Medtronic: 'Pivotal Moment' in Women's Heart Health - Seite 2

The trial studied 716 patients at 83 sites in Canada, Europe, the Middle East and Asia (EMEA), and the United States. It compared the performance of the Medtronic Evolut transcatheter aortic heart valve replacement (TAVR) system against the Edwards Sapien TAVR system, in patients with severe aortic stenosis and smaller heart valves. The groundbreaking findings, released on April 7, concluded that the Medtronic Evolut TAVR system performed better, particularly in terms of post-procedure hemodynamics (blood flow).

"We have to stop thinking that men and women are the same because they're not," added Goodheart. "A woman's physiology is different, so she may also present different symptoms. We urgently need to start addressing this underrepresentation of women in clinical trials. That's why the SMART study results are so important in the history of women's health."

In the case of Julia Garcia, who was not involved in the SMART study, cardiologists eventually determined that she too suffered from AS - her aortic valve was almost completely closed. Doctors recommended replacing her diseased valve with the Medtronic Evolut TAVR system. Cardiologist Dr. Jorge A. Alvarez of the Cardiology Clinic of San Antonio, TX, says they got to Julia in the nick of time. "Had her case gone undiagnosed much longer we may not be talking about the positive impact we had on her," he said.

"I wasn't afraid at all," Garcia said. "I was more afraid of what I had been going through. I knew I was in good hands. I felt better almost immediately after the surgery. I have a new life."

More needs to be done

Garcia's experience demonstrates not only the promise of heart valve replacement treatment, but also how much farther the healthcare system has yet to go in detecting and treating heart disease equally in men and women.

Even though heart disease is the number one killer of both sexes, many people don't know the symptoms of heart problems can be significantly different for women than men.⁴ Even doctors aren't always aware of the differences, and the reasons lie in the data. Research has found that female patients are included in less than 40 percent of clinical studies.⁵

"The SMART trial is an exciting starting point, but we have a lot more work to do to close the gender gap in medicine," Goodheart said. "This trial shows we can change the trajectory of medical care. Now we're going to need everyone - physicians, hospitals, governments, medical societies, insurers and companies - to work together and focus on re-shaping the future of medical treatment for women."

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