Coapsys mitral annuloplasty for chronic functional ischemic mitral regurgitation: 1-year results

Background. Untreated functional ischemic mitral regurgitation (MR) leads to reduced survival in patients undergoing coronary artery bypass grafting (CABG). However, mitral repair or replacement increases mortality and morbidity over CABG alone. The Myocor Coapsys annuloplasty system potentially reduces these risks by facilitating MR reduction on a beating heart without atriotomy. We present data from the first 11 patients completing 1-year follow-up of a total of 34 implanted patients. Methods. Patients referred for CABG with preoperative grade 2 or greater ischemic functional MR were included in this study. Patients with structural valve defects or who demonstrated MR less than grade 2 after CABG, despite hemodynamic challenge, were intraoperatively excluded. Coapsys consists of two epicardial pads connected by a flexible chord implanted by passing the chord across the left ventricle with special instruments without cardiopulmonary bypass. The system was sized to reduce critical valve dimensions and MR. Serial clinical and echocardiographic data were collected out to 1 year. Results. Mean age was 58.1 +/- 6.6 years and mean ejection fraction, 38.5% +/- 7.1%. From baseline to 1-year follow-up, effect on MR grade, MR jet area (cm(2)), and New York Heart Association class were, respectively, 2.9 +/- 0.5 to 1.1 +/- 0.8, 7.4 +/- 2.9 to 3.0 +/- 1.6, and 2.5 +/- 0.5 to 1.2 +/- 0.4 (all p < 0.05 versus baseline). During follow-up, there were no deaths, device failures, reemergence of grade 3 or 4 MR, heart failure readmission, or valve reoperations. Conclusions. The Coapsys annuloplasty system is effective in reducing functional ischemic MR and improving NYHA class. The initial data are encouraging and suggest that the device is safe and benefits are sustained at 1 year.