Cerebral embolic protection devices during transcatheter aortic valve implantation: a meta-analysis of randomised controlled trials

Abstract

Abstract Background Stroke is a feared complication of transcatheter aortic valve implantation (TAVI), which may be mitigated by embolic protection devices (EPDs). Purpose We performed a systematic review and meta-analysis of randomised controlled trials (RCTs) to test the effect of EPDs in TAVI. Methods All RCTs comparing EPDs with control during TAVI were systematically identified. Pre-specified primary endpoints were all stroke, disabling stroke, non-disabling stroke and all-cause mortality. Safety and neuroimaging parameters were assessed. Sensitivity analyses were stratified by EPD type. This study was prospectively registered. Results Eight trials randomising 4043 patients were included. There was no significant difference between EPDs and control for all stroke [RR 0.88, 95%CI 0.65–1.18, p=0.386, I2=0%], disabling stroke [RR 0.59, 95%CI 0.31–1.14, p=0.117, I2=0%], non-disabling stroke [RR 0.99, 95%CI 0.71–1.40, p=0.967, I2=0%] or all-cause mortality [RR 0.88, 95%CI 0.44–1.78, p=0.727, I2=0%]. There were no differences in safety endpoints of bleeding, vascular complications, or acute kidney injury. EPDs resulted in reduced cerebral lesion volume [SMD -0.55, 95%CI -0.91– -0.18, p=0.003, I2=63.6%], but no difference in number of patients with new lesions. The Sentinel EPD significantly reduced risk of disabling stroke [RR 0.42, 95%CI 0.20–0.88, p=0.022, I2=0%] but did not impact all stroke, non-disabling stroke or all-cause mortality. Conclusion The totality of randomised data for EPDs during TAVI demonstrated no safety concerns or significant differences in clinical endpoints, although total cerebral lesion volume was reduced. Analyses restricted to the Sentinel EPD demonstrated large, clinically meaningful reductions in disabling stroke. Ongoing RCTs may help validate these results.Effects of cerebral embolic protectionEffects of the Sentinel device