Login
- Titel:
Comparison of strategies for vascular ACCESS closure after Transcatheter Aortic Valve Implantation: the ACCESS-TAVI randomized trial.
- Dokumenttyp:
- Journal Article; Randomized Controlled Trial; Multicenter Study; Comparative Study
- Autor(en):
- 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 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.
- Zeitschriftentitel:
- Eur Heart J
- Jahr:
- 2025
- Band / Volume:
- 46
- Heft / Issue:
- 7
- Seitenangaben Beitrag:
- 635-645
- Volltext / DOI:
- doi:10.1093/eurheartj/ehae784
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/39474906
- Print-ISSN:
- 0195-668X
- TUM Einrichtung:
- Klinik für Herz- und Gefäßchirurgie (DHM) (Prof. Krane)
BibTeX