Ultrasound-Guided vs Non-Ultrasound-Guided Angio-Seal Vascular Hemosasis After Endovascular Treatment for Peripheral Artery Disease: An Observational Study.

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.Clinical ImpactUltrasound visualization of vascular closure devices during endovascular access closure leads to a significant decrease in overall and major post interventional access site complications. This non-invasive and often readily available imaging technique could therefore lead to an important decrease in morbidity and subsequent overall health care costs when added to the standard intervention protocol. With the increasing use of endovascular techniques to treat peripheral artery disease, the addition of ultrasound-techniques in closure of endovascular access sites could potentially have a large clinical impact, both on patient outcomes as well as financial outcomes.