NCHR and WomenHeart Comments on USPSTF Draft Recommendation Statement Cardiovascular Disease Risk: Screening with Electrocardiography (ECG)

National Center for Health Research & WomenHeart, January 22, 2018

We appreciate the opportunity to express our views on the U.S. Preventive Services Task Force (USPSTF) draft recommendations and evidence review on ECG as a screening tool to prevent cardiovascular disease. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. WomenHeart: The National Coalition for Women with Heart Disease is a nonprofit, patient advocacy organization committed to helping women live longer, healthier lives.

We support the efforts of the U.S. Preventive Services Task Force to re-evaluate the benefits and harms of screening low and intermediate to high-risk adults with electrocardiography (ECG). Although heart disease is at the top of the CDC’s Leading Causes of Death1, we agree that universal screening with ECG provides no net benefit for low risk adults and an unclear benefit in higher-risk adults. We also agree that over-screening with ECG can lead to serious harms, such as invasive procedures that carry substantial short-term and long-term risks. In addition, there is a lack of evidence that screening with ECG changes clinical management, such as the decision to start preventive medications. Therefore, we strongly agree with USPSTF recommendation to maintain the 2012 recommendations against screening low-risk adults with ECG (Grade “D”) and to encourage individualized decision-making for higher-risk adults given the lack of clear evidence (Grade “I”).

We offer the following additional comments:

There are disparities in cardiovascular health, but the value of targeted cardiovascular screening programs with ECG remains unknown.

We agree with the inclusion of KQ1a, which asks whether “improvement in health outcomes vary for subgroups defined by age, sex, or race/ethnicity.” It is important to identify whether specific groups are more likely to benefit from a screening program. Unfortunately, the included studies performed limited subgroup analysis and the findings may not be generalizable to adults in the United States, since most were conducted in Europe.

  1. Age: Age is a significant non-modifiable risk factor for cardiovascular disease, but the evidence remains insufficient to recommend screening with ECG in specific age groups for low-risk or higher-risk adults. Although, the DADDY-D study found that ECG may help to better predict cardiac death in adults ages 60 and over (0 events in ECG screened group vs. 4 events in unscreened group), the findings could be due to chance. In addition, the Healthy Aging and Body Composition (ABC) study, which recruited adults who were on average in their seventies, found that resting ECG data provided a net improvement on top of the Framingham Risk Score in classifying cardiovascular risk (NRI 5.7%). Although these studies suggest a potential benefit of ECG screening in older adults, additional data are needed to confirm a benefit.
  1. Sex: Heart disease is the number one killer of women and men in the U.S.; however, women are less likely than their male counterparts to be aggressively managed based on risk. It is more difficult to diagnose symptoms suggesting underlying heart disease in women because women often do not report symptoms or only report vague symptoms, and may therefore be misclassified as asymptomatic. Often, the first sign for women is a serious cardiac event, such as a heart attack. It is possible that a screening ECG may detect abnormalities earlier, which could lead to better outcomes, but the value of the ECG test (resting or exercise) is unclear in women (sensitivity is 60-70% compared to 80% in men) and women often have smaller vessel plaques, which may not lead to substantial changes on an ECG reading2. The USPSTF found that in the ARIC study, when the ECG finding of left ventricle enlargement (LVH) was added to a conventional risk score, the ability to discriminate between risk categories became worse in women and minimally improved in men. Given the gaps in the evidence, it unclear if there is a net benefit of ECG screening for women.

3. Race/Ethnicity: We know that racial and ethnic disparities exist for overall cardiovascular health outcomes and those differences have not changed substantially over the last few decades. A study in the Journal of the AHA3 found that non-Hispanic whites had better cardiovascular health than non-Hispanic blacks and Mexican Americans. In addition, racial/ethnic minorities are more likely to have diabetes and peripheral vascular disease. Given these disparities, perhaps there is a benefit of targeted ECG screening, but the USPSTF did not uncover studies which conducted racial subgroup analysis to support a targeted screening program and additional data is needed.

New evidence support the USPSTF conclusions

The review of the harms of screening indicates that an abnormal screening ECG may lead to additional follow-up tests and procedures that carry significant risks. New evidence on the benefits and risks of coronary revascularization procedures has come to light in the landmark ORBITA study4. The ORBITA study recruited symptomatic adults; however, it is relevant to the discussion of the evidence. The ORBITA study demonstrated that PCI (vascular stenting) provided no greater benefit than placebo, and underscores the fact that that 0.5 to 13% of adults with abnormal screening ECGs would have undergone an intervention that provides no additional benefit and poses serious harms.

In conclusion, we commend the USPSTF for reviewing the evidence and developing evidence-based recommendations. The evidence is substantial to recommend against screening in low risk adults and is insufficient to support screening in higher risk adults. Although there are disparities in cardiovascular health outcomes, there is limited evidence to support the value of targeted screening programs with ECG. The Choosing Wisely Campaign, a product of health professional societies and Consumer Reports, scrutinizes the value of “routine” tests. They hold the following position: “there are better and less costly ways to prevent heart disease than EKGs and exercise stress tests.”5 We appreciate the efforts of USPSTF to align the evidence with smart consumer decision making. Thank you for reviewing our comments.

References:

  1. CDC. FastStats: Leading Causes of Death. (March 2017). Available online: https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm

  2. McSweeney J, Pettey C, Lefler LL, Heo S. Disparities in heart failure and other cardiovascular diseases among women. Women’s health (London, England). 2012;8(4):473-485. doi:10.2217/whe.12.22.

  3. Lindsay R. Pool, Hongyan Ning, Donald M. Lloyd‐Jones, Norrina B. Allen Trends in Racial/Ethnic Disparities in Cardiovascular Health Among US Adults From 1999–2012.Journal of the American Heart Association. 2017;6:e006027. doi: 

    https://doi.org/10.1161/JAHA.117.006027

  4. Al-Lamee, RashaAl-Lamee, Rasha et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. The Lancet , 2018; 391(10115): 31 – 40. doi: http://dx.doi.org/10.1016/S0140-6736(17)32714-9.

  5. Choosing Wisely. EKGs and Exercise Stress Tests: When you need them—and when you don’t. (April 2012). Available online: http://www.choosingwisely.org/patient-resources/ekgs-and-exercise-stress-tests/