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Utilization of collagen-based vascular closure devices in patients with severe peripheral artery disease
Kaffer Kara1, Amir A Mahabadi, Marie H Berg
1West German Heart Center, Department of Cardiology, Hufelandstr. 55, 45147 Essen, Germany. Kaffer.Kara@uk-essen.de
Insights
Collagen-based vascular closure devices (VCD) show moderate complication rates in patients with significant peripheral artery disease (PAD). Angio-Seal appears safe for PAD patients post-catheter intervention, but more research is needed.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Collagen-based vascular closure devices (VCD) are widely used after femoral access catheterization.
- Limited data exists on VCD complication rates in patients with peripheral artery disease (PAD), who are often excluded from trials.
- This study evaluates VCD complication rates specifically in patients with significant PAD.
Purpose of the Study:
- To assess the complication rates of collagen-based VCDs in patients with significant peripheral artery disease (PAD).
Main Methods:
- A cohort of 121 patients with significant PAD (Fontaine ≥2b) undergoing percutaneous lower extremity interventions using Angio-Seal VCD were analyzed.
- In-hospital complications including bleeding, aneurysm, occlusion, dissection, and need for surgical repair were recorded.
Main Results:
- The overall major complication rate was 1.7%, and the minor complication rate was 5.0% among 112 treatments.
- While a trend towards increased complications with larger device size and higher PAD stage was observed, it was not statistically significant (P>.05).
Conclusions:
- Collagen-based VCDs demonstrate moderate complication rates in patients with significant PAD.
- The Angio-Seal device appears to be a safe option for PAD patients following catheter interventions.
- Further randomized trials comparing VCDs with manual compression in PAD patients are warranted.
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.
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