Medico-economic Evaluation of the Creation of Arteriovenous Access for Hemodialysis Between Surgical Technique and Endovascular Technique in Patients with End-stage Renal Disease

Официальное название

Cost-effectiveness Study Comparing Endovascular and Surgical Arteriovenous Fistula Creation for Haemodialysis in Patients with End-stage Renal Failure

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство WaveLinQ® device
  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.
• Устройство Ellipsys® device
  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.
• Устройство No device
  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.

Первичные конечные точки

• Cost-utility differential ratio (expressed as cost per Quality-Adjusted Life Year [QALY]) with endovascular AVF vs. open surgery [Срок оценки: month 18]

Вторичные конечные точки (12)

• Evaluation of total cost of care for endovascular [Срок оценки: Month 18]
• Real costs of initial hospitalization for endovascular AVF vs. surgical AVF creation [Срок оценки: Day 0]
• Evaluation of total cost of care for surgical AVF creation [Срок оценки: Month 18]
• Evaluation of total cost of care for endovascular [Срок оценки: Month 36]
• Evaluation of total cost of care for surgical AVF creation [Срок оценки: Month 36]
• Evaluation of cost functional AVF without reintervention [Срок оценки: Month 36]
• Evaluation of cost with adoption of endovascular AVF [Срок оценки: 5 years]
• Evaluation of frequency of reinterventions for vascular access [Срок оценки: Month 36]
• Number of AVF creation success [Срок оценки: Day 0]
• Number of mature AVFs [Срок оценки: Month 6]
• Number of mature AVFs [Срок оценки: Month 12]
• Number of mature AVFs [Срок оценки: Month 18]

Критерии участия

Критерии включения

Patients:

• Age> 18 years
• On chronic dialysis, or due to start chronic dialysis within 3 to 6 months
• Patient eligible for the creation of a native surgical AVF at the elbow crease and an endovenous AVF according to the instructions for use of the manufacturers of the two devices used, namely:
• Target venous diameter for fistula creation > or = 3 mm
• Target arterial diameter for fistula creation > or = 2 mm
• Artery to vein distance < or = 1.5mm
• At least one superficial outflow vein with a diameter ≥ 2.5 mm connected via a proximal forearm perforating vein with the target site
• Patency of the radial and ulnar arteries confirmed by Doppler ultrasound
• Presence of a connecting perforator between the deep and superficial venous network, relatively straight anatomy
• Distance between proximal radial artery and perforator junction/radial vein < 1.5mm
• Patient having been clearly informed about the study and having agreed to participate and attend follow-up visits
• Patient affiliated or beneficiary of a social security scheme.

Критерии исключения

• 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
• Hypercoagulable state
• Estimated life expectancy <1 year
• Pregnantly or breastfeeding woman
• Known allergies to medical devices and medications used in the protocol
• Inability to collect consent
• Patient not affiliated to a social security scheme

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 11 центров

• Centre Hospitalier Universitaire de Bordeaux — Bordeaux
• Polyclinique Bordeaux Nord Aquitaine - Centre Aquitain des pathologies vasculaire — Bordeaux
• AP-HP Centre Hospitalier Universitaire d'Ambroise Paré — Boulogne-Billancourt
• Clinique du parc — Castelnau-le-Lez
• Centre Hospitalier Universitaire de Dijon - Hôpital le Bocage — Dijon
• Centre Hospitalier Mutualiste de Grenoble — Grenoble
• Hôpital privé Jean Mermoz — Lyon
• Centre Hospitalier St Joseph - St Luc — Lyon
• … и ещё 3 центра

Публикации

• Jones RG, Morgan RA. A Review of the Current Status of Percutaneous Endovascular Arteriovenous Fistula Creation for Haemodialysis Access. Cardiovasc Intervent Radiol. 2019 Jan;42(1):1-9. doi: 10.1007/s00270-018-2037-6. Epub 2018 Jul 20. PMID 30030582
• Arnold RJG, Han Y, Balakrishnan R, Layton A, Lok CE, Glickman M, Rajan DK. Comparison between Surgical and Endovascular Hemodialysis Arteriovenous Fistula Interventions and Associated Costs. J Vasc Interv Radiol. 2018 Nov;29(11):1558-1566.e2. doi: 10.1016/j.jvir.2018.05.014. Epub 2018 Oct 5. PMID 30293731
• Shahverdyan R, Beathard G, Mushtaq N, Litchfield TF, Nelson PR, Jennings WC. Comparison of Outcomes of Percutaneous Arteriovenous Fistulae Creation by Ellipsys and WavelinQ Devices. J Vasc Interv Radiol. 2020 Sep;31(9):1365-1372. doi: 10.1016/j.jvir.2020.06.008. Epub 2020 Aug 11. PMID 32792280
• Mallios A, Bourquelot P, Franco G, Hebibi H, Fonkoua H, Allouache M, Costanzo A, de Blic R, Harika G, Boura B, Jennings WC. Midterm results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System, technical recommendations, and an algorithm for maintenance. J Vasc Surg. 2020 Dec;72(6):2097-2106. doi: 10.1016/j.jvs.2020.02.048. Epub 2020 Apr 8. PMID 32276012
• Hull J, Deitrick J, Groome K. Maturation for Hemodialysis in the Ellipsys Post-Market Registry. J Vasc Interv Radiol. 2020 Sep;31(9):1373-1381. doi: 10.1016/j.jvir.2020.03.001. Epub 2020 Aug 14. PMID 32800660
• Mallios A, Jennings WC, Boura B, Costanzo A, Bourquelot P, Combes M. Early results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System. J Vasc Surg. 2018 Oct;68(4):1150-1156. doi: 10.1016/j.jvs.2018.01.036. Epub 2018 Apr 19. PMID 29680297
• Bhojani MF, Malik J, Mumtaz A, Sophie Z, Waseem S. Beyond Conventional: A Systematic Review of Non-Conventional Techniques for Radio-Cephalic Arteriovenous Fistula. Ann Vasc Surg. 2025 Jan;110(Pt B):306-316. doi: 10.1016/j.avsg.2024.07.091. Epub 2024 Aug 7. PMID 39096957
• Rajan DK, Lok CE. Promises for the future: minimally invasive fistula creation. J Vasc Access. 2015;16 Suppl 9:S40-1. doi: 10.5301/jva.5000351. Epub 2015 Mar 8. PMID 25751549

Идентификаторы

NCT: NCT06679907 · CHUBX 2023/49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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