Incidence of Nephrogenic Systemic Fibrosis after Adoption of Restrictive Gadolinium-based Contrast Agent Guidelines
Abstract
The adoption of restrictive gadolinium-based contrast agent guidelines probably eliminated new cases of nephrogenic systemic fibrosis in the current study, and it enables the safe use of gadopentetate dimeglumine, even in patients who are undergoing chronic dialysis treatment and/or have an estimated glomerular filtration rate lower than 60 mL/min/m2.
Purpose
To retrospectively determine the incidence of nephrogenic systemic fibrosis (NSF) in a large academic medical center after the adoption of restrictive gadolinium-based contrast agent (GBCA) administration guidelines.
Materials and Methods
For this retrospective HIPAA-compliant study, institutional review board approval was obtained and the requirement for informed consent was waived. Restrictive GBCA guidelines were adopted in May 2007. The guidelines (a) require a recent serum creatinine level measurement in any patient who is aged 60 years or older and/or at risk for renal disease, (b) limit the maximal weight-based GBCA dose administered to any patient with an estimated glomerular filtration rate (eGFR) lower than 60 mL/min/m2 to 20 mL, and (c) prohibit the administration of any GBCA in patients who have an eGFR lower than 30 mL/min/m2 and/or are undergoing chronic dialysis treatment (except in emergency situations). The electronic medical records were searched for all contrast material–enhanced magnetic resonance (MR) imaging examinations performed during the post–guidelines adoption period between January 2008 and March 2010 and the pre–guidelines adoption and transitional period between January 2002 and December 2007. Separate pathology records were searched for biopsy-confirmed cases of NSF during the same study periods. The incidences of NSF during the pre–guidelines adoption and transitional period and post–guidelines adoption period were compared by using the paired Z test.
Results
A total of 52 954 contrast-enhanced MR examinations were performed during the post–guidelines adoption period. Of these 52 954 examinations, 46 464 (88%) were performed in adult patients with an eGFR of 60 mL/min/m2 or higher or presumed normal renal function and 6454 (12%) were performed in patients with an eGFR of 30–59 mL/min/m2. Thirty-six patients with an eGFR lower than 30 mL/min/m2 underwent contrast-enhanced MR imaging for emergent indications. Review of the pathology records for January 2008 to September 2010 revealed no new cases of NSF resulting from GBCA exposure.
Conclusion
After restrictive guidelines regarding GBCA administration were instituted, no new cases of NSF were identified among 52 954 contrast-enhanced MR examinations, including those performed in patients with an eGFR lower than 60 mL/min/m2.
© RSNA, 2011
References
- 1 . Scleromyxoedema-like cutaneous diseases in renal-dialysis patients. Lancet 2000;356(9234):1000–1001. Crossref, Medline, Google Scholar
- 2 . What nephrogenic fibrosing dermopathy might be. Arch Dermatol 2003;139(7):928–930. Crossref, Medline, Google Scholar
- 3 . Nephrogenic fibrosing dermopathy. Am J Dermatopathol 2001;23(5):383–393. Crossref, Medline, Google Scholar
- 4 . Nephrogenic fibrosing dermopathy: a novel cutaneous fibrosing disorder in patients with renal failure. Am J Med 2003;114(7):563–572. Crossref, Medline, Google Scholar
- 5 . Nephrogenic fibrosing dermopathy with systemic involvement. Arch Dermatol 2003;139(7):903–906. Crossref, Medline, Google Scholar
- 6 . Dialysis-associated systemic fibrosis (nephrogenic fibrosing dermopathy): study of inflammatory cells and transforming growth factor beta1 expression in affected skin. Arthritis Rheum 2004;50(8):2660–2666. Crossref, Medline, Google Scholar
- 7 . Involvement of skeletal muscle in dialysis-associated systemic fibrosis (nephrogenic fibrosing dermopathy). Muscle Nerve 2004;30(5):569–577. Crossref, Medline, Google Scholar
- 8 . Nephrogenic fibrosing dermopathy/nephrogenic systemic fibrosis: report of a new case with literature review. Am J Kidney Dis 2005;46(4):754–759. Crossref, Medline, Google Scholar
- 9 . Gadolinium: a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant 2006;21(4):1104–1108. Crossref, Medline, Google Scholar
- 10 . Gadolinium deposition in nephrogenic fibrosing dermopathy. J Am Acad Dermatol 2007;56(1):27–30. Crossref, Medline, Google Scholar
- 11 . Gadolinium is quantifiable within the tissue of patients with nephrogenic systemic fibrosis. J Am Acad Dermatol 2007;56(4):710–712. Crossref, Medline, Google Scholar
- 12 . Nephrogenic systemic fibrosis: a pathologic study of autopsy cases. Arch Pathol Lab Med 2009;133(12):1943–1948. Crossref, Medline, Google Scholar
- 13 . Gadolinium-based contrast exposure, nephrogenic systemic fibrosis, and gadolinium detection in tissue. AJR Am J Roentgenol 2008;190(4):1060–1068. Crossref, Medline, Google Scholar
- 14 . Preclinical investigation to compare different gadolinium-based contrast agents regarding their propensity to release gadolinium in vivo and to trigger nephrogenic systemic fibrosis-like lesions. Eur Radiol 2008;18(10):2164–2173. Crossref, Medline, Google Scholar
- 15 . Effect of haemodialysis after contrast medium administration in patients with renal insufficiency. Nephrol Dial Transplant 1998;13(2):358–362. Crossref, Medline, Google Scholar
- 16 . Does post-angiographic hemodialysis reduce the risk of contrast-medium nephropathy? Scand J Urol Nephrol 2000;34(5):323–326. Crossref, Medline, Google Scholar
- 17 . Nephrogenic systemic fibrosis after gadopentetate dimeglumine exposure: case series of 36 patients. Radiology 2009;253(1):81–89. Link, Google Scholar
- 18 . Acute adverse reactions to gadopentetate dimeglumine and gadobenate dimeglumine: experience with 32,659 injections. AJR Am J Roentgenol 2010;194(2):430–434. Crossref, Medline, Google Scholar
- 19 . Informatics in radiology: Render—an online searchable radiology study repository. RadioGraphics 2009;29(5):1233–1246. Link, Google Scholar
- 20 . Initial observations of electronic medical record usage during CT and MRI interpretation: frequency of use and impact on workflow. AJR Am J Roentgenol 2010;195(1):188–193. Crossref, Medline, Google Scholar
- 21 . A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation—Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999;130(6):461–470. Crossref, Medline, Google Scholar
- 22 . 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. J Magn Reson Imaging 2009;30(6):1335–1340. Crossref, Medline, Google Scholar
- 23 . ACR manual on contrast media, version 7. http://www.acr.org/SecondaryMainMenuCategories/quality_safety/contrast_manual/FullManual.aspx#page=8. Published 2010. Accessed November 16, 2010. Google Scholar
- 24 . Incidence of nephrogenic systemic fibrosis at two large medical centers. Radiology 2008;248(3):807–816. Link, Google Scholar
- 25 . Safety of gadolinium contrast agent in hemodialysis patients. Acta Radiol 2001;42(3):339–341. Crossref, Medline, Google Scholar
- 26 . New warnings required on use of gadolinium-based contrast agents. U.S. Food and Drug Administration Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225286.htm. Published September 9, 2010. Accessed November 16, 2010. Google Scholar
Article History
Received December 6, 2010; revision requested January 20, 2011; revision received February 10; accepted February 16; final version accepted March 3.Published online: July 2011
Published in print: July 2011