Clinical Outcomes of Transfemoral Transcatheter Mitral Valve Replacement: Results From the CHOICE-MI Registry

Transcatheter mitral valve replacement (TMVR) is an alternative for patients with mitral regurgitation (MR), but data on transfemoral (TF) devices are limited.

The aim of this study was to evaluate clinical, echocardiographic, and functional outcomes following TF TMVR in an international registry.

The CHOICE-MI (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) Registry included patients undergoing TMVR with dedicated devices at 41 international centers. This analysis included only TF TMVR. Outcomes were assessed per Mitral Valve Academic Research Consortium criteria. Echocardiographic, functional, and clinical outcomes up to 2 years were reported. The primary endpoint was a composite of all-cause mortality or heart failure hospitalization at 2 years. Predictors were identified using multivariable Cox regression.

A total of 124 patients (median age 79 years [Q1-Q3: 75-83 years], 50% women, median European System for Cardiac Operative Risk Evaluation II score 5.0% [Q1-Q3: 3.3-8.5]) underwent TF TMVR with 9 different devices. The leading MR etiology was primary MR (n = 49 [39.5%]), with mitral annular calcification in 12.9%. Technical success was achieved in 113 of 124 patients (91.1%), and procedural mortality was low (1 of 124 [0.8%]). Residual MR ≤1+ was achieved in 94.9% at discharge, with stable results at follow-up. The rates of cardiovascular mortality were 14.7% (95% CI: 7.9%-21.5%) and 20.3% (95% CI: 11.4%-29.1%) and of the primary endpoint 44.1% (95% CI: 30.6%-50.0%) and 52.4% (95% CI: 40.2%-62.1%) at 1 and 2 years, respectively, and NYHA functional class had significantly improved at 1- and 2-year follow-up. Atrial fibrillation was an independent predictor of the primary endpoint, whereas technical success was associated with survival.

TMVR using dedicated TF devices demonstrates favorable safety, durable MR reduction, and sustained functional improvement in high-risk patients. (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry [CHOICE-MI Registry]; NCT04688190).