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Eur Heart J. 2015 Aug 14;36(31):2070-2078. Epub 2015 May 19.

A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial.

Author information

1
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.
2
Cardiovascular Center, Hamburg University, Hamburg, Germany.
3
Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France.
4
Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
5
Division of Cardiology, Yale School of Medicine, New Haven, CT, USA Yale Cardiovascular Research Group, New Haven, CT, USA.
6
Department of Radiology, Baptist Hospital of Miami, Miami, FL, USA.
7
Division of Cardiology, Yale School of Medicine, New Haven, CT, USA.
8
Department of Cardiology and Angiology I, Heart Center, University of Freiburg, Freiburg, Germany.
9
Department of Cardiology, CHU Timone, Marseille, France.
10
Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds, UK.
11
Department of Cardiac Surgery, Rambam Health Care Campus, Haifa, Israel.
12
Praxisklinik Herz und Gefäße, Dresden, Germany.
13
Herzzentrum Dresden GmbH, Universitätsklinik, Dresden, Germany.
14
Department of Cardiology, Brest University, Brest, France.
15
Department of Cardiovascular Surgery, Hôpital Cardiologique, Lille, France.
16
Sussex Cardiac Centre, Brighton and Sussex University Hospital NHS Trust, Brighton, UK.
17
Keystone Heart Ltd., Caesarea, Israel.
18
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.
19
Global Institute for Research, Richmond, VA, USA.
20
Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.

Abstract

AIMS:

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).

METHODS AND 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.

CONCLUSION:

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.

KEYWORDS:

Cerebral ischaemia; Diffusion-weighted imaging; Neuroprotection; Stroke prevention; Transcatheter aortic valve implantation

PMID:
25990342
DOI:
10.1093/eurheartj/ehv191

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