title: Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial.
abstract: OBJECTIVE
  Our aim was to determine whether use of the filter-based Sentinel™ Cerebral Protection System (CPS) during transcatheter aortic valve implantation (TAVI) can affect the early incidence of new brain lesions, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI), and neurocognitive performance.
  
  
  RESULTS
  From January 2013 to July 2015, 65 patients were randomised 1:1 to transfemoral TAVI with or without the Sentinel CPS. Patients underwent DW-MRI and extensive neurological examination, including neurocognitive testing one day before and five to seven days after TAVI. Follow-up DW-MRI and neurocognitive testing was completed in 57% and 80%, respectively. New brain lesions were found in 78% of patients with follow-up MRI. Patients with the Sentinel CPS had numerically fewer new lesions and a smaller total lesion volume (95 mm3 [IQR 10-257] vs. 197 mm3 [95-525]). Overall, 27% of Sentinel CPS patients and 13% of control patients had no new lesions. Ten or more new brain lesions were found only in the control cohort (in 20% vs. 0% in the Sentinel CPS cohort, p=0.03). Neurocognitive deterioration was present in 4% of patients with Sentinel CPS vs. 27% of patients without (p=0.017). The filters captured debris in all patients with Sentinel CPS protection.
  
  
  CONCLUSIONS
  Filter-based embolic protection captures debris en route to the brain in all patients undergoing TAVI. This study suggests that its use can lead to fewer and overall smaller new brain lesions, as assessed by MRI, and preservation of neurocognitive performance early after TAVI.
  
  
  BACKGROUND
  Dutch trial register-ID: NTR4236. URL http://www.trialregister.nl/trialreg/admin/rctsearch.asp?Term=mistral.
authors.affiliation: Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: Van Mieghem
authors.forename: Lennart
authors.initials: L
authors.lastname: van Gils
authors.forename: Habib
authors.initials: H
authors.lastname: Ahmad
authors.forename: Floortje
authors.initials: F
authors.lastname: van Kesteren
authors.forename: Hendrik W
authors.initials: HW
authors.lastname: van der Werf
authors.forename: Guus
authors.initials: G
authors.lastname: Brueren
authors.forename: Michiel
authors.initials: M
authors.lastname: Storm
authors.forename: Mattie
authors.initials: M
authors.lastname: Lenzen
authors.forename: Joost
authors.initials: J
authors.lastname: Daemen
authors.forename: Ad F M
authors.initials: AF
authors.lastname: van den Heuvel
authors.forename: Pim
authors.initials: P
authors.lastname: Tonino
authors.forename: Jan
authors.initials: J
authors.lastname: Baan
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Koudstaal
authors.forename: Marguerite E I
authors.initials: ME
authors.lastname: Schipper
authors.forename: Aad
authors.initials: A
authors.lastname: van der Lugt
authors.forename: Peter P T
authors.initials: PP
authors.lastname: de Jaegere
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D002545:Brain Ischemia / Q000628:therapy*; D006328:Cardiac Catheterization / Q000379:methods; D038524:Diffusion Magnetic Resonance Imaging / Q000379:methods; D057505:Embolic Protection Devices; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006801:Humans; D020766:Intracranial Embolism / Q000517:prevention & control*; D008297:Male; D009483:Neuropsychological Tests; D012307:Risk Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods; D016896:Treatment Outcome