Cerebral protection devices in transcatheter aortic valve replacement: a clinical meta-analysis of randomized controlled trials.

BACKGROUND: Neurological complications after undergoing transcatheter aortic valve replacement (TAVR) may be reduced with cerebral protection (CP) devices. However, randomized controlled trials (RCTs) have failed to demonstrate convincing evidence of improvements in hard clinical endpoints in patients with CP. The aim of this study was to compare clinical outcomes of TAVR patients with and without CP devices.
METHODS: Electronic searches were performed using four electronic databases from their dates of inception to May 2017. RCTs that reported outcomes for patient cohorts that underwent TAVR procedures with and without CP were included. Crude odds ratios (ORs) and 95% confidence intervals were calculated using random effects model.
RESULTS: A total of five RCTs were included, totalling 643 patients, 386 of whom were randomized to TAVR + CP and 257 with TAVR only. The primary composite endpoint of all-cause mortality and stroke at 30 days was lower in patients undergoing CP devices compared to those patients with TAVR alone (OR, 0.54; 95% CI, 0.30 to 0.98). Use of CP devices was also associated with lower new total lesion volume (standardised mean difference, -0.49; 95% CI, -0.96 to -0.03). There was a non-significant reduction in the risk of secondary clinical endpoints of all-cause mortality, stroke, life-threatening bleed, acute kidney injury and major vascular complications in patients randomized to TAVR + CP.
CONCLUSIONS: Use of CP devices in TAVR appears to be safe and may be associated with a reduction in stroke/death.