Impact of Cerebral Embolic Protection On Cognitive Function Following Transcatheter Aortic Valve Implantation: Data From the BHF PROTECT-TAVI Randomized Trial.

Background: In addition to the risk of stroke, patients undergoing transcatheter aortic valve implantation (TAVI) are susceptible to a decline in neurocognitive function. This may occur due to embolization of material (e.g., valve, 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 where participants with aortic stenosis from across 33 centers in the United Kingdom were randomly assigned in 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 6-8 weeks post-TAVI. The secondary outcome was a ≥3-point drop in total t-MoCA score between baseline and 6-8 weeks post-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% female) randomized in BHF PROTECT-TAVI were included in the modified ITT population for this analysis. The median t-MoCA at presentation was 18 (IQR: 16 to 20). The median t-MoCA at 6-8 weeks was 20 (IQR: 17 to 21). The mean change in total t-MoCA score between baseline and 6-8 weeks adjusted for the baseline score was 0.83 (95% CI 0.70 to 0.96) in the Sentinel CEP group, and 0.91 (95% CI 0.79 to 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 154/1763 (8.7%) in the Sentinel CEP group and 142/1772 (8.0%) in the Control group. The corresponding RD was 0.72% (95% CI -1.10 to 2.55; p=0.44). These findings were robust to sensitivity analyses. There was no evidence for an interaction between treatment assignment and any of subgroups assessed.

Conclusions: In the BHF PROTECT-TAVI trial, the use of CEP did not impact cognition following TAVI.