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.
J Cardiovasc Magn Reson
; 17: 58, 2015 Jul 14.
Article
em En
| MEDLINE
| ID: mdl-26170152
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 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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imageamento por Ressonância Magnética
/
Doenças Cardiovasculares
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Sistemas de Notificação de Reações Adversas a Medicamentos
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Meios de Contraste
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
/
Gadolínio
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Risk_factors_studies
Limite:
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
J Cardiovasc Magn Reson
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
/
DIAGNOSTICO POR IMAGEM
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Alemanha