Short-Term Feasibility of Transseptal Mitral Valve Replacement in China

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.

This study assessed the short-term feasibility of the HighLife TSMVR system for treating symptomatic MR in China.

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).

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).

The HighLife TSMVR system demonstrated safety and efficacy in treating symptomatic MR in high-risk Chinese patients, supporting its potential clinical applicability.