Cerebral Embolic Protection Devices for the Prevention of Stroke in Patients Undergoing Transcatheter Aortic Valve Implantation: An Updated Meta‐Analysis of Randomized Controlled Trials

Stroke remains one of the most devastating complications following transcatheter aortic valve implantation (TAVI). Although cerebral embolic protection devices (CEPDs) have emerged to mitigate patients' risks, their impact on stroke risk, as well as other clinical and neurocognitive outcomes after TAVI, remains uncertain. We aimed to assess whether CEPDs alleviate stroke risks and neurocognitive outcomes after TAVI. We systematically searched MEDLINE, Scopus, Web of Science (WOS), and the Cochrane CENTRAL from inception until May 2025. We included randomized controlled trials (RCTs) that assessed the effectiveness of CEPD compared to the control group (no CEPD) in adult patients (> 18 years) undergoing TAVI. The primary endpoint was the incidence of all-cause stroke. In contrast, the secondary endpoints included disabling stroke, systemic bleeding, transient ischemic attack (TIA), and major adverse cardiovascular and cerebrovascular events (MACCE). Additionally, we assessed neurological outcomes, including changes in the Montreal Cognitive Assessment (MoCA) score, the National Institutes of Health Stroke Scale (NIHSS) score, and the presence of new ischemic lesions. Nine RCTs comprising 11,696 patients were included in the final analysis. The use of CEPDs showed no statistical difference in reducing all-cause stroke compared to the control group (OR = 0.91, 95% CI [0.73-1.15], p = 0.44). Additionally, there was no significant difference in other studies' secondary outcomes, including disabling stroke, MACCE, systemic bleeding, or neurological outcomes, such as worsening NISSS, decline in MoCA score, and the presence of new ischemic lesions. The use of CEPD during TAVI showed no benefit in reducing the risks of all-cause stroke and other neurological outcomes studied.