A novel user-friendly transcatheter edge-to-edge mitral valve repair device in a porcine model.

OBJECTIVES

The present study was performed to evaluate the feasibility and safety of the ValveClamp system for transcatheter edge-to-edge mitral valve repair in a porcine model.

BACKGROUND

The ValveClamp system is a novel, transapically delivered edge-to-edge mitral valve repair system designed for ease of operation.

METHODS

Thirteen young adult swine were enrolled in the study. The procedure was performed via the transapical approach under epicardial echocardiography guidance.

RESULTS

The acute procedure success rate was 92.3% (12/13). The catheter manipulation time was just 18.5 ± 8.2 min. Four pigs were explanted on the 14th day after the procedure. One pig died at the 20th day because of pneumonia. The other eight pigs lived to the study endpoint (140 days). No pig had severe mitral valve dysfunction. The gross observation showed that the clamp device was securely attached and created a double-orifice mitral valve in all pigs except the failed one. In the eight pigs living to the endpoint, the clamp device was noted to be completely endothelialized. None of the 13 pigs developed infective endocarditis, thrombosis, thromboembolism, or valve impairment. In two pigs for which mitral regurgitation (MR) was created, the degree of MR was reduced from severe to trace after the device implantation.

CONCLUSIONS

It was feasible and safe to use ValveClamp to perform a catheter-mediated edge-to-edge mitral valve repair in a porcine model. This system is potentially applicable as a novel user-friendly system for the treatment of MR.