Anatomic Applicability Of The Two Available Percutaneous Arteriovenous Fistula Creation Systems.
Michael F. Amendola, MD1, Daniel Newton, MD2, Karishma Popli3, James Dittman4.
1VA Medical Center/VCU Health System, Richmond, VA, USA, 2VCU Health System, Richmond, VA, USA, 3VCU School of Medicine, Richmond, VA, USA, 4James Dittman, Richmond, VA, USA.
BACKGROUND: Radiocephalic fistula (RCF) creation is the acceptable first line procedure for patients needing hemodialysis, generally requiring the radial artery and cephalic vein to measure ≥ 2 mm at the wrist. The Ellipsys TM Vascular Access System (EL) and WavelinQTM EndoAVF System (WQ) have recently been FDA approved to create percutaneous arteriovenous fistulas for hemodialysis access. The WQ initial indications for use were ulnar vein and ulnar artery diameters ≥ 2 mm with ≤ 2 mm distance between the two. The EL system requires a perforating cubital vein (PCV) and proximal radial artery to be ≥ 2 mm with ≤ 1.5 mm distance between the two. Although initial clinical trials show a high rate of success, they included selected patient populations and did not report applicability of their systems in all-comers. We sought to determine the real-world applicability of the EL and WQ systems according to their IFU, relative to the standard of RCF creation.
METHODS: All consults for first-time arteriovenous access from August 2018 to June 2019 were examined for anatomical suitability. Patients underwent a modified vein mapping of bilateral upper extremities to assess anatomical suitability for the EL and WQ systems. All percentages were compared with Fisher's Exact analysis.
RESULTS: During the time period 116 extremities were measured in 58 male patients. Vessel diameter and acceptability per IFU is presented in Table 1. Per IFU, extremity suitability was 93% and 52% for the WQ and EL systems respectively (P < .0001). In the same population, 32% of extremities had acceptable anatomy for RCF creation. Overall clinical usability of these systems was 55% for WQ and 44% for the EL system (P = .09). Usability of both pAVF systems was most limited by the size of the deep perforating cubital vein. Proximity of the antecubital perforator and proximal radial artery additionally limited EL usability. Based on a clinical algorithm, initial access creation would take place via RCF creation in 31% of the cohort, followed by WQ (32%) or EL (23%), surgical fistula creation at the elbow (18%), and graft placement (17%).
Anatomic suitability was far higher for the WQ than EL when considering the IFU alone. Once the full requirements for pAVF creation were considered however there was no significant difference in usability between the two systems either overall or after application of a distal-access-first clinical algorithm. Based on anatomic analysis, pAVF creation can make up a substantial part of a hemodialysis access practice.
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