In the Journals

Study: Gadolinium-enhanced MRI poses low risk of nephrogenic systemic fibrosis

The risk of developing nephrogenic systemic fibrosis was low with the use of gadolinium-based contrast agents for MRI in patients with CKD, according to a recently published study.

“Nephrogenic systemic fibrosis (NSF) is a rare, potentially fatal condition caused by iatrogenic gadolinium administration in patients with acute kidney injury or stage 4 or 5 chronic kidney disease (CKD),” Sean A. Woolen, MD, MS, of the department of radiology at the University of Michigan, and colleagues wrote. “After more than 500 cases of NSF were reported from 1997 to 2007, regulations were adopted to prevent NSF. In 2017, the U.S. Food and Drug Administration mandated a black box warning advising avoidance of all gadolinium-containing contrast agents (GBCA) in at-risk patients.”

The researchers continued that although these recommendations led to effective hospital policies that eliminated the disease, patients with severe kidney disease have had fewer contrast-enhanced MRIs which may contribute to misdiagnosis and delayed diagnosis. Due to this concern, they sought to assess the risk of NSF in patients with stage 4 or 5 CKD who received a group II GBCA by reviewing 16 studies published between May 2008 and April 2019 (including 4,931 patients).

They determined the pooled incidence of NSF to be 0 of 4,931, leading them to conclude the risk for these patients is likely less than 0.07%.

The risk of developing nephrogenic systemic fibrosis was low with the use of gadolinium-based contrast agents for MRI in patients with CKD.
Source: Adobe Stock

The researchers argued these data indicate the safety profile for contrast-enhanced MRI using GBCA is “clearer” than that for contrast-enhanced CT using a low-osmolality iodinated contrast agent.

They wrote, “In both cases (contrast-enhanced computed tomography and contrast-enhanced MRI), the harms of delayed diagnosis and misdiagnosis resulting from the withholding of contrast material in at-risk patients are incompletely measured but likely real. For many disease states, unenhanced imaging has poorer diagnostic accuracy than contrast-enhanced imaging, increasing the risk of diagnostic error and iatrogenic morbidity and mortality.”

In a related editorial, Saugar Maripuri, MD, and Kirsten L. Johansen, MD, both of Hennepin County Medical Center in Minnesota, suggested that group II GBCAs should be used “cautiously” with patients given the lowest possible dose and repeated exposures avoided.

“In the end, changing practice behavior could be challenging, especially among nephrologists who practiced during the emergence of NSF and the countless nephrology trainees who were taught to strictly avoid GBCAs,” they concluded. “Nephrologists may need to come to terms with our natural tendency to avoid errors of commission more assiduously than errors of omission. Perhaps the combination of zero events and a solid biochemical rationale will help get us there.” – by Melissa J. Webb

Disclosures: Woolen reports no relevant financial disclosures. Please see study for all other authors’ relevant financial disclosures.

The risk of developing nephrogenic systemic fibrosis was low with the use of gadolinium-based contrast agents for MRI in patients with CKD, according to a recently published study.

“Nephrogenic systemic fibrosis (NSF) is a rare, potentially fatal condition caused by iatrogenic gadolinium administration in patients with acute kidney injury or stage 4 or 5 chronic kidney disease (CKD),” Sean A. Woolen, MD, MS, of the department of radiology at the University of Michigan, and colleagues wrote. “After more than 500 cases of NSF were reported from 1997 to 2007, regulations were adopted to prevent NSF. In 2017, the U.S. Food and Drug Administration mandated a black box warning advising avoidance of all gadolinium-containing contrast agents (GBCA) in at-risk patients.”

The researchers continued that although these recommendations led to effective hospital policies that eliminated the disease, patients with severe kidney disease have had fewer contrast-enhanced MRIs which may contribute to misdiagnosis and delayed diagnosis. Due to this concern, they sought to assess the risk of NSF in patients with stage 4 or 5 CKD who received a group II GBCA by reviewing 16 studies published between May 2008 and April 2019 (including 4,931 patients).

They determined the pooled incidence of NSF to be 0 of 4,931, leading them to conclude the risk for these patients is likely less than 0.07%.

The risk of developing nephrogenic systemic fibrosis was low with the use of gadolinium-based contrast agents for MRI in patients with CKD.
Source: Adobe Stock

The researchers argued these data indicate the safety profile for contrast-enhanced MRI using GBCA is “clearer” than that for contrast-enhanced CT using a low-osmolality iodinated contrast agent.

They wrote, “In both cases (contrast-enhanced computed tomography and contrast-enhanced MRI), the harms of delayed diagnosis and misdiagnosis resulting from the withholding of contrast material in at-risk patients are incompletely measured but likely real. For many disease states, unenhanced imaging has poorer diagnostic accuracy than contrast-enhanced imaging, increasing the risk of diagnostic error and iatrogenic morbidity and mortality.”

In a related editorial, Saugar Maripuri, MD, and Kirsten L. Johansen, MD, both of Hennepin County Medical Center in Minnesota, suggested that group II GBCAs should be used “cautiously” with patients given the lowest possible dose and repeated exposures avoided.

“In the end, changing practice behavior could be challenging, especially among nephrologists who practiced during the emergence of NSF and the countless nephrology trainees who were taught to strictly avoid GBCAs,” they concluded. “Nephrologists may need to come to terms with our natural tendency to avoid errors of commission more assiduously than errors of omission. Perhaps the combination of zero events and a solid biochemical rationale will help get us there.” – by Melissa J. Webb

Disclosures: Woolen reports no relevant financial disclosures. Please see study for all other authors’ relevant financial disclosures.