339 * NORTH AMERICAN FDA TRIAL RESULTS AT ONE YEAR OF THE SORIN(R) FREEDOM SOLO PERICARDIAL AORTIC VALVE
Bibliographic record
Abstract
Objectives: A North American prospective, 15-centre FDA valve trial was designed to assess the safety and effectiveness of the Freedom SOLO stentless valve. Methods: Beginning in 2010, 249 patients (mean age 74 years, 60% male), were recruited in the trial. One hundred and nine patients have been followed for at least one year and are the basis of this review. Fifty-nine percent of patients were class III/IV. The majority of valves implanted were 25 mm or 27 mm (59%). Most patients had a normal ejection fraction (mean EF = 61.5%). The most common concomitant procedure was CABG (n = 57). Results: Ninety-five percent of patients were in NYHA class I or II (104/109). No patients suffered valve-related death, haemolysis, or structural valve deterioration at one year. Overall mean gradient for all patients was 7.86 mmHg, with a mean effective orifice area of 1.73 cm2. Mean gradients for valve sizes 21, 23, 25, and 27 were 9.7, 8.9, 6.9, and 7.3 mmHg respectively. Effective orifice area for valve sizes 21, 23, 25, and 27 were 1.3, 1.5, 1.7, 2.0 cm2. Thirty-day adverse events included atrial fibrillation (n = 31), pleural effusion (n = 12), and heart block (n = 3). Four patients had non-structural valve deterioration, 3 had paravalvular leak, and 2 had endocarditis at one year, non-valve related. One valve was explanted due to acute aortic insufficiency and was oversized at initial implantation. Conclusion: The Freedom SOLO valve demonstrated safety with no structural valve deterioration, and had excellent haemodynamics at one year.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.019 | 0.002 |
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".