Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients

Abstract

C ardiac MRI is a well-established cardiac imaging modality and is considered the reference standard for several diseases (1). According to international registries, intravenous gadolinium-based contrast agents (GBCAs) are used in most cardiac MRI examinations for indications ranging from myocarditis and cardiomyopathy imaging to myocardial viability assessment (2,3). GBCAs can be considered safe for the referred population in general and the cardiac MRI population in particular, with reported acute adverse event (AAE) rates between 0.04% and 2.2% (4-11).Because of the toxicity of free gadolinium 3+ ions, ligands are used to create gadolinium chelates for safe use of GBCAs in humans. Based on the type of ligand, GB-CAs can be generally classified as linear or macrocyclic (12). There have been growing concerns about cerebral gadolinium depositions after repeated GBCA administration, with some studies suggesting that the molecular GBCA structure affected these depositions, with higher likelihood for deposit with linear compounds compared with macrocyclic GBCAs (13,14). As a preventive measure, in late 2017, the European Medicines Agency (EMA) suspended the marketing authorization of linear GBCA types (except for hepatic imaging), and this suspension was ratified by the European Commission (15). To our knowledge, there are currently no data on the effects of these regulatory changes on case numbers or on the cardiac MRI safety profile.This study assesses the contemporary effect of the EMA regulatory decision on use of GBCAs in cardiac MRI and the associated safety profile of GBCAs with regard to AAEs using a multinational registry.

Current Status of Cardiovascular Imaging in Germany: Structured Data from the National Certification Program, ESCR Registry, and Survey among Radiologists

“…For cardiac CT and MRI, the transition from restricted local expertise to widely available expertise has successfully been accomplished, as demonstrated by data from the ESCR registry with growing numbers of non-university hospitals and medical practices. According to recent publications based on data of the ESCR registry, about 36 % of cardiac MRI examinations in Europe were performed at academic and 64 % at non-academic radiological centers [10][11][12].…”

Manual zur Indikation und Durchführung spezieller echokardiographischer Anwendungen

“…Shunts und ARDS werden bei den beiden anderen Substanzen mit einem Warnhinweis aufgeführt. Das Risiko für schwere anaphylaktische Reaktionen nach UEAs wird mit 1:10.000 Untersuchungen angegeben und liegt damit in der gleichen Größenordnung wie bei MRT-Kontrastmitteln und 10-fach niedriger als bei Röntgenkontrastmitteln [ 77 , 90 , 99 , 111 ]. Die Applikation setzt somit immer eine Risiko-Nutzen-Abwägung voraus sowie eine schriftliche Aufklärung in Analogie zur Verwendung von jodierten Kontrastmitteln.…”

“…Die Bolusinjektion eines lungengängigen UEAs ist geeignet zur Verbesserung der LV-Endokard-Abgrenzung für die Wandbewegungsanalyse in Ruhe und während Stressuntersuchungen, die Bestimmung von LV-Volumina und LVEF sowie zur Diagnose von ventrikulären Thromben oder strukturellen Herzerkrankungen wie der apikalen hypertrophen Kardiomyopathie. Die Infusion des UAEs mithilfe einer Infusionspumpe, die durch eine kontinuierliche Schwenkbewegung der Spritze eine Trennung von gasgefüllten Bläschen und NaCl-Lösung verhindert (VueJect-Pumpe), ist empfohlen für die myokardiale Kontrastechokardiographie im Rahmen der Stressechokardiographie sowie zur Analyse der Perfusion myokardialer Raumforderungen [ 99 , 100 , 111 , 116 ]. Der erste Schritt einer kontrastverstärkten Untersuchung besteht in der Anwahl eines Kontrastprogramms.…”

Emerging Techniques in Cardiac Magnetic Resonance Imaging

“…With emerging data on the superior safety of macrocyclic GBCA, cardiac MR examinations are mainly performed using a macrocyclic agent with a favorable safety profile. 10 Intravascular "blood-pool" contrast agents (eg, gadofosveset trisodium (Ablavar™)) have been previously used for vascular imaging and are highly popular in pediatric cardiac imaging. However, they are no longer clinically available.…”