title: Prospective study evaluating technical and clinical outcomes from the use of low profile angioplasty (LOPA) systems.
abstract: OBJECTIVE
  To compare the success and complication associated with 4 and 5 F access systems prospectively in the treatment of infra-inguinal vascular disease.
  
  
  METHODS
  One hundred and twenty consecutive patients were treated for lower limb vascular disease via a 4 F (n = 60) or 5 F (n = 60) access sheath over a 12 month period. All common femoral arteries were punctured in an antegrade direction with ultrasound guidance. Seven minutes of manual compression was applied and the groin assessed with ultrasound to document complications. Repeated manual compression was applied until haemostasis was achieved in all cases. Time to haemostasis, equipment used, patient biochemical data, and demographics were recorded. Patients were followed-up at a mean of 12 weeks post-procedure.
  
  
  RESULTS
  Antegrade access and sheath insertion was achieved in all cases. The technical success of the procedure was 56/60 (93%) cases using 4 F access and 57 (95%) cases using 5 F access. The time to haemostasis was reduced to a mean of 8.2 min (range 7-12 min) with a 4 F system compared to a mean of 12 min (range 7-30 minutes) with a 5 F system (p = 0.045). Overall there were 12 complications (10%; 11 <2 cm haematomas and one pseudoaneurysm) noted on ultrasound post-haemostasis, although there was no statistically significance difference between the two groups. Hypertension and renal dysfunction were associated with complications (p < 0.05). A 4 F system used an additional average of 5.1 (range 3-8) wires and catheters compared to an additional average of 3.5 (range 2-6) wires and catheters when using a 5 F system (p = 0.002). A 4 F technique cost three-times that of a 5 F technique.
  
  
  CONCLUSIONS
  Four and 5 F access sheaths allow safe and successful infra-inguinal angioplasty with a low complication rate. Hypertensive patients and those with impaired renal function are at increased risk of complications. There are increasing costs using a 4 F system offset by a decrease in time to haemostasis following manual compression but no reduction in complication rate.
authors: Department of Radiology, John Radcliffe Hospital, Oxford University Hospitals, Headington, Oxford, UK.
authors: C R
authors: CR
authors: Tapping
authors: M W
authors: MW
authors: Little
authors: J H
authors: JH
authors: Briggs
authors: J B
authors: JB
authors: Woodhouse
authors: S
authors: S
authors: Dixon
authors: S
authors: S
authors: Anthony
authors: R
authors: R
authors: Uberoi
authors: M J
authors: MJ
authors: Bratby
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000379:methods*; D005260:Female; D005263:Femoral Artery / Q000601:surgery; D006488:Hemostasis, Surgical; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional