Abstract
Non-invasive screenings have been widely utilized in the United States and worldwide to provide early identification of cardiovascular disease, allowing for earlier diagnosis and treatment. Screening sonography detects valve disease, cardiac dysfunction, and carotid disease in 5% to 20% of the population. This review discusses the current data regarding cardiovascular screening, the methodologies, and the resources required for performance of screenings. Cardiac and carotid sonography is highly accurate and discovers cardiovascular diseases that impact quality of life and risk of future events. Screenings are performed in a variety of settings and accuracy depends on the quality of personnel performing the non-invasive testing, the equipment utilized, and the personnel interpreting the studies. Despite the potential benefit for disease detection, population screening to detect cardiovascular disease is not widely supported by national organizations due to the theoretical cost of further testing and lack of cost versus benefit data. Additional studies are necessary to compare costs and benefits of non-invasive cardiovascular screening in the community setting.
Introduction
Despite advances in clinical cardiology and diagnostic imaging, cardiovascular disease (CVD) is the leading cause of death in the United States. 1 Early diagnosis facilitates treatment of CVD. Unrecognized cardiac and vascular abnormalities can be detected through population-based screening in up to 25% of participants. 2 Screening for CVD could aid in early identification to reduce morbidity through early intervention.3,4 This review describes the evidence for utilization of screening, discusses the concerns around community screening programs, and describes technologies performed in community non-invasive cardiovascular screening. Additional studies will be required to weigh the costs versus benefits of cardiovascular screenings in the community.
Screening examinations are defined as an abbreviated examination that briefly evaluates potential abnormalities in an asymptomatic patient. 5 Screening examinations differ from diagnostic examinations, which are ordered by a physician, require a sign or symptom as an indication for the examination, include comprehensive imaging by a modality, and are reimbursed by the Centers for Medicare & Medicaid Services (CMS). 6 Only one lifetime screening electrocardiogram and one aortic aneurysm screening are currently reimbursed by CMS, which requires a physician’s order, and performed in a diagnostic setting. The recommendations for or against as well as the potential reimbursement for screening examinations depend on the type of testing provided and imaging equipment used. Health screenings have been utilized internationally to stratify risk and detect significant cardiovascular findings in asymptomatic patients.7–9 Population screenings have demonstrated sonography as being effective in detecting a variety of CVD with the intent to increase detection of asymptomatic disease and lead to early intervention. 10 For example, cardiac sonography in the community screening populations has detected valve disease 11 and poor heart function in 4.1% of patients at risk of heart failure, 12 and carotid sonography has detected 9.6% of patients having ≥ 50% carotid arterial stenosis. 13
Companies such as Lifeline and Healthfair provide mobile self-referred, self-paid community screenings throughout the United States and suggest that physicians recommend preventive screenings for people at risk. 14 Because the consumer chooses the types of tests to be performed and the testing does not require a physician order and is not reimbursed by insurance, these types of screenings differ from other types of community screenings that target certain populations or are performed with a physician’s referral and are reimbursed.
Overview of the Literature
This review outlines the use of non-invasive cardiovascular testing performed in the community setting to screen for CVD, to include electrocardiogram (ECG), screening cardiac sonography, aortic sonography, screening carotid sonography, and ankle brachial index (ABI).
Use of Electrocardiogram in Screenings
ECG can detect electrical abnormalities such as atrial fibrillation in adults, which can, if undiagnosed, lead to stroke. Undiagnosed atrial fibrillation is present in 1.4% to 1.8% of the population greater than 65 years of age, which increases the risk of stroke.2,15 Early studies reported the risk of stroke in patients with atrial fibrillation to be 6.7% for ages 50 to 59 years and 36.2% for ages 80 to 89 years. 16 The annual rate of strokes in patients on anticoagulation with atrial fibrillation is 2.0 per 100 patient-years. 17 Asymptomatic atrial fibrillation, known as “silent atrial fibrillation,” has the same outcomes as symptomatic atrial fibrillation. 18 Screenings would be able to detect asymptomatic (silent) and symptomatic atrial fibrillation, thereby allowing for necessary therapeutic treatment to decrease the risk of stroke. Single ECG screenings are recommended 19 and reimbursed by CMS with a physician or provider order in patients with Medicare Part B insurance. 20 ECG screening in the adult population has been shown to be cost-effective and is paid for once in the patient’s lifetime. 19
In Europe, the use of ECG screenings in adolescents has demonstrated a decline in sudden cardiac disease in athletes screened for cardiac disease. 21 In young adults, history alone detects only about half of cardiac abnormalities. 22 With the addition of using ECG, sensitivity of cardiac disease is increased to 90% with a specificity of 82.7%. 23 Depending on populations, adding patient history or cardiac sonography to ECG alone can increase sensitivity from 2.5% using a preparticipation sports physical and athlete interpretation criteria to 50%. 21
Opponents of ECG screening in adolescents cite a false positive rate of 16.9%, with some rates as high as 40%, but guidelines have been revised to minimize the false positive rates.21,22,24 In 2010, the European Society of Cardiology adopted criteria differentiating normal, defined as ECG changes due to athletic physical peak performance training, from abnormal, defined as pathologic ECG changes. 25 Interobserver agreement for ECG using this criterion was demonstrated to be κ = 0.30 to 0.54 (poor to moderate). 25 Subsequently, the development of screening-specific interpretation criteria for athlete ECG has decreased false positive rates and increased cost-effectiveness.26–28 By adding a screening ECG with an incremental cost of $89 per participant, it is estimated to save 2.06 life-years per 1000 participants with a cost-effectiveness ratio of $42 900 per life-year. 29
ECG is recognized to have a high negative predictive value, but false negative rates can range from 4% to 5%. 21 Although mandatory ECG screening has not been adopted in the United States, there is a legal precedent to disqualify athletes from competitive sports, aimed to prevent the risk of death, with physicians adhering to American Heart Association guidelines. 30 If mandatory ECG training were translated to the United States, the estimated program costs of athletes to be screened by ECG would be $51 billion to $69 billion dollars over a 20-year program, with 4813 projected saved lives and a cost per life saved being estimated at $10.6 million to $14.4 million per life. 31 Some have suggested eliminating mandatory ECG screenings but providing the best practice options of screening without the cost of mandating the testing. 32
Cardiac Sonography Screening
Recent population screening in asymptomatic participants detected 10% to 20% new heart failure using low- and high-risk models. 33 Due to trials recommending early diagnosis in heart dysfunction, the SCREEN-HF study integrates echocardiography with a health screening as a mechanism to detect heart failure, save lives, provide economic benefit, and extend work longevity. 34 Screening may be appropriate in certain populations such as athletes or those identified with cardiovascular risk.35,36
A randomized study of 6861 middle-age participants (age range, 30-75 years) undergoing standard 2D and color Doppler imaging in the parasternal and apical views with a 15-year follow-up showed no mortality benefit for stroke or heart attack but did find a mortality benefit in patients who had a family history of heart attack. 37 Echocardiographic screening with subsequent medical treatment in childhood cancer survivors demonstrated that screening every 5 to 10 years extends life expectancy, increases quality-adjusted life-years, and reduces complications.3,38 Cardiac sonography also serves as a secondary diagnostic tool when used in conjunction with ECG screening. For example, when screening patients for hypertrophic cardiomyopathy and Wolff-Parkinson-White ECG abnormalities, 15% of the screened population would require follow-up cardiac sonogram. 4
Abdominal Aneurysm Screening
Screening for abdominal aortic aneurysm (AAA) of greater than 3 cm in size reduces the 83% mortality rate of asymptomatic undiagnosed AAA rupture. 39 The mortality reduction is more pronounced in men older than 65 years with familial and smoking history. 40 Due to the published efficacy of the benefit of sonographic screening for aortic aneurysm, in 2007, CMS began paying for one-time sonographic screening with a physician referral as a class B recommendation in men ages 65 to 75 years who have ever smoked.41,42 AAA screening remains cost-effective 43 and reduces mortality.44–46 For aneurysms 3.0 to 4.0 cm in size, cost-effectiveness analysis suggests reimaging every several years as the optimal screening surveillance time frame. Reimaging of AAA is indicated for aneurysms from 4.0 to 4.9 cm in size every 1 to 2 years and every 3 to 6 months for aneurysms 5.0 to 5.4 cm. 47
Carotid Sonographic Screening
The use of sonography to detect significant carotid artery stenosis (CAS) is well established in the American College of Cardiology/American Heart Association appropriate management guidelines. 48 The guidelines outline appropriate interventions in symptomatic and asymptomatic populations. Screening for CAS in both populations using sonography aids practitioners in treatment, including more than 250,000 carotid endarterectomies performed annually to reduce downstream risk of stroke and cardiovascular events. 49 Predicting patient risk is improved with the use of carotid sonographic screening in asymptomatic patients. 50 The presence of carotid plaque or focal thickening of greater than 50% detected through carotid imaging in asymptomatic low-risk patients has been termed subclinical. Although asymptomatic, this subclinical plaque detected in 34% of patients would reclassify patients into higher risk categories. 51 Prevalence of carotid stenosis varies by population from 5.2% to 7.7% in populations ranging from 50 to 80 years of age.52,53
Participants with detection of subclinical carotid disease have been demonstrated to have an event rate of 4.2% in an average of 2.7 years of follow up. 50 Asymptomatic carotid luminal narrowing has been associated with silent brain infarctions, which have a 2-fold increased risk of stroke. 54 Five-year survival of 96% has been demonstrated in low-risk asymptomatic patients with CAS having carotid endarterectomy to prevent future stroke events. 55 Carotid sonographic screening in the emergency department with specialist management has been shown to reduce unnecessary admissions to the hospital by 25% to 40%. 56
Calculated Ankle Brachial Index
Calculated ABI testing has few data evaluating the benefits while comparing possible harm from additional testing. 57 ABI testing detects pressure-flow-reducing peripheral arterial disease and has a sensitivity of 87.9% for predicting cardiovascular mortality. 58 Prevalence of peripheral arterial disease in the general population ranges from 3.5% to 6.7%, depending on ethnic background, with higher rates up to 25.3% in patients with diabetes.53,59,60 Screening for asymptomatic peripheral arterial disease may be especially important in patients with diabetes due to the lack of classic symptoms. 61 Some studies have demonstrated peripheral arterial disease rates of 29% using ABI screening in patients older than 50 years. 62 As with other disease states, early diagnosis and intervention can aid in slowing the progression to amputation in this population. 61 ABI testing used as a screening tool in conjunction with the Framingham risk score has been demonstrated to improve risk classification. 63
Screening Results
A variety of factors impact the results obtained during screening. Obtaining false positive and false negative results is an inherent risk of all screening tests. The sensitivity should be sufficiently high to ensure that significant disease is not missed (high sensitivity with limited false negative results), whereas the specificity must be high enough to minimize the number of false positive results. False positive and false negative rates can be influenced by the definitions of negative, positive, or indeterminate results as well as the population screened. For example, when differentiating normal versus abnormal mitral valve disease, a 90.2% sensitivity and 92.9% specificity using only 2D and color Doppler cardiac could be achieved. In the same study, when distinguishing between more specific abnormalities, the sensitivity drops to 66.7% with false negative results occurring. 64
Differing rates of positive screenings vary depending on the type of cardiovascular screening tool utilized. The prevalence of heart function abnormalities in screenings ranges from 1% to 14%. 8 Other studies indicate that only 4% of screenings demonstrate abnormal heart function in asymptomatic patients using cardiac sonography. 9 Population screening for carotid disease demonstrated a 9% positive detection rate of unilateral or bilateral carotid stenosis equal to or greater than 50% stenosis. 13 More recent data from screened patients undergoing cardiac surgery demonstrated a 16.3% rate of patients having CAS greater than or equal to 50%. 65 ABI screening in asymptomatic adult patients has demonstrated a 2% positive rate. 66
When positive results are obtained on screening studies, additional testing is often required. Utilization of minimal screening technology without confirmatory testing can result in unnecessary chronic medical treatment. 64 Handheld technology that may not be robust, especially in the hands of nonexperts (uncredentialed or untrained), 67 can result in false positive or false negative cases. Although few data for the use of handheld ultrasound devices in cardiovascular applications are available, the use of handheld ultrasound devices in breast applications has an 8.3% to 20.8% false positive rate. 68 When comparing high-end cardiac ultrasound equipment with handheld technology, adequate visualization of basic left ventricular function 69 (κ = 0.89) can be achieved, but more detailed analysis of valvular function is more challenging with less agreement (κ = 0.55). 70 False positive results often lead to additional testing. On the other hand, false negative testing results in missed opportunities to intervene early and stop disease progression with additional downstream costs from treatment in advanced disease states.
Overdiagnosis occurs when screening identifies CVD that would not have resulted in a patient’s death if left untreated. Potential harmful effects of overdiagnosis include stress that accompanies diagnosis as well as the mortality and morbidity that accompanies unnecessary procedures. Societal costs also result from lost work time.
Requirements of Facilities Providing a Screening Program
Facilities providing CVD imaging screenings should have appropriate resources to perform the testing that includes a sonographer with cardiovascular credentials obtained from a national credentialing organization, a reading physician with specialty cardiovascular credentials in interpretation, and a program of performance improvement and assessment. 71 Perhaps the most important part of the personnel requirements is the requirement of credentialed staff performing studies. Radiology studies have indicated a significant effect in screening results due to variation in mammography technologists, but more research is required to explore what types of variation affect the results. 72 National recommendations suggest that personnel performing sonography have, at a minimum, obtained a national credential in the modality in which they are performing the image acquisition. 73 Utilization of staff performing the imaging who have limited training can reduce sensitivity of disease to 21% to 33% in cardiac valvular abnormalities requiring Doppler evaluation. 74 Extending training to include didactic and 3 months of practical training can improve sensitivity in medical students with focused (limited) diagnosis but still results in wide performance variation among staff (correlation variation ranging from 0.29 to 0.93). 75 Additionally, poorly trained staff performing the imaging creates variability in image interpretation resulting in an interrater agreement between 0.55 and 0.88. 74
In addition to requiring credentialed staff to perform the screening examinations, it is also important to have cardiologists rather than general physicians perform the interpretations. Cardiologist interpretation of ECG can improve the negative predictive value from 82% to 92% in patients presenting with heart failure. 76 Cardiologists with training specific to cardiac sonography are also less likely to miss clinically important cardiac sonographic findings when compared with physicians with less training. 77 Differences in positive predictive value suggested that physicians with less training may also be more likely to overcall abnormalities, resulting in increased false positives and increased downstream testing with the associated increase in cost, stress to the patient, and loss to societal productivity. 77
Screening Program Accreditation
To ensure standards of organizations providing screening, the American College of Radiology and the Society of Radiologists in Ultrasound provide practice guidelines for the performance of screening ultrasound. The American Institute of Ultrasound in Medicine provides accreditation with specifications relating to nine topics to ensure that organizations adhere to the standards set forth by the American College of Radiology. 78 These standards include a requirement of all sonographers being credentialed and physicians’ interpretations performed by a physician who has training and experience in the specific area of sonography. The American Institute of Ultrasound in Medicine recommends that requests for screening require a physician or other appropriately licensed health care provider order, thereby limiting self-referrals found in community health screenings. The Commission for the Accreditation of Medical Screening Services provides an alternate accreditation for screening services to the general public. This accreditation also includes requirements relating to technical, professional, equipment, and reporting specifications. 71 The Intersocietal Accreditation Commission accredits vascular screening examinations and states that “standards of vascular testing similar to diagnostic examinations are nonetheless necessary to ensure high quality patient care and to promote health.” 71 This statement aids in highlighting the importance of high-quality imaging regardless of whether the imaging is for screening or diagnostic purposes.
Quality Assurance for Screening Patients
Standardized structured reporting, including the date of the screening examination; adequate description of the test performed; preliminary, positive, negative, and pertinent findings; reasons for incomplete examination; the interpreting physician’s typed name and date; and the performing technologist’s name, is required for accreditation. 71 Reproducible and accurate imaging can be obtained with standardized protocols and high-quality techniques. The interpretation criterion recommends values for carotid sonograms: normal, abnormal, and abnormal with significant findings. ABI testing and AAA screening recommend interpretation values of normal, abnormal, or nondiagnostic. Quality assurance helps to ensure ongoing evaluation of quality testing. 71 Evaluating screening results and comparing accuracy of additional diagnostic testing are important for ongoing improvement in testing.
Equipment Considerations When Performing a Screening Examination
The goal of screening is to provide detection of cardiac, venous, arterial, and electrocardiographic disease through a variety of cardiovascular testing including sonography, electrocardiography, and extremity blood pressure testing. Mobile compact ultrasound equipment now provides the ability to obtain high-quality diagnostic imaging and quantification in the remote setting. This should be differentiated from handheld point-of-care ultrasound equipment that provides imaging without diagnostic quantification, video loop storage, or reporting capabilities. 79 Handheld ultrasound devices have been utilized to perform focused imaging to detect cardiac abnormalities such as rheumatic heart disease,80–83 inferior vena cava size, 84 pericardial effusion,69,75 left ventricular dimensions,85–88 and global function evaluation.89,90 Detecting aortic stenosis, mitral regurgitation, tricuspid regurgitation, 91 pulmonary hypertension, 92 right ventricular function, and left ventricular regional wall motion abnormalities has been demonstrated to be unreliable with handheld ultrasound devices due to poor correlation with full-size diagnostic imaging equipment. 75 Furthermore, visualization of the abdominal aorta or pulmonary valve may be adequately assessed only 50% of the time using a handheld ultrasound device. 75 Adequate cardiovascular health screening services must utilize high-quality imaging, quantification, and reporting equipment to aid in providing accurate results and reduce the possibility of false positive or false negative results. 64
Concerns Relating to Community Screenings
The advocacy group Public Citizen has raised concerns relating to community screenings. A key topic in the national discussion relates to screening patients who may be asymptomatic. Screening for initial evaluation of heart function in asymptomatic patients is considered inappropriate under the 2011 Appropriate Use Criteria published and approved by 10 national organizations including the American Society of Echocardiography and the American College of Cardiology. 93 To aid in reducing inappropriate testing, the American Society of Echocardiography has partnered with the American Board of Internal Medicine Foundation’s Choosing Wisely® campaign to educate consumers to reduce unnecessary diagnostic testing.
The US Preventive Services Task Force released a statement against carotid sonographic screening in the asymptomatic general adult population due to the possibility of false positive tests resulting in additional unnecessary testing. 94 This decision was made because the literature demonstrates that benefits of screening do not outweigh the possible harms of additional invasive testing. To date, there is no published literature demonstrating harm caused by cardiovascular community screening as a result of additional invasive testing. Further research is warranted to evaluate possible harms due to additional testing after screening.
Symptomatic patients often seek medical care resulting in a complete history and physical examination that may identify risk factors and result in diagnostic testing. Asymptomatic patients most often do not seek medical care that could provide an important clinical assessment and history. It is unknown if participants who seek community screenings have symptoms or are seeking the results for preventive lifestyle modifications. Community screenings often do not provide a complete physical assessment, which some assert could detect disease without the need for screenings, including imaging.
Summary of Screening Recommendations
Despite the demonstrated benefits of screening, implementation in the asymptomatic population has been limited due to the theoretical cost of possible subsequent unnecessary downstream testing and avoidable complications. As a result, Medicare reimbursement for screenings in asymptomatic patients has been limited. It is unfortunate that asymptomatic patients with unrecognized, silent, or subclinical disease have been shown to have the same disease progression as those with symptoms. 18 Screenings may be able to detect disease and appropriately risk stratify patients who might need additional treatment or modification of prevention strategies.
Cost-effective simulations show that in targeted screening, 19.2% of high-risk individuals would have cardiovascular disease identified, with 4.1 people needing to be screened to detect disease in 1 person. 95 High-risk populations may benefit more from screenings. Targeting certain ethnic groups may be more cost-effective and could reduce ethnic health inequities. 95 Some data suggest that variable willingness to pay may justify doing screenings, especially in high-risk groups. 96
Synthesis of Screening
Despite cardiac sonography in community screening populations having detected a variety of CVD, widespread screening has been limited due to the national stance on screenings and the lack of CMS reimbursement for all cardiovascular imaging. ECG and AAA screening have been demonstrated to be cost-effective and are reimbursed by CMS. Due to the impact of decreasing risk of future events, carotid and cardiac sonographic screenings have not been approved for reimbursement due to the lack of sufficient data that defines the cost and harm versus benefit. Although echocardiography screening detects asymptomatic heart failure and vascular disease with demonstrated improvements in quality-adjusted life-years, the yield is different depending on the risk associated with the population. Carotid artery screening detecting stenosis reduces downstream risk of cardiovascular events, but prevalence in asymptomatic patients is low, resulting in a large number of required screens to make a significant difference. ABI testing to detect peripheral arterial disease predicts mortality but, again, the prevalence is low unless higher risk populations are screened. National recommendations suggest sonographer and physician credentialing with facility accreditation to improve accuracy of community screenings. Despite data reporting benefits in both symptomatic and asymptomatic populations, national organizations including the American Society of Echocardiography and the American College of Cardiology do not support screening in asymptomatic patients without a physician order. 93
Summary
Screening for CVD has been demonstrated to be effective at detecting disease through a variety of non-invasive testing methods. Early detection of CVD through the use of community health screenings may be an effective tool for detecting subclinical disease and improving the health status of patients through proactive follow-up. Utilization of credentialed personnel and high-end equipment with adherence to national standards of performance will optimize accuracy while minimizing false positive and false negative results. Few published data are available regarding who attends self-referred community cardiovascular screenings that are paid for by the consumer. Additional studies are required to provide data to demonstrate the cost and harm versus benefit of non-invasive cardiovascular screening in the community setting.
Footnotes
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
