Assessment of the incidence of medical events reported following Y90 treatment.

Abstract

491 Background: Radioembolization (Y90) is a minimally invasive procedure combining embolization and radiation therapy to treat primary and metastatic liver tumors. During radioembolization, resin beads loaded with the radioactive isotope, yttrium Y-90, are administered through the hepatic arterial vasculature. Although the safety profile of Y90 is well described, the number of dosage errors associated with treatment delivery is unknown. The purpose of this study is to assess incidence of medical events reported following Y90 treatment. Methods: A search was conducted of the US Nuclear Regulatory Commission events notification database for reported medical events between January 2000 and July 2016 using the following search terms: Y90, SIRS spheres, and TheraSpheres. Results: We recorded 96 reported medical events related to Y90 treatment: 26% were related to human error, 20% to equipment malfunction, 14% to catheter blockage, 2% were caused by catheter movement, 5% were the result of improper microsphere migration, and 33% had undetermined cause. The human error-related events consisted of application of an incorrect dose (82%), administration to the incorrect liver lobe (7%), or targeting of the wrong organ (11%). For the events involving incorrect dose administration, the total dosage exceeded the prescribed dose by greater than 20% in 5 events, while the total dosage was less than the prescribed dose by > 20% in 86 events. In 12 cases, dose inaccuracies were indicated but final dose administered was not reported. Conclusions: Although the incidence of medical events was relatively small, equipment failure and human errors were frequent. Under dosages occurred more often than over dosages. Stopcock malfunction and catheter blockage were common causes and equipment redesign should be considered. Human errors involving administration of the incorrect dose are potentially avoidable with procedural modifications.