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

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: Among 2425 Aveir VR LP and 21 335 TV-VVI patients included in this analysis, Aveir VR patients had significantly fewer acute device-related complications (1.4% versus 2.8%, P=0.002). Overall acute complications were similar between Aveir VR (6.5%) and TV-VVI (6.8%), P=0.69. Cardiac effusion/perforation rates were also similar between Aveir VR (0.4%) and TV-VVI (0.3%), P=0.45. Aveir VR had a 30% lower overall 12-month complication rate compared with TV-VVI (4.1% versus 5.7%, P=0.02), including a 47% lower device-related complication rate (2.8% versus 5.2%, P=0.0002). There were 61% fewer 12-month reinterventions with Aveir VR compared with TV-VVI (1.2% versus 3.2%, P<0.0001). Finally, Aveir maintained a comparable 30-day mortality but a lower 12-month mortality rate (17.0% versus 18.2%, P=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.