30-Day Outcomes of a Single-Stage Transfemoral Mitral Valve Replacement System in Severe Mitral Valve Disease

Background Transfemoral (TF) transcatheter mitral valve replacement (TMVR) has emerged as a therapeutic alternative for the treatment of patients with symptomatic mitral valve disease in patients with high surgical risk. Objectives The aim of this study was to present 30-day outcomes among all patients included in both the early feasibility study (EFS) and compassionate use experience using the Cephea TF TMVR system. Methods Thirty-one consecutive high-risk patients with symptomatic mitral valve disease were enrolled under an EFS protocol (n = 24) or treated under compassionate use (n = 7) with TF TMVR from August 2021 to June 2024. The cohort mean age was 75.0 ± 8.1 years, with mean Society of Thoracic Surgeons Predicted Risk of Mortality of 6.4% ± 2.9%. Procedural outcomes and survival through 30 days were reported for all patients; additionally, subjects enrolled in the EFS had comprehensive follow-up visits including independent echocardiographic core laboratory measurements. Results All patients had mitral regurgitation (MR) grade ≥III (93.5%) or isolated mitral stenosis (6.5%); 25.8% had severe mitral annular calcification. The prosthetic valve was implanted in 96.8% of attempted subjects (30 of 31), with a mean device time of 56 ± 32 minutes. One subject was converted to surgical bioprosthetic mitral valve implantation. There were no procedural deaths or strokes. The primary safety endpoint of 30-day survival was achieved in 97% of patients (30 of 31); the primary efficacy endpoint of MR reduction to mild or less was achieved in 100% of patients with evaluable echocardiograms (27 of 27). Conclusions TF TMVR in patients with complex anatomies achieved a high rate of implantation success, low 30-day mortality, and no significant residual MR.