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J Thorac Cardiovasc Surg 2006;131:1095-1098
© 2006 The American Association for Thoracic Surgery

Surgery for Acquired Cardiovascular Disease

Comparison of Coapsys annuloplasty and internal reduction mitral annuloplasty in the randomized treatment of functional ischemic mitral regurgitation: Impact on the left ventricle

E.A. Grossi, MD a , * , Y.J. Woo, MD b , C.F. Schwartz, MD a , D.M. Gangahar, MD c , V.A. Subramanian, MD d , N. Patel, MD d , J. Wudel, MD e , P.L. DiGiorgi, MD a , A. Singh, MD f , R.D. Davis, MD g

a New York University School of Medicine and Veterans Administration NY Harbor Healthcare System, New York, NY
b Hospital of the University of Pennsylvania, Philadelphia, Pa
c University of Nebraska Medical Center, Omaha, Neb
d Lenox Hill Hospital, New York, NY
e Nebraska Heart Institute, Lincoln, Neb
f Rhode Island Hospital, Providence, RI
g Duke University School of Medicine, Durham, NC

Read at the Thirty-first Annual Meeting of The Western Thoracic Surgical Association, Victoria, BC, Canada, June 22-25, 2005.

Received for publication June 23, 2005; revisions received November 8, 2005; accepted for publication November 29, 2005.

* Address for reprints: Eugene A. Grossi, MD, NYU Medical Center, Suite 9-V, 530 First Ave, New York, NY 10028 (Email: grossi{at}cv.med.nyu.edu).

BACKGROUND: Functional mitral regurgitation is associated with both annular and ventricular distortion. Aggressive reduction annuloplasty for functional mitral regurgitation acts primarily at the annulus, with variable impact on the left ventricle. The Coapsys device externally reshapes the left ventricle to correct functional mitral regurgitation. Left ventricular reshaping was analyzed in a randomized study.

METHODS: The RESTOR-MV study randomizes patients with coronary artery disease and functional mitral regurgitation to either reduction annuloplasty and coronary artery bypass grafting (the RA group) or Coapsys annuloplasty and bypass grafting (the CO group). The Coapsys device consists of epicardial pads connected by a cord. It was placed without cardiopulmonary bypass under echocardiographic guidance and sized to reduce annular dimension and improve leaflet coaptation. Internal reduction annuloplasty was performed by device placement. Intraoperative transesophageal echocardiograms were analyzed in 7 patients having reduction annuloplasty and 7 having Coapsys annuloplasty.

RESULTS: Baseline mitral regurgitation (0-4 scale) was similar for the RA (3.0 ± 0.6) and the CO groups (3.0 ± 0.6). Intraoperative mitral regurgitation was reduced from 2.86 ± 0.7 to 0.5 ± 0.7 (P < .01 pre vs post) for the RA group and from 2.64 ± 0.9 to 05 ± 0.7 (P < .01 pre vs post) for the CO group. Annular anteroposterior diameter was reduced with both techniques: RA, 3.45 ± 0.39 to 2.34 ± 0.37 cm (P < .01 pre vs post); CO, 3.40 ± 0.27 to 2.85 ± 0.34 cm (P < .05 pre vs post). Long-axis dimensions were unchanged with both techniques. Short-axis dimensions measured at three levels were significantly reduced only in the CO patients: basal diameter 4.77 ± 0.58 to 3.58 ± 0.38 cm (P < .01 pre vs post); mid diameter 4.88 ± 0.55 to 3.57 ± 0.43 cm (P < .01 pre vs post); and apical diameter 4.39 ± 0.46 to 3.38 ± 0.34 cm (P < .01 pre vs post).

CONCLUSIONS: Coapsys and reduction annuloplasty techniques both acutely reduce functional mitral regurgitation and annular dimension. The Coapsys device provided significantly greater left ventricular reshaping than did reduction annuloplasty. Further evaluation will assess the long-term valvular function and ventricular geometric stability associated with both techniques.

Abbreviations and Acronyms CABG = coronary artery bypass grafting; IDE = investigational device exemption; LV = left ventricle (ventricular); RESTOR-MV = Randomized Evaluation of a Surgical Treatment for Off-pump Repair of the Mitral Valve




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