Title :

A prospective randomized evaluation of the triguard (tm) hdh embolic deflection device during transcatheter aortic valve implantation: results fromthe deflect iii trial

Author(s) :

Lansky, Alexandra J. [Auteur]
Schofer, Joachim [Auteur]
Tchetche, Didier [Auteur]
Stella, Pieter [Auteur]
Pietras, Cody G. [Auteur]
Parise, Helen [Auteur]
Abrams, Kevin [Auteur]
Forrest, John K. [Auteur]
Cleman, Michael [Auteur]
Reinoehl, Jochen [Auteur]
Cuisset, Thomas [Auteur]
Blackman, Daniel J. [Auteur]
Bolotin, Gil [Auteur]
Spitzer, Stefan [Auteur]
Kappert, Utz [Auteur]
Gilard, Martine [Auteur]
Modine, Thomas [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U1171
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Hildick-Smith, David [Auteur]
Haude, Michael [Auteur]
Margolis, Pauliina [Auteur]
Brickman, Adam M. [Auteur]
Voros, Szilard [Auteur]
Baumbach, Andreas [Auteur]

Journal title :

European heart journal

Abbreviated title :

Eur. Heart J.

Volume number :

36

Pages :

2070-2078

Publication date :

2015-08-14

ISSN :

0195-668X

English keyword(s) :

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

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

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 ...
Show more >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.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
CNRS
Inserm
Université de Lille

Collections :

• Lille Neurosciences & Cognition (LilNCog) - U 1172

Research team(s) :

Troubles cognitifs dégénératifs et vasculaires

Submission date :

2019-11-27T14:30:15Z