title: Clinical and Subclinical Femoral Vascular Complications after Deployment of two Different Vascular Closure Devices or Manual Compression in the Setting of Coronary Intervention.
abstract: BACKGROUND
  In the past two decades vascular closure devices (VCD) have been increasingly utilized as an alternative to manual compression after percutaneous femoral artery access. However, there is a lack of data confirming a significant reduction of vascular complication in a routine interventional setting. Systematic assessment of puncture sites with ultrasound was hardly performed.
  
  
  METHODS
  620 consecutive patients undergoing elective or urgent percutaneous coronary intervention were randomly allocated to either Angioseal (AS; n = 210), or Starclose (SC; n = 196) or manual compression (MC; n = 214). As an adjunct to clinical evaluation vascular ultrasonography was used to assess the safety of each hemostatic method in terms of major and minor vascular complications. The efficacy of VCDs was assessed by achievement of puncture site hemostasis.
  
  
  RESULTS
  No major complications needing transfusion or vascular surgery were observed. Furthermore, the overall incidence of clinical and subclinical minor complications was similar among the three groups. There was no differences in the occurrence of pseudoaneurysmata (AS = 10; SC = 6; MC = 10), arteriovenous fistula (AS = 1; SC = 4; MC = 2) and large hematoma (AS = 11; SC = 10; MC = 14). The choice of access site treatment had no impact in the duration of hospital stay (AS = 6.7; SC = 7.4; MS = 6.4 days).
  
  
  CONCLUSIONS
  In the setting of routine coronary intervention AS and SC provide a similar efficacy and safety as manual compression. Subclinical vascular injuries are rare and not related to VCD use.
authors.affiliation: 1. Department of Cardiology, Johanniter-Hospital Duisburg Rheinhausen, Germany, Kreuzacker 1-7, 47228 Duisburg / Ruhr-University of Bochum, Universitätsstrasse 150, 44801 Bochum.
authors.forename: Hakan
authors.initials: H
authors.lastname: Yeni
authors.affiliation: 2. Department of Cardiology, Cologne-Merheim-Hospital, Germany.
authors.forename: Meissner
authors.initials: M
authors.lastname: Axel
authors.affiliation: 3. Department of Radiology, Ruhr-University Bochum, Germany.
authors.forename: Ahmet
authors.initials: A
authors.lastname: Örnek
authors.affiliation: 4. Department of Cardiology and Angiology, Universitätsklinik Marienhospital Herne, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Butz
authors.affiliation: 2. Department of Cardiology, Cologne-Merheim-Hospital, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Maagh
authors.affiliation: 1. Department of Cardiology, Johanniter-Hospital Duisburg Rheinhausen, Germany, Kreuzacker 1-7, 47228 Duisburg / Ruhr-University of Bochum, Universitätsstrasse 150, 44801 Bochum.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Plehn
mesh_terms: D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000150:complications / Q000473:pathology / Q000628:therapy; D005260:Female; D005263:Femoral Artery / Q000473:pathology / Q000601:surgery*; D006321:Heart / Q000503:physiopathology; D006487:Hemostasis; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods*; D011677:Punctures / Q000009:adverse effects; D016896:Treatment Outcome; D065506:Vascular Closure Devices / Q000009:adverse effects; D014656:Vascular Surgical Procedures / Q000295:instrumentation* / Q000379:methods
keywords: angioseal; randomized comparison; starclose; vascular closure device