Cerebral Embolic Protection Devices in Transcatheter Aortic Valve Implantation: Meta-Analysis With Trial Sequential Analysis.

Abstract

Background: We aimed to reevaluate randomized controlled trial data on outcomes of cerebral embolic protection device use during transcatheter aortic valve implantation. A conventional meta-analysis followed by trial sequential analysis was conducted to evaluate the strength of the current evidence.

Methods and results: Databases were searched for randomized controlled trials. Primary outcomes included all stroke, disabling stroke, and all-cause mortality. Conventional study-level meta-analysis was performed using random-effects modeling. Trial sequential analysis was conducted to generate adjusted significance boundaries, futility boundaries, and the required information size considering a type I error of 5% and a power of 90%. Seven trials were included with a total of 4031 patients, of whom 2171 were treated with a device and 1860 were not. Conventional meta-analysis showed no significant difference in all stroke (relative risk [RR], 0.85 [95% CI, 0.61-1.18]; P=0.339) and disabling stroke (RR, 0.59 [95% CI, 0.30-1.13]; P=0.113) with device use. The trial sequential analysis determined an absence of evidence for all stroke (required information size of 71 650 [5.6%]) and disabling stroke (required information size of 337 256 [1.2%]). Conventional meta-analysis determined no significant difference in all-cause mortality (RR, 1.03 [95% CI, 0.49-2.17]; P=0.928) with device use. The trial sequential analysis determined that the futility boundary was reached (required information size of 5772 [69.3%]).

Conclusions: There are insufficient randomized controlled trial data on cerebral embolic protection device use to provide conclusive meta-analytic findings for stroke outcomes.