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 valveimplantation (TAVI) are susceptible to a decline in neurocognitive function. This may occurdue to embolization of material (e.g., valve, calcium) to the brain. Cerebral embolicprotection (CEP) devices are engineered to capture this debris, potentially mitigating itsincidence.Methods: This is a secondary analysis of the BHF PROTECT-TAVI trial where participantswith aortic stenosis from across 33 centers in the United Kingdom were randomly assigned ina 1:1 ratio to undergo TAVI with a CEP device (SENTINEL, Boston Scientific; Sentinel CEPgroup) or TAVI without a CEP device (control group). This analysis is restricted to those whounderwent cognitive assessment. The primary outcome was the mean change in the telephoneversion of the Montreal Cognitive Assessment (t-MoCA) between baseline and 6-8 weekspost-TAVI. The secondary outcome was a ≥3-point drop in total t-MoCA score betweenbaseline and 6-8 weeks post-TAVI.Results: A total of 3535 participants,1763 in the Sentinel CEP group and 1772 in the Controlgroup (mean age 81.0 years, 37.7% female) randomized in BHF PROTECT-TAVI wereincluded in the modified ITT population for this analysis. The median t-MoCA atpresentation was 18 (IQR: 16 to 20). The median t-MoCA at 6-8 weeks was 20 (IQR: 17 to21). The mean change in total t-MoCA score between baseline and 6-8 weeks adjusted for thebaseline score was 0.83 (95% CI 0.70 to 0.96) in the Sentinel CEP group, and 0.91 (95% CI0.79 to 1.04) in the Control group. There was no difference in means between the treatmentgroups (-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 theControl group. The corresponding RD was 0.72% (95% CI -1.10 to 2.55; p=0.44). Thesefindings were robust to sensitivity analyses. There was no evidence for an interactionbetween treatment assignment and any of subgroups assessed.Conclusion: In the BHF PROTECT-TAVI trial, the use of CEP did not impact cognitionfollowing TAVI.