Gadolinium-enhanced cardiac magnetic resonance imaging: administered dose in relationship to United States Food and Drug Administration (FDA) guidelines

Abstract

Summary The Food and Drug Administration (FDA) has recently recommended that the label dose of Gadolinium (Gd)based contrast agents (GBCA) not be exceeded. The primary concern for high dose GBCAs application is nephrogenic systemic fibrosis (NSF). For the majority of conventional GBCA, the label dose is 0.1 mmol/kg. GBCA use for evaluation of myocardial disease is currently considered off-label use in the United States. Little information is present in the literature regarding optimal GBCA dose for CMR. Therefore, we evaluated the current status of GBCA use for CMR of the myocardium as presented in the peer-reviewed literature, emphasizing trends before and after nephrogenic fibrosis guidelines were issued in 2008. This meta-analysis showed that the median GBCA dose for English peer reviewed publications on CMR (19,934 patients) was 0.2 mmol/kg. Further, no change in mean or median gadolinium dose was present before, versus after the FDA issued GBCA black box warnings (p>0.05). This appears surprising, given the amount of attention and many publications regarding NSF. It remains to be seen if future CMR studies will incorporate and report lower gadolinium doses. Clinical trials should be supported to determine the appropriate doses of gadolinium enhancement of the myocardium. Background Myocardial delayed enhancement MRI was originally validated using higher than label-recommended doses of gadolinium chelate. The objective of this study was to evaluate available evidence for various gadolinium dosing regimens used for cardiac MRI. The relationship of gadolinium dose warnings (due to nephrogenic systemic fibrosis) announced in 2008 to gadolinium dosing regimens was also examined. Methods