title: Surgical complications from hemostatic puncture closure devices.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, University of Arkansas for Medical Sciences and John L. McClellan VAMC, Little Rock, USA.
authors.forename: J F
authors.initials: JF
authors.lastname: Eidt
authors.forename: S
authors.initials: S
authors.lastname: Habibipour
authors.forename: J F
authors.initials: JF
authors.lastname: Saucedo
authors.forename: J
authors.initials: J
authors.lastname: McKee
authors.forename: F
authors.initials: F
authors.lastname: Southern
authors.forename: G W
authors.initials: GW
authors.lastname: Barone
authors.forename: J D
authors.initials: JD
authors.lastname: Talley
authors.forename: M
authors.initials: M
authors.lastname: Moursi
mesh_terms: D001157:Arterial Occlusive Diseases / Q000209:etiology* / Q000601:surgery; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006489:Hemostatic Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011677:Punctures; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration