title: Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis.
abstract: OBJECTIVE
  This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures.
  
  
  BACKGROUND
  Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial.
  
  
  METHODS
  Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion.
  
  
  RESULTS
  A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79).
  
  
  CONCLUSIONS
  In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.
authors.affiliation: Cardiovascular Research Foundation and the Lenox Hill Heart and Vascular Institute, New York, New York 10022, USA.
authors.forename: Eugenia
authors.initials: E
authors.lastname: Nikolsky
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Amir
authors.initials: A
authors.lastname: Halkin
authors.forename: Eve D
authors.initials: ED
authors.lastname: Aymong
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: Zoran
authors.initials: Z
authors.lastname: Lasic
authors.forename: Manuela
authors.initials: M
authors.lastname: Negoita
authors.forename: Martin
authors.initials: M
authors.lastname: Fahy
authors.forename: Shoshana
authors.initials: S
authors.lastname: Krieger
authors.forename: Issam
authors.initials: I
authors.lastname: Moussa
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.forename: George
authors.initials: G
authors.lastname: Dangas
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation*; D001458:Bandages; D016022:Case-Control Studies; D015331:Cohort Studies; D004868:Equipment Failure; D005263:Femoral Artery / Q000601:surgery*; D006801:Humans; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000627:therapeutic use; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D016032:Randomized Controlled Trials as Topic; D013223:Statistics as Topic; D014652:Vascular Diseases / Q000453:epidemiology / Q000209:etiology*
chemical_list: D019039:Platelet Glycoprotein GPIIb-IIIa Complex