Freeway paclitaxel-releasing balloons to treat recurrent stenosis of arteriovenous fistula in hemodialysis patients.

Abstract

To evaluate early and mid-term outcomes of Freeway paclitaxel-releasing balloons (Eurocor GmbH, Bonn, Germany) in hemodialysis patients with recurrent stenosis of arteriovenous fistula. Between July 2013 and December 2016 27 hemodialysis patients with recurrent stenosis of arteriovenous fistula underwent endovascular treatment with a Freeway balloon. About inclusion criteria, all patients were previously treated at the target lesion with a standard balloon angioplasty (BA). The intervals in months between standard BA and procedure with DCB (time BA-DCB) and between procedure with DCB and new restenosis (time DCB-restenosis) were evaluated and compared with T-test. 2-year estimated outcomes in terms of survival, primary patency, primary assisted patency, secondary patency, and freedom from target lesion restenosis (TLR) were assessed with Kaplan-Meier curves. Technical success was obtained in 96.3% of the cases. During the follow-up (mean duration 13.6 months, range 1-33) 13 patients (48.1%) had a new restenosis. Mean time BA-DCB was 4.8 months, and the mean time DCB-restenosis was 7.6 months with a statistically significant difference at T-test (P<0.001). Estimated 2-year rates of primary patency, primary assisted patency, secondary patency, and freedom from TLR were 31.8%, 76.4%, 90.5%, and 30.2%, respectively. In our experience Freeway paclitaxel-releasing balloons were effective in the treatment of recurrent stenosis in hemodialysis patients previously treated with standard BA. At follow-up about half of patients had no new target lesion restenosis and the time to a new restenosis was much longer compared to recurrence of stenosis after standard BA.