Sex differences in leadless pacemaker implantation: A propensity-matched analysis from the i-LEAPER registry

Gianfranco Mitacchione; Marco Schiavone; Alessio Gasperetti; Gianmarco Arabia; Fabrizio Tundo; Alexander Breitenstein; Elisabetta Montemerlo; Cinzia Monaco; Simone Gulletta; Pietro Palmisano; Daniel Hofer; Giovanni Rovaris; Antonio Dello Russo; Mauro Biffi; Ennio C L Pisanò; Paolo Della Bella; Luigi Di Biase; Gian Battista Chierchia; Ardan M Saguner; Claudio Tondo; Antonio Curnis; Giovanni B Forleo

doi:10.1016/j.hrthm.2023.07.061

Sex differences in leadless pacemaker implantation: A propensity-matched analysis from the i-LEAPER registry

Heart Rhythm. 2023 Oct;20(10):1429-1435. doi: 10.1016/j.hrthm.2023.07.061. Epub 2023 Jul 20.

Authors

Gianfranco Mitacchione¹, Marco Schiavone², Alessio Gasperetti³, Gianmarco Arabia⁴, Fabrizio Tundo⁵, Alexander Breitenstein⁶, Elisabetta Montemerlo⁷, Cinzia Monaco⁸, Simone Gulletta⁹, Pietro Palmisano¹⁰, Daniel Hofer⁶, Giovanni Rovaris⁷, Antonio Dello Russo¹¹, Mauro Biffi¹², Ennio C L Pisanò¹³, Paolo Della Bella⁹, Luigi Di Biase¹⁴, Gian Battista Chierchia⁸, Ardan M Saguner⁶, Claudio Tondo¹⁵, Antonio Curnis⁴, Giovanni B Forleo¹⁶

Affiliations

¹ Department of Cardiology, Luigi Sacco University Hospital, Milan, Italy. Electronic address: gianfrancomit@hotmail.com.
² Department of Cardiology, Luigi Sacco University Hospital, Milan, Italy; Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
³ Department of Medicine, Division of Cardiology, Johns Hopkins University, Baltimore, Maryland.
⁴ Department of Cardiology, Spedali Civili Hospital, University of Brescia, Brescia, Italy.
⁵ Department of Clinical Electrophysiology & Cardiac Pacing, Centro Cardiologico Monzino, IRCCS, Milan, Italy.
⁶ Department of Cardiology, University Hospital Zurich, Zurich, Switzerland.
⁷ Department of Cardiology, ASST Monza, San Gerardo Hospital, Monza, Italy.
⁸ Heart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate Program in Cardiac Electrophysiology and Pacing, Vrije Universiteit Brussel, Brussels, Belgium.
⁹ Arrhythmology and Electrophysiology Unit, San Raffaele Hospital, IRCCS, Milan, Italy.
¹⁰ Cardiology Unit, "Card. G. Panico" Hospital, Tricase, Italy.
¹¹ Cardiology and Arrhythmology Clinic, University Hospital "Umberto I-Salesi-Lancisi", Ancona, Italy.
¹² Department of Cardiology, IRCCS, Azienda Ospedaliero Universitaria Di Bologna, Policlinico S. Orsola, Bologna, Italy.
¹³ U.O.S.V.D. Elettrofisiologia Cardiologica-Ospedale "V. Fazzi", Lecce, Italy.
¹⁴ Department of Medicine, Albert Einstein College of Medicine, Montefiore Hospital, New York.
¹⁵ Department of Clinical Electrophysiology & Cardiac Pacing, Centro Cardiologico Monzino, IRCCS, Milan, Italy; Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.
¹⁶ Department of Cardiology, Luigi Sacco University Hospital, Milan, Italy.

PMID: 37481220
DOI: 10.1016/j.hrthm.2023.07.061

Abstract

Background: The impact of sex in clinical and procedural outcomes in leadless pacemaker (LPM) patients has not yet been investigated.

Objective: The purpose of this study was to investigate sex-related differences in patients undergoing LPM implantation.

Methods: Consecutive patients enrolled in the i-LEAPER registry were analyzed. Comparisons between sexes were performed within the overall cohort using an adjusted analysis with 1:1 propensity matching for age and comorbidities. The primary outcome was the comparison of major complication rates. Sex-related differences regarding electrical performance and all-cause mortality during follow-up were deemed secondary outcomes.

Results: In the overall population (n = 1179 patients; median age 80 years), 64.3% were men. After propensity matching, 738 patients with no significant baseline differences among groups were identified. During median follow-up of 25 [interquartile range 24-39] months, female sex was not associated with LPM-related major complications (hazard ratio [HR] 2.03; 95% confidence interval [CI] 0.70-5.84; P = .190) or all-cause mortality (HR 0.98; 95% CI 0.40-2.42; P = .960). LPM electrical performance results were comparable between groups, except for a higher pacing impedance in women at implant and during follow-up (24 months: 670 [550-800] Ω vs 616 [530-770] Ω; P = .014) that remained within normal limits.

Conclusion: In a real-world setting, we found differences in sex-related referral patterns for LPM implantation with an underrepresentation of women, although major complication rate and LPM performance were comparable between sexes. Female patients showed higher impedance values, which had no impact on overall device performance. Electrical parameters remained within normal limits in both groups during the entire follow-up.

Keywords: Cardiac implantable electronic device; Device-related complications; Leadless pacemaker; Micra; Sex differences.