Gender differences in procedure-related adverse events in patients receiving implantable cardioverter-defibrillator therapy.

BACKGROUND Women are at higher risk than men for adverse events with certain invasive cardiac procedures. Our objective was to compare rates of in-hospital adverse events in men and women receiving implantable cardioverter- defibrillator (ICD) therapy in community practice. METHODS AND RESULTS Using the National Cardiovascular Data Registry ICD Registry, we identified patients undergoing first-time ICD implantation between January 2006 and December 2007. Outcomes included in-hospital adverse events after ICD implantation. Multivariable analysis assessed the association between gender and in-hospital adverse events, with adjustment for demographic, clinical, procedural, physician, and hospital characteristics. Of 161,470 patients, 73% were male, and 27% were female. Women were more likely to have a history of heart failure (81% versus 77%, P<0.01), worse New York Heart Association functional status (57% versus 50% in class III and IV, P<0.01), and nonischemic cardiomyopathy (44% versus 27%, P<0.01) and were more likely to receive biventricular ICDs (39% versus 34%, P<0.01). In unadjusted analyses, women were more likely to experience any adverse event (4.4% versus 3.3%, P<0.001) and major adverse events (2.0% versus 1.1%, P<0.001). In multivariable models, women had a significantly higher risk of any adverse event (OR 1.32, 95% CI 1.24 to 1.39) and major adverse events (OR 1.71, 95% CI 1.57 to 1.86). CONCLUSIONS Women are more likely than men to have in-hospital adverse events related to ICD implantation. Efforts are needed to understand the reasons for higher ICD implantation-related adverse event rates in women and to develop strategies to reduce the risk of these events.