Safety and efficacy of cerebral protection devices in transcatheter aortic valve replacement: A clinical end-points meta-analysis.

Abstract

Stroke after transcatheter aortic valve replacement (TAVR) occurs with an incidence of 4-11% and is a particularly devastating adverse event associated with the procedure. Several cerebral protection devices (CPD) have been developed to prevent cerebrovascular events during TAVR. While most studies have shown CPD to be associated with decreased number and volume of lesions on diffusion weighted magnetic resonance imaging, the clinical benefit of these devices remains uncertain. We aimed to use meta-analysis techniques to study the clinical safety and efficacy of these CPD in prospective randomized and non-randomized studies. Data was summarized as Mantel-Haenszel relative risk (RR) and 95% confidence intervals (CI). We used the Higgins' I2 statistic to evaluate heterogeneity. We found no evidence of difference between patients with and without CPD [RR 0.70 (95% CI 0.40-1.21)] for the primary composite outcome of stroke and mortality at 30 days. The two groups were also comparable in peri-procedural strokes [RR 0.53 (95% CI 0.27-1.07)], stroke at 30 days [RR 0.69(95% CI 0.38-1.26)], mortality [RR 0.59 (95% CI 0.22-1.59) at 30 days, AKI [RR 0.68(95% CI 0.28-1.62)], major bleeding [RR 0.56 (95% CI 0.26-1.18)], life threating bleeding [0.54 (95% CI 0.19-1.53)] and major vascular complications [RR 0.80 (95% CI 0.52-1.24)]. The risk of strokes within the first week of TAVR was significantly lower in the CPD group [0.56(95% CI 0.33-0.96)]. CPD are associated with a decreased incidence of strokes within 1 week of follow-up without showing any evidence of increased risk of other peri-procedural adverse events.