title: Prospective controlled pilot study of arteriovenous fistula placement using the novel Optiflow device.
abstract: OBJECTIVE
  Arteriovenous fistula (AVF) maturation failure remains a significant problem with reported early failure rates around 50%. Suboptimal hemodynamics, variable surgical skills, and technique dependency are widely believed to contribute to AVF nonmaturation. The Optiflow (Bioconnect Systems, Ambler, Pa) is a novel anastomotic device placed in situ that has potential for improving hemodynamics and standardizing AVF placement. We report results from a prospective nonrandomized controlled pilot study designed to investigate the safety and performance of the Optiflow.
  
  
  METHODS
  Forty-one participants underwent AVF formation using either a 3-mm or 4-mm Optiflow and 39 matched control participants underwent AVF formation using the standard technique at two sites. Patients were observed for 90 days after AVF placement. The primary end point was unassisted maturation, which was defined as an outflow vein with a diameter ≥5 mm and blood flow ≥500 mL/min measured by Doppler ultrasound. The secondary performance end point was unassisted patency, and the primary safety end point was freedom from device-related serious adverse events.
  
  
  RESULTS
  Unassisted maturation rates at 14, 42, and 90 days were 76%, 72%, and 68%, respectively, for the Optiflow group and 67%, 68%, and 76%, respectively, in the control group (P = .38, .69, and .47 at 14, 42, and 90 days). There was a trend to earlier maturation (assessed at 14 days) in the 4-mm Optiflow group compared with the control group (P = .059). There were no device-related serious adverse events.
  
  
  CONCLUSIONS
  Maturation results for both the Optiflow and control groups were highly favorable compared with historical assisted maturation rates of approximately 50%. The Optiflow appears to be safe and effective in the placement of AVFs, with high maturation rates.
authors.affiliation: Department of Renal Medicine, Manchester Royal Infirmary, Manchester, United Kingdom; Division of Nephrology, Khoo Teck Puat Hospital, Singapore, Singapore. Electronic address: milindnikam@gmail.com.
authors.forename: Milind
authors.initials: M
authors.lastname: Nikam
authors.affiliation: Department of Transplantation, St George's Healthcare NHS Trust, London, United Kingdom.
authors.forename: Eric Solomon
authors.initials: ES
authors.lastname: Chemla
authors.affiliation: Department of Renal Medicine, Manchester Royal Infirmary, Manchester, United Kingdom.
authors.forename: Jackie
authors.initials: J
authors.lastname: Evans
authors.affiliation: Department of Renal Medicine, Manchester Royal Infirmary, Manchester, United Kingdom.
authors.forename: Angela
authors.initials: A
authors.lastname: Summers
authors.affiliation: Department of Renal Medicine, Manchester Royal Infirmary, Manchester, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Brenchley
authors.affiliation: Department of Transplantation, Manchester Royal Infirmary, Manchester, United Kingdom.
authors.forename: Afshin
authors.initials: A
authors.lastname: Tavakoli
authors.affiliation: Division of Nephrology, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Prabir
authors.initials: P
authors.lastname: Roy-Chaudhury
authors.affiliation: Department of Renal Medicine, Manchester Royal Infirmary, Manchester, United Kingdom.
authors.forename: Sandip
authors.initials: S
authors.lastname: Mitra
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects / Q000295:instrumentation*; D001783:Blood Flow Velocity; D004739:England; D004867:Equipment Design; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D006435:Renal Dialysis; D013997:Time Factors; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D034941:Upper Extremity / Q000098:blood supply*; D014654:Vascular Patency; D014680:Veins / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery