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Comparison of EVEREST II High Surgical Risk and Continued Access High Surgical Risk Patient Cohorts 1 Year Preliminary

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. Disclosures. Consulting Fees/Honoraria

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Comparison of EVEREST II High Surgical Risk and Continued Access High Surgical Risk Patient Cohorts 1 Year Preliminary

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  1. Comparison of EVEREST II High Surgical Risk and Continued Access High Surgical Risk Patient Cohorts1 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 TherapyWorldwide 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. High Surgical Risk Patients Treated with the MitraClip Device in EVEREST II Trials As of April 12, 2011

  6. BackgroundEVEREST 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 KatzSt. 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 CriteriaEVEREST II and Continued Access High Surgical Risk Patients All high risk patients were enrolled using the same inclusion/exclusion criteria • 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 • 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

  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

  11. Mitral Valve Anatomic CriteriaHigh Surgical Risk Concurrent Control(N=36)

  12. EVEREST II High Surgical Risk CohortEnrollment EVEREST II High Surgical Risk Cohort N = 372* REALISM High Surgical Risk Trial^ N = 294 Enrolled EVEREST High Surgical Risk Trial^ N = 78 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 AccountabilityEVEREST II and Continued AccessHigh Surgical Risk Patients 211 EVEREST II High Surgical Risk Patients With 1 Year Follow-up Continued Access High Surgical Risk Patients N = 133 EVEREST II High Surgical Risk Patients N = 78 N = 5 Withdrawals N = 3 Withdrawals N = 128 1 Year Analysis N = 75 1 Year Analysis 96% of patient data available for analysis Enrolled by 28 Feb 2010

  14. Baseline Demographics and Co-MorbiditiesEVEREST II and Continued AccessHigh Surgical Risk Patients *STS risk calculated or surgeon estimate based on prespecified co-morbidities

  15. Implant Rate and Procedural ResultsEVEREST II and Continued AccessHigh Surgical Risk Patients

  16. Implant Rate and Procedural ResultsEVEREST II and Continued AccessHigh Surgical Risk Patients

  17. Predicted vs Observed 30 Day MortalityEVEREST II and Continued AccessHigh Surgical Risk Patients P = 0.006 P < 0.0001 18.2% 18.2% P = 0.34 7.7% 3.8% N = 133 N = 78

  18. 30 Day MAEEVEREST II and Continued AccessHigh Surgical Risk Patients

  19. Investigator MitraClip Procedure ExperienceEVEREST II and Continued AccessHigh Surgical Risk Patients * Includes patients treated in all EVEREST studies

  20. Baseline Demographics and Co-MorbiditiesEVEREST II, Continued Access and Concurrent Control ^p<0.001, REALISM HR vs CC

  21. Kaplan-Meier Freedom from Death At 1 YearEVEREST II, Continued Access and Concurrent Control At 1 Year 75.6% EVEREST II High Risk p = 0.048 vs CC Continued Access High Risk 75.2% p = 0.008 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 YearEVEREST II and Continued Access High Surgical Risk Patients At 1 Year 100% EVEREST II High Risk 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 p < 0.0001 p < 0.0001 2+ 0+ 2+ 1+ 1+ 78% 3+ 83% 3+ 2+ 2+ 3+ 3+ 4+ 4+ 4+ 4+ Continued Access High Surgical Risk Patients (n=69 matched cases) EVEREST IIHigh Surgical Risk Patients (n=54 matched cases)

  24. LV End Diastolic and Systolic VolumesEVEREST II and Continued Access High Surgical Risk Patients p < 0.0001 p = 0.0012 p = 0.0003 p = 0.011 158 143 Volume (mL) 172 140 89 80 82 72 Baseline 1 year Baseline 1 year Baseline 1 year Baseline 1 year Continued AccessHigh Surgical Risk Patients (n=63 matched cases) EVEREST IIHigh Surgical Risk Patients (n=54 matched cases)

  25. NYHA Functional Class at 1 YearEVEREST II and Continued Access High Surgical Risk Patients P < 0.0001 P < 0.0001 I II II I I 74% III 84% III II II III III IV IV IV IV EVEREST II High Surgical Risk Patients (n=54 matched cases) Continued Access High Surgical Risk Patients (n=89 matched cases)

  26. SF-36 Quality of Life Scores at 1 YearEVEREST II and Continued Access High Surgical Risk Patients Baseline 1 Year Physical Component Mental Component p < 0.06 p < 0.0001 p < 0.05 p < 0.001 Baseline 1 year Baseline 1 year Baseline 1 year Baseline 1 year EVEREST II HR n=47 matched Continued Access HRn=70 matched EVEREST II HRn=47 matched Continued Access HRn=70 matched

  27. Hospitalization for CHFEVEREST 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=0.0002 p=0.02 48% Reduction 45% Reduction 1 Year Post N=128 1 Year Post N=75 1 Year Prior N=133 1 Year Prior N=78 *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.

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