Dr. Selim Süleyman Sert

Name of the study: Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation: The ACCESS-TAVI Randomized Trial

Published in Congress: TCT 2024

Link: https://www.tctmd.com/slide/comparison-strategies-vascular-access-closure-after-transcatheter-aortic-valve-implantation

Introduction:
In transcatheter aortic valve procedures, femoral access is the route used in more than 90% of centers. Many studies indicate that femoral access is the safest route for patients. Despite the increased experience of operators and the development of valves, vascular complications can still occur due to the minimal invasiveness of the procedure with percutaneous closure devices.

Objective:
The ACCESS-TAVI study aims to compare the safety and efficacy of two different vascular closure device strategies after transfemoral transcatheter aortic valve implantation using large-bore vascular access.

Methods:
The ACCESS-TAVI study is a prospective, randomized, multicenter, open-label clinical trial conducted in Germany with 450 patients. In this study, patients undergoing transfemoral TAVI were randomized into groups using a combined suture/plug-based vascular closure method with ProGlide™/ProStyle™ (Abbott Vascular) and Angio-Seal (Terumo) devices, and a group using only suture-based vascular closure with ProGlide™/ProStyle™ devices. The primary endpoints were major or minor access site-related vascular complications occurring during hospitalization according to Valve Academic Research Consortium (VARC)-3 criteria. Secondary endpoints included the time to hemostasis, type ≥2 bleeding according to VARC-3 bleeding classifications, and all-cause mortality within 30 days.

Results:
The average age of the enrolled patients was 80. The suture/plug group included 230 patients, while the suture-only group included 224 patients. The suture/plug group was predominantly female (51,7%), whereas the suture-only group was predominantly male (58%). In the suture/plug group, ultrasound-guided puncture was 57.8%, and the average procedure time was 55.3 ± 16,2  minutes; in the suture-only group, these figures were 59.4% and 59.4 ± 21,6 minutes, respectively. The primary endpoint occurred in 27% (62/230) of the suture/plug group and 54% (121/224) of the suture-only group, showing a significant difference between the two groups (p<0.001). The time to hemostasis was 108±208 seconds in the suture/plug group and 206±171 seconds in the suture-only group, with the suture/plug group demonstrating a significantly shorter hemostasis time (p<0.001). At 30 days, type ≥2 bleeding occurred less frequently in the suture/plug group compared to the suture-only group (6.2% vs. 12.1%, p=0.032). No significant difference was observed in mortality.

Conclusions:
When considering major or minor access site-related vascular complications, as well as bleeding events and hemostasis time, the combined suture/plug-based vascular closure method using ProGlide™/ProStyle™ (Abbott Vascular) and Angio-Seal (Terumo) devices was found to be superior to the suture-only method using ProGlide™/ProStyle™ devices.

Comment:
TAVI is a developed treatment for high-risk patients with severe aortic stenosis who cannot undergo surgery. The transfemoral artery is the most commonly used access site. Vascular complications, including bleeding, transfusion needs, and mortality, are limiting factors for TAVI. Improper closure at the access site, whether due to operator or device issues, can lead to patients requiring surgery and longer hospital stays. In the ACCESS-TAVI study, although there was no superiority in terms of mortality, the combined suture/plug-based vascular closure method using ProGlide™/ProStyle™ (Abbott Vascular) and Angio-Seal (Terumo) devices was considered preferable due to its reduction of bleeding complications and shorter hemostasis time.