The Effect of a Novel Transcatheter Edge-to-Edge Mitral Valve Repair Device in a Porcine Model of Mitral Regurgitation.

Abstract

A new technique has been developed for treating mitral regurgitation (MR) via a transapical approach, which encompasses an easy-to-use leaflet clamp and a smaller-sized delivery system (14F-16F). We aimed to evaluate the effectiveness of this device in a porcine model of acute MR. Acute MR was induced in 36 anesthetized porcine subjects by severing the chordae supporting the corresponding segment of the leaflet. The ValveClamp system was then transapically implanted on the prolapsing segment under epicardial echocardiographic guidance. Echocardiographic assessments were performed before and after the transapical interventions. All of the animals were killed 30 days after the procedure to verify the proper location of the implanted devices. Epicardial echocardiography revealed severe MR (n = 26) or moderate to severe MR (n = 10) in the pig model of acute MR. Overt MR reduction was observed following the procedure through echocardiography; residual MR was absent in 10 cases, mild in 17 cases, and moderate in 9 cases. There was no evidence of mitral stenosis at the end of the procedure in terms of mitral valve area and mitral valve pressure gradient. Autopsy demonstrated that all ValveClamp devices were precisely placed to clamp the prolapsing segment of the mitral valve. Transapical implantation of the ValveClamp device under epicardial echocardiographic guidance was effective and safe in reducing acutely induced MR in this pig model. It is potentially applicable as a novel user-friendly transcatheter edge-to-edge mitral valve repair device for the treatment of MR in humans.