TY - JOUR
T1 - Balloon-expandable versus self-expandable valves in transcatheter aortic valve implantation
T2 - Complications and outcomes from a large international patient cohort
AU - van Nieuwkerk, Astrid C.
AU - Santos, Raquel B.
AU - Andraka, Leire
AU - Tchetche, Didier
AU - de Brito, Fabio S.
AU - Barbanti, Marco
AU - Kornowski, Ran
AU - Latib, Azeem
AU - D’onofrio, Augusto
AU - Ribichini, Flavio
AU - Ten, Francisco
AU - Dumonteil, Nicolas
AU - Baan, Jan
AU - Piek, Jan J.
AU - Abizaid, Alexandre
AU - Sartori, Samantha
AU - D’errigo, Paola
AU - Tarantini, Giuseppe
AU - Lunardi, Mattia
AU - Orvin, Katia
AU - Pagnesi, Matteo
AU - Nogales-Asensio, Juan Manuel
AU - Ghattas, Angie
AU - Dangas, George
AU - Mehran, Roxana
AU - Delewi, Ronak
N1 - Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/9
Y1 - 2021/9
N2 - Background: Both balloon-expandable (BE) and self-expandable (SE) valves for tran-scatheter 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.
AB - Background: Both balloon-expandable (BE) and self-expandable (SE) valves for tran-scatheter 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.
KW - Aortic valve stenosis
KW - Balloon-expandable
KW - Mortality
KW - Self-expandable
KW - Stroke
KW - Transcatheter aortic valve implantation
UR - http://www.scopus.com/inward/record.url?scp=85114216922&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85114216922&partnerID=8YFLogxK
U2 - 10.3390/jcm10174005
DO - 10.3390/jcm10174005
M3 - Article
AN - SCOPUS:85114216922
SN - 2077-0383
VL - 10
JO - Journal of Clinical Medicine
JF - Journal of Clinical Medicine
IS - 17
M1 - 4005
ER -