title: An embolic deflection device for aortic valve interventions.
abstract: OBJECTIVE
  We describe initial human experience with a novel cerebral embolic protection device.
  
  
  BACKGROUND
  Cerebral emboli are the major cause of procedural stroke during percutaneous aortic valve interventions.
  
  
  METHODS
  With right radial artery access, the embolic protection device is advanced into the aortic arch. Once deployed a porous membrane shields the brachiocephalic trunk and the left carotid artery deflecting emboli away from the cerebral circulation. Embolic material is not contained or removed by the device. The device was used in 4 patients (mean age 90 years) with severe aortic stenosis undergoing aortic balloon valvuloplasty (n = 1) or transcatheter aortic valve implantation (n = 3).
  
  
  RESULTS
  Correct placement of the embolic protection device was achieved without difficulty in all patients. Continuous brachiocephalic and aortic pressure monitoring documented equal pressures without evidence of obstruction to cerebral perfusion. Additional procedural time due to the use of the device was 13 min (interquartile range: 12 to 16 min). There were no procedural complications. Pre-discharge cerebral magnetic resonance imaging found no new defects in any of 3 patients undergoing transcatheter aortic valve implantation and a new 5-mm acute cortical infarct in 1 asymptomatic patient after balloon valvuloplasty alone. No patient developed new neurological symptoms or clinical findings of stroke.
  
  
  CONCLUSIONS
  Embolic protection during transcatheter aortic valve intervention seems feasible and might have the potential to reduce the risk of cerebral embolism and stroke.
authors.affiliation: Department of Cardiology, St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Fabian
authors.initials: F
authors.lastname: Nietlispach
authors.forename: Namal
authors.initials: N
authors.lastname: Wijesinghe
authors.forename: Ronen
authors.initials: R
authors.lastname: Gurvitch
authors.forename: Edgar
authors.initials: E
authors.lastname: Tay
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Carpenter
authors.forename: Carol
authors.initials: C
authors.lastname: Burns
authors.forename: David A
authors.initials: DA
authors.lastname: Wood
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000503:physiopathology / Q000628:therapy*; D001794:Blood Pressure; D001955:British Columbia; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D002404:Catheterization; D057505:Embolic Protection Devices; D005240:Feasibility Studies; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D020766:Intracranial Embolism / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D008279:Magnetic Resonance Imaging; D008297:Male; D011474:Prosthesis Design; D017534:Radial Artery; D015641:Radiography, Interventional; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome