Safety and efficacy of an innovative external support device for de novo arterio-venous fistula creation: a French bicentric experience.

Abstract

Background: The aim of this study was to evaluate the safety and efficacy of VasQ^TM, a permanent extravascular nitinol vascular support device, implanted around the anastomosis of de novo arteriovenous fistulas (AVF), in consecutive patients.

Methods: This was a French prospective bicentric study. All patients with an indication for creation of a distal or proximal end to side AVF performed by supervised trainee were eligible. Follow-up was performed clinically and by Duplex scan at 6 weeks and 6 months post fistula creation. Primary endpoint was functional maturation at 6 weeks defined as successful use for dialysis via 2-needle cannulation in dialysis patients or a flow rate of ≥600 mL/min and a target vein diameter ≥6 mm for pre-dialysis patients. Overall functional success for dialysis patients was assessed as well.

Results: Between March and November 2022, 21 patients received the VasQ^TM device and were followed for an average of 165 days. Median age was 61. Eleven patients (52%) were on dialysis at the time of implantation. AVFs were created with distal radial (N.=8), proximal radial (N.=5), brachial cephalic (N.=4) or brachial basilic (N.=4) arteries with 100% technical success . Functional maturation at 6-weeks was achieved in 81% (17/21). Functional success was 80% (12/15) with unassisted functional success of 67% (10/15) at 6 months for patients requiring dialysis at that time point. Two reoperations were performed within the device, one thrombectomy and one angioplasty, both were successful. Freedom from access-related interventions occurred in 71% (15/21) of the study population at 6-months.

Conclusions: This study demonstrates that the VasQ^TM AVFs achieved high rates of maturation at 6-weeks, without the need to modify standards of care. VasQ^TM can successfully assist in achieving excellent results at the introduction of the device to a new center.