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CLINICAL RESEARCH: VALVULAR HEART DISEASE

Percutaneous Mitral Repair With the MitraClip System

Safety and Midterm Durability in the Initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) Cohort

Ted Feldman, MD^_*,_*, Saibal Kar, MD, Michael Rinaldi, MD, Peter Fail, MD, James Hermiller, MD^||, Richard Smalling, MD, PhD^¶, Patrick L. Whitlow, MD^#, William Gray, MD^_**, Reginald Low, MD, Howard C. Herrmann, MD, Scott Lim, MD, Elyse Foster, MD^||||, Donald Glower, MD^¶¶ for the EVEREST Investigators

^_* Evanston Hospital, Evanston, Illinois
Cedar Sinai Medical Center, Los Angeles, California
Carolina Heart Institute, Charlotte, North Carolina
Terrebonne General Medical Center, Houma, Louisiana
^|| The Care Group, Indianapolis, Indiana
^¶ Houston Health Sciences Center, Houston, Texas
^# The Cleveland Clinic, Cleveland, Ohio
^_** Columbia University, New York, New York
University of California at Davis, Sacramento, California
University of Pennsylvania, Philadelphia, Pennsylvania
University of Virginia, Charlottesville, Virginia
^|||| University of California at San Francisco, San Francisco, California
^¶¶ Duke University Medical Center, Durham, North Carolina

Manuscript received August 11, 2008; revised manuscript received March 23, 2009, accepted March 24, 2009.

^_* Reprint requests and correspondence: Dr. Ted Feldman, Evanston Hospital, Cardiology Division-Walgreen Building, 3rd Floor, 2650 Ridge Avenue, Evanston, Illinois 60201 (Email: tfeldman{at}scai.org).

Objectives: We undertook a prospective multicenter single-arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system (Evalve Inc., Menlo Park, California).

Background: Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the Evalve MitraClip device to secure the mitral leaflets.

Methods: Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory.

Results: A total of 107 patients were treated. Ten (9%) had a major adverse event, including 1 nonprocedural death. Freedom from clip embolization was 100%. Partial clip detachment occurred in 10 (9%) patients. Overall, 79 of 107 (74%) patients achieved acute procedural success, and 51 (64%) were discharged with MR of 1+. Thirty-two patients (30%) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84% (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66%) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy end point). Kaplan-Meier freedom from death was 95.9%, 94.0%, and 90.1%, and Kaplan-Meier freedom from surgery was 88.5%, 83.2%, and 76.3% at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability.

Conclusions: Percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion (EVEREST I; NCT00209339. EVEREST II; NCT00209274).

Key Words: mitral repair • percutaneous valve therapy • mitral regurgitation

Abbreviations and Acronyms   ACC = American College of Cardiology   AHA = American Heart Association   APS = acute procedural success   ASE = American Society of Echocardiography   CDS = Clip Delivery System   LV = left ventricle   MAE = major adverse event   MR = mitral regurgitation   MV = mitral valve   NYHA = New York Heart Association   STS = Society of Thoracic Surgeons

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