title: Pain and discomfort in closure of femoral access coronary angiography. The CLOSuredEvices Used in everyday Practice (CLOSE-UP) pain sub study.
abstract: BACKGROUND
  Pain and discomfort in relation to vascular closure are the predominant patient complaints after coronary angiography (CAG). No large-scale randomized studies have evaluated pain and discomfort after CAG with access site closure by manual compression versus a vascular closure device (VCD).
  
  
  OBJECTIVE
  To compare pain and discomfort after femoral artery closure by manual compression versus FemoSeal® VCD.
  
  
  METHODS
  The study is a sub study to the CLOSE-UP study, a randomized, single centre comparison of FemoSeal(®) VCD versus manual compression after CAG. Pain and discomfort score was assessed immediately after the closure procedure, at time for mobilization, at discharge and after 14 days.
  
  
  RESULTS
  1014 patients were included and 1001 patients entered analysis. In-hospital follow-up was obtained for all patients and 14-day follow-up was completed for 96% of patients. The closure procedure lasted 1 (1-1) min in the FemoSeal(®)VCD group and 8 (6-10) min in the manual compression group. Pain and discomfort score at the procedure was significantly higher in the FemoSeal(®)VCD group. No differences in pain and discomfort were detected after leaving the catheterization laboratory.
  
  
  CONCLUSIONS
  Closure of femoral access after CAG by the FemoSeal(®)VCD was associated with significantly more pain and discomfort compared with closure by manual compression. No difference in pain and discomfort was found at follow-up.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
authors.forename: Birthe
authors.initials: B
authors.lastname: Sindberg
authors.forename: Mia
authors.initials: M
authors.lastname: Schou
authors.forename: Lotte
authors.initials: L
authors.lastname: Hansen
authors.forename: Karen Juelsgaard
authors.initials: KJ
authors.lastname: Christiansen
authors.forename: Kristina Søgaard
authors.initials: KS
authors.lastname: Jørgensen
authors.forename: Marianne
authors.initials: M
authors.lastname: Søltoft
authors.forename: Niels Ramsing
authors.initials: NR
authors.lastname: Holm
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.forename: Steen Dalby
authors.initials: SD
authors.lastname: Kristensen
authors.forename: Jens Flensted
authors.initials: JF
authors.lastname: Lassen
mesh_terms: D059787:Acute Pain / Q000209:etiology / Q000451:nursing* / Q000517:prevention & control; D001510:Bed Rest / Q000451:nursing; D058128:Compression Bandages; D017023:Coronary Angiography / Q000009:adverse effects* / Q000451:nursing*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000451:nursing / Q000628:therapy; D005263:Femoral Artery; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000209:etiology / Q000451:nursing* / Q000517:prevention & control; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000451:nursing; D065506:Vascular Closure Devices / Q000009:adverse effects*
keywords: Manual compression; bleeding; coronary; coronary angiography; pain; vascular closure device