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The COVID-19 pandemic led to disruptions in iodinated contrast media (ICM) production and produced a global product shortage in the spring of 2022. The ACIST CVi system is an automated contrast injector system approved by the FDA for multi-patient dosing of ICM from a single container. A transition from the traditional manifold system for contrast injection to the ACIST CVi automated injector system in our cardiac angiographic labs during the COVID-19 pandemic led to reductions in contrast waste and cost while limiting patient exposure to ICM.

Background: Hypersensitivity reactions (HSRs) can occur unexpectedly and be life-threatening when gadolinium-based contrast agents (GBCAs) are used. Gadolinium deposition disease (GDD) and symptoms associated with gadolinium exposure (SAGE) have been controversial for a long time. However, similar studies are currently incomplete or outdated. Therefore, comparing the safety of different GBCAs in terms of HSRs and GDD/SAGE using the latest post-marketing safety data should yield further insights into safely using GBCAs., Methods: The safety differences between all GBCAs to GDD and the spectrum of GBCA-related HSRs were all compared and analyzed by using the World Health Organization database VigiBase and the FDA Adverse Event Reporting System (FAERS) database in this study. A further analysis of SAGE was also conducted using FAERS data. The lower limit of the reporting odds ratio (ROR) 95% confidence interval was used for signal detection. Moreover, the frequency of HSRs was calculated by dividing the number of reports in VigiBase by the total sales volume (measured in millions) from 2008 to 2022 in the IQVIA Multinational Integrated Data Analysis System. All adverse events were standardized using the Medical Dictionary for Drug Regulatory Activities (MedDRA) 26.0., Results: This study shows that all GBCAs have the potential to induce HSRs, with nonionic linear GBCAs exhibiting a comparatively lower signal. According to standardized MedDRA query stratification analysis, gadobutrol had a greater ROR 025 for angioedema. The ROR 025 of gadobenate dimeglumine and gadoteridol is larger for anaphylactic/anaphylactoid shock conditions. Regarding severe cutaneous adverse reactions, only gadoversetamide and gadodiamide showed signals in FAERS and VigiBase. There were also differences in the frequency of HSRs between regions. Regarding GDD, gadoterate meglumine, and gadoteridol had a lower ROR 025 . An analysis of the 29 preferred terms linked to SAGE indicated that special consideration should be given to the risk of skin induration associated with gadoversetamide, gadopentetate dimeglumine, gadobenate dimeglumine, gadodiamide, and gadoteridol. Additionally, gadodiamide and gadoteridol pose a greater risk of skin tightness compared to other GBCAs., Conclusions: The risk differences among GBCAs using data from several sources were compared in this study. However, as a hypothesis-generating method, a clear causal relationship would require further research and validation., (© 2024. The Author(s).)

Background: To detect and analyze risk signals of the drug-related adverse events (AEs) of 4 gadolinium-based contrast agents (GBCAs) (gadopentetate dimeglumine (Gd-DTPA), gadobenate dimeglumine (Gd-BOPTA), gadoteridol (Gd-HP-DO3A), and gadobutrol (Gd-BT-DO3A)) according to the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and ensure the clinical safety., Research Design and Methods: The AEs that are associated with the 4 GBCAs were collected from the FAERS database from 2004Q1 to 2022Q3. The risk signals were mined using reporting odds ratio (ROR) and proportional reporting ratio (PRR)., Results: 424 risk signals were excavated, in which 151 risk signals were associated with Gd-DTPA, 93 risk signals were related to Gd-BOPTA, 79 risk signals were relevant to Gd-HP-DO3A, and 101 risk signals were associated with Gd-BT-DO3A. The AE signals involved 20 system organ classes (SOCs). Two of the top four SOCs were identical, namely 'skin and subcutaneous tissue disorders' and 'general disorders and administration site conditions.', Conclusions: The safety signals of 4 GBCAs were detected, and the SOCs associated with the AEs of the 4 GBCAs were different. Besides, some AEs obtained in this study were not mentioned in the package inserts, which need more attention and research to ensure the clinical safety.

Objective: Contrast-sparing strategies have been developed for percutaneous coronary intervention (PCI) patients at increased risk of contrast-induced acute kidney injury (CI-AKI), and numerous CI-AKI risk prediction models have been created. However, the potential clinical and economic consequences of using predicted CI-AKI risk thresholds for assigning patients to contrast-sparing regimens have not been evaluated. We estimated the clinical and economic consequences of alternative CI-AKI risk thresholds for assigning Medicare PCI patients to contrast-sparing strategies., Methods: Medicare data were used to identify inpatient PCI from January 2017 to June 2021. A prediction model was developed to assign each patient a predicted probability of CI-AKI. Multivariable modeling was used to assign each patient two marginal predicted values for each of several clinical and economic outcomes based on (1) their underlying clinical and procedural characteristics plus their true CI-AKI status in the data and (2) their characteristics plus their counterfactual CI-AKI status. Specifically, CI-AKI patients above the predicted risk threshold for contrast-sparing were reassigned their no CI-AKI (counterfactual) outcomes. Expected event rates, resource use, and costs were estimated before and after those CI-AKI patients were reassigned their counterfactual outcomes. This entailed bootstrapped sampling of the full cohort., Results: Of the 542,813 patients in the study cohort, 5,802 (1.1%) had CI-AKI. The area under the receiver operating characteristic curve for the prediction model was 0.81. At a predicted risk threshold for CI-AKI of >2%, approximately 18.0% of PCI patients were assigned to contrast-sparing strategies, resulting in (/100,000 PCI patients) 121 fewer deaths, 58 fewer myocardial infarction readmissions, 4,303 fewer PCI hospital days, $11.3 million PCI cost savings, and $25.8 million total one-year cost savings, versus no contrast-sparing strategies., Limitations: Claims data may not fully capture disease burden and are subject to inherent limitations such as coding inaccuracies. Further, the dataset used reflects only individuals with fee-for-service Medicare, and the results may not be generalizable to Medicare Advantage or other patient populations., Conclusions: Assignment to contrast-sparing regimens at a predicted risk threshold close to the underlying incidence of CI-AKI is projected to result in significant clinical and economic benefits.

The United States (US) Food and Drug Administration (FDA) has issued multiple statements and guidelines since 2015 on the topic of thyroid function testing in babies and children through 3 years old after receiving iodinated contrast media for medical imaging exams. In April 2023, the FDA adjusted this recommendation to target babies and young children younger than 4 years of age who have a history of prematurity, very low birth weight, or underlying conditions which affect thyroid gland function, largely in response to solid arguments from expert statements from the American College of Radiology (ACR) which is endorsed by the Society for Pediatric Radiology (SPR), Pediatric Endocrinology Society (PES), and the Society for Cardiovascular Angiography & Intervention (SCAI). Herein we describe our approach and development of a clinical care guideline along with the steps necessary for implementation of the plan including alterations in ordering exams requiring iodinated contrast media, automatic triggering of lab orders, reporting, and follow-up, to address the 2022 FDA guidance statement to monitor thyroid function in children after receiving iodinated contrast media. The newly implemented clinical care guideline at Ann and Robert H. Lurie Children's Hospital of Chicago remains applicable following the 2023 updated recommendation from the FDA. We will track patients less than 3 months of age who undergo thyroid function testing following computed tomography (CT), interventional radiology, and cardiac catheterization exams for which an iodinated contrast media is administered as a clinical care quality initiative., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: This study aimed to evaluate the Pharmacovigilance (PV) and severity of hypersensitivity reactions induced by non-ionic Iodinated Contrast Media (ICM) in the radiology diagnosis reported to the United States Food and Drug Administration Adverse Event Reporting System (FAERS)., Methods: We retrospectively reviewed the reports of ICM-induced hypersensitivity reactions submitted to the FAERS database between January 2015 and January 2023 and conducted a disproportionality analysis. The seven most common non-ionic ICM, including iohexol, iopamidol, ioversol, iopromide, iomeprol, iobitridol, and iodixanol, were chiefly analyzed. Our primary endpoint was the PV of non-ionic ICM-induced total hypersensitivity events. STATA 17.0 MP was used for statistical analysis., Results: In total, 35357 reports of adverse reaction events in radiology diagnosis were retrieved from the FAERS database. Among them, 6181 reports were on hypersensitivity reaction events (mean age: 57.1 ± 17.8 years). The hypersensitivity reaction-related PV signal was detected for iohexol, ioversol, iopromide, iomeprol, iobitridol, and iodixanol, but not for iopamidol. The proportion of iomeprol-induced hypersensitivity reactions and the probability of ioversol-induced severe hypersensitivity reactions have been found to be significantly increased., Conclusion: The probability and severity of hypersensitivity reaction events in non-ionic ICM are different. Iohexol, ioversol, iopromide, iomeprol, iobitridol, and iodixanol have higher risks compared to iopamidol. In addition, the constituent ratio of hypersensitivity reactions induced by iomeprol is significantly increased, and the associated probability induced by ioversol is significantly increased.

Background: Acute kidney injury (AKI), including contrast-induced AKI (CI-AKI), is an important complication of percutaneous coronary intervention (PCI), resulting in short- and long-term adverse clinical outcomes. While prior research has reported an increased cost burden to hospitals from CI-AKI, the incremental cost to payers remains unknown. Understanding this incremental cost may inform decisions and even policy in the future. The objective of this study was to estimate the short- and long-term cost to Medicare of AKI overall, and specifically CI-AKI, in PCI., Methods: Patients undergoing inpatient PCI between January 2017 and June 2020 were selected from Medicare 100% fee-for-service data. Baseline clinical characteristics, PCI lesion/procedural characteristics, and AKI/CI-AKI during the PCI admission, were identified from diagnosis and procedure codes. Poisson regression, generalized linear modelling, and longitudinal mixed effects modelling, in full and propensity-matched cohorts, were used to compare PCI admission length of stay (LOS) and cost (Medicare paid amount inflated to 2022 US$), as well as total costs during 1-year following PCI, between AKI and non-AKI patients., Results: The study cohort included 509,039 patients, of whom 104,033 (20.4%) were diagnosed with AKI and 9,691 (1.9%) with CI-AKI. In the full cohort, AKI was associated with +4.12 (95% confidence interval = 4.10, 4.15) days index PCI admission LOS, +$11,313 ($11,093, $11,534) index admission costs, and +$14,800 ($14,359, $15,241) total 1-year costs. CI-AKI was associated with +3.03 (2.97, 3.08) days LOS, +$6,566 ($6,148, $6,984) index admission costs, and +$13,381 ($12,118, $14,644) cumulative 1-year costs (all results are adjusted for baseline characteristics). Results from the propensity-matched analyses were similar., Conclusions: AKI, and specifically CI-AKI, during PCI is associated with significantly longer PCI admission LOS, PCI admission costs, and long-terms costs., Competing Interests: Conflict of interest RIG, RC, AMM, AB, LMH: Employee and shareholder. CAS: Consultant. APA: None., (Copyright © 2023. Published by Elsevier Inc.)

Background: A comparative hypersensitivity risk profile of frequently used iodinated contrast media (ICM) may be required for their safer use., Objective: To explore the association between hypersensitivity reactions (HSRs) and specific ICM and characterize the spectrum of ICM-related HSRs., Methods: We performed a disproportionality analysis and proportionality test to assess the safety profile of ICM-related HSRs and compare the frequency ratio of specific HSRs in diverse age, sex, and country subgroups. We used reports downloaded from the US Food and Drug Administration Adverse Event Reporting System and data on the national use of individual ICM for this analysis., Results: A total of 11,343,365 adverse event reports were collected from the first quarter of 2013 to the first quarter of 2021, among which 5,432 cases were identified as ICM-induced HSRs. All of the studied ICMs were associated with overreporting frequencies of HSRs, in which iomeprol showed the highest reporting odds ratio (ROR) of 24.75 (95% CI, 19.61-31.24). Iopromide (ROR = 22.29; 95% CI, 20.18-24.62) and ioversol (ROR = 20.85; 95% CI, 18.54-23.44) were more likely to cause angioedema than other ICMs, particularly in the group aged 45 to 64 years. Iomeprol was associated with the largest disproportionality for severe cutaneous adverse reactions (ROR = 127.90; 95% CI, 103.32-159.88), whereas iodixanol exhibited maximal incidence when total use cases were considered. Regarding anaphylactic shock, iopamidol presented the highest disproportionality (ROR = 31.11; 95% CI, 27.15-35.65), especially in males or seniors aged greater than 65 years, whereas iopromide resulted in the maximum frequency in China and the United States., Conclusions: Different ICMs exhibited diverse profiles regarding HSRs, which could be further affected by age, sex, or geographic area. Prospective studies are required for patient safety., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Up to 14% of patients in the United States undergoing cardiac catheterization each year experience AKI. Consistent use of risk minimization preventive strategies may improve outcomes. We hypothesized that team-based coaching in a Virtual Learning Collaborative (Collaborative) would reduce postprocedural AKI compared with Technical Assistance (Assistance), both with and without Automated Surveillance Reporting (Surveillance)., Methods: The IMPROVE AKI trial was a 2×2 factorial cluster-randomized trial across 20 Veterans Affairs medical centers (VAMCs). Participating VAMCs received Assistance, Assistance with Surveillance, Collaborative, or Collaborative with Surveillance for 18 months to implement AKI prevention strategies. The Assistance and Collaborative approaches promoted hydration and limited NPO and contrast dye dosing. We fit logistic regression models for AKI with site-level random effects accounting for the clustering of patients within medical centers with a prespecified interest in exploring differences across the four intervention arms., Results: Among VAMCs' 4517 patients, 510 experienced AKI (235 AKI events among 1314 patients with preexisting CKD). AKI events in each intervention cluster were 110 (13%) in Assistance, 122 (11%) in Assistance with Surveillance, 190 (13%) in Collaborative, and 88 (8%) in Collaborative with Surveillance. Compared with sites receiving Assistance alone, case-mix-adjusted differences in AKI event proportions were -3% (95% confidence interval [CI], -4 to -3) for Assistance with Surveillance, -3% (95% CI, -3 to -2) for Collaborative, and -5% (95% CI, -6 to -5) for Collaborative with Surveillance. The Collaborative with Surveillance intervention cluster had a substantial 46% reduction in AKI compared with Assistance alone (adjusted odds ratio=0.54; 0.40-0.74)., Conclusions: This implementation trial estimates that the combination of Collaborative with Surveillance reduced the odds of AKI by 46% at VAMCs and is suggestive of a reduction among patients with CKD., Clinical Trial Registry Name and Registration Number: IMPROVE AKI Cluster-Randomized Trial (IMPROVE-AKI), NCT03556293., (Copyright © 2023 by the American Society of Nephrology.)

Background: Iodine-induced thyroid dysfunction is a potential risk among susceptible individuals. Iodinated contrast media is a common source of an acute iodine load used in the health care setting and is frequently required for diagnostic computed tomography scans, coronary angiograms, and other radiologic studies. However, the epidemiologic risks of iodine-thyroid dysfunction have not been fully established in the United States. Methods: This population-based retrospective cohort study used the U.S. Veterans Health Administration database between 1998 and 2021 and included adults aged ≥18 years with a serum thyrotropin (TSH) measurement. Multivariable logistic regression was used to ascertain the risk of incident thyroid dysfunction (defined by repeated measurements of serum thyroid function) following iodine exposure, adjusting for age, sex, race/ethnicity, baseline serum TSH concentration, and duration between baseline and follow-up TSH concentration. Results: The cohort was composed of N  = 4,253,119 veterans (mean ± SD = 63.5 ± 14.3 years; 92.9% men; 65.6% non-Hispanic Whites) with 8,729,155 corresponding pairs of serum TSH measurements, from which there were 499,897 TSH pairs with intervening iodine exposure. Thyroid dysfunction occurred in 4.8% of those pairs who had received iodine contrast and 3.6% of those without iodine exposure. Iodinated exposure was associated with an increased risk of thyroid dysfunction (odds ratio [OR] = 1.39, 95% confidence intervals [CI] = 1.37-1.41, p  < 0.001) and consistent for all types of serum thyroid dysfunction (overt or subclinical hypo-/hyperthyroidism). Men were at higher risk for the development of thyroid dysfunction than women (men: OR = 1.42, 95% CI = 1.40-1.44; women: OR = 1.16, 95% CI = 1.11-1.21; p -for-interaction <0.001). Conclusions: In this largest analysis of U.S. adults to date, iodine exposure was associated with only clinically small absolute increased risks of thyroid dysfunction, particularly in men. These findings suggest that screening of thyroid function following iodinated contrast administration should be targeted to high-risk individuals.

In this article, members of the American College of Radiology Committee on Drugs and Contrast Media propose a new term for symptoms reported after intravascular exposure to gadolinium-based contrast agents-Symptoms Associated with Gadolinium Exposure, or SAGE. This term is advocated in lieu of other proposed nomenclature that presumes a causal relationship that has not yet been scientifically verified. The purpose of this new term, SAGE, is to assist researchers and clinical providers in describing such symptoms without prematurely causally attributing them to a disease and to standardize reporting of these symptoms to allow for coherent interpretation of related studies., (© RSNA, 2021.)

Background: In 2007, the United States Food and Drug Administration mandated safety reviews of commercially available echocardiographic contrast agents (ECA), following reports of death. During the past years, different studies have proven the safety of ECA, but there have been few studies on SonoVue®., Objectives: To evaluate the safety of SonoVue® during pharmacological stress echocardiography (PSE), by analyzing the incidence of allergic reactions and comparing groups regarding the appearance of arrhythmia, minor side effects and adverse events., Methods: In this observational, prospective study, 2346 patients underwent PSE, and they were divided into the following 2 groups: group 1 with ECA (n = 1099) and group 2 without ECA (n = 1247). Patients were evaluated during PSE, at 24 hours, and at 30 days. Statistical significance was defined as p < 0.05., Results: Group 1 had fewer minor side effects, such as headache (5/0.5% versus 19/1.5%, p = 0.012) and less reactive hypertension (3/0.3% versus 19/1.5%, p = 0.002); fewer arrhythmias, such as ventricular extrasystoles (180/16.4% versus 247/19.8%, p = 0.032) and paroxysmal supraventricular tachycardia (2/0.2% versus 15/1.2%, p = 0.003); and no adverse events, such as acute myocardial infarction (AMI) or death. In group 2, 1 patient had AMI in < 24 hours (1/01%), and there were 2 deaths in < 30 days (2/0.1%). SonoVue®-related urticaria was seen in 3 (0.3%) patients, without anaphylactic reaction., Conclusion: SonoVue® demonstrated safety during PSE. No cases of death, AMI, or anaphylactic reaction were observed. There was a lower incidence of minor side effects and arrhythmias in the group that received ECA, as well as a low incidence of mild allergic reactions.

Aim: Acute kidney injury (AKI) is a known complication of patients undergoing cardiac catheterization or percutaneous coronary interventions (PCI).The Mehran score was developed to identify patients at risk for AKI after cardiac catheterization or PCI, but its use of contrast volume as part of the score calculation limits its application prior to the procedure. In this study, we evaluated the utility of a modified Mehran score that utilizes only pre-procedural data by excluding contrast volume., Methods: This was done in a retrospective fashion using data from patients who received PCI at our institution between July 2015 and December 2017 by evaluating the discriminative ability of the scoring systems for predicting outcomes through a receiver-operator characteristic curve analysis., Results: One thousand five hundred and seven patients were included in the study. A total of 70 (4.6%) patients developed AKI. The removal of contrast volume from the Mehran score resulted in a small loss of discrimination with AUROC 0.73 vs 0.74, P = .01 for the pre-procedural Mehran and the original Mehran, respectively. When compared to the original score, the pre-procedural Mehran score had a four-category net discrimination index (NRI) of -0.10 and an integrated discrimination index (IDI) for of -0.12., Conclusion: Despite a small loss in discrimination, there was no difference in the four-category net discrimination index between the two scores. The pre-procedural modified Mehran score is a useful clinical predictor of the risk of AKI in patients undergoing PCI., (© 2020 Asian Pacific Society of Nephrology.)

Inaugural consensus statements were developed and endorsed by the American College of Radiology (ACR) and the National Kidney Foundation to improve and standardize the care of patients with kidney disease who have indication(s) to receive ACR-designated group II or group III intravenous gadolinium-based contrast media (GBCM). The risk of nephrogenic systemic fibrosis (NSF) from group II GBCM in patients with advanced kidney disease is thought to be very low (zero events following 4931 administrations to patients with estimated glomerular filtration rate [eGFR] <30 mL/min per 1.73 m 2 ; upper bounds of the 95% confidence intervals: 0.07% overall, 0.2% for stage 5D chronic kidney disease [CKD], 0.5% for stage 5 CKD and no dialysis). No unconfounded cases of NSF have been reported for the only available group III GBCM (gadoxetate disodium). Depending on the clinical indication, the potential harms of delaying or withholding group II or group III GBCM for an MRI in a patient with acute kidney injury or eGFR less than 30 mL/min per 1.73 m 2 should be balanced against and may outweigh the risk of NSF. Dialysis initiation or alteration is likely unnecessary based on group II or group III GBCM administration. This article is a simultaneous joint publication in Radiology and Kidney Medicine . The articles are identical except for stylistic changes in keeping with each journal's style. Either version may be used in citing this article., (© 2020 RSNA and the National Kidney Foundation published by Elsevier Inc. This is an open access article under the CC BY NC-ND license.)

Objective: Postcontrast acute kidney injury (PC-AKI) is a dreaded complication of peripheral vascular interventions (PVIs) that depends on the volume of contrast administered as well as a patient's baseline kidney function. However, there is currently no guidance on the volume of contrast that is considered safe especially for patients with advanced chronic kidney disease (CKD). This study aims to characterize the incidence, risk factors for, and outcomes after PC-AKI and define thresholds of safety for contrast volume., Methods: The Vascular Quality Initiative files for PVI (2010-2018) were reviewed. Patients on dialysis, with renal transplants, or who developed a bleeding complication were excluded. Only records with complete data on baseline creatinine, contrast volume, and PC-AKI (creatinine increase of ≥0.5 mg/dL, or new dialysis requirement) were included. The cumulative incidence of PC-AKI with contrast volume at each stage of CKD was derived. A safe threshold for contrast volume was defined as the volume at which the cumulative incidence of PC-AKI is 0.5% or less. Multivariable logistic regression was used to define risk factors for PC-AKI, and survival analysis was performed using Kaplan-Meier and multivariable Cox proportional hazards regression., Results: A total of 53,780 procedures were included. There were 16,062 patients (29%) with normal kidney function or CKD1, 21,769 (39%) with CKD2, 14,234 (25%) with CKD3, 1471 (3%) with CKD4, and 199 (<1%) with CKD5. The incidence of PC-AKI was 0.9% and increased with each stage of CKD (CKD1, 0.39%; CKD2, 0.45%; CKD3, 1.5%; CKD4, 4.3%; and CKD5, 7.5%). The safe thresholds for contrast volume for advanced CKD were 50, 20, and 9 mL for CKD3, CKD4, and CKD5, respectively. Regression analysis demonstrated that white race (odds ratio [OR], 0.67; 95% confidence interval [CI], 0.54-0.82) and elective surgery (OR, 0.77; 95% CI, 0.62-0.95) were associated with decreased risk of PC-AKI, whereas inpatient status (OR, 14.5; 95% CI, 9.97-21.2), diabetes (OR, 1.27; 95% CI, 1.02-1.58), advanced CKD (CKD3: OR, 3.65; 95% CI, 2.68-4.98; CKD4: OR, 6.98; 95% CI, 4.72-10.3; CKD5: OR, 8.94; 95% CI, 4.53-17.6), critical limb ischemia (OR, 1.51; 95% CI, 1.14-2.00), acute limb ischemia (OR, 2.47; 95% CI, 1.70-3.59), and contrast-to-eGFR ratio (CGR) (2 ≤ CGR < 3: OR, 1.33; 95% CI, 1.02-1.74; 3 ≤ CGR < 4: OR, 1.90; 95% CI, 1.32-2.75; CGR ≥ 4: OR, 1.79; 95% CI, 1.18-2.70) were significantly associated with increased risk for PC-AKI. Patients who developed PC-AKI had worse in-hospital (16.1% vs 0.45%; P < .01) mortality and long-term survival (log-rank P < .01) compared with those without PC-AKI., Conclusions: PVI are associated with low risk of PC-AKI that significantly increases when patients with advanced CKD undergo high acuity cases. Given the strong association with short-term and long-term mortality, risk of PC-AKI should be minimized by using safe thresholds of contrast volume., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Since the first peripheral endovascular intervention (PVI) in 1964, the procedure's technical aspects and indications have advanced significantly. Today, endovascular procedures span the spectrum of presentations from acute limb ischemia to critical limb ischemia and symptomatic limiting claudication. Goals of PVI remain restoring limb perfusion, minimizing rates of amputation and mortality, and sparing the need for the high-risk bypass surgery. Unfortunately, there are no large randomized controlled trials that address the optimal approach to peripheral arterial disease revascularization in chronic kidney disease (CKD) patients., Competing Interests: Disclosure The authors have nothing to disclose., (Published by Elsevier Inc.)

Background: Contrast-Associated Acute Kidney Injury (CA-AKI) is a serious complication associated with percutaneous coronary intervention (PCI). Patients with chronic kidney disease (CKD) have an elevated risk for developing this complication. Although CA-AKI prophylactic measures are available, the supporting literature is variable and inconsistent for periprocedural hydration and N-acetylcysteine (NAC), but is stronger for contrast minimization., Methods: We assessed the prevalence and variability of CA-AKI prophylaxis among CKD patients undergoing PCI between October 2007 and September 2015 in any cardiac catheterization laboratory in the VA Healthcare System. Prophylaxis included periprocedural hydration with normal saline or sodium bicarbonate, NAC, and contrast minimization (contrast volume to glomerular filtration rate ratio ≤ 3). Multivariable hierarchical logistic regression models quantified site-specific prophylaxis variability. As secondary analyses, we also assessed CA-AKI prophylaxis measures in all PCI patients regardless of kidney function, periprocedural hydration in patients with comorbid CHF, and temporal trends in CA-AKI prophylaxis., Results: From 2007 to 2015, 15,729 patients with CKD underwent PCI. 6928 (44.0%) received periprocedural hydration (practice-level median rate 45.3%, interquartile range (IQR) 35.5-56.7), 5107 (32.5%) received NAC (practice-level median rate 28.3%, IQR 22.8-36.9), and 4656 (36.0%) received contrast minimization (practice-level median rate 34.5, IQR 22.6-53.9). After adjustment for patient characteristics, there was significant site variability with a median odds ratio (MOR) of 1.80 (CI 1.56-2.08) for periprocedural hydration, 1.95 (CI 1.66-2.29) for periprocedural hydration or NAC, and 2.68 (CI 2.23-3.15) for contrast minimization. These trends were similar among all patients (with and without CKD) undergoing PCI. Among patients with comorbid CHF (n = 5893), 2629 (44.6%) received periprocedural hydration, and overall had less variability in hydration (MOR of 1.56 (CI 1.38-1.76)) compared to patients without comorbid CHF (1.89 (CI 1.65-2.18)). Temporal trend analysis showed a significant and clinically relevant decrease in NAC use (64.1% of cases in 2008 (N = 1059), 6.2% of cases in 2015 (N = 128, p = < 0.0001)) and no significant change in contrast-minimization (p = 0.3907)., Conclusions: Among patients with CKD undergoing PCI, there was low utilization and significant site-level variability for periprocedural hydration and NAC independent of patient-specific risk. This low utilization and high variability, however, was also present for contrast minimization, a well-established measure. These findings suggest that a standardized approach to CA-AKI prophylaxis, along with continued development of the evidence base, is needed.

There are limitations to the sensitivity and specificity of conventional two-dimensional echocardiograms in making an accurate diagnosis in certain patient populations. This led to the development of specific contrast-enhancing agents with the following characteristics: small enough to cross the pulmonary capillary bed, remain stable throughout the length of the procedure, do not dissolve in blood, and rapidly cleared from the body with low toxicity. Unfortunately, the use of contrast echocardiography has not taken off as expected. The low take-up rate among clinicians can largely be attributed to the black box warning by the United States Food and Drug Administration in 2007, after the coincidental occurrence of four patient deaths and about 190 severe cardiopulmonary reactions shortly after contrast agent administration. In this article, we address the clinical safety of contrast agents, share our institution's experience in using it and elaborate on the clinical indications of contrast echocardiography., (Copyright: © Singapore Medical Association.)

Importance: Risk of nephrogenic systemic fibrosis (NSF) to individual patients with stage 4 or 5 chronic kidney disease (CKD; defined as estimated glomerular filtration rate of <30 mL/min/1.73 m2) who receive a group II gadolinium-based contrast agent (GBCA) is not well understood or summarized in the literature., Objective: To assess the pooled risk of NSF in patients with stage 4 or 5 CKD receiving a group II GBCA., Data Sources: A health sciences informationist searched the Ovid (MEDLINE and MEDLINE Epub Ahead of Print, In-Process & Other Non-Indexed Citation, and Daily and Versions), Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Open Grey databases from inception to January 29, 2019, yielding 2700 citations., Study Selection: Citations were screened for inclusion in a multistep process. Agreement for final cohort inclusion was determined by 2 blinded screeners using Cohen κ. Inclusion criteria consisted of stage 4 or 5 CKD with or without dialysis, administration of an unconfounded American College of Radiology classification group II GBCA (gadobenate dimeglumine, gadobutrol, gadoterate meglumine, or gadoteridol), and incident NSF as an outcome. Conference abstracts, retracted manuscripts, narrative reviews, editorials, case reports, and manuscripts not reporting total group II GBCA administrations were excluded., Data Extraction and Synthesis: Data extraction was performed for all studies by a single investigator, including publication details, study design and time frame, patient characteristics, group II GBCA(s) administered, total exposures for patients with stage 4 or stage 5 CKD, total cases of unconfounded NSF, reason for GBCA administration, follow-up duration, loss to follow-up, basis for NSF screening, and diagnosis., Main Outcomes and Measures: Pooled incidence of NSF and the associated upper bound of a 2-sided 95% CI (risk estimate) for the pooled data and each of the 4 group II GBCAs., Results: Sixteen unique studies with 4931 patients were included (κ = 0.68) in this systematic review and meta-analysis. The pooled incidence of NSF was 0 of 4931 (0%; upper bound of 95% CI, 0.07%). The upper bound varied owing to different sample sizes for gadobenate dimeglumine (0 of 3167; upper bound of 95% CI, 0.12%), gadoterate meglumine (0 of 1204; upper bound of 95% CI, 0.31%), gadobutrol (0 of 330; upper bound of 95% CI, 1.11%), and gadoteridol (0 of 230; upper bound of 95% CI, 1.59%)., Conclusions and Relevance: This study's findings suggest that the risk of NSF from group II GBCA administration in stage 4 or 5 CKD is likely less than 0.07%. The potential diagnostic harms of withholding group II GBCA for indicated examinations may outweigh the risk of NSF in this population., Trial Registration: PROSPERO identifier: CRD42019123284.

Background: Intravenous fluid (IVF) administration for the prevention of contrast-induced nephropathy (CIN) is considered standard of care, but the effect of IVF therapy on longer-term outcomes after radiocontrast dye administration is not well known., Methods and Results: We studied 4367 patients undergoing coronary and peripheral angiography and intervention at a veterans' administration medical center. 2653 patients (61%) received IVF prior to the procedure and 1714 (39%) did not. Of the 4367 subjects 1962 (45%) had repeat creatinine values at 72 h and 3100 (70%) had repeat creatinine values at 3 months. CIN at 72 h occurred in 68 (6.7%) patients in the IVF group and in 87 patients (9.8%) in the group receiving no IVF (odds ratio [OR] 0.97; 95% confidence interval [CI] 0.94-0.99; p = 0.004). At 3 months, renal dysfunction was seen in 224 (11.5%) patients of the IVF group versus 152 (13.1%) of the group receiving no IVF (OR 0.98, CI 0.96-1.01; p = 0.18). In adjusted analyses using a propensity score, IVF therapy was associated with a significant reduction in CIN occurrence at 72 h (OR = 0.97, (95% CI 0.94-0.99, p = 0.01) but was not associated with a change in the incidence of renal dysfunction at 3 months (OR 0.98, 95% CI 0.96-1.01. p = 0.18)., Conclusion: In this cohort of US veterans, IVF administration was associated with a decreased incidence of CIN at 72 h but was not associated with a decreased incidence of renal dysfunction at 3 months., (Published by Elsevier Inc.)

Gadolinium-based contrast agents (GBCAs) have an excellent safety profile. However, over the last 2 decades, two specific concerns have surfaced. GBCAs are associated with nephrogenic systemic fibrosis (NSF) and tissue retention of gadolinium. NSF is a rare fibrosing disorder with a poor prognosis, which is characterized by skin and subcutaneous thickening as well as systemic manifestations. The disease has been reported exclusively in patients with advanced renal disease, and it is associated with higher doses and specific types of GBCAs. The number of new cases of NSF has fallen over the past decade, presumably because of adherence by health care providers to regulatory guidelines, which continue to evolve. While gadolinium retention has been known to occur in the liver and bones, the relatively recent findings of deposition and retention in the brain have reignited the debate concerning the safety profile of GBCAs. Despite these concerns, there have been no proven health effects related to gadolinium deposition and retention other than NSF. The authors review the different categories of GBCAs available for commercial use, discuss NSF and gadolinium retention in the brain, and provide updates on the latest U.S. and European regulatory guidelines regarding use of these agents. Given the frequency with which GBCAs are used in clinical practice, it is imperative for all radiologists to learn the current guidelines to provide the safest and highest quality of patient care. © RSNA, 2019.

Purpose: To evaluate the safety of power injectors for contrast-enhanced computed tomography (CT) in children, namely: the prevalence and injury severity of contrast extravasations related to power injectors and the factors associated with these events., Methods: The need to obtain informed consent was waived for this HIPAA-compliant and IRB approved retrospective study. Around 2429 contrast-enhanced CT performed with a power injector were identified during a 3-year period. Data collected included patient demographic, power injector, and contrast agent information. The patients' symptoms, severity of injury and treatment with contrast extravasation were recorded. Around 1496 cases (823 boys, 673 girls) were included in the analysis. Independent-sample t test and Chi-square were used. For a sub-analysis using the extravasation cases, nonparametric tests were used., Results: The mean age was 9.5 ± 6.1 years. The most common access site, catheter site, and contrast agent used were the antecubital fossa, 22 gauge and Iohexol. The mean peak pressure was 68.9 ± 62.3 psi and the flow rate was 1.7 ± 0.9 mL/s. Eighteen cases of contrast extravasation were identified with a mean age of 11.2 ± 6.2 years. There were seven mild, six moderate, and five severe. Cases with extravasation had significantly higher peak pressure (p < 0.001) and flow rate (p < 0.001) compared to those without extravasation. Patients who received Iohexol-350 had significantly more contrast extravasation compared to those who used Iohexol-300 (p = 0.03). However, after post-hoc correction, only peak pressure (p < 0.01) and flow rate (p = 0.01) remained significant., Conclusion: The use of power injectors in children undergoing contrast-enhanced CT is associated with a low rate of extravasation and of long-term injury., (Copyright © 2019 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

Objectives: Recent studies have questioned whether intravascular iodinated contrast remains an independent cause of acute kidney injury (AKI). We sought to assess whether iodinated contrast administered during coronary angiography is an independent cause of AKI., Methods: We identified all of the patients who underwent coronary angiography between July 1, 2015 and June 30, 2017 with a discharge diagnosis of AKI that developed within 7 days following angiography. Using chart review, we categorized patients as having multifactorial AKI if ≥1 insults other than intravascular contrast potentially contributed to kidney injury or contrast-induced AKI (CI-AKI) if the only insult was contrast administration. We compared the severity of AKI and renal function upon discharge between patients with CI-AKI and multifactorial AKI., Results: We identified 78 patients who experienced AKI within 7 days following angiography, 10 (13%) of whom had CI-AKI and 68 of whom (87%) experienced multifactorial AKI. Nine (90%) patients with CI-AKI manifested stage 1 disease, 1 (10%) had stage 2 disease, and 9 (90%) experienced full recovery of kidney function. More patients with multifactorial AKI developed stage 2 or 3 disease (42% vs 10%, χ 2 = 3.73, P = 0.05) and experienced either partial recovery of kidney function or persistent kidney impairment compared with patients with CI-AKI (25% vs 10%, χ 2 = 1.9, P = 0.17), although the latter comparison was not statistically significant., Conclusions: The intravascular administration of iodinated contrast remains an independent cause of AKI. Compared with those with multifactorial AKI, patients with CI-AKI appear to be more likely to experience mild decrements in kidney function that recover completely.

Objective: To evaluate contrast media (CM) volume (CMV) saved using the DyeVert™ Plus Contrast Reduction System (DyeVert Plus System, Osprey Medical) in patients undergoing diagnostic coronary angiogram (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections., Background: Current guidelines advocate for monitoring and minimization of the total volume of CM in chronic kidney disease (CKD) patients undergoing invasive cardiac procedures. The DyeVert Plus System is an FDA cleared device designed to reduce CMV delivered during angiography and permit real-time CMV monitoring., Methods: We performed a multicenter, single-arm, observational study. Eligible subjects were ≥ 18 years old with baseline estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m 2 . The primary endpoint was % CMV saved over the total procedure. A secondary objective was to evaluate adverse events (AEs) related to DyeVert Plus System or to CM use., Results: A total of 114 subjects were enrolled at eight centers. Mean age was 72 ± 9 years, 72% were male, and mean body mass index was 29 ± 5. Baseline eGFR was 43 ± 11 mL/min/1.73 m 2 . CAG-only was performed in 65% of cases. One hundred and five subjects were evaluable for the primary endpoint. Mean CMV attempted was 112 ± 85 mL (range 22-681) and mean CMV delivered was 67 ± 51 mL (range 12-403), resulting in an overall CMV savings of 40.1 ± 8.8% (95% CI 38.4, 41.8; P < 0.0001) per procedure. Image quality was maintained in all but one case where the system was turned off for one injection. No DyeVert Plus System-related AEs were reported. Acute kidney injury (AKI; defined as serum creatinine rise of >0.3 mg/dL from baseline) was reported in 11 cases with seven occurring in subjects with baseline eGFR < 30 and three AKI events were attributed to CM. AKI rates increased as CMV/eGFR ratios increased., Conclusions: These data suggest DyeVert Plus System use in CKD patients undergoing CAG and/or PCI results in clinically meaningful CMV savings while maintaining image quality., (© 2018 Wiley Periodicals, Inc.)

Background: The molecular structure, charge, thermodynamic and kinetic stability are approximately the same for gadodiamide and gadoversetamide, the main substantive difference is that gadodiamide is manufactured with 5% free ligand to form Omniscan® and gadoversetamide with 10% free ligand to form OptiMARK®., Purpose: To determine the relative risk of Nephrogenic Systemic Fibrosis (NSF) between gadodiamide (Omniscan®) and gadoversetamide (OptiMARK®) and to explore the potential contribution of the amount of excess ligand added to their commercial formulations., Materials and Methods: In this retrospective observational study, the number of doses and NSF cases associated with these agents were calculated based on two different approaches: the number of doses was determined based on pharmaceutical companies' information, and the number of unconfounded NSF cases was obtained from the previously published literature based on a legal database. A second analysis estimates the number of doses and NSF cases from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS)., Results: Approximately 87 million and 12 million doses of Omniscan® and OptiMARK®, respectively, have been administered worldwide since their original approval for use in the various countries throughout the world. A total of 197 and 8 unconfounded cases of NSF have been reported with Omniscan® and OptiMARK®, rendering an incidence of 2.3/million and 0.7/million for these agents, respectively. The FAERS analysis suggested reported incidences of 13.1/million and 5.0/million., Conclusion: There is an approximately 3-fold greater incidence of NSF from Omniscan® than OptiMARK®. The difference in incidence might reflect the lesser quantity of added free ligand to the formulation of Omniscan®., (Copyright © 2018. Published by Elsevier Inc.)

Background: Although it is generally acknowledged that exposure to iodine contrast agents can interfere with thyroid function, little is known about the incidence of iodine-induced hypothyroidism in young children (younger than the age of 4 years)., Study Objectives: This was a retrospective cohort study to estimate the incidence rate of detected hypothyroidism in a US-based general population of pediatric patients exposed to an iodinated contrast agent., Setting: The study was conducted in Kaiser Permanente Northern California, an integrated health care delivery system., Study Population: This study included 2320 pediatric patients younger than 4 years of age who had a diagnostic procedure with an iodinated contrast agent during years 2008 to 2016., Results: Among 2320 young children who met our study criteria, we identified 34 who met the initial criteria to be a case of hypothyroidism. The incidence density ratio for all hypothyroidism in iodine contrast agent-exposed patients was 1.33 per 1000 person months (95% confidence interval, 0.9-1.8). Most cases appeared to have subclinical hypothyroidism. The rate was higher for the probably iodine-induced cases (0.90 per 1000 person months) compared with cases with a possible alternate etiology (0.43 per 1000 person months), for males compared with females, and among children who had a heart catheterization compared with those with a computed tomography scan. It was also highest among the youngest children (younger than 3 months old), and decreased with increasing age., Discussion: Our finding of hypothyroidism in young children exposed to iodine contrast agents (1.33 per 1000 person months [95% confidence interval, 0.9-1.8]) is broadly consistent with the sparse literature on this outcome.

Objective: This study assessed the rate of major adverse renal or cardiac events (MARCE) when iohexol is used during interventional cardiovascular procedures compared to other low osmolar contrast media (LOCMs)., Background: Interventional cardiovascular procedures are often essential for diagnosis and treatment, the risk of MARCE should be considered., Methods: Data were derived from the Premier Hospital Database January 1, 2010 through September 30, 2015. Patient encounters with an inpatient primary interventional cardiovascular procedure with a single LOCM (iohexol, ioversol, ioxilan, ioxaglate, or iopamidol) were included. The primary outcome was a composite endpoint of MARCE, which included: renal failure with dialysis, acute kidney injury (AKI) with or without dialysis, contrast induced AKI, acute myocardial infarction, angina, stent occlusion/thrombosis, stroke, transient ischemic attack, or death. Multivariable regression analysis was performed using the hospital fixed-effects specification to assess the relationship between MARCE and iohexol compared to other LOCMs, while controlling for patient demographics, comorbid conditions and reason for hospitalization. As a sensitivity analysis, direct comparisons of iohexol were made to other LOCMs., Results: A total of 458,091 inpatient encounters met inclusion criteria of which 26% used iohexol and 74% used other LOCMs. Results of multivariable modeling revealed no differences in MARCE rates between iohexol and other LOCMs. When direct comparisons of iohexol vs. ioversol and iopamidol were modeled, no differences in MARCE nor the renal component of MARCE were found., Conclusions: In this retrospective multicenter study, there were no differences in MARCE events with iohexol compared to other LOCMs during inpatient interventional cardiovascular procedures., (© 2018 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

The risk for developing immediate or delayed hypersensitivity reactions to radiocontrast media (RCM) interferes with the diagnosis and treatment of a number of patients requiring imaging diagnostic methods for many common diseases. A group of experts met in Orlando, Florida, in March 2018 to analyze the similarities and differences in the management of RCM reactions in different areas of the world. This paper presents a summary of the recommendations provided by this consensus group, highlighting controversial issues and unmet needs that require further research., (Copyright © 2019 American Academy of Allergy, Asthma & Immunology. All rights reserved.)

MRI is a ubiquitous medical imaging technology typically using superconductivity to generate a strong, homogeneous, and generally ceaseless magnetic field. MRI and its magnetic field pose many safety hazards, including magnetic forces on metals, tissue heating and burns, nerve stimulation, bioeffects, acoustic noise, and contrast agent complications. The primary concern is that a wide variety of patients, staff members, technologists, and physicians can approach the incessant magnetic field, creating great potential for accidents that could occur if metals from the environment, adornments, implants, and other unintended sources are also present in or near the field. Many accidents have occurred and are occasionally reported in the United States and countries all over the world. Through carefully structured oversight and the establishment of strict guidelines regarding access, responsibilities, and training, these risks can be mitigated, and accidents can be prevented. Fortunately, there is currently a wide variety of resources available to facilitate the successful implementation of an effective MRI safety program. This article presents a general overview of and the authors' experience with an MRI safety program in terms of risk management and training. The MR safety program requirements and regulations in the United States devised by The Joint Commission and the ACR are also discussed. With these resources and a carefully selected team, the risk for MRI-related accidents can be vastly reduced if not completely eliminated., (Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare intravenous (IV) sodium bicarbonate with IV sodium chloride and oral acetylcysteine with placebo for the prevention of contrast-associated acute kidney injury (CAAKI) and intermediate-term adverse outcomes., Background: Data are conflicting on the optimal strategy to reduce CAAKI and related complications after percutaneous coronary intervention (PCI)., Methods: The PRESERVE (Prevention of Serious Adverse Events Following Angiography) trial used a 2 × 2 factorial design to randomize 5,177 patients with stage III or IV chronic kidney disease undergoing angiography to IV 1.26% sodium bicarbonate or IV 0.9% sodium chloride and 5 days of oral acetylcysteine or placebo. A subgroup analysis was conducted of the efficacy of these interventions in patients who underwent PCI during the study angiographic examination. The primary endpoint was a composite of death, need for dialysis, or persistent kidney impairment at 90 days; CAAKI was a secondary endpoint., Results: A total of 1,161 PRESERVE patients (mean age 69 ± 8 years) underwent PCI. The median estimated glomerular filtration rate was 50.7 ml/min/1.73 m 2 (interquartile range: 41.7 to 60.1 ml/min/1.73 m 2 ), and 952 patients (82%) had diabetes mellitus. The primary endpoint occurred in 15 of 568 patients (2.6%) in the IV sodium bicarbonate group and 24 of 593 patients (4.0%) in the IV sodium chloride group (odds ratio: 0.64; 95% confidence interval: 0.33 to 1.24; p for interaction = 0.41) and in 23 of 598 patients (3.8%) in the acetylcysteine group and 16 of 563 patients (2.8%) in the placebo group (odds ratio: 1.37; 95% confidence interval: 0.71 to 2.62; p for interaction = 0.29). There were no significant between-group differences in the rates of CAAKI., Conclusions: Among patients with CKD undergoing PCI, there was no benefit of IV sodium bicarbonate over IV sodium chloride or of acetylcysteine over placebo for the prevention of CAAKI or intermediate-term adverse outcomes., (Published by Elsevier Inc.)

Gadolinium-based contrast agents (GBCAs) have revolutionized MRI, enabling physicians to obtain crucial life-saving medical information that often cannot be obtained with other imaging modalities. Since initial approval in 1988, over 450 million intravenous GBCA doses have been administered worldwide, with an extremely favorable pharmacologic safety profile; however, recent information has raised new concerns over the safety of GBCAs. Mounting evidence has shown there is long-term retention of gadolinium in human tissues. Further, a small subset of patients have attributed a constellation of symptoms to GBCA exposure, although the association of these symptoms with GBCA administration or gadolinium retention has not been proven by scientific investigation. Despite evidence that macrocyclic GBCAs show less gadolinium retention than linear GBCAs, the safety implications of gadolinium retention are unknown. The mechanism and chemical forms of gadolinium retention, as well as the biologic activity and clinical importance of these retained gadolinium species, remain poorly understood and underscore the need for additional research. In February 2018, an international meeting was held in Bethesda, Md, at the National Institutes of Health to discuss the current literature and knowledge gaps about gadolinium retention, to prioritize future research initiatives to better understand this phenomenon, and to foster collaborative standardized studies. The greatest priorities are to determine (a) if gadolinium retention adversely affects the function of human tissues, (b) if retention is causally associated with short- or long-term clinical manifestations of disease, and (c) if vulnerable populations, such as children, are at greater risk for experiencing clinical disease. The purpose of the research roadmap is to highlight important information that is not known and to identify and prioritize needed research. ©RSNA, 2018 Online supplemental material is available for this article .

Objective: To evaluate risk predictors of acute kidney injury (AKI) after contrast-media procedures in a broader cohort of patients than previously reported., Data Sources: Comprehensive medical and pharmacy commercial claims data from 2012 to 2014., Data Collection and Extraction Methods: Claims associated with contrast-media procedures for 2,737,020 persons between January 1, 2012 and November 30, 2014, were reviewed., Principal Findings: The overall incidence of AKI after a contrast-media procedure was 0.85%. AKI occurred in 26% of cases that had two or more contrast procedures within 30 days, compared with 9% of non-AKI cases. Although the incidence of postcontrast AKI was low, 10% of patients who developed AKI had a recent previous episode of AKI. In cases when AKI had occurred within 180 days of contrast administration, the odds of subsequent kidney injury was 9.39., Conclusions: Overall, there is a low risk (0.85%) of developing an AKI after a procedure with contrast-media consistent with several recent studies. However, in adults with a recent history of AKI, physicians must consider this history as a risk factor for subsequent AKI., (Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

The issue of dechelation (transmetallation) in vivo after administration of the linear gadolinium-based contrast agents, and potential safety concerns, is considered on the basis of an extensive, focused literature review. Early indications of potential problems included the high level of excess ligand used in the formulation of 2 agents (indeed the 2 least stable thermodynamically) and interference with laboratory tests when blood was drawn from patients relatively soon after administration of these same agents. The advent of nephrogenic systemic fibrosis in the late 2000s raised additional major concerns.The correlation in 2014 of dentate nucleus hyperintensity on precontrast T1-weighted scans with multiple prior injections of linear gadolinium chelates, in patients with normal renal function, has driven subsequent research concerning dechelation of these agents in vivo. Unexpectedly high levels of gadolinium in the bone, skin, and liver have been found long term after administration, in animal models and in humans, although the latter data are limited. Bone may serve as a long-term reservoir, with a residual excretion phase for gadolinium after intravenous injection of the linear agents due to a subsequent slow release from bone. Many different patient populations could be vulnerable and potentially later develop clinical symptoms, although at this stage there are only limited data and small retrospective uncontrolled studies. Possible vulnerable populations include children, menopausal women, patients with osteoporosis (who are predisposed to fractures and often slow to heal or heal poorly), those receiving multiple doses, those with proinflammatory conditions, moderate renal dysfunction, or an undefined genetic predisposition. Of particular concern would be nephrogenic systemic fibrosis-like symptoms-including particularly pain and skin/joint symptoms, or disease related to the incorporation of gadolinium in hydroxyapatite in bone, in small subgroups of patients with a not yet defined propensity and/or cofactor. These concerns have led to withdrawal of the linear agents from the largest clinical market, Europe, with the exception of the hepatobiliary agents for delayed liver imaging, an indication that cannot be fulfilled by the current macrocyclic gadolinium chelates (for which these concerns do not apply).

Importance: Acute kidney injury (AKI) after percutaneous coronary intervention (PCI) is common, morbid, and costly; increases patients' mortality risk; and can be mitigated by limiting contrast use., Objective: To examine the national variation in AKI incidence and contrast use among US physicians and the variation's association with patients' risk of developing AKI after PCI., Design, Setting, and Participants: This cross-sectional study used the American College of Cardiology National Cardiovascular Data Registry (NCDR) CathPCI Registry to identify in-hospital care for PCI in the United States. Participants included 1 349 612 patients who underwent PCI performed by 5973 physicians in 1338 hospitals between June 1, 2009, and June 30, 2012. Data analysis was performed from July 1, 2014, to August 31, 2016., Main Outcomes and Measures: The primary outcome was AKI, defined according to the Acute Kidney Injury Network criteria as an absolute increase of 0.3 mg/dL or more or a relative increase of 50% or more from preprocedural to peak creatinine. A secondary outcome was the mean contrast volume as reported in the NCDR CathPCI Registry. Physicians who performed more than 50 PCIs per year were the main exposure variable of interest. Hierarchical regression with adjustment for patients' AKI risk was used to identify the variation in AKI rates, the variation in contrast use, and the association of contrast volume with patients' predicted AKI risk., Results: Of the 1 349 612 patients who underwent PCI, the mean (SD) age was 64.9 (12.2) years, 908 318 (67.3%) were men, and 441 294 (32.7%) were women. Acute kidney injury occurred in 94 584 patients (7%). A large variation in AKI rates was observed among individual physicians ranging from 0% to 30% (unadjusted), with a mean adjusted 43% excess likelihood of AKI (median odds ratio, 1.43; 95% CI, 1.41-1.44) for statistically identical patients presenting to 2 random physicians. A large variation in physicians' mean contrast volume, ranging from 79 mL to 487 mL with an intraclass correlation coefficient of 0.23 (interquartile range, 0.21-0.25), was also observed, implying a 23% variation in contrast volume among physicians after adjustment. There was minimal correlation between contrast use and patients' AKI risk (r = -0.054). Sensitivity analysis after excluding complex cases showed that the physician variation in AKI remained unchanged., Conclusions and Relevance: Acute kidney injury rates vary greatly among physicians, who also vary markedly in their use of contrast and do not use substantially less contrast in patients with higher risk for AKI. These findings suggest an important opportunity to reduce AKI by reducing the variation in contrast volumes across physicians and lowering its use in higher-risk patients.

Objectives: We sought to compare 2 contrast-induced nephropathy (CIN) risk prediction models in a validation cohort using a consensus definition., Background: Contrast-induced nephropathy (CIN) is independently associated with mortality following percutaneous coronary intervention (PCI). Multiple prediction models for the development of CIN have been published using heterogeneous outcome definitions., Methods: We analyzed 5,540 patients who underwent PCI from January 2005 to June 2012 at a single academic medical center. The primary outcome was development of CIN, defined as an increase in serum creatinine of ≥0.5 mg/dl or a relative increase of ≥25% from baseline. Receiver operator characteristic (ROC) curves were used to evaluate the discriminatory power of Mehran and WBH prediction models., Results: The mean age of our cohort was 68 ± 12 years. The mean baseline creatinine was 1.2 ± 0.53 mg/dl (eGFR 73 ± 27 ml/min). The mean contrast volume used was 212 ± 92 ml. CIN occurred in 436 patients (7.9%). The Mehran risk score demonstrated better discrimination than the William Beaumont Hospital (WBH) risk score to predict the occurrence of CIN (c statistic: 0.82 vs. 0.73, respectively). Mortality at 30 days was approximately 8 times higher among patients with CIN as compared to those without (14.7% vs. 1.8% P < 0.01)., Conclusions: In an independent validation cohort, the Mehran risk model demonstrates greater discriminatory power than the WBH model in predicting the incidence of CIN. Mortality was significantly higher in patients who developed CIN after PCI., (© 2016, Wiley Periodicals, Inc.)

Purpose: To investigate the cause of imaging artifacts observed during gadoxetic acid-enhanced arterial phase imaging of the liver., Materials and Methods: This HIPAA-compliant study was approved by the institutional review board. Data were collected prospectively at two sites (site A, United States; site B, Japan) from patients undergoing contrast material-enhanced MR imaging with gadoxetic acid (site A, n = 154, dose = 0.05 mmol/kg; site B, n = 130, 0.025 mmol/kg) or gadobenate dimeglumine (only site A, n = 1666) from January 2014 to September 2014 at site A and from November 2014 to January 2015 at site B. Detailed comparisons between the two agents were made in the patients with dynamic liver acquisitions (n = 372) and age-, sex-, and baseline oxygen saturation (Spo2)-matched pairs (n = 130) at site A. Acquired data included self-reported dyspnea after contrast agent injection, Spo2, and breath-hold fidelity monitored with respiratory bellows., Results: Self-reported dyspnea was more frequent with gadoxetic acid than with gadobenate dimeglumine (site A, 6.5% [10 of 154] vs 0.1% [two of 1666], P < .001; site B, 1.5% [two of 130]). In the matched-pair comparison, gadoxetic acid, as compared with gadobenate dimeglumine, had higher breath-hold failure rates (site A, 34.6% [45 of 130] vs 11.7% [15 of 130], P < .0001; site B, 16.2% [21 of 130]) and more severe artifacts during arterial phase imaging (site A, 7.7% [10 of 130] vs 0% [none of 130], P < .001; site B, 2.3% [three of 130]). Severe imaging artifacts in patients who received gadoxetic acid were significantly associated with male sex (P = .023), body mass index (P = .021), and breath-hold failure (P < .001) but not with dyspnea or Spo2 decrease., Conclusion: Severe motion-related artifacts in the arterial phase of gadoxetic acid-enhanced liver MR imaging are associated with breath-hold failure but not with subjective feelings of dyspnea or a substantial decrease in blood Spo2. Subjective feelings of dyspnea are not necessarily associated with imaging artifacts. The phenomenon, albeit at a lower rate, was confirmed at a second site in Japan.

Objective: Acute kidney injury is a common complication associated with angiography and percutaneous coronary intervention (PCI). Increasing doses of contrast are associated with an increase in the likelihood of AKI. The objective of our study was to estimate projected reduction in the burden of AKI in association with varying degrees of contrast media dose reduction among patients undergoing PCI., Methods: We assessed the relationship between contrast volume to creatinine clearance among consecutive patients undergoing PCI in the state of Michigan between January 2010 and September 2013. Computational modeling was used to estimate the anticipated reduction in risk of AKI across varying degrees of reduction in contrast volume., Results: The risk of AKI was significantly and substantially increased in patients in whom the contrast dose exceeded 2.99 times the creatinine clearance. The benefit of contrast dose reduction was most evident in those at greater predicted risk of AKI. An across the board 30% reduction in contrast dose would be expected to prevent one-eighth of AKI cases, although clinical benefits could also be anticipated with smaller dose reductions., Conclusion: Our study provides estimates of reduction in AKI that could be achieved with contrast dose reduction in clinical practice. These data should help guide planning of clinical trials and the application of contrast-saving strategies to routine clinical practice.

Although subjective and objective benefits of high-fidelity simulation have been reported in medicine, there has been slow adoption in radiology. The purpose of our study was to identify the perceived barriers in the use of high-fidelity hands-on simulation for contrast reaction management training. An IRB exempt 32 questions online web survey was sent to 179 non-military radiology residency program directors listed in the Fellowship and Residency Electronic Interactive Database Access system (FREIDA). Survey questions included the type of contrast reaction management training, cost, time commitment of residents and faculty, and the reasons for not using simulation training. Responses from the survey were summarized as count (percentage), mean ± standard deviation (SD), or median (range). 84 (47%) of 179 programs responded, of which 88% offered CRM training. Most (72%) conducted the CRM training annually while only 4% conducted it more frequently. Didactic lecture was the most frequently used training modality (97%), followed by HFS (30%) and computer-based simulation (CBS) (19%); 5.5% used both HFS and CBS. Of the 51 programs that offer CRM training but do not use HFS, the most common reason reported was insufficient availability (41%). Other reported reasons included cost (33%), no access to simulation centers (33%), lack of trained faculty (27%) and time constraints (27%). Although high-fidelity hands-on simulation training is the best way to reproduce real-life contrast reaction scenarios, many institutions do not provide this training due to constraints such as cost, lack of access or insufficient availability of simulation labs, and lack of trained faculty. As a specialty, radiology needs to better address these barriers at both an institutional and national level., (Copyright © 2015 Mosby, Inc. All rights reserved.)

Introduction: Perflutren microbubble/microsphere ultrasound contrast agents have a black-box warning based on case reports of serious cardiopulmonary events. There have been several subsequent observational safety studies. Large spontaneous reporting databases may help detect/refine signals of rare adverse events that elude other data sources/study designs., Objective: The objective of this study was to supplement existing knowledge of the reported safety of perflutren using statistical analysis of spontaneous reports., Methods: We analyzed information from the US Food and Drug Administration Adverse Event Reporting System using a disproportionality analysis. Analysis of overall reporting for perflutren was supplemented by subset (age, indication) analysis. A signal of disproportionate reporting (SDR) was defined as EB05 >2., Results: Overall, 18/380 Preferred Terms and 1/83 Standardized Medical Queries had SDRs. Most were small (EB05 = 2-4). Back pain and flank pain were the largest SDRs followed by events compatible with signs/symptoms of hypersensitivity. The general pattern of SDRs in the subset analysis was consistent with the overall analysis. Almost all events with SDRs were literally or conceptually labeled. Except for chest pain (higher in the age <65 years subgroup) and back pain (higher in the age ≥65 years subgroup), there were no statistically significant differences between age subsets. Except for the Preferred Terms Pruritus and Urticaria and the narrow Standardized Medical Queries Ventricular tachyarrhythmia, Angioedema, Oropharyngeal allergic conditions, and Hypersensitivity (higher in the stress test subgroup), there were no statistically significant reporting differences between indication subsets. There were no SDRs associated with the major cardiovascular events of death, myocardial infarction/ischemia, angina, arrhythmias, or convulsions in any analysis., Conclusions: Our combined signal detection/evaluation analysis did not identify SDRs of novel adverse events or major cardiovascular events associated with perflutren ultrasound contrast agents. The negative results for major cardiovascular events extend previous signal evaluation exercises supporting the relative cardiovascular safety of these agents.

Background: Contrast-induced acute kidney injury (CI-AKI) is a potential complication of radio-contrast investigations. Many organisations have published guidance documents on the prevention of CI-AKI. Our aim is to explore the scope, content, consistency, practicality in clinical practice and reasons for eventual underlying discrepancies of these documents., Methods: We searched the literature for guidance documents developed to guide prevention of CI-AKI up to 09/2014. Four reviewers appraised guideline quality using the 23-item AGREE-II instrument, which rates reporting of the guidance development process across six domains: scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, applicability and editorial independence. Total scores were calculated as standardised averages by domain., Results: Twenty-four guidance documents were evaluated. The guidance documents were produced by radiologists (N = 7), intensivists (N = 2), nephrologists (N = 6) or multidisciplinary teams (N = 9). One document did not mention the background of the authors. Only guidance documents (N = 15) that were not mere adaptations of existing guidelines were evaluated more in depth, using the AGREE tool. Overall, quality was mixed: only one clinical practice guidance document obtained an average score of >50% for all domains. The evidence was rated in a systematic way in only 11, and only 7 graded the strength of the recommendations. The Kidney Diseases Improving Global Outcomes guideline was the only one recommended without adaptions by all assessors. The guidance documents agreed in recommending pre-hydration as the main preventive measure, but there was difference in recommended total volumes, composition, rate and duration of the infused solutions. There was no consensus on the use of NaHCO3, with eight recommending it, six considering it and one not. Five guidance documents mentioned oral pre-hydration as a possibility, and none recommended N-acetylcysteine as solitary preventive measure. More recent guidance documents recommend avoiding hypertonic contrast media, but did not recommend preference of iso-osmolar over low-osmolar contrast media. Most guidance documents recognised pre-existing chronic kidney disease, diabetes, age and cardiovascular comorbidity as risk factors., Conclusions: There seems to be a relative consensus on the need for adequate pre-hydration to avoid CI-AKI, but recommendations to define at-risk populations for whom these measures should be applied and how they should be implemented differ substantially. Based on accumulating evidence, more recent guidelines do not recommend iso-osmolar over low-osmolar contrast media, whereas all recommend avoiding hypertonic agents., (© The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.)

Background: β-Blockers are often used for heart rate control during coronary CT angiography (CTA). Increased frequency and severity of allergic reactions to radiocontrast media (RCM) have been reported with concomitant use of β-blockers., Objectives: The objectives of this study were to determine whether there is a higher incidence of allergic reactions to low-osmolar nonionic RCM in patients undergoing coronary CTA with concomitant β-blockers and to define the overall incidence and severity of allergic reactions in patients undergoing coronary CTA with and without a history of allergy to RCM., Methods: Patients undergoing coronary CTA at 47 institutions participating in the Advanced Cardiovascular Imaging Consortium registry were analyzed. The incidence and severity of allergic reactions were compared between those patients who did and those who did not receive β-blockers, as well as in subgroups of patients with and without a history of prior allergy to RCM., Results: The incidence of allergic reaction in patients who received β-blockers was 45 of 23,867 (0.19%) compared with those who did not receive β-blockers, which was 9 of 5232 (0.17%; P = .84; odds ratio = 1.1). Of the patients with history of allergy to RCM, 4 of 706 patients (0.6%) on β-blockers experienced allergic reactions compared to 1 of 77 patients (1.3%) without β-blockers (P = .40; odds ratio = 0.43)., Conclusions: β-Blocker pretreatment had no effect on the frequency or severity of allergic reaction in patients undergoing coronary CTA, even in patients with a past history of allergy to RCM., (Copyright © 2015 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

The emergence of an association between gadolinium-based contrast agents (GBCA) and the rare condition nephrogenic systemic fibrosis (NSF) led to a warning in 2006 from the Food and Drug Administration (FDA) restricting the use of the GBCAs to patients with an estimated glomerular filtration rate of >30 mL/min/1.73m(2) . We discuss our experience with a post-FDA restriction presentation of NSF and subsequent patient death in which the prolonged lead-time of ∼5.5 years led to challenges in ensuring a secure diagnosis of NSF and establishing risk exposures. Accurate contemporary records of contrast administration and clinical factors alongside clinical and pathological expertise ensured that we were able to confidently diagnose NSF, despite the length of lead time and confounding factors., (© 2014 Wiley Periodicals, Inc.)

Purpose: Establish 3 performance benchmarks for intravenous contrast extravasation during CT examinations: extravasation frequency, distribution of extravasation volumes, and severity of injury. Evaluate the effectiveness of implementing practice quality improvement (PQI) methodology in improving performance for these 3 benchmarks., Methods: The Society of Abdominal Radiology and ACR developed a registry collecting data for contrast extravasation events. The project includes a PQI initiative allowing for process improvement., Results: As of December 2013, a total of 58 radiology practices have participated in this project, and 32 practices have completed the 2-cycle PQI. There were a total of 454,497 contrast-enhanced CT exams and 1,085 extravasation events. The average extravasation rate is 0.24%. The median extravasation rate is 0.21%. Most extravasations (82.9%) were between 10 mL and 99 mL. The majority of injuries, 94.6%, are mild in severity, with 4.7% having moderate and 0.8% having severe injuries. Data from practices that completed the PQI process showed a change in the average extravasation rate from 0.28% in the first 6 months to 0.23% in the second 6 months, and the median extravasation rate dropped from 0.25% to 0.16%, neither statistically significant. The distribution of extravasation volumes and the severity of injury did not change between the first and second measurement periods., Conclusions: National performance benchmarks for contrast extravasation rate, distribution of volumes of extravasate, and distribution of severity of injury are established through this multi-institutional practice registry. The application of PQI failed to have a statistically significant positive impact on any of the 3 benchmarks., (Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Background: Anaphylaxis-related deaths in the United States have not been well characterized in recent years., Objectives: We sought to define epidemiologic features and time trends of fatal anaphylaxis in the United States from 1999 to 2010., Methods: Anaphylaxis-related deaths were identified by using the 10th clinical modification of the International Classification of Diseases system diagnostic codes on death certificates from the US National Mortality Database. Rates were calculated by using census population estimates., Results: There were a total of 2458 anaphylaxis-related deaths in the United States from 1999 to 2010. Medications were the most common cause (58.8%), followed by "unspecified" (19.3%), venom (15.2%), and food (6.7%). There was a significant increase in fatal drug-induced anaphylaxis over 12 years: from 0.27 (95% CI, 0.23-0.30) per million in 1999 to 2001 to 0.51 (95% CI, 0.47-0.56) per million in 2008 to 2010 (P < .001). Fatal anaphylaxis caused by medications, food, and unspecified allergens was significantly associated with African American race and older age (P < .001). Fatal anaphylaxis to venom was significantly associated with white race, older age, and male sex (P < .001). The rates of fatal anaphylaxis to foods in male African American subjects increased from 0.06 (95% CI, 0.01-0.17) per million in 1999 to 2001 to 0.21 (95% CI, 0.11-0.37) per million in 2008 to 2010 (P < .001). The rates of unspecified fatal anaphylaxis decreased over time from 0.30 (95% CI, 0.26-0.34) per million in 1999 to 2001 to 0.09 (95% CI, 0.07-0.11) per million in 2008 to 2010 (P < .001)., Conclusion: There are strong and disparate associations between race and specific classes of anaphylaxis-related mortality in the United States. The increase in medication-related deaths caused by anaphylaxis likely relates to increased medication and radiocontrast use, enhanced diagnosis, and coding changes., (Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)