TY - JOUR
T1 - Sex differences in leadless pacemaker implantation
T2 - A propensity-matched analysis from the i-LEAPER registry
AU - Mitacchione, Gianfranco
AU - Schiavone, Marco
AU - Gasperetti, Alessio
AU - Arabia, Gianmarco
AU - Tundo, Fabrizio
AU - Breitenstein, Alexander
AU - Montemerlo, Elisabetta
AU - Monaco, Cinzia
AU - Gulletta, Simone
AU - Palmisano, Pietro
AU - Hofer, Daniel
AU - Rovaris, Giovanni
AU - Dello Russo, Antonio
AU - Biffi, Mauro
AU - Pisanò, Ennio C.L.
AU - Della Bella, Paolo
AU - Di Biase, Luigi
AU - Chierchia, Gian Battista
AU - Saguner, Ardan M.
AU - Tondo, Claudio
AU - Curnis, Antonio
AU - Forleo, Giovanni B.
N1 - Publisher Copyright:
© 2023 Heart Rhythm Society
PY - 2023/10
Y1 - 2023/10
N2 - 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.
AB - 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.
KW - Cardiac implantable electronic device
KW - Device-related complications
KW - Leadless pacemaker
KW - Micra
KW - Sex differences
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U2 - 10.1016/j.hrthm.2023.07.061
DO - 10.1016/j.hrthm.2023.07.061
M3 - Article
C2 - 37481220
AN - SCOPUS:85167998160
SN - 1547-5271
VL - 20
SP - 1429
EP - 1435
JO - Heart Rhythm
JF - Heart Rhythm
IS - 10
ER -