title: Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation.
abstract: OBJECTIVE
  Transcatheter aortic valve implantation (TAVI) results in the dislodgement of debris with risk of cerebral lesions or stroke. The EMBOL-X protection device (Edwards Lifesciences, Irvine, CA) is positioned within the ascending aorta to capture such debris.
  
  
  METHODS
  Between July 2012 and April 2014 we randomly assigned 30 high-risk patients to undergo transaortic TAVI with the SAPIEN XT prosthesis (Edwards Lifesciences) combined with either the EMBOL-X device (group-1, n = 14) or without (group-2, n = 16). Periprocedural cerebral lesions were assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) at baseline and within 7 days post-procedurally.
  
  
  RESULTS
  New foci of restricted diffusion on cerebral DW-MRI were found in 69% in group-2 and 50% in group-1. Lesion size was smaller in patients treated with the EMBOL-X device than in those without (88 ± 60 vs 168 ± 217 mm(3), p = 0.27, t = 1.2, degrees of freedom = 10). Transaortic TAVI patients treated with the EMBOL-X device had significantly smaller lesion volumes in the supply region of the middle cerebral artery (33 ± 29 vs 76 ± 67 mm(3), p = 0.04). There were no neurologic events after transaortic TAVI.
  
  
  CONCLUSIONS
  The intraaortic protection device seems to reduce both the incidence and the volume of new cerebral lesions (ClinicalTrials.gov number, NCT01735513).
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany. Electronic address: daniel.wendt@uk-essen.de.
authors.forename: Daniel
authors.initials: D
authors.lastname: Wendt
authors.affiliation: Institute for Pathophysiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Kleinbongard
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Knipp
authors.affiliation: Department of Cardiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Fadi
authors.initials: F
authors.lastname: Al-Rashid
authors.affiliation: Institute for Pathophysiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Nilgün
authors.initials: N
authors.lastname: Gedik
authors.affiliation: Department of Cardiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Karim
authors.initials: K
authors.lastname: El Chilali
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Schweter
authors.affiliation: Institute of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen, Germany.
authors.forename: Marc
authors.initials: M
authors.lastname: Schlamann
authors.affiliation: Department of Cardiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Kahlert
authors.affiliation: Department of Mathematics and Technology, Koblenz University of Applied Science, Remagen, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Neuhäuser
authors.affiliation: Institute of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Forsting
authors.affiliation: Department of Cardiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Raimund
authors.initials: R
authors.lastname: Erbel
authors.affiliation: Institute for Pathophysiology, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Gerd
authors.initials: G
authors.lastname: Heusch
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Heinz
authors.initials: H
authors.lastname: Jakob
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Hospital Essen, Essen, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D004617:Embolism / Q000209:etiology* / Q000517:prevention & control*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000295:instrumentation*