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Published online before print September 11, 2007, 10.1148/radiol.2451061280
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(Radiology 2007;245:433-439.)
© RSNA, 2007

Evidence-Based Practice

Lower Extremity Arterial Disease: Multidetector CT Angiography—Meta-Analysis1

Majanka H. Heijenbrok-Kal, PhD, Marc C. J. M. Kock, MD, and M. G. Myriam Hunink, MD, PhD

1 From the Program for the Assessment of Radiological Technology, Department of Epidemiology and Biostatistics and Department of Radiology, Erasmus MC-University Medical Center Rotterdam, Dr Molewaterplein 50, Room H Ee 2140b, 3015 GD Rotterdam, the Netherlands. Received July 25, 2006; revision requested September 26; revision received January 24, 2007; final version accepted March 1. Supported by a Program Grant (no. 904-66-091) from the Netherlands Organization for Scientific Research. Address correspondence to M.H.H. (e-mail: m.heijenbrok{at}erasmusmc.nl).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 ADVANCES IN KNOWLEDGE
IMPLICATION FOR PATIENT CARE...
 References
 
Purpose: To obtain the best available estimates of the diagnostic performance of multidetector computed tomographic (CT) angiography compared with that of digital subtraction angiography (DSA) in the assessment of symptomatic lower extremity arterial disease and to identify the most important sources of variation in diagnostic performance between studies.

Materials and Methods: Reports of studies published from January 2000 through April 2006 in English, German, French, or Spanish were searched for by using the MEDLINE, EMBASE, and Cochrane databases. Studies were included if they allowed construction of 2 x 2 contingency tables for the detection of stenosis of 50% or greater at multidetector CT angiography compared with that at DSA—the reference standard—in patients with claudication or critical ischemia. Two observers extracted data about study design, patient characteristics, arterial tracts, and technical protocols. Random-effects summary receiver operating characteristic analysis was performed to examine the influence of these data on diagnostic performance.

Results: Of the 70 studies initially identified, 12 were included in which multidetector CT angiography was used to evaluate 9541 arterial segments in 436 patients. The pooled sensitivity and specificity for detecting a stenosis of at least 50% per segment were 92% (95% confidence interval: 89%, 95%) and 93% (95% confidence interval: 91%, 95%), respectively. Three studies provided data about the diagnostic performance of multidetector CT angiography in subdivisions of the arterial tract. The diagnostic performance of multidetector CT angiography in the infrapopliteal tract was lower than but not significantly different from that in the aortoiliac (P > .11) and femoropopliteal (P > .40) tracts. Regression analysis showed that diagnostic performance was not significantly influenced by differences in study characteristics.

Conclusion: Multidetector CT angiography is an accurate diagnostic test in the assessment of arterial disease (≥50% stenosis) of the entire lower extremity.

© RSNA, 2007


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 ADVANCES IN KNOWLEDGE
IMPLICATION FOR PATIENT CARE...
 References
 
Digital subtraction angiography (DSA), the standard of reference in the evaluation of lower extremity arterial disease, is an invasive procedure with substantial costs and a small risk of complications (1,2). Noninvasive techniques for anatomic assessment of the peripheral arteries that could replace DSA are therefore desirable. For this reason, noninvasive techniques such as magnetic resonance (MR) angiography and computed tomographic (CT) angiography are increasingly used in the assessment of lower extremity arterial disease.

Over the years, results of several studies have been published that validate contrast material–enhanced CT angiography as a noninvasive alternative to conventional DSA for imaging the vascular tree. Most studies in which single-section CT angiography was evaluated reported high estimates of sensitivity (range, 73%–100%) and specificity (range, 94%–100%) in the assessment of lower extremity arterial disease; however, they also identified problems of limited scan coverage and resolution (3,4). Since the advent of hardware with multiple detectors, spatial and temporal resolution could be improved, allowing the depiction of the entire vascular tree, including the inflow and runoff arteries. The first reports of evaluations of multidetector CT angiography showed that important disagreements between conventional DSA and multidetector CT angiography results still occurred in the smaller arteries—in particular, the arteries of the calves (5,6). Further advances in CT angiography technology resulted in an increased number of detector rows, enabling thinner collimation, faster scan speed, and improved tube capacity, which could improve the diagnostic performance of this modality.

The diagnostic performance of multidetector CT angiography in the assessment of lower extremity arterial disease has been evaluated in multiple, relatively small, studies from 2000 onward. These studies yielded varying estimates of sensitivity and specificity, which are probably caused by advances in technology, differences in scan protocols, and heterogeneity in patient populations. The purpose of the current study was to obtain the best available estimates of the diagnostic performance of multidetector CT angiography compared with that of DSA in the assessment of symptomatic lower extremity arterial disease and to identify the most important sources of variation in diagnostic performance between studies.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 ADVANCES IN KNOWLEDGE
IMPLICATION FOR PATIENT CARE...
 References
 
Study Selection
To find the best available evidence, we formulated a PICO question (the patient population [P], the intervention or diagnostic test [I], the comparison [C], and the outcome(s) of interest [O]) (7). The question was: "In patients with claudication or critical ischemia, how accurate is multidetector CT angiography compared with DSA in the assessment of lower extremity arterial disease in terms of sensitivity and specificity?"

The MEDLINE, EMBASE, and Cochrane databases were searched by two authors (M.H.H., M.C.J.M.K.) for studies published from January 2000 through April 2006 by using the following search terms: computed tomography AND (peripheral OR lower limb OR lower extremity) AND artery AND specificity NOT pulmonary embolism. A manual search of the reference lists of review articles and cited articles was performed to locate additional studies (M.H.H., M.C.J.M.K.).

Published studies were included if they met the following criteria: The data were acquired with a multidetector CT angiographic scanner with at least two detectors; DSA was used as the reference standard; patients were referred because of the clinical suspicion of peripheral arterial disease; and the absolute numbers of true-positive, false-negative, false-positive, and true-negative test results were available or derivable from the available data to construct 2 x 2 contingency tables. Potential articles in the English, Dutch, French, German, and Spanish languages were included. Studies were excluded if they were single-section CT studies, studies that concentrated on a part of the lower extremity, review articles or editorials, or studies with potentially overlapping study populations.

Data Extraction
Two independent readers (M.H.H., M.C.J.M.K.) evaluated the retrieved studies for possible inclusion in the meta-analysis and extracted the data by using a standard data-extraction form, taking into account the Standards for Reporting of Diagnostic Accuracy checklist (8). In case of inconsistent findings, a consensus decision was made.

The absolute numbers of false-negative, false-positive, true-positive, and true-negative test results were retrieved or calculated from the published data. This was done separately for the total peripheral vascular tract (the abdominal aorta through the ankles) and by anatomic area—namely, the aortoiliac, femoropopliteal, and infrapopliteal areas—if the latter information was available. Clinically significant disease was present if at least one stenosis of 50%–100% of the luminal diameter was present per arterial segment at DSA, the reference standard. If the imaging studies were evaluated by multiple observers, the data reported by the first observer were used.

The characteristics considered to be indicators of advances in CT angiography technology (eg, the number of detectors of the CT scanner) were extracted from each study. The year of publication was considered to be an indicator of advances in technology and advances in the learning experience of radiologists associated with the reading of multidetector CT angiograms. The section thickness and table feed per second were extracted or derived from the protocol as indicators of spatial and temporal resolution. Also documented were scan coverage, reconstruction interval, and extent of image evaluation—that is, the number of postprocessing methods that were supplementarily used to review the transverse source images. Contrast material volume, iodine concentration, injection rate, and method of acquisition timing (fixed, bolus triggering, test bolus) were considered to be indicators of image quality. For each study population, the following patient characteristics were extracted: mean age, prior probability of clinically important disease, proportion of men, proportion of previous revascularizations, and proportion of patients with claudication and critical ischemia. The following characteristics of study design were extracted: number of patients, number of segments per patient, total number of segments analyzed, exclusion of segments, and proportion of segments that could not be assessed with multidetector CT angiography and DSA.

Data Synthesis and Statistical Analysis
The main analysis was performed for the total peripheral vascular tree, which was defined as the anatomic area covering the abdominal aorta through the ankles. Secondary analyses were performed on available data for the aortoiliac, femoropopliteal, and infrapopliteal areas.

First, sensitivity and specificity were pooled by using a random-effects model, which takes into account variability between studies. Then, we performed a random-effects summary receiver operating characteristic (ROC) analysis to estimate the relationship between sensitivity and specificity, taking into account potential differences in positivity criterion and other factors of heterogeneity between clinical settings.

In a summary ROC analysis, the logits (log odds) of sensitivity and 1 – specificity are subtracted to calculate D, the log of the diagnostic odds ratio, which represents a summary measure of the diagnostic performance or discriminatory power. These logits are summed to calculate S, a proxy for the positivity criterion of the diagnostic test. Different positivity criteria exist among studies when institutions use different thresholds for scoring a test result as positive. Subsequently, a linear regression model, D = a + bS, is estimated, weighted by the inverse of the variance of D (9–11). Additional covariates were added to the model to adjust for the indicators of advances in technology and image quality and for differences in patient populations and study design. Missing data were imputed by using the mean of the variable, assuming that the data were missing at random. We evaluated the individual effect of each variable on the diagnostic odds ratio. Variables with a significance level of P ≤ .10 were added to the model in a stepwise forward manner. A variable was kept in the model if the P value was less than .05.

The residual between-study variance {tau}2 was used as a measure of the model fit. A lower {tau}2 value is indicative of less residual between-study variance and, therefore, a better model fit and a better explanatory power by the model of the heterogeneity across studies. We used the meta and metareg commands of Stata, version 8.0 (Stata, College Station, Tex) for all regression analyses.

Interobserver agreement for data extraction was evaluated with the Cohen {kappa} test. The {kappa} statistic indicates the agreement beyond chance. Strength of agreement can be interpreted as poor ({kappa} < 0.20), fair (0.21 < {kappa} < 0.40), moderate (0.41 < {kappa} < 0.60), good (0.61 < {kappa} < 0.80), or excellent ({kappa} > 0.81) (12).

The quality of evidence was graded according to the levels of evidence from the Oxford Centre for Evidence-Based Medicine (13).

Publication Bias
The presence of publication bias (ie, the bias resulting from the greater likelihood of publication of studies reporting a positive result than the likelihood for studies with a negative result) can be detected with a funnel plot. In a funnel plot, a measure of the study size (number of patients or number of segments) is plotted against the measure of interest (the natural logarithm of the diagnostic odds ratio) (14,15). In the absence of publication bias, the funnel plot shows a symmetric funnel-shaped distribution, whereas the distribution is asymmetric and skewed if publication bias is involved. The symmetry and shape of the funnel plot were evaluated by means of visual inspection (M.H.H, M.C.J.M.K.).


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 ADVANCES IN KNOWLEDGE
IMPLICATION FOR PATIENT CARE...
 References
 
Study Selection and Data Extraction
The PubMed search and the manual search for original articles resulted in 70 articles. Forty-one articles were excluded on the basis of their title and abstract (32 studies did not evaluate lower extremity arterial disease, two did not use multidetector CT angiography, six were review articles, and one was an editorial), leaving 29 articles for further evaluation on the basis of the original publication. From these 29 articles, 12 studies were finally included in the meta-analysis (5,6,16–25). One or more reasons for exclusion of articles were as follows: single-section CT was performed (n = 5), no reference test was used (n = 3), it was not possible to reconstruct 2 x 2 contingency tables (n = 7), only part of the vascular tree was studied (n = 5), and there was potential patient overlap (n = 2). All reports supplied data about the entire peripheral vascular tree; three reports (25%) also supplied separate data about the aortoiliac, femoropopliteal, and infrapopliteal areas.

Missing data that were imputed with the mean included the proportion of patients referred for evaluation of claudication and critical ischemia (four studies), proportion of previous revascularizations (five studies), section thickness (one study), table feed per second (four studies), scan coverage (seven studies), reconstruction interval (one study), and proportion of segments that could not be assessed with multidetector CT angiography or DSA (two and three studies, respectively).

Data Synthesis and Statistical Analysis
In one of the 12 included studies, the patients were randomly assigned to one of three CT angiography protocols, which were separately analyzed (24). Thus, a total of 14 patient series, including 436 patients and 9541 segments, were analyzed (Table 1). Interobserver agreement for the data extraction between the two readers was excellent ({kappa} = 0.832). Consensus was reached between the two data extractors for all inconsistent data. The level of evidence of the included studies was graded as 1b.


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  		Table 1. Selected Characteristics of Included Studies

 
The mean sample size of the 12 studies was 31 patients (range, 16–50 patients per study) and 682 segments (range, 168–1365 segments per study). The number of segments per patient varied considerably among the studies (mean, 23 segments per patient; range, 6–35 segments per patient per study). Mean patient age over all studies was 65 years; the mean age per study ranged from 53 to 71 years. Seventy-seven percent of the patients were men; the proportion of men ranged from 55% to 96%. On average, 75% of patients were referred for evaluation of claudication (range, 56%–97%), and 25% were referred for evaluation of critical ischemia (range, 3%–44%).

The random-effects pooled sensitivity and specificity of multidetector CT angiography in the detection of at least one clinically significant stenosis (≥50%) per segment for the entire tract of the lower extremities were 92% (95% CI: 89%, 95%) and 93% (95% CI: 91%, 95%), respectively (Table 1). The published pairs of sensitivities and specificities and the estimated summary ROC curve are shown in Figure 1.


Figure 1
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  		Figure 1: Graph shows published pairs of sensitivities and specificities ({diamondsuit}) for multidetector CT angiography of lower extremity arterial disease and the estimated summary ROC curve (line).

 
With regard to the diagnostic performance in the three subdivisions of the arterial tract in the three studies that reported that data (Table 2), the pooled sensitivity and specificity for the infrapopliteal tract were lower than those for the aortoiliac (P > .11) and the femoropopliteal (P > .40) tracts, although these differences were not statistically significant. The lower accuracy in the infrapopliteal tract was mainly caused by the results of the study of Mesurolle et al (19), who used a CT scanner with only two detectors and a section thickness of 5 mm that could not depict the complete infrapopliteal tract through the ankles. The best results in the infrapopliteal tract were reported by Willmann et al (25), who used a 16-section CT scanner with a section thickness of only 0.75 mm.


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  		Table 2. Pooled Estimates of Sensitivity and Specificity for Subdivisions of Arterial Tract of Lower Extremities

 
The metaregression analysis revealed that none of the indicators of advances in technology and image quality and differences in clinical settings and study design had a significant influence on the diagnostic performance of multidetector CT angiography.

Publication Bias
Visual inspection of the funnel plot (Fig 2) revealed that the inverted funnel was not symmetric. The right tail, which represented the publication of small studies with a high diagnostic performance, seemed for the most part to be missing. The shape of the funnel implied that publication bias might be present. The figure, however, indicates that the publication of small studies with low diagnostic performance is more common than that of small studies with high diagnostic performance. The diagnostic performance of multidetector CT angiography may thus be underestimated.


Figure 2
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  		Figure 2: Funnel plot demonstrates a measure of study size (number [N] of segments) plotted as a function of the natural logarithm of the diagnostic odds ratio (LnDOR). Asymmetry of the shape of the inverted funnel may indicate the presence of publication bias. Small studies (involving a low number of segments) with high diagnostic performance are underrepresented in this funnel plot, which suggests that the pooled diagnostic performance of multidetector CT angiography may be underestimated.

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
ADVANCES IN KNOWLEDGE
IMPLICATION FOR PATIENT CARE...
 References
 
Our analysis of the available literature about multidetector CT angiography revealed that the pooled sensitivity and specificity of multidetector CT angiography for lower extremity arterial disease (≥50% stenosis) were 92% and 93%, respectively. The funnel plot suggests that these estimates of the diagnostic performance of multidetector CT angiography may be underestimated. The summary ROC curve lies close to the upper left corner of the ROC space, which indicates that the diagnostic performance of multidetector CT angiography is almost as good as that of DSA. Our results imply that multidetector CT angiography is a highly accurate diagnostic imaging tool in the assessment of arterial stenosis of 50% or greater in lower extremity arterial disease.

With advances in CT angiography technology—especially the introduction of multiple detectors—spatial resolution and scanning time have improved considerably. In single-section CT angiography studies, the table speed varied from 5 to 10 mm/sec, which could be increased to 36 mm/sec in a study with 16-section CT angiography. Although the use of a faster scan speed can technically decrease the amount of contrast medium needed, it results in decreased spatial resolution and timing difficulties. The section thickness has decreased from 5.5 mm with single-section CT angiography to 0.75 mm with 16-section CT angiography. These technologic advances have led to improved diagnostic imaging that can cover the aorta through the ankles. The indicators of advances in technology and image quality, however, did not reach statistical significance in terms of improving diagnostic performance in our study.

The additional use of advanced postprocessing techniques may also be important for the evaluation of lower extremity arterial disease. Ota et al (20) found that the use of curved planar reformations in iliac arteries resulted in a higher sensitivity (97% vs 89%) and specificity (100% vs 96%) than did the use of transverse images. In our analysis, however, the use of additional postprocessing techniques did not have a significant influence on diagnostic performance. This may be caused by the low number of studies included in our meta-analysis, and, thus, our low power to detect statistical differences.

A major drawback of multidetector CT angiography is the hampered vessel assessment caused by the depiction of arterial wall calcifications. Several studies have reported a decreased accuracy in severely calcified arteries compared with accuracy in arteries without severe calcifications (5,20,26). Only one of our included studies published results stratified for severe calcifications that significantly decreased the diagnostic accuracy (20).

The few studies that provided additional data about the aortoiliac, femoropopliteal, and infrapopliteal tracts showed no significant differences in diagnostic accuracy among these areas. However, the subgroup results suggest that the use of a two-section CT scanner is insufficient for depicting the entire vascular tree in the lower extremities (sensitivity of 43% and specificity of 86% in the first 10 cm of the infrapopliteal arteries) (19). The best results in the infrapopliteal tract were obtained with a 16-section CT scanner with 0.75-mm-thick sections (sensitivity, 96%; specificity, 95%) (25). The subgroup results suggest that 16-section CT is an accurate diagnostic tool for the complete evaluation of lower extremity arterial disease. Unfortunately, only one study involving 16-section CT angiography of the entire lower extremity arterial tract could be included in the analysis. A recent report by Schertler et al (26), who evaluated the diagnostic accuracy of 16-detector CT angiography with different section widths and increments, showed that diagnostic performance improved when the thinnest section width of 0.75 cm was used. The data from that study, however, could not be included in our analysis because only the lower legs were scanned (26).

At the time of writing of this article, no studies had been published in which 64-section CT was used in the assessment of lower extremity arterial disease. By extrapolating the results of those studies that evaluated arterial disease in other anatomic areas, however, we can expect that sensitivity and specificity will improve if 16- or 64-detector CT angiography is used in future studies (27).

In comparison with other noninvasive diagnostic imaging technologies for lower extremity arterial disease, multidetector CT angiography showed similar pooled estimates of sensitivity and specificity. A meta-analysis of contrast-enhanced MR angiography in the diagnosis of lower extremity arterial disease (28) reported a pooled sensitivity of 97.5% and a pooled specificity of 96.2% versus 87.6% and 94.7%, respectively, for color-guided duplex ultrasonography. Another meta-analysis (29) estimated a 94% sensitivity and specificity for three-dimensional gadolinium-enhanced MR angiography. The advantages of multidetector CT angiography over MR angiography are the relatively short imaging time and lower cost (30). MR angiography is contraindicated in patients with claustrophobia or metal implants. Other limitations of MR angiography include slow flow that mimics stenosis and limitations in spatial resolution. Disadvantages of multidetector CT angiography include the use of radiation and the presence of severe calcifications that may cause overestimation of stenosis, especially in patients with diabetes (31,32).

Limitations of our study were the relatively small number of published studies of multidetector CT angiography in this anatomic area and the relatively small study populations analyzed, which resulted in limited power to detect patient characteristics or technologic details of the scan protocols that may have a statistically significant effect on diagnostic accuracy. Furthermore, the number of publications reporting results with the newest multidetector CT angiography scanners (16- and 64-detector CT scanners) in lower extremity arterial disease was almost nil, precluding thorough evaluation of the most recent technologic developments.

Furthermore, we found that the reporting quality of the published studies was such that we had to exclude several studies that did not satisfy the inclusion criteria. In addition, we had to impute some crucial data that were not reported in all studies. It was not possible to reconstruct 2 x 2 contingency tables for all studies—contradicting results were reported in two studies (33,34), and incomplete results were given in one study (35). In one study (36), reading was not performed independently, and in three studies, no reference test was used to confirm the results (37–39). These conditions are necessary to conform to the Standards for Reporting of Diagnostic Accuracy guidelines for the conduct and reporting of diagnostic research to improve the quality of such studies (8). It is desirable that future studies adhere to this concept to make comparison of the results between studies possible and to improve the performance of systematic reviews, thereby facilitating the appreciation of new imaging techniques.

In conclusion, multidetector CT angiography is an accurate diagnostic imaging technology (sensitivity, 92%; specificity, 93%) in the assessment of lower extremity arterial disease (≥50% stenosis).


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


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


   FOOTNOTES
 

Abbreviations: CI = confidence interval • DSA = digital subtraction angiography • ROC = receiver operating characteristic

Author contributions:Guarantor of integrity of entire study, M.H.H.; 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, M.H.H., M.C.J.M.K.; statistical analysis, M.H.H.; and manuscript editing, all authors

Authors stated no financial relationship to disclose.


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

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