Leadless Versus Transvenous Single-Chamber Ventricular Pacemakers: Real-World Evidence From Aveir VR Coverage With Evidence Development Study.

ABSTRACT:

Background

Aveir VR, a helix-fixation leadless pacemaker (LP), was US Food and Drug Administration (FDA)-approved in 2022. The performance of this novel LP has not been evaluated against transvenous single chamber ventricular pacemakers (TV-VVI) in a real-world setting. This observational coverage with evidence development study of Aveir VR implants (Aveir coverage with evidence development) evaluates complications and outcomes among Medicare beneficiaries implanted with Aveir VR immediately after FDA approval compared with those implanted with TV-VVI.

Methods

Medicare fee-for-service and Abbott device registration data were used to identify de novo Aveir VR LP (implanted 6/2022-6/2024) or TV-VVI (all manufacturers, implanted 1/2021-6/2024). Outcomes evaluated included 30-da

SUBMITTER: Ip JE 

PROVIDER: S-EPMC12684545 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature