Medtronic: 'Pivotal Moment' in Women's Heart Health

Female-specific results from first-of-its-kind clinical trial

NORTHAMPTON, MA / ACCESSWIRE / May 1, 2024 / Teaching first graders takes a lot of energy. So when Julia Garcia started feeling worn out, teaching became extremely difficult.

"I got very tired and couldn't lift heavy things," she remembers. "I had dizzy spells and could barely walk. I thought 'my life is wreaking havoc on me.'"

Doctors struggled to pinpoint the problem, frustrating Julia and her husband Jose, both desperate for answers.

"Someone would diagnose one thing, then someone else would diagnose something else," Jose said. "I felt helpless. We didn't know which path to take."

Julia's case isn't unusual. Because when it comes to detecting and treating heart disease, the healthcare system often tilts in favor of men.¹

"Heart disease is regularly undetected, misdiagnosed and undertreated in women. Part of the reason is that historically, clinical heart research mainly studied men. So detection, treatment and standards of care often favor men over women," said Dr. Roxana Mehran, MD, Director of Cardiovascular Research at the Icahn School of Medicine at Mount Sinai in New York.

In 2021, Dr. Mehran led an international commission studying gender inequities in heart health care. And in 2020, she became one of two principal investigators in the Medtronic SMART study.

"The SMART study finally gives us female-specific data that allows us to more effectively treat women with aortic stenosis (AS). It's a critical step forward in treating women with heart disease," said Dr. Mehran.

"Pivotal Moment"

The groundbreaking SMART clinical trial focused on women with AS, a potentially deadly heart condition. In patients with AS, the aortic heart valve thickens and narrows to the point that blood flow is severely restricted. Left untreated the condition can be fatal;² treatment often requires replacement of the patient's aortic heart valve.³ While the study looked at both men and women with small annulus (heart valves), women typically have smaller heart valves than men, so nearly 90% of the patients in the study were women.

"It's a pivotal moment in women's health," said Nina Goodheart, senior vice president of the Structural Heart and Aortic Operating Unit at Medtronic. "For the first time, this trial gives physicians data from a head-to-head trial that tells them which transcatheter heart valve performs better, specifically in women with aortic stenosis. They've never had access to such female-specific data before."

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