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Gadovist® among agents with exceedingly low or non-existent risk of NSF according to CAR guidelines

The Canadian Association of Radiologists (CAR) has recently released a 2019 update to its clinical practice guideline regarding the use of gadolinium based contrast agents (GBCAs) in kidney disease.1 The purpose of this guideline is to address concerns about the use of GBCAs and the development of nephrogenic systemic fibrosis (NSF) and to improve access for patients with renal impairment to GBCA-enhanced MRI when considered medically necessary.

Building on CAR guidelines issued in 20172 and following an extensive review of the literature looking for new unconfounded cases of NSF, the CAR working group concluded that the evidence has demonstrated an exceedingly low or non-existent risk of NSF using macrocyclic or newer linear ionic* gadolinium based contrast agents (GBCAs), even in the most at-risk patients. Gadovist®, a macrocyclic agent with high relaxivity3, is included in this category.

Gadovist

Based on their review, the CAR updated its clinical practice guideline as follows:

  1. Informed consent is no longer recommended before administration of macrocyclic or newer linear ionic* GBCAs
  2. Outpatient screening for renal function with questionnaires is no longer recommended before administration of macrocyclic or newer linear ionic* GBCAs

 

Background

NSF is a serious late reaction associated with the use of GBCAs in patients with reduced renal function. The first association between the use of GBCAs and the development of NSF was reported by Grobner in 2006.4 Case reports with new onset fell sharply after 2006 following Grobner’s publication and raised awareness about the risk factors for NSF development.5 Although pathophysiology is not completely understood, risk factors include: stability of the administered contrast agent and its tendency to release gadolinium, dose of contrast agent, and impaired renal function of the patient.6

In 2017, the CAR issued a clinical practice guideline that allowed the administration of macrocyclic and newer linear* GBCAs in at-risk populations when a contrast-enhanced MRI is considered necessary and no alternative test is available.2 At-risk patients include those with acute kidney injury (AKI), chronic kidney disease (CKD) Stage 4 or 5 (estimated Glomerular Filtrate Rate [eGFR] < 30 mL/min/1.73m2) or those on dialysis. As part of the 2017 guideline, the CAR also recommended obtaining informed consent in these at-risk populations and screening for renal disease in outpatients using a questionnaire at time of MRI scheduling only.

The 2019 update to the guideline was based on a comprehensive review of the literature between the dates of January 1, 2017 and December 31, 2018 searching for new unconfounded cases of NSF. During this time frame, only a single unconfirmed case report of a fibrosing dermopathy was reported in a patient who received gadobenate dimeglumine with Stage 2 CKD. This audit of the last two years of data supports recommendations from the American College of Radiology (ACR), which suggest optional screening for renal impairment when using a macrocyclic agent or gadobenate dimeglumine, given the exceedingly low or non-existent risk of NSF using these agents.7 Thus, the recently updated CAR guidelines are now similar to those provided by the ACR.7

*the newer linear ionic agents referred to in this guideline are gadobenate dimeglumine and gadoxetate disodium

References

1. Schieda N, Maralani PJ, Hurrell C et al. Updated Clinical Practice Guideline on Use of Gadolinium-Based Contrast Agents in Kidney Disease Issued by the Canadian Association of Radiologists. Can Assoc Radiol J. 2019 [Epub ahead of print]

2. Schieda N, Blaichman JI, Costa AF, et al. Gadolinium-based contrast agents in kidney disease: a comprehensive review and clinical practice guideline issued by the Canadian Association of Radiologists. Can J Kidney Health Dis 2018;5. 2054358118778573.

3. Szomolanyi P, Rohrer M, Frenzel T, et al. Comparison of the Relaxivities of Macrocyclic Gadolinium-Based Contrast Agents in Human Plasma at 1.5, 3, and 7 T, and Blood at 3 T. Invest Radiol 2019 [Epub ahead of print]

4. Grobner T. Gadolinium: a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis. Nephrol Dial Transplant 2006;21:1104–1108

5. Endrikat J, Dohanish S, Schleyer N, et al. 10 Years of Nephrogenic Systemic Fibrosis A Comprehensive Analysis of Nephrogenic Systemic Fibrosis Reports Received by a Pharmaceutical Company from 2006 to 2016. Invest Radiol 2018; 53(9):541-550

6. Thomsen HS, Morcos SK, Almen T, et al. Nephrogenic systemic fibrosis and gadolinium-based contrast media: updated ESUR Contrast Medium Safety Committee guidelines. Eur Radiol 2013;23:307-318

7. American College of Radiology. Manual on Contrast Media v10.3; Chapter 15 Nephrogenic Systemic Fibrosis (NSF) 2017. Available at: https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Accessed July 31, 2019

Gadovist® among agents with exceedingly low or non-existent risk of NSF according to CAR guidelines

The Canadian Association of Radiologists (CAR) has recently released a 2019 update to its clinical practice guideline regarding the use of gadolinium based contrast agents (GBCAs) in kidney disease.1 The purpose of this guideline is to address concerns about the use of GBCAs and the development of nephrogenic systemic fibrosis (NSF) and to improve access for patients with renal impairment to GBCA-enhanced MRI when considered medically necessary.

Building on CAR guidelines issued in 20172 and following an extensive review of the literature looking for new unconfounded cases of NSF, the CAR working group concluded that the evidence has demonstrated an exceedingly low or non-existent risk of NSF using macrocyclic or newer linear ionic* gadolinium based contrast agents (GBCAs), even in the most at-risk patients. Gadovist®, a macrocyclic agent with high relaxivity3, is included in this category.

Gadovist

Based on their review, the CAR updated its clinical practice guideline as follows:

  1. Informed consent is no longer recommended before administration of macrocyclic or newer linear ionic* GBCAs
  2. Outpatient screening for renal function with questionnaires is no longer recommended before administration of macrocyclic or newer linear ionic* GBCAs

 

Background

NSF is a serious late reaction associated with the use of GBCAs in patients with reduced renal function. The first association between the use of GBCAs and the development of NSF was reported by Grobner in 2006.4 Case reports with new onset fell sharply after 2006 following Grobner’s publication and raised awareness about the risk factors for NSF development.5 Although pathophysiology is not completely understood, risk factors include: stability of the administered contrast agent and its tendency to release gadolinium, dose of contrast agent, and impaired renal function of the patient.6

In 2017, the CAR issued a clinical practice guideline that allowed the administration of macrocyclic and newer linear* GBCAs in at-risk populations when a contrast-enhanced MRI is considered necessary and no alternative test is available.2 At-risk patients include those with acute kidney injury (AKI), chronic kidney disease (CKD) Stage 4 or 5 (estimated Glomerular Filtrate Rate [eGFR] < 30 mL/min/1.73m2) or those on dialysis. As part of the 2017 guideline, the CAR also recommended obtaining informed consent in these at-risk populations and screening for renal disease in outpatients using a questionnaire at time of MRI scheduling only.

The 2019 update to the guideline was based on a comprehensive review of the literature between the dates of January 1, 2017 and December 31, 2018 searching for new unconfounded cases of NSF. During this time frame, only a single unconfirmed case report of a fibrosing dermopathy was reported in a patient who received gadobenate dimeglumine with Stage 2 CKD. This audit of the last two years of data supports recommendations from the American College of Radiology (ACR), which suggest optional screening for renal impairment when using a macrocyclic agent or gadobenate dimeglumine, given the exceedingly low or non-existent risk of NSF using these agents.7 Thus, the recently updated CAR guidelines are now similar to those provided by the ACR.7

*the newer linear ionic agents referred to in this guideline are gadobenate dimeglumine and gadoxetate disodium

References

  1. Schieda N, Maralani PJ, Hurrell C et al. Updated Clinical Practice Guideline on Use of Gadolinium-Based Contrast Agents in Kidney Disease Issued by the Canadian Association of Radiologists. Can Assoc Radiol J. 2019 [Epub ahead of print]

  2. Schieda N, Blaichman JI, Costa AF, et al. Gadolinium-based contrast agents in kidney disease: a comprehensive review and clinical practice guideline issued by the Canadian Association of Radiologists. Can J Kidney Health Dis 2018;5. 2054358118778573.

  3. Szomolanyi P, Rohrer M, Frenzel T, et al. Comparison of the Relaxivities of Macrocyclic Gadolinium-Based Contrast Agents in Human Plasma at 1.5, 3, and 7 T, and Blood at 3 T. Invest Radiol 2019 [Epub ahead of print]

  4. Grobner T. Gadolinium: a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis. Nephrol Dial Transplant 2006;21:1104–1108

  5. Endrikat J, Dohanish S, Schleyer N, et al. 10 Years of Nephrogenic Systemic Fibrosis A Comprehensive Analysis of Nephrogenic Systemic Fibrosis Reports Received by a Pharmaceutical Company from 2006 to 2016. Invest Radiol 2018; 53(9):541-550

  6. Thomsen HS, Morcos SK, Almen T, et al. Nephrogenic systemic fibrosis and gadolinium-based contrast media: updated ESUR Contrast Medium Safety Committee guidelines. Eur Radiol 2013;23:307-318

  7. American College of Radiology. Manual on Contrast Media v10.3; Chapter 15 Nephrogenic Systemic Fibrosis (NSF) 2017. Available at: https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Accessed July 31, 2019

Gadovist® among agents with exceedingly low or non-existent risk of NSF according to CAR guidelines

The Canadian Association of Radiologists (CAR) has recently released a 2019 update to its clinical practice guideline regarding the use of gadolinium based contrast agents (GBCAs) in kidney disease.1 The purpose of this guideline is to address concerns about the use of GBCAs and the development of nephrogenic systemic fibrosis (NSF) and to improve access for patients with renal impairment to GBCA-enhanced MRI when considered medically necessary.

Building on CAR guidelines issued in 20172 and following an extensive review of the literature looking for new unconfounded cases of NSF, the CAR working group concluded that the evidence has demonstrated an exceedingly low or non-existent risk of NSF using macrocyclic or newer linear ionic* gadolinium based contrast agents (GBCAs), even in the most at-risk patients. Gadovist®, a macrocyclic agent with high relaxivity3, is included in this category.

Gadovist

Based on their review, the CAR updated its clinical practice guideline as follows:

  1. Informed consent is no longer recommended before administration of macrocyclic or newer linear ionic* GBCAs
  2. Outpatient screening for renal function with questionnaires is no longer recommended before administration of macrocyclic or newer linear ionic* GBCAs

 

Background

NSF is a serious late reaction associated with the use of GBCAs in patients with reduced renal function. The first association between the use of GBCAs and the development of NSF was reported by Grobner in 2006.4 Case reports with new onset fell sharply after 2006 following Grobner’s publication and raised awareness about the risk factors for NSF development.5 Although pathophysiology is not completely understood, risk factors include: stability of the administered contrast agent and its tendency to release gadolinium, dose of contrast agent, and impaired renal function of the patient.6

In 2017, the CAR issued a clinical practice guideline that allowed the administration of macrocyclic and newer linear* GBCAs in at-risk populations when a contrast-enhanced MRI is considered necessary and no alternative test is available.2 At-risk patients include those with acute kidney injury (AKI), chronic kidney disease (CKD) Stage 4 or 5 (estimated Glomerular Filtrate Rate [eGFR] < 30 mL/min/1.73m2) or those on dialysis. As part of the 2017 guideline, the CAR also recommended obtaining informed consent in these at-risk populations and screening for renal disease in outpatients using a questionnaire at time of MRI scheduling only.

The 2019 update to the guideline was based on a comprehensive review of the literature between the dates of January 1, 2017 and December 31, 2018 searching for new unconfounded cases of NSF. During this time frame, only a single unconfirmed case report of a fibrosing dermopathy was reported in a patient who received gadobenate dimeglumine with Stage 2 CKD. This audit of the last two years of data supports recommendations from the American College of Radiology (ACR), which suggest optional screening for renal impairment when using a macrocyclic agent or gadobenate dimeglumine, given the exceedingly low or non-existent risk of NSF using these agents.7 Thus, the recently updated CAR guidelines are now similar to those provided by the ACR.7

*the newer linear ionic agents referred to in this guideline are gadobenate dimeglumine and gadoxetate disodium

References

  1. Schieda N, Maralani PJ, Hurrell C et al. Updated Clinical Practice Guideline on Use of Gadolinium-Based Contrast Agents in Kidney Disease Issued by the Canadian Association of Radiologists. Can Assoc Radiol J. 2019 [Epub ahead of print]
  2. Schieda N, Blaichman JI, Costa AF, et al. Gadolinium-based contrast agents in kidney disease: a comprehensive review and clinical practice guideline issued by the Canadian Association of Radiologists. Can J Kidney Health Dis 2018;5. 2054358118778573.
  3. Szomolanyi P, Rohrer M, Frenzel T, et al. Comparison of the Relaxivities of Macrocyclic Gadolinium-Based Contrast Agents in Human Plasma at 1.5, 3, and 7 T, and Blood at 3 T. Invest Radiol 2019 [Epub ahead of print]
  4. Grobner T. Gadolinium: a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis. Nephrol Dial Transplant 2006;21:1104–1108
  5. Endrikat J, Dohanish S, Schleyer N, et al. 10 Years of Nephrogenic Systemic Fibrosis A Comprehensive Analysis of Nephrogenic Systemic Fibrosis Reports Received by a Pharmaceutical Company from 2006 to 2016. Invest Radiol 2018; 53(9):541-550
  6. Thomsen HS, Morcos SK, Almen T, et al. Nephrogenic systemic fibrosis and gadolinium-based contrast media: updated ESUR Contrast Medium Safety Committee guidelines. Eur Radiol 2013;23:307-318
  7. American College of Radiology. Manual on Contrast Media v10.3; Chapter 15 Nephrogenic Systemic Fibrosis (NSF) 2017. Available at: https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Accessed July 31, 2019