Study protocol for a French multicenter randomized controlled trial evaluating the medicoeconomic impact of Surgical vs Endovascular Arteriovenous Access Creation for Hemodialysis in End-stage Renal Disease (ENDO-FAV)

Abstract

Background

Vascular access is indispensable for performing hemodialysis in patients with end-stage renal disease. The Kidney Disease Outcome Quality Initiative and the French Health Authority advocate for native arteriovenous fistulas (AVFs) as a primary option owing to their association with lower morbidity, mortality, and enhanced quality of life. However, a significant proportion of AVFs fail to mature, and many require multiple re-interventions, increasing overall costs. To address these issues, endovascular techniques for AVF creation have been developed. These methods use energy-based technologies, avoiding vessel dissection and preserving perivascular tissues. Initial results are promising, but these devices are expensive, and the technical act of creating an endovenous fistula is not recorded in the coding of the common classification of medical procedures and, as such, cannot be reimbursed by health insurance in France. Although international studies suggest their effectiveness, no French studies have yet replicated or confirmed these findings in the local context, which would help to support a reimbursement request from health insurance.

Methods

This protocol represents the first French medicoeconomic study to compare the two available endovascular AVF creation devices (Ellipsys and WaveLinQ) with traditional open surgery. This multicenter, comparative clinical trial will randomize patients into two parallel groups: (1) endovascular AVF creation using either the WaveLinQ or Ellipsys device, and (2) surgical proximal AVF creation (brachiocephalic/brachiobasilic). Randomization will be balanced and stratified by center and dialysis timing. Follow-up assessments will occur at 1 week and 1, 3, 6, 12, and 18 months. The primary objective is to evaluate the cost effectiveness of endovascular AVF creation compared with open surgery from the perspective of the French health care system. The primary end point is the cost-utility ratio (cost per quality-adjusted life year gained) of endovascular AVF vs open surgery. Utility is assessed using the EQ-5D-5 L questionnaire, with costs derived from micro-costing and the National Health Data System. Secondary outcomes include health economics with total costs at 18 and 36 months, success rate of vascular access creation, AVF maturation and functionality, recirculation rates, early and late access failures, cannulation success, primary and secondary patency, reintervention rates, and adverse events. Based on a cost-utility threshold of €30,000 per quality-adjusted life year, cost difference estimates, and standard deviations from previous studies, anticipated sample size is 126 patients per group (endovascular and surgical), totaling 252 patients with approximately 142 patients for the Ellipsys device and 110 patients for WaveLinQ, based on the capacity of 7 centers using Ellipsys and 4 centers using WaveLinQ.

Conclusions

This multicenter randomized controlled trial will provide contemporary data on the clinical outcomes and prognoses for endovascular AVF techniques, potentially establishing endovascular methods as a viable and cost-effective alternative to traditional surgical AVF creation.