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Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for
Talje M Fokkema1, Robert C Minnee1, Gert-Aldert H Kock2
1Department of Vascular Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Insights
Arterial closure devices (ACDs) may increase risks for patients undergoing endovascular procedures for peripheral artery disease. Manual compression (MC) showed fewer ischemic and hemorrhagic complications compared to ACDs.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Peripheral Artery Disease Management
Background:
- Arterial closure devices (ACDs) are commonly used for hemostasis after vascular access.
- Evidence regarding ACD safety and efficacy in peripheral endovascular interventions is limited.
- Comparison of ACDs versus manual compression (MC) for femoral artery access in peripheral artery disease (PAD) is needed.
Purpose of the Study:
- To compare ischemic and hemorrhagic complications between ACDs and MC.
- To evaluate the safety and effectiveness of ACDs in endovascular lower extremity procedures.
Main Methods:
- Retrospective review of endovascular interventions for PAD from January 2012 to April 2014.
- Primary outcome: ischemic complication requiring reintervention.
- Secondary outcomes: hematoma, infection; multivariate analysis for predictors of complications.
Main Results:
- ACDs were used in 54% of interventions.
- Five patients (2%) with ACDs required emergency surgery for ischemic complications versus none with MC (P=0.06).
- Hematomas occurred in 9% with ACDs versus 3% with MC (OR, 3.4; P=0.015). ACD use and smoking predicted complications.
Conclusions:
- ACD use in PAD patients is associated with increased morbidity and serious adverse events.
- The potential benefits of ACDs over MC should be carefully considered.
- ACDs may pose higher risks in peripheral endovascular procedures.
Objective:
Arterial closure devices (ACDs) seem to be safe and effective to obtain hemostasis for cardiac interventions and diagnostic vascular procedures. However, only limited evidence is presented on therapeutic interventions in patients with peripheral atherosclerotic disease. We compared ischemic and hemorrhagic complications of an ACD vs manual compression (MC) after puncture of the femoral artery for endovascular lower extremity procedures.
Methods:
The records of all subsequent endovascular interventions for peripheral artery disease performed in a large teaching hospital, from January 2012 to April 2014, were retrospectively reviewed. The primary outcome was an ischemic complication requiring reintervention. Secondary outcomes were hematoma (needing conservative or invasive intervention) and infection (needing intervention or antibiotics). Multivariate analysis was performed to identify predictors for any complication.
Results:
The Angio-Seal (St. Jude Medical, Minnetonka, Minn) closure device was used in 244 of 463 endovascular interventions (54%). Five patients (2%) who received an ACD needed emergency surgery for ischemic complications vs none in the MC group (P = .06). Hematomas occurred in 22 patients (9%) after ACD vs in six (3%) after MC (adjusted odds ratio [OR], 3.4; 95% confidence interval [CI], 1.4-8.9; P = .015). There were no infections in either group. ACD (OR, 3.8; 95% CI, 1.5-9.7) and current smoking (OR, 2.6; 95% CI, 1.01-6.7) were independent predictors for any complication.
Conclusions:
This study demonstrates that ACD use in patients with peripheral artery disease can lead to serious adverse events resulting in increased morbidity. Therefore, the potential benefits of an ACD over MC should be carefully weighed.
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