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 EllipsysTMVascular 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 September 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 chi-squared analysis. RESULTS: During the time period 96 extremities were measured in 48 male patients. Vessel diameter and acceptability per IFU is presented in Table 1. Overall extremity suitability was 95% (n=90) and 54% (n=52) for the WQ and EL systems respectively (p < 0.00001). In the same population, 33% of extremities (n=32) had acceptable anatomy for RCF creation (p < 0.00001). Of the 64 extremities that were not candidates for RCF, 92% (n=59) and 44% (n=28) had anatomy suitable for the WQ and EL systems respectively (p < 0.0001). CONCLUSIONS: The overwhelming majority of patients being referred for hemodialysis access creation were candidates for the WQ. Significantly fewer were candidates for EL and RCF. Among extremities that were not candidates for RCF, the majority had acceptable WQ anatomy. These data should help surgeons understand the applicability of each of these systems, especially in those who lack the appropriate distal anatomy for primary RCF placement.
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