No abstract

Background: This was a retrospective longitudinal analysis investigating the safety and effectiveness of consecutive treatments with the Lutonix Drug-Coated Balloons (DCB) in dysfunctional arteriovenous access; both fistulae (AVF) and grafts (AVG). Method(s): From January 2015 to December 2017 (3 years), 339 Lutonix DCB were used in 257 procedures of 165 patients with a dysfunctional AVF or AVG. Of these patients, 33 had ≥2 procedures, adequate data and were included in the analysis. In these patients, 112 procedures were performed (22 treated twice, 4 patients 3 times, 7 patients 4 times, 2 patients 5 times and 3 patients 6 times) using 133 devices. Mean lesion follow-up was 247 days (min. 20 days -max. 908 days). Mean balloon diameter was 8.13 mm (3-12 mm) and length 63.16 mm (40-150 mm). Primary outcome measure safety, defined as freedom from any serious adverse event(s) involving the AV access circuit through 30 days for all procedures and target lesion primary patency (TLPP). Secondary outcome measures included investigation of independent factors that may influence outcomes. Result(s): Safety was reached in all cases (112/112 procedures, 100%). Median TLPP was 227 days for the first intervention and 280 days for the second consecutive intervention [p=0.37; Hazard ratio: 1.271 (CI: 0.75-2.16)]. Conclusion(s): Consecutive use of the Lutonix DCB for the treatment of dysfunctional dialysis access was safe. There was no significant difference in TLPP between the 1st and 2nd procedure, although a numerical improvement was observed. Results suggest consistency in TLPP regardless of the aging arterio-venous access.