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Randomized comparison of effects of suture-based and collagen-based vascular closure devices on post-procedural leg
H I M Kälsch1, H Eggebrecht, S Mayringer
1Department of Cardiology, West-German Heart Center, Hufelandstr. 55, 45122, Essen, Germany. Hagen.Kaelsch@uk-essen.de
Insights
Vascular closure devices (VCDs) for cardiac catheterization do not clinically impair leg perfusion, regardless of collagen or suture type. Both devices are safe for patients with reduced ankle-brachial index (ABI), showing no significant difference in flow impairment.
Area of Science:
- Cardiology
- Vascular Surgery
- Medical Devices
Background:
- Vascular closure devices (VCDs) are standard for hemostasis after cardiac catheterization.
- Concerns exist regarding femoral artery diameter reduction and subsequent blood flow impairment.
- Evaluating leg perfusion pre- and post-VCD application is crucial.
Purpose of the Study:
- To assess and compare leg perfusion following the use of collagen-based and suture-based VCDs.
- To determine if VCDs cause clinically relevant reductions in blood flow.
Main Methods:
- 366 patients undergoing coronary catheterization were randomized to collagen-based (n=214) or suture-based (n=152) VCDs.
- Ankle-brachial index (ABI) was measured before and one day after VCD application.
- Analysis included patients with and without peripheral vascular disease (PVD).
Main Results:
- Both VCD groups showed a statistically significant but clinically irrelevant decrease in post-procedural ABI.
- No significant difference in ABI reduction (DeltaABI) was observed between the collagen and suture groups (p=0.55).
- In PVD patients, neither device caused significant leg perfusion impairment, and no claudication aggravation was noted.
Conclusions:
- Neither collagen-based nor suture-based VCDs lead to clinically relevant reductions in ABI.
- Both VCD types demonstrate comparable safety profiles regarding leg blood flow.
- VCDs can be safely utilized in patients with pre-existing reduced ABI.
Background:
Vascular closure devices (VCD) are well established to facilitate hemostasis after cardiac catheterization procedures. However, impairment of flow due to the reduction of femoral artery diameter remains a major concern. The present study aims to evaluate leg perfusion before and after application of collagen- and suture-based vascular closure devices.
Methods:
A total of 366 patients (age: 64.3 years+/-10.7, male: 71.3%) were randomized to receive femoral access site closure with either a collagen-based closure device (group A) (n=214) or a suture-mediated device (group B) (n=152), immediately following coronary catheterization procedures. In all patients, the ankle-brachial-index (ABI) was measured before and the day after closure device application.
Results:
In group A, mean ABI at baseline was 1.09+/-0.2, in group B 1.11+/-0.2. In both groups, there was a significant, albeit clinically not relevant, reduction in post-procedural ABI (group A: 1.04+/-0.2, p<0.01 vs baseline, group B: 1.06+/-0.2, p<0.01 vs baseline). DeltaABI was not different between both VCD groups (p=0.55). In patients with peripheral vascular disease (PVD), neither the Angioseal device (mean ABI at baseline 0.76+/-0.1) nor the Perclose-device (mean ABI at baseline 0.79+/-0.1) induced a remarkable impairment of leg perfusion (Angioseal: 0.77+/-0.1, p=0.9 vs baseline, Perclose: 0.78+/-0.1, p=1.0 vs baseline). Clinically, no aggravation of claudication was observed in the PVD patient group.
Conclusion:
Both vascular closure devices are not associated with clinically relevant reduction in ABI. There was no difference between the two groups with respect to the level of flow impairment. Both devices may be safely used in patients with reduced ABI.
