Key result
Leadless pacemakers show similar long-term mortality and complication rates between women and men.
Why the study?
Safety and efficacy are established for leadless cardiac pacemakers, but the presence of sex-specific disparities remains unclear.
Does female sex affect short- and long-term outcomes in patients undergoing leadless cardiac pacemaker implantation?
Observational (n=378)
No
Does female sex affect short- and long-term outcomes in patients undergoing leadless cardiac pacemaker implantation?
Leadless cardiac pacemaker implantation demonstrates comparable safety and long-term mortality between sexes, suggesting that the lower utilization in women is likely driven by differing clinical indications rather than worse outcomes.
Answers are grounded in this paper and cite their sources.
Supports leadless pacemaker use in eligible women; reinforces that lower utilization reflects indications rather than outcomes.
Background Safety and efficacy have been well demonstrated for Micra™ leadless cardiac pacemakers (LCPs). However, the presence of sex-specific disparities remains unclear. Methods The aim of this single-centre observational study was to assess the sex-specific short- and long-term outcomes in patients undergoing LCP implantation. Results In total, 378 LCPs were implanted in 127 women (33.6%) and 251 men (66.4%). The most frequent indications included atrial fibrillation with slow conduction (women: 31.5%, men: 44.6%), third-degree atrioventricular block (women: 31.5%, men: 33.5%) and sick sinus syndrome (women: 21.3%, men: 9.6%). Electrical performance parameters of LCPs were similar between sexes. Procedure-related complications during LCP implantation occurred more frequently in women (3.1%) compared to men (0.4%), though no difference was observed for all complications during the index stay (women: 3.9%, men: 1.6%, p = 0.18 ). In-hospital mortality was low for women (0.8%) and men (0.8%, p = 0.96 ). A multivariable logistic regression analysis adjusted for sex, age, diabetes, chronic kidney disease, coronary artery disease and transcatheter and surgical valve replacement revealed concomitant lead extraction (OR 9.153, p = 0.001) as the only predictor for complication or death during index stay. All-cause mortality was 30.7% in women ( n = 39) and 27.5% in men ( n = 69, p = 0.28) during a median follow-up of 41 months (IQR 22–65 months). Conclusions No sex-specific disparities were observed with respect to complications during index stay, in-hospital and all-cause mortality. Less frequent use of LCP therapy in women may relate to differing indications between sexes. Further prospective studies may help to develop sex-specific recommendations for LCP therapy.
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Kiblboeck et al. (2026) conducted an observational in Bradyarrhythmias (n=378). Leadless cardiac pacemaker (Micra) vs. Male patients was evaluated on All-cause mortality (p=0.28). Leadless cardiac pacemaker implantation resulted in similar long-term all-cause mortality (30.7% vs 27.5%) and index stay complications (3.9% vs 1.6%) between women and men.