A prospective, single-center, single-arm, and open-design study was performed to evaluate the feasibility and safety of transseptal transcatheter mitral valve replacement in the treatment of severe mitral regurgitation. Patients with symptomatic moderate-severe or severe mitral regurgitation at high-surgical risk and anatomically appropriate for the HighLife transseptal mitral valve replacement (TSMVR) system in West China Hospital, Sichuan University from December 2021 to August 2022 were enrolled. Four patients (1 male and 3 females) with severe mitral regurgitation were included, with a median age of 68.5 (64.0-77.0) years and a median Society of Thoracic Surgeons (STS) score of 8.1% (6.4%-8.9%). Technical success was achieved in all the patients. There was no residual mitral regurgitation, paravalvular leakage, or left ventricular outflow tract obstruction. Three major cardiovascular and cerebrovascular adverse events occurred within 30 days after the procedure, including ventricular tachycardia, iatrogenic atrial septal defect closure, and heart failure readmission. The current study preliminarily demonstrates that transcatheter mitral valve replacement using the HighLife system via the transseptal approach for severe mitral regurgitation is feasible and relatively safe.
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