Does the Aveir VR leadless pacemaker improve safety outcomes compared to transvenous single chamber ventricular pacemakers in Medicare beneficiaries?
In a real-world Medicare population, the Aveir VR helix-fixation leadless pacemaker demonstrated better safety outcomes compared to traditional transvenous single-chamber ventricular pacemakers.
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-day and 12-month complications, reinterventions, and mortality rates, adjusted for demographics, comorbidities, and hospital encounter characteristics. RESULTS: =0.02). CONCLUSIONS: This real-world evidence study, conducted immediately after commercialization of Aveir VR, demonstrates that safety of helix-fixation LPs is better than traditional TV-VVI pacemakers.
Ip et al. (Thu,) studied this question.
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