One procedure or two? Comparing concomitant and staged leadless pacemaker strategies after device infection (LEXIS subanalysis)

Background

Leadless pacemakers (LP) have emerged as an attractive re-implantation option in patients undergoing transvenous lead extraction (TLE) for cardiac implantable electronic device (CIED) infection. However, evidence comparing staged versus concomitant LP implantation strategies remains sparse.

Methods

The "LEadless pacemaker implantation after device eXtraction – a multIcenter retrospective regiStry (LEXIS)" that included 430 patients from19 centers worldwide who underwent LP implantation following CIED extraction due to infection. LP systems included passive tine (PTF) and active helix fixation (AHF). Indications for extraction were systemic infection, pocket infection, or both. TLE-related complications were classified according to EHRA criteria, and LP implantation complications were recorded. Outcomes were assessed at 1 and 12 months. This subanalysis compares staged versus concomitant LP implantation strategies.

Resutls:

Among 400 eligible patients, 239 (59.7%) underwent staged and 161 (40.3%) concomitant LP implantation. Baseline characteristics were similar except for more valve dysfunction > grade II (81 vs. 50; p=0.012) and greater pacemaker dependency (87 vs. 103; p=0.028) in the concomitant group. Procedural time was longer with concomitant implantation (75 [40–115] vs. 90 [60–123] min; p=0.006), while rates of incomplete lead removal, systemic infection, and lead vegetation were comparable.

Major complications or death did not differ between groups (1.0% vs. 3.0%; p=0.174). Periprocedural mortality, minor complications, ICU admission, and ICU days were similarly distributed. In staged patients, the median interval between TLE and LP implantation was 10 days (IQR 5–17); in the staged procedure, overall complication occured in 3.5% of cases, pericardial effusion occurred in 4 patients (1.4%) and arterial injury in 2 (0.7%). Hospital stay was significantly longer in the staged group, both from admission to discharge (20 [13–28] vs. 8 [3.5–16.3] days; p<0.0001) and from extraction to discharge (14 [8–22] vs. 3 [2–9] days; p<0.0001). Thirty-day mortality was numerically higher with concomitant implantation (10.3% vs. 6.3%), while 12-month mortality was comparable (21.2% vs. 19.2%).

Conclusion

Early mortality was numerically higher in the concomitant group, although not statistically significant, while 12-month mortality was identical between strategies. This early difference is likely influenced by selection bias, as patients who deteriorate or die around the time of TLE cannot undergo a staged procedure and therefore remain exclusively in the concomitant cohort. Concomitant LP implantation was associated with a substantially shorter hospital stay and allowed patients to undergo only a single procedure, while no significant differences in clinical outcomes were observed. Overall, both staged and concomitant strategies proved safe and feasible in patients undergoing TLE for device infection.