Comparison of strategies for vascular ACCESS closure after transcatheter aortic valve implantation: the ACCESS-TAVI randomized trial.

Rheude, Tobias; Ruge, Hendrik; Altaner, Niklas; Pellegrini, Costanza; Alvarez Covarrubias, Hector; Mayr, N Patrick; Cassese, Salvatore; Kufner, Sebastian; Taniguchi, Yousuke; Thilo, Christian; Klos, Markus; Erlebach, Magdalena; Schneider, Simon; Jurisic, Martin; Laugwitz, Karl-Ludwig; Lange, Rüdiger; Schunkert, Heribert; Kastrati, Adnan; Krane, Markus; Xhepa, Erion; Joner, Michael

doi:10.1093/eurheartj/ehae784

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Title:: Comparison of strategies for vascular ACCESS closure after transcatheter aortic valve implantation: the ACCESS-TAVI randomized trial.
Document type:: Journal Article
Author(s):: Rheude, Tobias; Ruge, Hendrik; Altaner, Niklas; Pellegrini, Costanza; Alvarez Covarrubias, Hector; Mayr, N Patrick; Cassese, Salvatore; Kufner, Sebastian; Taniguchi, Yousuke; Thilo, Christian; Klos, Markus; Erlebach, Magdalena; Schneider, Simon; Jurisic, Martin; Laugwitz, Karl-Ludwig; Lange, Rüdiger; Schunkert, Heribert; Kastrati, Adnan; Krane, Markus; Xhepa, Erion; Joner, Michael
Abstract:: 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.
Journal title abbreviation:: Eur Heart J
Year:: 2024
Fulltext / DOI:: doi:10.1093/eurheartj/ehae784
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/39474906
Print-ISSN:: 0195-668X
TUM Institution:: Klinik für Herz- und Gefäßchirurgie (DHM) (Prof. Krane)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Lehr- und Forschungskooperationen mit den Kliniken und Instituten am Deutschen Herzzentrum Klinik für Herz- und Gefäßchirurgie (DHM) (Prof. Krane)2024