The safety of deFinity and Optison for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses.
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.


CONCLUSIONS
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.
Oregon Health and Science University, Portland, Oregon 97239, USA. weik@ohsu.edu
Kevin
K
Wei
Sharon L
SL
Mulvagh
Lisa
L
Carson
Ravin
R
Davidoff
Ruvin
R
Gabriel
Richard A
RA
Grimm
Stephanie
S
Wilson
Lorrie
L
Fane
Charles A
CA
Herzog
William A
WA
Zoghbi
Rhonda
R
Taylor
Michael
M
Farrar
Farooq A
FA
Chaudhry
Thomas R
TR
Porter
Waleed
W
Irani
Roberto M
RM
Lang
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000009:adverse effects; D000707:Anaphylaxis / Q000139:chemically induced / Q000453:epidemiology*; D003287:Contrast Media; D005260:Female; D005466:Fluorocarbons / Q000009:adverse effects; D006801:Humans; D007089:Image Enhancement; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D014463:Ultrasonography / Q000706:statistics & numerical data*; D014481:United States; D055815:Young Adult
D000418:Albumins; D003287:Contrast Media; C099458:FS 069; D005466:Fluorocarbons; C042852:perflutren