Comparative midterm results of surgical mitral valve replacement and transcatheter mitral valve replacement with the Tendyne System.

OBJECTIVES

To compare the midterm clinical and echocardiographic outcomes of high-risk patients who underwent surgical mitral valve replacement (SMVR) or transcatheter mitral valve replacement (TMVR) with the Tendyne System in a single-center setting.

METHODS

The study included all consecutive high-risk patients who underwent TMVR or SMVR at the University of Pisa, Pisa, Italy, between March 2018 and December 2023. The primary outcome was cardiovascular (CV) mortality at follow-up (FU), whereas secondary outcomes were overall mortality and rehospitalization for heart failure at FU.

RESULTS

We included 30 patients who underwent TMVR and 50 who underwent SMVR. Although the European System for Cardiac Operative Risk Evaluation II and Society of Thoracic Surgeons scores were similar, patients who underwent TMVR were older and had worse renal function and left ventricular ejection fraction (LVEF, 41.80 ± 13% and 56.89 ± 10.23%). The 30-day CV mortality was lower in the TMVR group (P = .055). Over a median FU of 1.9 (0.8-3.4) years, the overall mortality was 37.5% and 50% in the SMVR and TMVR groups, respectively (P = .277), whereas CV mortality was 25% and 33%, respectively (P = .496). New hospitalizations for heart failure were similar between the 2 groups (P = .352). Univariate analysis showed no impact of procedure type on CV (hazard ratio, 1.57; 95% confidence interval, 0.66-3.73, P = .311) and overall survival (hazard ratio, 1.67, 95% confidence interval, 0.82-3.41, P = .157). Mild paravalvular leak rate was low in both groups at discharge and FU. In both groups, the mean transmitral gradient was low at discharge and significantly decreased in the TMVR group during FU. In the TMVR group, LVEF did not change after the procedure (Δ pre-post -16 ± 28% P = .111) and then remained stable at FU (Δ post-FU -0.09 ± 17%, P = .695), whereas in the SMVR group, LVEF decreased after surgery (Δ pre-post 7 ± 19%, P = .031) to slightly improve over FU (Δ post-FU 7 ± 21%, P = .202). Right ventricular function did not change at any point in either group. In the SMVR group, patients experienced more tricuspid regurgitation worsening than those in the TMVR group (42% vs 15%, P = .101).

CONCLUSIONS

SMVR and TMVR showed similar early and midterm clinical and echocardiographic outcomes in a high-risk population. However, TMVR resulted in a lower postoperative complication rate and faster recovery. Therefore, TMVR might be a possible alternative to surgery for selected high-risk patients.