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Diagnostic Performance of Coronary CT Angiography by Using Different Generations of Multisection Scanners: Single-Center Experience¹

¹ From the Department of Radiology and Cardiology, Erasmus MC University Medical Center Rotterdam, Dr Molewaterplein 40, 3015GD Rotterdam, the Netherlands. From the 2005 RSNA Annual Meeting. Received January 17, 2007; revision requested March 16; revision received April 30; accepted May 29; final version accepted July 23. Address correspondence to F.P. (e-mail: francesca.pugliese{at}libero.it).

	ABSTRACT

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION ADVANCE IN KNOWLEDGE IMPLICATION FOR PATIENT CARE... References

 
Purpose: To retrospectively compare sensitivity and specificity of four generations of multidetector computed tomographic (CT) scanners for diagnosing significant (50%) coronary artery stenosis, with quantitative conventional coronary angiography as reference standard.

Materials and Methods: The institutional review board approved this study. All patients consented to undergo CT studies prior to conventional coronary angiography, after they were informed of the additional radiation dose, and to the use of their data for future retrospective research. Two hundred four patients (157 men, 47 women; mean age, 58 years ± 11 [standard deviation]), classified in four groups of 51 patients each, underwent coronary CT angiography with four-section, first- and second-generation 16-section, and 64-section CT scanners. Patients in sinus rhythm scheduled for conventional coronary angiography (stable angina, atypical chest pain) were included. Patients with bypass grafts and stents were excluded. Two readers unaware of results of conventional coronary angiography evaluated CT scans. Coronary artery segments of 2 mm or larger in diameter were included for comparative evaluation with quantitative coronary angiography. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for detection of significant stenoses (50% luminal diameter reduction) were calculated.

Results: Image quality was rated poor for the following percentages of coronary artery segments: 33.1% at four-section CT, 14.4% at first-generation 16-section CT, 6.3% at second-generation 16-section CT, and 2.6% at 64-section CT. Sensitivity, specificity, PPV, and NPV, respectively, were as follows: 57%, 91%, 60%, and 90% at four-section CT; 90%, 93%, 65%, and 99% at first-generation 16-section CT; 97%, 98%, 87%, and 100% at second-generation 16-section CT; and 99%, 96%, 80%, and 100% at 64-section CT. Diagnostic performance of four-section CT was significantly poorer than that of second-generation 16-section CT (odds ratio = 4.57) and 64-section CT (odds ratio = 2.89).

Conclusion: Diagnostic performance of coronary CT angiography varies among scanners of different generations. Earlier-generation scanners (four sections) had significantly poorer performance; performance of 16- compared with 64-section CT scanners showed progressive, although not significant, improvement.

© RSNA, 2008

	INTRODUCTION

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Coronary multidetector computed tomographic (CT) angiography is an emerging technique that allows noninvasive detection of significant coronary stenoses (50% luminal diameter reduction) (1,2). After the initial promising results obtained with four-section CT scanners, progressively higher temporal and spatial resolutions have been achieved by increasing gantry rotation speed and the number of detector rows and by reducing individual detector size (3–6). This achievement was obtained through various configurations, including six-, eight-, 10-, 12-, 16-, 32-, 40-, 64- and 256-section CT scanners. With the exception of 256-section CT, several studies have been published in which the diagnostic performance of each CT scanner is explored separately (7–22).

The purpose of our study was to retrospectively compare the sensitivity and specificity of four generations of multidetector CT scanners for diagnosis of significant (50%) coronary artery stenosis by using quantitative conventional coronary angiography as the reference standard.

	MATERIALS AND METHODS

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General Study Design
This study was designed as a retrospective evaluation of the diagnostic performance of a four-section CT scanner (Somatom Plus 4 VolumeZoom; Siemens, Erlangen, Germany) from February 2000 to January 2002; a first-generation 16-section CT scanner (Somatom Sensation 16; Siemens) from April 2002 to May 2003, featuring 12 sections per rotation in cardiac protocols; a second-generation 16-section CT scanner (Somatom Sensation 16 Straton; Siemens) from July 2003 to April 2004; and a 64-section CT scanner (Somatom Sensation 64 Cardiac Configuration; Siemens) from May 2004 to March 2006. Multisection CT was performed to detect significant (50% luminal narrowing) coronary stenoses by using conventional coronary angiography with quantitative stenosis assessment (quantitative coronary angiography) as the reference standard (23). As a result of z-flying focal spot technology, with the 64-section system, 64 sections per rotation were acquired with a 32-row detector array.

The institutional review board approved our study and was made aware of the additional radiation dose. All patients consented to undergo the CT studies prior to conventional coronary angiography after they were informed of the additional radiation dose and its risks. They also consented to the use of their data for future retrospective research.

Patients
A total of 204 patients (157 men, 47 women; mean age, 58 years ± 11 [standard deviation]) with stable angina pectoris or atypical chest pain underwent coronary multidetector CT angiography a mean of 7 days ± 3 prior to conventional coronary angiography. The first 51 consecutive patients examined with each CT scanner were included in four equally sized groups and were scheduled for conventional coronary angiography on the basis of their clinical status (Fig 1). Patients with bypass grafts and coronary stents were excluded.

View larger version (12K): [in this window] [in a new window] [Download PPT slide]   Figure 1: Flow diagram shows inclusion criteria for the study.

Scan Protocol and Image Reconstruction
All patients underwent unenhanced CT for determination of calcium score before CT angiography, and the parameters used with each scanner are presented in Table 1. Images were reconstructed by using a monosegmental electrocardiographically gated reconstruction algorithm. For this algorithm, data are used from a single heartbeat obtained during half-gantry rotation, resulting in a temporal resolution equal to half of the rotation time. Data sets were reconstructed during the interval between the mid- and end-diastolic phases (eg, 300, 350, 400, and 450 msec before the next R wave). We also reconstructed data sets during the end-systolic phase (between 25% and 35% of the R-R interval). Medium-sharp convolution kernels (B30f) were used for image reconstruction.

Stenoses were evaluated and classified as significant if the mean luminal narrowing was 50% or greater by using a validated quantitative coronary angiographic algorithm (Cardiovascular Angiography Analysis System, CAAS II; Pie Medical Imaging, Maastricht, the Netherlands).

CT Image Evaluation
Independent review of the CT scans was performed by two readers (N.R.M., F.C., with 3 years of experience each in cardiac radiology) who were blinded to the results of conventional coronary angiography and quantitative coronary angiography. All images from studies were evaluated at an off-line workstation (Leonardo VB30A; Siemens). Disagreement between both observers was resolved with consensus. All available coronary segments were identified by following the 17-segment American Heart Association model used for the evaluation of conventional angiograms (24). Image quality was classified as good (defined as the absence of any image-degrading artifacts related to motion, calcification, or noise), adequate (defined as the presence of image-degrading artifacts but with evaluation possible with moderate confidence), poor (defined as the presence of image-degrading artifacts but with evaluation possible with low diagnostic confidence), or nonevaluable (defined as no evaluation possible). CT images were visually classified for the presence of significant stenosis by using multiplanar reconstruction and curved multiplanar reconstruction; blood vessels with a diameter of 2 mm or larger were considered, because of their clinical relevance and because they are amenable to revascularization.

Statistical Analysis
Statistical analysis was performed by using commercially available software (Stata, version 8.2 for Windows; StataCorp, College Station, Tex). Results were reported in accordance with the Standards for Reporting of Diagnostic Accuracy, or STARD, criteria (23). Quantitative variables were expressed as means ± standard deviations, and categoric variables were expressed as frequencies or percentages. The percentages of significant stenoses and of cardiovascular risk factors were compared among the groups by using the ² test. The Kruskal-Wallis nonparametric test was used to compare ordinal variables, such as the number of risk factors and severity of coronary artery disease (defined as the number of blood vessels with significant stenoses). Analysis of variance was used to compare ages, heart rates, and log-transformed Agatston calcium scores. The log-transformed Agatston calcium scores were used because the calcium scores demonstrated a skewed distribution. A difference with P < .01 was used as the level of significance to account for multiple testing.

To compensate for uninterpretability bias caused by the presence of excluded segments (25, p 104), diagnostic performance in the four-section CT group was evaluated by using the multiple imputation function. Analysis of missing values was performed with the statistical package, and the results of coronary CT angiography in excluded segments were obtained as a function of the patient's age, sex, and available CT angiographic findings.

We calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of coronary CT angiography for the detection of significant coronary artery stenosis, with the corresponding 95% confidence intervals (CIs). These parameters were computed (a) per patient, (b) per segment, and (c) per location, that is, for proximal segments, middle segments, and distal segments or side branches. Segments 1, 5, 6, and 11 were defined as proximal segments; segments 2, 7, and 13 were defined as middle segments; and segments 3, 4a, 4b, 8, 9, 10, 12, 14, 15, and 16 were defined as distal segments or side branches (24). Two additional sensitivity analyses were performed to explore the effect of the clustered nature of the data, in that the data consisted of multiple potentially correlated observations (ie, segments) per patient. First, we reanalyzed the results for all segments by using generalized estimating equations, with the assumption of a binomial distribution of the dependent variable, a logit-link function, the patient as cluster, an equal-correlation model within each cluster, and the robust sandwich estimator of the variance (25, p 157;26,27). Subsequently, we reanalyzed the data by using the bootstrap approach, with the patient as cluster, sampling with replacement, performing 1000 replications, and analyzing the bias-corrected 95% CI (25, p 168;28).

Finally, we used the generalized estimating equation approach with a logit-link function on segment data to explore the strength of association between conventional coronary angiography and coronary CT angiography adjusted according to the generation of the CT scanner. In this analysis, conventional coronary angiography was considered as the dependent variable, defined as one, meaning the presence of a 50% or greater luminal stenosis, and as zero, meaning the absence of a 50% or greater luminal stenosis; the CT scanner type was considered as the explanatory variable, and a difference with P < .05 was considered significant. Interobserver agreement for the detection of significant coronary stenosis was determined by calculating the statistic. The values that were less than 0.20 were considered to indicate poor agreement; those between 0.21 and 0.40 indicated fair agreement; those between 0.41 and 0.60 indicated moderate agreement; those between 0.61 and 0.80 indicated good agreement; and those greater than 0.81 indicated very good agreement.

	RESULTS

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Clinical Data
No patients were excluded because of a high Agatston calcium score (Table 2). The overall agreement between observers in detecting significant coronary stenoses was good: values were 0.65 for four-section CT scanners; 0.69 for first-generation 16-section CT scanners; 0.72 for second-generation 16-section CT scanners; and 0.73 for 64-section CT scanners.

Image Quality
One-fourth (25.6%, 136 of 532) of coronary segments with a diameter of 2 mm or larger were classified as unevaluable in the group examined with four-section CT scanners (Table 3, Fig 2). Of these 136 unevaluable segments, 34 (25%) were proximal segments (segments 1, 5, 6, and 11), 57 (42%) were middle segments (segments 2, 7, and 13), and 45 (33%) were distal segments or side branches (segments 3, 4a, 4b, 8, 9, 10, 12, 14, 15, and 16) (24). When newer-generation (16- and 64-section) scanners were used, no segments were judged unevaluable.

View larger version (122K): [in this window] [in a new window] [Download PPT slide]   Figure 2a: Example of image quality obtained with scanners of various generations at heart rate of approximately 60 beats per minute. Transverse CT images obtained through the left main (arrowhead) and left anterior descending (arrow) arteries in (a) 60-year-old man with heart rate of 59 beats per minute examined with four-section CT scanner, with poor image quality; (b) 58-year-old man with same heart rate as patient in a examined with first-generation 16-section CT scanner, with adequate image quality; (c) 61-year-old man with heart rate of 60 beats per minute examined with second-generation 16-section CT scanner, with good image quality; and (d) 59-year-old man with same heart rate as patient in c examined with 64-section CT scanner, with good image quality.

View larger version (124K): [in this window] [in a new window] [Download PPT slide]   Figure 2b: Example of image quality obtained with scanners of various generations at heart rate of approximately 60 beats per minute. Transverse CT images obtained through the left main (arrowhead) and left anterior descending (arrow) arteries in (a) 60-year-old man with heart rate of 59 beats per minute examined with four-section CT scanner, with poor image quality; (b) 58-year-old man with same heart rate as patient in a examined with first-generation 16-section CT scanner, with adequate image quality; (c) 61-year-old man with heart rate of 60 beats per minute examined with second-generation 16-section CT scanner, with good image quality; and (d) 59-year-old man with same heart rate as patient in c examined with 64-section CT scanner, with good image quality.

View larger version (114K): [in this window] [in a new window] [Download PPT slide]   Figure 2c: Example of image quality obtained with scanners of various generations at heart rate of approximately 60 beats per minute. Transverse CT images obtained through the left main (arrowhead) and left anterior descending (arrow) arteries in (a) 60-year-old man with heart rate of 59 beats per minute examined with four-section CT scanner, with poor image quality; (b) 58-year-old man with same heart rate as patient in a examined with first-generation 16-section CT scanner, with adequate image quality; (c) 61-year-old man with heart rate of 60 beats per minute examined with second-generation 16-section CT scanner, with good image quality; and (d) 59-year-old man with same heart rate as patient in c examined with 64-section CT scanner, with good image quality.

View larger version (123K): [in this window] [in a new window] [Download PPT slide]   Figure 2d: Example of image quality obtained with scanners of various generations at heart rate of approximately 60 beats per minute. Transverse CT images obtained through the left main (arrowhead) and left anterior descending (arrow) arteries in (a) 60-year-old man with heart rate of 59 beats per minute examined with four-section CT scanner, with poor image quality; (b) 58-year-old man with same heart rate as patient in a examined with first-generation 16-section CT scanner, with adequate image quality; (c) 61-year-old man with heart rate of 60 beats per minute examined with second-generation 16-section CT scanner, with good image quality; and (d) 59-year-old man with same heart rate as patient in c examined with 64-section CT scanner, with good image quality.

View larger version (16K): [in this window] [in a new window] [Download PPT slide]   Figure 3: Diagnostic performance parameters calculated at segmental level (all segments 2 mm in diameter). Segmental sensitivity, specificity, PPV, and NPV obtained with four-section, first-generation 16-section, second-generation 16-section, and 64-section CT scanners are plotted with 95% CIs (error bars). A general performance improvement is seen as the number of sections of the scanners increases from four to 64. Sensitivity and NPV of four-section CT scanner are significantly lower than those obtained with other scanners, as shown by nonoverlapping 95% CIs. PPV for four-section CT scanner is significantly lower than that for second-generation 16-section and 64-section CT scanners.

View larger version (18K): [in this window] [in a new window] [Download PPT slide]   Figure 4: Diagnostic performance parameters calculated at patient level. Per-patient sensitivity, specificity, PPV, and NPV obtained with four-section, first-generation 16-section, second-generation 16-section, and 64-section CT scanners are plotted with 95% CIs (error bars). NPV of 16- and 64-section CT scanners is 100%. Sensitivity of four-section CT scanner is significantly lower than that obtained with other scanners, whereas some overlap of 95% CIs is observed for remaining parameters.

	DISCUSSION

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A surprising finding was that sensitivity, specificity, and NPV obtained with second-generation 16-section and 64-section CT scanners were similar. A possible explanation for this result is that our evaluation with 16-section coronary CT angiography was restricted to vessels of 2 mm or larger in diameter, and this result is in keeping with the findings reported by others (9–11,13,14,29).

Sixty-four–section CT, however, has been reported to have the capability for assessment of coronary branches smaller than 2 mm (16,18–20). In our study, we showed that, when the entire coronary tree was evaluated, the diagnostic performance was similar to the performance when only vessels of 2 mm or larger in diameter were included.

The absolute frequency of coronary segments affected by poor image quality, whatever its cause (ie, calcification, motion, or low contrast-to-noise ratio), decreased progressively as the number of sections of the scanners increased from four to 64. However, the decrease in motion and low contrast-to-noise ratio predominated over the decrease in calcifications. For this reason, the percentage of coronary calcification as a cause of poor image quality increased as the number of sections of the scanners increased from four to 64 as a consequence of the decrease in the percentage of motion and low contrast-to-noise ratio.

Previously, the trade-off for improved diagnostic performance and clinical reliability was increased radiation exposure (30,31). However, electrocardiographically controlled dose modulation is now available with all scanners. Dose modulation involves nominal tube output during diastole, accompanied by a reduction in tube output during systole. The result is a total dose reduction of 30%–50%, depending on the patient's heart rate. The introduction of dual-source CT scanners (32) heralds potential additional benefits with respect to a decrease in x-ray exposure as the pitch increases at higher heart rates, leading to a reduction in the examination time and the radiation dose to the patient. Moreover, the improved temporal resolution of these systems suggests that pharmacologic control of the heart rate will become unnecessary.

Our study had limitations. Because we included subjects referred for conventional angiography, it was inevitable that there would be a high prevalence of disease in the groups available for comparison. Such a condition favors any test aiming for high sensitivity (33). Moreover, because there was a high prevalence of disease, the differences among the various generations of scanners may have been somewhat reduced.

Another limitation was that our study was conducted as a retrospective evaluation of data acquired over time about different patient cohorts. More important, however, the baseline characteristics (age, sex, heart rate, coronary calcium score, prevalence of obese subjects, comorbidity) and the prevalence of stenosis in the four groups included in the comparison were similar.

In conclusion, results of this study indicate that the diagnostic performance of coronary CT angiography with four-section CT is inferior to that with 16-section CT. The added value offered by 64-section CT is high diagnostic performance in the evaluation of the entire coronary tree.

	ADVANCE IN KNOWLEDGE

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• Sixteen- and 64-section coronary CT angiography have significantly higher diagnostic performance than does four-section coronary CT angiography for stenosis detection (odds ratios, 4.57 and 2.89, respectively).
  

	IMPLICATION FOR PATIENT CARE

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION ADVANCE IN KNOWLEDGE IMPLICATION FOR PATIENT CARE... References

 

• Four-section coronary CT angiography has inferior diagnostic performance compared with 16- and 64-section coronary CT angiography.
  

	FOOTNOTES

 

Abbreviations: CI = confidence interval • NPV = negative predictive value • PPV = positive predictive value

Guarantors of integrity of entire study, F.P., P.J.d.F., G.P.K.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, F.P., N.R.M., M.G.M.H., F.C., W.B.M., A.C.W.; clinical studies, F.P., N.R.M., F.C., K.N., C.V.M., M.L.D., P.J.d.F.; statistical analysis, F.P., M.G.M.H., R.T.v.D.; and manuscript editing, F.P., N.R.M., M.G.M.H., P.J.d.F., G.P.K.

Authors stated no financial relationship to disclose.

	References

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