It’s an exciting time medically and technologically as we look at what’s new and on the horizon for cardiac care for women. Demilade A. Adedinsewo, M.B., Ch.B., M.P.H., Director of Research for the Women’s Heart Clinic at Mayo Clinic Florida, says: “There’s now more emphasis on research that focuses on sex differences, and we have more scientific evidence that demonstrates the pathophysiology, manifestation and outcomes of cardiovascular disease in women are different from men.”
Recent scientific advances and novel tools that have the potential transform women’s cardiovascular health include:
- Use of artificial intelligence to improve diagnosis and treatment
- Expansion of digital health technology to bring women and doctors closer
- Development of female-specific medical devices
- Breakthroughs in understanding the genetic distinctions between females and males that influence heart health.
1. Using AI to increase insights into women’s cardiovascular risk and create individually tailored care
Artificial intelligence — AI — uses computers and machines to imitate the problem-solving and decision-making capabilities of the human mind. Furthermore, AI can apply this complex analytical “thinking” process to identify patterns in large amounts of data — and tease out health issues for specific groups of women — that are either impossible or incredibly time-consuming for physicians or other people to analyze.
In a recent study published in Circulation Research, Dr. Adedinsewo and her Mayo Clinic colleagues, including Sharonne N. Hayes, M.D., and Amy W. Pollak, M.D., call out potential opportunities to utilize the massive amounts of data generated by women through their electronic health records, routine diagnostic imaging tests such as ECGs and mammograms — and through the use of digital activity trackers — to improve women’s cardiovascular care.
They address the concepts of gender and sex as it relates to cardiovascular disease — two terms that are often used interchangeably, albeit incorrectly. They also caution that AI algorithms may have built-in blind spots and could potentially propagate bias without appropriate oversight. But if used responsibly and correctly, they say, AI can optimize our understanding of heart disease patterns in women by integrating data ranging from distinct biomarkers to environmental factors. In the future, cardiologists may offer women of all ages and backgrounds a robust almanac of evidence that can be used to provide sex and gender-specific health advice that’s individually targeted to each woman’s needs.
“A simple example,” says Dr. Adedinsewo, “is the use of AI as a predictive tool to analyze data from an electrocardiogram. This is a commonly available and relatively inexpensive test but running its results through a specific AI program can reveal patterns in ECG data that are not detectable by a human.” That process can flag a patient who is at high-risk for reduced heart function or cardiomyopathy well before it becomes a serious health crisis.
2. Making digital health monitoring and telehealth a part of every woman’s healthcare
The pandemic made telehealth visits more popular—and now they’re here to stay. A Harris poll found that these days around 58% of folks say they want even greater online access to their health care providers. According to Rita Khan, Mayo Clinic’s first Chief Digital Officer, “Video visits at Mayo Clinic have increased by 12,000% since before the pandemic.” That’s propelled Mayo Clinic to develop ever more ways to use digital interaction with patients. “We are still only scratching the surface of the digital acceleration that Mayo Clinic is embarking on,” says Khan. “We think about digital health more broadly than virtual care, remote patient monitoring or diagnostics — which are incredibly important. The goal is to support improved patient outcomes.”
Besides televisits, text messaging programs and wearable devices are also making digital health a part of everyday life. They can help keep track of blood pressure or blood sugar in real-time, correlate symptoms with biometric data — or predict the onset of a heart failure episode before symptoms develop, allowing for earlier treatment. Research shows that supportive, individualized text-message programs that help patients stay aware of their health behaviors and goals may reduce the risk of cardiovascular disease and improve medication adherence. And wearable devices have been found to encourage more physical activity — great for the heart — and to detect irregular heart rhythms.
3. Creating medical devices and drugs tailored to women: incorporating sex and gender
Some medical devices are not designed for or offered to women. The first artificial hearts were too large and heavy for use in most women and small men. Women account for around a third of cases of advanced heart failure but far fewer receive advanced heart failure therapies including left ventricular assist devices (LVADs) than men do “There are many reasons why this has happened, but it may go back to the 1970s and 1980s when decisions were made to exclude women of childbearing age from many clinical trials of drugs and devices,” says Dr. Hayes. “We are still paying the price from a lack of knowledge and inclusion four decades later.”
Ironically, while women are less likely to be given the option of receiving some medical devices, when they do get them, they are injured by them far more than men are. According to the Food and Drug Administration (FDA), 67% of the 340,000 people that the agency knows to have been injured by a medical device are women. Problems are seen in wide-ranging situations, such as failure of implanted hips devices, immune reactions to metals in implants or poor outcomes from surgical heart valve replacements. Similarly, the vast majority of prescription drug reactions occur in women once the drug is approved and in wide distribution. The lack of inclusion women in preclinical trials often means that the harm to women is not observed until the drug or device is in widespread use.
Now, the FDA’s Center for Devices and Radiological Health (CDRH) has launched a Health of Women Program strategic plan. Its goal is to strengthen regulatory science, and address current and emerging issues in medical device research and regulation for women. “A lack of representation can have serious consequences for health outcomes for women. An example of this is cardiovascular devices like pacemakers that may have different outcomes and complication rates in men and women,” wrote Terri Cornelison, M.D., Ph.D., Chief Medical Officer and Director of the Health of Women Program in a January 2022 statement. The plan calls for sex- and gender-specific analysis and reporting, an integrated approach for current and emerging issues related to the health of women, and a research roadmap to address identified gaps and unmet needs in development and use of medical devices.
4. Using breakthroughs in genetic analysis to improve heart health
Every cell has a sex. Historically, many researchers have not incorporated that concept into investigations or their reporting of results. The sex differences are present in types of cardiovascular diseases experienced, risk factors, responses to treatments, and clinical outcomes.
This highlights the need to incorporate analysis of sex differences at all levels of investigation, but particularly in evaluation of genetic contributions to disease and response to treatment. If these analyses are done consistently, improvements may be achievable in targeting optimal diagnostic, preventive, and treatment protocol women and men.
For example, a study of 160 women and 160 men with advanced atherosclerosis found there are significant differences in their trouble-causing genes. Genes that were more active in women with coronary artery disease were strongly associated with cells in the walls of their blood vessels. Genes more active in men were linked to the immune system. Males and females also were found to have different gene networks that are involved in the development of coronary artery disease. These insights ultimately may help in the development of sex-specific, targeted treatments.
An international collaboration of genome-wide association studies found a mutation on a single gene allele — which appears mostly in women — made it more likely that the person would be at risk for a certain kind of heart attack called spontaneous coronary artery dissection (SCAD) — or have a condition called fibromuscular dysplasia. People with the opposite genetic variant were more likely to be male, and at risk for developing narrowed or clogged arteries (atherosclerosis) and artery-blocking blood clots. More investigations like this will help provide insights into providing optimal sex and gender based cardiovascular care.
5. Increasing the number of cardiovascular studies that are women-centered
“Mayo Clinic recognizes the importance of cardiovascular research targeting women’s unique cardiovascular issues,” says Dr. Adedinsewo. “For example, Mayo Clinic is participating in the multi-site WARRIOR study looking at whether intensive medical therapy in women with non-obstructive coronary arteries who have cardiac symptoms such as chest pain will reduce their risk for a heart attack or stroke — and make it less likely they will be hospitalized or die.”
There are multiple ongoing studies at Mayo Clinic with a focus on women’s cardiovascular health and these include:
- Using AI to screen for cardiomyopathy late in pregnancy or postpartum
- Evaluating the cardiac risk of estrogen therapy in young women who have had both ovaries removed
- Looking at the blood vessel health of non-pregnant women to get a clearer picture of who is at risk for heart disease and for preeclampsia in pregnancy.
If you are interested in participating in a clinical trial, visit the Mayo Clinic Clinical Trial homepage.
Looking Ahead
According to Dr. Hayes, “Gratifying progress is being made in our understanding of sex and gender differences in cardiovascular conditions and its risks and treatment. New AI and digital investigations and interventions show promise in providing tailored care and recommendations. That said, we continue to play catch up in developing an understanding of — and optimal recommendations for — cardiovascular disease management in women. This is because of historical exclusion of women from research and the lack of sex-specific interpretation of the data, even when women were included. The gaps are particularly stark in elderly women, reproductive- age women and pregnant and lactating women. We must continue to push for — and insist on — improving health equity and investing in women’s health research, particularly on the number 1 killer of women: cardiovascular disease.”
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