Abstract
BACKGROUND: Cerebral embolism remains a concern during transcatheter aortic valve replacement (TAVR). Cerebral embolic protection (CEP) devices have been developed to mitigate this risk, but their clinical benefit remains unclear. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials comparing TAVR with and without CEP devices. Primary endpoint was overall stroke; secondary endpoints included disabling stroke, all-cause mortality, life-treating bleeding, vascular complications related to CEP access and acute kidney injury. RESULTS: Eight trials comprising 11,625 patients (group CEP, n = 5,843 patients; group NCEP, n = 5,782 patients, 57.3 % male, 81.5 mean age years) were included. No significant differences were found for primary endpoint, overall stroke (RR 1.03, 95 % CI 0.82-1.29), and secondary outcomes between CEP and non-CEP groups at 30 days follow-up. Complications related to CEP access were minimal, 1.1 % (95 % CI: -0.6 to 2.8). CONCLUSIONS: CEP devices do not significantly reduce short-term stroke or major complications after TAVR. However, given the prevalence of silent cerebral ischemia, further studies are needed to assess long-term neurological outcomes and identify high-risk subgroups who may benefit.