Comparison of baseline characteristics of population in france LEADLESS Registry and first ventricular leadless pacemaker implants in US

Background

Leadless pacemakers (LP) have been developed as an alternative to transvenous pacemakers (TVP) for patients in whom TVP is contraindicated or associated with high risk of lead- and pocket-related complications. A new ventricular (VR) LP system became available in US in 2022 and in Europe in 2023; it features active fixation with a helix, allows sensing and pacing parameter measurements prior to fixation, and is upgradable to a dual-chamber LP system.

Methods

The French Cardiology Society sponsors the France LEADLESS registry to evaluate the safety and performance of this VR LP system in 1,265 all-comer patients indicated for VVI(R) pacing. This observational study includes all early implants in French patients. We report preliminary demographic and clinical data for patients implanted between December 2023 and September 2025 at 39 sites. These data were compared with the early implants in U.S. population described in AVEIR VR CED study, which included 2,425 patients implanted with the same single-chamber LP between June 2022 and June 2024 after CMS approval. The objective was to identify similarities and differences between these two real-world cohorts and subgroups most likely to benefit from LP technology.

Results

When comparing the France LEADLESS cohort with the AVEIR VR CED leadless cohort, several notable differences emerged in demographic and clinical characteristics:

French patients were younger (mean age 74.1 ± 14.5 years, median 77 [69–84]) compared to U.S. patients (80 ± 8.8 years). Female representation was slightly lower in France (35.2% vs. 40.9%). The U.S. population exhibited a substantially higher prevalence of cardiovascular and systemic comorbidities : hypertension (94.3% in US cohort vs. 63.8% in French cohort), diabetes (43.9% vs. 27.5%), hypercholesterolemia (84.7% vs. 35.6%), renal disease (52.5% vs. 21.2%), COPD (27.5% vs. 8.2%), and coronary artery disease (57.5% vs. 24.6%).

Indications differed markedly between cohorts: AV block predominated in France (59.2%) versus 48.5% in the U.S., while sinus node dysfunction was rare in France (7.5%) but common in the U.S. (63.6%).

Conclusion

The France LEADLESS cohort represents a younger, less comorbid population with AV block as the main indication, whereas the U.S. cohort includes older patients with higher systemic disease burden and sinus node dysfunction. These differences likely reflect variations in clinical practice and patient selection criteria. LP adoption in both countries occurred immediately after commercialization, but patient profiles diverge significantly, suggesting that LP technology addresses distinct clinical needs across healthcare systems. Future analyses will assess outcomes and identify subgroups deriving the greatest benefit from LP therapy.