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• W4251311170 abstract "HomeCirculationVol. 102, No. 1American College of Cardiology/American Heart Association Expert Consensus Document on Electron-Beam Computed Tomography for the Diagnosis and Prognosis of Coronary Artery Disease Free AccessOtherPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessOtherPDF/EPUBAmerican College of Cardiology/American Heart Association Expert Consensus Document on Electron-Beam Computed Tomography for the Diagnosis and Prognosis of Coronary Artery Disease Committee Members Robert A. O’Rourke, Bruce H. Brundage, Victor F. Froelicher, Philip Greenland, Scott M. Grundy, Rory Hachamovitch, Gerald M. Pohost, Leslee J. Shaw, William S. Weintraub and William L. WintersJr James S. Forrester, Pamela S. Douglas, David P. Faxon, John D. Fisher, Gabriel Gregoratos, Judith S. Hochman, Adolph M. HutterJr, Sanjiv Kaul, Robert A. O’Rourke, William S. Weintraub, William L. WintersJr and Michael J. Wolk Robert A. O’RourkeRobert A. O’Rourke Search for more papers by this author , Bruce H. BrundageBruce H. Brundage Search for more papers by this author , Victor F. FroelicherVictor F. Froelicher Search for more papers by this author , Philip GreenlandPhilip Greenland Search for more papers by this author , Scott M. GrundyScott M. Grundy Search for more papers by this author , Rory HachamovitchRory Hachamovitch Search for more papers by this author , Gerald M. PohostGerald M. Pohost Search for more papers by this author , Leslee J. ShawLeslee J. Shaw Search for more papers by this author , William S. WeintraubWilliam S. Weintraub Search for more papers by this author and William L. WintersJrWilliam L. WintersJr Search for more papers by this author Search for more papers by this author James S. ForresterJames S. Forrester Search for more papers by this author , Pamela S. DouglasPamela S. Douglas Search for more papers by this author , David P. FaxonDavid P. Faxon Search for more papers by this author , John D. FisherJohn D. Fisher Search for more papers by this author , Gabriel GregoratosGabriel Gregoratos Search for more papers by this author , Judith S. HochmanJudith S. Hochman Search for more papers by this author , Adolph M. HutterJrAdolph M. HutterJr Search for more papers by this author , Sanjiv KaulSanjiv Kaul Search for more papers by this author , Robert A. O’RourkeRobert A. O’Rourke Search for more papers by this author , William S. WeintraubWilliam S. Weintraub Search for more papers by this author , William L. WintersJrWilliam L. WintersJr Search for more papers by this author and Michael J. WolkMichael J. Wolk Search for more papers by this author and American College of Cardiology Task Force on Clinical Expert Consensus Documents Originally published4 Jul 2000https://doi.org/10.1161/01.CIR.102.1.126Circulation. 2000;102:126–140Executive SummaryCoronary artery calcification is part of the development of atherosclerosis; it occurs exclusively in atherosclerotic arteries and is absent in the normal vessel wall. Electron-beam computed tomography (EBCT), the focus of this document, is a highly sensitive technique for detecting coronary artery calcium and is being used with increasing frequency for the screening of asymptomatic people to assess those at high risk for developing coronary heart disease (CHD) and cardiac events, as well as for the diagnosis of obstructive coronary artery disease (CAD) in symptomatic patients. The use of EBCT has the greatest potential for further determination of risk, particularly in elderly asymptomatic patients and others at intermediate risk. The calcium score has been advocated by some as a potential surrogate for age in risk-assessment models. EBCT has also been proposed as a useful technique for assessing the progression or regression of coronary artery stenosis in response to treatment of risk factors such as hypercholesterolemia.EBCT uses an electron beam in stationary tungsten targets, which permits very rapid scanning times. Serial transaxial images are obtained in 100 ms with a thickness of 3 to 6 mm for purposes of detecting coronary artery calcium. Thirty to 40 adjacent axial scans are obtained during 1 to 2 breath-holding sequences. Current EBCT software permits quantification of calcium area and density. Histological studies support the association of tissue densities of 130 Hounsfield units (HU) with calcified plaque. However, a plaque vulnerable to fissure or erosion can be present in the absence of calcium. Also, sex differences play a role in the development of coronary calcium, the prevalence of calcium in women being half that of men until age 60 years. EBCT calcium scores have correlated with pathological examination of the atherosclerotic plaque.This American College of Cardiology (ACC)/American Heart Association (AHA) Writing Group reviewed the literature on EBCT published between 1988 and 1999 and also used information obtained when possible from articles in press and data sets from EBCT research centers. We also reviewed the Blue Cross/Blue Shield (BC/BS) Technology Evaluation Center (TEC) assessment of EBCT for screening asymptomatic patients for CAD and for diagnosing CHD in symptomatic patients. Three members of this Writing Group attended the recent AHA Prevention V Conference on “Identification of the High-Risk Patient for Primary Prevention,” and one of our members is also a participant in the design of the National Institutes of Health/National Heart, Lung, and Blood Institute (NIH/NHLBI) forthcoming Multiethnic Study of Atherosclerosis (MESA), which will include a prospective assessment of EBCT in asymptomatic people.We performed meta-analysis on the relationship between CHD and calcium prevalence in patients undergoing EBCT and cardiac catheterization to determine the diagnostic accuracy of EBCT in catheterized patients. We also performed a meta-analysis of published data in order to compare the diagnostic characteristics of the available alternative tests for detecting angiographic obstructive CAD. The studies demonstrate a high sensitivity of EBCT for CAD, a much lower specificity, and an overall predictive accuracy of ≈70% in typical CAD patient populations. The test has proven to have a predictive accuracy approximately equivalent to alternative methods for diagnosing CAD but has not been found to be superior to alternative noninvasive methods (eg, SPECT [single photon emission computed tomography] imaging). The majority of the members of the Writing Group would not recommend EBCT for diagnosing obstructive CAD because of its low specificity (high percentage of false-positive results), which can result in additional expensive and unnecessary testing to rule out a diagnosis of CAD. The 1999 ACC/AHA Coronary Angiography Guideline Committee reached a similar conclusion.1Because the severity of coronary atherosclerosis is known to be associated with risk of coronary events, coronary calcium scores should likewise correlate with risk for coronary events. However, for a test to be most valuable when asymptomatic patients are screened, it should increase the likelihood of CHD above the probability determined by standard and readily available assessments, such as the Framingham risk model based on levels of blood pressure, cholesterol, high-density lipoprotein (HDL) cholesterol, cigarette smoking, plasma glucose, and age. The published literature does not completely answer the question of whether the EBCT calcium score is additive to the Framingham score for defining CHD risk in asymptomatic patients. In one recent large study,2 the addition of EBCT data provided no incremental value to the risk determined by the Framingham and National Cholesterol Education Program risk factors in a direct comparison. There have been other studies that examine this point,234 but those reports did not adequately test whether EBCT scores were incremental to the other risk factor data. This is an area of important current investigation, including the NIH/NHLBI’s MESA study. It is possible that a positive calcium score might be valuable in determining whether a patient who appears to be at intermediate CHD risk is actually at high risk. Conversely, a low or absent EBCT calcium score may also prove useful in determining a low likelihood of developing CHD. This may be particularly beneficial in elderly asymptomatic patients in whom the management of other risk factors may be modified according to the calcium score. Selected use of coronary calcium scores when a physician is faced with the patient with intermediate coronary disease risk may be appropriate. However, the published literature does not clearly define which asymptomatic people require or will benefit from EBCT. Additional appropriately designed studies of EBCT for this purpose are strongly encouraged. In the setting of this degree of uncertainty, EBCT screening should not be made available to the general public without a physician’s request.The usefulness of EBCT in determination of changing calcium scores that correlate with regression or progression of CHD is currently being studied intensively. However, the test-to-test variability and the interrater reliability of the calcium score measurement in the same individual studied at close intervals in time have been deterrents to the recommendation of serial EBCT scans for determining the response of coronary artery stenosis lesions to medical interventions designed to cause regression of disease. The Writing Group concluded that this is a promising use of EBCT, but the small number of published studies require corroboration before EBCT can be widely recommended for this purpose.Our conclusions are consistent with the recommendation of the Agency for Health Care Policy and Research–funded BC/BS TEC, the Prevention V Conference report of the AHA (Dr Philip Greenland), and the MESA project currently being planned by the NIH/NHLBI. The latter study will evaluate EBCT and other techniques in the long-term assessment of CHD risk in 6500 apparently healthy people. As additional data are obtained, our conclusion might require revision.This Writing Group encourages further properly designed outcomes research using EBCT and additional studies of the role of EBCT and patient follow-up for assessing progression or regression of CHD.I. PreambleThe present document is an Expert Consensus Document that includes evidence about the use of EBCT for the detection of calcium as a marker of coronary atherosclerosis. This type of document is intended to inform practitioners, payers, and other interested parties of the opinion of the ACC, often in collaboration with the AHA, concerning evolving areas of clinical practice and/or technologies that are widely available or new to the practice community. Topics chosen for coverage by Expert Consensus Documents are so designed because the evidence base and experience with technology or clinical practice are not considered sufficiently well developed to be evaluated by the formal ACC/AHA Practice Guidelines process. Often, as in this case, the topic is the subject of considerable ongoing investigation. Thus, the reader should view the Expert Consensus Document as the best attempt of the ACC and AHA to inform and guide clinical practice in areas where rigorous evidence may not yet be available or the evidence to date is not widely accepted. Where feasible, Expert Consensus Documents will include indications or contraindications. Some topics covered by Expert Consensus Documents will be addressed subsequently by the ACC/AHA Practice Guidelines Committee.II. Consensus Statement MethodThe ACC has not previously provided a scientific statement or a consensus document relative to the use of EBCT. At its first meeting, each member of this ACC/AHA Writing Group indicated in writing any relationship to advisory committees, speakers’ bureaus, or stock holdings that could be perceived as a conflict of interest; no relevant conflicts of interest were reported. The first step in the development of this document was to obtain a complete literature review from the Griffith Resource Library at the ACC concerning EBCT from 1995 to 1998 (National Library of Medicine’s Elhill System). Additional relevant prior or subsequently published references have also been identified, as well as manuscripts currently in press. At the first meeting, various members of the Writing Group were asked to provide a description and analysis of EBCT for identifying coronary risk in the asymptomatic patient, for determining the likelihood of obstructive CAD in symptomatic patients, and for detecting the progression or regression of coronary atherosclerotic lesions in patients with known CHD. Each individual contributor to these parts of the document had his or her initial written presentation critiqued by 1 or 2 additional members of this Writing Group. Additional members of the Writing Group provided text concerning the accuracy of the test, alternative approaches to the detection of obstructive CAD, and the economic impact of developing new technology in this era of constrained resources.During the time when this document was being developed, a discussion of EBCT and CHD risk prediction in the asymptomatic individual (atherosclerotic burden) was held at the Prevention V Conference of the AHA in San Francisco, Calif, on October 28, 1998. It was cochaired by 2 members of this Writing Group (Drs Philip Greenland and Scott Grundy). A third member of this Writing Group (Dr Victor Froelicher) participated in Writing Group III at the AHA Prevention Conference.The BC/BS TEC, with a large research staff and one of the AHCPR evidence-based practice centers, provides technology assessment services to BC/BS member plans, managed care plans, and others. They do not directly recommend reimbursement or nonreimbursement. They recently assessed the EBCT detection of coronary artery calcium, including its cost-effectiveness, and presented their results to the BC/BS Medical Advisory Board on December 10, 1998, at a meeting attended by the Chair of this Writing Group (Dr O’Rourke). In discussions with ACC leadership, the BC/BS Advisory Panel TEC indicated their willingness to make the results of their assessment on EBCT available to this Writing Group. The BC/BS “TEC Assessment of Diagnosis and Screening for Coronary Artery Disease With Electron Beam Computed Tomography” has recently been completed.*Also relevant to this report is the initiation of the MESA project by the NHLBI. The MESA protocol, which is in its design phase, will assess the relationship between baseline risk factors and other possible indicators of subclinical disease and future clinical outcomes. There will be a 10-year follow-up, and coronary artery calcium will be evaluated by either EBCT or helical computed tomography (CT) to determine its utility in risk stratification.III. Principles of Technology AssessmentThe development of new medical technology has been a major factor contributing not only to the improved health of the American public, but also to the rising cost of health care.5 On the basis of current estimates, as much as one third to one half of the higher real expenditures for health care are due to an increase in the volume and intensity of services that include the use of new technology.567 Of course, this technology has been invaluable for many patients.During the past 2 decades, a number of innovative techniques have been introduced within diagnostic cardiology that have resulted in improved test performance (ie, sensitivity) for the detection of obstructive CAD. Improvements in test accuracy in the area of diagnostic cardiology have been uniformly associated with higher test costs. Historically, as new technology was developed, it was expected that users would pay for newer, more high-tech imaging tests without any justification of the incremental cost of the new technology. The resulting economic pressures placed on physicians in the current era of healthcare reform are forcing a rethinking of the medical applications of a number of testing modalities. The evaluation of CHD can utilize many testing modalities. The Writing Group accepted the principle that the future of any new technology must now undergo a rigorous evaluation before routine use and application in daily clinical decision making. The limited diffusion of new technologies (eg, EBCT and contrast-enhanced echocardiography) in today’s healthcare market indicates that clinicians and healthcare administrators are making more cautious choices about new technology by awaiting a greater compendium of results applied throughout a wide variety of patient subsets. Although a new test may be less expensive than others previously available, in some cases, tests with low specificity may result in add-on tests that lead to additional costs without improving patient outcomes.Although not every decision in clinical medicine will be supported by randomized trials, broader evidence for the use of EBCT is needed. Promising tests or therapies that seem intuitively attractive have often not proved to be effective when evidence was required (eg, systolic time intervals, digital subtraction left cineangiography, and aortic valvuloplasty).In estimating the accuracy of a noninvasive test for obstructive CAD, there are methodological limitations that hinder our understanding of true predictive accuracy. In general, positive results are more likely to be published, reflecting publication bias, with an overestimation of test accuracy.Another common problem that often occurs early in the evaluation of a new imaging modality is that of limited challenge. Limited challenge is present in studies that compare test results from diseased and normal populations (extreme ends of the disease-prevalence continuum). In general, it is the goal of this type of analysis for the abnormal test results to occur in diseased patients and for normal test results to occur in patients without obstructive disease. Because the patient populations are extremely skewed, the results overestimate test accuracy.The most notable limitation to assessing diagnostic accuracy is the calculation of test sensitivity and specificity. The patients who proceed to diagnostic cardiac catheterization define this calculation. In general, a predominant number of patients who proceed to cardiac catheterization are those with abnormal test results, reflecting the routine workup for suspected obstructive CAD (workup or verification bias). As a result of a greater number of patients with abnormal test results being referred to the “gold standard” of coronary angiography, test sensitivity is enhanced. Conversely, those patients with normal test results who are referred to arteriography include patients with high-risk clinical history of symptoms and those with other myocardial or valvular heart disease. Thus, test specificity is lowered and poorly reflects the exclusion of disease in patients with normal or low-risk test results.The failure to eliminate workup bias has been a problem with most of the studies evaluating the diagnostic characteristics of a noninvasive test for the detection of obstructive CAD. Normal clinical practice results in certain patients being selected or referred for a test (referral bias), with only certain patients being selected for further evaluation (posttest bias). For instance, after an exercise test, cardiac catheterization would be chosen particularly for those with a low exercise capacity and/or abnormal ST response. Most of the studies that have evaluated the characteristics of tests for CAD, using the appropriate gold standard of cardiac catheterization, have some degree of workup bias.An important third consideration is the importance of the end points chosen when data other than the coronary arteriogram are used. Hard end points are myocardial infarction and death, whereas soft end points include chest pain and coronary interventions. Screening studies provide the best example of the problem with using soft end points instead of hard end points. When angina is included as an end point, nonspecific symptoms in a subject with an abnormal test result are more likely to be called CAD during the follow-up period. Hard end points, like death or myocardial infarction, eliminate this misclassification and are more appropriate.There is a definite problem with the use of interventions as cardiac end points. With modern treatment, there often are inadequate numbers of cardiovascular deaths and infarctions in most populations studied to obtain statistically significant results. Therefore, to have enough end points, follow-up studies have often included bypass surgery or percutaneous coronary artery interventions as end points. In fact, very often the majority of the end points are interventions. This is problematic, because the test result often determines who undergoes these procedures, and it is invalid to include them as events predicted by the test.In screening studies, the populations should truly be asymptomatic and should represent a random or systematically selected sample of the target population. Volunteers are not appropriate, because they usually represent the extremes of the population: the most healthy and those who are concerned for personal reasons regarding their health (eg, family history or symptoms they chose to deny). Volunteers represent a subtle form of limited challenge by introducing the extremes into the data set.A problematic surrogate is the use of other test results such as nuclear imaging instead of angiography as a gold standard. It is well known that nuclear imaging has limitations in predicting obstructive CAD and cannot be used to replace the best standard available. Surrogates for standards should be considered carefully and justified only when they perform equal to or better than the standard itself.Screening can be defined as the presumptive identification of unrecognized disease by the use of procedures that can be applied rapidly. The relative value of techniques for identifying individuals who have asymptomatic or latent obstructive CAD should be assessed to optimally and cost-effectively direct secondary preventive efforts toward those with disease.Eight criteria have been proposed for the selection of a screening procedure: The procedure is acceptable and appropriate.The quantity and/or quality of life can be favorably altered.The results of intervention outweigh any adverse effects.The target disease has an asymptomatic period during which its outcome can be altered.Acceptable treatments are available.The prevalence and seriousness of the disease justify the costs of intervention.The procedure is relatively easy and inexpensive.Sufficient resources are available.In addition, 7 guidelines have been recommended for deciding whether a community screening program does more harm than good:Has the program’s effectiveness been demonstrated in a randomized trial, and if so,Are efficacious treatments available?Does the current burden of suffering warrant screening?Is there a good screening test?Does the program reach those who could benefit from it?Can the healthcare system cope with the screening program?Will those who had a positive screening comply with subsequent advice and interventions?The demonstration of the effectiveness of a screening technique requires the randomization of the target population, with half receiving the screening technique; standardized action taken in response to the screening test results; and then outcomes assessment. For the screening technique to be effective, the screening group must have lower mortality and/or morbidity. Such a study has been completed for mammography but not for any cardiac testing modalities. The next best validation of efficacy is to demonstrate that the technique improves the determination of those asymptomatic individuals with higher risk for events over that possible with the available risk factors. Mathematical modeling makes it possible to determine how well a population will be classified if the characteristics of the testing methods are known.IV. Introduction to EBCT Consensus ReportCoronary arterial calcification is part of the development of atherosclerosis, occurs exclusively in atherosclerotic arteries, and is absent in the normal vessel wall.8910 Coronary artery calcification occurs in small amounts in the early lesions of atherosclerosis that appear in the second and third decades of life; it is found more frequently in advanced lesions and in older age. Although there is a positive correlation between the site and the amount of coronary artery calcium and the percent of coronary luminal narrowing at the same anatomic site, the relation is nonlinear and has large confidence limits.11 The relation of arterial calcification, like that of angiographic coronary artery stenosis, to the probability of plaque rupture is unknown.1213 Vulnerable plaque is frequently present in the absence of calcification.14 Although EBCT and helical CT have been very sensitive in defining coronary artery calcium and may provide a measure of total coronary plaque burden, calcium does not concentrate exclusively at sites with severe coronary artery stenosis.15EBCT, the subject of this document, uses an electron gun and a stationary tungsten “target” rather than a standard x-ray tube to generate x-rays, thus permitting very rapid scanning times. EBCT serial transaxial images are obtained in 100 ms with a scan slice thickness of 3 to 6 mm for the purpose of detecting coronary calcium. Thirty to 40 adjacent axial scans usually are obtained. The scans usually are obtained during 1 or 2 breath-holding sequences and are triggered by the ECG signal at 80% of the R-R interval, near end diastole before atrial contraction, thus minimizing the effect of cardiac motion. The rapid image-acquisition time virtually eliminates motion artifact related to cardiac contraction. Thus, specific epicardial coronary arteries are easily visualized by EBCT because the lower CT density of periarterial fat markedly contrasts to blood in the coronary arteries, whereas the mural calcium is identified because of its high CT density relative to soft tissue and blood.16 Also, the scanner software allows quantification of calcium area and density. A calcium scoring system has been devised based on the x-ray attenuation coefficient, or CT number measured in Hounsfield units, and the area of calcium deposits.17 A study for coronary calcium is completed within 10 to 15 minutes, requiring only a few seconds of scanning time.EBCT has been used with increasing frequency in the United States and other countries during the past 10 years in screening asymptomatic individuals for the purpose of identifying those at high risk for developing clinical signs and symptoms due to obstructive CHD. More recently, EBCT has been used to identify the likelihood of CHD in patients who present with nondiagnostic chest pain. Currently, EBCT is being studied for the assessment of progression or regression of coronary artery lesions after interventions in patients with modifiable risk factors for CHD.18 There have been considerable data published in various medical journals supporting the usefulness of EBCT for detecting the presence and density of calcium in atherosclerotic coronary arteries.A writing group of the AHA developed a scientific statement for health professionals in 199615 that concluded that there was no role at that time for the use of EBCT for screening populations of young, healthy individuals with no risk factors and that the importance of calcification in such individuals was inconclusive.This Writing Group agrees with the following points indicated in that scientific statement: A negative EBCT test makes the presence of atherosclerotic plaque, including unstable plaque, very unlikely.A negative test is highly unlikely in the presence of significant luminal obstructive disease.Negative tests occur in the majority of patients who have angiographically normal coronary arteries.A negative test may be consistent with a low risk of a cardiovascular event in the next 2 to 5 years.A positive EBCT confirms the presence of a coronary atherosclerotic plaque.The greater the amount of calcium, the greater the likelihood of occlusive CAD, but there is not a 1-to-1 relationship, and findings may not be site specific.The total amount of calcium correlates best with the total amount of atherosclerotic plaque, although the true “plaque burden” is underestimated.A high calcium score may be consistent with moderate to high risk of a cardiovascular event within the next 2 to 5 years.V. Risk Assessment for CHD in Asymptomatic PopulationsPossibly as many as half of first coronary events (including sudden cardiac death) occur in asymptomatic people. Therefore, screening for both clinically silent CHD and the risk of developing clinical CHD represents 2 major health challenges. Lipid-lowering drug trials in asymptomatic people,19 including those with hypercholesterolemia and with relatively unremarkable lipid levels,20 have revealed the potential for risk reduction of CHD events in primary prevention. Thus, the potential exists for many asymptomatic people to benefit from identification and risk reduction in the asymptomatic phase of CHD. A screening modality that properly classifies at-risk asymptomatic individuals could be extremely valuable in prevention of CHD. The AHA Prevention V Conference was designed to consider the opportunities that might currently exist to improve risk stratification among asymptomatic people. EBCT was considered at the Prevention V Conference along with several other" @default.
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• W4251311170 title "American College of Cardiology/American Heart Association Expert Consensus Document on Electron-Beam Computed Tomography for the Diagnosis and Prognosis of Coronary Artery Disease" @default.
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