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

PURPOSE

To assess current use and acute safety profiles of gadolinium-based contrast agents (GBCAs) in cardiac MRI given recent suspensions of GBCA approval.

MATERIALS AND METHODS

Patients were retrospectively included from the multinational multicenter European Society of Cardiovascular Radiology (ESCR) MR/CT Registry collected between January 2013 and October 2019. GBCA-associated acute adverse events (AAEs) were classified as mild (self-limiting), moderate (pronounced AAE requiring medical management), and severe (life threatening). Multivariable generalized linear mixed-effect models were used to assess AAE likelihood.

RESULTS

A total of 154 779 patients (average age, 53 years ± 19 [standard deviation]; 99 106 men) who underwent cardiac MRI were included, the majority of whom underwent administration of GBCAs (94.2% [ = 145 855]). While linear GBCAs were used in 15.2% of examinations through 2011, their use decreased to less than 1% in 2018 and 2019. Overall, 0.36% ( = 556) of AAEs were documented (mild, 0.12% [ = 178]; moderate, 0.21% [ = 331]; severe, 0.03% [ = 47]). For nonenhanced cardiac MRI, examination-related events were reported in 2.59% (231 of 8924) of cases, the majority of which were anxiety (0.98% [ = 87]) and dyspnea (0.93% [ = 83]). AAE rates varied significantly by pharmacologic stressor, GBCA molecular structure (macrocyclic vs linear GBCA: multivariable odds ratio, 0.634; 95% confidence interval: 0.452, 0.888; = .008), GBCA subtype, and imaging indication.

CONCLUSION

Gadolinium-based contrast agent administration changed according to recent regulatory decisions, with use of macrocyclic agents almost exclusively in 2018 and 2019; these agents also demonstrated a favorable acute safety profile.© RSNA, 2020.