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

Abstract

The aim of this study was to evaluate the safety and efficacy of VasQTM, a permanent extravascular nitinol vascular support device, implanted around the anastomosis of de novo arteriovenous fistulas (AVF), in consecutive patients. 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. Between March and November 2022, 21 patients received the VasQTM 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. This study demonstrates that the VasQTM AVFs achieved high rates of maturation at 6-weeks, without the need to modify standards of care. VasQTM can successfully assist in achieving excellent results at the introduction of the device to a new center.