The worldwide mid-term experience with the Medtronic ADVANTAGE bileaflet mechanical heart valve.
Bibliographic record
Abstract
BACKGROUND AND AIM OF THE STUDY: A total of 639 patients (479 men, 160 women; mean age 60 +/- 10 years) underwent isolated aortic valve replacement (AVR) between 25 November 1999 and 20 October 2003, using the Medtronic ADVANTAGE bileaflet mechanical heart valve. The study aim was to quantify the clinical performance of a valve with two design modifications: (i) an enlarged central orifice intended to improve blood flow characteristics; and (ii) an asymmetric butterfly pivot recess with expanded outflow component designed to enhance the washing of blood flow through the pivot region. METHODS: Patients were enrolled at 21 centers located in Europe, Canada, Australia, and the USA. The study was conducted under the authority of regional ethics committees, as well as the respective national regulatory agencies. All centers adhered to a common protocol. RESULTS: The total follow up was 1,215.9 patient-years. The average systolic mean pressure gradient across the prosthesis was < 10 mmHg. The mean left ventricular mass index decreased by 22.87 g/m2 (13% reduction) over 12 months. The numbers of valve-related intraoperative, early (< or = 30 days or prior to discharge) and late (> or = 31 days) deaths were 0, 10 and 19, respectively. After one year and four years of follow up, 99.3% (n = 560) and 100% of patients (n = 37), respectively, were in NYHA class I or II. CONCLUSION: The evolutionary bileaflet design of the ADVANTAGE valve achieved the desired clinical functionality and performance.
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".