Balloon-Expandable Versus Self-Expanding Valves in Bicuspid Aortic Stenosis: Insights From the SWEDEHEART Registry

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is increasingly used in patients with bicuspid aortic valve (BAV) stenosis, but there is limited comparative data on balloon-expandable (BEV) versus self-expanding valves (SEV) in this population. Aim: To compare clinical and hemodynamic outcomes between BEVs and SEVs in patients with BAV stenosis. Methods: This observational cohort included all patients who underwent TAVR in Sweden between 2016 and 2022. Exclusion criteria included procedures for pure aortic insufficiency and valve-in-valve interventions. The analysis focused on Evolut, Sapien, Acurate, and Portico/Navitor valve families. A doubly robust approach was applied combining inverse probability of treatment weighting and multivariable regression. Sensitivity analyses were also conducted. Results: Of 577 patients, 274 (47.5%) received a BEV. The majority in the SEV group received an Evolut valve (62%). The mean EUROSCORE II-predicted mortality risk was 4.1% for BEV and 3.6% for SEV. BEVs were used more in patients with reduced ejection fraction (EF ≤ 40%) and larger aortic annuli. There were no significant differences between groups in periprocedural mortality, all-cause mortality at a median follow-up of 675 days, or device success. However, SEVs had higher technical success (aOR: 2.21, p = 0.006), lower postprocedural gradients (adjusted coefficient: −3.72, p < 0.001), and reduced risk of prosthesis-patient mismatch (aOR: 0.10, p = 0.02). SEVs, though, had a higher incidence of paravalvular leakage (aOR: 7.5, p < 0.01). Conclusion: Both BEVs and SEVs were feasible with similar clinical outcomes in BAV stenosis. SEVs had better hemodynamic outcomes but more paravalvular leakage. Randomized trials are needed to determine the optimal valve choice.