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Comparison of collagen-based vascular closure devices in patients with vs. without severe peripheral artery disease
Kaffer Kara1, Philip Kahlert, Amir A Mahabadi
11 Department of Cardiology, West-German Heart Center Essen, University of Duisburg-Essen, Germany.
Insights
Collagen-based vascular closure devices (VCDs) showed similar complication rates in patients with and without peripheral artery disease (PAD). However, PAD patients experienced more severe complications requiring surgical repair.
Area of Science:
- Cardiovascular Interventions
- Vascular Access Management
Background:
- Femoral artery access is common for endovascular procedures.
- Peripheral artery disease (PAD) may influence vascular closure device (VCD) safety.
- Collagen-based VCDs are widely used for achieving hemostasis.
Purpose of the Study:
- To compare complication rates of a collagen-based VCD in patients with versus without significant PAD.
- To assess the safety and efficacy of VCDs in diverse patient populations undergoing lower limb endovascular procedures or percutaneous coronary interventions (PCI).
Main Methods:
- Prospective study of 382 patients undergoing lower limb endovascular procedures (PAD group, n=132) or PCI (n=250).
- Hemostasis achieved using a collagen-based VCD (Angio-Seal).
- Significant PAD excluded in PCI group via ankle-brachial index; major in-hospital complications recorded.
Main Results:
- Low and similar rates of major complications observed: 1.5% in PAD group vs. 1.2% in PCI group (p=1.0).
- No significant difference in VCD efficacy between groups (99.2% vs. 100%, p=0.35).
Conclusions:
- Collagen-based VCDs demonstrate comparable safety and efficacy in patients with and without severe lower limb PAD.
- Complications in the PAD group, though infrequent, were more severe and necessitated surgical intervention.
Purpose:
To compare complication rates of a collagen-based vascular closure device (VCD) in patients with vs. without significant peripheral artery disease (PAD).
Methods:
A total of 382 patients (268 men; mean age 64.6±10.8 years) undergoing either an endovascular procedure of the lower limb (PAD group, n=132) or a percutaneous coronary intervention (PCI group, n=250) via a common femoral artery access were enrolled in this prospective study if hemostasis was achieved using the collagen-based Angio-Seal. In the PCI group, significant PAD was excluded by measurement of the ankle-brachial index. In-hospital major complications (bleeding, large hematoma, pseudoaneurysm, vessel occlusion, dissection) were recorded.
Results:
Similar and low rates of major complications were observed in both arms of the study: 2 (1.5%) major complications in the PAD group and 3 (1.2%) in the PCI group (p=1.0). There was no significant difference in efficacy of the VCDs in the groups (PAD group 99.2% vs. 100% in PCI group, p=0.35).
Conclusion:
Our study shows no significant differences in the rate of major complications after utilization of a collagen-based VCD for femoral artery access site closure in patients with severe lower limb PAD compared to those without; however, complications in the PAD group tended to be more severe, with the need for surgical repair.
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