The efficacy and safety of cerebral embolic protection devices in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis with trial sequential analysis of randomized controlled trials.

Abstract

Introduction: Transcatheter aortic valve replacement (TAVR) is an established treatment for severe aortic stenosis but carries a risk of stroke and cerebral embolism. Cerebral embolic protection devices (CEPD), including filter-based and deflection-based systems (Sentinel and TriGUARD), aim to reduce embolic complications; however, their clinical benefit remains uncertain. This study evaluated the efficacy and safety of CEPD during TAVR using trial sequential analysis (TSA) and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework.

Methods: Randomized controlled trials (RCTs) comparing TAVR with and without CEPD were identified through four electronic databases from inception to April 2025. Primary outcomes were all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), stroke, and disabling stroke. Pooled risk ratios (RR) with 95% confidence intervals (CI) were calculated. TSA was conducted with a 5% type I error and 80% power.

Results: Nine RCTs including 11,876 patients were analyzed. CEPD use showed no significant reduction in mortality, MACCE, stroke, or disabling stroke. Secondary and subgroup analyses yielded consistent findings. TSA demonstrated that the accrued evidence was insufficient to confirm a clinical benefit.

Conclusions: Current evidence does not support the routine use of CEPD during TAVR, given the lack of significant benefit in key clinical outcomes.

Registration: The protocol of this study was registered at Prospero CRD420251036308.