Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve).
OBJECTIVE
we sought to determine whether patients with functional mitral regurgitation (FMR) would benefit from ventricular reshaping by the Coapsys device (Myocor, Inc., Maple Grove, Minnesota).


BACKGROUND
FMR occurs when ventricular remodeling impairs valve function. Coapsys is a ventricular shape change device placed without cardiopulmonary bypass to reduce FMR. It compresses the mitral annulus and reshapes the ventricle. We hypothesized that Coapsys for FMR would improve clinical outcomes compared with standard therapies.


METHODS
RESTOR-MV (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) was a randomized, prospective, multicenter study of patients with FMR and coronary disease with core laboratory analysis. After enrollment, patients were stratified to the standard indicated surgery: either coronary artery bypass graft alone or coronary artery bypass graft with mitral valve repair. In each stratum, randomization was to either control (indicated surgery) or treatment (coronary artery bypass graft with Coapsys ventricular reshaping).


RESULTS
the study was terminated when the sponsor failed to secure ongoing funding; 165 patients were randomized. Control and Coapsys both produced decreases in left ventricular (LV) end-diastolic dimension and MR at 2 years (p < 0.001); Coapsys provided a greater decrease in LV end-diastolic dimension (p = 0.021). Control had lower MR grades during follow-up (p = 0.01). Coapsys showed a survival advantage compared with control at 2 years (87% vs. 77%) (hazard ratio: 0.421; 95% confidence interval: 0.200 to 0.886; stratified log-rank test; p = 0.038). Complication-free survival (including death, stroke, myocardial infarction, and valve reoperation) was significantly greater with Coapsys at 2 years (85% vs. 71%) (hazard ratio: 0.372; 95% confidence interval: 0.185 to 0.749; adjusted log-rank test; p = 0.019).


CONCLUSIONS
analysis of RESTOR-MV indicates that patients with FMR requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and a significant decrease in major adverse outcomes. This trial validates the concept of the ventricular reshaping strategy in this subset of patients with heart failure. (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve [RESTOR-MV]; NCT00120276).
New York University School of Medicine and New York Harbor Veterans Healthcare System, New York, New York 10028, USA. grossi@cv.med.nyu.edu
Eugene A
EA
Grossi
Nirav
N
Patel
Y Joseph
YJ
Woo
Judith D
JD
Goldberg
Charles F
CF
Schwartz
Valavanur
V
Subramanian
Ted
T
Feldman
Robert
R
Bourge
Norbert
N
Baumgartner
Christopher
C
Genco
Scott
S
Goldman
Marco
M
Zenati
J Alan
JA
Wolfe
Yugal K
YK
Mishra
Naresh
N
Trehan
Sanjay
S
Mittal
Shulian
S
Shang
Todd J
TJ
Mortier
Cyril J
CJ
Schweich
D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006352:Heart Ventricles; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D016896:Treatment Outcome