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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

View larger version (109K): [in a new window]   Figure 1 Photograph of the clip attached to the delivery system. The clip is covered with polyester fabric. The two arms are opened and closed by control mechanisms on the clip delivery system. The two arms have an opened span of approximately 2 cm and a width of 4 mm.

View larger version (55K): [in a new window]   Figure 2 Schematic drawing of the components of the clip. On the inner portion of the clip is a U-shaped gripper that matches up to each arm and helps to stabilize the leaflets from the atrial aspect as they are captured during closure of the clip arms. Leaflet tissue is secured between the closed arms and each side of the gripper, and the clip is then closed and locked to effect and maintain coaptation of the two leaflets.

View larger version (28K): [in a new window]   Figure 3 Flow chart showing overall results for the 27 study patients.

View larger version (72K): [in a new window]   Figure 4 Short axis transthoracic echocardiogram showing a double-orifice mitral valve. The clip can be seen plainly in the center of the double orifice (arrow). The image was obtained from the first patient enrolled in the EVEREST I trial at the 30-day echocardiogram follow-up time point.