Leadless pacemaker implantation at the time of infected device extraction: Ready for prime time? Insights from the LEXIS global registry
R R Tilz, M Heinrich, H Burri, P Defaye, A Rinaldi, F Migliore, R Schaller, E Kiehl, U Birgersdotter-Green, M El-Chami, P Mitkowski, F Steinwender, I Diemberger, P Krisai, A TraubAbstract
Background
Leadless pacemakers (LPs) represent a potential alternative pacing strategy after extraction of infected cardiac implantable electronic devices (CIEDs) Preliminary studies have suggested that LP implantation may be safe in an infectious environment; however, evidence remains sparse.
Methods
The "LEadless pacemaker implantation after device eXtraction – a multIcenter retrospective regiStry (LEXIS)" that included 430 patients from 19 centers worldwide who underwent LP implantation following CIED extraction due to infection. Leadless pacemaker systems included devices with passive tine fixation (PTF) and active helix fixation (AHF). Indications for extraction included systemic infection, pocket infection, or both. LP implantation was performed either concomitantly (concomitant group) during the extraction procedure or as a staged intervention (staged group). Major and minor complications related to transvenous lead extraction were assessed according to the EHRA consensus document. In addition, LP procedural complications were recorded. Outcomes were evaluated at 1 and 12 months of follow-up.
Results
A total of 430 patients from 19 centers were included in the analysis(Table 1). The majority of devices were PTF systems (n = 210; 81.1%). Concomitant LP- implantation was performed in 48.0% of patients. Minor complications occurred in 7.6% of procedures, while major complications related to the extraction procedure were rare, affecting 8 (2.0%) patients in total (pericardial tamponade requiring pericardiocentesis n=3, intraprocedural cardiac arrests n=2, flail tricuspid leaflet n=1, postprocedural, procedure-related death n=2). There were no significant differences on early major complications (p= 0.17), while procedure time differed significantly between concomitant(90 min) and staged implantation(75min) (p=0.01). At 1-month follow-up, mortality was 6.5% (n=23). Active infection was still present in 5 patients (2.0%). Importantly, no vegetation at a LP was observed. Twelve months FU was completed in 243/403 (60.2 %) pts. At 12 months, mortality was 17,6% (n=52), and n=1 (0.4%) LP reinfections occurred, which was managed by extraction. Reimplantation of a transvenous system was required in 16 patients (6.5%), most frequently due to pacemaker syndrome (43.7%), followed by heart failure (31.3%) and defibrillator indication (25.0%). Among these, 7 LPs (44.8%) were extracted, and 9 (53.2%) were left in situ and turned off.
Conclusion
LP implantation after extraction for CIED infection was feasible and safe, with low periprocedural complication rates and only one reinfection during 12-month follow-up. Concomitant implantation during extraction was as safe as a staged approach. The need for later reimplantation of a transvenous system was infrequent. These findings support leadless pacing as a reliable strategy in patients requiring device removal for infection.Baseline characteristics