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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

Bruder, O. ; Schneider, S. ; Pilz, G. ; Rossum, A.C. ; Schwitter, J. ; Nothnagel, D. ; Lombardi, M. ; Buss, Sebastian ; Wagner, A. ; Petersen, S. ; Greulich, S. ; Jensen, C. ; Nagel, E. ; Sechtem, U. ; Mahrholdt, H.

In: Journal of cardiovascular magnetic resonance, 17 (2015), Nr. 58. pp. 1-7. ISSN 1532-429X

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Download (411kB) | Lizenz: Creative Commons Lizenzvertrag2015 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 by Bruder, O. ; Schneider, S. ; Pilz, G. ; Rossum, A.C. ; Schwitter, J. ; Nothnagel, D. ; Lombardi, M. ; Buss, Sebastian ; Wagner, A. ; Petersen, S. ; Greulich, S. ; Jensen, C. ; Nagel, E. ; Sechtem, U. ; Mahrholdt, H. underlies the terms of Creative Commons Attribution 3.0 Germany

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Abstract

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 37788 doses of Gadolinium based contrast agent were administered to 37788 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.

Document type: Article
Journal or Publication Title: Journal of cardiovascular magnetic resonance
Volume: 17
Number: 58
Publisher: BioMed Central
Place of Publication: London
Date Deposited: 08 Jan 2016 14:02
Date: 2015
ISSN: 1532-429X
Page Range: pp. 1-7
Faculties / Institutes: Medizinische Fakultät Heidelberg > Medizinische Universitäts-Klinik und Poliklinik
DDC-classification: 610 Medical sciences Medicine
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