A new device to treat mitral valve regurgitation: a proof of concept in bench test study.

ABSTRACT

Mitral valve repair is typically performed by implanting a ring-like device at the valve annulus to reshape the annulus and to improve leaflet coaptation. In most cases, some additional procedures are needed, including leaflet resection and artificial chordae implantation. However, artificial chordae implantation could be technically challenging and postoperative left ventricular remodeling could increase the risk of recurrent mitral regurgitation. We propose an innovative annular device made of chromo-cobalt, finalized not only to reshape the annulus but also to enable anchoring of leaflets to a fixed intraventricular structure. Durability evaluation of the device was tested by applying eight radial force vectors equally spaced along the ring and related fatigue analysis. To evaluate the efficacy of the mitral valvuloplasty using the tested ring, the device was implanted in five adult swine hearts. Functional analysis of the ring was performed by measuring left ventricular pressure and fluid volume loss, following implantation in normal and dysfunctional mitral valve leaflets. Both fatigue and functional analysis showed satisfactory and promising results in terms of durability and efficacy of mitral valve repair. Because of its favorable durability and functional characteristics this device appears promising and provides good results in terms of valve competence, thus avoiding both manipulations of papillary muscles and interference in left ventricular hemodynamics. However, an in vivo test is mandatory to fully understand the impact of the device on subvalvular apparatus.