title: Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis.
abstract: BACKGROUND
  Arterial puncture closing devices (APCDs) were developed to replace standard compression at the puncture site and to shorten bed rest following percutaneous coronary intervention.
  
  
  OBJECTIVE
  To assess the safety and efficacy of APCDs (Angioseal, Vasoseal, Duett, Perclose, Techstar, Prostar) compared with standard manual compression in patients undergoing coronary angiography or percutaneous vascular interventions.
  
  
  METHODS
  A systematic literature search of MEDLINE (1966-January 2003), EMBASE (1989-January 2003), PASCAL (1996-January 2003), BIOSIS (1990-January 2003), and CINHAL (1982-January 2003) databases and the Cochrane Central Register of Controlled Trials for relevant articles in any language.
  
  
  METHODS
  Included randomized controlled trials reporting vascular complications at the puncture site (hematoma, bleeding, arteriovenous fistula, pseudoaneurysm) and efficacy (time to hemostasis, time to ambulation, time to discharge from hospital).
  
  
  METHODS
  Two reviewers abstracted the data independently and in duplicate. Disagreements were resolved by discussion among at least 3 reviewers. The most important criteria were adequacy of allocation concealment, whether the analysis was according to the intention-to-treat principle, and if person assessing the outcome was blinded to intervention group. Random-effects models were used to pool the data.
  
  
  RESULTS
  Thirty trials met the selection criteria and included up to 4000 patients. When comparing any APCD with standard compression, the relative risk (RR) of groin hematoma was 1.14 (95% confidence interval [CI], 0.86-1.51; P =.35); bleeding, 1.48 (95% CI, 0.88-2.48; P =.14); developing an arteriovenous fistula, 0.83 (95% CI, 0.23-2.94; P =.77); and developing a pseudoaneurysm at the puncture site, 1.19 (95% CI, 0.75-1.88; P =.46). Time to hemostasis was shorter in the group with APCD compared with standard compression (mean difference, 17 minutes; range, 14-19 minutes), but there was a high degree of heterogeneity among studies. Only 2 studies explicitly reported allocation concealment, blinded outcome assessment, and intention-to-treat analysis. When limiting analyses to only trials that used explicit intention-to-treat approaches, APCDs were associated with a higher risk of hematoma (RR, 1.89; 95% CI, 1.13-3.15) and a higher risk of pseudoaneurysm (RR, 5.40; 95% CI, 1.21-24.5).
  
  
  CONCLUSIONS
  Based on this meta-analysis of 30 randomized trials, many of poor methodological quality, there is only marginal evidence that APCDs are effective and there is reason for concern that these devices may increase the risk of hematoma and pseudoaneurysm.
authors.affiliation: Department of Emergency Medicine, University of Vienna, Vienna General Hospital, Vienna, Austria.
authors.forename: Maria
authors.initials: M
authors.lastname: Koreny
authors.forename: Eva
authors.initials: E
authors.lastname: Riedmüller
authors.forename: Mariam
authors.initials: M
authors.lastname: Nikfardjam
authors.forename: Peter
authors.initials: P
authors.lastname: Siostrzonek
authors.forename: Marcus
authors.initials: M
authors.lastname: Müllner
mesh_terms: D017541:Aneurysm, False / Q000209:etiology / Q000517:prevention & control; D001164:Arteriovenous Fistula / Q000209:etiology / Q000517:prevention & control; D001458:Bandages; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000379:methods; D017023:Coronary Angiography; D004434:Early Ambulation; D006406:Hematoma / Q000209:etiology / Q000517:prevention & control; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation; D006801:Humans; D011312:Pressure; D011677:Punctures / Q000009:adverse effects; D014945:Wound Healing