title: Comparison of the novel Angio-Seal Evolution with Angio-Seal STS closure device.
abstract: BACKGROUND
  Angio-Seal Evolution (ASE) is a novel vascular closure device (VCD) engineered to reduce deployment skills. It is unknown if these changes translated into better clinical results.
  
  
  RESULTS
  Early VCD failure and major and minor vascular complications were prospectively assessed in 584 consecutive patients treated by ASE (ASE group) and in 633 consecutive patients treated by the older Angio-Seal STS (AS-STS group). Early VCD failure was rare (ASE 1.7% vs AS-STS 1.3%, P = .52). Major vascular complication risk was similar (odds ratio [OR] = 1.76, 95% confidence interval [CI] = 0.79-3.90, P = .17), but minor vascular complication rate was significantly higher in the ASE group (OR = 3.36, 95% CI = 1.57-7.21, P = .002). At logistic regression ASE was an independent predictor of vascular complications. Early VCD failure was associated with the highest risk for vascular complications.
  
  
  CONCLUSIONS
  In a large unselected population, ASE-treated patients showed increased risk for minor vascular complications. Early VCD failure negatively affected short-term vascular prognosis.
authors.affiliation: Maggiore della Carità Hospital, Novara, Italy. lupialessandro1@tin.it
authors.forename: Alessandro
authors.initials: A
authors.lastname: Lupi
authors.forename: Andrea
authors.initials: A
authors.lastname: Rognoni
authors.forename: Gioel G
authors.initials: GG
authors.lastname: Secco
authors.forename: Maurizio
authors.initials: M
authors.lastname: Lazzero
authors.forename: Laura
authors.initials: L
authors.lastname: Plebani
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cossa
authors.forename: Danilo
authors.initials: D
authors.lastname: Reale
authors.forename: Mara
authors.initials: M
authors.lastname: Sansa
authors.forename: Angelo S
authors.initials: AS
authors.lastname: Bongo
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000401:mortality; D016009:Chi-Square Distribution; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D007558:Italy; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011446:Prospective Studies; D011677:Punctures; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome