A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas.

The role of paclitaxel-coated balloons has been established in the coronary and peripheral arterial circulations with recent interest in the use of paclitaxel-coated balloons to improve patency rates following angioplasty of arteriovenous fistulas. To assess the efficacy of paclitaxel-coated angioplasty balloons to prolong the survival time of target lesion primary patency in arteriovenous fistulas, we designed an investigator-led multi-center randomized controlled trial with follow up time variable for a minimum of one year. Patients with an arteriovenous fistula who were undergoing an angioplasty for a clinical indication were included but patients with one or more lesions outside the treatment segment were excluded. Following successful treatment with a high-pressure balloon, 212 patients were randomized. In the intervention arm, the second component was insertion of a paclitaxel-coated balloon. In the control arm, an identical procedure was followed, but using a standard balloon. The primary endpoint was time to loss of clinically driven target lesion primary patency. Primary analysis showed no significant evidence for a difference in time to end of target lesion primary patency between groups: hazard ratio 1.18 with a 95% confidence interval of 0.78 to 1.79. There were no significant differences for any secondary outcomes, including patency outcomes and adverse events. Thus, our study demonstrated no evidence that paclitaxel-coated balloons provide benefit, following standard care high-pressure balloon angioplasty, in the treatment of arteriovenous fistulas. Hence, in view of the benefit suggested by other trials, the role of paclitaxel-coated angioplasty balloons remains uncertain.

Pulsatile tinnitus as a presenting symptom of central venous stenosis secondary to an ipsilateral upper arm arteriovenous PTFE graft.

A 51-year-old man presented with a swollen left arm and unilateral pulsatile tinnitus 2 weeks after a left upper arm polytetrafluoroethylene graft was created for haemodialysis access. A fistulogram of the left upper arm showed a central venous stenosis and significant retrograde flow up the left internal jugular vein. Percutaneous transluminal angioplasty was attempted unsuccessfully and fistula ligation was subsequently performed. This led to immediate resolution of the tinnitus. The venous stenosis was likely secondary to a cardiac resynchronisation therapy defibrillator, which had been removed 1 year previously. Central venous stenosis is a common but often asymptomatic complication of a cardiac device, with the exception of patients with upper extremity arteriovenous fistulas, who frequently develop symptomatic venous hypertension. This generally presents with ipsilateral arm swelling and/or high venous pressures during dialysis. To our knowledge, this is the first report of pulsatile tinnitus arising in this context.