TY - JOUR
T1 - Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement
AU - Samim, Mariam
AU - Agostoni, Pierfrancesco
AU - Hendrikse, Jeroen
AU - Budde, Ricardo P J
AU - Nijhoff, Freek
AU - Kluin, Jolanda
AU - Ramjankhan, Faiz
AU - Doevendans, Pieter A.
AU - Stella, Pieter R.
PY - 2015/1/1
Y1 - 2015/1/1
N2 - 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 < .001). Moreover, total infarct volumes of more than 1000 μL were only seen in the TAVR-only group. More lesions occurred in the right side of the brain in the Embrella group, whereas in the TAVR-only group lesions were distributed equally between left and right. One patient in the TAVR-only group suffered from a transient ischemic attack. Postoperative evaluation was clinically uneventful in the Embrella group.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.
AB - 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 < .001). Moreover, total infarct volumes of more than 1000 μL were only seen in the TAVR-only group. More lesions occurred in the right side of the brain in the Embrella group, whereas in the TAVR-only group lesions were distributed equally between left and right. One patient in the TAVR-only group suffered from a transient ischemic attack. Postoperative evaluation was clinically uneventful in the Embrella group.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.
KW - aortic valve stenosis
KW - cerebral embolic protection device
KW - cerebral ischemic injury
KW - Embrella Embolic Deflector System
KW - intracranial embolism
KW - transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=84926176786&partnerID=8YFLogxK
U2 - 10.1016/j.jtcvs.2014.05.097
DO - 10.1016/j.jtcvs.2014.05.097
M3 - Article
C2 - 25455466
AN - SCOPUS:84926176786
SN - 0022-5223
VL - 149
SP - 799-805.e2
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 3
ER -