Why the study?
Comparative data among contemporary self-expanding transcatheter heart valve designs remain limited.
Does Navitor improve 1-year all-cause mortality compared to Evolut in patients undergoing transcatheter aortic valve replacement?
Cohort (n=2,673)
Yes
Does Navitor improve 1-year all-cause mortality compared to Evolut in patients undergoing transcatheter aortic valve replacement?
Answers are grounded in this paper and cite their sources.
Contemporary self-expanding TAVR platforms offer comparable 1-year clinical outcomes, though Evolut provides superior hemodynamic performance with lower transvalvular gradients.
Background Comparative data among contemporary self-expanding transcatheter heart valve designs remain limited. We compared clinical and hemodynamic outcomes following transcatheter aortic valve replacement (TAVR) using two leading contemporary platforms. Methods This multicenter cohort study utilized the AMTRAC registry to evaluate consecutive patients treated with either Evolut PRO/PRO+/FX or Navitor. The primary analysis employed a 1:1 propensity score-matched (PSM) cohort, utilizing multilevel mixed-effects models to adjust for center-level clustering. The primary endpoint was 1-year all-cause mortality. Results Of 2,673 patients, PSM yielded a balanced cohort of 1,200 patients. At 1-year, all-cause mortality was similar between groups (Navitor: 7.1% vs. Evolut: 9.2%; HR 0.75; 95% CI: 0.47–1.21; p=0.24). In-hospital mortality (0.8%), periprocedural stroke (2.3%), permanent pacemaker implantation (Navitor: 14.4% vs. Evolut: 15.9%; p=0.554), and paravalvular leak (p = 0.221) were comparable. Initial differences showing lower vascular and bleeding events with Navitor were completely attenuated after accounting for center-level clustering (vascular: p=0.838; bleeding: p=0.745). Conversely, post-procedural mean transaortic gradient was lower with Evolut (7.3 ± 3.9 mmHg vs. 8.6 ± 4.1 mmHg; p < 0.001), a hemodynamic advantage that remained highly robust after center adjustment (OR 2.43; 95% CI: 1.66–3.58; p < 0.001). Sensitivity analyses yielded consistent results. Conclusions Contemporary self-expanding platforms demonstrate comparable 1-year mortality and stroke rates. Periprocedural vascular and bleeding safety profiles are strongly modulated by center-specific clustering and practice variations. Conversely, the superior hemodynamic performance of the Evolut platform remains independent of institutional factors. These findings support an anatomy-driven approach to valve selection integrating patient profiles with institutional practices.
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Levi et al. (2026) conducted a cohort in Severe aortic stenosis (n=2,673). Navitor vs. Evolut PRO/PRO+/FX was evaluated on 1-year all-cause mortality (HR 0.75, 95% CI 0.47-1.21, p=0.24).
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