Clinical evaluation of the Hydra self‐expanding transcatheter aortic valve: 6 month results from the GENESIS trial
Bibliographic record
Abstract
OBJECTIVES: To evaluate the safety and performance of the Hydra transcatheter aortic valve (THV) in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND: The Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) is a novel flexible repositionable self-expanding system with supra-annular bovine pericardial leaflets, available in three sizes, covering aortic annuli between 17 and 27 mm. METHODS: The GENESIS trial was a prospective, multi-center, single-arm, 6 month follow-up study conducted in India. The primary performance endpoint was device success defined as per VARC-II criteria at 30 days. The primary safety endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: at 6 months (p < .0001). Mean aortic valve gradient decreased from 53.5 ± 18.1 to 8.9 ± 4.9 mmHg at 30 days and to 7.6 ± 2.7 mmHg at 6 months (p < .0001). The rate of new permanent pacemaker implantation was 7.5% at 30 days, and no patient had more than mild paravalvular leak at 6 months. The 30 days and 6 month all-cause mortality was 10.0 and 17.5%, cardiovascular mortality 7.5 and 7.5%, device-related mortality 5.0 and 5.0%, respectively. No patients had stroke up to 6 months. CONCLUSIONS: The GENESIS trial demonstrated high efficacy of the self-expanding Hydra THV. The cardiovascular mortality rate of 7.5% may partly be explained by the inclusion of some centres with no or limited previous experience in transcatheter aortic valve implantation.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".