2-Year Outcomes After Transcatheter Mitral Valve Replacement.

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.