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Todd K. Rosengart, M.D.
The Coapsys device represents a novel approach to functional mitral regurgitation (MR) that seeks to reduce MR by reducing the antero-posterior mitral annular diameter, thereby re-approximating the anterior and posterior mitral valve leaflets. This device includes an anterior and posterior epicardial pad connected and drawn together by a trans-ventricular chord that brings together intervening structures, such as the anterior and posterior mitral valve annulus. The Coapsys system reflects an advancement of pre-existent trans-ventricular technology that sought to improve ischemic cardiomyopathy by reducing the A-P left ventricular size. After encouraging results in animal models of MR, Phase I clinical trials were initiated to evaluate the Copasys device for the treatment of functional MR.
The RESTOR-MV study randomized patients with CAD and functional MR to either standard mitral annuloplasty and CABG or CABG with the Coapsys system (n=7 patients per group reported to date). In this trial, the Copasys system was placed without cardiopulmonary bypass under echocardiographic guidance and sized to reduce annular dimension and improve leaflet coaptation. Intraoperative MR was similarly reduced in both groups (2.9 ± 0.7 vs. 0.5±0.7 and 2.6 ± 0.9 vs. 05±0.7, respectively). Annular dimension was significantly reduced with both techniques, but short axis diameters and sphericity indices were significantly reduced only in the Coapsys patients. The study investigators concluded that Coapsys provided significantly greater LV remodeling as compared to standard mitral annuloplasty.
The TRACE study examined COpasys application in an off-pump setting in 30 patients (mean age 57.8 ± 7.9 years, 6 female, mean ejection fraction 35 ± 7%) with sustained MR grade 2 or more after undergoing concomitant CABG. There were no implant-related adverse events. All patients survived to 3 months with 27 reporting for follow-up. No chronic changes in relative device position were noted. MR grade improved from 3.0 ± 0.6 to 1.3 ± 1.0 and maximum MR jet area (cm²) improved from 7.6 ± 3.2 to 3.4 ± 2.0 at 3 month f/u (p<0.005). NYHA Classification improved from 2.6 ± 0.5 to 1.6 ± 0.5.
In conclusion, the Copasys system has yielded encouraging initial results in reducing functional mitral regurgitation in clinical trials. Additional clinical data are anticipated prior to potential FDA approval.
References
1. The Coapsys device to treat functional mitral regurgitation: In vivo long-term canine study. Inoue M, McCarthy P, Popovic Z, Doi K, Schenk S, Nemeh H, Ootaki Y, Kopcak M, Dessoffy R, Thomas J, Fukamachi K. Journal Thorac Cardiovasc Surg 2004; 127: 1068-77.
2. Changes in mitral annular and left ventricular dimensions and left ventricular pressure- volume relations after off-pump treatment of mitral regurgitation with the Coapsys device. Fukamachi K., Popovic Z., Inoue M., Doi K., Schenk S., Ootaki Y., Kopcak M., McCarthy P. E J Cardio-thoracic Surg 2004; 25: 352-357.
3. Off-Pump Mitral Valve Repair Using the Coapsys Device: A Pilot Study in a Pacing-Induced Mitral Regurgitation Model. Fukamachi K., Inoue M., Popovic Z., Doi K., Schenk., Nemeh H., Ootaki Y., Kopcak M., Dessoffy R., Thomas J., Bianco R., Berry J., McCarthy P. Ann Thorac Surg 2004;77: 688-93.
4. Reduction in Functional Mitral Regurgitation Using the Coapsys Device: Complete 3 Month Results of the TRACE (Treatment of Functional Mitral Regurgitation without Atriotomy or CPB Clinical Evaluation) Feasibility Trial. Mishra Y.,Mittal S., Metha Y., Trehan N. International Society of Minimally Invasive Surgery (ISMICS) 2005.
5. Intraoperative Outcomes of the Coapsys Annuloplasty System in a Randomized Evaluation (RESTOR-MV) of Functional Ischemic Mitral Regurgiation. Grossi E., Woo Y., Gangahar D., Laschinger J., Kress D., Caskey M. American Heart Association 2004.
