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(Circulation. 2004;110:988-993.)
© 2004 American Heart Association, Inc.

Original Articles

Beating Heart Catheter-Based Edge-to-Edge Mitral Valve Procedure in a Porcine Model

Efficacy and Healing Response

James I. Fann, MD; Frederick G. St. Goar, MD; Jan Komtebedde, DVM; Mehmet C. Oz, MD; Peter C. Block, MD; Elyse Foster, MD; Jagdish Butany, MBBS, MS; Ted Feldman, MD; Thomas A. Burdon, MD

From Stanford University (J.I.F., T.A.B.), Stanford, Calif; Cardiovascular Institute (F.G.S.G.), Mountain View, Calif; Evalve, Inc (J.K.), Redwood City, Calif; Columbia University (M.C.O.), New York, NY; Emory University (P.C.B.), Atlanta, Ga; University of California (E.F.), San Francisco, Calif; University of Toronto (J.B.), Ontario, Canada; and Evanston Northwestern Healthcare (T.F.), Evanston, Ill.

Correspondence to James I. Fann, MD, Department of Cardiothoracic Surgery, Stanford University Medical Center, 300 Pasteur Dr, Stanford, CA 94305. E-mail jfann{at}stanford.edu

Received November 18, 2003; de novo received January 19, 2004; revision received March 23, 2004; accepted March 25, 2004.

Background— Surgical edge-to-edge repair has been used in the treatment of mitral regurgitation. We evaluated the ability of a catheter-delivered clip (Evalve, Inc) to achieve edge-to-edge mitral valve approximation without cardiopulmonary bypass and the healing response of this technique.

Methods and Results— Twenty-one pigs underwent general anesthesia and left thoracotomy. A 10F flexible delivery catheter with a clip was placed into the left atrium. With echocardiographic and fluoroscopic guidance, the clip grasped and approximated the mid portion of the anterior and posterior leaflets. After a double orifice had been confirmed, the clip was detached and the catheter withdrawn. All animals survived and had successful clip placement. Three animals were euthanized at 4 weeks, 9 at 12 weeks, 1 at 17 weeks, 7 at 24 weeks, and 1 at 52 weeks. The clip was well positioned, with leaflet approximation in all animals except 1, in which the clip separated from the posterior leaflet at 4 weeks without affecting valve function. The clip was modified and implanted in 4 pigs; all were intact at 12 to 24 weeks. Scanning electron microscopy showed clip encapsulation with complete endothelialization. Mitral stenosis and thromboembolism did not develop. Two animals developed endocarditis (1 at 12 weeks and 1 at 17 weeks). Progressive healing occurred in all other animals.

Conclusions— Edge-to-edge mitral valve approximation can be successfully and reliably achieved with a catheter-delivered clip without cardiopulmonary bypass, resulting in durable healing. The success of this device supports the development of a percutaneous catheter-based system for mitral valve repair.

Key Words: mitral valve • catheters • surgery • echocardiography

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