title: Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial.
abstract: OBJECTIVE
  Stroke remains a major predictor of mortality after transcatheter aortic valve implantation (TAVI). Cerebral protection devices might reduce brain injury as determined by diffusion-weighted magnetic resonance imaging (DWMRI).
  
  
  OBJECTIVE
  To determine the effect of a cerebral protection device on the number and volume of cerebral lesions in patients undergoing TAVI.
  
  
  METHODS
  Investigator-initiated, single center, blinded, randomized clinical trial in higher-risk patients with severe aortic stenosis undergoing TAVI at the University of Leipzig Heart Center. Brain MRI was performed at baseline, 2 days, and 7 days after TAVI. Between April 2013 and June 2014, patients were randomly assigned to undergo TAVI with a cerebral protection device (filter group) or without a cerebral protection device (control group). The last 1-month follow-up occurred in July 2014.
  
  
  METHODS
  TAVI with or without a cerebral protection device (filter system).
  
  
  METHODS
  The primary end point was the numerical difference in new positive postprocedure DWMRI brain lesions at 2 days after TAVI in potentially protected territories. The first hierarchical secondary outcome was the difference in volume of new lesions after TAVI in potentially protected territories.
  
  
  RESULTS
  Among the 100 enrolled patients, mean (SD) age was 80.0 (5.1) years in the filter group (n = 50) and 79.1 (4.1) years in the control group (n = 50), and the mean (SD) procedural risk scores (logistic EuroScores) were 16.4% (10.0%) in the filter group and 14.5% (8.7%) in the control group. For the primary end point, the number of new lesions was lower in the filter group, 4.00 (interquartile range [IQR], 3.00-7.25) vs 10.00 (IQR, 6.75-17.00) in the control group (difference, 5.00 [IQR, 2.00-8.00]; P < .001). For the first hierarchical secondary end point, new lesion volume after TAVI was lower in the filter group (242 mm3 [95% CI, 159-353]) vs in the control group (527 mm3 [95% CI, 364-830]) (difference, 234 mm3 [95% CI, 91-406]; P = .001). Considering adverse events, 1 patient in the control group died prior to the 30-day visit. Life-threatening hemorrhages occurred in 1 patient in the filter group and 1 in the control group. Major vascular complications occurred in 5 patients in the filter group and 6 patients in the control group. One patient in the filter group and 5 in the control group had acute kidney injury, and 3 patients in the filter group had a thoracotomy.
  
  
  CONCLUSIONS
  Among patients with severe aortic stenosis undergoing TAVI, the use of a cerebral protection device reduced the frequency of ischemic cerebral lesions in potentially protected regions. Larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVI and to devise methods that will provide more complete coverage of the brain to prevent new lesions.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01833052.
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Haussig
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany.
authors.forename: Norman
authors.initials: N
authors.lastname: Mangner
authors.affiliation: Buffalo Neuroimaging Analysis Center, Department of Neurology, University of Buffalo, Buffalo, New York.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Dwyer
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany.
authors.forename: Lukas
authors.initials: L
authors.lastname: Lehmkuhl
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Lücke
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Woitek
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany.
authors.forename: David M
authors.initials: DM
authors.lastname: Holzhey
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany3Leipzig Heart Institute, Leipzig, Germany.
authors.forename: Friedrich W
authors.initials: FW
authors.lastname: Mohr
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Gutberlet
authors.affiliation: Buffalo Neuroimaging Analysis Center, Department of Neurology, University of Buffalo, Buffalo, New York.
authors.forename: Robert
authors.initials: R
authors.lastname: Zivadinov
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany3Leipzig Heart Institute, Leipzig, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D001024:Aortic Valve Stenosis / Q000601:surgery*; D002545:Brain Ischemia / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D038524:Diffusion Magnetic Resonance Imaging / Q000379:methods; D004311:Double-Blind Method; D057505:Embolic Protection Devices / Q000009:adverse effects; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D009460:Neurologic Examination; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000379:methods; D016896:Treatment Outcome