title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Cardiology and Angiology, Elisabeth Hospital, Essen, Germany. O.Bruder@contilia.de.
authors.forename: O
authors.initials: O
authors.lastname: Bruder
authors.affiliation: Institut für Herzinfarktforschung, Department of Biometrics, Ludwigshafen, Germany. Schneider@stiftung-ihf.de.
authors.forename: S
authors.initials: S
authors.lastname: Schneider
authors.affiliation: Department of Cardiology, Hospital Agatharied, Hausham, Germany. Guenter.Pilz2@khagatharied.de.
authors.forename: G
authors.initials: G
authors.lastname: Pilz
authors.affiliation: Department of Cardiology, VU University Medical Centre, Amsterdam, The Netherlands. Ac.vrossum@vumc.nl.
authors.forename: A C
authors.initials: AC
authors.lastname: van Rossum
authors.affiliation: Centre Hospitalier Universitaire Vaudois - CHUV University of Lausanne, Lausanne, Switzerland. Jurg.Schwitter@chuv.ch.
authors.forename: J
authors.initials: J
authors.lastname: Schwitter
authors.affiliation: Department of Cardiology, Klinikum Ludwigsburg, Ludwigsburg, Germany. Detlev.Nothnagel@kliniken-lb.de.
authors.forename: D
authors.initials: D
authors.lastname: Nothnagel
authors.affiliation: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy. lomass@ifc.cnr.it.
authors.forename: M
authors.initials: M
authors.lastname: Lombardi
authors.affiliation: Department of Cardiology, University of Heidelberg, Heidelberg, Germany. Sebastian.Buss@med.uni-heidelberg.de.
authors.forename: S
authors.initials: S
authors.lastname: Buss
authors.affiliation: Cardiology Associates of Fairfield, Stamford, CT, USA. anja.wagner@gmail.com.
authors.forename: A
authors.initials: A
authors.lastname: Wagner
authors.affiliation: Barts and The London NIHR Biomedical Research Unit, London Chest Hospital, London, United Kingdom. S.e.petersen@qmul.ac.uk.
authors.forename: S
authors.initials: S
authors.lastname: Petersen
authors.affiliation: Department of Cardiology, Robert Bosch Medical Centre, Stuttgart, 70376, Germany. Simon.greulich@rbk.de.
authors.forename: S
authors.initials: S
authors.lastname: Greulich
authors.affiliation: Department of Cardiology and Angiology, Elisabeth Hospital, Essen, Germany. C.Jensen@contilia.de.
authors.forename: C
authors.initials: C
authors.lastname: Jensen
authors.affiliation: Division of Cardiovascular Imaging, J.W. Goethe University Frankfurt, Frankfurt am Main, Germany; German Center of Cardiovascular Research, Frankfurt, Germany. eike.nagel@cardiac-imaging.org.
authors.forename: E
authors.initials: E
authors.lastname: Nagel
authors.affiliation: Department of Cardiology, Robert Bosch Medical Centre, Stuttgart, 70376, Germany. Udo.sechtem@rbk.de.
authors.forename: U
authors.initials: U
authors.lastname: Sechtem
authors.affiliation: Department of Cardiology, Robert Bosch Medical Centre, Stuttgart, 70376, Germany. Heiko.Mahrholdt@rbk.de.
authors.forename: H
authors.initials: H
authors.lastname: Mahrholdt
mesh_terms: D000208:Acute Disease; D016907:Adverse Drug Reaction Reporting Systems; D002318:Cardiovascular Diseases / Q000175:diagnosis*; D003287:Contrast Media / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000208:ethnology*; D005060:Europe / Q000453:epidemiology; D005682:Gadolinium / Q000009:adverse effects*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects*; D061214:Patient Safety; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index
chemical_list: D003287:Contrast Media; D005682:Gadolinium