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EXPEDITED REVIEW

Percutaneous Mitral Valve Repair Using the Edge-to-Edge Technique

Six-Month Results of the EVEREST Phase I Clinical Trial

Ted Feldman, MD, FACC, FSCAI^_*,_*, Hal S. Wasserman, MD, FACC, FSCAI, Howard C. Herrmann, MD, FACC, FSCAI, William Gray, MD, FACC, FSCAI, Peter C. Block, MD, FACC, FSCAI^||, Patrick Whitlow, MD, FACC, FSCAI^¶, Fred St. Goar, MD, FACC, FSCAI^#, Leonardo Rodriguez, MD, FACC^¶, Frank Silvestry, MD, FACC, Allan Schwartz, MD, FACC, Timothy A. Sanborn, MD, FACC, FSCAI^_*, Jose A. Condado, MD^_** and Elyse Foster, MD, FACC

^_* Evanston Hospital, Evanston Illinois
Columbia University, New York, New York
University of Pennsylvania, Philadelphia, Pennsylvania
Swedish Medical Center, Seattle, Washington
^|| Emory University, Atlanta, Georgia
^¶ The Cleveland Clinic, Cleveland, Ohio
^# Cardiovascular Institute, Mt. View, California
^_** Hospital Miguel Perez-Carrefio, Centro Medico Caracas, Caracas, Venezuela
University of California, San Francisco, California

Manuscript received June 3, 2005; revised manuscript received July 12, 2005, accepted July 19, 2005.

^_* Reprint requests and correspondence: Dr. Ted Feldman, Evanston Hospital, Cardiology Division-Burch 300, 2650 Ridge Avenue, Evanston, Illinois 60201. (Email: tfeldman{at}enh.org).

OBJECTIVES: This study sought to evaluate the clinical results of a percutaneous approach to mitral valve repair for mitral regurgitation (MR).

BACKGROUND: A surgical technique approximating the middle scallops of the mitral leaflets to create a double orifice with improved leaflet coaptation was introduced in the early 1990s. Recently, a percutaneous method to create the same type of repair was developed. A trans-septal approach was used to deliver a clip device that grasps the mitral leaflet edges to create the double orifice.

METHODS: General anesthesia, fluoroscopy, and echocardiographic guidance are used. A 24-F guide is positioned in the left atrium. The clip is centered over the mitral orifice, passed into the left ventricle, and pulled back to grasp the mitral leaflets. After verification that MR is reduced, the clip is released.

RESULTS: Twenty-seven patients had six-month follow-up. Clips were implanted in 24 patients. There were no procedural complications and four 30-day major adverse events: partial clip detachment in three patients, who underwent elective valve surgery, and one patient with post-procedure stroke that resolved at one month. Three additional patients had surgery for unresolved MR, leaving 18 patients free from surgery. In 13 of 14 patients with reduction of MR to 2+ after one month, the reduction was maintained at six months.

CONCLUSIONS: Percutaneous edge-to-edge mitral valve repair can be performed safely and a reduction in MR can be achieved in a significant proportion of patients to six months. Patients who required subsequent surgery had elective mitral valve repair or intended replacement.

Abbreviations and Acronyms   MAE = major adverse event   MR = mitral regurgitation

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