The NavigIIster: Transcatheter Aortic Valve Implantation With the Navitor Platform in Bicuspid Anatomy.

Background: Transcatheter aortic valve implantation (TAVI) for the treatment of bicuspid aortic valve (BAV) is still debated. Although several registries reported favorable outcomes with various transcatheter heart valves (THV) in BAV, there is no published data on the Navitor platform.

Aims: To provide preliminary data on the efficacy and the safety of the Navitor valve in BAV.

Methods: We retrospectively included patients who underwent TAVI using the Navitor valve (Abbott, Minneapolis, Minnesota, USA) for severe aortic stenosis in BAV anatomies, from October 2021 until August 2024. Patients were enrolled at six high TAVI volume centers. The endpoints were procedural device success and early safety, according to the VARC-3 criteria.

Results: A total of 47 patients were included in this registry. The mean age was 83.7 ± 7.9, and 66% of the patients were women. Bicuspid type 1 L-R fusion (72.3%) was the dominant anatomical subtype. A high device success rate was achieved: 91.5% in-hospital and 91.1% at 30-day follow-up, while early safety was 70.2% in-hospital and 66.7% at 30 days. No 30-day prosthesis-patient mismatch (PPM) and no ≥moderate paravalvular regurgitation (PVR) were observed at 30 days; meanwhile, rates of permanent pacemaker implantation (PPI) were not negligible (23.4% in-hospital and 26.7% at 30-day follow-up).

Conclusions: The Navitor THV appears to be a safe and effective treatment option for patients with severe bicuspid aortic stenosis. Larger registries and comparison with different platforms are required to validate these outcomes.