Sex Differences in Early Complications After Cardiac Implantable Electronic Device Implantation: Myth or Reality

Abstract

Background Early complications after cardiac implantable electronic device (CIED) implantation remain clinically relevant and have been widely examined in large registry studies. Advanced age, comorbidities, device complexity, and antithrombotic therapy are recognized predictors of early complications. This study planned to examine the effect of sex on early (<= 30 days) device-related complications and to determine independent predictors of early major adverse cardiac events (MACE). Methods This retrospective, single-center study enrolled 1807 sequential patients (729 women, 1078 men) undergoing pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy implantation. Early MACE was described as consisting of pocket hematoma, pneumothorax, pericardial effusion/tamponade, and device-related infection within 30 days. Univariable and multivariable logistic regression analyses were conducted to determine autonomous prognostic factors. Results Early MACE occurred in 26 (3.6%) women and 41 (3.8%) men (p = 0.893). Device type distribution differed significantly by sex, with defibrillators more frequently implanted in men and pacemakers and resynchronization devices in women (all p < 0.001). Sex was not independently related to early MACE (OR 1.28, 95% CI 0.77-2.13; p = 0.337). Higher PORT scores (OR 1.06, p = 0.035), higher white blood cell counts (OR 1.09, p = 0.004), lower hemoglobin levels (OR 0.86, p = 0.024), and the presence of heart failure (OR 0.35, p = 0.002) remained independent predictors of early MACE. Conclusion Early CIED-related complications were infrequent and occurred at similar rates in women and men. Sex was not an independent predictor of early MACE; instead, overall clinical risk burden and systemic factors were the primary determinants of early adverse outcomes.