From Vulnerable Plaque to Vulnerable Patient—Part III: Executive Summary of the Screening for Heart Attack Prevention and Education (SHAPE) Task Force Report

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Screening for early-stage asymptomatic cancers (eg, cancers of breast and colon) to prevent late-stage malignancies has been widely accepted. However, although atherosclerotic cardiovascular disease (eg, heart attack and stroke) accounts for more death and disability than all cancers combined, there are no national screening guidelines for asymptomatic (subclinical) atherosclerosis, and there is no government- or healthcare-sponsored reimbursement for atherosclerosis screening. Part I and Part II of this consensus statement elaborated on new discoveries in the field of atherosclerosis that led to the concept of the “vulnerable patient.” These landmark discoveries, along with new diagnostic and therapeutic options, have set the stage for the next step: translation of this knowledge into a new practice of preventive cardiology. The identification and treatment of the vulnerable patient are the focuses of this consensus statement.

In this report, the Screening for Heart Attack Prevention and Education (SHAPE) Task Force presents a new practice guideline for cardiovascular screening in the asymptomatic at-risk population. In summary, the SHAPE Guideline calls for noninvasive screening of all asymptomatic men 45–75 years of age and asymptomatic women 55–75 years of age (except those defined as very low risk) to detect and treat those with subclinical atherosclerosis. A variety of screening tests are available, and the cost-effectiveness of their use in a comprehensive strategy must be validated. Some of these screening tests, such as measurement of coronary artery calcification by computed tomography scanning and carotid artery intima–media thickness and plaque by ultrasonography, have been available longer than others and are capable of providing direct evidence for the presence and extent of atherosclerosis. Both of these imaging methods provide prognostic information of proven value regarding the future risk of heart attack and stroke. Careful and responsible implementation of these tests as part of a comprehensive risk assessment and reduction approach is warranted and outlined by this report. Other tests for the detection of atherosclerosis and abnormal arterial structure and function, such as magnetic resonance imaging of the great arteries, studies of small and large artery stiffness, and assessment of systemic endothelial dysfunction, are emerging and must be further validated. The screening results (severity of subclinical arterial disease) combined with risk factor assessment are used for risk stratification to identify the vulnerable patient and initiate appropriate therapy. The higher the risk, the more vulnerable an individual is to a near-term adverse event. Because <10% of the population who test positive for atherosclerosis will experience a near-term event, additional risk stratification based on reliable markers of disease activity is needed and is expected to further focus the search for the vulnerable patient in the future. All individuals with asymptomatic atherosclerosis should be counseled and treated to prevent progression to overt clinical disease. The aggressiveness of the treatment should be proportional to the level of risk. Individuals with no evidence of subclinical disease may be reassured of the low risk of a future near-term event, yet encouraged to adhere to a healthy lifestyle and maintain appropriate risk factor levels. Early heart attack care education is urged for all individuals with a positive test for atherosclerosis. The SHAPE Task Force reinforces existing guidelines for the screening and treatment of risk factors in younger populations.

Cardiovascular healthcare professionals and policymakers are urged to adopt the SHAPE proposal and its attendant cost-effectiveness as a new strategy to contain the epidemic of atherosclerotic cardiovascular disease and the rising cost of therapies associated with this epidemic.

Section snippets

Burden of Atherosclerotic Cardiovascular Disease

Atherosclerosis is responsible for nearly all cases of coronary heart disease (CHD), intermittent claudication and critical limb ischemia, and many cases of stroke. CHD alone is the single greatest killer of men and women in the United States (479,300 CHD deaths in 2003), causing >1 of every 5 deaths.3 In 2006, an estimated 875,000 individuals in the United States will have a first heart attack, and 500,000 will have a recurrent attack.3 Because the risk of CHD increases markedly with age, and

Risk Factors, Susceptibility, and Vulnerability

Atherosclerosis begins to develop early in life and progresses with time, but the speed of progression is, to a large extent, unpredictable and differs markedly among seemingly comparable individuals. At every level of risk factor exposure, the amount of established atherosclerosis and the vulnerability to acute events varies greatly, probably because of genetic variability in an individual’s susceptibility to atherosclerosis and propensity to arterial thrombosis (“vulnerable blood”) and

Current Guidelines in Primary Prevention

The current guidelines in primary prevention recommend initial assessment and risk stratification based on traditional risk factors (eg, the Framingham Risk Score in the United States and the Systemic Coronary Risk Evaluation [SCORE] in Europe), followed by goal-directed therapy when necessary.19, 34, 35, 36 Although this approach may identify persons at very low or very high risk of a heart attack or stroke within the next 10 years, the majority of the population belongs to an

In search of the vulnerable patient

Parts I and II of this consensus statement elaborated on new discoveries in the field of atherosclerosis that led to the concept of the vulnerable patient.39, 40 This focus on the identification and aggressive treatment of the previously unrecognized very-high-risk population neglected the majority of the population who are not in the very-high-risk category. To rectify this major omission, the SHAPE report introduces a new paradigm to stratify the entire US population at risk and to tailor

The First SHAPE Guideline

A conceptual flow chart illustrating the principles of the new paradigm is shown in Figure 3.

In contrast to the existing traditional risk factor–based guidelines, this new strategy is primarily based on noninvasive screening for subclinical atherosclerosis using 2 well-established noninvasive imaging modalities: CT for measurement of CACS and B-mode ultrasound for measurement of CIMT and carotid plaque.41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64

Genetic, structural, and functional assessment

Serum markers that can accurately identify the vulnerable individual with both high sensitivity and specificity might be derived from a thorough proteomic survey of blood samples collected from heart attack victims within a few months before the event.110 The incremental predictive value of genes over existing and emerging nongene predictors will need careful scientific and economic evaluation.111, 112 Noninvasive screening tests for subclinical atherosclerosis are rapidly advancing, and

Conclusion

The SHAPE Task Force strongly recommends screening of the at-risk asymptomatic population (men 45–75 years of age and women 55–75 years of age) for subclinical atherosclerosis to more accurately identify and treat patients at high risk for acute ischemic events, as well as to identify those at lower risk who may be treated more conservatively. The Task Force reinforces the existing guidelines for screening and treatment of atherosclerosis risk factors in the younger, very-low-risk population.

Acknowledgment

The Association for the Eradication of Heart Attack (AEHA) thanks the following individuals for their administrative support of the Screening for Heart Attack Prevention and Education (SHAPE) Task Force: Asif Ali, MD, Lori Cantu, Suzanne Ekblad, MPH, Uzma Gul, and Daniel Jamieson. Special thanks to Khawar Gul, MD, Lisa Brown, Craig Jamieson, Brian Jenkins, Mark Johnson, Daniel Keeney, and Kelly Papinchak.

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    For a complete list of Task Force members, please see Appendix.

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