Alomari, Amal

Background: We conducted an updated meta-analysis of the routine use of cerebral embolic protection (CEP) devices in Transcathter Aortic Valve Replacement (TAVR). This analysis follows the recent BHF PROTECTED TAVI trial which is the largest randomized controlled trial to date. Methods: Electronic databases were searched through April 2025 for eligible randomized controlled trials (RCTs). The primary outcome was overall incidence of stroke, disabling stroke and non-disabling stroke all reported at 2-5 days and 30 days were primary outcomes for our analyses. Results: 8 RCTs with a total of 11,692 patients were included. No statistically significant difference was found between CEP group and the control group in overall stroke incidence at 2-5 days and 30 days as the following (RR=0.95, 95%CI: [0.75,1.19], p=0.64) and (RR=0.93, 95%CI: [0.57,1.53], p=0.79). Similarly, the pooled analysis revealed no statistically significant difference between the two groups in terms of disabling stroke at 2-5 days (RR=0.70, 95%CI: [0.41,1.18], p=0.18), and at 30 days (RR=1.18, 95%CI: [0.36,3.87], p=0.78). CEP group and control group didn’t show statistically significant difference in non- disabling stroke at 2-5 days and 30 days as the results showed: (RR=1.17, 95%CI: [0.84,1.63], p=0.36) and (RR=0.86, 95%CI: [0.49,1.51], P=0.61) respectively. Conclusion: Our meta-analysis found no statistically significant evidence that cerebral embolic protection (CEP) devices reduce the incidence of stroke—disabling or non-disabling in the 2-5 days following TAVR or after 30 days. Major bleeding, major vascular complication and AKI showed no statistically significant results indicating a neutral safety profile.