Since the FDA issued its Black Box warning about the use of ultrasound contrast agents last October, ASE has worked hard to assist its members in dealing with this unexpected development.  As we changed our practice to comply with the guidelines, many ASE members were concerned that the new labeling was unnecessarily restrictive and would preclude the use of contrast in situations where its diagnostic benefit was well established. 

As a result, an exhaustive review of the safety data and the mechanisms by which perfluro-containing contrast agents could produce adverse events was undertaken.  The specific reported adverse events that led to the issuance of the Black Box warning were also reviewed.  This culminated in a series of frank and productive visits and communications with the FDA.  Several ASE members played key roles in this grassroots effort.  We were encouraged by the willingness of FDA officials to engage in dialog and reexamine data.  

Over the past several months, a more complete picture of the risks and benefits of echo contrast use has emerged.  Working directly with the manufacturers, the FDA has recently revised the relabeling of the two commercially available echo contrasts agents, Optison^TM and Definity (R).  The changes have been communicated to the companies which have now issued statements in the form of notification letters to health care providers. 

The changes represent a significant relaxation of the limitations on the use of ultrasound contrast agents.  The contraindications and warnings have been revised and the mandate for 30 minute post-infusion monitoring has been modified to include only high-risk patients.  These new directives represent an acknowledgement of the benefits and utility of contrast agents.  At the same time, any associated risks are now more accurately understood and can be viewed in the context of the true risk-benefit balance. Ongoing and future studies will continue to assess the safety of ultrasound contrast agents.  

As echocardiographers, we should applaud these recent developments.  The new labeling guidelines reasonably address patient safety while at the same time facilitating the appropriate use of contrast agents to improve the value of the echo examination.  We want to thank our members who worked diligently to collect and communicate the information that ultimately led to the revisions.  We also thank the FDA for its open communication and willingness to consider all the available information and, in the end, to act in the best interest of the patients.  ASE will continue to engage with the FDA regarding future indications for the use of ultrasound contrast agents.

We are providing the following resources to cardiovascular ultrasound practitioners to assist with the administration and use of contrast agents.

• Boston Medical Center

Sample Definity Protocol (PDF Format)

• Richard A. Grimm, DO, FACC - Contrast Echocardiography Policy (PDF Format)
  Director, Echocardiography Laboratory
  Cleveland Clinic