title: First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions.
abstract: OBJECTIVE
  To report our first-in-man experience with a new cerebral embolic deflection device (SMT Embolic Deflection Device) during transcatheter aortic valve implantation (TAVI). A significant number of strokes and brain infarcts are caused by embolisation of atherosclerotic material, clots and other debris during various phases of invasive cardiac procedures, especially TAVI. The application of a temporary filter in the aortic arch averting dislodged emboli from entering the cerebral circulation might prevent this.
  
  
  RESULTS
  In 15 patients (mean age 79 years) with severe aortic stenosis undergoing percutaneous transfemoral or transapical aortic valve implantation, the SMT Embolic Deflection Device was advanced utilising the contralateral femoral artery access using a 9 Fr delivery sheath. Once deployed in the aortic arch, a porous membrane shields the supraaortic-cerebral trunks by deflecting emboli away from the cerebral circulation. Embolic material is not contained or removed by the device. A 6 Fr pigtail catheter can be used through the same sheath throughout the whole procedure. Brain diffusion weighted (DW)-MRI was obtained in 10 patients before and at 4 days after (± 2 days) the procedure and retrospectively compared to 20 patients previously undergoing TAVI without a protection device. Successful placement of the embolic protection device was achieved in all patients. Additional procedural time due to the use of the device was 7 min (± 2 min). There were no procedural complications. No patient developed new neurological symptoms or clinical findings of stroke except one patient who suffered from a transient ischaemic attack (TIA) two days after the procedure. DW-MRI showed 3.2 new cerebral lesions per patient, compared to 7.2 new lesions per patient in the group without SMT filter.
  
  
  CONCLUSIONS
  In this first-in-man experience, the feasibility of a new embolic deflection device is demonstrated. Larger randomised, prospective studies are required to confirm these findings and prove safety and efficacy by reducing the incidence of cerebral embolism and stroke after TAVI.
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Kevin
authors.initials: K
authors.lastname: Onsea
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.forename: Mariam
authors.initials: M
authors.lastname: Samim
authors.forename: Michiel
authors.initials: M
authors.lastname: Voskuil
authors.forename: Jolanda
authors.initials: J
authors.lastname: Kluin
authors.forename: Ricardo
authors.initials: R
authors.lastname: Budde
authors.forename: Jeroen
authors.initials: J
authors.lastname: Hendrikse
authors.forename: Faiz
authors.initials: F
authors.lastname: Ramjankhan
authors.forename: Jan
authors.initials: J
authors.lastname: van Klarenbosch
authors.forename: Pieter
authors.initials: P
authors.lastname: Doesburg
authors.forename: Gertjan
authors.initials: G
authors.lastname: Sieswerda
authors.forename: Pieter
authors.initials: P
authors.lastname: Stella
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D038524:Diffusion Magnetic Resonance Imaging; D057505:Embolic Protection Devices; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D020766:Intracranial Embolism / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D009426:Netherlands; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome