Journal Article

Gadolinium-enhanced cardiovascular magnetic resonance: administered dose in relationship to united states food and drug administration (FDA) guidelines

Arai, Andrew E, Bluemke, David A, Lima, Joao AC, Nacif, Marcelo S

2012

Overview

Myocardial late gadolinium enhancement 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 CMR. The relationship of gadolinium dose warnings (due to nephrogenic systemic fibrosis) announced in 2008 to gadolinium dosing regimens was also examined. 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. Case reports, review articles, editorials, MRA related papers and all reports that did not indicate gadolinium type or weight-based dose were excluded. For all included references, full text was available to determine the total administered gadolinium dose on a per kg basis. Average and median dose values were weighted by the number of subjects in each study. 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 late gadolinium enhancement. In 2004, the weighted-median and weighted-mean contrast dose were 0.15 and 0.16 ± 0.06 mmol/kg, respectively. Median contrast doses for 2005-2010 were: 0.2 mmol/kg for all years, 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). Gadopentetate dimeglumine was the most frequent gadolinium type [114 (48.9%) studies]. No change in mean gadolinium dose was present before, versus after the Food and Drug Administration (FDA) black box warning (p > 0.05). Three multi-center dose ranging trials have been published for cardiac MRI applications. CMR studies in the peer-reviewed published literature routinely use higher gadolinium doses than regulatory agencies indicated in the package leaflet. Clinical trials should be supported to determine the appropriate doses of gadolinium for CMR studies.

• Publisher: Elsevier Inc,BioMed Central,BioMed Central Ltd,Elsevier
• Subject: Adolescent / Adult / Aged / Angiology / Cardiology / Cardiovascular Diseases - diagnosis / Child / Contrast media / Contrast Media - administration & dosage / Contrast Media - adverse effects / Contrast Media - standards / Diagnosis / Dose-Response Relationship, Drug / Drug Labeling - standards / Gadolinium / Gadolinium - administration & dosage / Gadolinium - adverse effects / Gadolinium - standards / Guideline Adherence / Health aspects / Heart / Humans / Imaging / Magnetic resonance imaging / Magnetic Resonance Imaging - standards / Medicine / Medicine & Public Health / Middle Aged / Myocardial ischemia / Nephrogenic Fibrosing Dermopathy - chemically induced / Nephrogenic Fibrosing Dermopathy - prevention & control / Practice Guidelines as Topic / Radiology / Risk Assessment / Risk Factors / United States / United States Food and Drug Administration - standards / Young Adult