Objectives: To estimate and stratify the risk of development of nephrogenic systemic fibrosis (NSF) in well-defined at-risk subpopulations from a large single institution, and to perform a single-institution case series study of patients with biopsy-proven NSF. Design: Retrospective cohort of patients exposed to gadolinium-based contrast agents (GBCAs) at a single institution during an 8-year period (January 1, 1999, to December 31, 2006), and a case series study of patients with biopsy-proven NSF. Setting: A primary, secondary, and tertiary health care center that treated more than 2.2 million outpatients and had 135 000 hospital admissions in 2007. Patients: A total of 94 917 patients exposed to GBCAs; patients at risk for NSF (3779 patients on hemodialysis, 1694 patients with renal transplants, and 717 patients with liver transplants, a well-defined subgroup that includes patients at risk for reduced renal function); and 61 patients with a clinical diagnosis of NSF. Main Outcome Measure: Risk estimate for NSF. Results: The risk of development of NSF is 1.0% for patients who undergo hemodialysis (8 of 827), 0.8% for patients with renal transplantation (4 of 527), and 0% for patients with liver transplantation at our institution (0 of 327). Conclusions: Despite the limitations, this study, which reviewed a large number of patients who underwent intravascular GBCA injections, demonstrates a 77-fold higher risk of NSF among patients who undergo hemo-dialysis and a 69-fold higher risk in patients with renal transplantation. This increased risk is thought to be associated with poor clearance of most GBCAs.
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