Caroline Cassels
January 15, 2007 (updated March 6, 2007) — Following the recent US Food and Drug Administration (FDA) warning about an association between gadolinium-based contrast agents and nephrogenic systemic fibrosis (NSF) in patients with renal failure, a team from Yale University, which includes the world's foremost authority on the rare condition, says dialysis should be aggressively used as soon as possible after magnetic resonance (MR) investigations in such patients.Yale maintains an international NSF registry, headed by world authority on the disease, Shawn E. Cowper, MD. The registry includes records on more than 215 NSF known cases worldwide. A survey now under way reveals that more than 95% of all NSF patients surveyed (approximately 100) were exposed to a gadolinium-based contrast agent 2 to 3 months before disease onset, said Dr. Kuo
First described in 1997 and named nephrogenic fibrosing dermopathy, the condition is characterized by increased deposits of collagen in tissue that results in thickening and hardening of the skin. In turn, this restricts movement of the joints and can result in patients being confined to a wheelchair within a matter of weeks.
The condition was renamed NSF after it was discovered that, in addition to the skin, the disease could also have systemic effects and an impact on internal organs, resulting in multiorgan failure and death.
"We estimate about 97% of the time when you give an MR contrast agent to a patient with severe renal failure, which is the susceptible population, they do not develop the disease. NSF develops in only a very small minority of cases, so there truly have to be other risk factors at play, and we're working to determine what those are," he said.
In addition to a first dialysis session within 3 hours of MR investigation with gadolinium contrast and a second session within 24 hours, the Yale team's recommendations, which they are publicizing for the purposes of information sharing and not as official practice guidelines, also include the following:
- Consider alternative imaging or nonimaging modalities that can provide the requested clinical diagnostic data at a lower potential risk.
- If administration of gadolinium-based MR contrast agent is deemed necessary, use the lowest possible dose to reliably provide the diagnostic information.
- Inform patients with stage 4 (eGFR 15–30 mL/min per 1.73 m2} or 5 (eGFR <15>2)CKD of the benefits, risks, and alternatives, based on current information.
- Perform any additional nonenhanced sequences that might be helpful and monitor the study to evaluate the continuing necessity of contrast agent.
- Consider hemodialysis in patients undergoing peritoneal dialysis and possible patients with CKD stage 4 deemed at higher risk.
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