Gadolinium-enhanced magnetic resonance imaging for renovascular disease and nephrogenic systemic fibrosis: critical review of the literature and UK experience.

PURPOSE: To examine the positive reporting bias regarding the link with gadolinium (Gd) exposure and nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This link has impacted strongly the international radiology safety guidelines. We believe that positive reporting bias has prevailed in the literature and that very few patients with a glomerular filtration rate (GFR) 15-29 mL/min (stage 4 chronic kidney disease [CKD]) should be regarded as high risk.

MATERIALS AND METHODS: To examine this, we conducted the following steps: 1. A critical literature search on NSF. 2. An analysis of our centers magnetic resonance angiography (MRA) experience since 1999. 3. A survey of participating centers of the multicenter ASTRAL trial to assess whether any patients screened or enrolled into ASTRAL had developed NSF.

RESULTS: The vast majority (90%) of NSF cases reported in the literature have occurred in patients with endstage renal disease treated with dialysis; very have had stable stage 4 or 5 (nondialysis) CKD. In all, 562 patients were followed up at our center: 30.4% were CKD4, 14.4% CKD5, 5.3% on dialysis, and 0.2% had renal transplants when imaged. No patients developed any symptoms or signs of NSF. In all, 347 patients were enrolled into ASTRAL on the basis of MRA (32% CKD4/5). One patient out of 45 centers (CKD5, received two Gd scans) developed NSF. Approximately 5 times as many patients were screened as were entered into ASTRAL.

CONCLUSION: No cases of NSF were observed at our center. By extrapolation, 1/1735 patients screened for the ASTRAL trial developed NSF, giving a crude incidence rate of 0.06%. We would argue that patients with CKD4 can safely undergo Gd-MRA, albeit using a minimal dose of a macrocyclic agent and avoiding repeat doses.