Totally Extravascular Bioresorbable Closure Reduces Access Complications after Endovascular Peripheral Intervention.

BACKGROUND

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 and 2020 were studied. Demographic characteristics and the incidence of access complications were recorded. The complication rate of TEBC and manual compression (MC) 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 (CLTI) (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 MC (75%), or 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 (odds ratio [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).

CONCLUSION

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.