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

Overview

abstract

BACKGROUND: Small aortic annulus is associated with poorer hemodynamic outcomes in transcatheter aortic valve replacement (TAVR). In these cases, supra-annular (SA) self-expandable valves (SEVs) may offer better results than intra-annular SEVs (IA SEVs). This study evaluated clinical and hemodynamic outcomes for SA SEVs (Evolut valves, Acurate valves) and IA SEVs (Portico/Navitor valves). METHODS: We analyzed data from patients who underwent TAVR in Sweden between 2013 and 2022 with an annular diameter ≤23 mm, using inverse probability of treatment weighting. Endpoints included mortality, device, and technical success as per Valve Academic Research Consortium 3 definitions. Other endpoints were the incidence of post-TAVR mean or peak gradients over 20 and 40 mmHg, respectively, significant paravalvular leakage, new pacemaker implantation, and postprocedural aortic valve gradients. RESULTS: The study included 1068 patients, with a median age of 81.2 years, and 88% were women. After inverse probability of treatment weighting adjustment, no differences were observed in the outcomes apart from a marginally lower risk of postprocedural mortality in the Portico/Navitor valves compared to the Evolut valves (adjusted odds ratio: 0.99; p = 0.05; 95% CI: 0.98-1.00). Hemodynamically, the Evolut valves showed the lowest mean gradients, followed by the Portico/Navitor valves and the Acurate valves (7.97 vs 9.02 mmHg vs. 0.84 mmHg, respectively, p < 0.001; 95% CI: 0.35-1.00). CONCLUSIONS: SA and IA SEVs show comparable clinical outcomes and excellent hemodynamic performance in patients with small aortic annuli. Further studies, including randomized trials, are needed to provide clearer guidance on valve selection.