Acute Adverse Reactions to Gadolinium-Based Contrast Agents in CMR: Multicenter Experience With 17,767 Patients From the EuroCMR Registry

Study Questions:

What is the frequency, nature, and severity of acute adverse reactions following the administration of gadolinium-based contrast agents (GBCAs) to patients undergoing cardiac magnetic resonance imaging (CMR)?

Methods:

This was a prospective evaluation of 17,767 consecutive patients from 45 European centers receiving one of several different GBCAs. Complications occurring within 60 minutes of administration were characterized and tabulated with respect to the nature of the complication, precise GBCA utilized, and indication for CMR.

Results:

The indication for CMR was for suspected coronary artery disease (CAD) in 7,285 patients, most of whom were overtly healthy; evaluation of cardiomyopathy or myocarditis in 5,813, and assessment of myocardial viability in 2,146. Overall, only 30 adverse reactions occurred in the 17,767 patients (0.17%), all of which were mild and transient. Adverse reactions included rashes and hives in nine, nausea in seven, and anxiety in six. The event rate varied depending on the precise GBCA utilized, from a low of 0.06% with gadodiamid to a high of 0.47% for gadobenat. The mean dose administered was 25.6 ml (range 5-80 ml), and there was no relation between frequency of adverse reactions and dose administered. While there was a variation in event frequency depending on specific GBCA, there was no identifiable relationship between frequency of events and the specific molecular structure of the agent. The event rate was 0.1% for largely healthy patients undergoing evaluation of suspected CAD, 0.17% for those with cardiomyopathy, and 0.42% for those with indications for assessment of myocardial viability.

Conclusions:

Following administration of GBCAs for CMR, the acute adverse reactions are infrequent and universally mild.

Perspective:

This study screened for adverse events in a large population of patients undergoing CMR with gadolinium-based agents for contrast enhancement. Of note, while GBCAs are approved in the United States for MR contrast imaging for general radiology purposes, they are not Food and Drug Administration (FDA) approved for cardiology purposes, and as such, use of GBCA for CMR is an off-label indication. This study demonstrates a superb safety profile with respect to short-term side effects when used for this indication. The reported incidence of adverse reactions of GBCA when used for general radiology purposes has ranged between 0.04% and 2.2%, and up to 17% of reactions occurring for general radiology indications have been graded as moderate and 6.3% as severe, compared to 0% moderate and severe in this CMR study. Of note, the increasing rates of adverse events in the sicker patient populations being evaluated for cardiomyopathy and viability may have more to do with the nonspecificity of the adverse reactions than true cause and effect. While currently not FDA approved for cardiac use, this study should provide excellent support for the argument that use of GBCAs in patients with known and suspected cardiac disease is safe, with a side effect profile equal to or more favorable to general radiology use.

Clinical Topics: Heart Failure and Cardiomyopathies, Noninvasive Imaging, Atherosclerotic Disease (CAD/PAD), Magnetic Resonance Imaging

Keywords: Nausea, Coronary Artery Disease, Health Resources, Drug-Related Side Effects and Adverse Reactions, Gadolinium, Myocarditis, Urticaria, Risk Factors, Magnetic Resonance Imaging, Heart Diseases, Contrast Media, Registries, Incidence, Cardiomyopathies, United States


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