TMVR outcomes in severe MR patients persist up to 2 years

Transcatheter mitral valve replacement (TMVR) in patients with severe symptomatic mitral regurgitation (MR) has sustained impact on severity of MR, reduction in heart failure hospitalization (HFH), and improvement in symptom through 2 years, a study has shown. Moreover, the first 3 months after the procedure show the highest all-cause mortality and need for HFH.

The investigators sought to examine the safety and effectiveness of TMVR in the first 100 high-surgical-risk patients with severe MR enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System, an open-label, nonrandomized, prospective study of transapical TMVR, through a 2-year follow-up.

Patients (aged 74.7±8.0 years, 69.0 percent male) had symptomatic (66.0 percent New York Heart Association [NYHA] functional class III or IV) grade 3+ or 4+ MR that was secondary or mixed in 89 (89.0 percent). Ninety-seven patients (97 percent) had a successful prosthesis implantation.

All-cause mortality was 39.0 percent at 2 years, of which 17 (43.6 percent) occurred during the first 90 days. HFH decreased from 1.30 to 0.51 event per year 2 years after TMVR, and the majority of surviving patients (93.2 percent) had no MR at follow-up. Notably, no patient had more than one MR.

The improvement in symptoms at 1 year (88.5 percent NYHA functional class I or II) persisted through 2 years (81.6 percent NYHA functional class I or II).

The left ventricular ejection fraction among survivors was 45.6±9.4 percent at baseline and 39.8±9.5 percent at 2 years (p=0.0012), while the estimated right ventricular systolic pressure dropped from 47.6±8.6 to 32.5±10.4 mm Hg (p<0.005).

“TMVR is feasible for selected patients with severe MR who are poor candidates for valve surgery,” the investigators noted.