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Release on using mammograms to detect early heart disease raised some red flags

Routine mammography–widely recommended for breast cancer screening–may also be a useful tool to identify women at risk for heart disease, potentially allowing for earlier intervention, according to a study scheduled for presentation at the American College of Cardiology’s 65th Annual Scientific Session.

Data from this study show for the first time a link between the amount of calcium in the arteries of the breast–readily visible on digital mammography–and the level of calcium buildup in the coronary arteries. Coronary arterial calcification, or CAC, is considered a very early sign of cardiovascular disease. Importantly, the presence of breast arterial calcification also appears to be an equivalent or stronger risk factor for CAC than other well-established cardiovascular risk factors such as high cholesterol, high blood pressure and diabetes. Earlier research had shown a link between breast arterial calcification and atherosclerotic disease–even heart attack, stroke and other cardiovascular disease events, but researchers said these data provide a more direct relationship between the extent of calcified plaque in the mammary and coronary arteries, as well as a comparison to standard risk evaluation.

“Many women, especially young women, don’t know the health of their coronary arteries. Based on our data, if a mammogram shows breast arterial calcifications it can be a red flag–an ‘aha’ moment–that there is a strong possibility she also has plaque in her coronary arteries,” said Harvey Hecht, M.D., professor at the Icahn School of Medicine and director of cardiovascular imaging at Mount Sinai St. Luke’s hospital, and lead author of the study.

All told, 70 percent of the women who had evidence of breast arterial calcification on their mammogram were also found to have CAC as shown on a noncontrast CT scan of the chest. For women under 60 years of age with CAC, half also had breast arterial calcification–an important finding as very few would be thinking about or considered for early signs of heart disease. There were even fewer false positives among younger patients; researchers said that if a younger woman had breast arterial calcification, there was an 83 percent chance she also had CAC.

Notably, breast arterial calcification also appeared to be as strong a predictor for cardiovascular risk as standard risk scores such as the Framingham Risk Score, which underestimates women’s risk, and the 2013 Cholesterol Guidelines Pooled Cohort Equations, which tends to overestimate risk, Hecht said. When researchers added 33 asymptomatic women with established CAD, breast arterial calcification was more powerful than both risk assessment formulas, which suggests the presence of subclinical atherosclerosis may be a more important indicator of heart disease than other risk factors.

“This information is available on every mammogram, with no additional cost or radiation exposure, and our research suggests breast arterial calcification is as good as the standard risk factor-based estimate for predicting risk,” Hecht said. “Using this information would allow at-risk women to be referred for standard CAC scoring and to be able to start focusing on prevention–perhaps even taking a statin when it can make the most difference.”

Multivariate analysis showed that early signs of a buildup of plaque in the coronary arteries were most strongly related to breast arterial calcification. While CAC was about two times as likely with advancing age or high blood pressure, it was three times more likely with breast arterial calcification.

“The message is if a woman is getting a mammogram, look for breast arterial calcification. It’s a freebie and provides critical information that could be lifesaving for some women,” Hecht said, adding he hopes these findings will prompt clinicians, who rarely report breast arterial calcification, to routinely report not just the presence or absence of breast arterial calcifications but also to estimate and note the amount.

“The more breast arterial calcification a women has, the more likely she is to have calcium in her heart’s arteries as well. If all it requires is to take a closer look at the images, how can we ignore it?,” he said.

A total of 292 women who had digital mammography and noncontrast CT scans within one year were included in the study. Of these, 124, or 42.5 percent, were found to have evidence of breast arterial calcification. Mammograms were reviewed by a second radiologist who was blinded to the CAC results. Women with breast arterial calcification were more likely to be older, have high blood pressure and chronic kidney disease, and less likely smokers. Women with established cardiovascular diseases were excluded. Breast arterial calcification was evaluated on a scale from zero to 12 by increasing severity, and CAC was measured on the CT using a validated 0-12 severity score. The overall accuracy of breast arterial calcification for the presence of CAC was 70 percent, and 63 percent of those with CAC also had breast arterial calcification.

To date, there is no consensus on using CAC as a screening test, though a very large outcome study of 39,000 subjects is underway in the Netherlands. Mammography, however, is widely used and accepted and, as Hecht said, may provide an opportunity to risk stratify asymptomatic women by breast arterial calcification who might have calcium in the coronary arteries and ordinarily would not have been readily considered for cardiovascular screening.

Heart disease is the leading cause of death among women, yet breast cancer is often the most feared.

Roughly 37 million mammograms are performed annually in the U.S. Mammography is recommended annually for women over 40 years of age by the American Cancer Society and every other year for women 50-75 years old and women at high risk for breast cancer by the U.S. Preventive Service Task Force. Digital mammography is more sensitive to the presence of calcifications and is now available in 96 percent of mammography units in the U.S.

Another intriguing point that deserves additional study, according to the researchers, is that the nature of the atherosclerosis is different in breast arterial calcification and CAC, making it unclear why one should be related to the other.

Hecht stresses that these findings warrant further evaluation and validation in larger studies. Future prospective trials are needed to see what the prognostic significance of breast arterial calcification might be. Because the study involved women who received both mammography and CT scan for clinical indications, these women may have been more likely than the average woman to have coexisting conditions, although Hecht said these were unrelated to heart disease.

This study is being published simultaneously online in JACC: Cardiovascular Imaging.

In an accompanying editorial in JACC: Cardiovascular Imaging, Khurram Nasir, M.D., M.P.H., and John McEvoy, from the Center for Healthcare Advancement and Outcomes at Baptist Health South Florida, said that the report provides impetus to document breast arterial calcification in mammography reports, to improve education of primary care and radiology providers on the link with heart disease, and other actions to establish best practices for incorporating this research into care.

“Even by the conservative estimate of 10 percent, approximately 4 million women nationwide undergoing screening mammography will exhibit breast arterial calcification; with 2 to 3 million of them likely to have signs of premature coronary atherosclerotic disease,” the authors said. “Whether the best use of breast arterial calcification is to trigger additional testing or to directly inform preventive treatment decisions, either by flagging high-risk women to their providers or by reclassifying traditional (heart disease) risk estimates, is worth further discussion.”

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The study was funded, in part, by the Flight Attendants Medical Research Institute.

The study, “Digital Mammography: Screening for Coronary Artery Disease?,” will be presented on April 3, 2016, at 9:45 a.m. CT/10:45 a.m. ET/3:45 p.m. UTC at the American College of Cardiology’s 65th Annual Scientific Session in Chicago. The meeting runs April 2-4.

The ACC’s Annual Scientific Session, which in 2016 will be April 2-4 in Chicago, brings together cardiologists and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention. Follow @ACCMediaCenter and #ACC16 for the latest news from the meeting.

The American College of Cardiology is a 52,000-member medical society that is the professional home for the entire cardiovascular care team. The mission of the College is to transform cardiovascular care and to improve heart health. The ACC leads in the formation of health policy, standards and guidelines. The College operates national registries to measure and improve care, offers cardiovascular accreditation to hospitals and institutions, provides professional medical education, disseminates cardiovascular research and bestows credentials upon cardiovascular specialists who meet stringent qualifications.

Laurie Margolies, M.D., associate professor of radiology at the Icahn School of Medicine at Mount Sinai, and co-author of the study will be available to the media in an embargoed web briefing on Tuesday, March 22, 2016, at 2 p.m. ET/1 p.m. CT/6 p.m. UTC. Eligible media should contact Shealy Molpus, smolpus@acc.org, to receive access to the briefing.

Hecht will present the study, “Digital Mammography: Screening for Coronary Artery Disease?,” on Sunday, April 3, 2016, at 9:45 a.m. CT/10:45 a.m. ET/3:45 p.m. UTC in Poster Area, South Hall A1.

Mammograms: Another way to screen for heart disease?

Our Review Summary

Doctor examining a mammogramThis news release from the American College of Cardiology describes a study that suggests mammograms should be used to screen not only for breast cancer but also for calcium build-up in the breast arteries, which could be a sign of heart disease. The study looked at digital mammography and computerized tomography (CT) scans of 292 women who had been screened within the past year. A very high percentage of women (42.5 percent) were found to have calcium in their breast arteries.  Among those women, 70 percent also had calcium deposits in their heart arteries. (The CT scans found calcium in breast arteries in 47.5 percent of the women.)

We observed a fair amount of fear mongering in the release (that sometimes carried over into news stories) and a lack of quantification of the benefits. We aren’t told how including this assessment from a mammogram improves lives.

 

Why This Matters

Coronary heart disease (CHD), in which plaque builds up on the inner walls of coronary arteries, affects a wide number of both men and women. As the news release states, heart disease is the leading cause of death among women and that is confirmed by the National Institutes of Health. Intuitively, one expects new or improved screening tools would lead to earlier diagnosis and more effective efforts at prevention of heart disease. Physicians might recommend lifestyle changes, medication or surgery to help women lower their risk for CHD. However, more screening could also lead to more false positives and more stress, more invasive tests, perhaps more unnecessary aggressive treatments including long-term medications like statins and surgery. This news release matters because it encourages physicians to begin immediately to report on calcium build-up found during regular breast cancer screening mammograms because its “critical information that could be life-saving for some women.” This is very premature since the study was small and, as the release points out, there is no consensus among experts on using coronary arterial calcification as a predictor of heart disease.

The study is being presented at a large medical conference on April 3, and simultaneously published in a medical journal, Cardiovascular Imaging. But already the study has received significant media coverage with stories appearing in Reuters, the Wall Street Journal, Newsweek and dozens of other media outlets. Despite its small size and need for larger studies (as stated by the researchers in the release), a study author told Reuters that based on the research, “Women should ask their radiologists if there was any calcification in their breast arteries. This information can then be given to their primary care doctors to be used in conjunction with standard risk factors to determine if further evaluation (or treatment) would be of benefit.” That is a big leap from a news release that asks in its headline: “Mammograms: Another way to screen for heart disease?”

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release discusses cost in terms of it being a no-cost screen, since the information would be gleaned from a woman’s mammogram for breast cancer. This is not the whole story. The study authors suggested that identification of calcification on breast screening would indicate the need for additional coronary artery screening. And if some 40 percent of women undergoing mammography have breast artery calcification, this will mean a lot of additional coronary imaging tests and possibly additional medications and surgery, all at unknown cost.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release does attempt to quantify the accuracy of the test when it states that 70 percent of the women that were shown to have breast arterial calcification (BAC) were also found through CT scans to have coronary artery calcification (CAC). While that may sound impressive, the release doesn’t acknowledge that this equates to a 30 percent false-positive rate. So 30 percent of women may be unnecessarily worried or inconvenienced and sent for additional testing based on these results. Also, we’re not told what percentage of women who tested negative for breast calcification in fact would have have had CAC according to a CT scan of their chest. That’s an important piece of information that speaks to the test’s usefulness. And if it wasn’t addressed in the study, we think the release should have said so. We always encourage news release writers to address both the sensitivity and specificity of screening tests.

The release also suggests that measuring breast arterial calcification is a better, more accurate risk factor assessment tool than standard risk scores (Framingham Risk Score and the 2013 Cholesterol Guidelines Pooled Cohort Equations). But it doesn’t provide us with any quantification. Instead it says calcification is a “more powerful” measure for assessing risk than the standard risk assessment. What exactly does that mean?

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release didn’t acknowledge that false-positive scans can lead to additional expense, anxiety, further testing, and perhaps treatment with unnecessary medications that have unwanted side effects. Follow-up tests may also expose women to additional radiation.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

A fairly good description of the study protocol is provided. The volunteer group included 292 women who had undergone digital mammography or CT scans within the past year. The group only included women with no previously known heart disease. The mammograms of the 124 women who were found to have BAC were sent to a second radiologist who was blinded to the BAC results. BAC was rated on a severity score of 0-12, with 12 being the most severe. The researchers found CAC present in 70 percent in the group of 124, while 63 percent of those with CAC also had BAC.

There is also reasonable attention to limitations. A quoted researcher says, for example, “Future prospective trials are needed to see what the prognostic significance of breast arterial calcification might be. Because the study involved women who received both mammography and CT scan for clinical indications, these women may have been more likely than the average woman to have coexisting conditions.”

Does the news release commit disease-mongering?

Not Satisfactory

The use of fear-mongering language was a weakness of this release. The release calls BAC a “red flag” and says, “Many women, especially young women, don’t know the health of their coronary arteries.”

That statement presumes that young women should know this information because it can lead to health benefits — something not established here. It’s not at all clear that BAC is a useful “red flag,” but it does seem pretty certain that this kind of language will cause women to worry about BAC, perhaps unnecessarily.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The release states that the Flight Attendants Medical Research Foundation was a partial funder. We aren’t told who else sponsored the research or if there were any potential conflicts of interest.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release mentions alternatives, the standard risk assessment tools, as the Framingham Risk Score and the 2013 Cholesterol Guidelines Pooled Cohort Equations. Although it’s questionable, as noted above, if there is an accurate comparison.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The digital mammogram is widely used and available and neither the release or the study seem to be calling for additional testing beyond what is already taking place. So while availability is not specifically addressed, it’s pretty evident from the release that such testing is widely available.

Does the news release establish the true novelty of the approach?

Satisfactory

The news release claims novelty through this statement: “Data from this study show for the first time a link between the amount of calcium in the arteries of the breast — readily visible on digital mammography — and the level of calcium buildup in the coronary arteries.”

It also notes, “Earlier research had shown a link between breast arterial calcification and atherosclerotic disease–even heart attack, stroke and other cardiovascular disease events, but researchers said these data provide a more direct relationship between the extent of calcified plaque in the mammary and coronary arteries, as well as a comparison to standard risk evaluation.”

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release does not cross our line on unjustifiable language. While some statements seem to imply that women will immediately benefit from the additional assessment of their mammograms, they are tempered with some cautionary language such as “these findings warrant further evaluation and validation in larger studies.”

Total Score: 6 of 10 Satisfactory

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