The National Coverage Decision for MitraClip in Functional Mitral Regurgitation

Abstract

Transcatheter edge-to-edge mitral valve repair has advanced the treatment of mitral regurgitation (MR). The MitraClip (Abbott Laboratories) remains the only transcatheter edge-to-edge mitral valve repair system approved by the US Food and Drug Administration and was studied as part of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial, 1 which showed a hazard ratio of 0.62 (95% CI, 0.46-0.82; P < .001) for 2-year all-cause death in patients with functional MR treated with MitraClip compared with medical therapy. This result led to the decision by the US Centers for Medicare and Medicaid Services to offer coverage for the procedure through a recently proposed national coverage decision (NCD). 2 However, the NCD criteria for coverage for MitraClip misses the mark in 2 very important ways: (1) it does not emphasize the importance of heart failure optimization by the direct involvement of a heart failure expert and (2) the NCD insists that patients with functional MR be deemed nonsurgical candidates. In our opinion, there are no data that patients with functional MR have ever benefited from isolated mitral valve surgical repair or replacement, and the insistence in the NCD that patients be examined by a surgeon face to face but not necessarily a heart failure expert is imprudent.