Background and aims: Data from randomized trials investigating different access closure strategies after transfemoral transcatheter aortic valve implantation (TF-TAVI) remain scarce. In this study, two vascular closure device (VCD) strategies to achieve hemostasis after TF-TAVI were compared.
Methods: The ACCESS-TAVI (Comparison of Strategies for Vascular ACCESS Closure after Transcatheter Aortic Valve Implantation) is a prospective, multicenter 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 ProGlideTM/ProStyleTM (Abbott Vascular) and one Angio-Seal® (Terumo) versus a suture-based VCD strategy (suture-only group) using two ProGlidesTM/ProStylesTM. The primary endpoint was a composite of major or minor access site-related vascular complications during index hospitalization according to Valve Academic Research Consortium (VARC)-3 criteria. Key secondary endpoints included time to hemostasis, VARC-3 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 [RR] 0.55 [95% confidence interval: 0.44;0.68]; p<0.001). Time to hemostasis was significantly shorter in the suture/plug group compared to the suture-only group (108±208 s vs. 206±171 s; p <0.001). At 30 days, bleeding type ≥2 occurred less often in the suture/plug group compared to the sutureonly group (6.2% vs. 12.1%, RR 0.66 [0.43;1.02]; p=0.032), with no significant difference in mortality.
Conclusions: With regard to the composite of major or minor access-related vascular complications, a combined suture-/plug-based VCD strategy was superior to a suturebased VCD strategy for vascular access closure in patients undergoing TF-TAVI.
Keywords: transcatheter aortic valve implantation; vascular closure devices; vascular complications.
© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.