Limited data on the real-world safety and efficacy of leadless pacemakers (LPMs) post–transvenous lead extraction (TLE) are available.
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.
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.
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.
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.
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Published online: December 06, 2022
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.
© 2022 Heart Rhythm Society. All rights reserved.
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- 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.