Cerebral embolic protection devices during TAVR did not significantly reduce all-cause stroke (RR 0.93; 95% CI 0.74-1.16), disabling stroke, mortality, or MACCE compared to control.
Meta-Analysis (n=11,876)
Does the use of cerebral embolic protection devices reduce mortality, MACCE, or stroke in patients undergoing TAVR?
Routine use of cerebral embolic protection devices during TAVR does not significantly reduce the risk of stroke, mortality, or major adverse cardiovascular and cerebrovascular events.
Effect estimate: RR 0.93 (95% CI 0.74-1.16)
Abstract Background and aims Transcatheter aortic valve replacement (TAVR) is an established therapy for severe aortic stenosis; however, periprocedural stroke remains a serious complication. Cerebral embolic protection devices (CEPDs) have been introduced to reduce cerebral embolization during TAVR, but their clinical effectiveness is uncertain. We evaluated the efficacy and safety of CEPDs using trial sequential analysis (TSA) and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework. Methods We performed a systematic review and meta-analysis of randomized controlled trials comparing TAVR with versus without CEPD. Four electronic databases were searched from inception to April 2025. Primary outcomes were all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), all-cause stroke, and disabling stroke. Risk ratios (RR) with 95% confidence intervals (CI) were pooled using random-effects models. TSA assessed information size, statistical significance, and futility (α=5%, power=80%). Results Nine trials including 11,876 patients (CEPD 6,140; control 5,736) were analyzed. CEPD use was not associated with significant reductions in mortality (RR 1.04, 95% CI 0.68–1.58), MACCE (RR 1.13, 95% CI 0.69–1.86), all-cause stroke (RR 0.93, 95% CI 0.74–1.16), or disabling stroke (RR 0.77, 95% CI 0.47–1.26). Secondary neurological and imaging outcomes showed no meaningful benefit. TSA and subgroup analyses confirmed the absence of statistically robust or clinically relevant effects. Current evidence does not support routine CEPD use during TAVR, as no significant reduction in stroke or major clinical outcomes was demonstrated. Conflict of interest None Figure 1 - belongs to Methods Figure 2 - belongs to Methods Figure 3 - belongs to Results
Noha Hammad (Fri,) conducted a meta-analysis in severe aortic stenosis (n=11,876). Cerebral embolic protection devices (CEPD) vs. TAVR without CEPD was evaluated on all-cause stroke (RR 0.93, 95% CI 0.74-1.16). Cerebral embolic protection devices during TAVR did not significantly reduce all-cause stroke (RR 0.93; 95% CI 0.74-1.16), disabling stroke, mortality, or MACCE compared to control.