Cyril J. Schweich

Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve)

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).

Novel device to change left ventricular shape for heart failure treatment: device design and implantation procedure.

The Myocor Myosplint is designed to decrease left ventricular (LV) wall stress by changing LV shape, thus improving contractile function in dilated hearts. This shape change is accomplished by surgically placing three Myosplints perpendicular to the LV long axis, drawing the LV walls inward, and creating a symmetric, bilobular LV. Specially designed instruments aid in the precise delivery of these devices. The purpose of this study was to test the safety and feasibility of the procedure in dogs. Dilated cardiomyopathy was induced in 40 healthy dogs (26.3 ± 1.7 kg) by ventricular pacing at 230 beats per minute for an average of 25 ± 4 days. Using epicardial echocardiography, we placed the Myosplints across the LV chamber, avoiding the major coronary arteries, papillary muscles, and mitral valve. Once placed, the Myosplints were used to draw the LV walls inward to a prescribed distance. In all cases, we successfully implanted three Myosplints without using cardiopulmonary bypass. There were no complications related to the device or procedure. Myosplint implantation to change LV shape is safe and repeatable on a beating cardiomyopathic canine heart. Further study of the procedure will be needed in humans.