Do leadless pacemakers improve short-term outcomes and reduce complications compared to conventional transvenous pacemakers in elderly patients?
In elderly patients, leadless pacemakers demonstrate comparable short-term safety and clinical outcomes to conventional transvenous pacemakers, with no statistically significant reduction in complications.
Abstract Background Leadless pacemakers (LPMs) have emerged as a promising alternative to traditional transvenous pacemakers (TVPs), particularly in reducing complications related to the pacemaker pocket and leads. This potential advantage could offer significant benefits to certain patient populations. However, evidence regarding the safety and performance of LPMs in elderly and very elderly individuals remains sparse and inconclusive, with few studies directly comparing these devices in this high-risk group. Methods A systematic search of multiple databases, including PubMed, Cochrane Library, Embase, Web of Science, and Scopus, was conducted to identify studies comparing LPMs to TVPs specifically in elderly patients. Random-effects models were utilized to calculate risk ratios (RRs) with 95% confidence intervals (CIs) for several outcomes, including all-cause mortality, device-related complications, rehospitalization rates, and lead/device dislodgement. The degree of heterogeneity among the included studies was assessed using the I² statistic. All statistical analyses were performed using R software (version 4.2.3). Results Four retrospective studies comprising 526 elderly patients were included, of which 277 (52.7%) received an LPM. The studies examined several clinical outcomes, with no statistically significant differences observed between the two groups. Specifically, all-cause mortality was comparable between the LPM and TVP groups (RR 1.08; 95% CI 0.48–2.42; p=0.85). Furthermore, LPM implantation did not show a significant reduction in acute complications (RR 0.51; 95% CI 0.22–1.17; p=0.11) or lead/device dislodgement (RR 0.54; 95% CI 0.13–2.16; p=0.38). Although point estimates favored LPMs, the wide confidence intervals for these outcomes reflect considerable uncertainty and suggest no clear or statistically significant benefit in the short term. Conclusions In elderly patients, leadless pacemakers (LPMs) show safety and short-term outcomes comparable to conventional transvenous pacemakers (TVPs). While trends suggest a potential reduction in complications and lead dislodgement, these differences were not statistically significant. Larger, prospective studies are needed to determine if LPMs offer meaningful clinical benefits in this population.
Filho et al. (Mon,) studied this question.