title: Embrella embolic deflection device for cerebral protection during transcatheter aortic valve replacement.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Cardiology, University Medical Centre, Utrecht, The Netherlands.
authors.forename: Mariam
authors.initials: M
authors.lastname: Samim
authors.affiliation: Department of Cardiology, University Medical Centre, Utrecht, The Netherlands.
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.affiliation: Department of Radiology, University Medical Centre, Utrecht, The Netherlands.
authors.forename: Jeroen
authors.initials: J
authors.lastname: Hendrikse
authors.affiliation: Department of Radiology, University Medical Centre, Utrecht, The Netherlands.
authors.forename: Ricardo P J
authors.initials: RP
authors.lastname: Budde
authors.affiliation: Department of Cardiology, University Medical Centre, Utrecht, The Netherlands.
authors.forename: Freek
authors.initials: F
authors.lastname: Nijhoff
authors.affiliation: Department of Thoracic Surgery, University Medical Centre, Utrecht, The Netherlands.
authors.forename: Jolanda
authors.initials: J
authors.lastname: Kluin
authors.affiliation: Department of Thoracic Surgery, University Medical Centre, Utrecht, The Netherlands.
authors.forename: Faiz
authors.initials: F
authors.lastname: Ramjankhan
authors.affiliation: Department of Cardiology, University Medical Centre, Utrecht, The Netherlands.
authors.forename: Pieter A
authors.initials: PA
authors.lastname: Doevendans
authors.affiliation: Department of Cardiology, University Medical Centre, Utrecht, The Netherlands. Electronic address: p.stella@umcutrecht.nl.
authors.forename: Pieter R
authors.initials: PR
authors.lastname: Stella
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D002545:Brain Ischemia / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D038524:Diffusion Magnetic Resonance Imaging; D057505:Embolic Protection Devices; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: Embrella Embolic Deflector System; aortic valve stenosis; cerebral embolic protection device; cerebral ischemic injury; intracranial embolism; transcatheter aortic valve replacement