Estelle C. Nijssen

Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy (AMACING): a prospective, randomised, phase 3, controlled, open-label, non-inferiority trial

BACKGROUND Intravenous saline is recommended in clinical practice guidelines as the cornerstone for preventing contrast-induced nephropathy in patients with compromised renal function. However, clinical-effectiveness and cost-effectiveness of this prophylactic hydration treatment in protecting renal function has not been adequately studied in the population targeted by the guidelines, against a group receiving no prophylaxis. This was the aim of the AMACING trial. METHODS AMACING is a prospective, randomised, phase 3, parallel-group, open-label, non-inferiority trial of patients at risk of contrast-induced nephropathy according to current guidelines. High-risk patients (with an estimated glomerular filtration rate [eGFR] of 30-59 mL per min/1·73 m2) aged 18 years and older, undergoing an elective procedure requiring iodinated contrast material administration at Maastricht University Medical Centre, the Netherlands, were randomly assigned (1:1) to receive intravenous 0·9% NaCl or no prophylaxis. We excluded patients with eGFR lower than 30 mL per min/1·73 m2, previous dialysis, or no referral for intravenous hydration. Randomisation was stratified by predefined risk factors. The primary outcome was incidence of contrast-induced nephropathy, defined as an increase in serum creatinine from baseline of more than 25% or 44 μmol/L within 2-6 days of contrast exposure, and cost-effectiveness of no prophylaxis compared with intravenous hydration in the prevention of contrast-induced nephropathy. We measured serum creatinine immediately before, 2-6 days, and 26-35 days after contrast-material exposure. Laboratory personnel were masked to treatment allocation. Adverse events and use of resources were systematically recorded. The non-inferiority margin was set at 2·1%. Both intention-to-treat and per-protocol analyses were done. This trial is registered with ClinicalTrials.gov, number NCT02106234. FINDINGS Between June 17, 2014, and July 17, 2016, 660 consecutive patients were randomly assigned to receive no prophylaxis (n=332) or intravenous hydration (n=328). 2-6 day serum creatinine was available for 307 (92%) of 332 patients in the no prophylaxis group and 296 (90%) of 328 patients in the intravenous hydration group. Contrast-induced nephropathy was recorded in eight (2·6%) of 307 non-hydrated patients and in eight (2·7%) of 296 hydrated patients. The absolute difference (no hydration vs hydration) was -0·10% (one-sided 95% CI -2·25 to 2·06; one-tailed p=0·4710). No hydration was cost-saving relative to hydration. No haemodialysis or related deaths occurred within 35 days. 18 (5·5%) of 328 patients had complications associated with intravenous hydration. INTERPRETATION We found no prophylaxis to be non-inferior and cost-saving in preventing contrast-induced nephropathy compared with intravenous hydration according to current clinical practice guidelines. FUNDING Stichting de Weijerhorst.

Intravascular enhancement with identical iodine delivery rate using different iodine contrast media in a circulation phantom.

PurposeBoth iodine delivery rate (IDR) and iodine concentration are decisive factors for vascular enhancement in computed tomographic angiography. It is unclear, however, whether the use of high–iodine concentration contrast media is beneficial to lower iodine concentrations when IDR is kept identical. This study evaluates the effect of using different iodine concentrations on intravascular attenuation in a circulation phantom while maintaining a constant IDR. Materials and MethodsA circulation phantom with a low-pressure venous compartment and a high-pressure arterial compartment simulating physiological circulation parameters was used (heart rate, 60 beats per minute; stroke volume, 60 mL; blood pressure, 120/80 mm Hg). Maintaining a constant IDR (2.0 g/s) and a constant total iodine load (20 g), prewarmed (37°C) contrast media with differing iodine concentrations (240–400 mg/mL) were injected into the phantom using a double-headed power injector. Serial computed tomographic scans at the level of the ascending aorta (AA), the descending aorta (DA), and the left main coronary artery (LM) were obtained. Total amount of contrast volume (milliliters), iodine delivery (grams of iodine), peak flow rate (milliliter per second), and intravascular pressure (pounds per square inch) were monitored using a dedicated data acquisition program. Attenuation values in the AA, the DA, and the LM were constantly measured (Hounsfield unit [HU]). In addition, time-enhancement curves, aortic peak enhancement, and time to peak were determined. ResultsAll contrast injection protocols resulted in similar attenuation values: the AA (516 [11] to 531 [37] HU), the DA (514 [17] to 531 [32] HU), and the LM (490 [10] to 507 [17] HU). No significant differences were found between the AA, the DA, and the LM for either peak enhancement (all P > 0.05) or mean time to peak (AA, 19.4 [0.58] to 20.1 [1.05] seconds; DA, 21.1 [1.0] to 21.4 [1.15] seconds; LM, 19.8 [0.58] to 20.1 [1.05] seconds). ConclusionsThis phantom study demonstrates that constant injection parameters (IDR, overall iodine load) lead to robust enhancement patterns, regardless of the contrast material used. Higher iodine concentration itself does not lead to higher attenuation levels. These results may stimulate a shift in paradigm toward clinical usage of contrast media with lower iodine concentrations (eg, 240 mg iodine/mL) in individual tailored contrast protocols. The use of low–iodine concentration contrast media is desirable because of the lower viscosity and the resulting lower injection pressure.

Coronary CT angiography using low concentrated contrast media injected with high flow rates: Feasible in clinical practice.

PURPOSE Aim of this study was to test the hypothesis that peak injection pressures and image quality using low concentrated contrast media (CM) (240 mg/mL) injected with high flow rates will be comparable to a standard injection protocol (CM: 300 mg/mL) in coronary computed tomographic angiography (CCTA). MATERIAL AND METHODS One hundred consecutive patients were scanned on a 2nd generation dual-source CT scanner. Group 1 (n=50) received prewarmed Iopromide 240 mg/mL at an injection rate of 9 mL/s, followed by a saline chaser. Group 2 (n=50) received the standard injection protocol: prewarmed Iopromide 300 mg/mL; flow rate: 7.2 mL/s. For both protocols, the iodine delivery rate (IDR, 2.16 gI/s) and the total iodine load (22.5 gI) were kept identical. Injection pressure (psi) was continuously monitored by a data acquisition program. Contrast enhancement was measured in the thoracic aorta and all proximal and distal coronary segments. Subjective and objective image quality was evaluated between both groups. RESULTS No significant differences in peak injection pressures were found between both CM groups (121 ± 5.6 psi vs. 120 ± 5.3 psi, p=0.54). Flow rates of 9 mL/s were safely injected without any complications. No significant differences in contrast-to-noise ratio, signal-to-noise ratio and subjective image quality were found (all p>0.05). No significant differences in attenuation levels were found in the thoracic aorta and all segments of the coronary arteries (all p>0.05). CONCLUSION Usage of low iodine concentration CM and injection with high flow rates is feasible. High flow rates (9 mL/s) of Iopromide 240 were safely injected without complications and should not be considered a drawback in clinical practice. No significant differences in peak pressure and image quality were found. This creates a doorway towards applicability of a broad variety in flow rates and IDRs and subsequently more individually tailored injection protocols.

Automated quantification of epicardial adipose tissue (EAT) in coronary CT angiography; comparison with manual assessment and correlation with coronary artery disease

BACKGROUND Epicardial adipose tissue (EAT) is emerging as a risk factor for coronary artery disease (CAD). OBJECTIVE The aim of this study was to determine the applicability and efficiency of automated EAT quantification. METHODS EAT volume was assessed both manually and automatically in 157 patients undergoing coronary CT angiography. Manual assessment consisted of a short-axis-based manual measurement, whereas automated assessment on both contrast and non-contrast-enhanced data sets was achieved through novel prototype software. Duration of both quantification methods was recorded, and EAT volumes were compared with paired samples t test. Correlation of volumes was determined with intraclass correlation coefficient; agreement was tested with Bland-Altman analysis. The association between EAT and CAD was estimated with logistic regression. RESULTS Automated quantification was significantly less time consuming than automated quantification (17 ± 2 seconds vs 280 ± 78 seconds; P < .0001). Although manual EAT volume differed significantly from automated EAT volume (75 ± 33 cm(³) vs 95 ± 45 cm(³); P < .001), a good correlation between both assessments was found (r = 0.76; P < .001). For all methods, EAT volume was positively associated with the presence of CAD. Stronger predictive value for the severity of CAD was achieved through automated quantification on both contrast-enhanced and non-contrast-enhanced data sets. CONCLUSION Automated EAT quantification is a quick method to estimate EAT and may serve as a predictor for CAD presence and severity.

Feasibility of low contrast media volume in CT angiography of the aorta.

Objectives Using smaller volumes of contrast media (CM) in CT angiography (CTA) is desirable in terms of cost reduction and prevention of contrast-induced nephropathy (CIN). The purpose was to evaluate the feasibility of low CM volume in CTA of the aorta. Methods 77 patients referred for CTA of the aorta were scanned using a standard MDCT protocol at 100 kV. A bolus of 50 ml CM (Iopromide 300 mg Iodine/ml) at a flow rate of 6 ml/s was applied (Iodine delivery rate IDR = 1.8 g/s; Iodine load 15 g) followed by a saline bolus of 40 ml at the same flow rate. Scan delay was determined by the test bolus method. Subjective image quality was assessed and contrast enhancement was measured at 10 anatomical levels of the aorta. Results Diagnostic quality images were obtained for all patients, reaching a mean overall contrast enhancement of 324 ± 28 HU. Mean attenuation was 350 ± 60 HU at the thoracic aorta and 315 ± 83 HU at the abdominal aorta. Conclusions A straightforward low volume CM protocol proved to be technically feasible and led to CTA examinations reaching diagnostic image quality of the aorta at 100 kV. Based on these findings, the use of a relatively small CM bolus can be incorporated into routine clinical imaging.

Contrast material-induced nephropathy in the era of hydration.

978 radiology.rsna.org Radiology: Volume 265: Number 3—December 2012 CIN is associated with long-term risk, although the quality and number of studies is limited (3). We agree that hydration is not without risk, although our patients responded promptly to intravenous diuretics. Still, we would welcome carefully conducted trials that evaluate the benefits, risks, and cost-effectiveness of hydration. While waiting for such studies, we suggest that patients be treated according to current guidelines, thus including hydration for high-risk patients. These guidelines were created after weighing the available evidence. It certainly is plausible to deliberately deviate from these guidelines. In such a case, we suggest that high-risk patients be carefully assessed for the development of CIN, thus allowing evaluation of the given care. Our data can be used as a comparator for such prospective data collections.

Contrast Enhancement of the Right Ventricle during Coronary CT Angiography--Is It Necessary?

Purpose It is unclear if prolonged contrast media injection, to improve right ventricular visualization during coronary CT angiography, leads to increased detection of right ventricle pathology. The purpose of this study was to evaluate right ventricle enhancement and subsequent detection of right ventricle disease during coronary CT angiography. Materials and Methods 472 consecutive patients referred for screening coronary CT angiography were retrospectively evaluated. Every patient underwent multidetector-row CT of the coronary arteries: 128x 0.6mm coll., 100-120kV, rot. time 0.28s, ref. mAs 350 and received an individualized (P3T) contrast bolus injection of iodinated contrast medium (300 mgI/ml). Patient data were analyzed to assess right ventricle enhancement (HU) and right ventricle pathology. Image quality was defined good when right ventricle enhancement >200HU, moderate when 140-200HU and poor when <140HU. Results Good image quality was found in 372 patients, moderate in 80 patients and poor in 20 patients. Mean enhancement of the right ventricle cavity was 268HU±102. Patients received an average bolus of 108±24 ml at an average peak flow rate of 6.1±2.2 ml/s. In only three out of 472 patients (0.63%) pathology of the right ventricle was found (dilatation) No other right ventricle pathology was detected. Conclusion Right ventricle pathology was detected in three out of 472 patients; the dilatation observed in these three cases may have been picked up even without dedicated enhancement of the right ventricle. Based on our findings, right ventricle enhancement can be omitted during screening coronary CT angiography.

Intravenous hydration according to current guidelines in the prevention of contrast induced nephropathy—the AMACING trial

We thank Vikram Raje and Akira Sato and colleagues for their interest in our work. To put the AMACING trial into perspective, the guideline on contrast induced nephropathy (CIN) is one of ten measures to increase patient safety in the Netherlands. Since their introduction and to date, the ten measures have been imposed on hospitals quite strictly, and compliance to these is part of the annual hospital quality assessment carried out by government instances. However, the intravenous hydration to prevent CIN was introduced without its effect having been proven, and its implementation incurs risk of clinical complications as well as increased health care costs.

Assessing the Risk of Contrast-Induced Nephropathy Using a Finger Stick Analysis in Recalls from Breast Screening: The CINFIBS Explorative Study

Purpose To evaluate whether a handheld point-of-care (POC) device is able to predict and discriminate patients at potential risk of contrast-induced nephropathy (CIN) prior to iodine-based contrast media delivery. Methods and Materials Between December 2014 and June 2016, women undergoing contrast-enhanced spectral mammography (CESM) with an iodine-based contrast agent were asked to have their risk of CIN assessed by a dedicated POC device (StatSensor CREAT) and a risk factor questionnaire based on national guidelines. Prior to contrast injection, a venous blood sample was drawn to compare the results of POC with regular laboratory testing. Results A total of 351 patients were included; 344 were finally categorized as low risk patients by blood creatinine evaluation. Seven patients had a eGFR below 60 ml/min/1.73 m2, necessitating additional preparation prior to contrast delivery. The POC device failed to categorize six out of seven patients (86%), leading to (at that stage) unwanted contrast administration. Two patients subsequently developed CIN after 2–5 days, which was self-limiting after 30 days. Conclusion The POC device tested was not able to reliably assess impairment of renal function in our patient cohort undergoing CESM. Consequently, we still consider classic clinical laboratory testing preferable in patients at potential risk for developing CIN.