Gadolinium-based contrast agents for cardiac mri: Use of linear and macrocyclic agents with associated safety profile from 154 779 european patients

Abstract

Purpose: To assess current use and acute safety profiles of gadolinium-based contrast agents (GBCAs) in cardiac MRI given recent sus-pensions 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 threaten-ing). 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% [n = 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% (n = 556) of AAEs were documented (mild, 0.12% [n = 178]; moderate, 0.21% [n = 331]; severe, 0.03% [n = 47]). For nonenhanced cardiac MRI, examina-tion-related events were reported in 2.59% (231 of 8924) of cases, the majority of which were anxiety (0.98% [n = 87]) and dyspnea (0.93% [n = 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; P = .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.