TY - JOUR
T1 - Comparison of strategies for vascular ACCESS closure after Transcatheter Aortic Valve Implantation
T2 - the ACCESS-TAVI randomized trial
AU - Rheude, Tobias
AU - Ruge, Hendrik
AU - Altaner, Niklas
AU - Pellegrini, Costanza
AU - Covarrubias, Hector Alvarez
AU - Mayr, Patrick
AU - Cassese, Salvatore
AU - Kufner, Sebastian
AU - Taniguchi, Yousuke
AU - Thilo, Christian
AU - Klos, Markus
AU - Erlebach, Magdalena
AU - Schneider, Simon
AU - Jurisic, Martin
AU - Laugwitz, Karl Ludwig
AU - Lange, Rüdiger
AU - Schunkert, Heribert
AU - Kastrati, Adnan
AU - Krane, Markus
AU - Xhepa, Erion
AU - Joner, Michael
N1 - Publisher Copyright:
© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved.
PY - 2025/2/14
Y1 - 2025/2/14
N2 - Background and Data from randomized trials investigating different access closure strategies after transfemoral transcatheter aortic valve Aims implantation (TF-TAVI) remain scarce. In this study, two vascular closure device (VCD) strategies to achieve haemostasis after TF-TAVI were compared. Methods The ACCESS-TAVI (Comparison of Strategies for Vascular ACCESS Closure after Transcatheter Aortic Valve Implantation) is a prospective, multicentre trial in which patients undergoing TF-TAVI were randomly assigned to a strategy with a combined suture-/plug-based VCD strategy (suture/plug group) using one ProGlide™/ProStyle™ (Abbott Vascular) and one Angio-Seal® (Terumo) vs. a suture-based VCD strategy (suture-only group) using two ProGlides™/ProStyles™. The primary endpoint was a composite of major or minor access site-related vascular complications during index hospitalization according to Valve Academic Research Consortium 3 criteria. Key secondary endpoints included time to haemostasis, bleeding type ≥ 2, and all-cause mortality over 30 days. Results Between September 2022 and April 2024, 454 patients were randomized. The primary endpoint occurred in 27% (62/230) in the suture/plug group and 54% (121/224) in the suture-only group [relative risk .55 (95% confidence interval: .44, .68); P < .001]. Time to haemostasis was significantly shorter in the suture/plug group compared with the suture-only group (108 ± 208 s vs. 206 ± 171 s; P < .001). At 30 days, bleeding type ≥ 2 occurred less often in the suture/plug group compared with the suture-only group [6.2% vs. 12.1%, relative risk .66 (.43, 1.02); P = .032], with no significant difference in mortality. Conclusions With regard to the composite of major or minor access site-related vascular complications, a combined suture-/plug-based VCD strategy was superior to a suture-based VCD strategy for vascular access closure in patients undergoing TF-TAVI.
AB - Background and Data from randomized trials investigating different access closure strategies after transfemoral transcatheter aortic valve Aims implantation (TF-TAVI) remain scarce. In this study, two vascular closure device (VCD) strategies to achieve haemostasis after TF-TAVI were compared. Methods The ACCESS-TAVI (Comparison of Strategies for Vascular ACCESS Closure after Transcatheter Aortic Valve Implantation) is a prospective, multicentre trial in which patients undergoing TF-TAVI were randomly assigned to a strategy with a combined suture-/plug-based VCD strategy (suture/plug group) using one ProGlide™/ProStyle™ (Abbott Vascular) and one Angio-Seal® (Terumo) vs. a suture-based VCD strategy (suture-only group) using two ProGlides™/ProStyles™. The primary endpoint was a composite of major or minor access site-related vascular complications during index hospitalization according to Valve Academic Research Consortium 3 criteria. Key secondary endpoints included time to haemostasis, bleeding type ≥ 2, and all-cause mortality over 30 days. Results Between September 2022 and April 2024, 454 patients were randomized. The primary endpoint occurred in 27% (62/230) in the suture/plug group and 54% (121/224) in the suture-only group [relative risk .55 (95% confidence interval: .44, .68); P < .001]. Time to haemostasis was significantly shorter in the suture/plug group compared with the suture-only group (108 ± 208 s vs. 206 ± 171 s; P < .001). At 30 days, bleeding type ≥ 2 occurred less often in the suture/plug group compared with the suture-only group [6.2% vs. 12.1%, relative risk .66 (.43, 1.02); P = .032], with no significant difference in mortality. Conclusions With regard to the composite of major or minor access site-related vascular complications, a combined suture-/plug-based VCD strategy was superior to a suture-based VCD strategy for vascular access closure in patients undergoing TF-TAVI.
KW - Transcatheter aortic valve implantation
KW - Vascular closure devices
KW - Vascular complications
UR - http://www.scopus.com/inward/record.url?scp=85218503931&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehae784
DO - 10.1093/eurheartj/ehae784
M3 - Article
C2 - 39474906
AN - SCOPUS:85218503931
SN - 0195-668X
VL - 46
SP - 635
EP - 645
JO - European Heart Journal
JF - European Heart Journal
IS - 7
ER -