Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI.

Background Ferumoxytol is approved for use in the treatment of iron deficiency anemia, but it can serve as an alternative to gadolinium-based contrast agents. On the basis of postmarketing surveillance data, the Food and Drug Administration issued a black box warning regarding the risks of rare but serious acute hypersensitivity reactions during fast high-dose injection (510 mg iron in 17 seconds) for therapeutic use. Whereas single-center safety data for diagnostic use have been positive, multicenter data are lacking. Purpose To report multicenter safety data for off-label diagnostic ferumoxytol use. Materials and Methods The multicenter ferumoxytol MRI registry was established as an open-label nonrandomized surveillance databank without industry involvement. Each center monitored all ferumoxytol administrations, classified adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (grade 1-5), and assessed the relationship of AEs to ferumoxytol administration. AEs related to or possibly related to ferumoxytol injection were considered adverse reactions. The core laboratory adjudicated the AEs and classified them with the American College of Radiology (ACR) classification. Analysis of variance was used to compare vital signs. Results Between January 2003 and October 2018, 3215 patients (median age, 58 years; range, 1 day to 96 years; 1897 male patients) received 4240 ferumoxytol injections for MRI. Ferumoxytol dose ranged from 1 to 11 mg per kilogram of body weight (≤510 mg iron; rate ≤45 mg iron/sec). There were no systematic changes in vital signs after ferumoxytol administration (P > .05). No severe, life-threatening, or fatal AEs occurred. Eighty-three (1.9%) of 4240 AEs were related or possibly related to ferumoxytol infusions (75 mild [1.8%], eight moderate [0.2%]). Thirty-one AEs were classified as allergiclike reactions using ACR criteria but were consistent with minor infusion reactions observed with parenteral iron. Conclusion Diagnostic ferumoxytol use was well tolerated, associated with no serious adverse events, and implicated in few adverse reactions. Registry results indicate a positive safety profile for ferumoxytol use in MRI. © RSNA, 2019 Online supplemental material is available for this article.

Nephrogenic systemic fibrosis: review of 370 biopsy-confirmed cases.

Discovery of an association between gadolinium-based contrast agents (GBCAs) and nephrogenic systemic fibrosis (NSF) has led to less use of GBCA-enhanced magnetic resonance imaging in dialysis patients and patients with severe renal failure at risk of NSF, and the virtual elimination of new cases of NSF. But shifting patients with renal failure to alternative imaging methods may subject patients to other risks (e.g., ionizing radiation or iodinated contrast). This review paper examines 370 NSF cases reported in 98 articles to analyze NSF risk factors. Eliminating multiple risk factors by limiting GBCA dose to a maximum of 0.1 mmol/kg, dialyzing patients undergoing dialysis quickly following GBCA administration, delaying GBCA in acute renal failure until after renal function returns or dialysis is initiated, and avoiding nonionic linear GBCA in patients with renal failure especially when there are proinflammatory conditions may substantially reduce the risk of NSF.

Risk factors for NSF: a literature review.

Emerging evidence linking gadolinium-based contrast agents (GBCAs) to nephrogenic systemic fibrosis (NSF) has changed medical practice patterns toward forgoing GBCA-enhanced magnetic resonance imaging (MRI) or substituting other imaging methods, which are potentially less accurate and often radiation-based. This shift has been based on reports of high NSF incidence at sites where a confluence of risk factors occurred in patients with severe renal dysfunction. This review article explores the factors that affect NSF risk, compares risks of alternative imaging procedures, and demonstrates how risk can be managed by careful selection of GBCA dose, timing of injection with respect to dialysis, and other factors. Nearly half of NSF cases are a milder form that does not cause contractures or reduce mobility. It appears that eliminating even a single risk factor can reduce NSF incidence/risk at least 10-fold. Elimination of multiple risk factors by using single-dose GBCA, dialyzing dialysis patients quickly following GBCA administration, avoiding GBCA in acute renal failure while serum creatinine is rising, and avoiding nonionic linear GBCA in renal failure patients may reduce NSF risk more than a thousand-fold, thereby allowing safe GBCA-enhanced MRI in virtually all patients. J. Magn. Reson. Imaging 2009;30:1298-1308. (c) 2009 Wiley-Liss, Inc.

Diagnosis and targeted percutaneous management of a critical subclavian artery stenosis in a patient with absent peripheral pulses with the use of cardiac computed tomography.

Current clinical practice dictates that invasive management strategies frequently are adopted in patients with both ST-segment elevation and non-ST-segment elevation acute coronary syndromes. Such strategies rely on obtaining vascular access and, as such, are not always technically feasible. We report a case in which cardiac computed tomography was used to great effect in the diagnostic and (targeted) interventional management of a patient who was the recipient of a previous coronary artery bypass grafting and presented with global myocardial ischemia, in whom the lack of peripheral pulses had previously rendered an early invasive strategy hazardous.

Vascular imaging: an unparalleled decade.

Vascular imaging techniques, such as catheter angiography, ultrasound, computed tomography (CT), and magnetic resonance (MR), have all undergone unprecedented innovation and incredible technological leaps in the last 10 years. Ultrasound, CT, and MR have progressed in acquisition speed, resolution, and accuracy to the point that they have now supplanted the former mainstay, invasive catheter-based angiography, despite the advent of digitized angiographic image recording. This review explores the advantages and shortcomings of each technique and how they have changed the diagnosis and assessment of the cardiovascular system for endovascular intervention.