title: Multicenter safety and efficacy analysis of assisted closure after antegrade arterial punctures using the StarClose device.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of the StarClose device for closure of antegrade punctures following infrainguinal endovascular interventions.
  
  
  METHODS
  A retrospective review was conducted of 221 consecutive patients treated with the StarClose device in a 12-month period at 5 centers (4 French and 1 British). Of these, 107 patients (69 men; median age 75 years, range 44-93) were from the UK cohort (111 closures), and 94 patients (75 men; median age 67 years, range 32-95) were from the French cohort (111 closures). Technical success, complication rates, demographic data, medical history, and procedural details were gathered for all patients. Residual bleeding and the requirement for additional manual compression were recorded when the device failed. Clinical evaluation was performed at discharge; color-coded duplex ultrasonography was done in a subset of French patients.
  
  
  RESULTS
  The overall technical success rate was 94.6% (210/222; 95% CI 3.1%-9.2%). The results were similar in the 2 cohorts: 95.5% (106/111; 95% CI 1.9%-10.1%) in the UK and 93.7% (104/111; 95% CI 3.1%-12.4%) in France. The 12 failures (5 UK and 7 France) were due to several mechanisms: device failure (n=5), obesity (n=1), groin scarring (n=2), and unexplained (n=4). In 2 failed cases, open surgical closure of the arteriotomy was performed because pressure hemostasis failed. Two pseudoaneurysms were observed: one after immediate failure was successfully treated by prolonged pressure; the other, after apparent success of the device, required surgical therapy. The incidence of serious vascular complication was 1.8% (4/222; 95% CI 0.7%-4.5%); 2 patients from each cohort.
  
  
  CONCLUSIONS
  The StarClose device safely and effectively closes antegrade punctures after infrainguinal endovascular intervention, even in patients who would be considered to be at high risk for puncture-site bleeding. However, a randomized trial would be required to support any definitive recommendations.
authors: Interventional Radiology/Northern Vascular Center, Freeman Hospital, Newcastle Upon Tyne, UK.
authors: Robin Edward Thomas
authors: RE
authors: Williams
authors: Claude Y
authors: CY
authors: Angel
authors: Ryad
authors: R
authors: Bourkaib
authors: Philippe
authors: P
authors: Brenot
authors: Philippe
authors: P
authors: Commeau
authors: Robert Kendall
authors: RK
authors: Fisher
authors: Ralph
authors: R
authors: Jackson
authors: Caroline Helen
authors: CH
authors: Kay
authors: Olivier
authors: O
authors: Le Dref
authors: Jean-Yves
authors: JY
authors: Riou
authors: John
authors: J
authors: Rose
authors: Sumaira
authors: S
authors: Macdonald
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002406:Catheterization, Peripheral; D004739:England; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005602:France; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011677:Punctures / Q000009:adverse effects*; D012189:Retrospective Studies; D016896:Treatment Outcome