What are the risks of nephrogenic systemic fibrosis (NSF) after using Gadolinium (Gd)-based contrast agents (GBCA) in patients with impaired renal function?

From the Guidelines

Patients with impaired renal function are at significant risk of developing nephrogenic systemic fibrosis (NSF) after receiving gadolinium-based contrast agents (GBCAs), particularly those with severe renal impairment (eGFR <30 mL/min/1.73m²) or those on dialysis, as stated in the 2021 consensus statements from the American College of Radiology and the National Kidney Foundation 1. The risk of NSF is highest with linear GBCAs, while macrocyclic agents are considered safer due to their greater stability. To minimize risk, clinicians should:

• Screen patients for renal dysfunction before GBCA administration
• Consider alternative imaging techniques
• Use the lowest effective dose of the safest GBCA class if contrast is necessary
• Arrange prompt dialysis after exposure for patients already on dialysis, as suggested by the FDA advisory 1 Key factors to consider include:
• The dose-related risk of NSF from group II and group III GBCM is unknown, but the lowest diagnostic dose of GBCM should be used 1
• Kidney function screening prior to group II GBCM administration is optional, but necessary for group III GBCM 1
• The risk of NSF does not appear to be related to the cause or duration of kidney disease, and initial concerns about other risk factors such as coincident liver disease without associated kidney disease have not been supported in the literature 1

From the FDA Drug Label

GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of gadobutrol injection in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR <30 mL/min/1. 73m 2), or Acute kidney injury.

The risk of nephrogenic systemic fibrosis (NSF) after using Gadolinium (Gd)-based contrast agents (GBCA), such as gadobutrol, in patients with impaired renal function is increased. Key factors that increase this risk include:

• Chronic, severe kidney disease (GFR <30 mL/min/1.73m^2)
• Acute kidney injury It is recommended to avoid use of GBCAs in patients with impaired renal function unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities 2.

From the Research

Risks of Nephrogenic Systemic Fibrosis (NSF) after Gadolinium-Based Contrast Agents (GBCA)

The use of Gadolinium-Based Contrast Agents (GBCA) in patients with impaired renal function has been associated with an increased risk of nephrogenic systemic fibrosis (NSF) [ 3, 4 ]. NSF is a rare but serious condition characterized by the formation of excess fibrous tissue in the skin and internal organs.

Factors Influencing the Risk of NSF

Several factors can influence the risk of NSF after GBCA administration, including:

• Degree of renal dysfunction [ 4 ]
• Dose of contrast agent [ 4 ]
• Stability of the gadolinium contrast agent [ 4, 5 ]
• Severity of concomitant illness [ 4 ]

Studies on the Risk of NSF

Studies have shown that the risk of NSF varies from negligible to 2-5% in select high-risk clinical situations [ 4 ]. A systematic review of the literature found a strong association between the use of GBCA and the development of NSF in patients with renal disease [ 4 ].

Safe Administration of GBCA

However, other studies have suggested that safe administration of GBCA can be performed even in patients with severe kidney disease, with no significant decrease in estimated glomerular filtration rate (eGFR) observed after administration [ 3 ]. The use of GBCA with increased thermodynamic and kinetic stability or increased relaxivity, along with a restricted use policy, has dramatically reduced NSF risk in patients with chronic kidney disease (CKD) [ 6 ].

Precautions and Recommendations

It is essential to weigh the benefits of magnetic resonance imaging (MRI) using GBCA against the risk of NSF on a case-by-case basis, especially in patients with renal dysfunction [ 4 ]. The fear of NSF should not lead to a denial of a well-indicated enhanced MRI examination [ 7 ].