Update on Nephrogenic Systemic Fibrosis: Should We Stop Screening?
Sadhana Nandwana

Synopsis

This presentation will provide a current update on nephrogenic systemic fibrosis (NSF) and where we stand with exposure of selected gadolinium based contrast agents (GBCAs) in renally impaired patients and risk of NSF. Risk stratification based on safety profiles of GBCAs and current national and international guidelines and recommendations will be examined. Evaluation of whether these guidelines should be modified in light of recent publications demonstrating a lack of NSF occurrence in patients exposed to specific GBCAs will be discussed.

Highlights

1. Timeline of the discovery of NSF

2. Current guidelines (FDA, ACR, EMA)

3. Theories of varying risk with different gadolinium based contrast agents (GBCAs)

4. Recent literature of NSF risk with non group 1 agents/agents with no unconfounded cases

5. Benefits and risks of discontinuing screening of patients

Objective/Purpose

Review the issue of NSF in renal failure patients with usage of gadolinium based contrast agents (GBCAs) and provide an update of current literature regarding risks of NSF with certain GBCAs. Also, will discuss current national/international recommendations and explore eliminating screening of at-risk patients.

Background

This presentation will review the history of NSF discovery and current FDA, ACR and EMA guidelines regarding NSF, renal disease and GBCAs and screening policies. Theories regarding varying risk of individual GBCAs based on differing safety profiles will be discussed. In depth review of several large and smaller studies that have been recently published regarding the safety of certain GBCAs in terms of NSF occurrence in high risk (renal impaired) patients will be presented. Specifically, published data on GBCAs that have no known unconfounded cases of NSF will be discussed including agents such as gadobenate dimeglumine, gadoxetic acid, gadoterate meglumine, gadofosveset and gadoteridol.

Discussion

Interpretation of the data provided by recent publications as well as prior smaller studies warrants consideration of revising current screening practices for at risk patients with specific “low risk” agent use. While there may be benefits of continued patient screening including opportunities for future research and adherence to current guidelines, the scientific community should evaluate whether these guidelines are possibly outdated. For example, over 3,000 high risk patients have received gadobenate dimeglumine with no cases of NSF detected when combining the results of several studies. Similar studies of high risk population patients receiving gadoexetic acid, gadoterate meglumine, gadofosveset and gadoteridol also demonstrate no NSF cases, albeit the number of patients exposed was much smaller (ranging from 69 to 631 patients depending on the type of GBCA).

Conclusion

Radiology practices may consider changing their screening policy of patients undergoing MRIs with contrast when using certain GBCAs.

Acknowledgements

None

References

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Proc. Intl. Soc. Mag. Reson. Med. 24 (2016)