Retrospective assessment of prevalence of nephrogenic systemic fibrosis (NSF) after implementation of a new guideline for the use of gadobenate dimeglumine as a sole contrast agent for magnetic resonance examination in renally impaired patients

Abstract

Stage 3-5 chronic kidney disease (CKD) undergoing gadobenate dimeglumine (GBD)-enhanced magnetic resonance (MR) examinations were included in the retrospective investigation. The electronic medical records were reviewed to assess the prevalence of nephrogenic systemic fibrosis (NSF) in renally impaired patients underwent GBDenhanced MR examinations. In all, 250 patients (98 men, mean age 72.6 years) were included: 97% of the patients had Stage 3 CKD (estimated GFR 30-59 mL/min/ 1.73 m 2 ); 37% had been exclusively exposed to GBD. The remaining were exposed to GBD and other gadoliniumbased contrast agents (GBCAs). The mean dose of GBD was 22 mL (standard deviation [SD], 11.2). Including exposure to other GBCAs, the mean cumulative dose of gadolinium was 61 mL (SD, 62.3). A total of 206 patients (82%) had skin examinations following the last GBD administration (mean duration, 108 days). No evidence of suspected or diagnosed NSF was found. In conclusion, on the basis of a retrospective chart review there was no skin evidence of NSF in predominantly Stage 3 CKD patients who were exposed to GBD at an average followup of 108 days, either solely or in combination with other GBCAs.

Incidence of nephrogenic systemic fibrosis at a large university hospital in Sweden

“…The consequence of this awareness is that this group of patients often avoids MRI and this may contribute to a delay in diagnosing serious diseases. Retrospective reviews of data from China [14] and the USA [15], however, seem to confirm the safety of low-dose contrast-enhanced MRI, even in patients with renal impairment. In addition, a recently published study by Chrysochou et al [16] reported that no patients developed NSF even after multiple gadolinium doses and Gd-MRI can be safely undertaken in the majority of patients with CKD.…”

“…There were 194 event dates in 2006, 128 event dates in 2007, 55 event dates in 2008 and only six in 2009, as of 3 September [13]. From late 2009 no more new cases were presented according to published reports [14][15][16][17].…”

Gadolinium and nephrogenic systemic fibrosis: an update

“…The remaining were in the immediate post-renal-transplant period [16]. Until 2011, no cases of NSF had been reported in CKD stage 3, and there were limited reports in CKD stage 4 [39,59]. One recent study from 2011, however, reported three cases of NSF in patients with CKD stage 3 and 4 [58].…”

“…This reflects a culture shift highlighted by a recent report of widely adopted policy changes among nephrologists across the USA relating to Gd contrast use in renal impairment and awareness of the risk factors and morbidity associated with NSF [62]. Since 2007, there has been a dramatic drop in the number of NSF cases reported, with multiple large studies in Sweden and the USA identifying reduced incidence or no new cases of NSF following restrictive prescribing policies [42,44,59,63]. In particular, no new pediatric cases of NSF have been reported to the Yale Registry in the period 2007-2013 (personal communication, Yale NSF Registry).…”

Special issue: Nephrogenic systemic fibrosis

“…The issue of relative risk of NSF versus CIN is addressed in the excellent review by Martin and other experts on this topic (25). Finally, retrospective reviews of data from China (26) and the United States (27) confirm the safety of low-dose contrast-enhanced MRI, even in patients with renal impairment.…”