title: Safety and effectiveness of a novel vascular closure device: a prospective study of the ExoSeal compared to the Angio-Seal and ProGlide.
abstract: OBJECTIVE
  To prospectively assess the safety and efficacy of a novel absorbable vascular closure device (ExoSeal) in patients undergoing cardiac catheterization with femoral access compared to the established collagen-based (Angio-Seal) and suture-mediated (ProGlide) closure devices.
  
  
  METHODS
  This prospective, observational, dual-center, non-randomized, non-blinded study enrolled 1013 patients (65.1 ± 11.8 years) undergoing cardiac catheterization via a common femoral artery access in which hemostasis was achieved using a vascular closure device (255 Angio-Seal, 258 ProGlide, and 500 ExoSeal). In hospital complications (bleeding, hematoma, pseudoaneurysm, vessel occlusion, dissection, and arteriovenous fistula) of the puncture site and device failures (persistent bleeding) were recorded and compared for ExoSeal vs. the established devices (Angio-Seal + ProGlide).
  
  
  RESULTS
  There were more complications after utilization of ExoSeal compared to established devices (3.6% vs. 1.2%, p=0.012). No significant difference was observed in the device success rate between the established vascular closure devices (96.3%) and the novel device (94.8%, p=0.28). Considering each closure system, Angio-Seal had the lowest complication rate (0.4%) and the highest efficacy (99.2%); the latter differed significantly from ExoSeal (94.8%, p=0.001). Logistic regression analysis revealed a >3-fold odds of complications when using ExoSeal, which remained unchanged in multivariate analysis.
  
  
  CONCLUSIONS
  Utilization of the novel vascular closure device is associated with a higher complication rate and a similar device failure rate compared to collagen-based and suture-mediated devices, with Angio-Seal having the lowest complication and device failure rates.
authors.affiliation: 1 Cardiovascular Center, St. Josef Hospital, Ruhr-University Bochum, Germany.
authors.forename: Kaffer
authors.initials: K
authors.lastname: Kara
authors.forename: Amir A
authors.initials: AA
authors.lastname: Mahabadi
authors.forename: Hanna
authors.initials: H
authors.lastname: Rothe
authors.forename: Patrick
authors.initials: P
authors.lastname: Müller
authors.forename: Jan
authors.initials: J
authors.lastname: Krüger
authors.forename: Horst
authors.initials: H
authors.lastname: Neubauer
authors.forename: Oliver
authors.initials: O
authors.lastname: Klein-Wiele
authors.forename: Andreas
authors.initials: A
authors.lastname: Mügge
authors.forename: Philipp
authors.initials: P
authors.lastname: Kahlert
authors.forename: Raimund
authors.initials: R
authors.lastname: Erbel
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000379:methods*; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005263:Femoral Artery; D005858:Germany; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011446:Prospective Studies; D011677:Punctures; D012307:Risk Factors; D016896:Treatment Outcome
keywords: absorbable plug; collagen-based closure device; complications; femoral artery access; hemostasis; suture-mediated closure device; vascular access; vascular closure devices