title: The Angio-Seal™ femoral closure device allows immediate ambulation after coronary angiography and percutaneous coronary intervention.
abstract: OBJECTIVE
  To test the safety of immediate mobilisation of patients undergoing coronary angiography and percutaneous coronary intervention (PCI) closed with Angio-Seal™ -a femoral vascular closure device.
  
  
  RESULTS
  First, a randomised controlled trial of immediate mobilisation vs. delayed ambulation was performed followed by a prospective validation registry to test the obtained results in a real-world situation. The randomised trial comprised 300 patients; the validation registry comprised 1,097 patients. Primary endpoints were complications defined as: small haematoma <5 cm and/or minor bleeding/oozing from the puncture site, haematomas ≥ 5 cm, bleeding needing transfusion, bleeding needing surgical attention, pseudoaneurysm and vasovagal reaction. In the randomised trial, overall complications were similar in both groups (16.0%vs.18.8%; p=0.53). Small haematomas/small bleedings/oozing were the most frequent (12.2% vs.15.3; p=0.44). There were no bleedings needing transfusion or surgical attention, and no pseudoaneurysms occurred. The prospective registry showed similar results. In the standard-care cohort, complications were similar to those in the implementation cohort (9.6% vs.11.3%; p=0.41), mainly consisting of small haematomas/minor bleedings/oozing (6.1% vs.7.3%; p=0.49). No bleedings needed transfusion or surgical attention. Pseudoaneurysms occurred in 1 (0.34%) vs. 3 (0.37%; p=0.94) and vasovagal reactions in three (1.0%) vs. four (0.5%; p=0.33) patients. It was possible to mobilise 87% of patients in the implementation cohort.
  
  
  CONCLUSIONS
  In patients undergoing coronary angiography or PCI, the use of immediate mobilisation after Angio-Seal™ deployment is safe. With routine use of a femoral vascular closure device, approximately 87% of patients are suitable for immediate mobilisation.
authors.affiliation: Department of Cardiology, Gentofte University Hospital, Hellerup, Denmark. Hvelplund@dadlnet.dk
authors.forename: Anders
authors.initials: A
authors.lastname: Hvelplund
authors.forename: Raban
authors.initials: R
authors.lastname: Jeger
authors.forename: Remo
authors.initials: R
authors.lastname: Osterwalder
authors.forename: Majken
authors.initials: M
authors.lastname: Bredahl
authors.forename: Jan Kyst
authors.initials: JK
authors.lastname: Madsen
authors.forename: Jan Skov
authors.initials: JS
authors.lastname: Jensen
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.forename: Matthias
authors.initials: M
authors.lastname: Pfisterer
authors.forename: Soren
authors.initials: S
authors.lastname: Galatius
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D004434:Early Ambulation; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006488:Hemostasis, Surgical / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged