2015 Update on Acute Adverse Reactions to Gadolinium based Contrast Agents in Cardiovascular MR. Large Multi-National and Multi-Ethnical Population Experience With 37788 Patients From the EuroCMR Registry.

Détails

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Etat: Public
Version: Final published version
ID Serval
serval:BIB_A42715601B88
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
2015 Update on Acute Adverse Reactions to Gadolinium based Contrast Agents in Cardiovascular MR. Large Multi-National and Multi-Ethnical Population Experience With 37788 Patients From the EuroCMR Registry.
Périodique
Journal of Cardiovascular Magnetic Resonance : Official Journal of the Society For Cardiovascular Magnetic Resonance
Auteur(s)
Bruder O., Schneider S., Pilz G., van Rossum A.C., Schwitter J., Nothnagel D., Lombardi M., Buss S., Wagner A., Petersen S., Greulich S., Jensen C., Nagel E., Sechtem U., Mahrholdt H.
ISSN
1532-429X (Electronic)
ISSN-L
1097-6647
Statut éditorial
Publié
Date de publication
2015
Peer-reviewed
Oui
Volume
17
Pages
58
Langue
anglais
Notes
Publication types: Comparative Study ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't Publication Status: epublish
Résumé
OBJECTIVES: Specifically we aim to demonstrate that the results of our earlier safety data hold true in this much larger multi-national and multi-ethnical population.
BACKGROUND: We sought to re-evaluate the frequency, manifestations, and severity of acute adverse reactions associated with administration of several gadolinium- based contrast agents during routine CMR on a European level.
METHODS: Multi-centre, multi-national, and multi-ethnical registry with consecutive enrolment of patients in 57 European centres.
RESULTS: During the current observation 37,788 doses of Gadolinium based contrast agent were administered to 37,788 patients. The mean dose was 24.7 ml (range 5-80 ml), which is equivalent to 0.123 mmol/kg (range 0.01 - 0.3 mmol/kg). Forty-five acute adverse reactions due to contrast administration occurred (0.12%). Most reactions were classified as mild (43 of 45) according to the American College of Radiology definition. The most frequent complaints following contrast administration were rashes and hives (15 of 45), followed by nausea (10 of 45) and flushes (10 of 45). The event rate ranged from 0.05% (linear non-ionic agent gadodiamide) to 0.42% (linear ionic agent gadobenate dimeglumine). Interestingly, we also found different event rates between the three main indications for CMR ranging from 0.05% (risk stratification in suspected CAD) to 0.22% (viability in known CAD).
CONCLUSIONS: The current data indicate that the results of the earlier safety data hold true in this much larger multi-national and multi-ethnical population. Thus, the "off-label" use of Gadolinium based contrast in cardiovascular MR should be regarded as safe concerning the frequency, manifestation and severity of acute events.
Mots-clé
Acute Disease, Adverse Drug Reaction Reporting Systems, Cardiovascular Diseases/diagnosis, Contrast Media/adverse effects, Dose-Response Relationship, Drug, Drug-Related Side Effects and Adverse Reactions/diagnosis, Drug-Related Side Effects and Adverse Reactions/ethnology, Europe/epidemiology, Gadolinium/adverse effects, Humans, Magnetic Resonance Imaging/adverse effects, Patient Safety, Registries, Risk Assessment, Risk Factors, Severity of Illness Index
Pubmed
Web of science
Open Access
Oui
Création de la notice
08/08/2015 16:10
Dernière modification de la notice
20/08/2019 16:09
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