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.
Chronic kidney disease (CKD) is a global public health issue, affecting approximately 10% of the population.1,2 The number of patients starting renal replacement therapy has grown exponentially in recent years.3 Effective hemodialysis relies on a well-functioning vascular access (VA). The Kidney Disease Outcome Quality Initiative (KDOQI)4, the French Health Authority (HAS)5, and the European Society of Vascular and Endovascular Surgery (ESVS)6 recommend native arteriovenous fistulas (AVFs) as a primary option, referring to their lower morbidity, reduced mortality, and improved quality of life.7,8 An ideal AVF should allow cannulation with two needles, provide a blood flow of 300 to 600ml/min, resist infection and thrombosis, and have minimal adverse events.6 Between 2005 and 2007, 67-91% of patients in France used native AVFs.7 Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) showed that AVF maturation varies significantly by country, patient and center characteristics. In Japan, 84% of AVFs were created in the forearm, compared to 54% in EUR/ANZ (Belgium, France, Germany, Italy, Spain, Sweden, United Kingdom, Australia, and New Zealand), and 32% in the United States (US).9 Catheter-dependence following AVF creation remained high in EUR/ANZ and US patients, with nearly 70% still dependent 8 months after AVF creation. Failure to use AVFs within 6 months was associated to a 53% higher mortality rate in the following 6 months.9 A systematic review and meta-analysis of 318 studies10 reported that average AVF primary, assisted primary and secondary patency rates at one year were 64%, 73% and 79%, respectively. However, not all patent AVFs were suitable for dialysis: only 26% were mature at 6 months, and 21% were abandoned without ever being used. Furthermore, up to 85% of AVFs require multiple re-interventions, including angioplasty, stenting, transposition, thrombectomy or thrombolysis within the first year.11-13 On average, up to 3.43 reinterventions per patient were required over the study duration, with higher rates for brachio-basilic accesses, contributing significantly to the overall cost of care.11-13 To improve outcomes, endovascular AVF creation techniques have been developed.14 These methods use radiofrequency or thermo-coagulation energy, guided by fluoroscopy and/or duplex ultrasound. Avoiding vessel dissection and mobilization, while minimizing trauma to the vascular wall and surrounding tissues, may help reduce the risk of intimal hyperplasia and AVF failure. This approach could lead to similar benefits as those demonstrated by surgical no-touch techniques.15 Preliminary results show a technical success rate of 97.5%, a 3-month maturation rate of 89.3%, a 1-year patency rate of 85.7%, and an average of 0.59 reinterventions per patient per year.16-19 As a results, data from the United States Renal Data System (USRDS) were compared to data from the Novel Endovascular Access Trial (NEAT) and both incident and prevalent patients with endoAVF required fewer interventions and had lower costs within the first year compared with matched patients with surgical AVFs.20 However, these devices are expensive (approximately €5,200 per patient) and the creation of an endovenous fistula is not yet listed in France's common classification of medical procedures (CCAM), making it ineligible for reimbursement by health insurance.21,22 In 2019, there were 15,653 hospitalizations in France for AVF creation and re-interventions to aid AVF maturation or restore patency in patients with end-stage renal disease. Although international studies suggest that endovascular AVF creation is effective,18,20,23 no French studies have yet replicated or confirmed these findings in the local context to support reimbursement claims. The 2018 ESVS guidelines also cite a lack of evidence on endovascular AVF creation.6 This protocol represents the first French medico-economic study to compare the two available endovascular AVF creation devices - Ellipsys® (Medtronic, Dublin, Ireland) and WaveLinQ® (BD, Bard, Franklin Lakes, New Jersey, United States of America) - with traditional open surgery. This randomized clinical trial aims to provide crucial data for healthcare decision-makers, potentially paving the way for the adoption of these devices in France, enhancing patient care, and improving quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
252
The 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.
The 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.
Surgical 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.
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine - Centre Aquitain des pathologies vasculaire
Bordeaux, France
AP-HP Centre Hospitalier Universitaire d'Ambroise Paré
Boulogne-Billancourt, France
Clinique du parc
Castelnau-le-Lez, France
Centre Hospitalier Universitaire de Dijon - Hôpital le Bocage
Dijon, France
Centre Hospitalier Mutualiste de Grenoble
Grenoble, France
Hôpital privé Jean Mermoz
Lyon, France
Centre Hospitalier St Joseph - St Luc
Lyon, France
Centre Hospitalier Universitaire de Nice - Hôpital Pasteur 1
Nice, France
Groupe Hospitalier Paris St Joseph - Centre Hospitalier Chartres
Paris, France
...and 1 more locations
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.
Time frame: month 18
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.
Time frame: Month 18
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.
Time frame: Day 0
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.
Time frame: Month 18
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.
Time frame: Month 36
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.
Time frame: Month 36
Evaluation of cost functional AVF without reintervention
This measure assesses the cost-effectiveness ratio as the cost per additional functional AVF without the need for reintervention at 36 months for WaveLinQ® or Ellipsys® devices compared to open surgery.
Time frame: Month 36
Evaluation of cost with adoption of endovascular AVF
Cost differences for health insurance over 5 years based on the adoption of endovascular techniques for AVF creation in patients requiring hemodialysis within 3-6 months or those already on dialysis in France. Data linkage between the clinical trial and the SNDS database will be performed through indirect matching using: age, postal code of residence, gender, date of hospital discharge, Diagnosis-Related Group Discharge Summary Code (GHM RSS), principal diagnosis of the stay, associated diagnoses, related diagnosis, stay number (NDA). Matching will enable continued follow-up without additional data collection, relying solely on SNIIRAM and PMSI data ensuring comprehensive tracking of AVF-related events across different care settings. Social determinants of health such as education, access to healthcare, housing stability, and socioeconomic status, will also be searched for to assess their po
Time frame: 5 years
Evaluation of frequency of reinterventions for vascular access
This measure calculates the frequency of reinterventions, including angioplasties, thrombectomies, AVF repairs, and new AVF creations, for each type of AVF creation. Data is derived from the French National Hospital Discharge Database (PMSI) and the French National Health Insurance Inter-Scheme Information System (SNIIRAM), with healthcare costs estimated from the SNDS.
Time frame: Month 36
Number of AVF creation success
This clinical endpoint measures the success rate of AVF creation. AVF creation success will be determined by the presence of a palpable "thrill" and/or confirmation of patency via immediate postoperative duplex scan.
Time frame: Day 0
Number of mature AVFs
This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.
Time frame: Month 6
Number of mature AVFs
This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.
Time frame: Month 12
Number of mature AVFs
This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.
Time frame: Month 18
Evaluation of time to maturation
This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.
Time frame: Month 6
Evaluation of time to maturation
This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.
Time frame: Month 18
Evaluation of time to maturation
This measure includes the proportion of AVFs that reach maturity and the time required for each AVF to mature, assessed at specific intervals. For dialysis patients, AVFs maturity will be defined as a vascular access allowing cannulation with two needles and providing adequate blood flow throughout hemodialysis. In pre-dialysis patients, maturity will be indicated by a pre-anastomotic humeral artery blood flow of at least 400 mL/min and an AVF diameter of at least 4 mm. AVF maturation time will be defined as the number of days between AVF creation and physiological maturation.
Time frame: Month 12
Number of Functional AVFs
This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. AVFs functionality will be defined as a VA allowing successful cannulation with two needles over at least six hemodialysis sessions within 30 days, delivering satisfactory blood flow and achieving adequate dialysis (typically a minimum of 300 mL/min).
Time frame: Month 6
Number of Functional AVFs
This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. AVFs functionality will be defined as a VA allowing successful cannulation with two needles over at least six hemodialysis sessions within 30 days, delivering satisfactory blood flow and achieving adequate dialysis (typically a minimum of 300 mL/min).
Time frame: Month 12
Number of Functional AVFs
This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. AVFs functionality will be defined as a VA allowing successful cannulation with two needles over at least six hemodialysis sessions within 30 days, delivering satisfactory blood flow and achieving adequate dialysis (typically a minimum of 300 mL/min).
Time frame: Month 18
Number of recirculation
This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. The recirculation rate will refer to the percentage of dialyzed blood that re-enters the systemic circulation without complete clearance.
Time frame: Month 6
Number of recirculation
This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. The recirculation rate will refer to the percentage of dialyzed blood that re-enters the systemic circulation without complete clearance.
Time frame: Month 12
Number of recirculation
This measure evaluates the proportion of functional AVFs and assesses the recirculation rate, indicating access efficiency. The recirculation rate will refer to the percentage of dialyzed blood that re-enters the systemic circulation without complete clearance.
Time frame: Month 18
Number of days hospitalised for AVF creation
This measure records the average length of stay, in days, for initial hospitalization associated with AVF creation.
Time frame: Day 15
Number of adverse events related to vascular access
his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow \> 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)
Time frame: Day 1
Number of adverse events related to vascular access
his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow \> 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)
Time frame: Month 1
Number of adverse events related to vascular access
his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow \> 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)
Time frame: Month 6
Number of adverse events related to vascular access
his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow \> 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)
Time frame: Month 12
Number of adverse events related to vascular access
his measure monitors complications arising from vascular access, including limb ischemia (steal syndrome), monomelic ischemic neuropathy, high-flow conditions (blood flow \> 1500 mL/min with cardiac consequences), aneurysms, hemorrhages, skin necrosis, infections, thrombosis, and AVF abandonment, with ischemia severity classified into four stages ranging from mild coldness and numbness (stage 1) to tissue loss affecting the extremities (stage 4)
Time frame: Month 18
Number of serious adverse events related to AVF device
This measure tracks serious adverse events directly related to the AVF device.
Time frame: Day 0
Number of serious adverse events related to AVF device
This measure tracks serious adverse events directly related to the AVF device.
Time frame: Month 1
Number of serious adverse events related to AVF device
This measure tracks serious adverse events directly related to the AVF device.
Time frame: Month 6
Number of serious adverse events related to AVF device
This measure tracks serious adverse events directly related to the AVF device.
Time frame: Month 12
Number of serious adverse events related to AVF device
This measure tracks serious adverse events directly related to the AVF device.
Time frame: Month 18
Number of serious adverse events related to AVF device
This measure tracks serious adverse events directly related to the AVF device.
Time frame: Month 36
Number of Reinterventions related to AVF device
This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.
Time frame: Day 0
Number of Reinterventions related to AVF device
This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.
Time frame: Month 1
Number of Reinterventions related to AVF device
This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.
Time frame: Month 6
Number of Reinterventions related to AVF device
This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.
Time frame: Month 12
Number of Reinterventions related to AVF device
This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.
Time frame: Month 18
Number of Reinterventions related to AVF device
This measure tracks early reinterventions (within 1 month) and late reinterventions (after 1 month) such as angioplasties, thrombectomies, AVF repairs, and new AVF creations.
Time frame: Month 36
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