This multicenter 1 :1 randomized controlled trial aims at comparing the cost-effectiveness of endovascular arteriovenous fistula (AVF) creation using Ellipsys® and WaveLinQ® devices with traditional surgical AVF creation for hemodialysis. The primary endpoint is the cost-utility ratio (cost per QALY gained), with an anticipated sample size of 252 patients. This study will provide critical insights into the viability and cost-effectiveness of endovascular techniques, potentially shaping future standards of care in hemodialysis access.
Age> 18 years
On chronic dialysis, or due to start chronic dialysis within 3 to 6 months
Target venous diameter for fistula creation > or = 3 mm
Target arterial diameter for fistula creation > or = 2 mm
Known central venous stenosis > 50% on imaging or presence of an indwelling central venous catheter or pacemaker on the same side as the side of creation of the AVF
Upper extremity arterial occlusive disease not amenable to endovascular or open repair
Eligibility for a native distal AVF (radio or ulno-cephalic)
New York Heart Association (NYHA) class III or IV heart failure
Parallel
WaveLinQ® device
DeviceThe WaveLinQ® system employs a dual catheter technique to establish communication between deep arteries and veins, typically using a ulnar or radial artery and vein. This procedure necessitates fluoroscopic guidance to position the catheters correctly, a control angiogram, and potential embolization to enhance blood flow.
Ellipsys® device
DeviceThe Ellipsys® system enables the entire AVF creation process to be conducted under ultrasound guidance without the need for fluoroscopy or contrast media. It uses a single needle to puncture the superficial vein, the perforator and the artery and potential balloon angioplasty to enhance blood flow.
No device
DeviceSurgical AVF creation will involve a direct approach to the proximal radial, ulnar, or brachial artery to create a 4-6 mm longitudinal arteriotomy. An oblique incision will be made at the elbow crease. The cephalic, basilic, or perforating vein may be used for the side-to-end anastomosis. If a transposition is required due to adiposity, it will be performed either during the same procedure or at a later time through tunneling or lipectomy.
Cost-utility differential ratio (expressed as cost per Quality-Adjusted Life Year [QALY]) with endovascular AVF vs. open surgery
This measure evaluates the cost-utility ratio by calculating the cost per QALY gained with the creation of an endovascular AVF using WaveLinQ® or Ellipsys® devices compared to an open surgical approach at 18 months. The assessment includes initial hospitalization costs via micro-costing and outpatient costs derived from the National Health Data System (SNDS) and evaluates utility using the EQ-5D-5L questionnaire.
Evaluation of total cost of care for endovascular
This measure evaluates the total cost of care for endovascular AVF compared to surgical AVF creation at 18 and 36 months from the perspective of Mandatory Health Insurance.
Real costs of initial hospitalization for endovascular AVF vs. surgical AVF creation
This measure compares the real costs associated with the initial hospitalization for endovascular versus surgical AVF creation procedures.
Evaluation of total cost of care for surgical AVF creation
This measure evaluates the total cost of care for endovascular AVF compared to surgical AVF creation at 18 and 36 months from the perspective of Mandatory Health Insurance.
Evaluation of total cost of care for endovascular
This measure evaluates the total cost of care for endovascular AVF compared to surgical AVF creation at 18 and 36 months from the perspective of Mandatory Health Insurance.
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