Leadless pacemaker implantation following transvenous lead extraction: data from i-LEAPER registry

Abstract

Abstract Funding Acknowledgements Type of funding sources: None. Background transvenous (TV) pacemakers are negatively associated with local and systemic device-related infections, often requiring transvenous lead extraction (TLE). Moreover, patients reimplanted with a TV device following TLE, exhibit substantial mortality and reinfection rates during the subsequent follow-up (FU). In this setting, leadless pacemakers (LPMs) are appealing as a first choice for TLE patients requiring a pacemaker reimplantation. To date, limited data on real-world safety and efficacy of LPMs in patients who underwent TLE are available. Purpose The present study aims to assess long-term safety and efficacy of LPM implantation in patients who previously underwent TLE of a transvenous pacemaker, compared to LPM de novo implant patients. Methods Consecutive patients who underwent LPM implantation in 12 centers joining the International LEAdless PacemakEr (i-LEAPER) registry were enrolled. Patients receiving LPM following TLE (n=184) were compared with patients with de novo implant (n=995). The primary endpoint was LPM-related major complications rate at implant and during FU. Additionally, differences in electrical performance were assessed between the two groups. Completion of 12-months FU was obtained in all patients. Results 1179 patients were enrolled in this study and followed for a median of 12 [IQR 11-14] months. Baseline clinical characteristics resulted balanced among the two groups, apart from a higher prevalence of heart failure among recipients of LPM following TLE (16.8% vs. 9.4%, p=0.013). As reported in the Table, LPM related major complications and all-cause mortality did not differ among the two groups (1.6% TLE group vs. 2.2% de novo group, p=0.785, and 5.4% TLE group vs. 7.8% de novo group, p=0.288, respectively). Pacing threshold (PT) resulted higher in the TLE group throughout the FU (Figure-Panel A). Higher PTs were recorded in LPMs implanted at same location from where the previous transvenous lead was removed, as far as 12-months postimplant (Figure-Panel B), with a higher proportion of patients with high PT (>1 to 2V @0.24ms) in the first group at implant, 1-month, and 12-month FU (Figure-Panel C). Conclusion In this real-world registry, LPMs showed a satisfactory safety and efficacy profile after TLE. In the post-TLE cohort, better electrical parameters were obtained when LPMs were implanted at a different location from where the previous transvenous lead was extracted.