Cerebral Embolic Protection Device protects against stroke during Transcatheter Aortic Valve Replacement (TAVR): An Updated Meta-Analysis

Abstract

Abstract Background Cerebral Embolic Protection Device (CEPD) is used to capture emboli during Transcatheter Aortic Valve Replacement (TAVR). Previous meta-analyses have yielded conflicting results regarding efficacy and safety of CEPD in TAVR. With recently published pivotal trial and multiple Cohort studies reporting new data, there is a need of re-calibration of available statistical evidence. Aims The aim of our study was to explore the effects of using CEPD on TAVR outcomes. Methods A systematic literature search was conducted across Pubmed, Cochrane, Embase, and clinicaltrials.gov from inception till February 2023. Dichotomous outcomes were pooled using Odds Ratio (OR) while continuous outcomes were pooled using Standardized Mean Difference (SMD). Revman 5.4 was used to pool the data using random effects model With Mantel-Haenszel method. Subgroup analysis for study type (RCT vs NRS) was conducted. Sensitivity analysis using leave one out method and multiple exit method was conducted to find out, if unadjusted cohort studies had an impact on the pooled outcomes. Results The initial search revealed 870 articles. After primary and secondary screening, data was included from 17 studies (6 RCTs, 11 cohorts, n= 180187). Use of CEPD was associated with 50% reduced odds of stroke (OR=0.50, 95% CI=0.03-0.75, p=<0.01, I2=32%). There was no significant difference in 30 days mortality between the two groups (OR=0.76, 95% CI=0.44-1.31, p=0.33, I2=18%). On Diffusion Weighted Magnetic Resonance Imaging (DW-MRI), the two groups did not have any significant differences in volume per lesion (SMD=-0.07,CI=-0.28-0.14, p=0.52,I2=71%), Total volume of lesions (SMD=-0.08, p=0.73, CI=-0.53,0.17, I2=84%) and Number of lesions per patient (SMD=-0.15, p=0.45, CI=-0.23,0.10, I2=84%). On subgroup analysis, RCTs were found to have high heterogeneity while NRS had zero heterogeneity. The pooled analysis revealed no significant association with either of the group regarding Acute Kidney Injury (OR=0.84, p=0.43,I2=0%), risk of pacemaker implantation (OR=1.17,p=0.35,I2=0%), major bleed (OR=0.97,p=0.94,I2=62%), Worsening National Institute of Health Stroke Scale (NIHSS) (OR=0.46,p=0.36,I2=76%), and Vascular complications VC (OR=0.85,p=0.35,I2=0%). The results remained insignificant for subgroup analysis for study type and sensitivity analysis using leave one out and exit multiple methods for unadjusted cohort studies. Conclusion The use of CEPD during TAVR was found to be associated with reduced risk of stroke, however, there was no significant association with mortality, DW-MRI findings, AKI, major bleed, minor bleed, risk of pacemaker implantation, worsening NIHSS score and vascular complications. Further, large scale prospective trials are needed to provide definitive evidenceFig 1:Plots for mortality and strokeFig 2:Plots for VC and AKI