Abstract 15586: Efficacy and Safety of Cerebral Embolic Protection Devices in Transcatheter Aortic-Valve Replacement: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Introduction: Transcatheter aortic-valve replacement (TAVR) has emerged as a viable alternative to surgical aortic-valve replacement for high-risk patients. However, the procedure carries a significant risk of cerebral embolism. Cerebral embolic protection (CEP) devices have been proposed to mitigate this risk, yet current evidence of their efficacy remains inconsistent. Hypothesis: This study aims to comprehensively evaluate the effectiveness and safety of CEP devices during TAVR. Methods: A systematic literature search was conducted in MEDLINE, EMBASE, and Scopus up to April 2023. Randomized controlled trials (RCTs) comparing TAVR with and without CEP were included. The study assessed total lesion volume using mean difference (MD), while stroke, mortality, bleeding and vascular complications, and new magnetic resonance imaging (MRI) detected lesions were evaluated with relative risk (RR); both were analyzed via random-effects models using R software (version 4.0.3) with the metafor and meta packages. Results: The meta-analysis incorporated five RCTs involving 3,845 patients (2,070 received CEP devices, and 1,775 served as a control). The pooled analysis showed a non-significant mean difference in total lesion volume of -14.43 (95% CI: -104.97 to 76.09, P=0.75, I2=90%), indicating that CEP devices did not significantly alter the total lesion volume. In terms of other outcomes, the use of CEP devices did not significantly reduce the risk of stroke (RR 0.86, 95% CI: 0.62 to 1.22, P=0.41, I2=0%), disabling stroke (RR 0.50, 95% CI: 0.24 to 1.04, P=0.06, I2=0%), overall mortality (RR 1.35, 95% CI: 0.59 to 3.12, P=0.48, I2=0%), life-threatening or major bleeding (RR 1.09, 95% CI: 0.37 to 3.22, P=0.88, I2=19%), vascular complications (RR 1.83, 95% CI: 0.80 to 4.19, P=0.15, I2=29%), or the occurrence of new lesions seen on MRI (RR 0.99, 95% CI: 0.93 to 1.06, P=0.78, I2=17%). Conclusions: The results indicate that CEP devices during TAVR did not significantly alter important clinical outcomes, challenging the presumed benefits of these devices. Owing to the limited number of studies and short follow-up periods, further large-scale RCTs with more sophisticated designs and longer follow-ups are needed to validate these results and inform future guidelines.