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1 BY RUDY MEIJER, B.SC., AND MICHIEL L. BOTS, M.D., PH.D. Carotid wall thickness test withstands scrutiny B-mode ultrasound can detect atherosclerosis at early stage and identify individuals at increased risk of atherosclerotic events Several population studies have shown that a relatively simple measurement of carotid vessel wall thickness (carotid intima media thickness, or CIMT) made by carotid B-mode ultrasound (Figure 1) could detect atherosclerosis at an early stage. The test can also identify individuals at increased risk for atherosclerotic events, such as acute myocardial infarction or ischemic stroke Clinics worldwide have begun to offer this noninvasive, lowcost risk-assessment service. Data from long-running population studies can also be used to estimate an individual s vascular age, that is, age based on the state of a person s blood vessels rather than that person s chronological age Evidence suggests that when carotid artery vessel walls show signs of aging (thickening, plaques) before an individual s chronological age would warrant, that person has a higher risk of experiencing cardiovascular events sooner than an agematched control. The market for cardiovascular risk screening is evolving rapidly. Major players in the ultrasound industry have identified this opportunity and implemented CIMT measurement and reporting software into the vascular calculation packages of their ultrasound systems (Figure 2). The growing interest in this area should be no surprise. Programs designed to prevent illness and to identify the presence of modifiable disease are becoming popular. More responsibility for wellbeing is being shifted from the state to individuals and employers with the intention of keeping the aging population fit and well, thereby reducing healthcare costs. Cardiovascular disease is the number one killer in the Western world. CIMT screening of underlying atherosclerosis has the potential to create a new market for ultrasound manufacturers and prevention clinics. Screening followed by adequate, appropriate risk management could help prevent future vascular events. Several studies have shown that development of atherosclerosis can be slowed Probe Carotid Intima-media complex Advential layer Region of interest B-mode image carotid artery Anterior wall Lumen Posterior wall Intima Media Adventitia FIGURE 1. Concept behind CIMT measurements. Distal common carotid artery is used to measure wall thickness in simple protocols. Bifurcation or tip of flow divider is frequently used as internal landmark to define region of interest. or even reversed by medication, change of lifestyle, change of diet, or a combination of all these approaches. 9,14-18 The real challenge is to not only identify individuals at risk, but also engender changes in lifestyle and diet that will lower those individuals risk of a cardiovascular event. CIMT may be a way to do this. Individuals who undergo screening can be shown signs of vascular damage directly, which should encourage them to comply with appropriate advice. The psychological impact of telling an apparently healthy person that significant plaque is present in his or her carotid artery and probably 32 DIAGNOSTIC IMAGING EUROPE DiagnosticImaging.com OCTOBER 2008

2 IMT (mm) FIGURE 2. Detail of IMT measurement from Arterial Health Package (AHP) software (Siemens Medical Solutions). Color denotes relative thickness (yellow/red = thicker). Green indicates normal IMT for age. Graph shows average IMT compared with population. elsewhere endangering future health, should not be ignored. Professional guidance will be necessary to handle this type of communication. Among the common imaging techniques that can be used to assess and monitor atherosclerosis in clinical trials and population studies, B-mode ultrasound stands out owing to its availability, low cost, noninvasiveness, and capacity to image peripheral vessel wall anatomy in great detail, including vessel wall dynamics. Examinations typically focus on the carotid artery. The carotid artery s superficial position in the neck means it can be imaged easily with B-mode ultrasound. Vessel wall thickness can be monitored and atherosclerotic plaques observed. The disadvantages are that B-mode ultrasound is highly operatordependent, access to the target area is restricted, and thick or short necks hamper imaging of the carotids with ultrasound. A Right Distal CCA Average IMT Compared to Population Mean IMT Age (years) CIMT measurements have evolved as a valuable and powerful biomarker for cardiovascular disease in clinical trials over the past two decades. More than 800 publications involving CIMT have appeared since the 1980s, and this number is growing rapidly. Standardization among CIMT imaging approaches and measurements, however, is lacking. Interstudy comparisons of data are, consequently, not always possible. This lack of standardization makes C FIGURE 3. A: Highly standardized image acquisition approach used in clinical trials. B: Transverse carotid image shows different CIMT thickness around artery, hence illustrating need for multi-angle protocol. C: Meijer carotid ARC (MCA) guides sonographer through multi-angle protocol to enhance data reproducibility and completeness. B it difficult to correlate CIMT values with any biological consequence. In one study, patients at high risk for a cardiovascular event who had undergone a coronary artery bypass graft showed common CIMT values of around 0.6 mm. In another study, CIMT values among the general population were around 0.7 mm. Comparisons of target patients with reference populations will not be meaningful if the imaging and measurement protocols are not identical. 1,9 Differences in CIMT values between separate groups may also be due to technical, not true biological differences. Researchers are still struggling to determine the best way to detect and monitor atherosclerosis. A carotid imaging protocol to assess CIMT in a clinical trial may range from a single image of a posterior vessel wall segment somewhere in the common carotid artery (CCA), with measurement acquired from the screen using calipers, to a highly standardized multi-angle protocol involving the anterior and posterior vessel wall, using a specially developed carotid arc (Meijer Carotid Arc) to verify scan angles on multiple predetermined segments (Figure 3). 15,19 These extensive protocols often use sophisticated offline analysis software with QA programs in an attempt to reduce operator and reader variability. Data on baseline CIMT values, annual progression, and treatment effects may vary according to the imaging and measurement methods used. CIMT values will depend on: characteristics of the population studied; ultrasound equipment and protocol; OCTOBER 2008 DiagnosticImaging.com DIAGNOSTIC IMAGING EUROPE 33

3 operator s expertise; carotid segments measured; and process for analyzing intima media thickness. Many background factors must also be considered. Populations with risk factors for atherosclerotic disease likely will have higher baseline values than healthy populations from similar age groups. Annual progression rates in subjects who have atherosclerotic disease are higher than those in subjects who have no signs of atherosclerosis. Progression of atherosclerosis is segment-specific, being more pronounced in the bifurcation and internal carotid then in the common carotid artery. 20 To determine the best way to conduct a study is clearly difficult and will depend on the goal of the CIMT measurement. panies that CIMT can help to identify subjects at risk. These entities are also coming to understand that the information from CIMT can increase patients awareness of risk and encourage them to actively change their lifestyle. Screening may be part of a prevention program, sponsored by the state or a health insurance provider, or it may be performed individually on a commercial basis. Application of the CIMT tool in cardiovascular screening makes sense. Increased CIMT or presence of plaque means increased risk of cardiovascular events. As yet, however, no hard evidence shows that CIMT can reliably add much to traditional risk factors and improve risk profiling. Questions about the type of CIMT measurement that should be used and the most appropriate reference population also remain unanswered. Some screening programs perform only a limited evaluation of the posterior CCA vessel wall and base their risk assessment on this single image. Individuals whose CIMT in the distal CCA segment is normal for their calendar age may, however, have significant atheromatous plaques in other carotid segments. Evaluations based on CCA alone will produce a certain proportion of false-negative results. Some clinics may use data from population studies but not follow the exact protocol used in the reference study, leading to a questionable outcome. RISK RATIONALE Numerous studies have indicated that observed abnormalities in the carotid artery mirror the presence of atherosclerosis in other areas of the cardiovascular system. The vascular age principle mentioned earlier relies on the fact that aging increases vessel wall thickness and stiffness, which are early signs of atherosclerosis. Focal plaques will then eventually appear. This vascular aging process is accelerated in some individuals who have an unhealthy lifestyle, higher levels of established vascular risk factors, and/or chronic disease. Vascular age then supersedes calendar age (Figure 4). These individuals will be at higher risk for stroke or heart infarct compared with people whose vessels are normal for their age. Traditional screening tools, such as the Framingham heart score, can also identify these high-risk groups. They are less accurate, however, when it comes to identifying and further stratifying high-risk subjects, especially in the younger groups. 9,11,21-23 Improvements to traditional screening methods will be most welcome. Max IMT Max IMT FIGURE 4. CCA images of two individuals of same age, gender, and lipid profile show clearly different CIMT. Subject with CIMT >1.5 (right) should be placed in higher risk group. CIMT might indeed help in refining individuals risk profiles and possibly shifting them to different risk classes. That is, when someone at intermediate risk based on Framingham score has an IMT that is compatible with a more advanced age, it may make sense to use that age in the table and therefore shift this person to a higher risk class. However, this claim has not yet been firmly established. The number of cardiovascular health screening programs that use CIMT to assess risk is growing rapidly; so is awareness among public, government, and health insurance com- The definition of increased CIMT is arbitrary. The risk of vascular disease increases gradually with increasing CIMT. Every cutoff point, whether 0.9 mm, 1 mm, or 1.2 mm, has been chosen arbitrarily. Controlling the quality and accuracy of cardiovascular screening based on CIMT is consequently of the utmost importance. National certification or centrally controlled analysis may be necessary to protect individuals from mistakes and from inappropriate treatment and/or advice. BEST PRACTICE CIMT measurements in many clinical trials are performed in three segments (distal CCA, bifurcation, and proximal internal carotid artery [ICA]) over a width of 10 mm per segment (Figure 5). CIMT thickening and any OCTOBER 2008 DiagnosticImaging.com DIAGNOSTIC IMAGING EUROPE 35

4 ICA BIF CCA emerging or preexisting plaques outside that predefined 10-mm segment are generally not taken in account. This imaging protocol is fine for studies comparing the effects of treatment in different groups, or in observational studies, but it raises an interesting question for risk assessment. Should we ignore plaques that are outside of our target region when assessing risk? Scientifically, we should not deviate from the image protocol of the particular study on whose data the risk assessment is based. Our clinical thinking will probably be in trouble if we assume that thickening and plaques elsewhere also increase cardiovascular risk. The locations from which CIMT measurements are taken are often based on internal landmarks; for example, the tip of the carotid flow divider (Figure 5). Most online and offline CIMT software packages use a default 10-mm measurement width so that they are compatible with published study data. This will increase the reproducibility of follow-up measurements. ECG is generally used to control timing, select the best enddiastolic frame for maximum CIMT measurement, and eliminate thickness during the cardiac cycle. The latest software program allows real-time CIMT measurements using a semiautomated boundary trace. Data on lumen changes are used to detect the end-diastolic phase, from which the maximal CIMT can be measured. This eliminates the need to use ECG. Other software programs calculate the average CIMT during one or more cardiac cycles. It is not yet clear which approach is best. The ideal imaging and analysis protocol should be accurate, reasonably simple to perform, and time-efficient. It should also be complete, reproducible, and compliant with the imaging protocol used as a baseline refer- ICA BIF CCA Tip of flow divider 10mm 10mm 10mm 30 mm B-mode carotid artery FIGURE 5. Example of the three carotid segments often used in multi-angle multisegment clinical trials. Tip of flow divider is used as internal landmark to standardize measurement. ence to assess age and cardiovascular risk. These requirements can be difficult to fulfill. Image acquisition and analysis protocols used in reference studies may be too demanding for routine use. Quality-control programs used to monitor the integrity of data generated during research may also be absent from a clinical screening situation. B-mode ultrasound CIMT imaging is extremely dependent on the operator s expertise and the subject being examined. Monitoring small changes to vessel wall thickness or plaques (<0.02 mm annually) is a considerable challenge. 14 A highly standardized imaging approach appears to be a prerequisite for measuring the effects of any intervention in large population studies. 9,14 The variability of CIMT measurements on ultrasound suggests that it would be wiser to evaluate the process affected by the intervention: blood pressure, lipids, or glucose levels. CLINICAL SCREENING Several ultrasound companies have introduced automated boundary trace software to measure and report CIMT. More will certainly follow, bringing CIMT measurement into the general clinical arena. Cardiologists and vascular specialists may want to start using such a tool to optimize risk profiling and patient care. Cardiovascular health screening centers may integrate CIMT measurement into their standard screening programs. Health insurance companies have shown some interest in offering this option to clients, to enhance awareness of cardiovascular disease and prompt at-risk individuals to implement lifestyle changes. Large companies may want to include a CIMT risk assessment in their existing corporate healthcare programs for the same reasons. Regulatory bodies and professional societies will probably ask that the technique be certified and standardized, or they will recommend centralized analysis, to safeguard quality and accuracy of results. 9 B-mode CIMT measurement may provide us with an opportunity to translate arterial wall thickness into a cardiovascular risk marker, allowing noninvasive identification of individuals at high risk for heart attack and stroke. The incremental value of CIMT measurement on top of information on predicted risk from other sources has not been established, however, and it is necessary to appreciate the technique s limitations and the need for standardization and quality control. Another important issue is the impact of a CIMT assessment on individuals being screened. Ideally, they will opt to follow an intervention pro- OCTOBER 2008 DiagnosticImaging.com DIAGNOSTIC IMAGING EUROPE 37

5 gram, preferably a lifestyle change, to try to slow down the atherosclerotic process and reduce cardiovascular risk. If so, CIMT measurement may have an important role in reducing premature mortality and morbidity in our aging population. Mr. Meijer is manager of scientific services for Bio- Imaging Technologies in Leiden, the Netherlands. Prof. Bots is an associated professor of epidemiology at the Julius Center for Health Sciences and Primary Care of the University Medical Center Utrecht, also in the Netherlands. Turn to page 47 for the references 1/2 page vertical Scanning guides dermoid treatment Calvarial dermoids and epidermoids in young pediatric patients can be monitored using ultrasound alone instead of x-ray-based imaging, according to German researchers. Besides being safer and cheaper, sonography could rule out unnecessary surgeries. CT and MR represent the current imaging standard for the examination of these lesions of the skull. Most of them are benign, however, and resolve with no intervention. Surgery is sometimes attempted, but it entails the risk of spreading infection if the mass ruptures. Principal investigator Dr. Thomas Riebel said the recent study shows that ultrasound is adequate as the only necessary imaging modality for the correct diagnosis of these lesions. Other especially radiation burdening procedures are avoidable, he said. Riebel and colleagues at the Charité Medical University in Berlin studied 100 consecutive children, 52 girls and 48 boys, aged four and younger. Each had at least one firm, palpable calvarial mass. The lesions were first studied with the children at a mean age of 8.3 months, ranging from one week to 40 months. The researchers examined a total of 103 masses with both B-mode and color Doppler ultrasound. They found that each mass had a similar ultrasound profile, showing a round or oval outline with a diameter between 3 mm and 18 mm. The masses were hypoechogenic with homogeneous internal structures showing a marked hyperechogenic superficial capsule next to or extending into the osseous external calvarial table. The color Doppler exam showed no conspicuous flow signs. Follow-up exams were possible on 33 lesions in DIAGNOSTIC IMAGING EUROPE DiagnosticImaging.com OCTOBER 2008

6 A B Sonograms of typical calvarial epidermoid first seen at three months of age (A) show marked spontaneous reduction in size at 16 months (B) and complete regression. (Provided by Prof. Thomas Riebel) patients up to 47 months later. Signs of regression were visible in 49% of the lesions, including a reduction of size, increase of internal echogenicity, and decrease of demarcation. Eight lesions, or 24%, showed no change in the follow-up studies, and the remaining 27% showed an increase in the diameter up to 17 mm but no increase in bone destruction. None of the cases showed a complete destruction of the underlying bone or intracranial extension. The researchers concluded that calvarial dermoids in infants and children resolve naturally in most cases and can be monitored easily with ultrasound, reducing the need for imaging modes requiring radiation. They published the study online June 17 in the journal Child s Nervous System. Surgery should not be the first treatment recourse for these lesions any more since most will disappear spontaneously during the first three to four years of life. They should be followed by ultrasound instead, Riebel said. This conservative management is now accepted by the pediatric physicians and neurosurgeons at our university hospital, who for the last few years have stopped operating on those lesions completely, he said. By Wendy Despain Osteoporosis and the incidence of fractures associated with the condition may become one of the most pressing public healthcare issues of the 21st century, according to several independent studies. Albeit effective, the dual x-ray absorptiometry exam used to determine bone mineral density may fall short of satisfying worldwide demand. The incidence of osteoporosis will outpace economic resources, said principal investigator Dr. Idris Guessous, a senior research fellow in the internal medicine department at Lausanne University Hospital. Safe and cost-effective methods to identify the best candidates for DXA measurements will be crucial to managing the condition successfully, Guessous said. With this premise in mind, Guessous team proposed a quantitative sonography exam of the heel that incorporates clinical factors to predict the risk of osteoporosis-related fractures. For three years, Guessous and colleagues prospectively enrolled 6174 women aged 70 and older at 10 major Swiss osteoporosis centers. Patients underwent a quantitative ultrasound exam that calculates bone strength at the heel, or the stiffness index. 1/4 page vertical Imaging weighs risks for elderly women An Achilles heel may not be such a bad thing after all. Data from a prospective study performed in Switzerland on more than 6000 women showed that an ultrasound scan of the heel, combined with other clinical parameters, may predict the risk of fractures in elderly women afflicted by osteoporosis. OCTOBER 2008 DiagnosticImaging.com DIAGNOSTIC IMAGING EUROPE 41

7 Investigators developed a predictive rule for osteoporotic fracture using the ultrasound stiffness index plus four other factors: age, history of fracture, a failed osteoporosis chair test, and a recent fall. A low stiffness index value was considered a high-risk indicator for fractures. The combined predictive rule helped classify 1464 women as lowrisk subjects and 4710 at higher risk. After a mean follow-up of 2.8 years, researchers found that 290 women (6.1%) in the high-risk group developed fractures compared with only 27 (1.8%) in the lower risk group. Ninety percent of women with hip fractures were in the high-risk group. Investigators published their findings in the July issue of Radiology. Study participants filled out questionnaires every six months to record changes in medical conditions or medications as well as fractures. When a fracture occurred, subjects had to specify its location and trauma level and include a medical report from their physicians. In addition to being portable and relatively inexpensive, quantitative sonography poses other advantages over DXA, according to researchers. Besides density, it can be used to assess bone architecture and elasticity. Previous studies have also established low quantitative stiffness values as an Bedside scanning provides easy way to monitor lungs Bedside ultrasound can be a valuable diagnostic tool for monitoring pulmonary congestion in patients with acute decompensated heart failure. As the heart weakens, fluid backs up into the lungs, and critical patients could benefit greatly by being monitored for their condition without having to be moved for radiographs or other Bone status can be evaluated by ultrasound measurements of the heel using the Achilles system from GE-Lunar. independent risk factor in peri- and postmenopausal women. The test is not perfect, however, with a specificity of about 23%. But just as with other screening tests, physicians who consider using this approach should privilege its high sensitivity (90%) to assess osteoporotic fracture risk, Guessous said. Study results suggest the test is not only effective at determining which women are the best candidates for further testing, it may also be helpful in identifying subjects who can safely do without them, she said. It can be used to identify a population at a very low fracture probability in which no further diagnostic evaluation may be necessary, Guessous said. By H. A. Abella diagnostic tests. Roughly a quarter of a million people die each year of heart failure, the leading cause of hospitalization in adults over 65. The estimated direct cost for heart failure in 2006 in the U.S. was $29.6 billion, according to the Centers for Disease Control and Prevention. Dr. Giovanni Volpicelli and colleagues at San Luigi Gonzaga Hospital in Torino, Italy, studied 70 patients with acute decompensated heart failure. They examined these patients with transthoracic ultrasound first upon admission to the hospital and again 4.2 (±1.7) days later, after they had received treatment. The researchers used bedside ultrasound to look for multiple B lines, a proposed sign of pulmonary congestion, on five anterolateral thoracic ultrasound exams conducted on each patient s left side and six on the right side. Standard diagnostic tests are chest x-rays and CT scans. Multiple B lines showed up on the first scans for all patients. The patient with the lowest number of subsequent scans showing B lines had three of 11 total scans turn out positive, while the patient with the most scans positive for B lines had nine. Across all patients, a median of eight scans per patient turned out positive for multiple B lines. When the exams were repeated after several days of treatment, the median number of scans per patient dropped to zero, with a range of zero to seven. Every scan was scored according to the presence and number of B lines. These scores had a positive linear correlation with scores given to radiologic exams showing extravascular lung water, plasma brain natriuretic peptide improvement, and clinical improvement. The changes in the sonographic score also correlated with changes in the clinical and radiologic scores. The researchers concluded that bedside ultrasound is a reliable diagnostic tool for monitoring the treatment of pulmonary congestion in patients with acute decompensated heart failure. They published their findings in June 3 online issue of the American Journal of Emergency Medicine. By Wendy Despain 42 DIAGNOSTIC IMAGING EUROPE DiagnosticImaging.com OCTOBER 2008

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