TY - JOUR
T1 - Outcomes of the RESTOR-MV trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve)
AU - Grossi, Eugene A.
AU - Patel, Nirav
AU - Woo, Y. Joseph
AU - Goldberg, Judith D.
AU - Schwartz, Charles F.
AU - Subramanian, Valavanur
AU - Feldman, Ted
AU - Bourge, Robert
AU - Baumgartner, Norbert
AU - Genco, Christopher
AU - Goldman, Scott
AU - Zenati, Marco
AU - Wolfe, J. Alan
AU - Mishra, Yugal K.
AU - Trehan, Naresh
AU - Mittal, Sanjay
AU - Shang, Shulian
AU - Mortier, Todd J.
AU - Schweich, Cyril J.
N1 - Funding Information:
This study was sponsored by Myocor, Inc. Dr. Bourge is a consultant to the research study for Myocor. Dr. Goldman is a consultant to Edwards, St. Jude, and ATS. Mr. Mortier and Dr. Schweich are former employees of Myocor. All other authors have reported that they have no relationships to disclose.
PY - 2010/12/7
Y1 - 2010/12/7
N2 - Objectives 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)
AB - Objectives 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)
KW - Functional mitral insufficiency
KW - Left ventricular reshaping
KW - Mitral valve repair
UR - http://www.scopus.com/inward/record.url?scp=78649693692&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2010.06.051
DO - 10.1016/j.jacc.2010.06.051
M3 - Article
C2 - 21126639
AN - SCOPUS:78649693692
SN - 0735-1097
VL - 56
SP - 1984
EP - 1993
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 24
ER -