Abstract Body (Do not enter title and authors here): Background:
Transcatheter aortic valve replacement (TAVR) is an established treatment for severe aortic stenosis, yet cerebrovascular complications such as stroke and transient ischemic attacks (TIA) remain significant concerns. Cerebral embolic protection (CEP) devices have emerged to mitigate these risks, but their efficacy remains debated. We aimed to evaluate the impact of CEP device use on cerebrovascular and mortality outcomes during TAVR using real-world data.
Methods:
This retrospective cohort analysis was conducted using TriNetX, a large federated health research network, capturing data from 68 healthcare organizations across the U.S. Patients undergoing TAVR with (Cohort 1) and without (Cohort 2) cerebral embolic protection devices were identified using ICD-10-PCS procedural codes. Outcomes evaluated included all-cause mortality, stroke, and TIA within one year post-procedure. Propensity score matching (1:1) was performed to balance cohorts on key variables, including age, sex, and race. Risk differences, odds ratios, and 95% confidence intervals (CIs) were calculated. Kaplan-Meier survival analysis and Cox proportional hazards modeling were used for mortality and cerebrovascular outcomes.
Results:
Following matching, each cohort comprised 25 patients. Baseline demographics were similar: mean age 82 vs. 81 years, 44% female in both groups. Mortality risk was identical in both groups (40% vs. 40%; risk difference 0.0, 95% CI [-0.272, 0.272]; p=1.00). TIA risk was also comparable (40% vs. 40%; risk difference 0.0, 95% CI [-0.272, 0.272]; p=1.00). However, the group with cerebral embolic protection demonstrated a significantly lower incidence of stroke (0% vs. 40%; risk difference -0.400, 95% CI [-0.592, -0.208]; p=0.000), indicating a potential protective benefit.
Conclusions:
This analysis suggests that the use of a cerebral embolic protection device during TAVR is associated with a significant reduction in stroke risk without impacting all-cause mortality or TIA risk. These findings support the selective use of cerebral embolic protection devices during TAVR to potentially reduce stroke risk. However, the small matched cohort size limits the generalizability of these results, and larger studies are warranted to validate these findings, assess cost-effectiveness, and refine patient selection criteria for optimal clinical outcomes.