Clinical Outcomes of a Dedicated TAVR Device for Native Aortic Regurgitation: Insights From a Multicenter Real-World Experience

BACKGROUND: The JenaValve Trilogy Transcatheter Heart Valve System (Trilogy) is a CE-marked transcatheter aortic valve replacement device designed for the treatment of symptomatic aortic regurgitation. Despite its unique indication, data from large cohorts remain limited. This study aimed to evaluate procedural characteristics and clinical outcomes in all-comers patients with symptomatic aortic regurgitation undergoing transfemoral transcatheter aortic valve replacement with the Trilogy valve. METHODS: This multicenter retrospective analysis included patients with symptomatic aortic regurgitation who underwent Trilogy implantation between June 2021 and June 2025 at 8 European centers. Baseline, procedural, and follow-up data were collected according to local protocols, and outcomes were defined per VARC-3 (Valve Academic Research Consortium-3). RESULTS: A total of 363 patients (median age, 81 years [interquartile range, 75-84]; 45% female patients; median European System for Cardiac Operative Risk Evaluation II, 3.4%; median left ventricular ejection fraction, 50%) were included. Transfemoral access was used in 359 (99%), and technical success was achieved in 98%. Valve embolization occurred in 5 patients: 2 managed with a second valve, 2 surgically, and 1 required valve-in-valve reintervention. Two additional technical failures involved hemodynamic instability and a vascular complication. At discharge, 86% had none or trace leakage, and the mean transvalvular gradient was 4 mm Hg. Permanent pacemaker implantation was required in 22%. In-hospital mortality was 0.3%. At 30 days, functional status had improved markedly, with 88% of patients in New York Heart Association class I or II. Kaplan-Meier estimated all-cause mortality at 6 months, 1, 2, and 3 years was 4.1%, 7.0%, 15.8%, and 25.9%, respectively, among patients with available follow-up. CONCLUSIONS: In this large analysis, transfemoral transcatheter aortic valve replacement with the Trilogy valve demonstrated high procedural success and favorable hemodynamic valve performance. These findings are encouraging and suggest a potential role for the Trilogy valve in patients with symptomatic aortic regurgitation who are unsuitable for surgery.