1. on behalf of the EVEREST Investigators
Percutaneous Edge-to-Edge Evalve Mitral Valve Repair in the US “High-Risk” MR Registry
on behalf of the EVEREST Investigators
Ramon Quesada, MD, FACP,FACC, FSCAI
Medical Director, Interventional Cardiology
Baptist Cardiac & Vascular Institute
Miami, Florida

2. Ramon Quesada, MD DISCLOSURES
I have no real or apparent conflicts of interest to report.

3. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
Grant/Research Support None
Consulting Fees/Honoraria Abbott, Cordis, St. Jude, W.L. Gore, NMT Medical, Terumo & Boston Scientific Corporation
Major Stock Shareholder/Equity None
Royalty Income None
Ownership/Founder None
Intellectual Property Rights None
Other Financial Benefit None

4. Percutaneous mitral repair with the MitraClip® System based on the Alfieri Technique
Repositionable
Real time assessment of reduction of MR
Received CE Mark Approval

5. Worldwide MitraClip Experience
Enrollment
Population n
EVEREST I
(100% enrolled)
Registry patients 55
EVEREST II
Roll-in
Randomized Clip
Randomized Surgery
High Risk Registry 60
184 95 78
EVEREST II: REALISM
Continued Access Registry
Registry Patients
(non HRR and HRR)
135
European Experience
219
TOTAL MitraClip Therapy Patients
731
* Data as of September 15, 2009 5

6. EVEREST I & II Enrollment
Population n
EVEREST I
Feasibility (completed)
Registry patients 55
EVEREST II
Randomized n=279
(100% enrolled)
Roll-in
Randomized Clip
Randomized Surgery 60
184 95
High Risk Registry 78
Total enrolled
472
EVEREST II High Risk Registry
Enrollment and one year follow up complete
38 sites

7. Perspective Therapeutic options for patients with FMR
Current surgical options are limited
Repair
Undersized annuloplasty
Double orifice repair
New surgical approaches without substantive data
Replacement
Medical management is largely ineffective
The MitraClip Therapy may be a reasonable alternative therapeutic option

8. EVEREST High Risk Registry (HRR) Endpoints
Primary Safety Endpoint : 30 Day Mortality
Observed vs. Predicted Mortality Risk
based on STS Calculator or Surgeon Estimate
Major Effectiveness Endpoint: 12 Months
Reduction in hospitalizations for CHF
Improvement in NYHA Class
Improvement in LV Function
Reduction in MR

9. EVEREST II High Risk Registry
KEY INCLUSION CRITERIA
Predicted procedural mortality risk ≥ 12% (STS calculated or Surgeon estimated)
Symptomatic 3+ or 4+ MR, Degenerative or Functional
78 Enrolled
FMR
N=46
(59%)
DMR
N=32
(41%)
KEY EXCLUSION CRITERIA
EF ≤ 20% and/or LVESD >60mm
MVA <4cm2
Leaflet anatomy unsuitable for MitraClip device
FMR Patients
12 month matched MR data
N=34

10. Predicted procedural mortality based on STS Risk Calculator or Surgeon Estimate
STS Surgical Risk Calculator
High Risk Eligibility met if STS calculated score ≥12% or based on surgeon judgment if one or more of following co-morbidities
Porcelain aorta or mobile ascending aortic atheroma
Post-radiation mediastinum
Previous mediastinitis
Functional MR with EF<40
Over 75 years old with EF<40
Re-operation with patent grafts
Two or more prior chest surgeries
Hepatic cirrhosis
Three or more of the following STS high risk factors:
Creatinine > 2.5 mg/dL
Prior chest surgery
Age over 75
EF<35

11. FMR Cohort: Baseline Co-morbidities
Significant co-morbidities
Baseline
Co-Morbidities
FMR
N=46
Age (mean) 73
NYHA Class III or IV
91%
History CAD
87%
History CHF
100%
Hypertension
Diabetes Mellitus
52%
COPD / Chronic Lung Disease
35%
Moderate to Severe Renal Failure
26%
Prior Cardiac Surgery
63%
Predicted Surgical Mortality
(STS risk Calculator or Surgeon Estimate)
17%

12. FMR Cohort: MitraClip Implant Rate
98% Implant Success Rate
2 Clips (n=13)
1 Clip (n=32)
0 Clip (n=1)

13. HRR 30 Day Mortality Safety Endpoint (ITT)
Actual
Mortality
Predicted Risk of Surgical Mortality
P Value
Primary Endpoint
HRR All *
(N=78)
7.7%
(n=6)
18.2%
0.006
Concurrent Control (n=36)
8.3%
(n=4)
16.4%
HRR FMR
(n=46)
8.7%
17.0%
Acute mortality is similar to patients managed to standard of care for High Risk Patients
* TCT 2008

14. HRR FMR (n=46): Major Adverse Events - 30 days
Freedom from MAE: 74% (34/46)
21 MAE Events occurred in 12 patients
Deaths (4)
MI* (1)
Stroke* (1)
Renal Failure (2)
Ventilation >48 hours** (2)
Transfusion ≥ 2 units of blood** (11)
Majority of transfusions related to chronic anemia
* Occurred in patient who died
** 1 event occurred in patient who died

15. HRR FMR (n=46): Partial Clip Detachment (ITT)
Clip Embolization
Partial Clip Detachment
2 (4.3%*)
1 procedural
1 > 30 days
* Incidence in preliminary cohort (N=107): 9.7%

16. FMR Cohort: Quantification of MR
Marked reduction in MR, RV, and RF at 12 months
Time point
Overall MR Grade (mean ± SD)
n=34
Regurgitant Volume (ml) (mean ± SD)
n=26
Regurgitant Fraction (%) (mean ± SD)
Baseline
3.2±0.5
42±18
44±13
12 month
1.8±0.9
20±16
25±17
p value
<0.0001

17. FMR Cohort: Mitral Regurgitation Grade
Sustained MR Reduction
21%
41%
MR 1
97%
79%
59%
MR 2
Grade 1+/ 2+
Grade 1+ = Mild MR
Grade 2+ = Moderate MR
Grade 3+ = Moderate - Severe MR
Grade 4+ = Severe MR
Grade 3+/ 4+
12 month Matched data, n=34

18. HRR FMR: NYHA Class (ITT)
MitraClip therapy results in sustained symptomatic improvement
80% Improved at 12 months with 74% Class I/II at 12 months
100% Improved or remained unchanged at 12 months 12 13 8 1 18 19 3
74%
n=34, Matched Data

19. FMR Cohort: Re-hospitalization for CHF
Significant reduction in rate of re-hospitalization for CHF
36%
Reduction
Re-Hospitalizations
Patients
Re-Hospitalization Rate
12 Months Prior to MitraClip
12 Months Prior to MitraClip
12 Months Following MitraClip
12 Months Following MitraClip

20. The effect of valve repair without annuloplasty on septo-lateral mitral annular diameter and left ventricular (LV) function in patients with functional mitral regurgitation (FMR) is unknown

21. HRR FMR: LV Function (ITT)
MitraClip therapy results in reverse LV remodeling
P=0.001
P=0.0002
LVEDV Baseline
LVEDV 12 Months
LVESV Baseline
LVESV 12 Months
192
153
103 87
Systolic
Diastolic
n=34, Matched Data

22. FMR Cohort: Left Ventricular Remodeling
MitraClip therapy results in reverse LV remodeling
P<0.0001
P<0.0001
P=ns
P=0.0002
192
153
6.0
5.6
4.3
4.5
103 87
Diastolic
Systolic
Diastolic
Systolic
Baseline, Diastolic
Baseline, Systolic
12 Months, Diastolic
12 Months, Systolic
12 month Matched data, n=34

23. FMR Cohort Ejection Fraction / Forward Stroke Volume
Improved LV Efficiency
P=0.06 51 55 47 44
EF(%)
n=34
FSV (ml/beat)
n=33
EF Baseline
FSV Baseline
EF 12 Months
FSV 12 Months

24. FMR Cohort: Septal-Lateral Annular Dimension
Annular Dimensions Unchanged at Discharge
3.8
3.7
3.2
3.2
Diastolic
Systolic
Baseline, Diastolic
Baseline, Systolic
Discharge, Diastolic
Discharge, Systolic
Matched data, n=33

25. FMR Cohort: Septal-Lateral Annular Dimension
Annular Dimensions Reduced at 12 Months
P<
P= 0.008
3.8
3.6
3.2
3.0
Baseline, Diastolic
Baseline, Systolic
12 Months, Diastolic
12 Months, Systolic
Matched data, n=33

26. FMR Cohort: Septal-Lateral Annular Dimension
Annular Dimensions Stabilized at 12 Months
3.8
3.6
3.2
3.0
Baseline, Diastolic
Baseline, Systolic
12 Months, Diastolic
12 Months, Systolic
12 month Matched data, n=18

27. 79 y/o ischemic cardiomyopathy Continued elevated Left atrial pressure
Medications
valsartan 320 mg
carvedilol 50 mg
isosorbide 120 mg
furosemide 160 mg (avg dose)
BP 90 sys
Creatinine 2.5
Hgb 8.8
LVEF 30%
Coronary angio: all vessels patent

28. Intermittent severe functional MR and atrial standstill
2DE when
LAP = 34 mm Hg BP 100/70 mm Hg

30. NYHA I, BP 110 sys, furosemide 40 mg, LVEF 40%, Creatinine 1.2, Hgb 11
Asymptomatic LAP controlled 22 months
NYHA I, BP 110 sys, furosemide 40 mg, LVEF 40%, Creatinine 1.2, Hgb 11

31. Sustained MR reduction at 18 months

32. Echo at Baseline and 18 months

33. Reduction of SL diameter at 18 months

34. Summary Baseline 12 Months P-value MR Grade 3.2±0.5 1.8±0.9 <0.0001
LVEDV (ml)
192±46
153±44
LVESV (ml)
103±37
87±35
0.0002
SL Annular diameter (diastole) (cm)
3.8±0.3
3.6±0.3
<
SL Annular diameter (systole) (cm)
3.2±0.4
3.0±0.3
0.008
NYHA Class I/II (%) 9 74
CHF Hospitalization Rate
0.76
0.49
36% decrease

35. HRR FMR Summary
The MitraClip device was successfully implanted in 98% of High Risk FMR patients
Clinical benefit was delivered and sustained to 12 months
Improvement in NYHA Class
Decreased rate of hospitalization for CHF
LV Function was improved through 12 months
Decrease in LV End Diastolic and Systolic Volumes
Increase in Forward Stroke Volume
Decrease in Septo-lateral Annular Dimensions

36. International Symposium on Endovascular Therapy
I S E T
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January, 2011
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