Multicenter European real-world utilization of VasQ anastomotic external support device for arteriovenous fistulae

Abstract

Objective: To evaluate the outcomes of arteriovenous fistulae (AVF), created with VasQ external support device under standard clinical practice across three vascular access clinics.

Methods: This multinational, retrospective study evaluated prospectively collected clinical outcomes of both forearm and upper arm brachiocephalic AVF (BCAVF) created using the VasQ device. Fifty-one AVF patients were pooled from three different vascular access centers in Germany, Italy, and Spain. Postprocedure outcomes were assessed by flow measurement with ultrasound examination in all centers. Primary failure, usability, patency, and intervention rates during the study period were evaluated.

Results: Fifty-one VasQ devices were implanted during 37 forearm (36 radiocephalic and 1 ulnar-basilic AVF) and 14 BCAVF procedures. The study population comprised mostly males (73%) and Caucasians (82%), with a mean age of 62.5 years (range, 38-84 years) and mean body mass index of 29.2. One patient died owing to access-unrelated reasons, and one patient was lost to follow-up without AVF assessment after its creation. From the remaining 49, 3 patients had a follow-up of less than 4 weeks and were excluded from maturation, primary failure, and dialysis initiation analysis (because those factors could not be evaluated yet), leaving 46 patients in this evaluation. Maturation was achieved in 91% of patients. The primary failure rate was 9%. A primary patency rate of 77% was observed at 6, 12, and 18 months. The secondary patency rate was 91% at 6 months, and 85% at 12 months and 18 months. Both primary patency and secondary patency did not differ statistically when comparing forearm AVF with BCAVF (P > .25). Successful cannulation was achieved in 86% of patients (32/37) requiring dialysis with a median time from creation to cannulation of 46 days. Of those patients, the functional patency rate was 94%. Five patients underwent seven interventions to maintain or restore patency or functionality, with an overall rate of 0.248 interventions per patient-year.

Conclusions: AVFs created with VasQ external support device demonstrated promising patency and functionality outcomes in multicentric real-world setting across the two most commonly used anatomic locations.

Keywords: AVF; Arteriovenous fistula; End-stage kidney disease; External support device; Hemodialysis access; VasQ.