Transcatheter Aortic Valve Replacement in Patients With Symptomatic, Severe Aortic Regurgitation: 1-Year Outcomes of the J-Valve Transfemoral Early Feasibility Study.

BACKGROUND: Clinically significant native aortic regurgitation (AR) increases with age. Surgical aortic valve replacement has been the only curative guideline-recommended therapy, while transcatheter options remain limited by anatomic constraints. METHODS: The J-Valve early feasibility study (NCT06034028) evaluated the safety and effectiveness of transfemoral J-Valve transcatheter heart valve implantation in patients with symptomatic, severe native AR. The prospective single-arm study enrolled 25 patients with symptomatic, severe, native AR deemed high risk for surgical aortic valve replacement at 8 centers. Clinical and echocardiographic assessments were performed at baseline, 30 days, 6 months, and 1 year with independent core laboratory and clinical events committee adjudication. The primary effectiveness end point was a non-hierarchical composite of all-cause mortality or disabling stroke at 30 days. RESULTS: Mean age was 80.6 ± 4.3 years; 76% were male; 100% were New York Heart Association (NYHA) class II/III; mean Society of Thoracic Surgeons-Predicted Risk of Mortality (STS-PROM) score was 5.6 ± 4.5%. Successful implantation occurred in 92% (23/25). The primary end point occurred in 2 patients (8.0%). All-cause mortality was 4.0% at 30 days and 1 year, with no cardiovascular-related deaths. Two strokes (1 disabling) (8.2%) and 2 new pacemaker implantations (10%) occurred within 30 days. At 1 year, none/trace AR was present in 95.5% (21/22) and mild AR in 4.5% (1/22), with a mean gradient of 5.5 ± 1.7 mm Hg, and an effective orifice area of 2.48 ± 0.53 cm2. Reverse left ventricular (LV) remodeling was evident at 30 days with sustained reductions in LV end-diastolic and end-systolic volume indices to 1 year. NYHA class improved in 72.7% (16/22) of patients, with 95.5% (21/22) in NYHA class I/II at 1 year. CONCLUSIONS: This study demonstrates preliminary safety and effectiveness of the J-Valve in high-risk patients with severe AR, with favorable 1-year outcomes and stable hemodynamic performance.