Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study.
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.


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.
Schofer
Joachim
J
Medical Care Center Professor Mathey, Professor Schofer Hamburg University Cardiovascular Center Hamburg, Hamburg, Germany.
Siminiak
Tomasz
T
Haude
Michael
M
Herrman
Jean P
JP
Vainer
Jindra
J
Wu
Justina C
JC
Levy
Wayne C
WC
Mauri
Laura
L
Feldman
Ted
T
Kwong
Raymond Y
RY
Kaye
David M
DM
Duffy
Stephen J
SJ
Tübler
Thilo
T
Degen
Hubertus
H
Brandt
Mathias C
MC
Van Bibber
Rich
R
Goldberg
Steve
S
Reuter
David G
DG
Hoppe
Uta C
UC
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000379:methods*; D002304:Cardiac Pacing, Artificial / Q000379:methods; D005062:European Union; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000502:physiology*; D008944:Mitral Valve Insufficiency / Q000453:epidemiology / Q000503:physiopathology* / Q000628:therapy*; D011446:Prospective Studies