Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement.

Abstract Aims To compare the extent of cerebral ischemic injury after transcatheter aortic valve replacement (TAVR) with the use of an Embrella Embolic Deflector System versus unprotected TAVR. Methods Fifteen patients with severe symptomatic aortic stenosis underwent TAVR with use of the Embrella Embolic Deflector System for cerebral protection. Cerebral diffusion-weighted magnetic resonance imaging (DWI) was performed in all patients at day 4 after the procedure and images were retrospectively compared to 37 patients who had previously undergone TAVR without a protection device (TAVR-only group). Results Successful placement of the Embrella device was achieved in all patients. DWI revealed an increase in the number of ischemic lesions in the Embrella group compared with the TAVR-only group (9.0 vs 5.0, P  = .044). The use of the Embrella device was however associated with a significant reduction in single-lesion volume: 9.7 μL [5.8, 18.4] versus 17.8 μL [9.5, 38.7] ( P Conclusions The use of the Embrella device during TAVR increased the number of cerebral ischemic lesions on postprocedural brain imaging. This increase in number was however accompanied by a significant reduction in single-lesion volume and the absence of large total infarct volumes.