Safety and effectiveness of vascular closure devices in interventional radiological procedures

Abstract

Background: Although it is well known that vascular closure devices (VCD) are commonly used in therapeutic interventional radiological procedures, standard use in diagnostic procedures is not as well studied.

Purpose: The aim of this study was to determine the real-world safety and effectiveness of the VCD in both diagnostic and therapeutic interventional radiological procedures.

Materials and methods: A retrospective, single center study included all patients where VCDs were used for either a diagnostic or therapeutic interventional procedure. Various demographic and clinical risk factors were recorded and examined for any significant association with successful deployment and complications.

Results: A total of 2072 patients were included. VCDs were successfully deployed in 95.2% of the patients with 4.8% of perioperative complications, which included minor oozing from the puncture site, small hematoma less than or equal to 5 cm, large hematoma greater than 5 cm, pain, and loss of vascular access. Therapeutic (vascular interventional radiology (VIR) and neuro-interventional radiology (NIR)) procedures (OR 3.03, 95% CI 1.51-6.09, p = 0.002), use of Angioseal (OR 5.26, 95% CI 3.13-8.33), p < 0.001), and no use of antiplatelet medications (OR 0.47, 95% CI 0.22-0.97, p = 0.041) were independently associated with successful deployment of VCDs when controlled for other risk factors. Smoking (OR 3.50, 95% CI 2.00-6.05, p = <0.001), use of antiplatelet (OR 2.01, 95% CI 1.04-3.87, p = 0.037) and use of heparin (OR 1.78, 95% CI 1.10-2.86, p = 0.018) were independently associated with higher complication rates.

Conclusion: VCD's were successfully deployed in 95.2% of the patients with 4.8% of perioperative minor complications.

Keywords: Vascular closure device; complications; femoral access; femoral artery; interventional radiology.