Document Detail


Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study.
MedLine Citation:
PMID:  19597051     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Joachim Schofer; Tomasz Siminiak; Michael Haude; Jean P Herrman; Jindra Vainer; Justina C Wu; Wayne C Levy; Laura Mauri; Ted Feldman; Raymond Y Kwong; David M Kaye; Stephen J Duffy; Thilo Tübler; Hubertus Degen; Mathias C Brandt; Rich Van Bibber; Steve Goldberg; David G Reuter; Uta C Hoppe
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2009-07-13
Journal Detail:
Title:  Circulation     Volume:  120     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2009 Jul 
Date Detail:
Created Date:  2009-07-28     Completed Date:  2009-08-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  326-33     Citation Subset:  AIM; IM    
Affiliation:
Medical Care Center Professor Mathey, Professor Schofer Hamburg University Cardiovascular Center Hamburg, Hamburg, Germany.
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Angioplasty, Transluminal, Percutaneous Coronary / instrumentation*,  methods*
Cardiac Pacing, Artificial / methods
European Union*
Female
Follow-Up Studies
Heart Valve Prosthesis Implantation / instrumentation,  methods
Humans
Male
Middle Aged
Mitral Valve / physiology*
Mitral Valve Insufficiency / epidemiology,  physiopathology*,  therapy*
Prospective Studies
Comments/Corrections
Comment In:
Circulation. 2009 Jul 28;120(4):272-4   [PMID:  19597045 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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