Observational studyJournal of the American Heart Association2025
Leadless Versus Transvenous Single-Chamber Ventricular Pacemakers: Real-World Evidence From Aveir VR Coverage With Evidence Development Study.
Observational study in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Double trouble in device infection: Concomitant transvenous and leadless pacemaker infection.HeartRhythm case reports · 2026Article
- Leadless Pacing and Dialysis Patients: A Match Made in Heaven.Journal of cardiovascular electrophysiology · 2026Article
- Inferior vena cava angiography through the protective sleeve for right-heart visualization in helix-fixation ventricular leadless pacemaker implantation.Heart rhythm O2 · 2026Article
- Leadless atrial versus transvenous pacing for sinus node dysfunction: 1-year outcomes from the leadless ARRIVE real-world study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAveir 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.
methodsMedicare 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.
resultsAmong 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%,
conclusionsThis 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.
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