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.
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.
Authors: Joseph Lunyera; Dinushika Mohottige; Anastasia-Stefania Alexopoulos; Hilary Campbell; C Blake Cameron; Nicole Sagalla; Timothy J Amrhein; Matthew J Crowley; Jessica R Dietch; Adelaide M Gordon; Andrzej S Kosinski; Sarah Cantrell; John W Williams; Jennifer M Gierisch; Belinda Ear; Karen M Goldstein Journal: Ann Intern Med Date: 2020-06-23 Impact factor: 25.391
Authors: Constantina Chrysochou; Albert Power; Aladdin E Shurrab; Sayed Husain; Steven Moser; James Lay; Alan D Salama; Philip A Kalra Journal: Clin J Am Soc Nephrol Date: 2010-01-21 Impact factor: 8.237
Authors: Babak Kateb; Katherine Chiu; Keith L Black; Vicky Yamamoto; Bhavraj Khalsa; Julia Y Ljubimova; Hui Ding; Rameshwar Patil; Jose Antonio Portilla-Arias; Mike Modo; David F Moore; Keyvan Farahani; Michael S Okun; Neal Prakash; Josh Neman; Daniel Ahdoot; Warren Grundfest; Shouleh Nikzad; John D Heiss Journal: Neuroimage Date: 2010-02-10 Impact factor: 7.400