* Determination of high surgical risk based on: logistic EuroSCORE ≥ 20%, or STS calculated mortality ≥ 12%, or pre-specified high surgical risk comorbidities.

5. EVEREST High Surgical Risk Clinical Trials
High Surgical Risk Patients Treated with the MitraClip Device in EVEREST II Trials
EVEREST High Surgical Risk Clinical Trials
EVEREST II – High Risk Trial 78
EVEREST II Continued Access – High Risk Trial
294
TOTAL High Surgical Risk Patients
372
As of April 12, 2011

6. Background EVEREST II Outcomes Through 2 Years
Randomized Controlled Trial (RCT) comparing percutaneous device and mitral valve surgery
Percutaneous repair provides increased safety
Surgery provides more complete MR reduction
Both percutaneous and surgical treatment reduced MR and demonstrated significant clinical benefits
High Risk study evaluating MitraClip device
Patients experienced reduced MR and significant clinical benefits

7. EVEREST II Continued Access Investigators
T Feldman, J Alexander, R Curran, E Chedrawy, S Smart, M Lampert NorthShore University HealthSystem, Evanston, IL
A Wang, D Glower, J Jollis Duke University, Durham, NC
M Kellett, P Weldner, R Quinn Maine Medical Center, Portland, ME
R Quesada, J Lamelas, N Moreno, R Machado Baptist Hospital of Miami, Miami, FL
P Grayburn, B Hamman, R Hebeler, M Mack, W Ryan Baylor University Medical Center, Dallas, TX
V Rajagopal, J Kauten, W Mashman Piedmont Hospital, Atlanta, GA
J Hermiller, D Heimansohn, K Allen, D Segar The Care Group, Indianapolis, IN
M Rinaldi, E Skipper, R Steigel, J Cook, G Rose Carolinas Medical Center, Charlotte, NC
S Kar, G Fontana, A Trento, R Kass, W Cheng, R Siegel, K Tolstrup Cedars-Sinai Medical Center, Los Angeles, CA
P Whitlow, T Mihaljevic, N Smidera, L Svenssen, E Roselli, L Rodriquez, W Stewart The Cleveland Clinic, Cleveland, OH
W Gray, A Stewart, M Williams, M Argenziano, S Homma, R Pizzarello, L Gillam Columbia University, New York, NY; Danville, CT
D Steinberg, F Crawford, J Ikonimidis, D Gregg, P Zwerner Medical University of South Carolina, Charleston, SC
B Whisenant, S Clayson, B Reid, S Horton, J Orford Latter Day Saints Hospital, Salt Lake City, UT
R Smalling, G Letsou, J Walkes, C Loghin Memorial Hermann Hospital, Houston, TX
W Pedersen, V Kshettry, F Eales, T Flavin, T Kroshus, R Bae Minneapolis Heart Institute, Minneapolis, MN
C Rammohan, C Vial, R Beygui, D Nair, A Prakash El Camino Hospital, Mountain View, CA
SC Wong, OW Isom, L Girardi, K Krieger, R Devereux, R Mishra New York Presbyterian Hospital, New York, NY
J Slater, A Galloway, G Perk, I Kronzon NYU Medical Center, New York, NY
C Ruiz, D Loulmet, V Subramanian, I Kronzon, N Marino Lenox Hill Hospital, New York, NY
R Kipperman, S Lucas, RM Bodenhamer, J Randolph, J Williams Oklahoma Heart Hospital, Okalahoma City, OK
Z Hijazi, R March, K Cao, J Soble Rush University Medical Center, Chicago, IL
P Kramer, B Castlemain, A Schwartz, L Crouse, V Pasnoori Shawnee Mission Medical Center, Shawnee Mission, KS
A Berke, N Robinson, R Colangelo, P Damus, H Fernandez, J Taylor, N Bercow, A Katz St. Francis Hospital, Long Island, NY
T Bajwa, D O’Hair, D Kress, K Sagar St. Luke’s Medical Center, Milwaukee, WI
M Sanz, S Tahta, JM Maxwell, B Berry, J Knapp St. Patrick's Hospital & Health Science Ctr, Missoula, MT
M Reisman, W Curtis, D Gartman, J Teply, D Warth, K Krabill Swedish Medical Center, Seattle, WA
P Fail, K Paape, T Fudge, M Trotter, M Allam, E Feinberg, V Tedesco, D Solet Terrebonne General Medical Center, Houma, LA
R Low, N Young, K Shankar, R Calhoun, W Bommer University of California at Davis, Sacramento, CA
J Carroll, J Cleveland, R Quaife University of Colorado Health Sciences Center, Denver, CO
H Herrmann, M Acker, YJ Woo, F Silvestry, S Wiegers University of Pennsylvania, Philadelphia, PA
S Bailey, E Sako, J Erikson University of Texas Health Sciences Ctr, San Antonio, TX
DS Lim, I Kron, J Kern, J Dent, H Gutgesell University of Virginia, Charlottesville, VA
R Kipperman, J Brown, D Cohen, H Hamrah Morristown Memorial Hospital, Morristown, NJ
K Kent, S Boyce. P Sears-Rogan Washington Hospital Center, Washington DC
J Lasala, M Moon, R Damiano, B Lindman, A Zajarias, J Madrazo Washington University Medical Center, St. Louis, MO
G Hanzel, F Shannon, M Sakwa, A Abbas, M Gallagher, P Markovitz William Beaumont Hospital, Royal Oak, MI
Interventional Cardiologist, Cardiac Surgeon, Echocardiologist

8. Purpose
To present initial safety and effectiveness data of MitraClip device in Continued Access “real world” high surgical risk patients
Enrollment is ongoing
To compare initial Continued Access high surgical risk study results to EVEREST II high surgical risk study results
To assess the impact of operator learning on outcomes of high surgical risk patients

9. Key Eligibility Criteria EVEREST II and Continued Access High Surgical Risk Patients
All high risk patients were enrolled using the same inclusion/exclusion criteria
KEY INCLUSION CRITERIA
Predicted procedural mortality risk ≥ 12%
(STS calculated or Surgeon estimated based
on specific co-morbidities)
Symptomatic significant (3+ or 4+) MR
Etiology: Degenerative or Functional
Primary regurgitant jet originates from leaflet
mal-coaptation at A2 / P2 region
KEY EXCLUSION CRITERIA
Evidence of an AMI in 2 weeks prior
EF ≤ 20% and/or LVESD > 60mm
Leaflet anatomy which may preclude
MitraClip device implantation / proper
positioning
Prior MV leaflet surgery
Echo evidence of intra-cardiac mass,
thrombus, vegetation
Active endocarditis
Clip implant criteria
Mitral valve area < 4 cm2
Flail gap ≥ 10 mm,
Flail width ≥ 15 mm
Coaptation length < 2 mm

10. High Surgical Risk Concurrent Control Group
Control group includes 36 patients screened for EVEREST II – High Surgical Risk
All patients met clinical eligibility criteria
All patients had significant MR (3+ to 4+) and met high surgical risk criteria
Baseline co-morbidities well matched with EVEREST II High Surgical Risk Cohort
Management of MR through 1 year
86% medical management
14% mitral valve surgery
Of the 5 patients who had MV surgery within 12 months
One (DMR) had an MV replacement and died at 7 months post
One (FMR) had MV repair and died at 4 months post
One (FMR) had MV repair and CABG and died at 3 months
Two (DMR) had MV repair and were alive at 12 months post
36 patients retrospectively consented and followed to determine 1 year mortality
86% medical management
14% mitral valve surgery

11. Mitral Valve Anatomic Criteria High Surgical Risk Concurrent Control (N=36)
22% who met all criteria were not treated because, a) study stopped before these patients were treated or patients withdrew and did not want to be treated

12. EVEREST II High Surgical Risk Cohort Enrollment
EVEREST High Surgical Risk Trial^
N = 78 Enrolled
REALISM High Surgical Risk Trial^
N = 294 Enrolled
1 Year
N = 78
1 Year
N = 133
EVEREST II High Surgical Risk Cohort
With 1 Year Follow-Up^
N = 211
* As of April 12, 2011, ^ Enrolled by February 28, 2010

13. Patient Accountability EVEREST II and Continued Access High Surgical Risk Patients
With 1 Year Follow-up
EVEREST II
High Surgical Risk Patients
N = 78
Continued Access
High Surgical Risk Patients
N = 133
N = 3
Withdrawals
N = 5 Withdrawals
N = 75
1 Year Analysis
N = 128
1 Year Analysis
96% of patient data available for analysis
Enrolled by 28 Feb 2010

14. Baseline Demographics and Co-Morbidities EVEREST II and Continued Access High Surgical Risk Patients
EVEREST II High Surgical Risk Patients (N = 78)
Continued Access High Surgical Risk Patients (N = 133)
p-value
Age, years, Mean ± SD
77 ± 10
76 ±11
0.43
Estimated Mortality Risk* (%)
18 ± 8
19 ± 8
0.73
Gender, male (%) 63 59
0.66
Coronary Artery Disease (%) 84 80
0.47
Atrial Fibrillation (%) 62 65
0.76
Moderate – Severe Renal Disease (%) 23 35
0.07
Prior CV Surgery (%) 58
0.89
Prior MI (%) 56 45
0.15
NYHA Class III/IV (%) 90
0.23
Functional MR (%) 78
0.008
LVEF, Mean ± SD (%)
54 ± 14
46 ± 13
< 0.001
LVID-s, Mean (cm)
3.9 ±1.1
4.5 ± 1.0
*STS risk calculated or surgeon estimate based on prespecified co-morbidities

15. Implant Rate and Procedural Results EVEREST II and Continued Access High Surgical Risk Patients
EVEREST II High Surgical Risk Patients (N = 78)
Continued Access High Surgical Risk Patients (N = 133)
p-value
MitraClip Implant Rate (%) 96 95
0.80
0 MitraClips 4 5
n/a
1 MitraClip 59 62
2 MitraClips 37 33
MR ≤ 2+ at discharge, all patients (%) 72 88
0.009
MR ≤ 2+ at discharge for patients with MR ≥ 3+ at baseline (%) 71 81
0.20
Procedural Results (min)
Mean Procedure Time
190
153
< 0.001
Mean Device Time
145
117
0.005
Mean Fluoroscopy Duration 53 39

16. Implant Rate and Procedural Results EVEREST II and Continued Access High Surgical Risk Patients
EVEREST II High Surgical Risk Patients (N = 78)
Continued Access High Surgical Risk Patients (N = 133)
p-value
Post-Procedural Results
ICU Duration (hours) 52 25
0.005
Hospital Stay (days)
3.9
2.5
0.05
Discharged To, (%)
0.26
Home 80 87
Home With Home Health Care 10 8
Nursing Facility 3
Died Prior to Discharge 4 2

17. Predicted vs Observed 30 Day Mortality EVEREST II and Continued Access High Surgical Risk Patients
18.2%
18.2%
P = 0.34
7.7%
3.8%
N = 78
N = 133

18. 30 Day MAE EVEREST II and Continued Access High Surgical Risk Patients
EVEREST II High Surgical Risk Patients (N = 78)
# (%) Patients
Continued Access High Surgical Risk Patients (N = 133)
p-value
Death
6 (7.7%)
5 (3.8%)
0.34
Major Stroke
2 (2.6%)
4 (3.0%)
> 0.99
Re-operation of Mitral-Valve
n/a
Urgent / Emergent CV Surgery
1 (0.8%)
Myocardial Infarction
0.56
Renal Failure
3 (3.8%)
0.14
Deep Wound Infection
Ventilation >48 hrs
2 (1.5%)
0.63
New Onset Permanent Atrial Fib
Septicemia
GI Complication Requiring Surgery
1 (1.3%)
0.37
Transfusions ≥ 2 Units
14 (17.9%)
16 (12.0%)
0.31
Total
21 (26.9%)
22 (16.5%)
0.08
Total Excluding Transfusions
10 (12.8%)
10 (7.5%)
0.23

19. Investigator MitraClip Procedure Experience EVEREST II and Continued Access High Surgical Risk Patients
EVEREST II High Surgical Risk Patients (N = 78)
Continued Access High Surgical Risk Patients (N = 133)
p-value
Number of Operators 25 34
Operator Experience:
Rolling average number of cases performed 10 23
<
Median (Inter-quartile range)
7 (5, 16)
17 (8, 27)
* Includes patients treated in all EVEREST studies

20. Baseline Demographics and Co-Morbidities EVEREST II, Continued Access and Concurrent Control
EVEREST II High Risk Patients (N = 78)
Continued Access High Risk Patients (N = 133)
Concurrent Control (N = 36)
Age, years, Mean ± SD
77 ± 10
76 ±11
77 ± 13
Estimated Mortality Risk (%)
18 ± 8
19 ± 8
17 ± 7
Gender, male (%) 63 59 50
Coronary Artery Disease (%) 84 80 71
Atrial Fibrillation (%) 62 65 53
Moderate – Severe Renal Disease (%) 23 35 31
Prior CV Surgery (%) 58
Prior MI (%) 56 45 36
NYHA Class III/IV (%) 90
Functional MR (%) 78 64
LVEF, Mean ± SD (%)
54 ± 14
46 ± 13^
55 ± 18
LVID-s, Mean (cm)
3.9 ±1.1
4.5 ±1.0^
3.8 ±1.1
^p<0.001, REALISM HR vs CC

21. Kaplan-Meier Freedom from Death At 1 Year EVEREST II, Continued Access and Concurrent Control
EVEREST II High Risk
75.6%
p = vs CC
Continued Access High Risk
75.2%
p = vs CC
Concurrent Control
55.6%
# At Risk
EVEREST II High Risk
REALISM High Risk
Concurrent Control
0 Days
30 Days 6m
1yr 78 72 64 58
133
126
115 53 36 32 28 20

22. Kaplan-Meier Freedom from MV Surgery At 1 Year EVEREST II and Continued Access High Surgical Risk Patients
At 1 Year
EVEREST II High Risk
100%
Continued Access High Risk
96.8%
# At Risk
EVEREST II High Risk
REALISM High Risk
0 Days
30 Days 6m
1yr 78 72 64 58
133
126
115 53

23. Core Lab MR Grade at 1 Year (matched) EVEREST II and Continued Access High Surgical Risk Patients
EVEREST II High Surgical Risk Patients
(n=54 matched cases)
Continued Access High Surgical Risk Patients
(n=69 matched cases)
78% 3+ 4+ 2+ 1+
p <
83% 0+

24. LV End Diastolic and Systolic Volumes EVEREST II and Continued Access High Surgical Risk Patients
EVEREST II High Surgical Risk Patients
(n=54 matched cases)
Continued Access High Surgical Risk Patients
(n=63 matched cases)
158
143 89 80
p =
p = 0.011
172
140 82 72
Volume (mL)
p <
p =
Baseline 1 year

25. NYHA Functional Class at 1 Year EVEREST II and Continued Access High Surgical Risk Patients
EVEREST II High Surgical Risk Patients
(n=54 matched cases)
Continued Access High Surgical Risk Patients
(n=89 matched cases) II
III IV I
P <
74%
84%

26. SF-36 Quality of Life Scores at 1 Year EVEREST II and Continued Access High Surgical Risk Patients
Baseline
1 Year
Physical Component
Mental Component
p < 0.06
p <
p < 0.05
p < 0.001
Interesting to observe 2+ control, though sample size is too small to conclude
QOLimproves similarly for both mechanisms of MR reduction regardless of the overall reduction in MR achieved.
Table 13: Change in SF-36 Quality of Life Score from
Baseline 1 year
Baseline 1 year
Baseline 1 year
Baseline 1 year
EVEREST II HR n=47 matched
Continued Access HR n=70 matched
EVEREST II HR n=47 matched
Continued Access HR n=70 matched

27. Hospitalization for CHF EVEREST II and Continued Access High Surgical Risk Patients
1 Year Prior to MitraClip
1 Year Post MitraClip
EVEREST II High Surgical Risk Patients
Continued Access High Surgical Risk Patients
p=0.02
p=0.0002
48%
Reduction
45%
Reduction
1 Year Prior
N=78
1 Year Post
N=75
1 Year Prior
N=133
1 Year Post
N=128
*CHF hospitalizations per patient-year

28. Summary
Results consistent with previously demonstrated data in high surgical risk patients
MitraClip procedure safe
MitraClip device provides significant MR reduction and clinical benefits
LV function, NYHA Function Class and Quality of Life (SF-36)
Procedural safety improved with increased experience
Significantly decreased procedure time with comparable effectiveness
Significantly decreased post-procedure ICU time and hospital stay
Decreased 30-day mortality

29. Conclusion
The MitraClip procedure provides significant clinical benefits in select patients with significant MR who are at high risk for surgical mortality.