Sex-based disparities in early complications following cardiac implantable electronic device implantation: a nationwide analysis

Background

Sex-based differences in outcomes following cardiac implantable electronic device (CIED) implantation remain incompletely characterized. Understanding disparities in acute in-hospital complications may inform procedural planning and patient safety strategies.

Methods

We analyzed the U.S. National Inpatient Sample (2016–2022) to identify adult hospitalizations undergoing CIED implantation. Among 1,279,800 identified admissions, patients <18 years and those undergoing concomitant coronary artery bypass grafting or ablation during the index hospitalization were excluded. Device types included pacemakers (802,220), implantable cardioverter-defibrillators ICD (201,720), and cardiac resynchronization therapy devices CRT (175,575).

The primary outcome was any major in-hospital complication. Secondary outcomes included in-hospital mortality, infective endocarditis, post-procedural shock, pericardial and pleural drainage, pocket drainage, pneumothorax, and CIED reoperation. Multivariable logistic regression assessed adjusted odds ratios (aOR) comparing females to males.

Results

Among 1,179,515 adult CIED implantations, 502,690 (42.6%) were females and 676,825 (57.4%) were males. Females had a lower incidence of any major in-hospital complication compared with males (15.6% vs 17.17%, p<0.001; aOR 0.94, 95% CI 0.92–0.97). Rates of in-hospital mortality were similar between sexes (1.07% vs 1.02%, p=0.30; aOR 0.96, 95% CI 0.87–1.05). Females had lower odds of infective endocarditis (0.65% vs 0.84%, p<0.001; aOR 0.76, 95% CI 0.69–0.85). However, females demonstrated higher odds of pericardial drainage (0.27% vs 0.19, p 0.01; aOR 1.28, 95% CI 1.06–1.55), pleural drainage (0.59 vs 0.51, p 0.04; aOR 1.13, 95% CI 1.00–1.27), and post-procedural pneumothorax (2.25% vs 1.34%, p<0.001; aOR 1.54, 95% CI 1.44–1.65). Rates of post-procedure shock and pocket drainage were similar between groups.

CIED reoperation during index hospitalization was less frequent in females (11.65% vs 14.25%, p<0.001; aOR 0.86, 95% CI 0.84–0.89). Mean length of stay was marginally shorter for females (6.02 vs 6.09 days, p=0.06). Total hospital charges were significantly lower among females ($142,215 vs $163,546, p<0.001).

Conclusions

In this large contemporary nationwide analysis, females undergoing CIED implantation experienced fewer overall major complications and reoperations compared with males but had significantly higher rates of thoracic procedural complications, including pneumothorax and pericardial or pleural drainage. These findings highlight the need for sex-specific procedural risk mitigation strategies to enhance patient safety and optimize outcomes following CIED implantation.

Clinical Implications

Recognition of sex-specific complication profiles may inform procedural planning, vascular access strategy, and peri-procedural monitoring to reduce preventable adverse events and improve equity in device-based cardiovascular care.Central IllustrationForest Plots