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

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Image Enhancement
Contrast Media
Safety
Critical Illness
Incidence
Acute Pain
Diagnostic Imaging
Chest Pain
Intensive Care Units
FS 069
Definity
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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