TCT-658 Neurologic Outcomes with Embolic Protection Devices in Patients Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Background: Clinical or subclinical cerebral embolization is a relatively frequent complication of transcatheter aortic valve replacement (TAVR). Randomized controlled trials (RCTs) investigating the efficacy of embolic protection devices during TAVR were relatively underpowered to detect meaningful differences in imaging and clinical endpoints. Methods: We performed a systematic review and study-level meta-analysis of RCTs that tested the efficacy and safety of EP during TAVR. RCTs using any type of EP and TAVR vascular access were included. Primary imaging efficacy endpoints were total lesion volume (TLV; in mm 3 ) and number of new ischemic lesions. Primary clinical efficacy endpoints were any deterioration in National Institute of Health Stroke Scale (NIHSS) and Montreal Cognitive Assessment (MoCA) score at hospital discharge. Primary analyses were performed with the intention-to-treat approach. Results: A total of 4 RCTs (total n=252) have been included. Use of EP was associated with lower TLV (Figure; standardized mean difference [SMD]: -0.65; 95% confidence interval [CI]: -1.06 to -0.25; p=0.002) and lower number of new ischemic lesions (Figure; SMD: -1.27; 95% CI: -2.45 to -0.09; p = 0.03). EP was associated with a trend to lower risk of deterioration in NIHSS at discharge (RR: 0.55; 95% CI: 0.27 to 1.09; p=0.09) and higher MoCA score (SMD: +0.40; 95% CI: +0.04 to +0.76; p = 0.03). Risk of overt stroke and all-cause mortality were non-significantly lower in the EP group. Conclusions: Use of EP seems to be associated with a reduction of imaging markers of cerebral infarction and early clinical neurologic effectiveness in patients undergoing TAVR. Key Words: TAVR; Embolic Protection; Stroke.