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Is Beta-blockade necessary to obtain diagnostic image quality at low radiation dose of coronary CT angiography using a 2nd generation 320-row scanner? Poster No.: 421 Congress: ESCR 2014 Type: Scientific Poster Authors: O. Ghekiere , J. Djekic , M. El Hachemi , D. Hansen , A.-S. 1 1 3 1 2 2 1 1 Vanhoenacker , P. Dendale , A. Nchimi Longang ; Liège/BE, 2 3 Hasselt/BE, Aalst/BE Keywords: Quality assurance, Radiation safety, CT-Angiography, Radioprotection / Radiation dose, Cardiac Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. www.escr.org Page 1 of 22 Purpose Coronary computed tomographic angiography (CCTA) is a noninvasive imaging tool for evaluation of the coronary arteries, with high sensitivity and high negative predictive value to exclude significant coronary artery disease (1). In the early days, effective radiation doses of up to 21 mSv have been reported for CCTA (2). Despite the recent advent of multidetector technologies allowing a better image quality and lower radiation doses, heart rate control by beta-blockers has remained key for improved cardiac image quality and radiation dose (3-5). Nevertheless, beta-blockers are not harmless and can't be administered to all patients. Moreover, 20 to 30% of patients do not achieve the target heart rate with preparation of beta-blockers (6-8). nd More recently, the 2 generation 320-detector row CT scanner with a gantry rotation time of 275 msec and volume coverage up to 16 cm allows excellent image quality while reducing the radiation dose over a wide range of body sizes and heart rates (9,10). Given these recent advances, we aim to investigate if beta-blocker administration for nd CCTA using a 2 generation 320-detector rows CT scanner is required for diagnostic image quality and low radiation dose. Methods and Materials 1. Patients and study design are described in table 1 Study design Prospective Ethics Committee Approved Written informed consent All patients Inclusion criteria CCTA referral Exclusion criteria - < 18 years - Contraindications to X-ray exposure, Allergy to iodinated contrast agents Page 2 of 22 - Mild to severe renal insufficiency (creatinine clearance < 60ml/min/1.73m² body surface area) Inclusion period June - July 2013 Table 1: Study design and cohort 2. Coronary CT acquisition protocol and image processing. nd All patients underwent the same imaging protocol using a 2 generation CT scanner (Aquilion ONE ViSION Edition; Toshiba Medical Systems, Otawara, Japan) equipped with 320 rows and a gantry rotation time of 275 ms. The protocol included a coronary calcium score scan (120kVp; 300mA; 3 mm slice thickness) and contrast-enhanced CCTA using the parameters described in table 2. Scanner Aquilion ONE ViSION Edition; Toshiba Medical Systems, Otawara, Japan N° of rows 320 Maximum gantry rotation time 275 ms Detector configuration; single step z-axis coverage 320 x 0.5 mm; 160 mm Scanning mode Axial, ECG-Triggered, N° of rotation depending on the heartrate · 1 rotation HR < 75 bpm · 2 rotations 75 bpm < HR < 100 bpm Arrhythmia detection Patient preparation 0.4 mg of sublingual nitroglycerine 2 min before scanning Tube voltage/current Automatic based on scout views SURE ( exposure3D, Toshiba Medical Systems). Contrast injection protocol • Dual injection of 100% Iomeron 400 (Bracco Diagnostics, Milan, Italy; 400 mg of iodine/ml) for 9s (+ 1s Page 3 of 22 • for every supplementary tube rotation) + 30 ml saline Injection rate adapted to the automatically set tube voltage/ current: - 3.5 ml/sec for 80 kVp protocol - 4 ml/sec for 100 kVp and < 450 mA - 5 ml/sec for 100 kVp and > 450 mA - 6 ml/sec for 120 kVp protocol. Scan triggering Automated bolus tracking Slice thickness/increments 0.5/0.25 mm Image reconstruction matrix 512² Reconstruction, algorithms and kernel Asymmetric cone beam reconstruction AIDR3D (Toshiba Medical Systems) Kernel FC03 (Standard) Best diastolic phase ± increments of 3%, in case of movements, depending on the heartrate. Table 2: Imaging consisted of calcium scoring and CCTA protocols. 3. Analysis of image quality Images were evaluated by 2 independent experienced readers on a dedicated workstation equipped with software enabling automatic centerline determination of each of the coronary segments. The window level and width levels were set to 300 and 800 respectively. They evaluated independently motion-related image quality on longitudinal and orthogonal reconstructions for all coronary segments # 1.5 mm in diameter according to the American Heart Association segmentation (S1-S15) by using a four-point Likert scale (Table 3). Grade 1 no artifact 2 minor, mild artifact 3 moderate artifact but still interpretable 4 Severe artifacts rendering interpretation not possible diagnostic Page 4 of 22 Table 3: 4-point Likert scale for motion-related image quality Consensus readings were performed to resolve all discordant inclusion criteria and segment location. Image noise was evaluated by assessing the noise levels in the ascending aorta and the endobronchial air (Hounsfield unit and standard deviation). Signal to noise ratio (SNR) is defined as the ratio between the mean attenuation and the standard deviation in the ascending aorta. 4. Statistical analysis All patient and examination data were stored in excel sheet. Interobserver agreement for image quality was calculated using Cohen's # test by using the following scale: # values of less than 0.20 are indicative of poor agreement; 0.21-0.40, fair agreement; 041-0.60, moderate agreement; 0.61-0.80, good agreement; 0.81-1.00, excellent agreement. The student t test was used to compare continuous variables, and chi-square test was used to compare nonparametric variables. A p-value of less than 0.05 is considered to express a statistically significant. To identify the predictors of the radiation dose (mSv), a linear regression model was used with continuous variable mSv as outcome and the following variables as potential predictors: age, beta-blocker administration, the number of heart beats, presence of arrhythmia, scanning length, Agatston calcification score, heart rate, BMI and SNR. A general linear model was fitted with a backwards model selection. The model assumptions of normality, constant variance and linearity were checked. For identifying the factors with impact on image quality, the following potential risk factors are investigated using a generalized linear mixed model (GLMM): diameter of the vessel, the age of the patient, use of beta-blockers, the number of heart beats (1, 2 or 3), arrhythmia, scan length, Agatston calcification score, SNR, heart rate, radiation dose and BMI. The original outcome for the mean quality of the two readers is a multinomial variable with an ordinal scale (grade 1, 1.5, 2 and 3). Results 208 consecutive and unselected patients were eligible. 8 were not included because of refusal (n =3), coronary bypass surgery (n = 3), and calcium channel blockade administration (n = 2). The remaining 200 patients (mean age 60±12, range 20-86 years; Page 5 of 22 92 females) were enrolled in this prospective study (Flowchart, figure 1); their clinical characteristics and cardiovascular risk factors are given in table 1, and in figures 2 and 3. 47 patients were receiving an oral beta-blocker as part of baseline medication, and 56 patients were prepared by receiving 5mg of Bisoprolol both the evening before and the morning of the examination (Emconcor mitis, Merck, Overijse, Belgium) and/ or intravenous bolus administration of 5 to15mg of metoprolol (Seloken, AstraZeneca, Brussels, Belgium) at the time of imaging. Therefore, a total number of 103 patients had beta-blockade administration and 97 patients had no beta-blockade prior to CCTA. Comparaison between the group with beta-blockade administration and the group without beta-blockade No significant difference (p>0,05) was observed between the two groups of patients regarding the BMI, the age of the patient, the radiation dose (mSv), the scan length, coronary stenting, Agatston coronary calcification score and the SNR, although the mean HR tended to be higher in the group without beta-blocker administration (63.1 versus 59.77 bpm) (p =0.05) (Table 2). This result may be regarded as a selection bias in our study population with only beta-blockade preparation in patients with high baseline HR. Conversely, it may be regarded as a failure of beta-blockade to control HR, as reported in other studies (7,8). The scanning conditions and parameters in the two groups were also quite similar (Table 3). Radiation dose The median DLP of all CCTA examinations was 105.3 ± 96.1 (range: 10.6-627.1) mGy.cm. Using a (k = 0,014) CT organ-specific effective dose index, the median radiation dose was 1.47± 1.35 (range: 0.15-8.78 mSv). Overall, the radiation dose was # 1 mSv in 98 (49 %) patients, and more than 4 mSv in 11 (5.5%) patients, including 6 with arrhythmia (Figure 4), one with (BMI>35) (Figure 5) and 4 with both overweight (BMI>25) and 2heartbeat scan. Image quality 695 of the 3200 coronary segments were absent or < 1.5 mm diameter, the image quality of the remaining 2505 (78.3%) was graded 1 or 2 in 2500 (99.8%) segments. The agreement between the two readers was good (#=0.61). 5 segments were scored "3" by both readers (Figure 6). Page 6 of 22 The image quality score was not significantly impacted by beta-blockade administration (p = 0.27). Identifying the predictors for the radiation dose (mSv) of CCTA The distribution of the effective radiation dose (mSv) is skewed (Figure 7). The adjusted coefficient of determination R²adjusted is 0.6448. There was a significant impact of the number of heart beats, patient age, BMI, arrhythmia, scan length and the Agatston calcification score on the effective radiation dose (p < 0.001), while the use of betablockers, HR and the SNR had no significant impact (Table 4). Identifying the risk factors that are associated with image quality (mean quality of the two readers) A greater caliber and a higher SNR have a positive effect on the image quality, while the age of the patient, a higher Agatston calcification score, and a higher HR have a negative effect (Table 5). Cut-off values for heart rate To determine a HR cut-off value for good to excellent image quality (mean image quality grade 1 or 1.5 of the two readers), a population-averaged cumulative probability with p=0.90 and p=0.95 is calculated. For patients with median values of the variables Age (61 years), Caliber (2.8 mm), Calcification Agatston score (75) and SNR (21.91), HR cutoff values with 90% and 95% probability for good to excellent image quality were 73 and 60 bpm respectively (Figure 7). This curve has a quadratic fit and the probability for good image quality seems to decrease rapidly above a HR of 80 bpm. HR cut-off values for good to excellent image quality are also measured for different scenarios using the minimal and maximum values of age, coronary artery caliber, Calcification Agatston score and SNR (Table 6). This confirms the impact of these parameters on the HR cut-offs for mean image quality grade 1 or 1.5. Images for this section: Page 7 of 22 Fig. 1: Flowchart Page 8 of 22 Table 1: Patients demographics and cardiovascular risk factors Page 9 of 22 Fig. 2: Distribution of the Body Mass Index (BMI) (n=200 patients) Page 10 of 22 Fig. 3: Heart rate during acquisition (n=200 patients) Page 11 of 22 Table 2: Comparaison of patients demographics and cardiovascular risk factors between both groups of patients with regard to the use of beta-blockers Page 12 of 22 Table 3: CCTA parameters with regard to the use of beta-blockers Page 13 of 22 Table 4: Risk factors associated with radiation dose Page 14 of 22 Table 5: Risk factors associated with image quality Page 15 of 22 Fig. 4 Page 16 of 22 Fig. 5 Page 17 of 22 Fig. 6 Page 18 of 22 Fig. 7 Page 19 of 22 Table 6: HR cut-off values of 90 and 95% probability for image quality grade 1 or 1.5 according to scenarios combining the minimal and maximum values of age, coronary artery caliber, calcification Agatston score and SNR Page 20 of 22 Conclusion In our study, the use of beta-blockers did not result into a significant difference in HR. Although HR remains a key determinant for image quality, it does not affect the effective nd radiation dose when using a 2 generation 320-row scanner. Furthermore, HR cutoff with a 90% probability for good to excellent image quality in an "average" patient is sufficiently high (73 bpm) to obviate the need for HR control in most subjects, even though this cut-off may vary on a per-patient basis according to other parameters such as the calcification score, age, SNR and the caliber of the coronary arteries. References 1. Budoff MJ, Dowe D, Jollis JG, et al. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of individuals undergoing invasive coronary angiography) trial. J Am Coll Cardiol. 2008;52:1724-32. 2. Mollet NR, Cademartiri F, van Mieghem CA, et al. High-resolution spiral computed tomography coronary angiography in patients reffered for diagnostic conventional coronary angiography. Circulation 2005;112:2318-23. 3. Cademartiri F, Maffei E, Arcadi T, et al. CT coronary angiography at an ultra-low radiation dose (<0.1 mSv): feasible and viable in times of constraint on healthcare costs. Eur Radiol 2013;23:607-13. 4. Maffei E, Palumbo AA, Martini C et al. "In-house"pharmacological management for computed tomography coronary angiography: heart rate reduction, timing and safety of different drugs used during patient preparation. Eur Radiol 2009 19:2931-40. 5. Schuhbaeck A, Achenbach S, Layritz C, et al. Image quality of ultra-low radiation exposure coronary CT angiography with an effective dose <0.1mSv using highpitch spiral acquisition and raw data-based iterative reconstruction. Eur Radiol 2013;23:597-606. 6. Khan M, Cummings KW, Gutierrez FR, et al. Contraindications and side effects of commonly used medicatins in coronary CT angiography. Int J Cardiovasc Imaging 2010;27:441-9. Page 21 of 22 7. de Graaf FR, Schuijf JD, van Velzen JE et al. Evaluation of contraindications and efficacy of oral beta blockade before computed tomographic coronary angiography. Am J Cardiol 2010;105:767-72 8. Sun G, Li M, Li L et al. Optimal systolic and diastolic reconstruction windows for coronary CT angiography using 320-detector rows dynamic volume CT. Clin Radiol 2011; 66:614-620 9. MY Chen, SM Shanbhag, AE Arai. Submillisievert Median Radiation Dose for coronary angiography with a second-generation 320-detector row CT scanner in 107 consecutive patients. Radiology 2013;267:76-85. 10. N Tomizawa, E Maeda, M Akahane, R Torigoe, S Kiryu, K Ohtomo. Coronary CT angiography using the second generation 320-detector row CT: assessement of image quality and radiation dose in various heart rates. Int J Cardiocvasc Imaging 2013;29:1613-8. Page 22 of 22