Why the study?
Contemporary self-expanding transcatheter heart valves have design refinements to reduce paravalvular leak and pacemaker implantation, but clinical outcomes after TAVR with these valves need characterization.
Do contemporary self-expanding valves (Navitor and Evolut PRO/PRO+/FX) provide safe and effective periprocedural and short-term outcomes in patients undergoing TAVR for severe aortic stenosis?
Meta-Analysis (n=21,349)
Yes
Do contemporary self-expanding valves (Navitor and Evolut PRO/PRO+/FX) provide safe and effective periprocedural and short-term outcomes in patients undergoing TAVR for severe aortic stenosis?
Absolute Event Rate: 1.5% vs 1.4%
p-value: p=0.63
Contemporary self-expanding valves (Navitor and Evolut PRO/PRO+/FX) for TAVR demonstrate high device success and low short-term mortality, though mild paravalvular leak and new pacemaker implantation remain frequent.
Comparable early outcomes support either Evolut or Navitor in TAVR; extends comparative evidence for contemporary SEV selection.
Background Contemporary self-expanding transcatheter heart valves (SEV) have incorporated design refinements to reduce paravalvular leak (PVL) and pacemaker implantation (PPI). We aimed to characterize clinical outcomes after transcatheter aortic valve replacement (TAVR) with contemporary SEVs in patients with severe aortic stenosis. Methods PubMed, EMBASE, and Scopus were searched through October 5, 2025, for studies reporting procedural, hemodynamic, and clinical outcomes for patients undergoing TAVR with the (1) Navitor or (2) Evolut PRO/ PRO+/ FX. Random-effects meta-analyses pooled single-arm event rates, stratified by SEV group, using the Freeman–Tukey double arcsine transformation. Between-platform differences were assessed using subgroup interaction testing. Results Fifty-two studies (n = 21,349; weighted mean age 82 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) 4.8%) were included. At 30 days, all-cause mortality was low among Evolut and Navitor cohorts (1.4% and 1.5%; p=0.63), and device success was high for both platforms (92.1% and 93.0%; p=0.73). Moderate or greater PVL occurred in 2.5% and 1.1% of Evolut and Navitor cohorts, respectively (p = 0.12), mild PVL occurred in 31.1% and 19.9% (p = 0.046), and new PPI occurred in 13.4% and 15.3%, respectively. Mean gradients remained low among Evolut and Navitor cohorts at 1 year (7.7 and 7.3 mmHg; p=0.65), while effective orifice area was higher among Evolut cohorts at 1 year (2.1 and 1.8 cm 2 ; p < 0.001) (p = p-interaction). Conclusions Navitor and Evolut PRO/PRO+/FX both demonstrated high device success, low mortality, favorable hemodynamic performance, and low rates of moderate or greater PVL at 1-year follow-up. Mild PVL and new PPI remained frequent. Observed comparative signals should be interpreted as indirect hypothesis-generating findings.
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Shaji et al. (2026) conducted a meta-analysis in severe aortic stenosis (n=21,349). Navitor vs. Evolut PRO/PRO+/FX was evaluated on 30-day all-cause mortality (p=0.63).
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