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The choice of vascular access location (Figure 2) and type is complex and critical to hemodialysis functionality and patient quality of life. 6 The reliability and integrity of the access site determines the longevity and quality of hemodialysis treatment and should be suitable for the patient’s needs and lifestyle, to the extent possible. 5 Vascular access is also an important driver of clinical outcomes, especially related to infection, thromboses and associated resource utilization and costs. 7 Historically, the majority of patients begin hemodialysis with a catheter prior to converting to other access types, 4 with the advent of the Centers for Medicare & Medicaid Services National Vascular Access Improvement Initiative in 2004, Fistula First arteriovenous fistula (AVF) was recommended as a first-line optimal access 8 because it is associated with higher survival and fewer complications, hospitalizations, and costs. 9,10 The Kidney Disease Outcomes Quality Initiative (KDOQI) in 2019 advocated for the right access, in the right patient, at the right time, and for the right reasons. 5 According to the United States Renal Data System 2020 report, 65.7% prevalent hemodialysis patients dialyzed with an AVF as of December 2018. 4

Figure 2 – Vascular Access Locations for AV Fistula Creation

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Arteriovenous Fistula Creation Current options for creation of an AVF have expanded to include percutaneous access. A percutaneous arteriovenous fistula (also referred to as an endovascular arteriovenous fistula “endoAVF”) is a minimally invasive alternative to the surgical arteriovenous fistula (sAVF) method to create an AVF for hemodialysis. Both devices are cleared by the FDA to create an arteriovenous anastomosis. 3 Vascular vessels are not clamped, mobilized, dissected, or anastomosed with sutures. • AV anastomosis is located in the deep vascular system. • AV anastomosis is located in the proximal forearm, close to a perforating vein. • AV anastomosis is created with heat or radiofrequency energy (depending on device utilized) through an endovascular catheter system. • Respective systems are cleared to create AVFs in different forearm anatomy, each product’s instructions for use should be consulted. Vascular Access Planning The KDOQI guidelines recommend that vascular access planning and creation include a focused physical examination specific for vascular anatomy and selective vessel mapping. 5 Recommended elements of a focused physical exam should include character of peripheral pulses, Allen test, bilateral upper extremity blood pressure measurements, arm sizes, presence of edema, presence of collateral veins, identification of scars, or confirmed history of central/peripheral venous catheterization or arm, chest, surgery, and/or trauma. 5 In addition to a focused physical assessment, conducting a preprocedure ultrasound (US) mapping and vascular assessment is another essential component for patients undergoing evaluation for creation of an endoAVF. 5 The endoAVF technology for both systems are based on similar concepts: 11 •