Background <p>Safety and efficacy have been well demonstrated for Micra™ leadless cardiac pacemakers (LCPs). However, the presence of sex-specific disparities remains unclear.</p> Methods <p>The aim of this single-centre observational study was to assess the sex-specific short- and long-term outcomes in patients undergoing LCP implantation.</p> Results <p>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%, <i>p</i> = <i>0.18</i>). In-hospital mortality was low for women (0.8%) and men (0.8%, <i>p</i> = <i>0.96</i>). 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, <i>p</i> = <i>0.001)</i> as the only predictor for complication or death during index stay. All-cause mortality was 30.7% in women (<i>n</i> = 39) and 27.5% in men (<i>n</i> = 69, <i>p</i> = <i>0.28)</i> during a median follow-up of 41 months (IQR 22–65 months).</p> Conclusions <p>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.</p> Graphical Abstract <p></p>

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Sex-specific short- and long-term outcomes in patients with leadless cardiac pacemakers

  • Daniel Kiblboeck,
  • Karim Saleh,
  • Jakob Boetscher,
  • Hannah Rohringer,
  • Julian Maier,
  • Justin Lacher,
  • Christian Reiter,
  • Joerg Kellermair,
  • Helga Wagner,
  • Stefan Raidl,
  • Thomas Lambert,
  • Clemens Steinwender,
  • Hermann Blessberger

摘要

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.

Graphical Abstract