1-Year Results From a Multicenter Trial of a Polymer Surgical Mitral Valve
Bibliographic record
Abstract
BACKGROUND: Polymer leaflet material may extend the durability of surgical mitral valve replacement (SMVR) to provide stable long-term hemodynamics. The India Mitral Surgical Trial sought to evaluate the safety and performance of a novel polymer leaflet material as part of a surgical mitral valve (MV) prosthesis. OBJECTIVES: In this study, the authors sought to report 1-year outcomes in patients undergoing SMVR for MV disease using the Tria Mitral Valve (Foldax). METHODS: Adult patients requiring MV replacement were enrolled in a prospective single-arm multicenter trial at 8 clinical sites in India from April to November 2023. An independent physician screening committee reviewed each patient for study eligibility before enrollment. Safety events were adjudicated per standard Valve Academic Research Consortium 3 criteria guidelines, and valve performance was assessed by means of echocardiographic and computed tomographic imaging at 30 days and 1 year. Patients were maintained on a vitamin K antagonist (target international normalized ratio: 2.5). RESULTS: and 4.6 ± 1.7 mm Hg, respectively. There were 2 thrombotic events and 3 ischemic strokes, all in patients with subtherapeutic international normalized ratio. CONCLUSIONS: The polymer surgical MV demonstrated an acceptable safety profile and maintained stable hemodynamic performance through 1 year in patients undergoing MV replacement. Further study of this promising polymer leaflet technology is ongoing. (Clinical Investigation for the Foldax Tria Mitral Valve-India; NCT06191718).
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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 | 0.005 | 0.005 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.005 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".