Surgical complications from hemostatic puncture closure devices

Am J Surg. 1999 Dec;178(6):511-6. doi: 10.1016/s0002-9610(99)00246-9.

Abstract

Background: For securing immediate hemostasis following percutaneous arterial catheterization, the Food and Drug Administration has approved three hemostatic puncture closure devices. We reviewed our institutional experience with one device (Angio-Seal).

Methods: A retrospective, single-center, nonrandomized observational study was made of all vascular complications following femoral cardiac catheterization.

Results: An immediate mechanical failure of the device was experienced in 34 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patients following Angio-Seal versus 0.3% (5 of 1662) following routine manual compression (P = 0.004). In 5 patients, the device caused either complete occlusion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery.

Conclusion: During the first year of utilization of a percutaneous hemostatic closure device following cardiac catheterization, we observed a marked increase in arterial occlusive complications requiring surgical repair. Surgeons must be familiar with the design of these devices to achieve precise repair of surgical complications.

MeSH terms

  • Arterial Occlusive Diseases / etiology*
  • Arterial Occlusive Diseases / surgery
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Equipment Design
  • Female
  • Femoral Artery
  • Hemostatic Techniques / adverse effects*
  • Hemostatic Techniques / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Punctures
  • Retrospective Studies
  • United States
  • United States Food and Drug Administration