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Published on: October 16, 2021
Coapsys mitral annuloplasty for chronic functional ischemic mitral regurgitation: 1-year results
Yugal K Mishra1, Sanjay Mittal, Pravesh Jaguri
1Department of Cardiac Surgery, Escorts Heart Institute and Research Centre, New Delhi, India. dryugal@yahoo.com
Insights
The Coapsys annuloplasty system effectively reduces functional ischemic mitral regurgitation (MR) in patients undergoing coronary artery bypass grafting (CABG). This innovative device shows sustained safety and efficacy at one year, improving patient outcomes.
Area of Science:
- Cardiovascular Surgery
- Interventional Cardiology
- Biomedical Engineering
Background:
- Untreated functional ischemic mitral regurgitation (MR) significantly reduces survival in patients undergoing coronary artery bypass grafting (CABG).
- Traditional mitral valve repair or replacement increases mortality and morbidity compared to CABG alone.
- The Myocor Coapsys annuloplasty system offers a potential solution by reducing MR on a beating heart without requiring atriotomy.
Purpose of the Study:
- To evaluate the safety and efficacy of the Myocor Coapsys annuloplasty system in reducing functional ischemic MR.
- To assess the impact of the Coapsys system on clinical outcomes and echocardiographic parameters at 1-year follow-up.
Main Methods:
- A prospective study included patients with preoperative grade 2 or greater ischemic functional MR referred for CABG.
- The Coapsys system, comprising epicardial pads and a flexible chord, was implanted without cardiopulmonary bypass.
- Serial clinical and echocardiographic data were collected for 1 year post-implantation.
Main Results:
- Significant reduction in MR grade (2.9 to 1.1), MR jet area (7.4 to 3.0 cm²), and NYHA class (2.5 to 1.2) was observed at 1 year (p < 0.05).
- No deaths, device failures, reemergence of severe MR, heart failure readmissions, or valve reoperations occurred during follow-up.
- Mean patient age was 58.1 years with a mean ejection fraction of 38.5%.
Conclusions:
- The Coapsys annuloplasty system demonstrates effectiveness in reducing functional ischemic MR and improving NYHA class.
- Initial data suggest the device is safe, with sustained benefits observed at the 1-year follow-up.
- The Coapsys system presents a promising approach for managing ischemic MR in CABG patients.
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 (cm2), 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.
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