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J Thorac Cardiovasc Surg 2004;127:1068-1077
© 2004 The American Association for Thoracic Surgery

Cardiopulmonary support and physiology

The Coapsys device to treat functional mitral regurgitation: In vivo long-term canine study

Masahiro Inoue, MD, PhD^a, Patrick M. McCarthy, MD^a,b, Zoran B. Popovi, MD^c, Kazuyoshi Doi, MD^a, Soren Schenk, MD^a, Hassan Nemeh, MD^a, Yoshio Ootaki, MD, PhD^a, Michael W. Kopcak, Jr, BA^a, Raymond Dessoffy, AA^a, James D. Thomas, MD^c, Kiyotaka Fukamachi, MD, PhD^a,*

^a Department of Biomedical Engineering, Lerner Research Institute, Cleveland, Ohio, USA
^b Department of Thoracic and Cardiovascular Surgery, Kaufman Center for Heart Failure, Cleveland, Ohio, USA
^c Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA

Read at the Eighty-third Annual Meeting of The American Association for Thoracic Surgery, Boston, Mass, May 4-7, 2003.

Received for publication May 1, 2003; revisions received November 19, 2003; accepted for publication December 1, 2003.

^* Address for reprints: Kiyotaka Fukamachi, MD, PhD, Department of Biomedical Engineering/ND20, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195, USA
fukamach{at}bme.ri.ccf.org

OBJECTIVE:: We evaluated the capability of the Myocor Coapsys device (Myocor, Inc, Maple Grove, Minn) to reduce functional mitral regurgitation in a canine model of dilated cardiomyopathy.

METHODS: Functional mitral regurgitation with heart failure was induced in 7 dogs by rapid ventricular pacing. The Coapsys device, which consists of anterior and posterior epicardial pads connected by a subvalvular chord, was then implanted. Heart failure was maintained by continued pacing for 8 weeks. Hemodynamic and echocardiographic measurements were performed at pre- and postsizing and after 8 weeks. The Coapsys subvalvular chord was cut to verify that maintenance of valve competency was due to the device.

RESULTS: All implants were performed off-pump without atriotomy. Mitral regurgitation was reduced in all animals; mean mitral regurgitation grade was reduced from 2.9 ± 0.7 to 0.7 ± 0.8 (P = .00005) and was maintained at 0.8 ± 0.8 after 8 weeks, without hemodynamic compromise or structural damage to the mitral valve. Mitral regurgitation returned to 3.6 ± 0.8 (P = .102 versus presizing) after cutting the Coapsys subvalvular chord.

CONCLUSION: The Coapsys device consistently and chronically reduced functional mitral regurgitation. This device is in clinical trials in the United States.

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