Literature DB >> 31287213

Observational study on the incidence of nephrogenic systemic fibrosis in patients with renal impairment following gadoterate meglumine administration: the NSsaFe study.

Richard G McWilliams1, Jennifer V Frabizzio2, Adelard I De Backer3, Anna Grinberg4, Bart D Maes5, Bruno Beomonte Zobel6, Andreas Gottschalk7.   

Abstract

BACKGROUND: Nephrogenic systemic fibrosis (NSF) is a rare life-threatening condition strongly associated with the administration of gadolinium-based contrast agents in patients with severe or endstage renal impairment.
PURPOSE: To prospectively determine the incidence of NSF in patients with renal impairment after administration of gadoterate meglumine. STUDY TYPE: Prospective. POPULATION: In all, 540 patients with moderate, severe, or endstage renal impairment, scheduled to undergo a routine contrast-enhanced MRI with gadoterate meglumine. Mean age was 69.7 ± 12.7 years (range: 21-95) with 58.4% of males. FIELD STRENGTH/SEQUENCE: 1.5T or 3.0T, sequence according to each site practice. ASSESSMENT: Medical history, indication(s) for current MRI and adverse events were recorded for each patient. Patients were followed up over 2 years after administration with three visits separated by at least 3 months to detect any signs/symptoms suggestive of NSF. STATISTICAL TESTS: Descriptive.
RESULTS: Renal impairment was graded as moderate for 69.4% of patients, severe for 16.0% and endstage for 12.1%; 2.6% had undergone a kidney transplant. Estimated glomerular filtration rate ranged from 4 to 59 mL/min/1.73 m2 except one value of 74 mL/min/1.73 m2 in a patient with kidney transplant. Central nervous system exploration was the main MRI indication (34.7%) and mean dose injected was 0.22 ± 0.09 mL/kg. Overall, 446 patients (82.6%) attended at least one follow-up visit and completed the NSF questionnaire and 329 (60.9%) attended the 2-year visit. No suspicion of NSF was reported in all 446 patients, including 119 patients with severe or endstage renal impairment. No deaths and no adverse events were reported during the MRI examination and the usual period of follow-up after gadoterate meglumine administration. DATA
CONCLUSION: No cases of NSF were observed in the 446 patients with moderate to endstage renal impairment followed up over a maximum of 2 years after injection of gadoterate meglumine. LEVEL OF EVIDENCE: 2 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2020;51:607-614.
© 2019 International Society for Magnetic Resonance in Medicine.

Entities:  

Keywords:  GBCA; gadoterate meglumine; nephrogenic systemic fibrosis; renal impairment; safety

Mesh:

Substances:

Year:  2019        PMID: 31287213     DOI: 10.1002/jmri.26851

Source DB:  PubMed          Journal:  J Magn Reson Imaging        ISSN: 1053-1807            Impact factor:   4.813


  7 in total

Review 1.  Safety issues related to intravenous contrast agent use in magnetic resonance imaging.

Authors:  Skorn Ponrartana; Michael M Moore; Sherwin S Chan; Teresa Victoria; Jonathan R Dillman; Govind B Chavhan
Journal:  Pediatr Radiol       Date:  2021-04-19

2.  Risk for Nephrogenic Systemic Fibrosis After Exposure to Newer Gadolinium Agents: A Systematic Review.

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

Review 3.  Gadolinium-Based Contrast Agents: Updates and Answers to Typical Questions Regarding Gadolinium Use.

Authors:  Benjamin Y C Cheong; James M Wilson; Ourania A Preventza; Raja Muthupillai
Journal:  Tex Heart Inst J       Date:  2022-05-01

4.  Group II GBCM Can Be Used Safely for Imaging in Stage 4/5 CKD Patients: COMMENTARY.

Authors:  Ali K Abu-Alfa
Journal:  Kidney360       Date:  2020-12-03

5.  Prognosis of unrecognised myocardial infarction determined by electrocardiography or cardiac magnetic resonance imaging: systematic review and meta-analysis.

Authors:  Yu Yang; Wensheng Li; Hailan Zhu; Xiong-Fei Pan; Yunzhao Hu; Clare Arnott; Weiyi Mai; Xiaoyan Cai; Yuli Huang
Journal:  BMJ       Date:  2020-05-07

Review 6.  Nephrogenic Systemic Fibrosis in Patients with Chronic Kidney Disease after the Use of Gadolinium-Based Contrast Agents: A Review for the Cardiovascular Imager.

Authors:  Sebastian Gallo-Bernal; Nasly Patino-Jaramillo; Camilo A Calixto; Sergio A Higuera; Julian F Forero; Juliano Lara Fernandes; Carlos Góngora; Michael S Gee; Brian Ghoshhajra; Hector M Medina
Journal:  Diagnostics (Basel)       Date:  2022-07-28

7.  Decreased native renal T1 up to one week after gadobutrol administration in healthy volunteers.

Authors:  Anneloes de Boer; Anita A Harteveld; Tobias T Pieters; Peter J Blankestijn; Clemens Bos; Martijn Froeling; Jaap A Joles; Marianne C Verhaar; Tim Leiner; Hans Hoogduin
Journal:  J Magn Reson Imaging       Date:  2019-12-04       Impact factor: 4.813

  7 in total

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