Reduction of mitral regurgitation using the Coapsys device: a novel ex vivo method using excised recipients' hearts.

The purpose of this study was to evaluate the ex vivo effects of the Coapsys device upon functional mitral regurgitation (MR) in human hearts. We used seven excised hearts from patients who underwent cardiac transplantation. All patients had functional MR of grade 2 or greater associated with dilated (n = 3) or ischemic (n = 4) cardiomyopathy. After the aortic valve was removed, the left ventricle was pressurized from the aorta with saline at a constant pressure. The degree of MR was then subjectively graded from the opened left atrium (from 0 to 4). The last three studies included volumetric measurements of MR. By tightening the device, the mean MR grade was reduced from 3.3 +/- 0.8 to 1.1 +/- 0.4 (p = 0.0002). In the quantitative analysis, mean regurgitation volume was reduced from 1,108 +/- 1,134 ml/min to 236 +/- 89 ml/min (p = not significant). The mitral annular septal-lateral dimension decreased from 2.0 +/- 0.3 cm to 1.6 +/- 0.5 (p = 0.043). The Coapsys device reduced functional MR in the ex vivo study using excised dilated hearts.