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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
PubMed

Insights

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.
Abstract

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