30-Day Outcomes of the Navitor transcatheter aortic valve implantation system from the NAVITOR CAPTAIN Register

Abstract Background The Navitor transcatheter aortic valve implantation (TAVI) system, developed by Abbott Inc., Illinois, USA, is an advanced successor to the Portico TAVI system. The Navitor Aortic valve bioprosthesis (NAV) is a self-expandable, intra-annular prosthesis designed to enhance TAVI procedures. It features the NaviSeal sealing cuff to minimize paravalvular leaks, ensures stable and precise placement, and maintains low gradients, facilitating access to small vessels and coronary arteries. Approved and CE certified in the European Union on May 25, 2021, its performance in real-world settings is still being evaluated. Objectives This study aims to report the 30-day safety and efficacy outcomes of the Navitor TAVI-system from the NAVITOR CAPTAIN Register following transfemoral TAVI in routine clinical practice. Methods This prospective, single-arm, multicenter registry included 306 patients with symptomatic severe aortic stenosis treated using NAV across four centres in Germany between June 2021 and November 2024. The primary outcomes were all-cause mortality, cardiovascular and device-related mortality, device success, technical success, early safety, and other post-TAVR events as defined by the safety criteria of the Valve Academic Research Consortium 3 (VARC 3) at 30 days. Pre- and post-procedure echocardiographic and angiographic evaluations of the hemodynamics of the novel NAV were also done. Results The mean age of the cohort was 82 ± 5.96 years; 61.8% were female. The mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score was 5.4 ± 3.7, and the EuroSCORE II was 4.49 ± 3.8. Technical and device success rates were achieved in 97.7% and 94.1% of cases, respectively. Early safety was reported in 79.9% of patients. At 30 days, all-cause mortality was 2.3%, cardiovascular mortality was 1.3%, and disabling stroke occurred in 1,6% of patients. 13.4% of patients required a new pacemaker implantation. Significant hemodynamic improvements were detected; the aortic valve area (AVA) increased from 0.74 ± 0.17 cm² to 2.02 ± 0.7 cm² (p 0.001), and the mean aortic valve mean pressure gradient (AV-MPG) was decreased from 39 ± 15 mmHg to 7.1 ± 3.2 mmHg (p 0.001). Conclusions The NAVITOR CAPTAIN Register has presented promising results for the intra-annular self-expanding NAV, showing excellent procedural success and favourable safety and efficacy profiles for the Navitor TAVI-system at 30 days. With significant hemodynamic improvements contrary to previously known intra-annular transcatheter heart valves (THV) and low rates of mortality and complications, these outcomes provide a strong foundation for further exploration and application of the Navitor TAVI-system.