Leadless Versus Transvenous Single‐Chamber Ventricular Pacemakers: Real‐World Evidence From Aveir VR Coverage With Evidence Development Study
Bibliographic record
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‐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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.014 | 0.059 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.004 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".