Prophylactic Intravenous Hydration to Protect Renal Function From Intravascular Iodinated Contrast Material (AMACING): Long-term Results of a Prospective, Randomised, Controlled TrialResearch in context

Background: The aim of A MAastricht Contrast-Induced Nephropathy Guideline (AMACING) trial was to evaluate non-inferiority of no prophylaxis compared to guideline-recommended prophylaxis in preventing contrast induced nephropathy (CIN), and to explore the effect on long-term post-contrast adverse outcomes. The current paper presents the long-term results. Methods: AMACING is a single-centre, randomised, parallel-group, open-label, phase 3, non-inferiority trial in patients with estimated glomerular filtration rate [eGFR] 30–59 mL/min/1.73 m2 combined with risk factors, undergoing elective procedures requiring intravenous or intra-arterial iodinated contrast material. Exclusion criteria were eGFR <30 mL/min/1.73 m2, dialysis, no referral for prophylaxis. The outcomes dialysis, mortality, and change in renal function at 1 year post-contrast were secondary outcomes of the trial. Subgroup analyses were performed based on pre-defined stratification risk factors. AMACING is registered with ClinicalTrials.gov: NCT02106234. Findings: From 28,803 referrals, 1120 at-risk patients were identified. 660 consecutive patients agreed to participate and were randomly assigned (1:1) to no prophylaxis (n = 332) or standard prophylactic intravenous hydration (n = 328). Dialysis and mortality data were available for all patients. At 365 days post-contrast dialysis was recorded in two no prophylaxis (2/332, 0.60%), and two prophylaxis patients (2/328, 0.61%; p = 0.9909); mortality was recorded for 36/332 (10.84%) no prophylaxis, and 32/328 (9.76%) prophylaxis patients (p = 0.6490). The hazard ratio was 1.118 (no prophylaxis vs prophylaxis) for one-year risk of death (95% CI: 0.695 to 1.801, p = 0.6449). The differences in long-term changes in serum creatinine were small between groups, and gave no indication of a disadvantage for the no-prophylaxis group. Interpretation: Assuming optimal contrast administration, not giving prophylaxis to elective patients with eGFR 30–59 mL/min/1.73 m2 is safe, even in the long-term. Funding: Stichting de Weijerhorst. Keywords: Contrast-induced nephropathy, Contrast-associated acute kidney injury, Prophylactic intravenous hydration, Intravascular iodinated contrast administration, Clinical practice guideline

Evaluation of Safety Guidelines on the Use of Iodinated Contrast Material Conundrum Continued

Objectives: Recently, safety guidelines for the use of intravascular iodinated contrast material have been updated, and the recommended threshold for giving prophylaxis to prevent contrast-induced nephropathy (CIN) has been reduced to estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m(2). Data on this population in the context of CIN, especially evidence for efficacy of the recommendation of prophylactic intravenous hydration, are lacking. The aim of the current study was to test implicit assumptions underlying the guideline update: (1) patients with eGFR &lt;30 mL/min/1.73 m(2), as opposed to former high-risk patients with eGFR &gt;= 30 mL/min/1.73 m(2), are at high risk of CIN and other unfavorable outcomes after intravascular iodinated contrast material administration; (2) prophylactic intravenous hydration mitigates this risk; and (3) the risk of administering prophylactic intravenous hydration does not outweigh the positive preventive effect. Materials and Methods: Retrospectively, data were collected from all patients with eGFR &lt;30 mL/min/1.73 m(2) referred for an elective procedure with intravascular iodinated contrast material administration and excluded from the AMACING trial (A MAastricht Contrast-Induced Nephropathy Guideline trial). We compared these patients with those prospectively included in the AMACING trial (with eGFR 30-59 mL/min/1.73 m(2) and risk factors). Main outcomes were CIN (defined as an increase in serum creatinine by more than 25% or 44 mu mol/L within 2-6 days postcontrast exposure), dialysis and mortality within 35 days postcontrast exposure, and complications of prophylactic intravenous hydration. Results: A total of 28,803 patients referred for an elective procedure with intravascular iodinated contrast administration were prospectively screened for inclusion in the AMACING trial. One hundred fifty-seven (0.5%) patients had eGFR &lt;30 mL/min/1.73 m(2), and 155 received intravascular iodinated contrast material. Standard prophylaxis was given to 119/155 of these patients. Data on 2- to 6-day serum creatinine, 35-day dialysis 35-day mortality, and complications of prophylactic intravenous hydration were available for 59/119 (50%), 118/119 (99%), 119/119 (100%), and 119/119 (100%) standard prophylaxis patients, respectively. Incidences in eGFR &lt;30 mL/min/1.73 m(2) versus AMACING patients are as follows: CIN 13.6% versus 2.7% (P = 0.0019); 35-day dialysis 0.9% versus 0.0% (P = 0.2646); 35-day mortality 9.2% versus 0.0% (P &lt; 0.0001); complications of prophylactic intravenous hydration 5.9% versus 5.5% (P = 0.8529). Conclusions: Postcontrast incidences of CIN and mortality at 35 days are significantly higher in the population with eGFR &lt;30 mL/min/1.73 m(2) than in the former high-risk population with eGFR 30 to 59 mL/min/1.73 m(2), even after prophylactic intravenous hydration. The risk of complications of prophylactic intravenous hydration is similar and substantial in both populations. Obtaining evidence from a randomized trial that efficacy of prophylactic intravenous hydration outweighs the risk of complications is important but may not be feasible

Individualized Scan Protocols in Abdominal Computed Tomography:Radiation Versus Contrast Media Dose Optimization

BACKGROUND: In contrast-enhanced abdominal computed tomography (CT), radiation and contrast media (CM) injection protocols are closely linked to each other, and therefore a combination is the basis for achieving optimal image quality. However, most studies focus on optimizing one or the other parameter separately. PURPOSE: Reducing radiation dose may be most important for a young patient or a population in need of repetitive scanning, whereas CM reduction might be key in a population with insufficient renal function. The recently introduced technical solution, in the form of an automated tube voltage selection (ATVS) slider, might be helpful in this respect. The aim of the current study was to systematically evaluate feasibility of optimizing either radiation or CM dose in abdominal imaging compared with a combined approach. METHODS: Six Göttingen minipigs (mean weight, 38.9 ± 4.8 kg) were scanned on a third-generation dual-source CT. Automated tube voltage selection and automated tube current modulation techniques were used, with quality reference values of 120 kVref and 210 mAsref. Automated tube voltage selection was set at 90 kV semimode. Three different abdominal scan and CM protocols were compared intraindividually: (1) the standard "combined" protocol, with the ATVS slider position set at 7 and a body weight-adapted CM injection protocol of 350 mg I/kg body weight, iodine delivery rate (IDR) of 1.1 g I/s; (2) the CM dose-saving protocol, with the ATVS slider set at 3 and CM dose lowered to 294 mg I/kg, resulting in a lower IDR of 0.9 g I/s; (3) the radiation dose-saving protocol, with the ATVS slider position set at 11 and a CM dose of 441 mg I/kg and an IDR 1.3 g I/s, respectively. Scans were performed with each protocol in arterial, portal venous, and delayed phase. Objective image quality was evaluated by measuring the attenuation in Hounsfield units, signal-to-noise ratio, and contrast-to-noise ratio of the liver parenchyma. The overall image quality, contrast quality, noise, and lesion detection capability were rated on a 5-point Likert scale (1 = excellent, 5 = very poor). Protocols were compared for objective image quality parameters using 1-way analysis of variance and for subjective image quality parameters using Friedman test. RESULTS: The mean radiation doses were 5.2 ± 1.7 mGy for the standard protocol, 7.1 ± 2.0 mGy for the CM dose-saving protocol, and 3.8 ± 0.4 mGy for the radiation dose-saving protocol. The mean total iodine load in these groups was 13.7 ± 1.7, 11.4 ± 1.4, and 17.2 ± 2.1 g, respectively. No significant differences in subjective overall image or contrast quality were found. Signal-to-noise ratio and contrast-to-noise ratio were not significantly different between protocols in any scan phase. Significantly more noise was seen when using the radiation dose-saving protocol (P < 0.01). In portal venous and delayed phases, the mean attenuation of the liver parenchyma significantly differed between protocols (P < 0.001). Lesion detection was significantly better in portal venous phase using the CM dose-saving protocol compared with the radiation dose-saving protocol (P = 0.037). CONCLUSIONS: In this experimental setup, optimizing either radiation (-26%) or CM dose (-16%) is feasible in abdominal CT imaging. Individualizing either radiation or CM dose leads to comparable objective and subjective image quality. Personalized abdominal CT examination protocols can thus be tailored to individual risk assessment and might offer additional degrees of freedom

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

A New Algorithm for Automatically Calculating Noise, Spatial Resolution, and Contrast Image Quality Metrics:Proof-of-Concept and Agreement With Subjective Scores in Phantom and Clinical Abdominal CT

OBJECTIVES: The aims of this study were to develop a proof-of-concept computer algorithm to automatically determine noise, spatial resolution, and contrast-related image quality (IQ) metrics in abdominal portal venous phase computed tomography (CT) imaging and to assess agreement between resulting objective IQ metrics and subjective radiologist IQ ratings.MATERIALS AND METHODS: An algorithm was developed to calculate noise, spatial resolution, and contrast IQ parameters. The algorithm was subsequently used on 2 datasets of anthropomorphic phantom CT scans, acquired on 2 different scanners (n = 57 each), and on 1 dataset of patient abdominal CT scans (n = 510). These datasets include a range of high to low IQ: in the phantom dataset, this was achieved through varying scanner settings (tube voltage, tube current, reconstruction algorithm); in the patient dataset, lower IQ images were obtained by reconstructing 30 consecutive portal venous phase scans as if they had been acquired at lower mAs. Five noise, 1 spatial, and 13 contrast parameters were computed for the phantom datasets; for the patient dataset, 5 noise, 1 spatial, and 18 contrast parameters were computed. Subjective IQ rating was done using a 5-point Likert scale: 2 radiologists rated a single phantom dataset each, and another 2 radiologists rated the patient dataset in consensus. General agreement between IQ metrics and subjective IQ scores was assessed using Pearson correlation analysis. Likert scores were grouped into 2 categories, "insufficient" (scores 1-2) and "sufficient" (scores 3-5), and differences in computed IQ metrics between these categories were assessed using the Mann-Whitney U test.RESULTS: The algorithm was able to automatically calculate all IQ metrics for 100% of the included scans. Significant correlations with subjective radiologist ratings were found for 4 of 5 noise (R2 range = 0.55-0.70), 1 of 1 spatial resolution (R2 = 0.21 and 0.26), and 10 of 13 contrast (R2 range = 0.11-0.73) parameters in the phantom datasets and for 4 of 5 noise (R2 range = 0.019-0.096), 1 of 1 spatial resolution (R2 = 0.11), and 16 of 18 contrast (R2 range = 0.008-0.116) parameters in the patient dataset. Computed metrics that significantly differed between "insufficient" and "sufficient" categories were 4 of 5 noise, 1 of 1 spatial resolution, 9 and 10 of 13 contrast parameters for phantom the datasets and 3 of 5 noise, 1 of 1 spatial resolution, and 10 of 18 contrast parameters for the patient dataset.CONCLUSION: The developed algorithm was able to successfully calculate objective noise, spatial resolution, and contrast IQ metrics of both phantom and clinical abdominal CT scans. Furthermore, multiple calculated IQ metrics of all 3 categories were in agreement with subjective radiologist IQ ratings and significantly differed between "insufficient" and "sufficient" IQ scans. These results demonstrate the feasibility and potential of algorithm-determined objective IQ. Such an algorithm should be applicable to any scan and may help in optimization and quality control through automatic IQ assessment in daily clinical practice.</p

Retrospectively ECG-gated helical vs. non-ECG-synchronized high-pitch CTA of the aortic root for TAVI planning

BACKGROUND:Multidetector computed tomography (MDCT) plays a key role in patient assessment prior to transcatheter aortic valve implantation (TAVI). However, to date no consensus has been established on what is the optimal pre-procedural imaging protocol. Variability in pre-TAVI acquisition protocols may lead to discrepancies in aortic annulus measurements and may potentially influence prosthesis size selection. PURPOSE:The current study evaluates the magnitude of differences in aortic annulus measurements using max-systolic, end-diastolic, and non-ECG-synchronized imaging, as well as the impact of method on prosthesis size selection. MATERIAL AND METHODS:Fifty consecutive TAVI-candidates, who underwent retrospectively-ECG-gated CT angiography (CTA) of the aortic root, directly followed by non-ECG-synchronized high-pitch CT of the entire aorta, were retrospectively included. Aortic root dimensions were assessed at each 10% increment of the R-R interval (0-100%) and on the non-ECG-synchronized scan. Dimensional changes within the cardiac cycle were evaluated using a 1-way repeated ANOVA. Agreement in measurements between max-systole, end-diastole and non-ECG-synchronized scans was assessed with Bland-Altman analysis. RESULTS:Maximal dimensions of the aortic root structures and minimum annulus-coronary ostia distances were measured during systole. Max-systolic measurements were significantly and substantially larger than end-diastolic (p<0.001) and non-ECG-synchronized measurements (p<0.001). Due to these discrepancies, the three methods resulted in the same prosthesis size selection in only 48-62% of patients. CONCLUSIONS:The systematic differences between max-systolic, end-diastolic and non-ECG-synchronized measurements for relevant aortic annular dimensions are both statistically significant and clinically relevant. Imaging strategy impacts prosthesis size selection in nearly half the TAVI-candidates. End-diastolic and non-ECG-synchronized imaging does not provide optimal information for prosthesis size selection. Systolic image acquisition is necessary for assessment of maximal annular dimensions and minimum annulus-coronary ostia distances

A clinician’s guide to understanding aortic 4D flow MRI

Abstract Four-dimensional flow magnetic resonance imaging is an emerging technique which may play a role in diagnosis and risk-stratification of aortic disease. Some knowledge of flow dynamics and related parameters is necessary to understand and apply this technique in clinical workflows. The purpose of the current review is to provide a guide for clinicians to the basics of flow imaging, frequently used flow-related parameters, and their relevance in the context of aortic disease. Clinical relevance statement Understanding normal and abnormal aortic flow could improve clinical care in patients with aortic disease. Graphical abstrac