5-Year Follow-Up After Transcatheter Mitral Valve Replacement Using the Cardiovalve System

Abstract

Severe mitral regurgitation (MR) in high-risk patients often precludes surgical repair, and suboptimal anatomy may limit edge-to-edge repair. Transcatheter mitral valve replacement (TMVR) has emerged as an alternative; however, long-term durability data remain limited. We report a 75-year-old man with ischemic MR (Carpentier IIIb), treated with transfemoral TMVR using the Cardiovalve device within the Cardiovalve FIM study (NCT03958773). The procedure was successful, with no MR postprocedural and only minor periprocedural complications. At 5-year follow-up, the patient remained clinically stable (NYHA functional class I) with preserved valve function, and absence of degeneration, thrombosis, or left ventricular outflow tract obstruction. This represents the longest reported follow-up of Cardiovalve to date and suggests sustained clinical and hemodynamic benefit. This is the first report of a 5-year follow-up after transfemoral TMVR with Cardiovalve, demonstrating excellent durability and safety. Cardiovalve TMVR offers a promising long-term option for high-risk MR patients with sustained clinical and echocardiographic success over 5 years.