Ultrasound-guided vs non-ultrasound-guided angio-seal vascular hemostasis after endovascular treatment for peripheral artery disease: an observational study

Abstract

Background: Vascular access complications after endovascular treatment for peripheral artery disease (PAD) are relatively frequent, even after the use of vascular closure devices (VCDs). This study investigates the impact of a protocol change toward the use of ultrasound-assisted Angio-Seal closure on vascular complications, compared with non–ultrasound-guided vascular closure. Methods: All endovascular procedures for PAD from 2017 to 2018 (group 1: non–ultrasound-guided) and 2020 to 2022 (group 2: ultrasound-guided) were included in this retrospective study. Inclusion criteria were endovascular treatment for PAD in the lower extremities with femoral access and use of Angio-Seal at femoral access site. Exclusion criteria were acute ischemia. The primary endpoints were total number of complications, the number of minor complications, and the number of major complications at vascular access site. Results: A total of 1298 vascular access closures in 826 patients were included. The ultrasound-guided group showed a significant lower rate of overall complications (n=53, 7.5% vs n=75, 12.6%, p=0.002), minor complications (n=49, 7.0% vs n=58, 9.9%, p=0.001), and major complications (n=4, 0.6% vs n=16, 2.7%, p=0.001). Multivariate analysis showed significantly fewer overall complications (odds ratio [OR]=0.696, 95% confidence interval [CI]=0.459-1.056, p=0.088) after ultrasound-guided deployment of the VCD. Ultrasound guidance lowered the chance of major vascular access complications significantly (OR=0.210, 95% CI=0.070-0.635, p=0.006). Furthermore, severe calcification was shown to be an individual predictor of complications after femoral vascular access (OR=2.014, 95% CI=1.341-3.025, p=0.001). Conclusion: The use of ultrasound when deploying the Angio-Seal device results in a significant decrease in vascular access complications and could be of significant clinical relevance in PAD patients. Severe calcification is an individual predictor of vascular access complications.