Safety and efficacy of cerebral embolic protection devices during TAVI: a meta-analysis and sequence analysis of trials

Cerebral embolic protection (CEP) devices have been developed to reduce postoperative neurological outcomes after transcatheter aortic valve implantation (TAVI); however, their effectiveness remains controversial. To evaluate the impact of CEP use during TAVI on the occurrence in clinical outcomes. Databases were used to search for randomized clinical trials. The occurrence of all strokes, of disabling strokes specifically, transient ischemic attacks (TIAs), all-cause mortality, and vascular complications were analyzed. Conventional meta-analysis was conducted using fixed-effects modeling and trial sequential analysis (TSA: type I error of 5%, power of 90%). The systematic review protocol was registered on the International Prospective Register of Systematic Reviews (PROSPERO; CRD420251081075). In total, eight clinical trials were included, gathering 11,589 patients randomized between those who used the devices (5,943) and those who did not (5,646). The meta-analysis demonstrated no significant association between CEP use and reduced odds of all-cause stroke (OR = 0.92, 95% CI: 0.73–1.15, p = 0.46) and disabling stroke (OR = 0.80, 95% CI: 0.57–1.13, p = 0.20). The sequential analysis identified a lack of evidence for all strokes (required sample size [rSS] = 38,626; 10.53%), disabling strokes (rSS = 59,732; 17.05%). In terms of mortality, there was no significance in the use of devices (OR = 1.09, 95% CI: 0.71–1.69, p = 0.69), reaching evidence for support (rSS = 7,053; 42.25%); The data on the use of CEP is insufficient to support meta-analytic conclusions regarding cerebrovascular outcomes. Nevertheless, TSA demonstrated evidence supporting futility regarding mortality reduction.