High-pressure drug-coated balloon angioplasty (APERTO OTW ^® ) without pre-dilatation for hemodialysis fistula stenosis: Midterm outcomes in 150 patients

BACKGROUND: Arteriovenous fistula stenosis is a major cause of access dysfunction in patients undergoing hemodialysis. Drug-coated balloons are a promising therapeutic option. This study evaluated the efficacy and safety of a high-pressure paclitaxel-coated balloon (APERTO OTW Cardionovum GmbH, Bonn, Germany) as a stand-alone treatment device without prior pre-dilatation. METHODS: A total of 168 angioplasties were performed using APERTO OTW in 150 patients. The mean follow-up was 15 months (range: 1-113). Most patients (89.3%) required only one intervention, with a mean of 1.13 interventions per patient (±0.38). De novo lesions accounted for 85.8% of cases. RESULTS: No device-related adverse events were observed. Vessel rupture was the most common complication (3.6%). The mean blood flow increased by 300.6 mL/min postoperatively. At follow-up, 37.5% of the fistulas remained functional, 26.8% required reintervention but remained patent, 28.6% progressed to non-salvageable thrombosis, and 7.1% underwent kidney transplantation with a functioning fistula. Overall patency rates at 6, 12, and 24 months were 81.54%, 61.3%, and 46.81%, respectively. Patency did not differ significantly between the de novo and previously treated lesions. CONCLUSION: Angioplasty with the APERTO OTW drug-coated balloon, applied as a single high-pressure step without pre-dilatation, proved safe, effective, and complication-free. It significantly improved blood flow and maintained competitive long-term patency, confirming its reliability for hemodialysis vascular access.