Hostname: page-component-848d4c4894-wzw2p Total loading time: 0 Render date: 2024-05-12T03:19:01.019Z Has data issue: false hasContentIssue false
  • English
  • Français

Safety of ferumoxytol in children undergoing cardiac MRI under general anaesthesia

Published online by Cambridge University Press:  31 May 2018

Lisa Wise-Faberowski ,
Nathalia Velasquez ,
Frandics Chan ,
Shreyas Vasanawala ,
Doff B. McElhinney  and
Chandra Ramamoorthy
Lisa Wise-Faberowski*
Affiliation:
Lucile Packard Children’s Hospital Heart Center, Stanford University School of Medicine, Palo Alto, CA, USA Department of Anesthesiology, Stanford University School of Medicine, Palo Alto, CA, USA
Nathalia Velasquez
Affiliation:
Lucile Packard Children’s Hospital Heart Center, Stanford University School of Medicine, Palo Alto, CA, USA
Frandics Chan
Affiliation:
Lucile Packard Children’s Hospital Heart Center, Stanford University School of Medicine, Palo Alto, CA, USA Department of Radiology, Stanford University School of Medicine, Palo Alto, CA, USA
Shreyas Vasanawala
Affiliation:
Lucile Packard Children’s Hospital Heart Center, Stanford University School of Medicine, Palo Alto, CA, USA Department of Radiology, Stanford University School of Medicine, Palo Alto, CA, USA
Doff B. McElhinney
Affiliation:
Lucile Packard Children’s Hospital Heart Center, Stanford University School of Medicine, Palo Alto, CA, USA Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, CA, USA
Chandra Ramamoorthy
Affiliation:
Lucile Packard Children’s Hospital Heart Center, Stanford University School of Medicine, Palo Alto, CA, USA Department of Anesthesiology, Stanford University School of Medicine, Palo Alto, CA, USA
*
Author for correspondence: L. Wise-Faberowski, Department of Anesthesiology, Stanford University/Lucile Packard Children’s Hospital, 300 Pasteur Drive, Palo Alto, CA 94305, USA. Tel: 650 24 1705; Fax: 650 725 8544; E-mail: lwf1212@stanford.edu
Get access Rights & Permissions [Opens in a new window]

Abstract

Background

Ferumoxytol, an “off-label” contrast agent, allows for better cardiac MRI quality as compared with gadolinium-based contrast agents. However, hypotension has been reported with the use of ferumoxytol for indications other than cardiac MRI. The purpose of our investigation was to evaluate the safety of ferumoxytol in children undergoing general anaesthesia for cardiac MRI.

Methods

Medical records of children undergoing general anaesthesia for cardiac MRI were reviewed. Baseline demographic and medical characteristics, as well as imaging and anaesthetic duration and technique, were collected. The incidence of hypotension or other adverse events’, need for vasoactive support, or airway intervention throughout the anaesthetic, was recorded.

Results

A total of 95 patients were identified, 61 received ferumoxytol and 34 received gadolinium. There were no significant differences between groups with respect to age, weight, or baseline blood pressure. The incidence of low blood pressure – systolic or mean – after contrast administration did not differ between groups, and there was no difference in sustained hypotension or use of vasopressors between groups. One patient who received ferumoxytol had possible anaphylaxis. The image acquisition time (45 versus 68 min, p=0.002) and anaesthesia duration (100 versus 132 min, p=0.02) were shorter in the ferumoxytol group.

Conclusion

Transient low blood pressure was common in children undergoing cardiac MRI with anaesthesia, but the incidence of hypotension did not differ between ferumoxytol and gadolinium groups. The use of ferumoxytol was associated with significantly shorter scan time and anaesthesia duration, as well as a decreased need for airway intervention.

Keywords

MRIferumoxytolpaediatriccardiac
Type
Original Articles
Information
Cardiology in the Young , Volume 28 , Issue 7 , July 2018 , pp. 916 - 921
Copyright
© Cambridge University Press 2018 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Ruangwattanapaisam, N, Hsiao, A, Vasanawala, SS. Ferumoxytol as an off-label contrast agent in body 3T MR angiography: a pilot study in children. Pediatr Radiol 2015; 45: 831–839.CrossRefGoogle Scholar
2. Prince, MR, Zhange, HL, Chabra, SG, et al. A pilot investigation of new super paramagnetic iron oxide (ferumoxytol) as a contrast agent for cardiovascular MRI. J Xray Sci Technol 2003; 11: 231–240.Google Scholar
3. Runge, VM. Safety of approved MR contrast media for intravenous injection. J Magn Reson Imaging 2000; 12: 205–213.3.0.CO;2-P>CrossRefGoogle ScholarPubMed
4. Hetzel, D, Strauss, W, Bernard, K, et al. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol 2014; 89: 646–650.CrossRefGoogle ScholarPubMed
5. Spinowitz, BS, Kausz, AT, Baptist, J, et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol 2008; 52: 907–915.Google Scholar
6. Neiser, S, Rentsch, D, Dippon, U, et al. Physico-chemcical properties of the new generation IV iron preparations ferumoxytol, iron isomlatoside 1000 and ferrie carboxymaltose. Biometals 2015; 28: 315–635.Google Scholar
7. Bernd, H, De Kerviler, E, Gaillard, S, et al. Safety and tolerability of ultra-small, super-paramagnetic, iron oxide contrast agent: comprehensive analysis of a clinical development program. Invest Radiol 2009; 44: 336–342.CrossRefGoogle Scholar
8. Li, W, Tutton, S, Vu, AT, et al. First-pass contrast-enhanced magnetic resonance angiography in humans using ferumoxytol, a novel ultra small superparamagnetic iron. (USPIO)-based blood pool agent. J Magn Reson Imaging. 2005; 21: 46–52.Google Scholar
9. Storey, P, Lim, RP, Chandaran, H, et al. MRI assessment of hepatic iron clearance rates after USPIO administration in healthy adults. Invest Radiol 2012; 47: 717–724.CrossRefGoogle ScholarPubMed
10. Schiller, B, Bhat, P, Sharma, A. Safety and effectiveness of ferumoxytol in hemodialysis patients at 3 dialysis chains in the United States over a 12-month period. Clin Ther 2014; 36: 70–83.Google Scholar
11. Lu, M, Cohen, MH, Rieves, D, Pazdur, R. FDA report: ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease. Am J Hematol 2010; 85: 315–319.Google Scholar
12. Varallyay, CG, Nesbit, E, Fu, R, et al. High-resolution steady-state cerebral blood volume maps in patients with central nervous system neoplasms using ferumoxytol, a superparamagnetic iron oxide nanoparticle. J Cereb Blood Flow Metab 2013; 33: 780–786.Google Scholar
13. McDonald, RJ, McDonald, JS, Kallmes, DF, et al. Intracranial gadolinium deposition after contrast-enhanced MR imaging. Radiology 2015; 275: 772–782.CrossRefGoogle ScholarPubMed
14. Chan, FP. MR and CT imaging of the pediatric patient with structural heart disease. Semin Thorac cardiovasc Surg 2008; 20: 393–399.Google Scholar
15. Cheng, JY, Hanneman, K, Zhang, T, et al. Comprehensive motion-compensated highly accelerated 4D flow MRI with ferumoxytol enhancement for pediatric congenital heart disease. J Magn Reson Imaging 2016; 43: 1355–1368.CrossRefGoogle ScholarPubMed
16. Hanneman, K, Kino, A, Cheng, JY, et al. Assessment of precision and reproducibility of ventricular volume, function and mass measurements with ferumoxytol-enhanced 4D flow MRI. J Magn Reson Imaging 2016: 1–10.Google Scholar
17. Vasanawala, SS, Hanneman, K, Alley, MT, Hsiao, A. Congenital heart disease assessment with 4D flow MRI. J Magn Reson Imaging 2015; 42: 870–886.Google Scholar
18. Wu, J, Mahmoud, M, Schmitt, M, et al. Comparison of dexmedetomedine techniques in children undergoing magnetic resonance imaging. Paediatr Anaesth 2014; 24: 813–818.CrossRefGoogle ScholarPubMed
19. Jain, R, Petrillo-Albarano, T, Parks, WJ, et al. Efficacy and safety of deep sedation by non-anesthesiologists for cardiac MRI in children. Pediatr Radiol 2013; 43: 605–611.Google Scholar
20. Dorfman, AL, Odegard, KC, Powell, AJ, et al. Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. J Cardiovasc Magn Reson 2007; 9: 793–798.Google Scholar
21. Ramamoorthy, C, Haberkern, C, Bhananker, SM, et al. Anesthesia-related cardiac arrest in children with heart disease: data from the pediatric perioperative cardiac arrest (POCA) registry. Anesth Analg 2010; 110: 1376–1382.CrossRefGoogle ScholarPubMed
22. Baum, VC, Barton, DM, Gutgesell, HP. Influence of congenital heart disease on mortality after noncardiac surgery in hospitalized children. Pediatrics 2000; 105: 332–335.Google Scholar
23. Faraoni, D, Zurakowski, D, Vo, D, et al. Postoperative outcomes in children with and without congenital heart disease undergoing noncardiac surgery. J Am Coll. Cardiology 2016; 67: 793–801.Google Scholar
24. Olivieri, L, Cross, R, O’Brien, KJ, et al. Free-breathing motion-corrected late gadolinium-enhancement imaging improves image quality in children. Pediatr Radiol 2016; 46: 983–990.Google Scholar
25. Fogel, MA, Weinberg, PM, Parave, E, et al. Deep sedation for cardiac resonance imaging: a comparison with cardiac anesthesia. J Pediatr 2008; 152: 534–539.Google Scholar
26. Fogel, MA, Pawlowski, TW, Harris, MA, et al. Comparison and usefulness of cardiac magnetic resonance versus computed tomography in infants six months of age or younger with aortic arch anomalies without deep sedation or anesthesia. Am J Cardiol 2011; 108: 120–125.Google Scholar
27. Joshi, G, Tobias, JD. Remifentanil to facilitate high-resolution computed tomography imaging of the chest or magnetic resonance imaging in infants. South Med 2009; 102: 1121–1124.Google Scholar
28. Muehe, A, Feng, D, von Eyben, R, et al. Safety report of ferumoxytol for magnetic resonance imaging in children and young adults. Invest Radiol 2016: 1–7.Google ScholarPubMed
29. Vasanawala, S, Nguyen, KL, Hope, MD, et al. Safety and technique of ferumoxytol administration for MRI. Magn Reson Med 2016: 1–5.Google Scholar
30. Rampton, D, Folkersen, J, Fishbane, S, et al. Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management. Haematologica 2014; 99: 1671–1676.CrossRefGoogle ScholarPubMed
31. Wysowski, DK, Swartz, L, Borders-Hemphill, BV, et al. Use of parenteral iron products and serious anaphylactic-type reactions. Am J Hematol 2010; 85: 650–654.Google Scholar
32. Dillman, JR, Ellis, JH, Cohan, RH, et al. Frequency and severity of acute allergic like reactions to gadolinium-containing i.v. contrast media in children and adults. AJR Am J Roentgenol 2007; 189: 1533–1538.Google Scholar
33. Murphy, KP, Szopinski, KT, Cohan, RH, et al. Occurrence of adverse reactions to gadolinium-based contrast material and management of patients are increased risk: a survey of the American Society of Neuroradiology Fellowship Directors. Acad Radiol 1999; 6: 656–664.CrossRefGoogle Scholar
34. Fakhran, S, Alihilali, L, Kale, H, et al. Assessment of rates of acute adverse reactions to adobenate dimeglumine: review of more than 130,000 administrations in 7.5 years. AJR Am J Roentgenol 2015; 204: 703–706.Google Scholar
35. Rangamani, S, Varghese, J, Li, L, et al. Safety of cardiac magnetic resonance and contrast angiography for neonates and small infants: a 10-year single-institution. Pediatr Radiol 2012; 42: 1339–1346.CrossRefGoogle ScholarPubMed
36. Hassan, N, Cahill, J, Rajashekaran, S, et al. Ferumoxytol infusion in pediatric patients with gastrointestinal disorders: first case series. Ann Pharmacother 2011; 45: e63.CrossRefGoogle ScholarPubMed
37. Mantadakis, E. Advances in pediatric intravenous iron therapy. Pediatr Blood Cancer 2016; 63: 11–16.CrossRefGoogle ScholarPubMed
38. Ning, P, Zucker, EJ, Wong, P, Vasanawala, SS. Hemodynamic safety and efficacy of ferumoxytol as an intravenous contrast agent in pediatric patients and young adults. Magn Reson Imaging 2016; 34: 152–158.Google Scholar
39. Luhar, A, Khan, S, Finn, JP, Ghahremani, S, et al. Contrast-enhanced magnetic resonance venography in pediatric patients with chronic kidney disease: initial experience with ferumoxytol. Pediatr Radiol 2016; 46: 1332–1340.CrossRefGoogle ScholarPubMed
40. Nayak, AB, Luhar, A, Hanudel, M, et al. High-resolution, whole-body vascular imaging with ferumoxytol as an alternative to gadolinium agents in a pediatric chronic kidney disease cohort. Pediatr Nephrol 2015; 30: 515–521.CrossRefGoogle Scholar