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Henrik S Thomsen - One of the best experts on this subject based on the ideXlab platform.
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Case-control study of gadodiamide-related Nephrogenic Systemic Fibrosis. Commentary
Nephrology Dialysis Transplantation, 2020Co-Authors: Joëlle Nortier, Peter Marckmann, Véronique Del Marmo, Lone Skov, Kristian Rossen, James Goya Heaf, Henrik S ThomsenAbstract:Background. Nephrogenic Systemic Fibrosis may be caused by gadolinium (Gd)-containing magnetic resonance imaging contrast agents. Most reported cases were associated with one particular agent, gadodiamide. Yet, unidentified cofactors might explain why only a minority of renal failure patients exposed to gadodiamide develop Nephrogenic Systemic Fibrosis. Methods. We conducted a case-control study of 19 histologically verified cases and 19 sex- and age-matched controls. All subjects had chronic renal failure when exposed to gadodiamide. Clinical, biochemical and pharmacological data were retrieved from medical records. Results. Cases had been exposed to a mean gadodiamide dose of 0.29 mmol/kg (range 0.18-0.50) shortly before first signs of Nephrogenic Systemic Fibrosis. Controls had been exposed to 0.28 mmol/kg (0.13-0.49). Cumulative gadodiamide exposure while in chronic kidney disease stage 5 was significantly higher among cases compared with controls (0.41 vs 0.31 mmol/kg, P = 0.05) and among severe cases (n = 9) compared with non-severe cases (0.49 vs 0.33 mmol/kg, P=0.02). Severe cases developed primarily among patients in regular haemodialysis therapy at exposure. Cases had higher serum concentrations of ionized calcium and phosphate than controls and tended to receive higher doses of epoietin-β than controls at time of exposure. Severe cases were treated with higher doses of epoietin-β than non-severe cases at exposure (10.8 vs 4.4 10 3 IU/week, P= 0.02). Conclusions. Increasing cumulative gadodiamide exposure, high-dose epoietin-β treatment, and higher serum concentrations of ionized calcium and phosphate increase the risk of gadodiamide-related Nephrogenic Systemic Fibrosis in renal failure patients. Severe cases seem to develop primarily among patients in regular haemodialysis therapy at exposure.
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Nephrogenic Systemic Fibrosis and Gadolinium-Based Contrast Media
Medical Radiology, 2020Co-Authors: Henrik S ThomsenAbstract:Nephrogenic Systemic Fibrosis (NSF) is an adverse reaction to gadolinium, which is toxic in its free, unchelated form. NSF is seen after the least stable gadolinium-based contrast agents in patients with reduced renal kidney function or on dialysis. The introduction of guidelines has led to a reduction in the incidence of NSF, but it is too soon to state that it has been totally eliminated. The long-term effects of retention of gadolinium in the body require further investigation.
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Nephrogenic Systemic Fibrosis in Denmark--a nationwide investigation.
PLOS ONE, 2013Co-Authors: Tina R. Elmholdt, Peter Marckmann, Lone Skov, Henrik S Thomsen, Anne Braae Olesen, Bettina Jørgensen, Stinne Kvist, Michael PedersenAbstract:Background Nephrogenic Systemic Fibrosis is a debilitating and painful disorder with an increased stimulation of the connective tissue in the skin and Systemic tissues. The disease is associated with exposure to gadolinium-based contrast agent used in magnetic resonance imaging in patients with renal impairment.
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Nephrogenic Systemic Fibrosis and gadolinium-based contrast media: updated ESUR Contrast Medium Safety Committee guidelines
European Radiology, 2013Co-Authors: Henrik S Thomsen, Sameh K. Morcos, Torsten Almén, Marie-france Bellin, Michele Bertolotto, Georg Bongartz, Olivier Clement, Peter Leander, Gertraud Heinz-peer, Peter ReimerAbstract:Purpose To update the guidelines of the Contrast Media Safety Committee (CMSC) of the European Society of Urogenital Radiology (ESUR) on Nephrogenic Systemic Fibrosis and gadolinium-based contrast media. Areas covered Topics reviewed include the history, clinical features and prevalence of Nephrogenic Systemic Fibrosis and the current understanding of its pathophysiology. The risk factors for NSF are discussed and prophylactic measures are recommended. The stability of the different gadolinium-based contrast media and the potential long-term effects of gadolinium in the body have also been reviewed. Key Points • Clinical features, risk factors and prevention of Nephrogenic Systemic Fibrosis are reviewed • Patients with GFR below 30 ml/min/1.73 m ^ 2 have increased risk of developing NSF • Low stability gadolinium contrast media show the strongest association with NSF • Following guidelines regarding gadolinium contrast agents minimises the risk of NSF • Potential long-term harm from gadolinium accumulation in the body is discussed
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Nephrogenic Systemic Fibrosis and gadolinium based contrast media updated esur contrast medium safety committee guidelines
European Radiology, 2013Co-Authors: Henrik S Thomsen, Sameh K. Morcos, Torsten Almén, Marie-france Bellin, Michele Bertolotto, Georg Bongartz, Olivier Clement, Peter Leander, Gertraud Heinzpeer, Peter ReimerAbstract:Purpose To update the guidelines of the Contrast Media Safety Committee (CMSC) of the European Society of Urogenital Radiology (ESUR) on Nephrogenic Systemic Fibrosis and gadolinium-based contrast media.
Peter Marckmann - One of the best experts on this subject based on the ideXlab platform.
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Case-control study of gadodiamide-related Nephrogenic Systemic Fibrosis. Commentary
Nephrology Dialysis Transplantation, 2020Co-Authors: Joëlle Nortier, Peter Marckmann, Véronique Del Marmo, Lone Skov, Kristian Rossen, James Goya Heaf, Henrik S ThomsenAbstract:Background. Nephrogenic Systemic Fibrosis may be caused by gadolinium (Gd)-containing magnetic resonance imaging contrast agents. Most reported cases were associated with one particular agent, gadodiamide. Yet, unidentified cofactors might explain why only a minority of renal failure patients exposed to gadodiamide develop Nephrogenic Systemic Fibrosis. Methods. We conducted a case-control study of 19 histologically verified cases and 19 sex- and age-matched controls. All subjects had chronic renal failure when exposed to gadodiamide. Clinical, biochemical and pharmacological data were retrieved from medical records. Results. Cases had been exposed to a mean gadodiamide dose of 0.29 mmol/kg (range 0.18-0.50) shortly before first signs of Nephrogenic Systemic Fibrosis. Controls had been exposed to 0.28 mmol/kg (0.13-0.49). Cumulative gadodiamide exposure while in chronic kidney disease stage 5 was significantly higher among cases compared with controls (0.41 vs 0.31 mmol/kg, P = 0.05) and among severe cases (n = 9) compared with non-severe cases (0.49 vs 0.33 mmol/kg, P=0.02). Severe cases developed primarily among patients in regular haemodialysis therapy at exposure. Cases had higher serum concentrations of ionized calcium and phosphate than controls and tended to receive higher doses of epoietin-β than controls at time of exposure. Severe cases were treated with higher doses of epoietin-β than non-severe cases at exposure (10.8 vs 4.4 10 3 IU/week, P= 0.02). Conclusions. Increasing cumulative gadodiamide exposure, high-dose epoietin-β treatment, and higher serum concentrations of ionized calcium and phosphate increase the risk of gadodiamide-related Nephrogenic Systemic Fibrosis in renal failure patients. Severe cases seem to develop primarily among patients in regular haemodialysis therapy at exposure.
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Nephrogenic Systemic Fibrosis in Denmark--a nationwide investigation.
PLOS ONE, 2013Co-Authors: Tina R. Elmholdt, Peter Marckmann, Lone Skov, Henrik S Thomsen, Anne Braae Olesen, Bettina Jørgensen, Stinne Kvist, Michael PedersenAbstract:Background Nephrogenic Systemic Fibrosis is a debilitating and painful disorder with an increased stimulation of the connective tissue in the skin and Systemic tissues. The disease is associated with exposure to gadolinium-based contrast agent used in magnetic resonance imaging in patients with renal impairment.
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Nephrogenic Systemic Fibrosis: a serious iatrogenic disease of renal failure patients.
Scandinavian Journal of Urology and Nephrology, 2009Co-Authors: Misbah Khurram, Kristian Rossen, Lone Skov, Henrik S Thomsen, Peter MarckmannAbstract:Nephrogenic Systemic Fibrosis (NSF) is a fibrotic disease seen in renal failure patients that may lead to severe physical disability. It has been demonstrated in recent studies that NSF can be caused by some gadolinium-containing MRI contrast agents. In this report we present one of a total of 26 cases of gadodiamide-related NSF from our hospital.
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update on Nephrogenic Systemic Fibrosis
Magnetic Resonance Imaging Clinics of North America, 2008Co-Authors: Peter Marckmann, Henrik S Thomsen, Vibeke LogagerAbstract:Gadolinium-based contrast agents were for many years considered safe, but this is no longer the case. The least stable agents may trigger the development of Nephrogenic Systemic Fibrosis (NSF), a generalized fibrotic disorder, in renal failure patients. The use of gadodiamide and gadopentetate dimeglumine is now contraindicated in Europe and Japan in patients who have a glomerular filtration rate less than 30 mL/min/1.73 m 2 , including those on dialysis. The fear of NSF, however, should not lead to an enhanced MR imaging examination being denied when there is a good clinical indication to give a gadolinium-based contrast agent.
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an epidemic outbreak of Nephrogenic Systemic Fibrosis in a danish hospital
European Journal of Radiology, 2008Co-Authors: Peter MarckmannAbstract:Abstract The nephrological department of Copenhagen University Hospital Herlev experienced an epidemic accumulation of patients developing Nephrogenic Systemic Fibrosis in the period 2002–2006. Systematic studies of these patients revealed that they all had a gadodiamide-enhanced magnetic resonance examination prior to their symptoms, and that they all had severe renal insufficiency (chronic kidney disease stage 5) at the time of their exposure to gadodiamide. Besides exposure to gadodiamide, our analyses indicated that increasing cumulative gadodiamide exposure (i.e. repeated exposures), and higher serum concentrations of ionized calcium and phosphate were cofactors that raised the risk of developing Nephrogenic Systemic Fibrosis. Higher cumulative gadodiamide exposure, higher prescribed erythropoietin dosage at exposure, and being hemodialysis patient were three factors associated with Nephrogenic Systemic Fibrosis in its most severe form. Retrospective reviews of patients records and patient interviews revealed the large variability in symptoms and clinical course of Nephrogenic Systemic Fibrosis, but also highlighted that the typical initial symptoms were symmetric swelling, discoloration and pain of lower legs, whereas the typical late symptoms of severely affected patients were skin thickening, stiffness, contractures, and debilitating disabilities. In conclusion, Nephrogenic Systemic Fibrosis is a serious iatrogenic disease of patients with renal insufficiency caused by some Gd-containing contrast agents, in particular gadodiamide. Unfortunately, there is no proven curative treatment. It is therefore essential that future cases of Nephrogenic Systemic Fibrosis are prevented.
Peter Reimer - One of the best experts on this subject based on the ideXlab platform.
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Nephrogenic Systemic Fibrosis and gadolinium-based contrast media: updated ESUR Contrast Medium Safety Committee guidelines
European Radiology, 2013Co-Authors: Henrik S Thomsen, Sameh K. Morcos, Torsten Almén, Marie-france Bellin, Michele Bertolotto, Georg Bongartz, Olivier Clement, Peter Leander, Gertraud Heinz-peer, Peter ReimerAbstract:Purpose To update the guidelines of the Contrast Media Safety Committee (CMSC) of the European Society of Urogenital Radiology (ESUR) on Nephrogenic Systemic Fibrosis and gadolinium-based contrast media. Areas covered Topics reviewed include the history, clinical features and prevalence of Nephrogenic Systemic Fibrosis and the current understanding of its pathophysiology. The risk factors for NSF are discussed and prophylactic measures are recommended. The stability of the different gadolinium-based contrast media and the potential long-term effects of gadolinium in the body have also been reviewed. Key Points • Clinical features, risk factors and prevention of Nephrogenic Systemic Fibrosis are reviewed • Patients with GFR below 30 ml/min/1.73 m ^ 2 have increased risk of developing NSF • Low stability gadolinium contrast media show the strongest association with NSF • Following guidelines regarding gadolinium contrast agents minimises the risk of NSF • Potential long-term harm from gadolinium accumulation in the body is discussed
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Nephrogenic Systemic Fibrosis and gadolinium based contrast media updated esur contrast medium safety committee guidelines
European Radiology, 2013Co-Authors: Henrik S Thomsen, Sameh K. Morcos, Torsten Almén, Marie-france Bellin, Michele Bertolotto, Georg Bongartz, Olivier Clement, Peter Leander, Gertraud Heinzpeer, Peter ReimerAbstract:Purpose To update the guidelines of the Contrast Media Safety Committee (CMSC) of the European Society of Urogenital Radiology (ESUR) on Nephrogenic Systemic Fibrosis and gadolinium-based contrast media.
Shawn E Cowper - One of the best experts on this subject based on the ideXlab platform.
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Pediatric Nephrogenic Systemic Fibrosis is rarely reported: a RADAR report
Pediatric Radiology, 2014Co-Authors: Beatrice Nardone, Elise Saddleton, Anne E. Laumann, Beatrice J. Edwards, Dennis W. Raisch, June M. Mckoy, Steven M. Belknap, Christian Bull, Anand Haryani, Shawn E CowperAbstract:Background Nephrogenic Systemic Fibrosis is a fibrosing disorder associated with exposure to gadolinium-based contrast agents in people with severely compromised renal function. Objective The purpose of this study was to determine the reported number of cases of Nephrogenic Systemic Fibrosis in children using three distinct publicly available data sources. Materials and methods We conducted systematic searches of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), the International Center for Nephrogenic Systemic Fibrosis Research (ICNSFR) registry and published literature from January 1997 through September 2012. We contacted authors of individual published cases to obtain follow-up data. Data sets were cross-referenced to eliminate duplicate reporting. Results We identified 23 children with Nephrogenic Systemic Fibrosis. Seventeen had documented exposure to gadolinium-based contrast agents. Six children had been reported in both the FAERS and the literature, four in the FAERS and the ICNSFR registry and five in all three data sources. Conclusion Nephrogenic Systemic Fibrosis has been rarely reported in children. Although rules related to confidentiality limit the ability to reconcile reports, active pharmaco-vigilance using RADAR (Research on Adverse Drug events And Reports) methodology helped in establishing the number of individual pediatric cases within the three major data sources.
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pediatric Nephrogenic Systemic Fibrosis is rarely reported a radar report
Pediatric Radiology, 2014Co-Authors: Beatrice Nardone, Elise Saddleton, Anne E. Laumann, Beatrice J. Edwards, Dennis W. Raisch, June M. Mckoy, Steven M. Belknap, Christian Bull, Anand Haryani, Shawn E CowperAbstract:Background Nephrogenic Systemic Fibrosis is a fibrosing disorder associated with exposure to gadolinium-based contrast agents in people with severely compromised renal function.
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Nephrogenic Systemic Fibrosis: concepts and perspectives.
Anais Brasileiros De Dermatologia, 2012Co-Authors: Ana Carolina De Souza Machado Igreja, Shawn E Cowper, Kleyton De Carvalho Mesquita, Izelda Maria Carvalho CostaAbstract:Nephrogenic Systemic Fibrosis is a chronic, progressive condition that develops in some patients with renal impairment after exposure to gadolinium-based contrast agents used in magnetic resonance imaging. Thickening of the skin is typical, usually affecting the extremities. Visceral organs can also be affected. The diagnosis of the disease requires careful clinicopathological correlation. Treatment aims at restoring renal function, which is associated with delayed progression and, eventually, remission of skin changes. Reduction and prevention of Nephrogenic Systemic Fibrosis cases are based on limiting the use of gadolinium-based contrast agents in patients with kidney disorders (especially in patients with advanced renal failure at stages 4 and 5), and restricting their use to situations in which they are essential to diagnosis/follow-up. Other than limiting exposure to gadolinium based contrast agents, no effective preventive methods have been reported. Due to increased awareness about the disease among radiologists and nephrologists, the incidence of Nephrogenic Systemic Fibrosis is declining.
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Nephrogenic Systemic Fibrosis
F1000 Medicine Reports, 2010Co-Authors: Irwin M Braverman, Shawn E CowperAbstract:Nephrogenic Systemic Fibrosis, initially called Nephrogenic fibrosing dermopathy, has been strongly linked to exposure to gadolinium-based contrast media used in magnetic resonance imaging in patients with renal insufficiency. This review discusses recent advances in our understanding of the pathophysiology and clinical approach to patients with chronic kidney disease who require diagnostic imaging with gadolinium-based contrast media.
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Nephrogenic Systemic Fibrosis an overview
Journal of The American College of Radiology, 2008Co-Authors: Shawn E CowperAbstract:In 1997, a new fibrosing skin disorder became apparent among patients with renal disease. Nephrogenic Systemic Fibrosis, as this disorder has come to be known, has recently been tied to the administration of contrast agents containing gadolinium. This overview examines the discovery and elucidation of the major research accomplishments to date. It was presented as the keynote address at the First Annual Scientific Symposium on Nephrogenic Systemic Fibrosis and MRI Contrast, conducted at Yale University on May 4, 2007.
Sam S Chang - One of the best experts on this subject based on the ideXlab platform.
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Association of Gadolinium Based Magnetic Resonance Imaging Contrast Agents and Nephrogenic Systemic Fibrosis. Commentary
The Journal of Urology, 2020Co-Authors: Gautam Bhave, Julia B Lewis, Sam S Chang, Robert E. Weiss, Eugene C. KennedyAbstract:Purpose: We investigated the recently discovered association between gadolinium based magnetic resonance imaging contrast agents and the development of Nephrogenic Systemic Fibrosis in patients with chronic kidney disease or acute kidney injury. Materials and Methods: A systematic review of the PubMed® database and publicly available patient databases was performed to characterize Nephrogenic Systemic Fibrosis and its possible association with exposure to gadolinium based magnetic resonance imaging contrast agents. Results: Data from case series reports, Nephrogenic Systemic Fibrosis patient databases, Nephrogenic Systemic Fibrosis case reporting to the Food and Drug Administration after gadolinium contrast agent exposure and retrospective case control studies suggest a strong association between the use of gadolinium based magnetic resonance imaging contrast agents and the subsequent development of Nephrogenic Systemic Fibrosis in patients with renal disease. These data also suggest that the risk of Nephrogenic Systemic Fibrosis depends on the degree of renal dysfunction, dose of contrast agent, gadolinium contrast agent stability and severity of concomitant illness. Thus, the occurrence of Nephrogenic Systemic Fibrosis after gadolinium contrast agent exposure may vary from negligible up to 2% to 5% in select high risk clinical situations. Conclusions: Magnetic resonance imaging using gadolinium based contrast agents must be performed judiciously in patients with renal dysfunction, carefully weighing on a case by case basis the benefits of magnetic resonance imaging and the risk of Nephrogenic Systemic Fibrosis as well as the disadvantages of undergoing alternative or foregoing imaging studies.
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association of gadolinium based magnetic resonance imaging contrast agents and Nephrogenic Systemic Fibrosis
The Journal of Urology, 2008Co-Authors: Gautam Bhave, Julia B Lewis, Sam S ChangAbstract:Purpose: We investigated the recently discovered association between gadolinium based magnetic resonance imaging contrast agents and the development of Nephrogenic Systemic Fibrosis in patients with chronic kidney disease or acute kidney injury.Materials and Methods: A systematic review of the PubMed® database and publicly available patient databases was performed to characterize Nephrogenic Systemic Fibrosis and its possible association with exposure to gadolinium based magnetic resonance imaging contrast agents.Results: Data from case series reports, Nephrogenic Systemic Fibrosis patient databases, Nephrogenic Systemic Fibrosis case reporting to the Food and Drug Administration after gadolinium contrast agent exposure and retrospective case control studies suggest a strong association between the use of gadolinium based magnetic resonance imaging contrast agents and the subsequent development of Nephrogenic Systemic Fibrosis in patients with renal disease. These data also suggest that the risk of nephro...
