A Semi-Stented and Chorded Mitral Valve Prosthesis: Design and Method of Chordal Setting and In Vitro Testing

Abstract

Mitral subvalvular apparatus plays an important role in mitral and ventricular dynamics by preserving annuloventricular continuity, known to be fundamental for ventricular function. While some proposed mitral valve prostheses designs do attempt to account for this relationship by using papillary flaps, they are not adjustable and do not mimic the native saddle shaped mitral annulus. Unfortunately, these designs are not versatile as their papillary flap lengths cannot be altered and the prostheses are unsuitable for percutaneous implantation. We address these issues through the design of a novel semistented and chorded mitral valve that better mimics the native mitral annulus, leaflets and chordae function and can be made from off-the-shelf biomaterials with the potential to be implanted percutaneously. We also propose a novel and reliable method to set the chordal lengths individually. Finally, we demonstrate the hydrodynamic performance of the valve, showing that it meets the minimum performance requirements stipulated by the international standard ISO 5840-3:2013.