Sex-Related Outcomes of Transcatheter Aortic Valve Implantation with Self-Expanding or Balloon-Expandable Valves: Insights from the OPERA-TAVI Registry
Bibliographic record
Abstract
ABSTRACT Background Evidence regarding sex-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study sought to evaluate the impact of sex on the treatment effect of Evolut-PRO/PRO+ (PRO) or Sapien 3 Ultra (ULTRA) devices on clinical outcomes. Methods Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter multinational registry including patients undergoing latest-iteration PRO or ULTRA implantation. Overall, 1174 out of 1897 patients were matched based on valve type and compared according to sex, while 470 males and 630 females were matched and compared according to valve type. Thirty-day and 1-year outcomes were evaluated. Results In both PRO and ULTRA group, males had a higher comorbidity burden, while females had smaller aortic root. Both 30-day (device success [DS], early safety outcome, permanent pacemaker implantation [PPI], patient-prosthesis mismatch [PPM], paravalvular regurgitation [PVR], bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke and heart failure hospitalization) did not differ according to sex in both valve groups. However, male sex decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction 0.047). A higher risk of 30-day PPI and 1-year stroke, and a lower risk of PPM was observed in PRO versus ULTRA, regardless of sex. No other differences were noted. Conclusions Sex did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, with the exception of 30-day DS that was decreased in males (versus females) receiving ULTRA (versus PRO).
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 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".