Clinical outcomes of second-generation intra-annular self-expanding transcatheter heart valve in an all-comers population with severe aortic valve disease

Abstract Background and Aims The Navitor™ transcatheter aortic valve implantation (TAVI) system is a second-generation intra-annular self-expanding device featuring NaviSeal™ technology for paravalvular leak (PVL) prevention. Real-world data in diverse populations remain limited. We aimed to evaluate 30-day and 1-year outcomes of the Navitor TAVI system in a large all-comers population, including challenging anatomies traditionally associated with suboptimal results. Methods and Results This retrospective, multicenter registry (NAVICORE—NAVItor Collaborative Outcomes REgistry) included all consecutive patients (N = 736) undergoing TAVI with Navitor at three high-volume European centres between July 2021 and October 2024 (age: 80.2 ± 6.6 years, 47.2% female, 68.3% low surgical risk). Outcomes were assessed using Valve Academic Research Consortium-3 criteria. The technical success rate was 98.4%. The primary endpoint was a composite of all-cause mortality, disabling stroke, ≥moderate paravalvular leak (PVL), and valve re-intervention. Freedom from the primary endpoint at 30 days was 94.7%. At 12 months, freedom from death or disabling stroke was 89.3% and modified clinical efficacy was 81.1%. The mean transprosthetic gradient was 8.6 ± 4.9 mmHg at 1 year with an effective orifice area of 2.1 ± 0.5 cm2. More than moderate PVL occurred in 1.9% post-procedure and 1.6% at 12 months. In subgroup analyses, device success was 92.4% in severely calcified aortic stenosis, 87.1% in bicuspid valves, and 92.2% in small annuli <23 mm. Permanent pacemaker implantation was noted in 17.3% of pacemaker-naive patients. Conclusions In the NAVICORE registry, the Navitor intra-annular TAVI system demonstrated high procedural success, favourable haemodynamics and low PVL rates supporting its use across a wide range of clinical and anatomical scenarios.