Cerebral embolic protection for stroke prevention during transcatheter aortic valve replacement.

Abstract

Introduction: Cerebral Embolic Protection Device (CEPD) captures emboli during Transcatheter Aortic Valve Replacement (TAVR). With recently published pivotal trials and multiple cohort studies reporting new data, there is a need to re-calibrate available statistical evidence.

Methods: A systematic literature search was conducted across databases from inception till February 2023. Dichotomous outcomes were pooled using Odds Ratio (OR), while continuous outcomes were pooled using Standardized Mean Difference (SMD) along with 95% corresponding intervals (95% CIs).

Results: Data was included from 17 studies (7 RCTs, 10 cohorts, n = 155,829). Use of CEPD was associated with significantly reduced odds of stroke (OR = 0.60, 95% CI = 0.43-0.85, p = 0.003). There was no significant difference in disabling stroke (p = 0.25), non-disabling stroke (p = 0.72), and 30-day mortality (p = 0.10) between the two groups. There were no significant differences between the two groups for Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) findings, acute kidney injury, risk of pacemaker implantation life-threatening bleed, major bleed, minor bleed, worsening National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and vascular complications (p > 0.05).

Conclusions: The use of CEPD during TAVR reduced the incidence of all-stroke (p = 0.003); however, there were no significant differences in any of the other pooled outcomes (p > 0.05).

Registration: The protocol of this meta-analysis was registered with the Open Science framework [https://doi.org/10.17605/OSF.IO/7W564] before data acquisition was started.