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August 2, 2026Pacing and Clinical Electrophysiology0 citations

Tricuspid Valve Regurgitation Following Stylet Lumen‐Less Active Fixation Lead or Leadless Pacemaker Implantation

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KKKotoko KawaguchiSOSatoshi OkaNUNobuhiko Ueda

Key Result

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).

Key Points

  • This study evaluates the progression of tricuspid valve regurgitation (TR) following leadless pacemaker and transvenous lead implantation.
  • Retrospective comparison of patients receiving a leadless pacemaker (n=27) versus a 4.1Fr transvenous lead (n=190).
  • Primary outcome measured was the prevalence of significant TR at 12 months post-implantation.
  • Secondary outcome assessed was the incidence of TR progression defined as worsening by ≥1 grade.
  • At 12 months, significant TR prevalence was comparable between LLPM (15%) and 4.1Fr lead groups (12%, p=0.54).
  • LLPM group had a higher incidence of TR progression compared to 4.1Fr lead group (33% vs. 16%, p=0.034).
  • Left ventricular ejection fraction <50% independently predicted TR progression (odds ratio 3.05, 95% CI 1.08-8.61, p=0.036).

Study Design

Type

Cohort (n=217)

Structured PICO

Does leadless pacemaker implantation compared to a 4.1Fr transvenous right ventricular lead increase the risk of tricuspid regurgitation progression in patients requiring pacemakers?

P
Population
217 patients receiving either a leadless pacemaker or a 4.1Fr transvenous right ventricular lead, evaluated at 12 months post-implantation.
E
Exposure
Leadless pacemaker (LLPM) implantation
C
Comparator
4.1Fr stylet lumen-less transvenous right ventricular lead implantation
O
Outcome
Prevalence of significant tricuspid regurgitation (moderate or severe) at 12 months post-implantationsurrogate

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.

Main Result

Absolute Event Rate: 15% vs 12%

p-value: p=0.54

Abstract

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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Cite This Study

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).

synapsesocial.com/papers/6a6eeb3b1b0468a7eeab437ahttps://doi.org/10.1111/pace.70372
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