Valvular & structural heart disease
Impact of Cerebral Embolic Protection on Cognitive Function After Transcatheter Aortic Valve Implantation: Data From the BHF PROTECT-TAVI Randomized Trial
Authors' conclusion
In the BHF PROTECT-TAVI trial, the use of CEP did not impact cognition after TAVI.
Study context
- Population
- Patients with AS undergoing transcatheter aortic valve implantation (TAVI) who underwent cognitive assessment, UKmodified ITT population
- Participants
- 3,535 patients
- Comparison
- TAVI with cerebral embolic protection (CEP) vs TAVI without CEP
- SENTINEL CEPn = 1,763
- Controln = 1,772reference
- Primary endpoint
- Mean change in telephone Montreal Cognitive Assessment (the Montreal Cognitive Assessment (t-MoCA)) score
- Follow-up
- Baseline to 6 to 8 weeks after TAVI
Methodological detailsmulticentre, 33 UK centres, 1:1 randomisation
- Multicentre
- 33 UK centres
- 1:1 randomisation
Primary result
As reported in the abstract
Mean change in t-MoCA, adjusted for baseline score
SENTINEL CEP
0.83
mean change · 95% CI 0.70–0.96
Control
0.91
mean change · 95% CI 0.79–1.04
- No difference in means between the treatment groups
- −0.07 [95% CI, −0.22 to 0.09], P=0.42
Secondary outcomes
| Outcome | SENTINEL CEP | Control | Risk difference (%) (95% CI) | P value | |
|---|---|---|---|---|---|
| ≥3-point drop in total t-MoCA score · 6 to 8 weeks | 8.7% | 8.0% | 0.72 (−1.10 to 2.55) | P = 0.44 | |
| −2024Difference, % (linear scale) |
Subgroups
- No evidence of interaction between treatment assignment and any subgroup
Original publication
Impact of Cerebral Embolic Protection on Cognitive Function After Transcatheter Aortic Valve Implantation: Data From the BHF PROTECT-TAVI Randomized Trial. Circulation. Published 30 August 2025. doi:10.
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