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Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort

Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study include...

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Detalles Bibliográficos
Autores principales: van Nieuwkerk, Astrid C., Santos, Raquel B, Andraka, Leire, Tchetche, Didier, de Brito, Fabio S., Barbanti, Marco, Kornowski, Ran, Latib, Azeem, D’Onofrio, Augusto, Ribichini, Flavio, Ten, Francisco, Dumonteil, Nicolas, Baan, Jan, Piek, Jan J., Abizaid, Alexandre, Sartori, Samantha, D’Errigo, Paola, Tarantini, Giuseppe, Lunardi, Mattia, Orvin, Katia, Pagnesi, Matteo, Nogales-Asensio, Juan Manuel, Ghattas, Angie, Dangas, George, Mehran, Roxana, Delewi, Ronak
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8432462/
https://www.ncbi.nlm.nih.gov/pubmed/34501454
http://dx.doi.org/10.3390/jcm10174005
Descripción
Sumario:Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. Results: In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0–12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02–1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86–1.37, p = 0.48). Conclusion: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.