068-I * CLINICAL AND HAEMODYNAMIC OUTCOMES IN 804 PATIENTS RECEIVING THE FREEDOM SOLO STENTLESS AORTIC VALVE: RESULTS FROM AN INTERNATIONAL PROSPECTIVE MULTICENTRE STUDY
Bibliographic record
Abstract
Objectives: The aim of this prospective, non-randomised, multicentre trial was to demonstrate the safety and effectiveness of the Freedom SOLO valve. Methods: From March 2009 to February 2013, a total of 804 consecutive patients (mean age 74.6 ± 6.3 years; 45.1% females; 91.4% in NYHA class II–III) underwent aortic valve replacement in 30 centres in Europe (18) and North America (6 US, 6 Canada). The cumulative follow-up was 1102 patient-years (mean 16.5 ± 10.8 months; range: 0–40.5 months). A total of 376 patients underwent concomitant procedures, with the majority of procedures being CABG (264 patients). Results: Sixty-four patients died (14 early, 50 late); 12 deaths (1 early, 11 late) were classified as valve-related. The actuarial freedom from valve-related death was 99.0%, 98.8%, 98.3% and 95.5% at 6 months, 1, 2 and 3 years, respectively. At 3 years, hazard rates were 1.55%/patient-year for endocarditis, 0.73%/patient-year for non-structural valve dysfunction, 0.55%/patient-year for SVD, 1.27%/patient-year for major thromboembolisms, 1.73%/patient-year for valve explants. No cases of valve thrombosis were observed. NYHA class I and II was observed in 95.7%, 97%, 95.5% and 91.4% of patients at 3–6 months, 1, 2 and 3 years postoperatively, respectively. Mean gradients and increase in effective orifice area for each valve size were stable over the follow-up period (Table 1). The mean left ventricular mass index decreased from 137.6 g/m2 at discharge to 127.1 g/m2 at 3–6 months, 121.8 g/m2 at 12 months, 120.5 g/m2 and 126.4 g/m2 at 2 and 3 years. Postoperative echocardiographic data by valve size Conclusion: The excellent clinical and haemodynamic results confirm the safety and effectiveness of the Freedom SOLO valve.
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How this classification was reachedexpand
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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, 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".