Abstract
Summary The incidence of nephrogenic systemic fibrosis in subjects receiving gadoversetamide for cardiovascular magnetic resonance is low (0.026% overall and 1.274% in those subjects with CKD Stage 5 on hemodialysis). Background Since 2006, the US Food and Drug Administration (FDA) has recommended restricting gadolinium based contrast agents (GBCAs) for magnetic resonance in patients with renal impairment due to an association of GBCA use with nephrogenic systemic fibrosis (NSF). The multiple FDA warnings have listed different glomerular filtration rate (GFR) cut-off values for restricting GBCA use. Consequently, hospital policies vary in renal impairment screening criteria and restrictions for both agent-specific and GFR cut-off values for GBCA use. Determining the incidence of developing NSF after exposure to specific GBCAs, and when stratified by chronic kidney disease (CKD) stage, may clarify which agents and patients are at highest risk for developing NSF. Currently, the incidence of developing NSF after exposure to gadoversetamide (Covidien, Mansfield MA) is unknown. The objective of this study was to determine the incidence and patients at highest risk of developing NSF in a large cohort of patients with suspected cardiovascular disease receiving gadoversetamide. Methods
Highlights
Since 2006, the US Food and Drug Administration (FDA) has recommended restricting gadolinium based contrast agents (GBCAs) for magnetic resonance in patients with renal impairment due to an association of GBCA use with nephrogenic systemic fibrosis (NSF)
Hospital policies vary in renal impairment screening criteria and restrictions for both agent-specific and glomerular filtration rate (GFR) cut-off values for GBCA use
Determining the incidence of developing NSF after exposure to specific GBCAs, and when stratified by chronic kidney disease (CKD) stage, may clarify which agents and patients are at highest risk for developing NSF
Summary
Since 2006, the US Food and Drug Administration (FDA) has recommended restricting gadolinium based contrast agents (GBCAs) for magnetic resonance in patients with renal impairment due to an association of GBCA use with nephrogenic systemic fibrosis (NSF). The multiple FDA warnings have listed different glomerular filtration rate (GFR) cut-off values for restricting GBCA use. Hospital policies vary in renal impairment screening criteria and restrictions for both agent-specific and GFR cut-off values for GBCA use. Determining the incidence of developing NSF after exposure to specific GBCAs, and when stratified by chronic kidney disease (CKD) stage, may clarify which agents and patients are at highest risk for developing NSF. The objective of this study was to determine the incidence and patients at highest risk of developing NSF in a large cohort of patients with suspected cardiovascular disease receiving gadoversetamide
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