title: A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial.
abstract: OBJECTIVE
  To evaluate the safety, efficacy, and performance of the TriGuard™ HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI).
  
  
  RESULTS
  From February 2014 to March 2015, 85 subjects undergoing TAVI at 13 centres in Europe and Israel were randomized to TriGuard protection vs. no protection. Subjects underwent neurologic and cognitive evaluation at baseline, pre-discharge and 30 days; cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days post-procedure and at 30 days. Technical success, which included complete 3-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard and 30.8% of control subjects (P = 0.34). In the Per Treatment population (subjects with complete three-vessel cerebral coverage), TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), fewer new neurologic deficits detected by the National Institutes of Health Stroke Scale (3.1 vs. 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task (P = 0.028) at discharge, and a >2-fold increase in recovery of normal cognitive function (MoCA score >26) at 30 days.
  
  
  CONCLUSIONS
  TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls.
authors.affiliation: Division of Cardiology, Yale School of Medicine, New Haven, CT, USA Yale Cardiovascular Research Group, New Haven, CT, USA alexandra.lansky@yale.edu alexandralansky@gmail.com.
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.affiliation: Cardiovascular Center, Hamburg University, Hamburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.affiliation: Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Tchetche
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Pieter
authors.initials: P
authors.lastname: Stella
authors.affiliation: Division of Cardiology, Yale School of Medicine, New Haven, CT, USA Yale Cardiovascular Research Group, New Haven, CT, USA.
authors.forename: Cody G
authors.initials: CG
authors.lastname: Pietras
authors.affiliation: Division of Cardiology, Yale School of Medicine, New Haven, CT, USA Yale Cardiovascular Research Group, New Haven, CT, USA.
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.affiliation: Department of Radiology, Baptist Hospital of Miami, Miami, FL, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Abrams
authors.affiliation: Division of Cardiology, Yale School of Medicine, New Haven, CT, USA.
authors.forename: John K
authors.initials: JK
authors.lastname: Forrest
authors.affiliation: Division of Cardiology, Yale School of Medicine, New Haven, CT, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Cleman
authors.affiliation: Department of Cardiology and Angiology I, Heart Center, University of Freiburg, Freiburg, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Reinöhl
authors.affiliation: Department of Cardiology, CHU Timone, Marseille, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Cuisset
authors.affiliation: Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Blackman
authors.affiliation: Department of Cardiac Surgery, Rambam Health Care Campus, Haifa, Israel.
authors.forename: Gil
authors.initials: G
authors.lastname: Bolotin
authors.affiliation: Praxisklinik Herz und Gefäße, Dresden, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Spitzer
authors.affiliation: Herzzentrum Dresden GmbH, Universitätsklinik, Dresden, Germany.
authors.forename: Utz
authors.initials: U
authors.lastname: Kappert
authors.affiliation: Department of Cardiology, Brest University, Brest, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
authors.affiliation: Department of Cardiovascular Surgery, Hôpital Cardiologique, Lille, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Modine
authors.affiliation: Sussex Cardiac Centre, Brighton and Sussex University Hospital NHS Trust, Brighton, UK.
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.affiliation: Sussex Cardiac Centre, Brighton and Sussex University Hospital NHS Trust, Brighton, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.affiliation: Keystone Heart Ltd., Caesarea, Israel.
authors.forename: Pauliina
authors.initials: P
authors.lastname: Margolis
authors.affiliation: Department of Neurology, College of Physicians and Surgeons, Columbia University, New York, NY, USA Taub Institute for Research on Alzheimer's Disease and the Aging Brain, College of Physicians and Surgeons, Columbia University, New York, NY, USA.
authors.forename: Adam M
authors.initials: AM
authors.lastname: Brickman
authors.affiliation: Global Institute for Research, Richmond, VA, USA.
authors.forename: Szilard
authors.initials: S
authors.lastname: Voros
authors.affiliation: Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Andreas
authors.initials: A
authors.lastname: Baumbach
keywords: Cerebral ischaemia; Diffusion-weighted imaging; Neuroprotection; Stroke prevention; Transcatheter aortic valve implantation