Comparative Analysis of Leadless Versus Transvenous Pacemakers in Non-Heart Failure Patients: A Multicenter US Retrospective Study.

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.