Background:High surgical risk may preclude mitral valve replacement in many patients. Transcatheter Mitral Valve Replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients.

Objective:This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study (EFS) in patients with ≥ moderate-severe MR.

Methods:The EFS is a multi-center, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to MVARC criteria.

Results:Thirty-three patients, enrolled at 9 U.S. sites between February 2020-August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean STS-PROM for MV replacement was 5.3%. Thirty-one patients were successfully implanted (93.9%). Median post-procedural hospitalization length of stay was 5 days and 87.9% of patients were discharged to home. At 30 days there were no deaths or strokes; 8 patients had major vascular complications (24.2%) none required surgical intervention; there were 4 cases of venous thromboembolism all successfully treated without sequelae; and 1 patient had MV re-intervention for severe LVOT obstruction. At 1-year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, no/trace paravalvular leak in all patients, median (Q1, Q3) mitral valve mean gradient was 4.6 (3.9, 5.3) mmHg, and 91.7% of survivors were in NYHA Class I/II with a median 11.4-point improvement in KCCQ overall summary scores.

Conclusion:The early benefits of the Intrepid Transfemoral Transseptal TMVR System were maintained up to 1 year with low mortality, low re-intervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.