Totally extravascular bioresorbable closure reduces access complications after endovascular peripheral intervention

Authors

Philip V. Bystrom, Department of Surgery, University of Illinois at Chicago, Chicago, IL. Electronic address: pbystr2@uic.edu.
Rohan Kulangara, Department of Surgery, University of Illinois at Chicago, Chicago, IL.
Rym El Khoury, Department of Surgery, Division of Vascular Surgery, Northshore University Health System/Endeavor Health, Evanston, IL.
Mitchell Piel, Rosalind Franklin University of Medicine and Science, Chicago, IL.
Michael Chaney, Department of Surgery, Western Michigan University School of Medicine, Kalamazoo, MI.
Chad E. Jacobs, Advocate Health - MidwestFollow
John V. White, Advocate Health - MidwestFollow
Lewis B. Schwartz, Advocate Health - MidwestFollow

Recommended Citation

Bystrom PV, Kulangara R, El Khoury R, et al. Totally Extravascular Bioresorbable Closure Reduces Access Complications After Endovascular Peripheral Intervention. Ann Vasc Surg. Published online April 30, 2025. doi:10.1016/j.avsg.2025.04.127

Affiliations

Advocate Lutheran General Hospital

Abstract

Objective:Percutaneous closure of the access artery has become commonplace after endovascular intervention. In patients with peripheral vascular occlusive disease, however, control of the puncture site is more problematic as the access artery is frequently plaque-laden and stenotic. Ischemic complications in the access extremity are more common in these cases, particularly when using devices that depend on the deployment of prosthetic material within the compromised arterial lumen. The purpose of this retrospective clinical study was to assess the efficacy of totally extravascular/bioresorbable closure (TEBC) of the femoral artery puncture sites after percutaneous peripheral intervention (PPI).

Methods:Consecutive PPIs performed at single institution between 2015-2020 were studied. Demographic characteristics and the incidence of access complications were recorded. The complication rate of TEBC and manual compression were analyzed with multivariate regression analysis. Major complications were defined as the composite of acute arterial ischemia, major bleeding and/or pseudoaneurysm requiring operation. Minor complications were defined as the aggregate of transient hypotension, groin hematoma and/or arteriovenous fistula.

Results:A total of 507 PPIs were performed in 345 patients during the study period. The mean age was 74 years; comorbidities were prevalent including diabetes (57%), obesity (28%) and end-stage renal failure requiring dialysis (10%). Indications for PPI were either chronic limb-threatening ischemia (68%) or claudication (32%). All procedures were performed using femoral artery access in a retrograde (93%) or antegrade (7%) fashion with ≤5 Fr (21%), 6 Fr (18%) or ≥7 Fr (61%) sheaths. Control of the femoral artery puncture site was achieved by either manual compression (MC, 75%), or totally extravascular/bioresorbable closure (TEBC, 25%). TEBC became the exclusive closure method in 2019. Acute arterial ischemia rarely complicated MC (1.3%) but was not observed in any patient undergoing TEBC. Bleeding and/or pseudoaneurysms requiring reoperation were also rare (MC 0.3% vs. TEBC 1.6%; p=0.64). On multivariate analysis there was no difference in major access complications between MC and TEBC (OR=1.45 [0.27-7.79]; p=0.66), while minor access complications were significantly reduced with the use of TEBC (OR=0.39 [0.19-0.75]; p<0.01).

Conclusions:TEBC after PPI for peripheral arterial disease is safe and effective. There were no instances of acute arterial ischemia following TEBC in this series, and TEBC significantly reduced the incidence of minor access complications compared to MC. Given the bioresorbable design of the device, and the lack of an intraluminal component of any kind, TEBC may be the ideal closure device for patients with peripheral arterial disease undergoing endovascular intervention.

Type

Article

PubMed ID

40316207