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Item A Patient-Centered Approach to Hemodialysis Vascular Access in the Era of Fistula First(Wiley, 2016-03) Kalloo, Sean; Blake, Peter G.; Wish, Jay; Department of Medicine, IU School of MedicineThe primary vascular access options for the hemodialysis population are arteriovenous fistulas (AVF), arteriovenous grafts, and cuffed central venous catheters (CVC). AVFs are associated with the most favorable outcomes with respect to complications, interventions required to maintain functionality and patency, and overall cost. These population-based outcomes, in conjunction with the efforts of the Fistula First Breakthrough Initiative, have propelled the prevalence of AVFs in the US hemodialysis population. While this endeavor remains steadfast in assuring the continued dominance of this policy for AVF preference, it fails to take into account a subset of the dialysis population who will fail to see the benefits of an AVF. This subset of patients may include the elderly, those with poor vasculature anatomy, those with slowly progressive CKD who are more likely to die than progress to ESRD, and those with an overall poor long-term prognosis and shortened life expectancy. Thus, in an effort to avoid numerous unnecessary surgical and interventional procedures with minimal to no gains in clinical outcomes, an individualized patient approach must be adopted. The Centers for Medicare and Medicaid Services–instituted quality incentive program is designed to reward high AVF prevalence while also penalizing high CVC prevalence. The current model is devoid of case-based adjustment, thus penalties are disbursed to dialysis providers in accordance with a “one-size-fits-all” fistula only approach. The most suitable access for a patient remains the one that takes into account the characteristics unique to the individual patient with a primary focus on patient comfort, satisfaction, quality of life, and clinical outcomes.Item Percutaneous arteriovenous fistula creation with the 4F WavelinQ EndoAVF System(Elsevier, 2022-03) Berland, Todd; Clement, Jason; Inston, Nicholas; Kreienberg, Paul; Ouriel, Kenneth; Surgery, School of MedicineBackground Percutaneous 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. Methods The 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. Results Procedural 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%]). Conclusions Percutaneous 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.