Key result
Leadless pacemakers are linked to similar significant TR vs 4.1Fr leads but ~106% higher progression.
Why the study?
While leadless pacemakers and 4.1Fr stylet lumen-less transvenous leads may reduce the risk of tricuspid regurgitation progression compared with conventional leads, the optimal strategy between these two approaches remains unclear.
Does leadless pacemaker implantation compared to a 4.1Fr transvenous right ventricular lead increase the risk of tricuspid regurgitation progression in patients requiring pacemakers?
Cohort (n=217)
Does leadless pacemaker implantation compared to a 4.1Fr transvenous right ventricular lead increase the risk of tricuspid regurgitation progression in patients requiring pacemakers?
Implantation of a 4.1Fr transvenous right ventricular lead may be associated with a lower risk of tricuspid regurgitation progression compared to a leadless pacemaker at 12 months.
Higher TR progression with leadless pacemakers warrants vigilance; leaves open need for randomized confirmation of clinical impact.
BACKGROUND: Tricuspid valve regurgitation (TR) progression is a recognized complication of cardiac-implantable electronic devices. Implanting a leadless pacemaker (LLPM) or using a 4.1Fr stylet lumen-less transvenous lead may lower the risk of TR progression compared to conventional 5-7Fr transvenous leads; however, the optimal strategy remains unclear. This study aimed to evaluate TR progression following those two approaches. METHODS: A retrospective comparison was conducted between patients receiving an LLPM (n = 27) and those implanted with a 4.1Fr transvenous right ventricular lead (n = 190). The primary outcome was the prevalence of significant TR, defined as moderate or severe TR, at 12 months post-implantation. The secondary outcome was the incidence of TR progression, defined as a worsening of ≥1 grade between baseline and 12 months post-implantation. RESULTS: Baseline TR severity did not differ significantly between the two groups. At the 12-month follow-up, the prevalence of significant TR remained comparable between the LLPM and 4.1Fr lead groups (15% vs. 12%, p = 0.54). While most patients in both groups experienced either no change or a one-grade worsening in TR severity, the LLPM group demonstrated a significantly higher incidence of TR progression compared to the 4.1Fr lead group (33% vs. 16%, p = 0.034). Multivariate analysis identified left ventricular ejection fraction <50% as an independent predictor of TR progression (odds ratio 3.05, 95% confidence interval 1.08-8.61, p = 0.036). CONCLUSIONS: Implantation of a 4.1Fr lead in the right ventricular septum may be an optimal strategy to minimize the risk of TR progression following pacemaker implantation.
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Kawaguchi et al. (2026) conducted a cohort in Pacemaker implantation (n=217). Leadless pacemaker (LLPM) vs. 4.1Fr transvenous right ventricular lead was evaluated on Prevalence of significant TR (moderate or severe) at 12 months post-implantation (p=0.54). Leadless pacemakers showed similar rates of significant tricuspid regurgitation compared to 4.1Fr leads (15% vs 12%, p=0.54) but a higher incidence of TR progression (33% vs 16%, p=0.034).
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