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Background: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft., Methods: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs., Discussion: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Frans Moll is a consultant to Xeltis B.V. All other authors declare no conflict of interest.

Two devices for the creation of an endovascular percutaneous (pAVF) endovascular (endoAVF) arteriovenous fistulae (AVF) are available: the Ellipsys and the WavelinQ-4F systems. The main difference is the location of the anastomosis, making it feasible to use both pAVFs and surgical Gracz-type AVF in an algorithm sequence. A 66-year-old male patient with end-stage kidney disease and HIV was referred for a creation of a dialysis access after failed peritoneal dialysis. A radial-radial WavelinQ-pAVF with simultaneous coil embolization of a brachial vein was created but failed within 4 weeks. Therefore, an Ellipsys-pAVF was successfully created between the proximal radial artery and perforating vein on the same arm. After 2 days, however, the Ellipsys-pAVF anastomosis occluded. The ipsilateral Gracz-AVF was created, anastomosing perforating vein with the antecubital brachial artery. Cannulations were started 28 days later. During the follow up of 807 days, the AVF remained patent with last known volume flow of 1500 ml/min and no need for secondary interventions. We report a successful creation of a Gracz-AVF after primary failed pAVFs created with both pAVF-systems in a single patient and in the same arm. Thus, based on that case we recommend creation of pAVF prior to Gracz-AVF as integral part of Vascular Access creation algorithm, based on each patient's life plan.

Background: High-flow arteriovenous fistulae (HF-AVF) may lead to adverse cardiac remodeling in hemodialysis patients. We have investigated whether a novel external stent is safe and effective in reducing and stabilizing flow rates during a 1-year follow-up after HF-AVF reconstruction., Methods: All patients with HF-AVF (access flow rate ⩾ 1500 ml/min), who underwent HF-AVF reconstruction with external stenting in two centers between June 2018 and May 2020, were included in this retrospective analysis. During HF-AVF reconstruction, the dilated vein segment was resected, underwent volume reduction, and was externally stabilized using a braided cobalt-chromium external stent. AVF flow rates were assessed preoperatively, intraoperatively, and at follow up visits using duplex ultrasound., Results: Forty-three HF-AVFs in 42 patients were reconstructed and supported with an external stent (mean age 49 years, range 20-86 years; 74% men). Fifty-one percent were forearm AVFs, 49% were upper arm. The mean preoperative flow rate was 2622 ± 893 ml/min (range: 1500-6000 ml/min) and was decreased to 710 ± 221 ml/min (range: 300-1300 ml/min) intra-operatively after HF-AVF reconstruction. At 6 and 12-months follow-up, the mean flow rates were 1132 ± 320 ml/min (range: 470-1700 ml/min) and 1453 ± 888 ml/min (range: 300-3800 ml/min), respectively. Recurrence of high flow (>1500 ml/min) occurred in 16% and 25% of the patients at 6 and 12 months and primary patency rates were 86% and 70%, respectively., Conclusions: This early experience with novel external stenting for HF-AVF reconstruction demonstrates that it is a safe and effective method for reducing and stabilizing flow rates up to 1-year post procedure. Additional studies are required to evaluate the durability of this procedure over the longer term and assess its effect on cardiac remodeling.

Background: Sixty years after the first description of Scribner-shunt, and 54 years after publication of the first radio-cephalic arterio-venous fistula (AVF), endovascular percutaneous AVF (pAVF) was introduced. We report a successful case of Ellipsys-pAVF creation and use for hemodialysis in a patient with a previous ipsilateral Scribner-shunt., Case: A 72-year old female patient with chronic kidney disease (CKD), previous right-sided Scribner-shunt and kidney transplant, underwent a successful creation of right-sided Ellipsys-pAVF. The procedure time was 12 min with intraoperative brachial artery volume flow of 720 ml/min. At 39 days, an ultrasound-guided balloon-angioplasty of the outflow cephalic vein stenosis was performed. Cannulations were started 41 days after the creation of pAVF. No additional interventions were required during the follow-up of 258 days with last follow-up volume flow of 1400 ml/min., Conclusions: This is the first report of the creation of pAVF in a patient with previous "traumatic" ipsilateral placement of a Scribner-shunt. It allows the creation of a small anastomosis in very short time, which can be successfully used for hemodialysis treatment on the same day, if necessary, and reduces the expected risk of high-flow AVF with associated peripheral steal and cardiac outcomes (especially in a patient with cardiomyopathy such this one).

Background: The VasQ TM device was designed to improve the outcome of arteriovenous fistulae by optimizing the hemodynamics of the flow in the juxta-anastomotic region of the arteriovenous fistulae through tailored external support. The aim of the study was to evaluate the impact of the VasQ on outcome of radiocephalic arteriovenous fistulae in a real-world setting., Methods: This was a single-center, retrospective analysis of patients with either fistula creation before or after dialysis initiation with implantation of the VasQ device during creation of end-to-side radiocephalic arteriovenous fistulae between June 2018 and May 2019. The flow rate and vein diameter were evaluated intraoperatively, at discharge within 48 h postprocedure and at a follow-up of 1, 3, 6, 9, and 12 months., Results: Thirty-three VasQ devices were implanted during 33 radiocephalic arteriovenous fistula procedures. The study population comprised mostly of men, with an average age of 66 years. Mean intraoperative flow was 428 mL/min (range: 130-945). All patients were discharged with patent arteriovenous fistulae and mean fistula flow of 740 mL/min (range: 230-1300 mL/min). The primary patency was 100% and 79% at 3 and 6 months, respectively. Cumulative/secondary patency was 100% and 90% at 3 and 6 months, respectively., Conclusion: Data presented here suggest that the VasQ device has the potential to provide benefit to the functionality of radiocephalic arteriovenous fistulae.

Purpose: Even though early transplantation is still the first-line therapy in paediatric patients with end-stage renal disease (ESRD), up to 30% of these patients still require haemodialysis (HD). Creating an arteriovenous fistula (AVF) is quite challenging, particularly in children, leading to disproportional use of catheters. In this paper, we describe our experience in the creation of AVF with currently no in-dwelling catheters in children and adolescents on HD., Methods: From January 2009 to December 2013, there were 34 patients rated as unfit for transplantation for at least the next 6 months or who had already been on HD through a central venous catheter (CVC). Three patients aged between 12 months and 3 years and weighing 9-12 kg were not suitable for AVF. Finally 31 patients, from 6 to 19 years of age with a mean weight of 43.3 ± 14.5 kg (19-80 kg), were assigned to the alternative of AVF., Results: During the above-mentioned time period, 31 patients were provided with 32 AVFs; 26 received a distal radiocephalic fistula, five a Gracz-type fistula and one a brachio-basilic fistula. All but two fistulae matured primarily, within an average time of 45 (range: 16-191) days until the first dialysis. The fistula's 1-year primary and primary assisted patency rates were 78% and 94%, respectively., Conclusions: The creation of a native vascular access is an effective and durable procedure in paediatric and adolescent patients. It reduces using of CVCs and is appropriate both for long-term treatment and as a bridging procedure until renal transplantation.