Transcatheter Mitral Valve Replacement Using Contemporary Dedicated Devices: A Systematic Review and Meta-Analysis

Abstract

Background

Dedicated transcatheter mitral valve replacement (TMVR) devices have emerged as a promising strategy for treating mitral regurgitation (MR) in high-risk patients with complex native valve anatomy. Early experience spans multiple devices utilizing both transapical and transseptal access. The aim of this study was to evaluate procedural, 30-day, and midterm outcomes of TMVR with contemporary dedicated mitral devices in patients with native MR.

Methods

A systematic search of Medline, Embase, and Cochrane Library (January 2010-January 2025) was conducted. Pooled outcome estimates were derived using random-effects models, excluding legacy devices and cases of mitral stenosis.

Results

Thirteen studies (914 patients) were included in the analysis. The mean age was 75.4 years, and 69.8% had functional or mixed MR. Technical success was 96.3%. Residual MR was mild or less in 99% of patients at 30 days and 98% at 1 year. All-cause mortality was 11.0% at 30 days and 26.4% at 1 year. Over a mean follow-up of 12.1 months, rates of heart failure (HF) hospitalizations, cerebrovascular events, and valve reinterventions were 26.2, 5.6, and 6.0 events per 100 patient-years, respectively. Compared with transseptal access, transapical showed higher 30-day major bleeding (19.2% vs. 10.4%, p = 0.03) and all-cause mortality at 30 days (14.0% vs. 4.7%, p ​<0.001) and 1 year (27.7% vs. 13.1%, p = 0.005). Midterm rates of HF readmissions, major bleeding, and valve reinterventions were comparable between access routes.

Conclusions

Contemporary dedicated TMVR devices demonstrate high technical success and sustained MR reduction. Transseptal access is associated with lower morbidity and mortality. Further research is needed to improve longer-term mortality and HF hospitalizations following TMVR with dedicated mitral devices.