Cerebral embolic protection devices for transcatheter aortic valve replacement: A meta-analysis and trial sequential analysis.

BACKGROUND

Transcatheter aortic valve replacement (TAVR) is associated with periprocedural stroke risk due to embolic debris. The efficacy and safety of cerebral embolic protection devices (CEPDs) remain uncertain, with conflicting results between trials. We performed a meta-analysis of randomized controlled trials (RCTs) of current-generation CEPDs for TAVR.

METHODS

Electronic databases were searched for RCTs comparing clinical outcomes with routine CEPD use vs no CEPD use. Outcomes of interest included any stroke, disabling stroke, and all-cause mortality. Risk ratios (RR) or mean differences with 95% confidence intervals (CIs) were pooled using random-effects models. The analysis was complemented by meta-regression and trial sequential analyses.

RESULTS

The meta-analysis included 8 RCTs (5 filter-based and 3 shield-based) with 11,596 patients. CEPD use was not associated with a lower incidence of any stroke (RR 0.92; 95% CI 0.75-1.14), disabling stroke (RR 0.80; 95% CI 0.55-1.15), new magnetic resonance imaging-detected lesions (RR 1.00; 95% CI 0.93-1.07), or all-cause mortality (RR 1.04; 95% CI 0.71-1.51). Trial sequential analysis provided conclusive meta-analytic evidence and affirmed the absence of CEPD benefit. Meta‑regression showed no significant association between stroke risk and patient-level covariates, including age, sex, or the presence of diabetes, prior stroke, or atrial fibrillation (all P > .05).

CONCLUSIONS

Current-generation CEPD devices during TAVR did not significantly reduce the risk of any stroke, disabling stroke, or all-cause mortality. Trial sequential analysis indicates that, at least with available data, cumulative evidence appears sufficient to question the predefined benefit thresholds for existing systems. These findings suggest the lack of routine use of current-generation CEPD in TAVR.