Key result
Leadless pacemakers linked to ~79% fewer mechanical complications but higher late mortality versus transvenous pacemakers.
Why the study?
Do leadless pacemakers compared to transvenous pacemakers improve clinical outcomes and reduce complications in adult patients without heart failure requiring a single-chamber ventricular pacemaker?
Cohort (n=2,316)
Yes
Do leadless pacemakers compared to transvenous pacemakers improve clinical outcomes and reduce complications in adult patients without heart failure requiring a single-chamber ventricular pacemaker?
Relative Risk: 0.21
p-value: p=<0.0001
In patients without heart failure, leadless pacemakers are associated with fewer mechanical complications but higher late mortality compared to transvenous pacemakers.
LPMs may reduce complications in non-HF patients but link to higher late mortality; leaves open need for randomized trials before any practice shift.
BACKGROUND: Despite leadless pacemakers (LPMs) showing promise, real-world data comparing them to transvenous pacemakers (TV-VVI) are insufficient and often contradictory, especially in patients without major comorbidities like heart failure. OBJECTIVES: Comparing LPMs with TV-VVIs in real-world patients without HF. METHODS: The TriNetX database (Jan 2015-June 2023) was queried to include adults receiving their first single-chamber ventricular pacemaker for heart block, bradycardia, sick sinus syndrome, atrial fibrillation, or syncope, excluding those with prior pacemakers, heart failure or enrolled for research settings. Propensity score matching (PSM) was done on 90 covariates. Primary outcomes were assessed after 1 week, 6 months, and 12 months and included mechanical complications, need for re-intervention, cardiac-related hemodynamic instability (CRHI), hospitalizations, and mortality. The risk ratio (RR) with a 95% confidence interval (CI) was reported. An E-sensitivity analysis assessed the impact of unmeasured confounders. RESULTS: Each group had 1,158 patients after PSM; 58.4% versus 58.9% were males, with mean ages of 74.9 versus 77.4 years. LPMs showed lower mechanical complications at all follow-up points (RR 0.16, 0.18, 0.21, p < 0.0001). CRHI was lower in the LPM group at 1 week and 6 months (RR 0.72, 0.85, p < 0.05) but higher mortality at 6 and 12 months (RR 1.436, 1.314, p < 0.05). Hospitalization rates and re-intervention rates were comparable between both groups. The E-value was satisfactory. CONCLUSION: In the absence of HF, LPM was associated with fewer rates of mechanical complications and CRHI. However, late mortality was higher with LPMs. Randomized trials comparing the two devices are crucial.
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Abdelsayed et al. (2025) conducted a cohort in Bradyarrhythmias without heart failure (n=2,316). Leadless pacemakers vs. Transvenous pacemakers (TV-VVI) was evaluated on Mechanical complications at 12 months (RR 0.21, p=<0.0001). Leadless pacemakers were associated with fewer mechanical complications at 12 months (RR 0.21, P<0.0001) but higher late mortality compared to transvenous pacemakers in patients without heart failure.
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