ABSTRACT NUMBER: ESOC2026YS112 STROKE PREVENTION WITH CEREBRAL EMBOLIC PROTECTION DEVICES DURING TRANSCATHETER AORTIC VALVE REPLACEMENT: SYSTEMATIC REVIEW AND META-ANALYSIS

Abstract

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