30-day and 1-year outcomes of Navitor transcatheter aortic valve in low- or intermediate-risk patients

Background The Navitor transcatheter aortic valve is a self-expanding, intra-annular valve indicated for patients with severe aortic stenosis (AS) at high or extreme surgical risk. Objectives The aim of this study was to assess the safety and effectiveness of the Navitor valve in severe AS patients at low or intermediate surgical risk. Methods VANTAGE (Evaluation of TAVR Using the Navitor Valve in a Global Investigation) is a prospective, single-arm, multicenter study. The primary effectiveness endpoint was moderate or greater paravalvular leak (PVL) at 30 days; the primary safety endpoint was all-cause mortality or fatal stroke or stroke with disability at 12 months. Both endpoints were assessed against a performance goal (PG) when the sample size requirements were met. Clinical events and imaging assessments were evaluated by an independent committee and a core laboratory, respectively. Results A total of 434 patients (203 at low risk, 231 at intermediate risk) underwent Navitor implantation between July 2021 and November 2024 across 36 sites in Europe, Australia, and Israel. The mean Society of Thoracic Surgeons Predicted Risk of Mortality scores were 1.5% and 2.6% for the low- and intermediate-risk groups. Technical success was 97.0%, with no procedural mortality. At 30 days, no patients had moderate or greater PVL (0%), which was significantly lower than the PG of 6.6% (P < 0.0001). In the first 262 patients with 12-month follow-up completed, the rate for all-cause mortality or fatal stroke or stroke with disability was 2.3%, also significantly lower than the PG of 11.3% (P < 0.0001). Sustained hemodynamic performance (mean gradient 8.0 mm Hg, effective orifice area 1.8 cm²) was seen through 12 months. Conclusions The Navitor valve demonstrated favorable safety and performance outcomes at 12 months, supporting its expansion to low- and intermediate-risk populations.