Long-term outcomes of paclitaxel-coated balloons for non-malignant ureteral strictures.

Abstract

To evaluate the clinical efficacy and safety of drug-coated balloon (DCB) ureteroplasty for the management of non-malignant ureteral strictures. A prospective "off-label" monocentric single-arm pilot study investigating the safety and efficacy of drug-coated balloon (DCB) (Lutonix®; BD, USA) was performed. Twenty-five patients with benign ureteral strictures related to uretero-enteric anastomosis (n = 13); lithiasis (n = 5), post-surgical complications (iatrogenic n = 5), transplanted kidney (n = 1) and post-radiotherapy (n = 1) were included. Following lesion crossing, predilatation was performed using 4-7mm high-pressure balloon catheter (5-6Fr) with a balloon pressure of 6-7atm based on the manufacturer's recommendation. In the absence of rupture of the ureteral wall, the DCB was dilated for 4min. across the lesion. The process was repeated if deemed necessary to a maximum of three stricture dilatations. We analysed both clinical and radiological primary patency (no signs of ipsilateral hydronephrosis or improvement of the existing residual dilatation at the follow-up examinations) and secondarily safety endpoints. Mean lesion length was 40 ± 28.5mm. Mean time follow up was 36months ± 10.46months. Strictures were located at upper ureteric (12%), lower ureteric (32%), ureterovesical anastomosis (4%) and uretero-enteric anastomosis (52%) levels. The overall radiological success at 1-year follow-up was 88% (22/25 patients). In 56% patients (14/25 patients with primary patency) the nephrostomy catheter was removed 21days following a single DCB procedure. In 32% (8/25 patients) an additional dilatation sessions were required for maintaining the ureteral patency. The overall failure rate at 1-year follow-up was 12% (3/25 patients). Only one case of febrile urinary tract infection in a female patient (acute pyelonephritis) was encountered after the first dilatation. Paclitaxel-coated balloon ureteroplasty proved to be safe and effective for the treatment of non-malignant ureteral strictures. Larger studies are warranted to validate these promising initial results.