The Safety of Definity and Optison for Ultrasound Image Enhancement: A Retrospective Analysis of 78,383 Administered Contrast Doses

Kevin Wei, Sharon L. Mulvagh, Lisa Carson, Ravin Davidoff, Ruvin Gabriel, Richard A. Grimm, Stephanie Wilson, Lorrie Fane, Charles A. Herzog, William A. Zoghbi, Rhonda Taylor, Michael Farrar, Farooq A. Chaudhry, Thomas R. Porter, Waleed Irani, Roberto M. Lang

    Research output: Contribution to journalArticle

    145 Citations (Scopus)

    Abstract

    Background: The purpose of this retrospective analysis was to define the incidence of severe adverse events after exposure to ultrasound contrast agents. Methods: Data between January 1, 2001, and September 30, 2007, were collected using invited responses to an on-line web-based questionnaire from 1 general and 12 cardiac ultrasound laboratories. During a period of 4.5 ± 2.4 years, a total of 66,164 doses of Definity (Lantheus Medical Imaging, North Billerica, MA) and 12,219 doses of Optison (GE Healthcare, Buckinghamshire, UK) were administered, reflecting contrast use in 5% of transthoracic and 28% of stress echocardiographic procedures. More than 10,000 doses were given to critically ill patients in intensive care unit settings or to patients with acute chest pain of suspected cardiac origin. The median age of patients who received an ultrasound contrast agent was 60 years, 49% were male, and the mean body mass index was 32 ± 1.4 g/m-2. Results: Severe reactions that were considered "probably" related to an ultrasound contrast agent developed in 8 patients (0.01%), all of whom were outpatients, and 4 (0.006%) of these were consistent with anaphylactoid reactions. There were no deaths reported. All patients recovered with treatment. No serious events were seen in inpatients. Conclusion: This multicenter, retrospective analysis includes the largest number of doses of ultrasound contrast agents ever published and a large number of patients evaluated in a wide variety of settings, including the critically ill. It shows that these agents have a good safety profile in both cardiac and abdominal ultrasound applications. The incidence of severe adverse reactions to ultrasound contrast agents is no greater, and may be lower, than that reported for contrast agents commonly used in other cardiac imaging tests.

    Original languageEnglish (US)
    Pages (from-to)1202-1206
    Number of pages5
    JournalJournal of the American Society of Echocardiography
    Volume21
    Issue number11
    DOIs
    StatePublished - Nov 2008

    Fingerprint

    Image Enhancement
    Contrast Media
    Safety
    Critical Illness
    Incidence
    Acute Pain
    Diagnostic Imaging
    Chest Pain
    Intensive Care Units
    Definity
    FS 069
    Inpatients
    Body Mass Index
    Outpatients
    Delivery of Health Care

    Keywords

    • Adverse events
    • Contrast agent
    • Echocardiography
    • Safety
    • Ultrasound

    ASJC Scopus subject areas

    • Radiology Nuclear Medicine and imaging
    • Cardiology and Cardiovascular Medicine

    Cite this

    The Safety of Definity and Optison for Ultrasound Image Enhancement : A Retrospective Analysis of 78,383 Administered Contrast Doses. / Wei, Kevin; Mulvagh, Sharon L.; Carson, Lisa; Davidoff, Ravin; Gabriel, Ruvin; Grimm, Richard A.; Wilson, Stephanie; Fane, Lorrie; Herzog, Charles A.; Zoghbi, William A.; Taylor, Rhonda; Farrar, Michael; Chaudhry, Farooq A.; Porter, Thomas R.; Irani, Waleed; Lang, Roberto M.

    In: Journal of the American Society of Echocardiography, Vol. 21, No. 11, 11.2008, p. 1202-1206.

    Research output: Contribution to journalArticle

    Wei, K, Mulvagh, SL, Carson, L, Davidoff, R, Gabriel, R, Grimm, RA, Wilson, S, Fane, L, Herzog, CA, Zoghbi, WA, Taylor, R, Farrar, M, Chaudhry, FA, Porter, TR, Irani, W & Lang, RM 2008, 'The Safety of Definity and Optison for Ultrasound Image Enhancement: A Retrospective Analysis of 78,383 Administered Contrast Doses', Journal of the American Society of Echocardiography, vol. 21, no. 11, pp. 1202-1206. https://doi.org/10.1016/j.echo.2008.07.019
    Wei, Kevin ; Mulvagh, Sharon L. ; Carson, Lisa ; Davidoff, Ravin ; Gabriel, Ruvin ; Grimm, Richard A. ; Wilson, Stephanie ; Fane, Lorrie ; Herzog, Charles A. ; Zoghbi, William A. ; Taylor, Rhonda ; Farrar, Michael ; Chaudhry, Farooq A. ; Porter, Thomas R. ; Irani, Waleed ; Lang, Roberto M. / The Safety of Definity and Optison for Ultrasound Image Enhancement : A Retrospective Analysis of 78,383 Administered Contrast Doses. In: Journal of the American Society of Echocardiography. 2008 ; Vol. 21, No. 11. pp. 1202-1206.
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    abstract = "Background: The purpose of this retrospective analysis was to define the incidence of severe adverse events after exposure to ultrasound contrast agents. Methods: Data between January 1, 2001, and September 30, 2007, were collected using invited responses to an on-line web-based questionnaire from 1 general and 12 cardiac ultrasound laboratories. During a period of 4.5 ± 2.4 years, a total of 66,164 doses of Definity (Lantheus Medical Imaging, North Billerica, MA) and 12,219 doses of Optison (GE Healthcare, Buckinghamshire, UK) were administered, reflecting contrast use in 5{\%} of transthoracic and 28{\%} of stress echocardiographic procedures. More than 10,000 doses were given to critically ill patients in intensive care unit settings or to patients with acute chest pain of suspected cardiac origin. The median age of patients who received an ultrasound contrast agent was 60 years, 49{\%} were male, and the mean body mass index was 32 ± 1.4 g/m-2. Results: Severe reactions that were considered {"}probably{"} related to an ultrasound contrast agent developed in 8 patients (0.01{\%}), all of whom were outpatients, and 4 (0.006{\%}) of these were consistent with anaphylactoid reactions. There were no deaths reported. All patients recovered with treatment. No serious events were seen in inpatients. Conclusion: This multicenter, retrospective analysis includes the largest number of doses of ultrasound contrast agents ever published and a large number of patients evaluated in a wide variety of settings, including the critically ill. It shows that these agents have a good safety profile in both cardiac and abdominal ultrasound applications. The incidence of severe adverse reactions to ultrasound contrast agents is no greater, and may be lower, than that reported for contrast agents commonly used in other cardiac imaging tests.",
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    AU - Carson, Lisa

    AU - Davidoff, Ravin

    AU - Gabriel, Ruvin

    AU - Grimm, Richard A.

    AU - Wilson, Stephanie

    AU - Fane, Lorrie

    AU - Herzog, Charles A.

    AU - Zoghbi, William A.

    AU - Taylor, Rhonda

    AU - Farrar, Michael

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    N2 - Background: The purpose of this retrospective analysis was to define the incidence of severe adverse events after exposure to ultrasound contrast agents. Methods: Data between January 1, 2001, and September 30, 2007, were collected using invited responses to an on-line web-based questionnaire from 1 general and 12 cardiac ultrasound laboratories. During a period of 4.5 ± 2.4 years, a total of 66,164 doses of Definity (Lantheus Medical Imaging, North Billerica, MA) and 12,219 doses of Optison (GE Healthcare, Buckinghamshire, UK) were administered, reflecting contrast use in 5% of transthoracic and 28% of stress echocardiographic procedures. More than 10,000 doses were given to critically ill patients in intensive care unit settings or to patients with acute chest pain of suspected cardiac origin. The median age of patients who received an ultrasound contrast agent was 60 years, 49% were male, and the mean body mass index was 32 ± 1.4 g/m-2. Results: Severe reactions that were considered "probably" related to an ultrasound contrast agent developed in 8 patients (0.01%), all of whom were outpatients, and 4 (0.006%) of these were consistent with anaphylactoid reactions. There were no deaths reported. All patients recovered with treatment. No serious events were seen in inpatients. Conclusion: This multicenter, retrospective analysis includes the largest number of doses of ultrasound contrast agents ever published and a large number of patients evaluated in a wide variety of settings, including the critically ill. It shows that these agents have a good safety profile in both cardiac and abdominal ultrasound applications. The incidence of severe adverse reactions to ultrasound contrast agents is no greater, and may be lower, than that reported for contrast agents commonly used in other cardiac imaging tests.

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