Document Detail

Intraoperative effects of the coapsys annuloplasty system in a randomized evaluation (RESTOR-MV) of functional ischemic mitral regurgitation.
MedLine Citation:
PMID:  16242443     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Functional ischemic mitral regurgitation (MR) frequently arises after myocardial infarction; it is characterized by annular enlargement or lateral displacement of the subvalvular apparatus. Coapsys is a ventricular-annular remodeling device designed to treat functional ischemic MR; it does not require cardiopulmonary bypass. Initial intraoperative results of the RESTOR-MV randomized clinical trial are presented. METHODS: Patients referred for coronary artery bypass grafting with preoperative MR grade of 2 or greater were studied, excluding those with structural valve abnormalities. The Coapsys device, which consists of two epicardial pads connected by a flexible cord, was surgically implanted in 19 patients. Under epicardial echocardiographic guidance, the cord was passed through the left ventricle and tightened externally to improve leaflet coaptation and stabilize the ventricular wall; tightening was conducted with color flow Doppler imaging. RESULTS: Patients were 64.5 +/- 9.2 years old with an ejection fraction of 0.383 +/- 0.089 and received 2.7 +/- 1.1 grafts. Intraoperative MR grade was 2.7 +/- 0.8 after induction and was reduced to 0.4 +/- 0.7 after implantation (p < 0.0001). Mean epicardial dimension was reduced from 8.5 +/- 1.2 to 6.4 +/- 0.9 cm (p < 0.0001). Intraoperative MR was reduced in 95% (18 of 19) of patients, and 84% (16 of 19) had MR grade 1 or less after implantation. All implants were performed without cardiopulmonary bypass or conversion to standard annuloplasty. No hemodynamic compromise or structural damage to the mitral apparatus was noted. Significant acute remodeling was noted in the left ventricular dimensions. CONCLUSIONS: In patients without structural valve disease, the Coapsys device acutely reduces functional MR. Further randomized evaluation will assess long-term stability and compare it with standard annuloplasty techniques.
Eugene A Grossi; Paul C Saunders; Y Joseph Woo; Deepak M Gangahar; John C Laschinger; David C Kress; Michael P Caskey; Charles F Schwartz; James Wudel
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Annals of thoracic surgery     Volume:  80     ISSN:  1552-6259     ISO Abbreviation:  Ann. Thorac. Surg.     Publication Date:  2005 Nov 
Date Detail:
Created Date:  2005-10-24     Completed Date:  2006-11-02     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  15030100R     Medline TA:  Ann Thorac Surg     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  1706-11     Citation Subset:  AIM; IM    
New York University Medical Center, New York, New York 10028, USA.
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MeSH Terms
Equipment Design / instrumentation*
Intraoperative Period*
Middle Aged
Mitral Valve Insufficiency / etiology,  surgery*
Multicenter Studies as Topic
Randomized Controlled Trials as Topic

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

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