title: Comparison of collagen-based vascular closure devices in patients with vs. without severe peripheral artery disease.
abstract: OBJECTIVE
  To compare complication rates of a collagen-based vascular closure device (VCD) in patients with vs. without significant peripheral artery disease (PAD).
  
  
  METHODS
  A total of 382 patients (268 men; mean age 64.6±10.8 years) undergoing either an endovascular procedure of the lower limb (PAD group, n=132) or a percutaneous coronary intervention (PCI group, n=250) via a common femoral artery access were enrolled in this prospective study if hemostasis was achieved using the collagen-based Angio-Seal. In the PCI group, significant PAD was excluded by measurement of the ankle-brachial index. In-hospital major complications (bleeding, large hematoma, pseudoaneurysm, vessel occlusion, dissection) were recorded.
  
  
  RESULTS
  Similar and low rates of major complications were observed in both arms of the study: 2 (1.5%) major complications in the PAD group and 3 (1.2%) in the PCI group (p=1.0). There was no significant difference in efficacy of the VCDs in the groups (PAD group 99.2% vs. 100% in PCI group, p=0.35).
  
  
  CONCLUSIONS
  Our study shows no significant differences in the rate of major complications after utilization of a collagen-based VCD for femoral artery access site closure in patients with severe lower limb PAD compared to those without; however, complications in the PAD group tended to be more severe, with the need for surgical repair.
authors: 1 Department of Cardiology, West-German Heart Center Essen, University of Duisburg-Essen, Germany.
authors: Kaffer
authors: K
authors: Kara
authors: Philip
authors: P
authors: Kahlert
authors: Amir A
authors: AA
authors: Mahabadi
authors: Björn
authors: B
authors: Plicht
authors: Alexander Y
authors: AY
authors: Lind
authors: Detlev
authors: D
authors: Longwitz
authors: Matthias
authors: M
authors: Bollow
authors: Raimund
authors: R
authors: Erbel
mesh_terms: D000368:Aged; D003094:Collagen / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D057510:Endovascular Procedures / Q000009:adverse effects*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000293:injuries*; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006490:Hemostatics / Q000008:administration & dosage*; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000628:therapy*; D011446:Prospective Studies; D011677:Punctures; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome; D057772:Vascular System Injuries / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*
chemical_list: D006490:Hemostatics; D003094:Collagen