title: Feasibility and exploratory efficacy evaluation of the Embrella Embolic Deflector system for the prevention of cerebral emboli in patients undergoing transcatheter aortic valve replacement: the PROTAVI-C pilot study.
abstract: OBJECTIVE
  This study sought to determine the feasibility, safety, and exploratory efficacy of the Embrella Embolic Deflector (EED) system (Edwards Lifesciences, Irvine, California) in patients undergoing transcatheter aortic valve replacement (TAVR).
  
  
  BACKGROUND
  Few data exist on the value of using embolic protection devices during TAVR.
  
  
  METHODS
  This pilot study included 52 patients who underwent transfemoral TAVR. The EED system was used in 41 patients, whereas 11 patients underwent TAVR without embolic protection (control group). Cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and within 7 days and 30 days after TAVR.
  
  
  RESULTS
  The EED system was successfully deployed at the level of the aortic arch in all patients with no complications. The deployment of the EED system was associated with high-intensity transient signals (HITS) as evaluated by transcranial Doppler (median: 48 [interquartile range: 17 to 198] HITS), and a higher total number of HITS was observed in the EED group (p < 0.001 vs. control group). DW-MRI performed within 7 days after TAVR showed the presence of new ischemic lesions in all patients in both groups, with a median number of 7 (interquartile range: 3 to 13) lesions per patient. The use of the EED system was associated with a lower lesion volume compared with the control group (p = 0.003). All new cerebral lesions had disappeared on the DW-MRI performed at 30 days after TAVR. Two strokes unrelated to the EED system occurred 2 and 29 days after TAVR.
  
  
  CONCLUSIONS
  This study showed the feasibility and safety of using the EED system in TAVR procedures. The EED system did not prevent the occurrence of cerebral microemboli during TAVR or new transient ischemic lesions as evaluated by DW-MRI, but it was associated with a reduction in lesion volume. Further studies are warranted to determine the efficacy of using the EED system during TAVR procedures.
authors.affiliation: Quebec Heart and Lung Institute, Quebec City, Quebec, Canada. Electronic address: josep.rodes@criucpq.ulaval.ca.
authors.forename: Josep
authors.initials: J
authors.lastname: Rodés-Cabau
authors.affiliation: University Hospital of Essen, Essen, Germany.
authors.forename: Philip
authors.initials: P
authors.lastname: Kahlert
authors.affiliation: Universtäts Herzzentrum Bad Krozingen, Krozingen, Germany.
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.affiliation: Universtäts Klinikum Karslruhe, Karslruhe, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schymik
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: Hôpital Bichat, Paris, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Amarenco
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Thomas
authors.initials: T
authors.lastname: Brott
authors.affiliation: Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Garami
authors.affiliation: Division of Cardiac Surgery, University of Padova, Padova, Italy.
authors.forename: Gino
authors.initials: G
authors.lastname: Gerosa
authors.affiliation: Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.affiliation: University Hospital of Essen, Essen, Germany.
authors.forename: Bjoern
authors.initials: B
authors.lastname: Plicht
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.affiliation: University Hospital of Essen, Essen, Germany.
authors.forename: Marc
authors.initials: M
authors.lastname: Schlamann
authors.affiliation: St. Thomas Hospital, London, United Kingdom.
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Edwards Lifesciences, Irvine, California.
authors.forename: Beverly
authors.initials: B
authors.lastname: Diamond
authors.affiliation: Edwards Lifesciences, Irvine, California.
authors.forename: Ihsen
authors.initials: I
authors.lastname: Merioua
authors.affiliation: Freiburg Universitats Bad Krozingen, Krozingen, Germany.
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.affiliation: Hôpital Bichat, Paris, France.
authors.forename: Alec
authors.initials: A
authors.lastname: Vahanian
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D002170:Canada; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D038524:Diffusion Magnetic Resonance Imaging; D057505:Embolic Protection Devices; D005060:Europe; 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*; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D017585:Ultrasonography, Doppler, Transcranial
keywords: Embrella Embolic Deflector; embolic protection; magnetic resonance imaging; transcatheter aortic valve implantation; transcranial Doppler