Percutaneous Mitral Repair With the MitraClip System: Safety and Midterm Durability in the Initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) Cohort

doi:10.1016/j.jacc.2009.03.077

Journal of the American College of Cardiology

Volume 54, Issue 8, 18 August 2009, Pages 686-694

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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

left ventricle

MAE

major adverse event

mitral regurgitation

mitral valve

NYHA

New York Heart Association

STS

Society of Thoracic Surgeons

Cited by (0)

: Dr. Feldman received research support from Evalve, Inc., Cardiac Dimensions, Edwards Life Sciences, and Myocor and was a consultant for QuantumCor. Dr. Kar received research support from Evalve, Inc., and was a scientific advisory board member for QuantumCor. Dr. Rinaldi was on the advisory board of Boston Scientific (<$3,000/year); was on the Speakers' Board for Abbott Cardiovascular (<$1,500/year); and received grant support from Evalve, Inc., as an investigator. Dr. Fail received research support from Evalve, Inc. Drs. Hermiller, Smalling, Whitlow, Gray, Lim, and Foster received research support from Evalve, Inc. Dr. Low received research support from Evalve, Inc., and is a consultant for Sadra Medical and Edwards LifeSciences. Dr. Herrmann received research support from Evalve, Inc., and equity from and is a consultant to Endovalve, Inc. Dr. Glower received research support from Evalve, Inc., Edwards Lifesciences, and St. Jude Medical.