Maturation for Hemodialysis in the Ellipsys Post-Market Registry

Jeffrey Hull, John Deitrick, Karey Groome
Journal of Vascular and Interventional Radiology: JVIR 2020, 31 (9): 1373-1381

PURPOSE: To prospectively evaluate the maturation of the endovascular arteriovenous fistula system (EndoAVF) for 2-needle cannulation (2NC).

MATERIALS AND METHODS: From October 2018 to June 2019, evaluation of 123 patients resulted in 95 arteriovenous fistulae, a rate of 63% (60 of 95) EndoAVF, and 37% (35 of 60) fistulae treated surgically. At 4 weeks, EndoAVF was not suitable for 2NC (defined as a palpable target vein [TV], 500 mL/min flow volume, and 5-mm diameter) underwent maturation procedures.

RESULTS: Technical success of EndoAVF creation was 96.7% (60 of 62). At 4 weeks, 67% (40 of 60) fistulae underwent maturation procedures: 62% (37 of 60) had balloon dilation, 32% (19 of 60) had brachial vein embolization, and 30% (18 of 60) had cubital vein banding, increasing TV flow volume from 182 ± 123 mL/min to 572 ± 225 mL/min (P < 0.0005). Transposition was required in 33% of patients (20 of 60), reducing the mean TV depth from 10.9 to 3.7 mm (P < .0001). 2NC and fistula success (2NC × 3) was achieved in 87% (47 of 54); 10% of patients (6 of 60) were not on dialysis; 6.8% of patients (4 of 60) died; 5% of fistulas (3 of 60) were abandoned for arm swelling, steal syndrome, and thrombosis. Time to 2NC, fistula success, and tunneled catheter removal were 65.6 ± 45.7 days, 79.1 ± 50.9 days, and 113.4 ± 62 days, respectively. Patients achieving 2NC had brachial artery flow of 944 ± 284 mL/min; and TV flow, diameter, and depth of 674 ± 292 mL/min, 6.1 ± 0.8 mm, and 3.6 ± 1.3 mm, respectively. Major complications were arm swelling, steal syndrome, and thrombosis.

CONCLUSIONS: Most patients had EndoAVF with maturation procedures at 4 weeks that achieved rapid maturation (Ellipsys Fistula for Hemodialysis Access; NCT03828253).

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