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 [email protected] 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 [email protected] 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.
Keywords
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Article info
Publication history
Published online: December 06, 2022
Footnotes
Trial Registration ClinicalTrial.gov identifier: NCT05528029.
Funding Sources: This research did not receive any grant from funding agencies in the public, commercial, or not-for-profit sectors.
Disclosures: The authors report no disclosures.
Identification
Copyright
© 2022 Heart Rhythm Society. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Leadless pacing after transvenous lead extraction: Are we out of the woods?Heart RhythmVol. 20Issue 3
- PreviewConventional transvenous lead–based pacing systems have reached a level of sophistication to the point that we have durable hardware, techniques for safe and effective implantation, and ability for physiological cardiac pacing or cardiac resynchronization to minimize the possibility of cardiomyopathy. Despite these developments, chronic venous occlusion, infectious complications, lead fracture, and valvular complications remain major drawbacks. Leadless pacemakers (LPMs) were developed to overcome such limitations.
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