Marcelo Souto Nacif MD, PhD, Presenter: Nothing to Disclose

Andrew E. Arai MD, Abstract Co-Author: Nothing to Disclose

Joao A. C. Lima MD, Abstract Co-Author: Grant, Toshiba Corporation Grant, Bracco Group Grant, Astellas Group Grant, Deltanoid Pharmaceuticals, Inc

David A. Bluemke MD, PhD, Abstract Co-Author: Nothing to Disclose

The objective of this study was determine to the current status of dosing regimens for Gd-based contrast agents in cardiac MRI, emphasizing trends before and after 2008.

We conducted a meta-analysis of peer reviewed publications from January, 2004 to December, 2010. Major subject search headings (MeSh) terms from the National Library of Medicine’s PubMed were: contrast media, gadolinium, heart, magnetic resonance imaging; searches were limited to human studies with abstracts published in English. Full text was evaluated for all matching references to determine the total administered gadolinium dose on a per kg basis. Case reports, review articles, editorials, MRA related papers and all reports that did not indicate gadolinium type or weight-based dose were excluded.

399 publications were identified in PubMed; 233 studies matched the inclusion criteria, encompassing 19,934 patients with mean age 54.2±11.4 (range 9.3 to 76 years). 34 trials were related to perfusion testing and 199 to myocardial delayed enhancement. In 2004, the weighted-median and -mean reported contrast dose was 0.15 and 0.16+0.06 mmol/kg, respectively. Gadopentetate dimeglumine (Magnevist®) was the most frequent gadolinium type. Median contrast doses for 2005-2010 were: 0.2, 0.2, 0.2, 0.2, 0.2 and 0.2 mmol/kg, respectively. Mean contrast doses for the years 2005-2010 were: 0.19+0.03, 0.18+0.04, 0.18+0.10, 0.18+0.03, 0.18+0.04 and 0.18+0.04 mmol/kg, respectively (p for trend, NS). No change in mean gadolinium dose was present before, versus after the FDA black box warning (p>0.05).

Cardiac MRI studies in the peer-reviewed published literature routinely use higher gadolinium doses than FDA indicated dose. Clinical trials should be supported to determine the appropriate doses of gadolinium enhancement of the myocardium.

In 2007, the United States Food and Drug Administration issued a black box warning regarding gadolinium contrast agents. The FDA recommends that label dose (0.1 mmol/kg or less) should not be exceeded.

Nacif, M, Arai, A, Lima, J, Bluemke, D, Gadolinium-enhanced Cardiac Magnetic Resonance Imaging: Administered Dose in Relationship to FDA Guidelines.  Radiological Society of North America 2011 Scientific Assembly and Annual Meeting, November 26 - December 2, 2011 ,Chicago IL. http://archive.rsna.org/2011/11034270.html