Functional Competency of a Novel 2-Ply Vacuum-Pressed Biological Scaffold for Posterior Mitral Valve Repair

Objective This study assessed the feasibility of posterior mitral valve leaflet and subvalvular reconstruction in an acute porcine model using a novel 2-ply vacuum-pressed small intestinal submucosal extracellular matrix (SIS-ECM) patch. Methods Reconstruction was performed in an acute 80-kg porcine model (n = 7), using a novel 2-ply vacuum-pressed SIS-ECM (CorMatrix®) patch for posterior mitral reconstruction. Echocardiography and left ventricular pressure were assessed pre- and post-interventional. Sonomicrometry was used to evaluate the geometry and valve dynamics. Results The reconstructed mitral valves were all fully competent. The peak left atrial pressure at baseline and post-reconstruction was 9.9 (1.1) vs 9.9 (1.0) mmHg, p = 0.676, diff = 0.002 mmHg, 95% CI: [-1.06;1.05], and the mean trans-mitral pressure difference was 4.5 (2.3) vs 4.1 (2.3) mmHg, p = 0.063, diff = -0.40, 95% CI: [-2,73;1.93] The out-of-plane characteristics and subvalvular geometry of the mitral valve were preserved after reconstruction. Slight atrial bending of the reconstructed posterior leaflet and systolic annular ballooning were observed. Conclusions In an acute porcine model, we successfully reconstructed the posterior mitral valve and subvalvular apparatus using our modified 2-ply vacuum-pressed SIS-ECM patch. The bioscaffold demonstrated short-term durability in vivo, warranting further investigation of its long-term durability.