Patient's lifetime budget impact of a leadless pacemaker compared to transvenous pacemakers in France

Abstract

Background

In France, >15,000 single-chamber pacemakers are implanted annually. Leadless pacemakers (LP) have emerged as an alternative to transvenous pacemakers (TVP), reducing complication and infection risks, especially for patients at high risk of complication. Since prior studies compared LP vs TVP costs over a single device lifespan, evidence remains limited on economic value across the patient’s lifetime, especially for those requiring multiple replacements or at high risk of infection.

Purpose

This study compares the lifetime economic value of LP vs TVP in pacing-eligible patients, accounting for successive replacements. It also evaluates budget impact across a simulated cohort, including high-risk subsets (ESRD, immunosuppression, CKD, COPD, cancer, diabetes and tricuspid disease).

Methods

A literature-based costing model was developed for LP and TVP. Complication rates were sourced from mainly French published data and multiplied by average per-patient costs. Device costs came from the reimbursement list (LPPR). Procedure costs were based on mean implant time and theatre rates. Hospital stay costs used patient stay distributions and daily tariffs. Only direct healthcare costs were included, adjusted to 2025 euros (€). Cumulative per-patient costs were modelled over time. Device and procedure costs were added at each implant/replacement using average battery life, while complication costs accrued linearly over each device’s lifespan.

A simulated cohort of 500 patients was drawn using mean implant age (72.1±11.8), sex ratio (M/F=1.27), and French life expectancy (80M/85.6F). Total costs until cohort death were simulated using survival time under pacing. Monte Carlo simulation (1,000 iterations) captured patients’ variability. Analyses covered total and high-risk populations, with or without maximal implantation age thresholds (MIAT) of 70, 75, and 80 years.

Results

At patient level, TVP implant cost (€5,259) was lower than LP (€8,542), but LP had lower de novo complication costs (€248 vs €918). Total lifespan cost was higher for LP (€8,790) than TVP (€6,177), though LP’s longer battery life (19.2y vs 10.1y) led to lower annual cost (€458 vs €613). TVP complication costs rose per replacement due to rising risk of infection following each replacement (1st: €1,328; €1,890; €3,014).

At population level, LP costs more than TVP in 74% of the 1,000 probabilistic cohort simulations, with a mean difference (MD) of €134k ±197k. LP became less costly in 85% of draws with MIAT 80y (MD=€174k±163k), and in 99.9% of draws with MIAT 75y (MD=€435k±105k). In ESRD, LP was cost saving without MIAT. LP was less costly in ≥95% of draws with MIAT 75y for tricuspid disease, and with MIAT 80y for all other high risk-groups.

Conclusion

Despite higher upfront LP costs, implanting LP in patients ≤75y (total population or tricuspid), ≤80y (high-risk excl. tricuspid and ESRD), and all ESRD patients yields ≥95% chance of lower long-term costs vs TVP.

**** Budget impact in total population

**** Budget impact in high-risk populations