ABSTRACT
PURPOSE: To compare the immediate results of ultrahigh-pressure (UHP) balloons vs. peripheral cutting balloons (PCB) for the treatment of stenoses associated with autogenous fistulas using intra-access blood flow measurements. MATERIALS AND METHODS: This prospective randomized study consisted of 22 hemodialysis (HD) patients with autogenous fistulas who had decreased intra-access blood flow (<500 mL/min). All patients underwent a fistulogram and intraprocedural blood flow measurements. Patients were randomized once into two groups; one group undergoing UHP angioplasty and the second group undergoing PCB angioplasty. Randomization occurred once after the diagnostic fistulogram and each patient in each arm only underwent percutaneous transluminal angioplasty with either UHP or PCB. The study cohort consisted of 12 patients in the UHP group and 10 patients in the PCB group. Data collected included fistula anatomy, degree of stenosis, length of stenosis, balloon specifications and residual stenosis. RESULTS: The 22 study patients underwent 35 angioplasty procedures; 23 in the UHP group (12 patients) and 12 in the PCB group (10 patients). The technical success rate was 91%. The pre-intervention mean blood flow was 288 mL/min in the UHP group and 391 mL/min in the PCB group. The post-intervention mean blood flow was 613 mL/min in the UHP group and 606 mL/min in the PCB group. The mean increase in blood flow was 325.8 mL/min in the UHP group and 213 mL/min in the PCB group. This represents a relative mean increase in blood flow of 253% in the UHP group and 85% in the PCB group. An unpaired t-test showed there was no significant difference between the groups with respect to pre-flow, post-flow, and mean and relative mean increase in flow. There were two failures; one in the UHP group and one in the PCB group. There was one minor complication (2.8%) but no major complications. CONCLUSIONS: In this small group of HD patients with autogenous fistulas our comparison of UHP to the PCB demonstrated that the immediate results, as determined by measurement of intra-access blood flow, were equivalent. Further long-term follow-up will be required to determine the longevity of these results.
