BACKGROUND: Collagen-based vascular closure devices (VCD) are commonly used after catheterization with femoral access. However, data about complication rates due to the utilization of VCDs in patients with known peripheral artery disease (PAD) of the lower limbs are inconsistent and patients with significant PAD are excluded in most VCD trials. In this study, we aimed to assess complication rates of collagen-based VCDs in patients with significant PAD. METHODS: Patients with significant PAD treated with a VCD (Angio-Seal; St Jude Medical, Inc) after percutaneous therapeutic interventions of lower extremities were included in this study. Significant PAD was defined as Fontaine ≥2b. In-hospital complications (bleeding, spurious aneurysm, vessel occlusion, dissection, surgical repair, vasovagal reaction) were recorded. RESULTS: A total of 121 patients (64.6 ± 11.3 years, 77% male) were included. PAD stage IIb was present in 99 patients (stage III in 8 patients, stage IV in 14 patients). A total of 112 treatments (93.3%) processed without complications (major complication rate, 1.7%; minor complication rate, 5.0%). There was a trend toward higher prevalence of complications with increasing size of closure device and with the stage of PAD; however, this trend was not statistically significant (P>.05 for all). CONCLUSION: We report moderate complication rates of collagen-based VCDs in patients with significant PAD. Our data suggest that Angio-Seal may be safe in patients with PAD after catheter intervention. Further randomized trials with larger sample size comparing VCD with standard manual compression in patients with significant PAD are required.
BACKGROUND: Collagen-based vascular closure devices (VCD) are commonly used after catheterization with femoral access. However, data about complication rates due to the utilization of VCDs in patients with known peripheral artery disease (PAD) of the lower limbs are inconsistent and patients with significant PAD are excluded in most VCD trials. In this study, we aimed to assess complication rates of collagen-based VCDs in patients with significant PAD. METHODS:Patients with significant PAD treated with a VCD (Angio-Seal; St Jude Medical, Inc) after percutaneous therapeutic interventions of lower extremities were included in this study. Significant PAD was defined as Fontaine ≥2b. In-hospital complications (bleeding, spurious aneurysm, vessel occlusion, dissection, surgical repair, vasovagal reaction) were recorded. RESULTS: A total of 121 patients (64.6 ± 11.3 years, 77% male) were included. PAD stage IIb was present in 99 patients (stage III in 8 patients, stage IV in 14 patients). A total of 112 treatments (93.3%) processed without complications (major complication rate, 1.7%; minor complication rate, 5.0%). There was a trend toward higher prevalence of complications with increasing size of closure device and with the stage of PAD; however, this trend was not statistically significant (P>.05 for all). CONCLUSION: We report moderate complication rates of collagen-based VCDs in patients with significant PAD. Our data suggest that Angio-Seal may be safe in patients with PAD after catheter intervention. Further randomized trials with larger sample size comparing VCD with standard manual compression in patients with significant PAD are required.
Authors: Joel L Ramirez; Devin S Zarkowsky; Thomas A Sorrentino; Caitlin W Hicks; Shant M Vartanian; Warren J Gasper; Michael S Conte; James C Iannuzzi Journal: J Vasc Surg Date: 2020-03-09 Impact factor: 4.268