This article is more than 5 years old. Information may no longer be current.

ASE consensus statement reaffirms importance of ultrasound contrast agents

Issue: December 2008

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Members of the American Society of Echocardiography have backed the use of contrast agents for the enhancement of echocardiograms.

The Society recently released a consensus statement and set of guidelines for the use of ultrasound contrast agents intended to replace the guidelines published in 2000. The updated guidelines became more pertinent, according to the ASE, after a black-box warning issued by the FDA in 2007 regarding potential risks with the use of contrast agents.

“Ultrasound contrast agents have an established role in clinical diagnosis, patient management and clinical research,” Sharon L. Mulvagh, MD, a cardiologist at the Mayo Clinic in Rochester, Minn., said in a press release. “Contrast agents can provide sonographers and physicians the clear images they need to diagnose life-threatening heart conditions that may not be otherwise visible.”

According to the consensus statement, a clinical application of contrast agents includes assessment of cardiac structure and function during rest and stress echocardiography. It may also be useful for echocardiograms performed in the emergency room and in intensive care units.

Ultrasound contrast agents had been the subject of controversy in 2007 when the FDA issued a black box label warning for the Definity (Lantheus Medical Imaging) contrast agent. The warning, which included contraindications such as acute MI and worsening or clinically unstable HF, applied to the entire class of perflutren-containing contrast agents. The warnings were prompted by reports of deaths in four patients that were temporally related to use of the contrast agents over a six-year period during which more than 2 million doses of contrast had been administered. In addition, there were reports of possible association between severe cardiopulmonary reactions and use of contrast agents in approximately 190 other patients. This had not been established as the cause of death.

According to the consensus statement, “There was widespread concern in the medical community over these new contraindications and requirements, which did not take into account the proven efficacy of ultrasound agents, the previously established safety of these compounds, the potential risks of alternative procedures and the likely confounding effect of pseudo complication in the reported events.” The FDA revised the contraindications in 2008, relaxing them for the Definity and Optison (GE Healthcare) contrast agents and replacing them instead with warnings. – by Eric Raible

For more information:

• Mulvagh SL, Rakowski H, Vannan MA, et al. American Society of Echocardiography consensus statement on the clinical applications of ultrasonic contrast agents in echocardiography.
• J Am Soc Echocardiogr. 2008;doi:10.1016/j.echo.2008.09.009.