Transcatheter Mitral Valve Repair

Transcatheter mitral valve repair (TMVR) is an alternative to surgical therapy for mitral regurgitation (MR). MR is a common valvular heart disease that can result from a primary structural abnormality of the mitral valve (MV) complex or a secondary dilatation of an anatomically normal MV due to a dilated left ventricle caused by ischemic or dilated cardiomyopathy. Surgical therapy may be underutilized, particularly in patients with multiple comorbidities, suggesting that there is an unmet need for less invasive procedures for MV repair. Two devices, MitraClip™ and PASCAL™, have approval from the U.S. Food and Drug Administration for the treatment of severe symptomatic MR due to a primary abnormality of the MV (primary MR) in patients considered at prohibitive risk for surgery. MitraClip is also approved for patients with heart failure and moderate-to-severe or severe symptomatic secondary MR despite the use of maximally tolerated guideline-directed medical therapy. The Edwards SAPIEN 3 transcatheter heart valve has been approved by the U.S. Food and Drug Administration for transcatheter mitral valve-in-valve replacement (TMViVR) in patients with a failing surgical bioprosthetic mitral valve who are at high or greater risk for repeat surgery.