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Midterm results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System, technical recommendations, and an algorithm for maintenance.
Journal of Vascular Surgery 2020 December
OBJECTIVE: The aim of this study was to report our midterm results of percutaneous arteriovenous fistula (pAVF) creation using the Ellipsys (Avenu Medical, San Juan Capistrano, Calif) device and to present technical recommendations and our algorithm of pAVF maintenance.
METHODS: A single-center comprehensive database of all consecutive predialysis and end-stage renal disease patients who had a pAVF creation with the Ellipsys device was reviewed retrospectively. Study end points included technical success, maturation, functional patency, and required interventions.
RESULTS: Between May 2017 and July 2019, there were 234 patients (mean age, 64 years; 148 male [63%]) who had a pAVF created. Technical success was achieved in 232 individuals (99%), and average duration of the procedure was 15 minutes (7-35 minutes). Average follow-up was 252 days (range, 83-696 days). The 1-year primary, primary assisted, and secondary patency rates were 54%, 85%, and 96%, respectively. Average pAVF flow was 923 mL/min (range, 425-1440 mL/min). There were no significant adverse events related to the procedure. Only three patients (1%) required a later conversion of the pAVF anastomosis to a surgical fistula. Twenty-four (10%) patients required superficialization of deep outflow veins because of difficult cannulation. Average maturation time was 4 weeks (range, 1-12 weeks). Fourteen patients (6%) had early (<2 weeks after creation) cannulation of the pAVF.
CONCLUSIONS: The Ellipsys pAVF device allows the rapid and safe creation of a reliable autogenous access. Rates of technical success, patency, and maturation were excellent. For patients unsuited for a distal radiocephalic arteriovenous fistula, it should be considered the next preferred access option.
METHODS: A single-center comprehensive database of all consecutive predialysis and end-stage renal disease patients who had a pAVF creation with the Ellipsys device was reviewed retrospectively. Study end points included technical success, maturation, functional patency, and required interventions.
RESULTS: Between May 2017 and July 2019, there were 234 patients (mean age, 64 years; 148 male [63%]) who had a pAVF created. Technical success was achieved in 232 individuals (99%), and average duration of the procedure was 15 minutes (7-35 minutes). Average follow-up was 252 days (range, 83-696 days). The 1-year primary, primary assisted, and secondary patency rates were 54%, 85%, and 96%, respectively. Average pAVF flow was 923 mL/min (range, 425-1440 mL/min). There were no significant adverse events related to the procedure. Only three patients (1%) required a later conversion of the pAVF anastomosis to a surgical fistula. Twenty-four (10%) patients required superficialization of deep outflow veins because of difficult cannulation. Average maturation time was 4 weeks (range, 1-12 weeks). Fourteen patients (6%) had early (<2 weeks after creation) cannulation of the pAVF.
CONCLUSIONS: The Ellipsys pAVF device allows the rapid and safe creation of a reliable autogenous access. Rates of technical success, patency, and maturation were excellent. For patients unsuited for a distal radiocephalic arteriovenous fistula, it should be considered the next preferred access option.
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