title: Intraoperative effects of the coapsys annuloplasty system in a randomized evaluation (RESTOR-MV) of functional ischemic mitral regurgitation.
abstract: 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.
authors.affiliation: New York University Medical Center, New York, New York 10028, USA. grossi@cv.med.nyu.edu
authors.forename: Eugene A
authors.initials: EA
authors.lastname: Grossi
authors.forename: Paul C
authors.initials: PC
authors.lastname: Saunders
authors.forename: Y Joseph
authors.initials: YJ
authors.lastname: Woo
authors.forename: Deepak M
authors.initials: DM
authors.lastname: Gangahar
authors.forename: John C
authors.initials: JC
authors.lastname: Laschinger
authors.forename: David C
authors.initials: DC
authors.lastname: Kress
authors.forename: Michael P
authors.initials: MP
authors.lastname: Caskey
authors.forename: Charles F
authors.initials: CF
authors.lastname: Schwartz
authors.forename: James
authors.initials: J
authors.lastname: Wudel
mesh_terms: D000368:Aged; D004867:Equipment Design / Q000295:instrumentation*; D005260:Female; D006801:Humans; D007432:Intraoperative Period; D008297:Male; D008875:Middle Aged; D008944:Mitral Valve Insufficiency / Q000209:etiology / Q000601:surgery*; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic