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Women Underrepresented in Heart Device Studies

More Safety Data Needed on Use of High-Risk Heart Devices in Women

Room for Improvement continued...

She says that “we pretty much have a lot of data on aspirin and statins and a lot of women should be on statins or aspirin and some shouldn’t be,” she says. “This situation is one where we have a therapy indicated for a special reason and we may be using it in women when we don’t have as much information about the risks and benefits for them.”

“There is increased awareness about heart disease in women, and we have come a long way in that many more studies look at women,” she says.

Although there were no encouraging trends seen in the new study, a recent report did show that cardiac resynchronization therapy with a defibrillator is more effective in women than in men.

“We need more studies like this,” she says.

None of the information in the study should be taken as a reason for women to refuse treatment with a heart device. “If women meet guidelines for pacemakers because their heart is too slow or needs a defibrillator because she has a potentially fatal arrhythmia (heart rhythm abnormality), these are important indications and we should not withhold them,” she says.

“We just need to evaluate each candidate individually,” Goldberg says.

“If a woman is being told she needs a device, she almost certainly does,” says Cynthia Tracy, MD, director the Electrophysiology Laboratories at the George Washington University Hospital in Washington, D.C.

Going forward, "we want to resolve some of the unanswered questions about whether women benefit as much as men from these devices,” she says.

The study designs may make it hard to get women into the study because the way women present symptoms can be different than men, which can make recruitment challenging, she says. “We have to have enough women with equivalent disease in order to compare equivalent outcomes to force the issue and make sure that women are being recruited appropriately,” she says.

Women also need to be empowered with information on clinical trials.

“Some women see trials as a way of providing themselves excellent care, but some view clinical trials as human experiments and can be intimidated,” she says. “When we have a patient who has that instinct, we need to explain the risks, benefits, and treatment alternatives and explain why we are trying to recruit.”

Informed consent is paramount. “We must be very sure the person knows what is going on and why they are being recruited,” she says.

Lack of Sex-Specific Data Can Be Dangerous

“It seems like women are still not taking heart disease personally and advocating for themselves [and] this leads to under-referral and under-diagnosis of heart disease, which may lead to delays in discovery of safety and efficacy concerns regarding new devices,” says Pam Marcovitz, MD, medical director of Ministrelli Women’s Heart Center at Beaumont Hospital in Royal Oak, Mich.

“Unfortunately, this lack of sex-specific data reporting only serves to perpetuate the old myth that heart disease is a man's disease,” Marcovitz says.

“This is 15 years after the FDA, National Institutes of Health, and Congress strongly recommended addressing gender-specific issues, and we are still treating women as small men,” she says. “We should all be outraged by this.”


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