Impact of Cerebral Embolic Protection on Cognitive Function After Transcatheter Aortic Valve Implantation: Data From the BHF PROTECT-TAVI Randomized Trial
Bibliographic record
Abstract
BACKGROUND: In addition to the risk of stroke, patients undergoing transcatheter aortic valve implantation (TAVI) are susceptible to a decline of neurocognitive function. This may occur because of embolization of material (eg, valve or calcium) to the brain. Cerebral embolic protection (CEP) devices are engineered to capture this debris, potentially mitigating its incidence. METHODS: This is a secondary analysis of the BHF PROTECT-TAVI trial (British Heart Foundation Randomized Trial of Routine Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation), in which participants with aortic stenosis from across 33 centers in the United Kingdom were randomly assigned at a 1:1 ratio to undergo TAVI with a CEP device (SENTINEL, Boston Scientific; SENTINEL CEP group) or TAVI without a CEP device (control group). This analysis is restricted to those who underwent cognitive assessment. The primary outcome was the mean change in the telephone version of the Montreal Cognitive Assessment (t-MoCA) between baseline and 6 to 8 weeks after TAVI. The secondary outcome was a ≥3-point drop in total t-MoCA score between baseline and 6 to 8 weeks after TAVI. RESULTS: A total of 3535 participants, 1763 in the SENTINEL CEP group and 1772 in the control group (mean age 81.0 years, 37.7% women) randomized in BHF PROTECT-TAVI were included in the modified intention-to-treat population for this analysis. The median t-MoCA at presentation was 18 (interquartile range, 16–20). The median t-MoCA at 6 to 8 weeks was 20 (interquartile range, 17–21). The mean change in total t-MoCA score between baseline and 6 to 8 weeks adjusted for the baseline score was 0.83 (95% CI, 0.70–0.96) in the SENTINEL CEP group and 0.91 (95% CI, 0.79–1.04) in the control group. There was no difference in means between the treatment groups (−0.07 [95% CI, −0.22 to 0.09], P =0.42). The incidence of a ≥3-point drop in the total t-MoCA score was 154 of 1763 (8.7%) in the SENTINEL CEP group and 142 of 1772 (8.0%) in the control group. The corresponding risk difference was 0.72% (95% CI, −1.10 to 2.55; P =0.44). These findings were robust to sensitivity analyses. There was no evidence of an interaction between treatment assignment and any of the subgroups assessed. CONCLUSIONS: In the BHF PROTECT-TAVI trial, the use of CEP did not impact cognition after TAVI. REGISTRATION: URL: https://www.isrctn.com ; Unique identifier: ISRCTN16665769.
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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 | 0.004 | 0.008 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.004 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".