Published Online
on July 13, 2009

A more recent version of this article appeared on July 28, 2009

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Submitted on January 8, 2009
Accepted on May 20, 2009

Percutaneous Mitral Annuloplasty for Functional Mitral Regurgitation. Results of the CARILLON Mitral Annuloplasty Device European Union Study

Joachim Schofer MD, Tomasz Siminiak MD, Michael Haude MD, Jean P. Herrman MD, PhD, Jindra Vainer MD, Justina C. Wu MD, PhD, Wayne C. Levy MD, Laura Mauri MD, MSc, Ted Feldman MD, Raymond Y. Kwong MD, David M. Kaye MD, PhD, Stephen J. Duffy MD, PhD, Thilo Tübler MD, Hubertus Degen MD, Mathias C. Brandt MD, Rich Van Bibber PhD, Steve Goldberg MD, David G. Reuter MD, PhD^*, and Uta C. Hoppe MD

From the Medical Care Center Professor Mathey, Professor Schofer Hamburg University Cardiovascular Center Hamburg, Hamburg, Germany (J.S., T.T.); Poznan University Medical Sciences, Poznan, Poland (T.S.); Stadtische Kliniken Neuss, Neuss, Germany (M.H., H.D.); Onze Lieve Vrouwe Gasthuis, Gasthuis, Netherlands (J.P.H.); Academisch Ziekenhuis Maastricht, Maastricht, Netherlands (J.V.); Brigham and Women's Hospital, Boston, Mass (J.C.W., R.Y.K.); University of Washington, Seattle (W.C.L.); Harvard Clinical Research Institute, Boston, Mass (L.M.); Evanston Hospital, Chicago, Ill (T.F.); Alfred Hospital, Melbourne, Australia (D.M.K., S.D.); Department of Internal Medicine III, University of Cologne, Cologne, Germany (U.C.H., M.C.B.); and Cardiac Dimensions, Inc, Kirkland, Wash (R.V.B., S.G., D.G.R.).

^* To whom correspondence should be addressed. E-mail: dreuter{at}cardiacdimensions.com.

Background—Functional mitral regurgitation (FMR), a well-recognized component of left ventricular remodeling, is associated with increased morbidity and mortality in heart failure patients. Percutaneous mitral annuloplasty has the potential to serve as a therapeutic adjunct to standard medical care.

Methods and Results—Patients with dilated cardiomyopathy, moderate to severe FMR, an ejection fraction <40%, and a 6-minute walk distance between 150 and 450 m were enrolled in the CARILLON Mitral Annuloplasty Device European Union Study (AMADEUS). Percutaneous mitral annuloplasty was achieved through the coronary sinus with the CARILLON Mitral Contour System. Echocardiographic FMR grade, exercise tolerance, New York Heart Association class, and quality of life were assessed at baseline and 1 and 6 months. Of the 48 patients enrolled in the trial, 30 received the CARILLON device. Eighteen patients did not receive a device because of access issues, insufficient acute FMR reduction, or coronary artery compromise. The major adverse event rate was 13% at 30 days. At 6 months, the degree of FMR reduction among 5 different quantitative echocardiographic measures ranged from 22% to 32%. Six-minute walk distance improved from 307±87 m at baseline to 403±137 m at 6 months (P<0.001). Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved from 47±16 points at baseline to 69±15 points at 6 months (P<0.001).

Conclusions—Percutaneous reduction in FMR with a novel coronary sinus–based mitral annuloplasty device is feasible in patients with heart failure, is associated with a low rate of major adverse events, and is associated with improvement in quality of life and exercise tolerance.

Key words: heart failure • mitral valve • regurgitation

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