Abstract
BackgroundPercutaneous devices for creation of native arteriovenous fistulae offer an alternative to traditional open surgical techniques. The 4F WavelinQ EndoAVF System was developed as a lower profile alternative to facilitate access through smaller vessels and minimize access site complications; The current report is the original first experience of this device, assessing outcome in 120 patients followed for 6 months. MethodsThe use of the 4F WavelinQ system in three studies, EASE (32 patients), EASE-2 (24 patients), and the EU postmarket clinical follow-up study (64 patients) was aggregated and analyzed. Patients were followed with duplex ultrasound at discharge and follow-up visits at 1, 3, and 6 months. Primary, assisted primary, and secondary patency rates were evaluated as Kaplan-Meier estimates and standard errors. Time to maturity and time to successful cannulation were defined as the mean ± standard deviation days from the procedure in patients enrolled on dialysis. ResultsProcedural success was achieved in 116 patients (96.7%). Primary, assisted-primary, and secondary 6-month patency rates were 71.9% ± 4.5%, 80.7% ± 4.1%, and 87.8% ± 3.3%, respectively. Time to maturity averaged 41 ± 17 days. Time to successful cannulation averaged 68 ± 51 days. Device-related serious adverse events were reported in 3 of 120 patients (2.5%) and procedure-related serious adverse events occurred in 7 of 120 patients (5.8%). Arterial or venous access complications were not reported in any of the patients. Access circuit reinterventions were performed in 23 patients (19.2%), split between those performed for EndoAVF maturation (13/120 [10.8%]) and maintenance (11/120 [9.2%]). ConclusionsPercutaneous creation of native dialysis fistulae with the 4F WavelinQ EndoAVF System is safe and effective, with favorable durability and a low rate of serious complications and reinterventions through 6-month follow-up. Use of the 4F device allows for percutaneous fistula creation between the radial artery and radial vein or the ulnar artery and ulnar vein. These findings suggest that the 4F device is a useful percutaneous alternative to open surgical AVF or endovascular AVF with larger bore devices.
Highlights
Patients with chronic kidney disease have few choices of access for dialysis: native arteriovenous fistulae (AVF), prosthetic grafts or long-term central venous catheters.[1]
Native AVF are associated with improved patency over prosthetic grafts and the infection rate is lower than central venous catheters.[2]
Ellipsys were CE-marked in Europe in 2014 and 2016 respectively with both devices cleared by the US Food and Drug Administration (FDA) in 2018
Summary
Patients with chronic kidney disease have few choices of access for dialysis: native arteriovenous fistulae (AVF), prosthetic grafts or long-term central venous catheters.[1]. The 4 Fr WavelinQ device was developed to enhance safety, for access in smaller vessels, with the potential to reduce the anesthetic requirements of the procedure. The purpose of the current study was to evaluate the 6-month outcome of the 4 Fr WavelinQ System as studied in a global clinical trial experience, assessing safety and effectiveness, including patency and functionality of the fistulae over time. The 4 Fr WavelinQ EndoAVF System was developed as a lower profile alternative to facilitate access through smaller vessels and minimize access site complications; The current report is the original first experience of this device, assessing outcome in 120 patients followed for 6 months
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