Purpose: To acknowledge the facts of gadoxetate disodium-related events in Japan and to achieve better MR practice by analyzing large cohort data with various MR parameters. Materials and methods: This prospective multi-institutional study included 1993 patients (1201 men, mean age 66.4 ± 12.8 years), who received dynamic MRI with gadoxetate disodium (gadoxetate group, n = 1646) or extracellular gadolinium-based contrast agents (other-GBCAs group, n = 347) between January and November 2016. Recorded data covered adverse reactions including dyspnea, breath-hold failure during acquisition, respiratory artifacts rated with a four-point scale, and MR parameters. We compared data between the two groups in whole cohort and age-, gender-, and institution-matched subcohort using χ2 test (n = 640). Logistic regression model was used to reveal independent associates of substantial artifacts in arterial phase imaging. Results: Transient dyspnea rarely occurred in gadoxetate or other-GBCAs group (both < 1%). Gadoxetate group (vs other-GBCAs group) showed higher rates of breath-hold failure (whole cohort, 18.2% vs 7.7%, p < 0.001; subcohort, 17.6% vs 6.3%, p < 0.001) and substantial artifacts in arterial phase (7.2% vs 2.2%, p = 0.001; 7.4% vs 1.7%, p = 0.001). With single arterial phase protocol, substantial artifacts under gadoxetate were independently associated with age (odds ratio [OR] = 1.04, p < 0.001), hearing difficulty (OR = 2.92, p = 0.008), breath-hold practice required (OR = 1.61, p = 0.039), and short acquisition time (OR = 0.43, p = 0.005). Multiple arterial phase acquisition did not reduce the incident rate of substantial artifacts. Conclusion: Gadoxetate disodium was associated with breath-hold failure and substantial artifacts in arterial phase imaging, but not with dyspnea in Japan. Shorter acquisition time should be used to sustain image quality in gadoxetate disodium-enhanced arterial phase imaging. Key Points: • Gadoxetate disodium administration leads to breath-hold failure and substantial imaging artifacts in arterial phase MRI in Japan. • Contrast agent-induced dyspnea in arterial phase and adverse reactions are rare in Japan, without showing differences between gadoxetate disodium or other extracellular gadolinium-based contrast agents. • Shorter acquisition time significantly reduces gadoxetate-induced imaging artifacts in the arterial phase.
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