Gender Differences in Procedure-Related Adverse Events in Patients Receiving Implantable Cardioverter-Defibrillator Therapy

Abstract

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.