Abstract

Abstract Background limited data on real-world safety and efficacy of leadless pacemakers (LPMs) in patients who underwent transvenous lead extraction (TLE) are currently available. The present study aims to assess long-term safety and efficacy of LPMs implantation following TLE, compared with 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 end retrospectively considered. Patients receiving LPM following TLE (n=184) were compared with patients with de novo implant (n=995). The primary endpoint was LPM-related complications rate at implant and during follow-up (FU). Additionally, differences in electrical performance were assessed between the two groups. Results 1179 patients were enrolled in this study and followed for a median of 33 months. 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 whole follow-up (FU) (Figure 1). Higher PTs were recorded in LPMs implanted at same location from where the previous transvenous lead was removed, as far as 24-months postimplant (Figure 2), 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 3). 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.

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