Journal of clinical medicine · 2021
Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort.
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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
Аннотация
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.
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.