Key result
Among patients undergoing CIED implantation, female sex was not associated with a difference in 1-year risk-adjusted all-cause mortality compared to male sex (HR 1.05; 95% CI 0.70-1.29; p=0.77).
Why the study?
Whether outcomes after CIED differ between women and men remains uncertain, and prospective Australian outcome data were lacking.
Does female sex affect mortality or major complications after CIED implantation compared to male sex?
Cohort (n=5,360)
Yes
Does female sex affect mortality or major complications after CIED implantation compared to male sex?
Hazard Ratio: 1.05 (95% CI 0.7–1.29)
p-value: p=0.77
In a large Australian registry, clinical outcomes and complication rates up to 1 year after CIED implantation did not differ significantly between men and women.
Suggests equivalent post-CIED mortality by sex; leaves open whether sex-specific device strategies warrant prospective study.
BACKGROUND: There is uncertainty regarding whether outcomes after Cardiac Implantable Electronic Devices (CIED) differ between women and men. There are no prospectively collected data regarding Australian CIED outcomes. This study aimed to determine whether the characteristics and outcomes of Australian patients undergoing CIED implantation differ by sex. METHODS: We prospectively followed 5,360 patients undergoing CIED implantation between 2015 and 2019 in a large multi-centre Australian registry. Patient characteristics, procedural data, medications and clinical outcomes to 1 year were analysed. RESULTS: The mean age was 76.2 + 11.2 years, and 2022 (37.7%) were female. Women were older than men at device implantation (77.0 ± 11.6 years vs. 75.5 ± 10.9 years, p < 0.001). Most implants were de novo (79.7%). Pacing was more commonly for sick sinus syndrome in women than men (54.4% vs. 47.2%, p < 0.001) and less often for A-V block (28.3% vs. 35.1%, p < 0.001). Adverse events at 30 days were low compared to international cohorts, for mortality (0.06%) and major complications (0.6%). There were no significant sex differences (women vs. men) for death (HR 1.33, 95% CI 0.58-3.13, p = 0.49) or major complications (HR 1.41, 95% 95% CI 0.65-3.03, p = 0.39). At 1-year, there was no difference in major complications or risk-adjusted all-cause mortality (HR 1.05, 95% CI 0.70-1.29, p = 0.77) between women and men. CONCLUSIONS: Clinical practice and 30-day outcomes after CIED implantation in Australia are consistent with international reports. There were no differences in procedural complication rates or clinical outcomes at 1-year between women and men, regardless of age or CIED system implanted.
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Eccleston et al. (2021) conducted a cohort in Cardiac Implantable Electronic Devices (CIED) implantation (n=5,360). Female sex vs. Male sex was evaluated on Risk-adjusted all-cause mortality at 1-year (HR 1.05, 95% CI 0.70-1.29, p=0.77). Among patients undergoing CIED implantation, female sex was not associated with a difference in 1-year risk-adjusted all-cause mortality compared to male sex (HR 1.05; 95% CI 0.70-1.29; p=0.77).
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