Heart Device Might be Useless for Women

Dr. Alfred A. Bove, a heart failure specialist from Temple University in Philadelphia and president of the American College of Cardiology, disagreed about the prospects for such a study.

In an interview, Bove pointed out that the five trials included in the meta-analysis were not originally designed to answer the gender question, so he cautioned that the results of comparing them should be considered hypothesis-generating.

But given the findings of the new study, Bove said there was no doubt that further research of ICDs in women was needed. Moreover, he said that the current push for comparative-effectiveness research in health care means that "there is now money available for this research."

Doctors Call for More Heart Attack and Gender Difference Studies

Dr. Douglas P. Zipes, professor of medicine at Indiana University School of Medicine's Krannert Institute of Cardiology in Indianapolis and Editor-in-Chief, of HeartRhythm, was also cautious about over-interpreting results of a meta-analysis.

"While unquestionably a woman's heart is different than a man's, nevertheless I would expect a heart in ventricular tachycardia or ventricular fibrillation to respond to appropriate therapy from an ICD regardless of sex," Zipes said when queried by MedPage Today and ABC News.

He said the most likely explanation for a difference, if in fact the difference is "real", the results are true, would be "competing causes of death between the sexes, i.e., women with heart failure are more likely to die of causes other than a ventricular tachyarrhythmia which can be treated by the ICD."

But Zipes with Bove that a prospective trial was needed to "prove or disprove this hypothesis."

However, use of these devices in women has been the exception rather than the rule—Medicare data indicate only 8.6 of every 1,000 women who meet criteria for ICD for primary prevention of sudden cardiac death receive a device within a year of diagnosis versus 32.3 of every 1,000 men with the same diagnosis.

Likewise, according to the American Heart Association's Get With the Guidelines program, "women represented only 27.2 percent of patients of the total population who received ICDs and 37.5 percent of patients who did not."

Yet the gender question does not appear to be simple, according to Boston Scientific spokesperson, David Kinugson, who pointed out that a study recently published in the New England Journal of Medicine showed there was no discernable difference in ICD deaths between men and women.

Still many doctors feel that women, and people from a variety of ethnic backgrounds, need to be included more often in clinical trials.

"There is no doubt that women are underrepresented in clinical trials -- the issues are complicated," said Dr. James B. Young, of the Cleveland Clinic in Ohio. "Many other demographic groups are underrepresented as well."

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