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An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial
Nikolaos Karydis1, Paul Bevis2, Timothy Beckitt2
1Department of Nephrology and Transplantation, Guy's and St Thomas' NHS Foundation Trust, London.
Summary
The VasQ implant safely improved functional patency and vein diameter in dialysis arteriovenous fistulas (AVFs) at 6 months. This external support device shows promise for enhancing hemodialysis vascular access outcomes.
Area of Science:
- Vascular Surgery
- Nephrology
- Biomedical Engineering
Background:
- Dialysis arteriovenous fistulas (AVFs) can suffer from hyperplasia and stenosis, negatively impacting outcomes for hemodialysis patients.
- Turbulent blood flow and radial stretching of the venous wall are implicated mechanisms contributing to AVF dysfunction.
Purpose of the Study:
- To evaluate the safety and efficacy of the VasQ implant in supporting the surgical arteriovenous anastomosis.
- To assess the impact of the VasQ implant on reducing turbulent flow and venous wall stretching in AVFs.
Main Methods:
- A prospective, randomized, controlled, multicenter study involving 40 patients with kidney failure undergoing brachiocephalic fistula creation.
- Patients were randomized to either standard AVF creation with VasQ implant placement (treatment) or standard AVF creation without the implant (control).
- Primary safety outcome was severe device-related adverse events; secondary efficacy outcomes included AVF maturation, functional and primary patency, vein diameter, and blood flow at 3 and 6 months.
Main Results:
- No severe device-related adverse events were reported, indicating a favorable safety profile for the VasQ implant.
- While maturation and primary patency at 6 months showed no significant difference, the VasQ group exhibited significantly larger vein luminal diameters at both 3 and 6 months.
- Functional patency at 6 months was significantly higher in the VasQ treatment group (100%) compared to the control group (56%).
Conclusions:
- The VasQ implant demonstrated a safe profile for external support of brachiocephalic AVFs.
- The device led to improved functional patency and increased vein luminal diameters, suggesting it can positively influence hemodynamic disturbances in the juxta-anastomotic region.
- VasQ shows potential for improving outcomes in hemodialysis patients by addressing key mechanisms of AVF failure.
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