Abstract 9310: Gender and Outcomes Following Primary Prevention ICD Placement: Analysis of the NCDR ICD Registry
Background: Due to the small numbers of women enrolled in implantable cardioverter defibrillator (ICD) trials, outcome for women has not been well-described. This study compares intermediate-term outcomes in a large cohort of men and women receiving single or dual chamber ICDs for primary prevention.
Methods: 38,912 initial implants (25% women) with single or dual chamber ICDs for primary prevention between 2006 and 2009 in the NCDR ICD Registry were identified. Baseline characteristics and outcomes, including complications, six-month heart failure (HF) readmission, and six-month mortality were compared between men and women using chi-square tests for categorical variables and unbalanced t-tests for continuous variables. Complications were considered within 30 or 90 days of implantation, including pneumothorax requiring chest tube, hematoma requiring transfusion or evacuation, tamponade, or death within 30 days, or mechanical complications with system revision, device-related infection, or post-index ICD within 90 days. The differences in outcomes between genders were also examined through multivariable logistic regression models adjusting for possible confounders.
Results: Differences in baseline characteristics and drug therapy were noted between men and women (Table). Complications at 30 or 90 days, 6-month mortality, and 6-month HF readmission were significantly more frequent in women (p<0.001 for all). Differences in complications or mortality (OR 1.40, 95% CI 1.27,1.54, p<0.001), or HF readmission (OR 1.34, 95% CI 1.25, 1.44, p<0.001) persisted after adjusting for differences in baseline characteristics and device type.
Conclusions: Following ICD implantation for primary prevention indications, complication rates, six-month HF readmission rates, and six-month mortality rates are higher in women than men. Whether these gender differences in outcome impact the benefit of ICDs in women requires further investigation.
- © 2012 by American Heart Association, Inc.