Transcatheter Aortic Valve Replacement With a Fully Retrievable Self-Expanding Dry-Tissue Valve: First-in-Man Study

Abstract

Contemporary self-expanding transcatheter aortic valve replacement (TAVR) devices are retrievable and repositionable at partial release, however, valve migration may occur during final release. The Venus-PowerX Valve is a novel self-expanding dry-tissue TAVR device which is retrievable at 100% full deployment. This first-in-man study sought to evaluate the feasibility and safety of the new TAVR device. The clinical outcomes and adverse events were assessed and reported according to the Valve Academic Research Consortium-3 criteria. A total of 25 patients with severe aortic stenosis (75.3 ± 5.3 years, 48.0% male, 52.0% bicuspid aortic valve) were enrolled. Acute technical success was achieved in 25 (100%) patients. Valve recapture at 100% full deployment was attempted in 2 patients due to suboptimal position or inappropriate valve size, and was successful in both. No patient required a second valve. At 30 days, device success was achieved in 88.0%. The reasons for unachieved device success included residual gradient (4.0%), moderate paravalvular leak (PVL, 4.0%) and VARC type 2 bleeding (4.0%). New permanent pacemaker was required in 5 (20.0%) patients. At 1-year follow-up, overall survival rate was 96.0%, there was no stroke, myocardial infarction, or cardiovascular rehospitalization. Mean aortic valve gradient improved significantly from 56.0 ± 17.9 mmHg to 11.6 ± 6.0 mmHg, and effective orifice area improved from 0.6 ± 0.2 cm² to 1.8 ± 0.4 cm²; 79.1% had none or trivial PVL. In conclusion, the novel fully retrievable Venus-PowerX Valve could enable highly predictable TAVR device positioning and produce satisfactory hemodynamic and clinical outcomes in both bicuspid and tricuspid aortic valve stenosis.