Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients

Abstract

Objectives To assess the incidence of acute adverse events (AAEs) in gadolinium-enhanced cardiac magnetic resonance (CMR) imaging. Methods Gadolinium-based contrast agent (GBCA)–enhanced CMR data from the multinational, multicenter European Society of Cardiovascular Radiology MRCT Registry was included. AAE severity was classified according to the American College of Radiology Manual on Contrast Media (mild, moderate, severe). Multivariable generalized linear mixed effect models were used to assess the likelihood of AAEs in various GBCA, adjusting for pharmacological stressor, main indications (i.e., suspected or known coronary artery disease or myocarditis), age, sex, and submitting center as a random effect. Results In the study population of 72,839 GBCA-enhanced CMRs, a total of 260 AAEs were reported (0.36%), with a minority of severe AAEs ( n = 24, 0.033%). Allergic-like AAEs were less likely than physiologic AAEs (29% versus 71%). Patients without pharmacological stress imaging had a lower AAE rate (0.22%) compared to stress imaging (0.75%), with the highest AAE rates for regadenoson (2.95%). AAE rates also varied by GBCA subtype (overall p < 0.001). There was significant interaction between GBCA and pharmacological stressor (interaction p = 0.025), with AAE rates ranging between 0 and 10% for certain GBCA/stressor combinations. There was further marginal evidence that higher GBCA volume was associated with higher AAE incidence (OR = 1.02, p = 0.05). Conclusion GBCA-enhanced CMR imaging demonstrates low AAE rates comparable to those of other body regions. AAE likelihood correlates with GBCA subtype, pharmacological stressor, and imaging indication. Intravenous fluid administration in patients with cardiac impairment might contribute to these findings. Key Points • Acute adverse event rates in cardiac magnetic resonance (CMR) imaging with gadolinium-based contrast agents (GBCAs) are low (0.36%), especially for severe adverse events (0.033%). • Mild and moderate adverse events are more frequent during stress CMR imaging. • Physiologic AAEs are more common than allergic AAEs in CMR imaging. Electronic supplementary material The online version of this article (10.1007/s00330-019-06171-2) contains supplementary material, which is available to authorized users.

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“…Furthermore, the incidence of AEs in this study is comparable with the incidence observed in other prospective post-authorisation studies and registries with various GBCAs in different indications. In a major European prospective registry, promoted by the European Society of Cardiovascular Radiology, with 72,839 GBCA-enhanced cardiac MRs, Uhlig et al found a total incidence of AEs of 0.36% and severe AEs of 0.03% [ 16 ]. In this study, gadoteric acid had the lowest incidence of AEs (odds ratio [OR] 0.89) with non-significant difference versus gadobutrol (reference OR 1), whereas gadoteridol had a significantly higher incidence of AEs than gadobutrol (OR 3.58).…”

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“…For cardiovascular radiology, comparable datasets are currently lacking and professional societies can play an important role in the assembly of large publicly available datasets with high-quality ground truth labels to allow for an objective comparison of different ML algorithms. Registries like the ESCR MR/CT registry ( https://www.mrct-registry.org ), providing large standardized data sets for further analyses with currently > 300,000 de-identified examinations [ 26 ], are also an important contribution in this direction.…”

Free-breathing non-contrast flow-independent cardiovascular magnetic resonance angiography using cardiac gated, magnetization-prepared 3D Dixon method: assessment of thoracic vasculature in congenital heart disease

“…Gadolinium-based contrast agents have a favorable tolerance and severe complications are rare since the introduction of new-generation agents. However, based on recent studies on gadolinium deposition in the brain, the restrained use of contrast agents is recommended due to uncertain long-term effects, especially in young patients [ 24 , 25 ]. Moreover, peripheral intravenous cannulation is often traumatic in children; therefore, contrast-free examinations can increase patient compliance.…”