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Published on: June 12, 2021
Surgical complications from hemostatic puncture closure devices
J F Eidt1, S Habibipour, J F Saucedo
1Department of Surgery, University of Arkansas for Medical Sciences and John L. McClellan VAMC, Little Rock, USA.
American Journal of Surgery
|February 12, 2000
Summary
The Angio-Seal device for arterial puncture closure led to a significant increase in surgical repair for arterial occlusive complications. Surgeons need to understand these hemostatic devices to manage complications effectively.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- The Food and Drug Administration has approved multiple hemostatic puncture closure devices for immediate hemostasis after percutaneous arterial catheterization.
- This study reviews institutional experience with the Angio-Seal device.
Purpose of the Study:
- To evaluate the safety and efficacy of the Angio-Seal hemostatic closure device.
- To assess the rate of vascular complications requiring surgical intervention after femoral cardiac catheterization using Angio-Seal compared to manual compression.
Main Methods:
- A retrospective, single-center, nonrandomized observational study.
- Inclusion of all patients undergoing femoral cardiac catheterization with either Angio-Seal device or routine manual compression.
- Analysis of vascular complications, including mechanical failures, arterial occlusion, stenosis, and embolization.
Main Results:
- The Angio-Seal device experienced immediate mechanical failure in 8% of patients.
- Surgical repair was required in 1.6% of patients following Angio-Seal use versus 0.3% with manual compression (P = 0.004).
- Five patients experienced femoral artery occlusion or stenosis due to the device; one patient had polymer anchor embolization.
Conclusions:
- The initial year of Angio-Seal utilization was associated with a significant rise in arterial occlusive complications necessitating surgical repair.
- Familiarity with the Angio-Seal device's design is crucial for surgeons to effectively manage associated surgical complications.
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