First‐in‐man transfemoral transcatheter aortic valve replacement with the 29 mm Edwards SAPIEN XT Valve
Bibliographic record
Abstract
OBJECTIVES: To demonstrate the feasibility of transfemoral transcatheter aortic valve replacement (TAVR) with the 29 mm Edwards SAPIEN XT valve and Novaflex™ + delivery system through a 20F expandable sheath (eSheath™, Edwards Lifesciences, USA). In addition, to describe the use of the Novaflex + delivery system and expandable sheath. BACKGROUND: TAVR has undergone significant advances in device technology resulting in smaller profile sheaths and delivery systems, allowing transfemoral delivery of a 29 mm valve. METHODS: Twelve patients underwent transfemoral TAVR with the 29 mm Edwards SAPIEN XT valve and Novaflex + delivery system through a 20F expandable sheath. Baseline clinical and procedural characteristics are evaluated. In-hospital and 30-day outcomes are reported according to Valve Academic Research Consortium criteria. RESULTS: All patients were male with a mean aortic annulus diameter of 25.0 ± 1.1 mm and 25.9 ± 1.2 mm, on transesophageal echocardiography and multidetector computerized tomography, respectively. Mean iliofemoral minimal luminal diameter (MLD) was 8.0 ± 0.8 mm. Successful deployment of the valve occurred in 11 out of 12 patients. Valve embolization occurred in one patient. Aortic valve area increased from 0.7 ± 0.2 to 2.0 ± 0.5 cm(2) (P < 0.001). There were two major vascular complications; however, there were no in-hospital or 30-day neurological events, need for pacemaker insertion, or mortality. CONCLUSIONS: Transfemoral TAVR with the 29 mm Edwards SAPIEN XT valve and Novaflex + delivery system through a 20F expandable sheath was feasible with acceptable short-term outcomes.
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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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.009 |
| 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".