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Early Real-world Results Of Percutaneous Arteriovenous Fistula Creation With The Ellipsys Vascular Access System Demonstrates Need For Improved Postoperative Assisted Maturation Protocol
Robin B. Osofsky, MD, Dominck Byrd, BA, Jaideep Das Gupta, MD, Ross Clark, MD, Jonathan G. Owens, MD, Anna G. Fabre, MD, Sundeep Guliani, MD, Muhammad A. Rana, MD, John Marek, MD, Mark Langsfeld, MD, LeAnn A. Chavez, MD.
University of New Mexico, Albuquerque, NM, USA.

OBJECTIVE: With promising industry-sponsored literature of the Ellipsys vascular access system for percutaneous arteriovenous fistula (pAVF) creation, we sought to evaluate our initial clinical outcomes following introduction of the pAVF procedure at our institution.
METHODS: Retrospective review of all patients who underwent pAVF using Ellipsys device from January 2019 to August 2019. Primary endpoints were technical success, clinical fistula maturation, successful hemodialysis (HD) cannulation, and frequency of assisted maturation interventions. Patients whom were candidates for surgical wrist radiocephalic AVF were excluded. Remaining patients were selected for pAVF if they met preoperative anatomic criteria of proximal radial artery diameter 2mm, deep perforator/communicating vein diameter 2mm, and cephalic vein diameter 2mm. All patients were scheduled for postoperative follow-up with duplex at 2 and 4 weeks.
RESULTS: A total of 20 patients from January 2019 to August 2019 underwent pAVF. Average age of patients was 5525 years, 11 (55%) were male, 9 (45%) were female, and 13 (65%) were already on HD through alternative access. The mean time since pAVF creation to data collection was 2611 wks. Technical success was achieved in 19 (95%) of patients. Mean PRA flow after creation with intraoperative duplex was 387 96 mL/min. Clinical fistula maturation was observed in 8 (42%) patients. Of those, 2 (11%) patients had successful HD cannulation, 5 (26%) are awaiting HD cannulation, and 1 (5%) had unsuccessful HD cannulation. Assisted maturation interventions were performed in 12 (63%) of patients, in which 11 (58%) underwent balloon-assisted maturation with angioplasty, 1 (5 %) underwent venous embolization of accessory veins, and 2 (11%) ultimately underwent basilic vein transposition following balloon angioplasty. Average time from procedure to assisted maturation intervention was 8564 days. Three (16%) patients developed pAVF occlusion, and 2 (11%) underwent conversion to surgical brachiocephalic AVF. Mean time from procedure to first follow-up was 4.46.3 weeks and mean total follow-up was 16.929.7 weeks. In total 3 (16%) of patients were lost to follow up.
CONCLUSIONS: Initial real-world results using the Ellipsys device for pAVF creation appear inferior to our institutionís historic outcomes following surgical AVF creation. Our analysis of early data identifies areas for improvement in patient selection, patient follow up retention, and postoperative intervention such as planned interval balloon angioplasty.


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