title: Evaluation of 4-mm to 7-mm versus 6-mm prosthetic brachial-antecubital forearm loop access for hemodialysis: results of a randomized multicenter clinical trial.
abstract: OBJECTIVE
  Prosthetic arteriovenous fistulas for hemodialysis vascular access have a high incidence rate of thrombotic occlusions that result in graft failure. This randomized multicenter study was performed to assess the patency rates and the effect of 4-mm to 7-mm grafts on the development of stenoses.
  
  
  METHODS
  A total of 109 patients who needed vascular access for hemodialysis were randomized to receive either 6-mm (n = 57) or 4-mm to 7-mm prosthetic brachial-antecubital forearm loop accesses (polytetrafluoroethylene). Duplex scanning, with measurement of blood flow and peak systolic velocity and detection of stenoses (>50%), was performed at 1, 6, and 12 months after surgery. Clinical data were obtained in a prospective manner and primary, assisted primary, and secondary patency rates were calculated with the Kaplan-Meier life-table analysis. Statistical analysis was performed with the independent samples t test and chi(2) test.
  
  
  RESULTS
  At 1 year, patency rates were similar for both 4-mm to 7-mm and 6-mm prostheses (primary, 46% versus 43%; assisted primary, 62% versus 58%; secondary, 87% versus 91%). The incidence rate of thrombotic occlusion was comparable for both groups (0.74/patient-year versus 0.88/patient-year; P >.05). Mean graft flow at 1, 6, and 12 months was 1416 versus 1415 mL/min, 1345 versus 1319 mL/min, and 1595 versus 1265 mL/min (P >.05) for 4-mm to 7-mm and 6-mm grafts, respectively. Also, no differences in peak systolic velocities in any part of the grafts were observed. The percentage of stenoses detected was equal in both groups at 1 year after surgery (27% versus 20%; P >.05).
  
  
  CONCLUSIONS
  A 4-mm to 7-mm tapered prosthetic brachial-antecubital forearm loop access did not reduce the incidence rates of stenoses and thrombotic occlusions compared with a 6-mm prosthetic conduit. Moreover, no differences in patency rates were observed. Therefore, we believe that the 4-mm to 7-mm graft should not be used routinely for hemodialysis vascular access.
authors.affiliation: Department of Surgery, University Hospital Maastricht, Maastricht, The Netherlands.
authors.forename: Ruben
authors.initials: R
authors.lastname: Dammers
authors.forename: R Nils
authors.initials: RN
authors.lastname: Planken
authors.forename: Katrien P m
authors.initials: KP
authors.lastname: Pouls
authors.forename: Rob J
authors.initials: RJ
authors.lastname: Van Det
authors.forename: Hens
authors.initials: H
authors.lastname: Burger
authors.forename: Frank M
authors.initials: FM
authors.lastname: Van Der Sande
authors.forename: Jan H m
authors.initials: JH
authors.lastname: Tordoir
mesh_terms: D001166:Arteriovenous Shunt, Surgical / Q000295:instrumentation*; D001783:Blood Flow Velocity; D001807:Blood Vessel Prosthesis; D001916:Brachial Artery; D002408:Catheters, Indwelling; D005260:Female; D005542:Forearm / Q000098:blood supply*; D006801:Humans; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency