Abstract: FR-OR045

VasQ™ External Support Device Improves Functionality of Arteriovenous Fistulas: Randomized Controlled Study Results

Session Information

Category: Dialysis

  • 603 Hemodialysis: Vascular Access

Authors

  • Karydis, Nikolaos, Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
  • Bevis, Paul, Bristol, Bath and Weston Vascular Network, Bristol, United Kingdom
  • Maytham, Gary, St Georges University Hospital NHS Foundation Trust, London, United Kingdom
  • Halak, Moshe, Sheba Medical Center, Ramat - Gan, Israel
  • Zilberman, Noam, Laminate Medical Technologies, Tel-Aviv, Israel
Background

Inadequate maturation is a major drawback of the Arteriovenous Fistula (AVF). Non-laminar flow at the peri-anastomotic area and venous exposure to arterial circulation are associated with development of neo-intimal hyperplasia, impairing venous remodeling. VasQ™ is a novel external support device designed to optimize anastomosis geometry, regulate flow patterns and support the venous wall, thus improving AVF outcomes. Interim results of a randomized controlled study designed to evaluate VasQ™ usability, safety and efficacy are presented here.

Methods

Sixty patients referred for a Brachiocephalic AVF (BCAVF) in 4 different hospitals were recruited and randomized to the 'Device' group (End-to-side BCAVF + VasQ™, n=40), or the 'Control' group (End-to-side BCAVF, n=20). Patients were followed up 1, 3, and 6 months post AVF creation.

Results

Device implantation easily integrated with the BCAVF procedure. All patients were free from device related complications. Of patients with patent AVFs undergoing hemodialysis, significantly higher rates of AVF use, larger diameter veins, and less stenosis were seen in the 'Device' group 3 months post AVF creation (Table 1)
Primary patency rates 6 months post AVF creation were 79% vs. 67%, and the secondary patency rates were 88% vs. 79% in the 'Device' and 'Control' groups respectively. Average blood flow rates (mL/min) were 1214 vs. 1208 at 1 month, 1426 vs. 1173 at 3 months, and 1269 vs. 1175 at 6 months post AVF creation, for the 'Device' and 'Control' groups respectively.

Conclusion

A significant increase in functionality 3 months post AVF creation was observed in the Device group. This may be associated with an increase in laminar flow and a decrease in venous wall tension promoted by VasQ™.

Table 1 - AVF functionality 3 months post creation
 Access used for dialysis (%)
(p=0.0126)
Average vein diameter (mm)
(p=0.0273)
AVF with reported stenosis (%)
AVFCatheter
Device (n=18)*9558.7616.66
Control (n=10)*50507.0430

* Patients with a patent AVF, on active hemodialysis

Funding

  • Commercial Support