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Sex Differences in Early Complications After Cardiac Implantable Electronic Device Implantation: Myth or Reality?
1Department of Cardiology, Dağkapı State Hospital, Diyarbakır, Turkey.
Insights
Early cardiac device complications occur similarly in men and women. Clinical risk factors, not sex, predict adverse outcomes after cardiac implantable electronic device (CIED) implantation.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Research
Background:
- Early complications after cardiac implantable electronic device (CIED) implantation are a significant concern.
- Known predictors include age, comorbidities, device complexity, and antithrombotic therapy.
- The role of sex as a predictor of early CIED complications requires further investigation.
Purpose of the Study:
- To evaluate the impact of sex on early (≤ 30 days) CIED-related complications.
- To identify independent predictors of early major adverse cardiac events (MACE) following CIED implantation.
Main Methods:
- A retrospective, single-center study of 1807 patients undergoing CIED implantation.
- Data collected included patient demographics, device type, and early MACE (pocket hematoma, pneumothorax, pericardial effusion/tamponade, infection).
- Univariable and multivariable logistic regression analyses were performed to determine prognostic factors.
Main Results:
- Early MACE rates were similar between women (3.6%) and men (3.8%).
- Device type distribution varied by sex, with more defibrillators in men and pacemakers/resynchronization devices in women.
- Sex was not an independent predictor of early MACE; higher PORT scores, elevated white blood cell counts, lower hemoglobin, and heart failure presence were significant predictors.
Conclusions:
- Early CIED-related complications are infrequent and occur at comparable rates in both sexes.
- Sex is not an independent predictor of early MACE.
- Overall clinical risk burden and systemic factors are the primary determinants of early adverse outcomes after CIED implantation.
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.
