Balloon-Expandable Versus Self-Expanding Prostheses for Transcatheter Treatment of Patients With Low-Flow, Low-Gradient Aortic Stenosis.
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Ferruzzi Germano Junior, Bellino Michele, Silverio Angelo, Saia Francesco, Bruno Antonio Giulio, Boragine Paride, Buono Andrea, De Rosa Maria Luisa, Cancro Francesco Paolo, Porto Italo, Crimi Gabriele, Calabrò Paolo, Moscarella Elisabetta, Ielasi Alfonso, Montonati Carolina, De Carlo Marco, Sticchi Alessandro, Lanni Francesca, Di Muro Francesca Maria, Maiellaro Francesco, Calchera Ivan Francesco, Boccuzzi Giacomo, Sorropago Antonio, Scudiero Fernando, Attisano Tiziana, Citro Rodolfo, Granata Giovanni, De Luca Giuseppe, Musumeci Giuseppe, Galasso Gennaro, LOW‐TAVR Investigators
Аннотация
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.