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© American Heart Association, Inc.

Basic Science Reports

Endovascular Edge-to-Edge Mitral Valve Repair

Short-Term Results in a Porcine Model

From the Cardiovascular Institute (F.G.S.G.), Mt View, Calif; the Division of Cardiovascular Surgery (J.I.F., T.J.F.), Stanford University Medical Center, Stanford, Calif; Evalve, Inc (J.K.), Redwood City, Calif; the Division of Cardiology (E.F.), University of California–San Francisco Medical Center, San Francisco, Calif; the Department of Cardiothoracic Surgery (M.C.O.), Columbia University, New York, NY; the Division of Cardiology (T.F.), Evanston Northwestern Healthcare, Evanston, Ill; and the Division of Cardiology (P.C.B.), Emory University, Atlanta, Ga.

Correspondence to Frederick St. Goar, MD, Cardiovascular Institute, 2660 Grant Rd, Mt View, CA 94040. E-mail fstgoar{at}aol.com

Received July 30, 2003; revision received August 21, 2003; accepted August 22, 2003.

Background— The edge-to-edge technique is an accepted method for the surgical repair of a regurgitant mitral valve. This study reports the initial use of an endovascular technology that enables a double-orifice edge-to-edge mitral valve repair without cardiopulmonary bypass in an animal model.

Methods and Results— Adult pigs (n=14) were anesthetized, and left thoracotomy was performed for epicardial echo imaging. Using femoral vein access, a steerable guide catheter was placed transseptally into the left atrium. An implantable clip designed to grasp and approximate the middle scallops of the anterior and posterior mitral leaflets was introduced through the guide catheter. The clip was opened in the left atrium, advanced through the mitral orifice, and retracted to grasp the leaflet edges. When a functional double-orifice valve was confirmed by echo, the clip was closed to coapt the leaflets and detached from the delivery catheter. Before final clip detachment, echo demonstrated a double orifice in all 14 animals. In 2 studies, the clip released from the anterior mitral leaflet. Retrospective analysis of echo images indicated an incomplete grasp of the anterior leaflet. Immediate postmortem examination revealed that the clip successfully approximated the middle scallops of the anterior and posterior leaflets in all 12 double-orifice studies.

Conclusions— This study demonstrates for the first time that an endovascular system can be successfully used to perform the edge-to-edge repair technique in a nondiseased porcine model. This technique is potentially applicable as a percutaneous catheterization laboratory procedure for the treatment of mitral regurgitation in humans.

Key Words: mitral valve • regurgitation • catheterization

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