First Dual-Center Clinical Experience With the Premounted Vienna Transcatheter Aortic Valve System: A Prospective Feasibility and Safety Study

Background: Transcatheter aortic valve implantation has become the preferred treatment for many patients with severe aortic stenosis. The Vienna valve is a next-generation, premounted self-expandable transcatheter heart valve designed to simplify procedural workflow and enhance deployment accuracy. Objective: To evaluate the feasibility, procedural safety, and early clinical and hemodynamic outcomes of the Vienna transcatheter aortic valve system in patients with severe symptomatic aortic stenosis. Method: This prospective, dual-center observational study enrolled 13 consecutive patients with severe symptomatic aortic stenosis who underwent transfemoral TAVI using the Vienna valve between February 2024 and July 2025. Clinical and echocardiographic assessments were performed at baseline, post-procedure, and during follow-up at 1 and 6 months. Primary endpoints were mortality, stroke, bleeding, pacemaker requirement, rehospitalization, and functional improvement. Outcomes were defined according to Valve Academic Research Consortium-3 criteria. Result: The mean patient age was 72 ± 9 years, and the mean EuroSCORE II was 6.7 ± 0.3%. Procedural success was achieved in 92.3% of cases. One intraprocedural cardiovascular death occurred due to valve infolding with cardiac tamponade. Mean transvalvular gradients decreased from 45.2 ± 19.0 mmHg at baseline to 11.7 ± 8.0 mmHg post-procedure and remained stable at 6 months. One patient (7.7%) required permanent pacemaker implantation during follow-up. No strokes, major bleeding events, or valve-related rehospitalizations were observed through 6 months. Conclusion: In this initial dual-center experience, the Vienna premounted self-expandable valve demonstrated encouraging feasibility, acceptable early safety, and sustained hemodynamic performance. Larger studies with longer follow-up are warranted to confirm long-term outcomes and durability.