title: Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.
abstract: OBJECTIVE
  This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR).
  
  
  RESULTS
  The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016).
  
  
  CONCLUSIONS
  Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.
authors: Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.
authors: Andreas
authors: A
authors: Baumbach
authors: Michael
authors: M
authors: Mullen
authors: Adam M
authors: AM
authors: Brickman
authors: Suneil K
authors: SK
authors: Aggarwal
authors: Cody G
authors: CG
authors: Pietras
authors: John K
authors: JK
authors: Forrest
authors: David
authors: D
authors: Hildick-Smith
authors: Stephanie M
authors: SM
authors: Meller
authors: Louise
authors: L
authors: Gambone
authors: Peter
authors: P
authors: den Heijer
authors: Pauliina
authors: P
authors: Margolis
authors: Szilard
authors: S
authors: Voros
authors: Alexandra J
authors: AJ
authors: Lansky
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D001021:Aortic Valve / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D002545:Brain Ischemia / Q000209:etiology / Q000517:prevention & control; D001938:Brazil; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D003071:Cognition; D003072:Cognition Disorders / Q000209:etiology / Q000517:prevention & control; D038524:Diffusion Magnetic Resonance Imaging; D057505:Embolic Protection Devices; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006801:Humans; D020766:Intracranial Embolism / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D008297:Male; D011237:Predictive Value of Tests; 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
chemical_list: D000497:Alloys; C013616:nitinol