Cerebral embolic protection devices for transcatheter aortic valve replacement: A meta-analysis and trial sequential analysis
Department
Internal Medicine
Document Type
Article
Publication Title
American Heart Journal
Abstract
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.
First Page
107449
DOI
10.1016/j.ahj.2026.107449
Volume
299
Publication Date
9-1-2026
Publisher
Mosby
Medical Subject Headings
Humans; Embolic Protection Devices; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Randomized Controlled Trials as Topic; Stroke; Intracranial Embolism
PubMed ID
42035975
Recommended Citation
Elbenawi, H., Hassan, I., Abdelgalil, M. S., Hanna, M., Almotawally, S., Fayed, M., Mohamed, K. A., Elnaggar, H., Abouainain, L., Hamed, B. M., Ibrahim, A., Khatib, A. A., Elhelw, M., Hassan, E., Eisa, M., Zaaya, M., Ibrahim, R., Goldsweig, A. M., Saad, M., Alfonso, F., Alkhouli, M., & Elgendy, I. Y. (2026). Cerebral embolic protection devices for transcatheter aortic valve replacement: A meta-analysis and trial sequential analysis. American Heart Journal, 299, 107449. https://doi.org/10.1016/j.ahj.2026.107449