First North American experience with the transfemoral ACURATE‐<i>neo</i><sup>TM</sup> self‐expanding transcatheter aortic bioprosthesis
Bibliographic record
Abstract
Background: Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative for patients presenting with severe symptomatic aortic stenosis and considered at high‐surgical risk. Paravalvular leak (PVL), conduction disorders, and coronary obstruction remain unresolved procedure‐related complications. The aim of this manuscript was to report the first North American experience with the ACURATE‐ neo TM aortic bioprosthesis and its ACURATE‐TF TM delivery system (Symetis S.A., Ecublens, Switzerland). Methods: Transfemoral ACURATE‐ neo TM aortic valve implantation was performed in 20 patients. Clinical and echocardiographic assessment was performed at baseline, postprocedure and at least 30 days. Outcomes were assessed according to valvular academic research consortium (VARC‐2) criteria. Results: The mean age was 82.7 ± 7.0 years with a mean logistic‐EuroSCORE‐II of 5.0 ± 2.9% and Society of Thoracic Surgeons score of 4.7 ± 2.3%. Device success was achieved in all patients. The mean distance between the aortic‐annulus and the left main coronary artery ostium was 14.3 ± 3.2 mm, and eight (40%) patients had <12 mm. At 30 days, there were no deaths, conversions to surgery, or major procedure‐related complications. New‐pacemaker implantation was required in one (5.3%) patient. ACURATE‐ neo TM implantation resulted in a significant reduction in mean transvalvular gradient (49.9 ± 15.8 to 9.7 ± 5.7 mm Hg, P < 0.0001) and increase in effective‐orifice area (0.65 ± 0.16 to 1.83 ± 0.36 cm 2 , P = 0.001) at hospital discharge. Paravalvular leak was absent in four (20%) patients, trace in nine (45%) patients, and mild in seven (35%) patients. Hospital discharge occurred at a mean of 7.0 ± 4.5 days, and all patients were in NYHA class I–II at a mean follow‐up of 8.6 ± 2.3 months. Conclusion: The present initial North American experience shows that the ACURATE‐ neo TM aortic bioprosthesis was safely and successfully implanted by transfemoral approach. The special design of this newer‐generation device affords a stable and predictable implantation, while providing optimal hemodynamic performance with a relatively low rate of PPI. © 2016 Wiley Periodicals, Inc.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".