The aim of this study was to investigate the efficacy and safety of cerebral protection devices during transcatheter aortic valve replacement (TAVR).
All randomized controlled trials investigating the efficacy of cerebral protection devices during TAVR are relatively small and lack statistical power for definitive conclusions.
That is the reason why this systematic review and meta-analysis was carried out. All trials using any type of cerebral protection device during TAVR were analyzed and included.
Primary imaging efficacy endpoints were total lesion volume and number of new ischemic lesions per magnetic resonance imaging scan. The primary clinical efficacy endpoint was any deterioration in the National Institutes of Health Stroke Scale (NIHSS) score at hospital discharge.
Four randomized trials with 252 total patients were included; in them, the use of cerebral protection devices reduced the total volume of new cerebral lesions (p = 0.002) as well as the number of new lesions (p = 0.03).
Cerebral protection device use was associated with a trend toward lower risk for deterioration in the NIHSS score at discharge (risk ratio [RR]: 0.55; 95% confidence interval [CI]: 0.27 to 1.09; p = 0.09).
The risk for stroke and all-cause mortality was lower in the cerebral protection group, although the difference was not significant.
Conclusion
The use of cerebral protection devices during transcatheter aortic valve replacement was associated with less amount and lower volume of new cerebral lesions.
Original title: Neurological Outcomes with Embolic Protection Devices in Patients Undergoing Transcatheter Aortic Valve Replacement. A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Reference: Gennaro Giustino et al. J Am Coll Cardiol Intv. 2016;9(20):2124-2133.
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