by Lynn Shapiro
, Writer | September 16, 2009
A puzzling study finds the use of defibrillators in women with heart failure does not decrease their chances of sudden cardiac death, according to researchers at Providence Hospital in Southfield, MI. The study is published in the Sept. 14, 2009 issue of the Archives of Internal Medicine.
Providence researchers conducted a meta-analysis of five major ICD (implantable cardiac defibrillator) clinical trials encompassing 934 women with heart failure. The analysis found no statistically significant benefit for those women that received an ICD, compared to patients treated with medical therapy.
Could the medical approach--treating with drugs rather than surgery or devices--be more appropriate in women? More research is needed, experts say.
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"Until now, the effectiveness of ICD treatment in women with heart failure had not been closely evaluated," says Christian Machado, M.D., electrophysiologist at the Providence Hospital and the study's principal investigator. "As a result of clinical trials, ICD therapy for heart failure is widely accepted as a standard of care for both men and women. However, the majority of the patients involved in clinical trials have been men," she says.
Dr. Machado adds the results make it clear that further study is necessary to determine whether using the same treatment strategy for men and women is the best approach.
In an editorial accompanying the study, Dr. Rita Redberg, a professor at the University of California in San Francisco, wrote that the review pointed up the need for women and minorities to be better represented in clinical trials.
Dr. Redberg added that given the cost of defibrillators and data showing that women suffer more post-implant complications than men, "it is important to know the benefits of ICD use for women."
The findings will no doubt be closely watched by Boston Scientific, Medtronic and St. Jude Medical. All sell defibrillators, which cost more than $35,000.