Observational studyClinical research in cardiology : official journal of the German Cardiac Society2026
Sex-specific short- and long-term outcomes in patients with leadless cardiac pacemakers.
Observational study in Clinical research in cardiology : official journal of the German Cardiac Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundSafety and efficacy have been well demonstrated for Micra™ leadless cardiac pacemakers (LCPs). However, the presence of sex-specific disparities remains unclear.
methodsThe aim of this single-centre observational study was to assess the sex-specific short- and long-term outcomes in patients undergoing LCP implantation.
resultsIn 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).
conclusionsNo 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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