A Novel Valvuloplasty Scoring Balloon Catheter for Aortic Stenosis
Bibliographic record
Abstract
Background There has been a renewed interest in balloon aortic valvuloplasty (BAV) since the inception of transcatheter aortic valve replacement (TAVR) in treating aortic stenosis (AS). This study aimed to demonstrate the safety and feasibility of a novel aortic valvuloplasty balloon catheter for the treatment of symptomatic severe aortic valve stenosis. Methods Data from 25 patients who underwent BAV with the AngioSculpt Valvuloplasty Scoring Balloon Catheter at two Canadian centers with clinical follow-up and echocardiographic assessment at 30 days, 6 months, and 12 months were analyzed. Results Mean age of the patients was 83.6 ± 5.8 years with 68% females. Mean gradient across the aortic valve was 44.0 ± 15.1 mmHg pre- and 33.6 ± 13.8 mmHg post-valvuloplasty (average reduction of 24% post-BAV, p < 0.05). 38% of patients showed ≥ 30% aortic gradient reduction. There were no major adverse cardiovascular events. Stroke and major vascular complication rates were zero. Two patients had moderate aortic regurgitation post-valvuloplasty. Conclusion Preliminary results with a novel valvuloplasty scoring balloon for aortic stenosis demonstrate no safety concerns with a favorable gradient reduction. Additional studies will be required to demonstrate clinical utility in selected patients.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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) | 0.001 | 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 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".