Advertisement

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

  • Author Footnotes
    # Qiuyang Li and Kaixiu Yang contributed equally to this article as the first author.
    Qiuyang Li
    Footnotes
    # Qiuyang Li and Kaixiu Yang contributed equally to this article as the first author.
    Affiliations
    Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, Beijing, China
    Search for articles by this author
  • Author Footnotes
    # Qiuyang Li and Kaixiu Yang contributed equally to this article as the first author.
    Kaixiu Yang
    Footnotes
    # Qiuyang Li and Kaixiu Yang contributed equally to this article as the first author.
    Affiliations
    Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, Beijing, China
    Search for articles by this author
  • Yongjiao Ji
    Affiliations
    Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, Beijing, China
    Search for articles by this author
  • Hongrui Liu
    Affiliations
    Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, Beijing, China
    Search for articles by this author
  • Xiang Fei
    Affiliations
    Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, Beijing, China
    Search for articles by this author
  • Yan Zhang
    Affiliations
    Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, Beijing, China
    Search for articles by this author
  • Jingbo Li
    Affiliations
    Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, Beijing, China

    Medical School of Chinese PLA, Beijing, China
    Search for articles by this author
  • Yukun Luo
    Correspondence
    Address correspondence to: Yukun Luo, Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, No. 28, Fuxing Road, Haidian District, Beijing 100853, China.
    Affiliations
    Department of Ultrasound, First Medical Center, Chinese PLA General Hospital, Beijing, China
    Search for articles by this author
  • Author Footnotes
    # Qiuyang Li and Kaixiu Yang contributed equally to this article as the first author.

      Abstract

      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.

      Key Words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Ultrasound in Medicine and Biology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Amamoto T
        • Sakata N
        • Ogata T
        • Shimada H
        • Inoue T.
        Intra-plaque vessels on contrast-enhanced ultrasound sonography predict carotid plaque histology.
        Cerebrovasc Dis. 2018; 46: 265-269
        • American College of Radiology (ACR)
        Manual on contrast media, version 7.
        ACR, Reston, VA2021
        • Barr RG
        • Peterson C
        • Hindi A.
        Evaluation of indeterminate renal masses with contrast-enhanced US: A diagnostic performance study.
        Radiology. 2014; 271: 133-142
        • Dietrich CF
        • Nolsøe CP
        • Barr RG
        • Berzigotti A
        • Burns PN
        • Cantisani V
        • Chammas MC
        • Chaubal N
        • Choi BI
        • Clevert DA
        • Cui X
        • Dong Y
        • D'Onofrio M
        • Fowlkes JB
        • Gilja OH
        • Huang P
        • Ignee A
        • Jenssen C
        • Kono Y
        • Kudo M
        • Lassau N
        • Lee WJ
        • Lee JY
        • Liang P
        • Lim A
        • Lyshchik A
        • Meloni MF
        • Correas JM
        • Minami Y
        • Moriyasu F
        • Nicolau C
        • Piscaglia F
        • Saftoiu A
        • Sidhu PS
        • Sporea I
        • Torzilli G
        • Xie X
        • Zheng R
        Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) in the liver—Update 2020. WFUMB in Cooperation with EFSUMB, AFSUMB, AIUM, and FLAUS.
        Ultraschall Med. 2020; 41: 562-585
        • Furtado RG
        • Rassi DDC
        • Melato LH
        • Oliveira ACR
        • Nunes PM
        • Baccelli PE
        • Santos SCO
        • Santos VE
        • Rassi Junior L
        • Nunes CG
        Safety of SF6 (SonoVue®) contrast agent on pharmacological stress echocardiogram.
        Arq Bras Cardiol. 2021; 117: 1170-1178
        • Geleijnse ML
        • Nemes A
        • Vletter WB
        • Michels M
        • Soliman OI
        • Caliskan K
        • Galema TW
        • ten Cate FJ.
        Adverse reactions after the use of sulphur hexafluoride (SonoVue) echo contrast agent.
        J Cardiovasc Med (Hagerstown). 2009; 10: 75-77
        • Hu C
        • Feng Y
        • Huang P
        • Jin J
        Adverse reactions after the use of SonoVue contrast agent: Characteristics and nursing care experience.
        Medicine (Baltimore). 2019; 98: e17745
        • Jakobsen JA
        • Oyen R
        • Thomsen HS
        • Morcos SK.
        Safety of ultrasound contrast agents.
        Eur Radiol. 2005; 15: 941-945
        • McCarville MB
        • Coleman JL
        • Guo J
        • Li Y
        • Li X
        • Honnoll PJ
        • Davidoff AM
        • Navid F.
        Use of quantitative dynamic contrast-enhanced ultrasound to assess response to antiangiogenic therapy in children and adolescents with solid malignancies: A pilot study.
        AJR Am J Roentgenol. 2016; 206: 933-939
        • Meloni MF
        • Smolock A
        • Cantisani V
        • Bezzi M
        • D'Ambrosio F
        • Proiti M
        • Lee F
        • Aiani L
        • Calliada F
        • Ferraioli G
        Contrast enhanced ultrasound in the evaluation and percutaneous treatment of hepatic and renal tumors.
        Eur J Radiol. 2015; 84: 1666-1674
        • Morcos SK
        • Thomsen HS
        • Webb JA.
        Contrast-media-induced nephrotoxicity: A consensus report. Contrast Media Safety Committee, European Society of Urogenital Radiology (ESUR).
        Eur Radiol. 1999; 9: 1602-1613
        • Piscaglia F
        • Bolondi L.
        The safety of Sonovue in abdominal applications: Retrospective analysis of 23188 investigations.
        Ultrasound Med Biol. 2006; 32: 1369-1375
        • Seitz K
        • Milestone Strobel D.A
        Approval of CEUS for diagnostic liver imaging in adults and children in the USA.
        Ultraschall Med. 2016; 37: 229-232
        • Sellaturay P
        • Nasser S
        • Ewan P.
        Polyethylene glycol-induced systemic allergic reactions (anaphylaxis).
        J Allergy Clin Immunol Pract. 2021; 9: 670-675
        • Tang C
        • Fang K
        • Guo Y
        • Li R
        • Fan X
        • Chen P
        • Chen Z
        • Liu Q
        • Zou Y.
        Safety of sulfur hexafluoride microbubbles in sonography of abdominal and superficial organs: Retrospective analysis of 30,222 cases.
        J Ultrasound Med. 2017; 36: 531-538