Balloon‐Expandable Versus Self‐Expanding Prostheses for Transcatheter Treatment of Patients With Low‐Flow, Low‐Gradient Aortic Stenosis

Background The use of balloon‐expandable valves (BEVs) or self‐expanding valves (SEVs) for transcatheter aortic valve replacement (TAVR) in patients with low‐flow, low‐gradient aortic stenosis (LFLG‐AS) has been poorly investigated. Aim of this study is to evaluate the procedural and clinical outcomes of patients with severe low‐flow, low‐gradient aortic stenosis undergoing TAVR with current‐generation prostheses. Methods This registry‐based, multicenter, cohort study included consecutive patients with low‐flow, low‐gradient aortic stenosis undergoing TAVR from January 2019 to December 2024 at 17 high‐volume Italian centers. The study population was divided into 2 groups according to the use of BEVs or SEVs. The primary outcome was all‐cause mortality up to 1 year. Results The study involved 1380 patients; 592 (42.9%) underwent TAVR with BEVs, and 788 (57.1%) with SEVs. At discharge, BEVs were linked to higher mean transvalvular gradients ( P <0.001) and a higher percentage of moderate predicted patient‐prosthesis mismatch ( P <0.001) compared with SEVs. After propensity score weighting, the Cox analysis showed no difference for the risk of the primary outcome (adjusted hazard ratio HR:1.23; 95% CI: 0.88–1.72), cardiovascular mortality (adjusted HR:1.37; 95% CI: 0.94–1.97), stroke (adjusted HR:1.83; 95% CI: 0.85–3.95), and myocardial infarction (adjusted HR:1.03; 95% CI: 0.40–2.69) between groups; however, the use of BEVs was associated with a significantly higher risk for HF hospitalization up to 1 year (adjusted HR: 1.54; 95% CI:1.05–2.25). Conclusions In this real‐world study on TAVR treatment for patients with low‐flow, low‐gradient aortic stenosis, there was no difference in mortality rates between BEVs and SEVs up to 1 year. However, the use of BEVs was linked to less favorable hemodynamic performance and a higher risk of HF hospitalization. Registration URL: https://clinicaltrials.gov/ ; Unique identifier: NCT06589063.