Adding access blood flow surveillance reduces thrombosis and improves arteriovenous fistula patency: a randomized controlled trial

Abstract

Purpose Stenosis is the main cause of arteriovenous fistula (AVF) failure. It is still unclear whether surveillance based on vascular access blood flow (QA) enhances AVF function and longevity. Methods We conducted a three-year follow-up randomized, controlled, multicenter, open-label trial to compare QA-based surveillance and pre-emptive repair of subclinical stenosis with standard monitoring/surveillance techniques in prevalent mature AVFs. AVFs were randomized to either the control group (surveillance based on classic alarm criteria; n = 104) or to the QA group (QA measured quarterly using Doppler ultrasound [ M-Turbo®] and ultrasound dilution [Transonic®] added to classic surveillance; n = 103). The criteria for intervention in the QA group were: 25% reduction in QA, QA<500 mL/min or significant stenosis with hemodynamic repercussion (peak systolic velocity [PSV] more than 400 cm/sc or PSV pre-stenosis/stenosis higher than 3). Results At the end of follow-up we observed a significant reduction in the thrombosis rate in the QA group (0.025 thrombosis/patient/year in the QA group vs. 0.086 thrombosis/patient/year in the control group [p = 0.007]). There was a significant improvement in the thrombosis-free patency rate (HR, 0.30; 95% CI, 0.11-0.82; p = 0.011) and in the secondary patency rate in the QA group (HR, 0.49; 95% CI, 0.26-0.93; p = 0.030), with no differences in the primary patency rate between the groups (HR, 0.98; 95% CI, 0.57-1.61; p = 0.935). There was greater need for a central venous catheter and more hospitalizations associated with vascular access in the control group (p = 0.034/p = 0.029). Total vascular access-related costs were higher in the control group (€227.194 vs. €133.807; p = 0.029). Conclusions QA-based surveillance combining Doppler ultrasound and ultrasound dilution reduces the frequency of thrombosis, is cost effective, and improves thrombosis free and secondary patency in autologous AVF.