TAVR Valve Face-Off Reveals Tradeoffs in Safety and Function

The NAVULTRA registry, the first large-scale, multicenter, observational head-to-head comparison of two modern intra-annular transcatheter heart valves—the self-expanding Navitor (Abbott) and the balloon-expandable SAPIEN 3 Ultra (Edwards Lifesciences)—sheds light on critical differences in clinical and hemodynamic performance at 1 year after transcatheter aortic valve replacement (TAVR).

Although both valves share intra-annular leaflet positioning, their design and clinical impact differ. The Navitor, a self-expanding valve with a dedicated outer cuff to reduce paravalvular leak (PVL), was designed to improve hemodynamics and preserve coronary access. The SAPIEN 3 Ultra builds on the SAPIEN 3 platform with an enhanced outer skirt aimed at minimizing PVL.

The NAVULTRA registry included 3,878 patients undergoing transfemoral TAVR between 2018 and 2024, yielding 1,363 matched patient pairs analyzed after propensity score adjustment. The primary end points—1-year all-cause mortality and a composite of mortality, disabling stroke, and hospitalization for heart failure—were similar between groups. Mortality occurred in 9.7% of Navitor recipients and 9.9% of those treated with SAPIEN 3 Ultra (hazard ratio [HR], 1.08; P=0.585), and the composite outcome occurred in 13.6% versus 12.6%, respectively (HR, 1.19; P=0.218).

However, secondary outcomes revealed clinically meaningful differences. Patients treated with the Navitor had higher rates of new permanent pacemaker implantation (20.6% vs 10.6%; HR, 2.14; P<0.01), hospitalization for HF (4.6% vs 2.8%; HR, 1.69; P=0.03), and mild or greater PVL (43.3% vs 26.1%; odds ratio [OR], 1.78 for mild PVL; OR, 3.92 for moderate or worse; both P<0.01). These findings raise concern about the downstream impact of conduction disturbances and regurgitation, both of which have been linked to adverse long-term outcomes.

Although the Navitor was associated with lower mean transvalvular gradients at discharge (7.9 mm Hg vs 11.8 mm Hg; P<0.01), the absolute difference was less than 4 mm Hg. Whether this modest improvement in hemodynamics translates into meaningful clinical benefit remains unclear, especially in light of higher morbidity from conduction abnormalities, paravalvular leak, and HF readmissions.

The results suggest that although both intra-annular valves offer similar short-term survival, the Navitor’s increased rates of pacemaker implantation, PVL, and hospitalization for HF may offset its modest hemodynamic advantages. Moreover, the latest iteration of the Sapien platform,  SAPIEN 3 Ultra Resilia, offers improved hemodynamics over SAPIEN 3 Ultra. These findings support the selection of devices based on individual patient anatomy and risk profile but remain exploratory, given their retrospective nature. Ongoing trials such as ENVISION (NCT05932615) will further clarify the long-term performance and optimal role of these platforms in TAVR therapy.

Reference

Cannata S, et al. Transcatheter aortic valve replacement with intra-annular self-expanding or balloon-expandable valves: the multicenter international NAVULTRA registry. JACC Cardiovasc Interv. 2025;xx(xx):xx-xx. doi:10.1016/j.jcin.2025.03.015