title: Evaluation of the 6-F ExoSeal vascular closure device in antegrade femoral artery punctures.
abstract: OBJECTIVE
  To evaluate the safety, comfort, and efficacy of an extravascularly deployed bioabsorbable plug-based vascular closure device (VCD) for sealing 6-F antegrade access sites in patients requiring peripheral endovascular intervention.
  
  
  METHODS
  A single-center, single-arm, prospective study to evaluate the 6-F ExoSeal VCD in terms of technical success, adverse events, and patient comfort enrolled 59 unselected symptomatic patients (42 men; mean age 72.1 ± 9.3 years) suffering from peripheral artery disease in an 11-month period. Patients with high body mass index (BMI) or calcification at the access site were not excluded. Calcifications of the access vessel were scored as grades 1-4 from fluoroscopic images. The pain level during implantation was evaluated after the procedure using a visual rating scale.
  
  
  RESULTS
  Technical success rate was 98.3%; 1 primary device failure was converted to manual compression. In addition, 1 (1.7%) pseudoaneurysm, 2 (3.4%) minor hematomas, and 1 (1.7%) minor secondary bleeding were observed. There was no intravascular application of the device detected. Neither BMI, calcification of the access vessel (present in 74.6%, mean score 1.4 ± 1.1), age, nor blood clotting had any statistically significant influence on adverse events. In total, 55 (93.2%) patients felt no pain during the VCD implantation.
  
  
  CONCLUSIONS
  The tested VCD was safe, with an excellent technical success rate even in cases with severe access vessel calcification.
authors.affiliation: Institute for Clinical Radiology, Ludwig-Maximilians-University Hospital Munich, Germany. Daniel.Maxien@med.uni-muenchen.de
authors.forename: Daniel
authors.initials: D
authors.lastname: Maxien
authors.forename: Barbara
authors.initials: B
authors.lastname: Behrends
authors.forename: Karla M
authors.initials: KM
authors.lastname: Eberhardt
authors.forename: Tobias
authors.initials: T
authors.lastname: Saam
authors.forename: Sven F
authors.initials: SF
authors.lastname: Thieme
authors.forename: Maximilian F
authors.initials: MF
authors.lastname: Reiser
authors.forename: Marcus
authors.initials: M
authors.lastname: Treitl
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017541:Aneurysm, False / Q000209:etiology; D002406:Catheterization, Peripheral / Q000009:adverse effects*; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005263:Femoral Artery; D005858:Germany; D006406:Hematoma / Q000209:etiology; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D017060:Patient Satisfaction; D011446:Prospective Studies; D011677:Punctures; D012307:Risk Factors; D016896:Treatment Outcome; D061205:Vascular Calcification / Q000150:complications