Device profile of the SAPIEN 3 transcatheter heart valve in low-risk patients with aortic stenosis: overview of its safety and efficacy
Bibliographic record
Abstract
INTRODUCTION: Transcatheter aortic valve replacement (TAVR) has become a treatment of reference for patients with symptomatic severe aortic stenosis, and the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems are two of the most broadly used worldwide. Lately, TAVR has progressively expanded toward the treatment of low-risk patients. AREAS COVERED: In this review we aimed to describe the main characteristics of the SAPIEN 3 valve, and to delineate the main clinical findings regarding the safety and efficacy associated with this THV system in low-risk patients undergoing TAVR. EXPERT OPINION: The approval of THV systems for use in low-risk patients has been a significant step forward in expanding current TAVR indications. Along with procedural refinement and growing operator experience, device iterations implemented in new-generation THV systems have played a vital role in the successful spread of TAVR. The availability of SAPIEN 3 represented an inflection point, as it allows for a predictable positioning and safer navigability while dramatically decreasing the rate of residual paravalvular leakage compared to previous balloon-expandable systems. However, some unresolved issues remain like the relatively high rates of conduction disturbances and the uncertainty about valve performance in the long-term. Future studies are warranted.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.004 |
| Bibliometrics | 0.000 | 0.001 |
| 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".