FLOW: Flow dysfunction of hemodialysis vascular access: A randomized controlled trial on the effectiveness of surveillance of arteriovenous fistulas and grafts.

INTRODUCTION: It is assumed that identification and correction of asymptomatic stenoses in the vascular access circuit will prevent thrombosis that would require urgent intervention to continue hemodialysis treatment. However, the evidence base for this assumption is limited. Recent international clinical practice guidelines reach different conclusions on the use of surveillance for vascular access flow dysfunction and recommend further research to inform clinical practice. METHODS: The FLOW trial is a double-blind, multicenter, randomized controlled trial with a 1:1 individual participant treatment allocation ratio over two study arms. In the intervention group, only symptomatic vascular access stenoses detected by clinical monitoring are treated, whereas in the comparison group asymptomatic stenoses detected by surveillance using monthly dilution flow measurements are treated as well. Hemodialysis patients with a functional arteriovenous vascular access are enrolled. The primary outcome is the access-related intervention rate that will be analyzed using a general linear model with Poisson distribution. Secondary outcomes include patient satisfaction, access-related serious adverse events, and quality of the surveillance process. A cost effectiveness analysis and budget impact analysis will also be conducted. The study requires 828 patient-years of follow-up in 417 participants to detect a difference of 0.25 access-related interventions per year between study groups. DISCUSSION: As one of the largest randomized controlled trials assessing the clinical impact of vascular access surveillance using a strong double-blinded study design, we believe the FLOW trial will provide much-needed evidence to improve vascular access care for hemodialysis patients.

Guideline recommendations on minimal blood vessel diameters and arteriovenous fistula outcomes.

OBJECTIVE: Clinical guidelines provide recommendations on the minimal blood vessel diameters required for arteriovenous fistula creation but the evidence for these recommendations is limited. We compared vascular access outcomes of fistulas created in agreement with the ESVS Clinical Practice Guidelines (i.e. arteries and veins >2 mm for forearm fistulas and >3 mm for upper arm fistulas) with fistulas created outside these recommendations. METHODS: The multicenter Shunt Simulation Study cohort contains 211 hemodialysis patients who received a first radiocephalic, brachiocephalic, or brachiobasilic fistula before publication of the ESVS Clinical Practice Guidelines. All patients had preoperative duplex ultrasound measurements according to a standardized protocol. Outcomes included duplex ultrasound findings at 6 weeks after surgery, vascular access function, and intervention rates until 1 year after surgery. RESULTS: In 55% of patients, fistulas were created in agreement with the ESVS Clinical Practice Guidelines recommendations on minimal blood vessel diameters. Concordance with the guideline recommendations was more frequent for forearm fistulas than for upper arm fistulas (65% vs 46%, p = 0.01). In the entire cohort, agreement with the guideline recommendations was not associated with an increased proportion of functional vascular accesses (70% vs 66% for fistulas created within and outside guideline recommendations, respectively; p = 0.61) or with decreased access-related intervention rates (1.45 vs 1.68 per patient-year, p = 0.20). In forearm fistulas, however, only 52% of arteriovenous fistulas created outside these recommendations developed into a timely functional vascular access. CONCLUSIONS: Whereas upper arm arteriovenous fistulas with preoperative blood vessel diameters <3 mm had similar vascular access function as fistulas created with larger blood vessels, forearm arteriovenous fistulas with preoperative blood vessel diameters <2 mm had poor clinical outcomes. These results support that clinical decision-making should be guided by an individual approach.

Novel cannulation strategy with a bidirectional cannula for distal limb perfusion during peripheral veno-arterial extracorporeal life support: A preliminary, single-centre study.

INTRODUCTION: Limb ischemia is a severe complication of peripheral veno-arterial extracorporeal life support (V-A ECLS). Several techniques have been developed to prevent this, but it remains a major and frequent adverse event (incidence: 10-30%). In 2019, a new cannula with bidirectional flow (retrograde towards the heart and antegrade towards the distal limb) has been introduced. A single-centre experience with this cannula in patients undergoing peripheral V-A ECLS is herewith reported. METHODS: This prospective observational study included adults (≥18 years) undergoing V-A ECLS from January 2021 to October 2022 with the use of a bidirectional femoral artery cannula. Primary outcome was limb ischemia requiring intervention during cardio-circulatory support. Secondary outcomes were compartment syndrome, limb amputation, cannulation site bleeding, need for other surgical intervention due to cannula related complications, duplex ultrasound parameters from the femoral vessels, and in-hospital survival. RESULTS: Twenty-two consecutive patients were included. During extracorporeal life support (ECLS) support, limb ischemia requiring intervention occurred in one patient (4.5%) and no patients developed a compartment syndrome, or required a fasciotomy or amputation. Significant bleeding was reported in two patients (9%) due to slight cannula dislodgement, easily solved with cannula repositioning. In-hospital survival was 63.6%. CONCLUSIONS: The bidirectional cannula is associated with a low risk for limb ischemia-related complications compared to current literature, and apparently represents a safe alternative to dedicated distal perfusion cannula. Further studies are warranted to confirm these preliminary findings.