Abstract 12244: Gender Differences in Leadless Pacemaker Peri-Procedural Adverse Events, Long-Term Device Functions, and Clinical Outcomes
Jingwen Huang, neal bhatia, Michael S Lloyd, Stacy Westerman, Anand Shah, Miguel A Leal, David B Delurgio, Anshul Patel, Christine Tompkins, Angel R Leon, Mikhael F El-Chami, Faisal M Merchant- Physiology (medical)
- Cardiology and Cardiovascular Medicine
Introduction: Some studies suggested gender differences in procedural complication rates and long-term outcomes for trans-venous pacemakers. Little is known about gender differences associated with leadless pacemaker (LP) implantation.
Methods: We reviewed all Medtronic Micra LP implants at our institution from 9/2014 to 9/2022. Device parameters (R wave sensing, impedance, and capture threshold), right ventricular pacing burden (RVP), left ventricular ejection fraction (LVEF), and 30-day adverse events post implant were obtained.
Results: Among 489 patients, 50.9% were men. Mean follow-up was 1.7 ± 1.5 years. Women were older than men at the time of LP implant (78.1 ± 14.7 vs 75.5 ± 15.3 years old, p=0.04). There were no significant differences in R wave sensing and RVP between genders. Impedance and LVEF were higher in women and capture thresholds were higher in men at both baseline and last follow up. Despite significant differences in device parameters between genders, differences were small and not clinically relevant in most cases (Figure). Mean number of device deployments required at implant was similar: women 1.3 ± 0.6 vs men 1.4 ± 0.9, p=0.16). Implant related complications were similar between women and men: access site hematoma (5 vs 9, p=0.42), pseudoaneurysm (0 vs 2, p=0.49), cardiac perforation (2 vs 1, p=0.62), 30-day re-hospitalization (16 vs 25, p=0.19) and 30-day mortality (16 vs 17, p=0.99). LVEF decreased over time in both genders (Figure). During follow-up, 4 women and 6 men required transvenous cardiac resynchronization therapy (CRT) implantation (p=0.75) and 4 women vs 2 men required transvenous dual chamber pacemaker implantation (p=0.44).
Conclusion: Outcomes of leadless pacemaker implantation are similar between women and men. Long-term device function is excellent in both genders. However, about 3% of all patients required device upgrade, highlighting the need for close electrophysiology follow-up after LP implant in both genders.