2-Year Outcomes After Transcatheter Mitral Valve Replacement

Abstract

Objectives: This study sought to determine late (2-year) outcomes following transcatheter mitral valve replacement (TMVR) with the FORTIS valve (Edwards Lifesciences, Irvine, California).

Background: No data exist on long-term clinical outcomes following TMVR in patients with severe native mitral regurgitation (MR).

Methods: This multicenter registry included consecutive patients with severe MR who underwent TMVR with the FORTIS valve under a compassionate clinical use program. Clinical and echocardiographic data were collected at baseline, 30-day, and 1- and 2-year follow-up.

Results: Thirteen patients (71 ± 8 years, 10 men, logistic European System for Cardiac Operative Risk Evaluation score = 23.7 ± 12.1%) with severe MR were included. MR was of ischemic origin in most (76.9%) patients, and the mean left ventricular ejection fraction was 34 ± 9%. Technical success was achieved in 10 patients (76.9%), and 5 patients (38.5%) died within the 30 days following the procedure. At 30-day follow-up, mean transmitral gradient was 3 ± 1 mm Hg, and there were no cases of moderate-severe residual MR or left ventricular outflow tract obstruction. Two patients died during the follow-up period due to terminal heart failure, leading to an all-cause mortality rate of 54% at 2-year follow-up. At 2-year follow-up, all patients but 1 were in New York Heart Association functional class II, and there were no cases of valve malfunction (increasing gradients or MR recurrence). Computed tomography exams performed at 2-year follow-up in 3 patients showed no valve prosthesis fractures or displacement.

Conclusions: TMVR with the FORTIS valve was feasible. MR reduction after TMVR was maintained at 2-year follow-up and no late device-related events were observed.

Keywords: heart failure; mitral regurgitation; transcatheter mitral valve replacement.