Outcomes of Leadless Pacemaker implantation following transvenous lead extraction in high-volume referral centers: real-world data from a large international registry

Gianfranco Mitacchione, Marco Schiavone, Alessio Gasperetti, Gianmarco Arabia, Alexander Breitenstein, Manuel Cerini, Pietro Palmisano, Elisabetta Montemerlo, Matteo Ziacchi, Simone Gulletta, Francesca Salghetti, Giulia Russo, Cinzia Monaco, Patrizio Mazzone, Daniel Hofer, Fabrizio Tundo, Giovanni Rovaris, Antonio Dello Russo, Mauro Biffi, Ennio C L PisanòGian Battista Chierchia, Paolo Della Bella, Carlo de Asmundis, Ardan M Saguner, Claudio Tondo, Giovanni B Forleo, Curnis Antonio

Onderzoeksoutput: Articlepeer review

8 Citaten (Scopus)

Samenvatting

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.

Originele taal-2English
Pagina's (van-tot)395-404
Aantal pagina's10
TijdschriftHeart Rhythm
Volume20
Nummer van het tijdschrift3
Vroegere onlinedatum7 dec 2022
DOI's
StatusPublished - mrt 2023

Bibliografische nota

Funding Information:
Funding Sources: This research did not receive any grant from funding agencies in the public, commercial, or not-for-profit sectors.

Publisher Copyright:
© 2022 Heart Rhythm Society

Copyright:
Copyright 2023 Elsevier B.V., All rights reserved.

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