Self-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: The SWEDEHEART Registry

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Devices

Background:

• Small aortic annulus is a known predictor of suboptimal hemodynamic outcomes following transcatheter aortic valve replacement (TAVR).
• Supra-annular (SA) self-expandable valves (SEVs) are hypothesized to provide superior hemodynamic performance compared to intra-annular (IA) SEVs in patients with small aortic annuli.
• This study compares clinical and hemodynamic results between SA SEVs (Evolut, Acurate) and IA SEVs (Portico/Navitor).

Purpose of the Study:

• To evaluate and compare the clinical and hemodynamic outcomes of SA SEVs versus IA SEVs in patients with small aortic annuli undergoing TAVR.
• To determine if SA SEVs offer improved results over IA SEVs in this specific patient population.
• To assess key performance indicators including mortality, success rates, and hemodynamic gradients post-TAVR.

Main Methods:

• Retrospective analysis of TAVR patients in Sweden (2013-2022) with an annular diameter ≤23 mm.
• Inverse probability of treatment weighting (IPTW) was used to adjust for baseline differences between valve groups.
• Primary endpoints included mortality and Valve Academic Research Consortium 3 (VARC-3) defined success; secondary endpoints included gradients, leakage, and pacemaker implantation.

Main Results:

• A total of 1068 patients were analyzed, with a median age of 81.2 years and 88% female.
• After IPTW adjustment, no significant differences in overall outcomes were observed between SA and IA SEVs.
• The Evolut valves (SA) showed the lowest mean gradients (7.97 mmHg), followed by Portico/Navitor (IA) (9.02 mmHg) and Acurate (SA) (0.84 mmHg), with a statistically significant difference (p < 0.001).

Conclusions:

• Both SA and IA SEVs demonstrate comparable clinical outcomes and robust hemodynamic performance in patients with small aortic annuli undergoing TAVR.
• While SA SEVs showed slightly lower mean gradients, the clinical implications require further investigation.
• Randomized controlled trials are recommended to establish definitive guidance for valve selection in this patient cohort.