Clinical or Symptomatic Leaflet Thrombosis Following Transcatheter Aortic Valve Replacement: Insights from the U.S. FDA MAUDE Database
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Bibliographic record
Abstract
BackgroundData on clinical or symptomatic leaflet thrombosis after transcatheter aortic valve replacement (TAVR) are limited. Whether clinical leaflet thrombosis has significance beyond peri-TAVR stroke or transient ischemic attacks (TIA) is yet to be elucidated.MethodsBetween January 2012 and October 2015, we searched the MAUDE database for all entries with the identifier code, “NPT,” designated by the U.S. FDA to identify TAVR-related adverse events (AEs). Selected entries were searched further for the terms “leaflet,” “central aortic regurgitation,” and “aortic stenosis” to capture all events related to leaflet thrombosis causing structural valve dysfunction (SVD). Presentation of leaflet thrombosis (aortic stenosis or regurgitation or mixed valve lesion), mode of diagnosis (echocardiography, computed tomography, surgical explantation, or autopsy), and timing of presentation after TAVR were recorded. For all AEs of SVD due to leaflet thrombosis, the following outcomes were recorded: stroke or TIA, cardiogenic shock, and death from any cause.ResultsA total of 5691 TAVR-related AEs were reported in the MAUDE database. SVD due to leaflet thrombosis was reported in 30 cases. Most cases (n = 18/30, 60.0%, 95% CI 0.41–0.77) occurred in the first year following TAVR. SVD manifested as either aortic stenosis (n = 16/30, 53.3%, 95% CI 0.34–0.72), or regurgitation (n = 7/30, 23.3%, 95% CI 0.10–0.42), or both (n = 4/30, 13.3%, 95% CI 0.04–0.31). Interventions to address leaflet thrombosis included either escalation of antiplatelet or anticoagulant therapy (n = 9/30, 30.0%, 95% CI 0.15–0.49), valve-in-valve TAVR (n = 5/30, 16.7%, 95% CI 0.06–0.35), or surgery (n = 14/30, 46.7%, 95% CI 0.28–0.66), or their combination. Outcome following leaflet thrombosis included stroke/TIA (n = 3/30, 10.0%, 95% CI 0.02–0.27), cardiogenic shock (n = 2/30, 6.7%, 95% CI 0.01–0.22), and death (n = 9/30, 30.0%, 95% CI 0.15–0.49).ConclusionClinically manifest leaflet thrombosis was associated with serious manifestations that included stroke, cardiogenic shock, and death.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it