Safety Analysis of Adverse Events of Ultrasound Contrast Agent Lumason/SonoVue in 49,100 Patients.

This study assessed the incidence of mild, moderate and severe adverse events (AEs) and examined their association with age, sex, body region examined, time to event and duration of the AE(s) in a large cohort of patients who underwent contrast-enhanced ultrasound (CEUS) with Lumason/SonoVue. In this retrospective observational study, 49,100 patients who underwent CEUS were analyzed. Forty-three (0.088%) patients experienced AEs, with 23 (0.047%) patients experiencing mild AEs, 13 (0.026%) experiencing moderate AEs and 7 (0.014%) experiencing severe AEs. No fatal event occurred. There was no age- or sex-related difference in the incidence of the AE(s) (p = 0.158 and p = 0.474). Inpatients (0.17%) more often experienced AEs than outpatients (0.06%, p = 0.003). The mean time to event for mild and moderate AEs was 14.50 ± 6.96 and 15.75 ± 10.40 min, respectively, whereas that for severe AEs was 1.89 ± 1.21 min after the injection. The remission time for mild and moderate AEs was approximately 30-40 min, and all patients with severe AEs recovered within 12 h. Twenty-one (48.8%) patients received medical treatment. In summary, Lumason/SonoVue has a good safety profile with a low incidence of AEs, most of which are mild with a short time to event and duration.

Competing Interests: Conflict of interest disclosure The authors declare that they have no competing interests that could be perceived as prejudicing the impartiality of the research reported in this study.

(Copyright © 2022. Published by Elsevier Inc.)