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. 2023 Mar;20(3):395-404.
doi: 10.1016/j.hrthm.2022.12.002. Epub 2022 Dec 7.

Outcomes of leadless pacemaker implantation following transvenous lead extraction in high-volume referral centers: Real-world data from a large international registry

Gianfranco Mitacchione  1 , Marco Schiavone  2 , Alessio Gasperetti  3 , Gianmarco Arabia  4 , Alexander Breitenstein  5 , Manuel Cerini  4 , Pietro Palmisano  6 , Elisabetta Montemerlo  7 , Matteo Ziacchi  8 , Simone Gulletta  9 , Francesca Salghetti  4 , Giulia Russo  10 , Cinzia Monaco  11 , Patrizio Mazzone  9 , Daniel Hofer  5 , Fabrizio Tundo  3 , Giovanni Rovaris  7 , Antonio Dello Russo  12 , Mauro Biffi  8 , Ennio C L Pisanò  10 , Gian Battista Chierchia  11 , Paolo Della Bella  9 , Carlo de Asmundis  11 , Ardan M Saguner  5 , Claudio Tondo  13 , Giovanni B Forleo  14 , Antonio Curnis  4
Affiliations

Outcomes of leadless pacemaker implantation following transvenous lead extraction in high-volume referral centers: Real-world data from a large international registry

Gianfranco Mitacchione et al. Heart Rhythm. 2023 Mar.

Abstract

Background: Limited data on the real-world safety and efficacy of leadless pacemakers (LPMs) post-transvenous lead extraction (TLE) are available.

Objective: The purpose of this study was to assess the long-term safety and effectiveness of LPMs following TLE in comparison with LPMs de novo implantation.

Methods: Consecutive patients who underwent LPM implantation in 12 European centers joining the International LEAdless PacemakEr Registry were enrolled. The primary end point was the comparison of LPM-related complication rate at implantation and during follow-up (FU) between groups. Differences in electrical performance were deemed secondary outcomes.

Results: Of the 1179 patients enrolled, 15.6% underwent a previous TLE. During a median FU of 33 (interquartile range 24-47) months, LPM-related major complications and all-cause mortality did not differ between groups (TLE group: 1.6% and 5.4% vs de novo group: 2.2% and 7.8%; P = .785 and P = .288, respectively). Pacing threshold (PT) was higher in the TLE group at implantation and during FU, with very high PT (>2 V@0.24 ms) patients being more represented than in the de novo implantation group (5.4% vs 1.6 %; P = .004). When the LPM was deployed at a different right ventricular (RV) location than the one where the previous transvenous RV lead was extracted, a lower proportion of high PT (>1-2 V@0.24 ms) patients at implantation, 1-month FU, and 12-month FU (5.9% vs 18.2%, P = .012; 3.4% vs 12.9%, P = .026; and 4.3% vs 14.5%, P = .037, respectively) was found.

Conclusion: LPMs showed a satisfactory safety and efficacy profile after TLE. Better electrical parameters were obtained when LPMs were implanted at a different RV location than the one where the previous transvenous RV lead was extracted.

Trial registration: ClinicalTrials.gov NCT05528029.

Keywords: CIED; Device-related complications; Leadless pacemaker; Micra; Transvenous lead extraction.

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