Cost-effectiveness of leadless versus transvenous single-chamber ventricular pacing: a propensity-weighted real-world study in France

Leadless pacemakers (LP) have emerged as an alternative to conventional transvenous single-lead ventricular pacemakers (SLP), with expanding indications beyond initially selected patients. This study evaluated the clinical and economic outcomes of LP compared with SLP in eligible patients from a real-world French hospital cohort.
We conducted a retrospective, propensity-weighted cost-effectiveness analysis from a hospital-based perspective, including all patients who underwent first LP or SLP implantation between 2016 and 2020 at our center. Patients with contraindications or high risk of device failure or infection were excluded. Four-year costs and life-years were used to estimate the incremental cost-effectiveness ratio (ICER). Cost-effectiveness acceptability curves (CEACs) were derived from the bootstrapped distribution of net monetary benefits. Sensitivity analyses explored cost drivers and robustness.
A total of 352 patients were included (104 LP, 248 SLP). After weighting, LP was associated with shorter procedure duration (52 vs 80 min; p < 0.001) and hospital stay (3.6 vs 4.3 days; p = 0.007). Major clinical events occurred in 25.2% (LP) vs 33.8% (SLP; p = 0.17). Although implantation costs were higher for LP (€11,344 vs €9,326; p < 0.001), total 4-year costs were comparable (€12,925 vs €11,713; p = 0.13). The survival difference was 0.06 years (p = 0.67), yielding an ICER of €20,387 per life-year gained. Bootstrap analysis indicated a 70% probability of cost-effectiveness at a €35,000 per life-year threshold.
In both device eligible patients, leadless pacemakers showed favorable procedural and clinical outcomes with comparable long-term costs, supporting their cost-effective use in real-world French hospital practice.
What is already known
Leadless pacemakers (LPs) were developed to overcome complications associated with conventional single-lead transvenous pacemakers (SLPs), such as pocket infection, lead dislodgement, and pneumothorax.
LPs have demonstrated lower complication and reintervention rates, as well as improved long-term survival in high-risk populations (e.g. dialysis or post–lead extraction patients).
Despite these advantages, their higher initial cost has limited widespread adoption, particularly among patients eligible for both pacing systems.

Leadless pacemakers (LPs) were developed to overcome complications associated with conventional single-lead transvenous pacemakers (SLPs), such as pocket infection, lead dislodgement, and pneumothorax.
LPs have demonstrated lower complication and reintervention rates, as well as improved long-term survival in high-risk populations (e.g. dialysis or post–lead extraction patients).
Despite these advantages, their higher initial cost has limited widespread adoption, particularly among patients eligible for both pacing systems.
What this study adds
This real-world, weighted cost-effectiveness analysis compares LP and SLP implantation over a 4-year follow-up in a population eligible for both devices from a hospital perspective.
The reduction in complications, operative time, and length of stay offsets approximately 65% of the initial additional cost of LPs in France.
Although survival benefit remains uncertain at 4 years due to wide confidence intervals, the incremental cost-effectiveness ratio (ICER) appears reasonable, with a 70% probability of cost-effectiveness. The overall value of LPs is strongly influenced by device price and by the time horizon considered.

This real-world, weighted cost-effectiveness analysis compares LP and SLP implantation over a 4-year follow-up in a population eligible for both devices from a hospital perspective.
The reduction in complications, operative time, and length of stay offsets approximately 65% of the initial additional cost of LPs in France.
Although survival benefit remains uncertain at 4 years due to wide confidence intervals, the incremental cost-effectiveness ratio (ICER) appears reasonable, with a 70% probability of cost-effectiveness. The overall value of LPs is strongly influenced by device price and by the time horizon considered.