The HERA-TAVI study is an international multicenter registry that compared the clinical and hemodynamic outcomes of contemporary self-expanding transcatheter heart valves with intra-annular (IA) and supra-annular (SA) designs. The primary objective was to evaluate 30-day and 1-year outcomes between the new-generation platforms Navitor/Navitor Vision (IA) and Evolut FX/FX+ (SA). The primary endpoint was a composite of all-cause mortality, disabling stroke, or hospitalization for heart failure.
The study included 2,607 patients treated between June 2021 and April 2025. To minimize baseline differences between groups, propensity score matching (PSM) was performed, resulting in 892 well-balanced patient pairs. The mean age was 81 years, most participants were women, and the average STS score was 4.2.
Regarding the results, no significant differences were observed in the composite endpoint of all-cause mortality, disabling stroke, or hospitalization for heart failure at 1 year (12.6% for IA vs 11.3% for SA; p=0.422). Likewise, device success rates were high and comparable between both groups, reaching 91.1% in the IA valve group and 90.9% in the SA valve group.
From a safety standpoint, the need for permanent pacemaker implantation was significantly higher with IA valves (22.1% vs 16.3%; p=0.007), whereas major or life-threatening bleeding occurred more frequently in the SA group (4.2% vs 2.6%; p<0.001).
In terms of hemodynamic performance, both valve types demonstrated excellent and sustained results at 1 year, with low mean transvalvular gradients and similar rates of moderate or severe paravalvular leak.
Personalized Valve Selection in TAVI: The Key to Optimizing Outcomes
The study concludes that contemporary intra-annular and supra-annular self-expanding valves provide comparable long-term clinical and hemodynamic outcomes despite exhibiting different procedural safety profiles.
Given these specific differences—namely, a higher rate of permanent pacemaker implantation with IA valves and a higher incidence of bleeding with SA valves—the authors recommend an individualized approach to valve selection. This strategy should integrate each patient’s anatomical characteristics, lifetime management considerations, including future coronary access, and the experience of the treating heart team.
Original Title: Clinical and haemodynamic outcomes with contemporary intra- and supra-annular self-expanding valves: the multicentre international HERA-TAVI registry.
Reference: Matteo Casenghi et al. EuroIntervention. 2026;22:e1-e1.
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