In recent years, improvements in surgical and percutaneous techniques, together with broader access to diagnostic tools, have led to a sharp increase in the number of valve procedures performed. Injury to the conduction system, with the consequent need for permanent pacemaker implantation (PPI), is a common complication after valve interventions, particularly those involving the aortic and tricuspid valves. Although technical refinements have helped reduce its incidence, it remains one of the most frequent adverse events in this setting.

Infectious complications related to conventional transvenous pacemakers (TVPs) are especially relevant in this population because they increase the risk of prosthetic valve endocarditis, thereby markedly worsening patient morbidity and mortality. The emergence of leadless pacemakers (LPs) over the past decade has substantially reduced pacing-related infectious complications, increasing interest in this technology for such patients. However, LP performance is variable, and their use remains limited in our setting because of their high cost, which has contributed to the limited evidence supporting their implementation.

The investigators of this study sought to consolidate the available data through a systematic review and meta-analysis of studies comparing outcomes in patients undergoing aortic or tricuspid valve interventions who required either a conventional pacing system or an LP.

To this end, they included retrospective and prospective studies, as well as case series with more than 10 patients, provided that they reported at least one of the main outcomes of interest: all-cause mortality, rehospitalization, residual tricuspid regurgitation, pacing burden, or device-related complications. Studies indexed in the main bibliographic databases (PubMed, Scopus, Web of Science, and the Cochrane Library) were reviewed through September 9, 2025.

Ultimately, 5 studies were included in the final analysis, comprising a total of 10494 patients, of whom 794 received an LP and 9700 received a conventional system. All studies were retrospective observational analyses and included only patients undergoing aortic valve procedures. Notably, one study accounted for more than 98% of the total population included (n = 10338). Study quality, assessed using the Newcastle-Ottawa Scale, was generally modest, with 4 of the 5 studies scoring between 4 and 6 out of 9 points. The resulting population showed the clinical profile typically seen in this setting, with advanced age and a substantial burden of comorbidity.

Compared with LPs, transvenous device implantation was associated with a higher rate of all-cause mortality (RR = 1.85; 1.06–3.20). LP use was also associated with a shorter hospital stay, although the absolute difference was modest (.67; .43–.90; fewer days of admission). No differences were found in rehospitalization rates between the 2 groups (RR = 1.13; .24–5.43), nor in the rates of pocket infection (RR = .37; .06–2.16) or lead dislodgement/device migration and vascular complications (RR = .72; .12–4.27). A qualitative assessment of residual tricuspid regurgitation was also performed, although this outcome was reported in only 2 studies with different follow-up durations, and no meaningful differences were identified.

In conclusion, the authors propose LPs as a tool worth considering in patients with bradyarrhythmias associated with transcatheter or surgical valve interventions.

Several limitations, most of them acknowledged by the authors themselves, must be borne in mind when interpreting these findings. The observational and retrospective design of the included studies precludes robust conclusions, and the level of evidence, according to the investigators, was low or very low. Selection bias may have influenced the differences observed in mortality, a finding that cannot be properly explored because of the limited individual characterization provided by each study. In addition, all included studies evaluated only patients undergoing aortic valve procedures, which prevents extrapolation to other settings, such as tricuspid valve intervention, where specific technical considerations could potentially maximize the benefit of LPs. Likewise, the small sample size of most studies likely resulted in limited statistical power for infrequent events, such as device dislodgement or infectious complications, which are probably among the most relevant endpoints when comparing LPs with conventional systems. Moreover, the magnitude of effect observed in the pooled analyses may have been heavily influenced by the study that represented more than 98% of the analyzed sample. A sensitivity analysis would have been necessary to confirm this and would likely have highlighted the low statistical power of the remaining studies.

COMMENTARY:

From a personal standpoint, I believe this study highlights the limited evidence currently available to assess the performance of LPs compared with conventional devices in valve patients. Although the methodological limitations prevent firm conclusions, the data do not suggest that these systems perform worse, which supports considering their use on the basis of the individual characteristics of each case.

REFERENCE:

Gad AS, Eissa OA, Awad L, Elkhouly A, Altaamreh SM, Saeed TZ. Leadless vs. Conventional Transvenous Pacemakers in Valve Intervention Patients: A Systematic Review & Meta-Analysis. Pacing Clin Electrophysiol. Published online February 3, 2026. doi:10.1111/pace.70148