NEW YORK (Reuters Health)—Women with heart failure (HF) derive as much benefit from implantable cardiac defibrillators (ICDs) for primary prevention as men, according to a comparative effectiveness study.
"Randomized clinical trials demonstrated that the ICD confers survival benefit to many patients with heart failure; however, data on ICDs in women were inadequate due to the relatively small number of women enrolled in those trials," study investigator Dr. Sana Al-Khatib, heart rhythm specialist from Duke Clinical Research Institute in Durham, North Carolina, told Reuters Health by email.
This analysis, online January 12 in Circulation: Heart Failure, showed that women with heart failure and an ICD had "significantly better survival than women with no ICD," Dr. Al-Khatib said.
"Our findings support the gender-neutral guideline recommendations regarding the use of primary prevention ICDs in eligible patients. As a result, women with heart failure should be equally considered for a primary prevention ICD as men," she added.
For the analysis, researchers linked data from 264 hospitals participating in the Get With The Guidelines Heart Failure registry with data from the Centers for Medicare and Medicaid
Using propensity score matching, they created a cohort of 430 women with heart failure and a preventive ICD and 430 similar women with heart failure but no ICD. For comparison, they propensity score matched 859 men with heart failure and an ICD to 859 men without an ICD.
After three years, 40.2% of women with an ICD had died, compared with 48.7% of women without an ICD. The corresponding mortality rates in men were 42.9% and 52.9%.
In the matched cohorts, an ICD was associated with "similarly better survival" in women and men (hazard ratios, 0.78 and 0.76, respectively). There was no interaction between sex and presence of an ICD with regard to survival (p=0.79).
"Despite the survival benefits of primary prevention ICDs in patients with HF demonstrated in randomized clinical trials, benefit in the subgroup of women from these trials has not been
definitively proved. This uncertainty on survival benefit may be one of several contributing factors to the lower rates of ICD referral and implantation in eligible women," the investigators note in their article.
The current data, they conclude, "support current guideline recommendations" for the implantation of a primary prevention ICD in eligible women and men with HF and reduced left ventricular ejection fraction.
The Agency for Healthcare Research and Quality funded the study. One author reported consulting for Medtronic.