According to the latest European guidelines, transcatheter aortic valve implantation (TAVI) is the recommended treatment for patients aged ≥70 years with symptomatic severe aortic stenosis, regardless of their estimated surgical risk. As TAVI is increasingly performed in patients with longer life expectancy, the focus has progressively shifted from procedural feasibility to device-specific performance, safety, and long-term clinical implications.
Technological advances have led to the development of new-generation self-expanding transcatheter heart valves (THVs), designed to improve implantation ease, annular sealing, and haemodynamic performance. In this setting, intra-annular (IA) and supra-annular (SA) valve designs represent two distinct engineering strategies, each with potential advantages and limitations. Supra-annular configurations have been associated with larger effective orifice areas and lower transvalvular gradients, whereas intra-annular platforms may offer advantages regarding coronary access and lifetime management.
Recent prospective single-arm studies have demonstrated excellent safety and optimal haemodynamic performance for both new-generation intra-annular and supra-annular self-expanding valves (SEVs).
However, comparative evidence between these contemporary platforms remains limited, as most available analyses originate from single-centre or single-country experiences, include mixed device generations, or focus on selected anatomical subgroups and short-term outcomes.
Read also: Redo-TAVI with SAPIEN 3: 30-Day Outcomes.
To address this gap, the HERA-TAVI study (Clinical and HEmodynamic Outcomes with ContempoRary Intra- and Supra-Annular Self-Expanding Valves) was designed to compare the clinical outcomes and haemodynamic performance of new-generation IA and SA SEVs at 30 days and 1 year using a large, contemporary real-world cohort.
A total of 2,607 patients treated between 2021 and 2025 were included. The IA-SEVs evaluated were Navitor/Navitor Vision (Abbott), while the SA-SEVs were Evolut FX/FX+ (Medtronic). Propensity score matching (PSM) was performed, yielding 892 well-balanced matched pairs.
Regarding the primary endpoint at 1 year, there were no significant differences in the composite of all-cause mortality, disabling stroke, or heart failure hospitalization (IA: 12.6% vs. SA: 11.3%; p=0.422).
Although overall efficacy was comparable, the two platforms exhibited distinct safety profiles. IA-SEVs (Navitor) were associated with higher rates of permanent pacemaker implantation (PPI) (22.1% vs. 16.3%; p=0.007) and pericardial tamponade (1.1% vs. 0.2%; p=0.020). Conversely, SA-SEVs (Evolut FX) were associated with a higher incidence of major or life-threatening bleeding (4.2% vs. 2.6%; p<0.001). Device success according to VARC-3 criteria was similarly high in both groups (>90%).
From a haemodynamic standpoint, both platforms maintained low and comparable mean transvalvular gradients at 1 year (7 mmHg in both groups; p=0.429). The incidence of moderate or severe paravalvular leak (PVL) was low and comparable (2.2% in IA vs. 1.6% in SA). The IA platform showed a higher rate of mild PVL at 30 days, although this difference diminished by the 1-year follow-up.
Conclusion: H3: Similar efficacy, different safety profiles
Contemporary intra-annular and supra-annular self-expanding valve platforms demonstrated equivalent clinical outcomes regarding mortality and major adverse events at 1 year. Device selection should therefore be individualized, taking into account patient anatomy, the risk of conduction disturbances, vascular access, and lifetime management strategies, particularly the potential need for future coronary access.
Reference: EuroIntervention. 2026;22:e730-e740.
