Minneapolis medical conference will address why men and women are treated differently for heart attacks

Men and women are different when it comes to matters of the heart. And that's not relationship advice.

Women's hearts are more susceptible to certain kinds of diseases, and they produce symptoms that can lead to different care in emergency situations than men would get. Rather than feeling the classic complaint of extreme pressure in the chest during a heart attack, some women feel shortness of breath or upper-abdominal pain that they or their doctors may chalk up to acid reflux or anxiety.

Even though coronary heart disease is the No. 1 killer of women, clinical trials for medical devices to treat cardiovascular disease still enroll two men for every female participant. That long-standing imbalance — and the efforts to address it — will be a topic for discussion this week at AdvaMed 2016, the national med-tech industry conference at the Minneapolis Convention Center that runs through Wednesday.

"Clearly, it's beyond cardiovascular disease, but it's a really important issue in cardiovascular because that's the No. 1 killer of women in the United States," said Dr. Susan Alpert, the former FDA official and Medtronic executive who will lead a presentation Tuesday on improving recruitment of women into clinical trials. "We're not learning enough."

Heart disease is bad for men, too — it remains their No. 1 killer as well. But death rates from heart disease have not dropped as dramatically for women as they have for men.

It's a topic of particular interest in Minnesota, where medical device companies have a particularly robust presence in devices used in or near the heart.

The National Heart, Lung and Blood Institute in Washington said one reason men have benefited more from recent medical advances in cardiovascular disease might stem from a subset of heart disease called coronary microvascular disease, or MVD, which is much more likely to affect women than men.

"Standard tests for (coronary heart disease) are not designed to detect ­coronary MVD," according to the NHLBI website. "Thus, test results for women who have coronary MVD may show that they are at low risk for heart disease."

The Food and Drug Administration has been addressing the issue since at least 1993, when it formally reversed a 1977 agency guideline that recommended excluding any "premenopausal female capable of becoming pregnant" from early-stage clinical trials. FDA documents said the 1970s-era policy reflected a concern at the time about fetal exposure to such damaging therapies as thalidomide.

"In later years, however, that recommendation began to raise important ethical and even legal questions about the appropriateness of assuming that women cannot take steps to avoid becoming pregnant, where appropriate, and of deciding for women that protecting the fetus outweighed other possible interests," the FDA's website said.

At AdvaMed 2016, Alpert's session will explore some of the nuanced causes and solutions to the issue.

For example, having more women involved in designing clinical trials tends to make the studies more gender-balanced, by eliminating "exclusion criteria" that affect only women or offering support services like child care for younger women and transportation for older women to make sure they can take part, she said.

Alpert hopes to find a receptive audience at the conference, which will attract professionals from all walks of life, including those still near the beginning of their careers.

"We think and hope that it can have a great impact on furthering the issues and making this something that we don't have to keep discussing over time, as it will be well-understood and automatic to do these things in clinical trials," she said.

Joe Carlson • 612-673-4779