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What’s Next For Female Cardiovascular Health? 4 Industry Experts Weigh In

According to the CDC, heart disease is the leading cause of death in women in the U.S., accounting for 1 in every 5 female deaths, and, according to the European Society of Cardiology, “cardiovascular disease (CVD) is the leading cause of death in women in Europe and worldwide. Heart attacks in women, which account for one-third of all female deaths globally, have worse outcomes and higher mortality than in men.”

In this article, I’m highlighting four industry experts that have committed their careers to improving healthcare outcomes for women in the cardiovascular space, from diversifying clinical trials, raising awareness, and educating patients and healthcare professionals, to creating technology solutions to reduce gender and racial biases that still exist in this space and improve diagnostics and therapeutics for all.

Dr. Juliet M. Nevins, Medical Director, CVS Health

As a board-certified obstetrician, a gynecologist, and an influential voice in the women’s health and maternity policy space, Dr. Nevins is fully committed to health equity, as well as to consumer health education and wellness. She fervently believes that health education is a critical tool that can change behavior, improve the health of individuals, and facilitate intact communities.

As an ever-evolving industry, she is aware of how education in this space is a critical factor in improving outcomes for patients, especially females. For her, other than (and possibly, in addition to) genetic factors that contribute to cardiovascular disease (e.g., propensity for high cholesterol), heart health, at any given point, is a cumulation of lifestyle and behavioral decisions throughout a woman’s life. For example, nutritional habits that begin in childhood persist into older ages and are an important variable in terms of cardiovascular risk. Consider that, according to CDC data, 1 in 16 women over the age of 20 have some level of coronary artery disease.

As a company, CVS Health has many initiatives. Next Best Actions (NBAs) are internal focus groups that target myriad health care topics, including those that support women and their cardiac health. One NBA, the Preeclampsia Aetna Maternity Program Initiative, is a program that identifies women who are pregnant and sends out communications to educate women about the risk of cardiovascular disease in pregnancy. It will then prompt women to have this discussion with their health care providers.

“We also piloted the Doula program, whereby CVS Health colleagues can access the support of a doula during the birthing process. This non-clinician support is meant to assist and empower women, especially women of color, so they can more fully share in the decisions about interventions that are offered during childbirth,” adds Nevins.

CVS Health also initiated a version of the “KnowYourNumbers” campaign to provide patients with objective data — weight and BMI (body mass index), cholesterol level, blood pressure levels, and fasting glucose — as a motivator to act, employ lifestyle changes and seek medical management to lower the risk of cardiovascular disease.

“Awareness is about building with respect to the need for prevention and risk mitigation management – processes that should really begin years before clinical manifestations of cardiac disease. Young women, and women in general, tend to focus on their reproductive health while paying very little attention to other important health categories (e.g., risk of colon cancer, diabetes, and cardiovascular health). The incidence of heart attacks in younger women has actually increased. We need an approach to heart health that is fluid and focused on education from a young age but that which adapts to life events and the physical changes that occur throughout a woman’s life. Cardiac awareness should be omnipresent, and we can find new ways, like using technology, to help achieve this,” she concludes.

Shavini Fernando, founder and CEO of OxiWear

After being diagnosed with severe pulmonary hypertension (PH) due to Eisenmenger’s Syndrome, and facing multiple cardiac arrests due to hypoxia necessitating self-CPR to revive herself, Fernando invented OxiWear in 2019 as a tool for herself and the larger PH community. OxiWear is the first wireless, ear-wearable pulse oximeter for medical-grade continuous oxygen monitoring and low oxygen alerting.

With more than 10% of the global population at risk of hypoxia (low oxygen levels in their body) due to cardiovascular and other chronic disease conditions, or living and recreating at high altitudes, OxiWear provides medical-grade oxygen tracking to help minimize one’s risks of cardiac arrest, stroke and long-term damage to vital organs. It is a device that serves both the sports and medical communities, ensuring accurate oxygen monitoring that is recorded on a mobile application and that can be shared with the user’s trainer or physician as needed.

“Our mission is to minimize the risks of silent hypoxia so that we can prevent lung scarring due to hypoxia and those with already scarred lungs can live their life to the fullest,” shares Fernando.

Despite increases in education and awareness of cardiac diseases, there’s still a lack of awareness of pulmonary diseases which is one of the leading causes of cardiac failure. Thus, cardiac disease is still a leading cause of death for women around the globe. With an increase in cardiovascular-related technology and accurate monitoring, products such as OxiWear will help to reduce risks by alerting the user when their oxygen levels are dropping below the safe threshold and enabling the patient to get help in time. For athletes, accurately tracking oxygen levels can help to avoid situations such as AMS, HAPE, HACE, and other serious medical conditions.

Fernando explains that, most of the time, the biggest issue is that other than the specialists who treat cardiopulmonary diseases most medical practitioners lack awareness and education surrounding diseases. Therefore they try to treat the patients by the book which does not work the same way for all patients, and therefore the patients need to be their own advocates and learn to SAY NO when they try to perform procedures or treatments that will have adverse effects on them. “And women are much stronger in taking in and handling pain therefore they tend to misjudge or give a blind eye to pain which may be an important indication that they need to seek medical attention.”

Relating to hypoxia, one of the aspects Fernando and her team focused on is providing accurate data for dark skin users. Multiple reports after COVID have shown that pulse oximeters do not accurately report oxygen saturation levels in dark skin patients. The FDA is convening a committee in November 2022 to discuss “ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations.”

OxiWear specifically focused its FDA clinical testing on a variety of patients with light, medium, and dark skin tones to ensure accuracy for these patient populations. In addition to that, the company signed a memorandum of understanding with the World’s Highest OCR (Obstacle Course Racing) to monitor the oxygen levels of race participants during training and high-altitude events. “We have also partnered with Mount Sinai’s Abilities Research Center in NYC to use our devices for pulmonary and spinal cord injury rehabilitation and the Lake Nona Performance Center in Florida.”

Fernando hopes to receive OxiWear’s FDA approval latest by Q2 2023, which will allow the device to be prescribed and covered by insurance, so any patient could receive it, regardless of their ability to purchase the device. So far, the company closed its pre-seed funding round at $1.25 million which included funding from angel investors, venture funds, and a state-wide economic innovation fund. “We are currently closing a bridge round of $2 million with a majority of private investors with $500k left in the round and plan to open our Series A round in 2023 to expand our FDA approval to over-the-counter, R&D for chip-level development to minimize the device for pediatric use and to expand our team,” concludes Fernando.

Jennifer Jones-McMeans, Ph.D., Divisional Vice President of Global Clinical Affairs at Abbott’s vascular business

Since joining Abbott over 15 years ago, Jones-McMeans has worked on gaining approval for numerous medical devices in the U.S. and globally, with the sole mission of driving innovation and leveraging technology to create diversity in clinical trials. She has become one of the leading experts in clinical trial design strategy with a focus on diversity. She has led many clinical trials, including those for resorbable technologies designed to treat cardiovascular disease and Peripheral Artery Disease (PAD), the latter of which disproportionately affects underrepresented communities.

The Covid-19 pandemic exposed the inequities that have existed for centuries in the healthcare system. With it coming to a new light, Jones-McMeans believes healthcare systems and leaders will double down in their efforts, placing a greater urgency to create a more equitable healthcare system. “These changes cannot happen with efforts from one company alone and it will take a collective effort from the entire healthcare ecosystem. I envision we’ll see more partnerships in the coming years to help close the gap in care and support for every individual.”

She also highlights that there will also be a greater emphasis on education – not only for the physicians but also for the patients. “More and more patients want to be involved in the decision-making process and are looking for a more personalized wellness journey. By enhancing education, everyone will become better informed on healthcare plans and outcomes,” she adds.

This year, Abbott highlighted gender bias in the cardiovascular care for women and people of color with Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD) – adversely impacting their health as a whole. It addressed key areas for creating more conscious inclusion in vascular care, including recognizing how symptoms of coronary artery disease present differently across patient populations.

According to the findings from the research, women reported a more challenging experience than their male counterparts in all surveyed factors, including access to care, emotional factors, and relationships with their physicians. Further, the study uncovered how:

  • Gender inequities contribute to the high rates of avoidable deaths and multiple chronic conditions
  • The lack of representation of women in clinical trials: women account for only 38% of participants in cardiovascular clinical trials despite representing about 50.5% of the U.S. population
  • How the healthcare industry can work together to address the inequities that exist for women to improve patient outcomes and overall quality of life

Right now, there are limited therapies for the treatment of PAD, which disproportionately affects African Americans, who are twice as likely to have PAD as any other racial/ethnic group and four times as likely to require an amputation. With this in mind, Jones-McMeans is set out to recruit doctors and patients to participate in this clinical trial that reflects the underrepresented communities most in need of treatment.

“Through my work at Abbott, we have created partnerships, like with Women as One, to help educate the next generation of clinical trial researchers and investigators. By starting with researchers, we can help move the needle on diversifying clinical trial participants because we know when people see someone who looks like them and they can relate to, they are more likely to pursue a career or seek help.”

Abbott’s 2030 Sustainability Plan further solidifies the company’s commitment to shaping the future of healthcare to have the greatest number of people live better and healthier lives. “Not only are we focused on cutting-edge innovations, but we are also increasing access and affordability to life-changing technologies and products. With the goal to improve the lives of more than three billion people by 2030, Abbott is working across businesses and in partnership with other leaders in the field to break down the four main barriers to care and bring innovation to the people who need it most. At the forefront of diversity in clinical trials, we are working to make a more inclusive, sustainable, and, as a result, moving the needle on creating a more equitable healthcare ecosystem,” she concludes.

Alicia Chong Rodriguez, founder and CEO of Bloomer Tech

At Bloomer Tech, a startup tackling healthcare disparities for women through an Augmented Garment (AG) Platform, Chong Rodriguez and her team are driven to build a cardiovascular disease and stroke database that contains valuable data for digital health tools using AI to be trained with good quality, diverse, women’s data to generate non-invasive digital biomarkers.

“We envision a world where the future of AI in healthcare performs the best it can in women. We also have created a digital biomarker pipeline where our digital biomarkers can explain, influence, and even improve health outcomes for women,” shares Chong Rodriguez. Her accolades are far and many - her TED Talk on a smart bra for better heart health has over 1.8 million views, she has also been recognized as a 2021 TED Fellow, 2018 Medtech Boston 40 under 40 Healthcare Innovator, and in the top 100 Female Founders across the U.S. by Inc Magazine.

Chong Rodriguez graduated in Electrical Engineering and Computer Science from MIT along with the MIT Integrated Design and Management Program, and together with her cofounder Aceil Halaby whom she met at MIT, she cofounded Bloomer Tech - the first venture-funded startup focused on solutions for cardiovascular disease and stroke in women. Their patented technology platform leverages more than 20 years of evidence-based research showing sex and ethnicity-related differences in the cardiovascular system. This enables women, researchers, and care providers to learn from each individual's unique physiology and provide data-driven care remotely.

Part of the key is their patented gateway to the data which comes in the form of an everyday bra and acquires reliable medical-grade data on women continuously without affecting their natural lifestyle.

“We have definitely seen the space evolve from awareness to research and now putting words into action using the evidence that shows heart diseases and stroke can present differently, uniquely, or predominantly in women because most of the solutions have not been designed for women’s physiology. When the FDA earlier this year announced strategic plans toward better understanding how medical devices perform in women, and there are many underperforming in the cardiovascular field, we see progress in taking responsibility to make changes that elevate the CDRH Health of Women Program,” adds Chong Rodriguez.

According to Chong Rodriguez, our standards of care use suboptimally performing diagnostic tests and medical devices and even the FDA provides a list of medical devices from major manufacturers where women are more likely than men to have complications. Some examples include devices like implantable cardioverter-type defibrillators where few women were enrolled in studies, or how after non-surgical procedures used to treat narrowing of the coronary arteries of the heart (percutaneous intervention) the ‘female sex’ can independently be a predictor of bleeding and death; and even women being ineligible to undergo certain treatments based solely on anatomy: length, diameter, size.

“The first thing is for women to have data when they need it the most, understanding their bodies, and being able to advocate for their own health. Being able to capture what her symptoms look like with medical-grade data and share it with her providers can optimize diagnosis and treatment for her. We as a society need to design more solutions around the unmet needs of women and other sub-populations that are receiving suboptimal health outcomes. AI in healthcare has the potential to either propagate disparities if trained without diverse data or to truly become personalized and effective if we develop solutions intentionally to improve health outcomes,” concludes Chong.

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