A Novel Polymer Film to Develop Heart Valve Prostheses

Abstract

Polymer heart valves are a promising alternative to bioprostheses, the use of which is limited by the risks of calcific deterioration of devitalized preserved animal tissues. This is especially relevant in connection with the increasingly widespread use of transcatheter valves. Advances in modern organic chemistry provide a wide range of polymers that can replace biological material in the production of valve prostheses. In this work, the main properties of REPEREN® polymer film, synthesized from methacrylic oligomers reinforced with ultra-thin (50 µm) polyamide fibers, are studied. The film structure was studied using scanning electron microscopy (SEM) and atomic force microscopy (AFM). The hydrophilicity and cytocompatibility with EA.hy926 endothelial cells were assessed, and a hemocompatibility evaluation was carried out by studying the platelet aggregation and adhesion upon contact of the REPEREN® with blood. The mechanical behavior and biocompatibility (subcutaneous implantation in rats for up to 90 days, followed by a histological examination) were studied in comparison with a bovine pericardium (BP) cross-linked with an ethylene glycol diglycidyl ether (DE). The results showed that REPEREN® films have two surfaces with a different relief, smooth and rough. The rough surface is more hydrophilic, hemo- and cytocompatible. Compared with the DE-BP, REPEREN® has a higher ultimate tensile stress and better biocompatibility when implanted subcutaneously in rats. The key properties of REPEREN® showed its potential for the development of a polymeric heart valve. Further studies should be devoted to assessing the durability of REPEREN® valves and evaluating their function during orthotopic implantation in large animals.