ABSTRACT
A novel transapical coaptation plate (TCP) device was developed and anchored by sutures in the mitral valve to treat functional mitral regurgitation. The objective of this study was to test efficacy of the TCP in an in vitro model. Eight fresh porcine mitral valves were mounted in a left heart simulator to simulate functional mitral regurgitation by means of annular dilatation and asymmetrical or symmetrical papillary muscle (PM) displacement. Six polyurethane TCPs in thickness of 6.4(#1), 4.8(#2), 3.2(#3) mm and hardness of durometer 30 A (H) and 30 OO(S),were fabricated and labeled as H1, H2, H3 and S1, S2, S3, respectively. These TCPs were anchored by the sutures in the mitral annulus and left ventricle apex, and tested. Steady backward flow leakage in a hydrostatic condition and regurgitant volume in a pulsatile flow were measured before and after implantation of the TCPs. Mean regurgitant volume fractions in the asymmetric PM displacement were reduced significantly from 59.1 to 37.2% for H1, 43.2% for H2, 35.9% for S1 and 34.2% for S2 (p < 0.021), after implantation of the TCPs. No significant reduction in mitral regurgitation was seen for H3 and S3 (p > 0.067). Mitral regurgitation was mild in the symmetric PM displacement, and was not significantly reduced after implantation of the TCPs. In conclusion, the TCP anchored by the sutures in the mitral annulus and left ventricle apex functions successfully as a plug in the mitral valve leaflet gap. The TCP with thickness equal to or greater than 4.8 mm is effective to reduce functional mitral regurgitation. The TCP hardness has no effect on difference in reduction of functional mitral regurgitation.