Early Safety and Feasibility Study of a Novel Transcatheter Aortic Valve With Polymeric Leaflets

Transcatheter aortic valve replacement is a promising alternative treatment for patients with severe aortic stenosis (AS), but uncertainties remain regarding its long-term durability.

This study aimed to evaluate the safety and feasibility of Sikelia transcatheter heart valve with polymeric leaflets in AS.

In this first-in-human, prospective, nonrandomized, single-arm, multicenter study, patients with severe symptomatic AS eligible for the novel valve were recruited. Clinical outcomes and hemodynamic performance were reported at discharge and 30-day, 6-month, and 1-year follow-up.

Twelve patients (73.75 ± 7.28 years, 25% female, mean Society of Thoracic Surgeons score 4.51% [4.07%-4.87%], 66.67% bicuspid valve) were enrolled. Procedural success was achieved in 83.33% (1 fully device retrieval and 1 death due to coronary obstruction). All patients successfully underwent transcatheter aortic valve replacement were in NYHA functional class I/II at the 30-day follow-up, and significant improvement was shown in 6-minute walk distance and Kansas City Cardiomyopathy Questionnaire score (all P < 0.001). At 1 year, the effective orifice area (2.31 ± 0.33 cm² vs 0.82 ± 0.14 cm²) and mean pressure gradient (6.33 ± 2.54 mm Hg vs 47.50 ± 13.82 mm Hg) improved substantially, so did those in bicuspid patients (all P < 0.001). No moderate/severe paravalvular leakage was recorded, and computed tomography scans revealed no evidence of subclinical leaflet thrombosis during follow-up. After discharge, no patients reported death, stroke, new pacemakers, or valve-related reintervention.

The preliminary outcomes of the novel transcatheter heart valve demonstrated a favorable hemodynamic performance with an acceptable safety profile at 1 year. Long-term follow-up is warranted to assess its durability in treating patients with AS.