Key result
Leadless pacemakers linked to ~174% higher mortality and greater perforation risk vs single-lead pacemakers.
Why the study?
Following a 2021 FDA warning regarding increased morbidity and mortality from perforation with leadless pacemakers, clinical outcome data remained limited.
Do leadless pacemakers increase the risk of mortality and adverse outcomes compared to single-lead pacemakers?
Observational
Yes
Do leadless pacemakers increase the risk of mortality and adverse outcomes compared to single-lead pacemakers?
Odds Ratio: 2.74
Absolute Event Rate: 5.3% vs 1.9%
p-value: p=< 0.001
Analysis of a US national database reveals that leadless pacemakers are associated with significantly higher risks of mortality and cardiac perforation compared to traditional single-lead pacemakers.
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Leadless pacemakers linked to higher mortality; leaves open whether selection bias drives findings in this retrospective analysis.
Parulkar et al. (2025) conducted an observational in Pacemaker implantation. Leadless pacemakers vs. Single-lead pacemakers (SL-PPM) was evaluated on Mortality (OR 2.74, p=< 0.001). Leadless pacemakers were associated with higher mortality (5.3% vs. 1.9%, p < 0.001; adjusted OR 2.74) and a higher risk of perforation (adjusted OR 2.92) compared to single-lead pacemakers.
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