Short-Term Feasibility of Transseptal Mitral Valve Replacement in China

Abstract

Backgrounds: Significant mitral regurgitation (MR) is common worldwide, yet surgical correction rates remain low due to high-risk patient profiles. Transseptal mitral valve replacement (TSMVR) has emerged as a minimally invasive alternative, but its feasibility in Asian populations remains underexplored. Aims: This study assessed the short-term feasibility of the HighLife TSMVR system for treating symptomatic MR in China. Methods: This prospective study included seven centers in China, integrating data from multicenter and localized cohorts with identical inclusion criteria. Patients with symptomatic MR (≥ 3+) and high surgical risk were included, excluding those with unsuitable anatomy for the HighLife system. Preprocedural imaging was centrally adjudicated, and 30-day outcomes were analyzed using R software (version 4.4.0). Results: Twenty-two patients (median age 70.5 years; 45.5% male) underwent the procedure. The predicted median mortality risk was 6.39%, with secondary MR in 81.8% of cases. Technical success was 95.5% (21/22). Median durations of valve delivery, ring closure, transseptal puncture, and looping were 4.00, 8.50, 22.25, and 42.75 min, respectively and 22.73% cases of tele-proctoring. One patient required conversion to transcatheter aortic valve replacement, and two deaths occurred within 30 days. Significant improvements were observed in New York Heart Association class (p = 0.033) and MR severity (p < 0.001). Conclusions: The HighLife TSMVR system demonstrated safety and efficacy in treating symptomatic MR in high-risk Chinese patients, supporting its potential clinical applicability.