American heart journal · 2026
Cerebral embolic protection devices for transcatheter aortic valve replacement: A meta-analysis and trial sequential analysis.
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Elbenawi Hossam, Hassan Ibrahim, Abdelgalil Mahmoud Shaaban, Hanna Mariam, Almotawally Salma, Fayed Mahmoud, Mohamed Kareem A, Elnaggar Hossam, Abouainain Louna, Hamed Belal Mohamed, Ibrahim Ahmed, Khatib Ahmed Al, Elhelw Mohamed, Hassan Ehab, Eisa Mahmoud, Zaaya Morad, Ibrahim Ramzi, Goldsweig Andrew M, Saad Marwan, Alfonso Fernando, Alkhouli Mohamad, Elgendy Islam Y
Аннотация
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.
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.