Your browser doesn't support javascript.
loading
Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.
Baumbach, Andreas; Mullen, Michael; Brickman, Adam M; Aggarwal, Suneil K; Pietras, Cody G; Forrest, John K; Hildick-Smith, David; Meller, Stephanie M; Gambone, Louise; den Heijer, Peter; Margolis, Pauliina; Voros, Szilard; Lansky, Alexandra J.
Affiliation
  • Baumbach A; Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.
EuroIntervention ; 11(1): 75-84, 2015 May.
Article in En | MEDLINE | ID: mdl-25868876
ABSTRACT

AIMS:

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). METHODS AND

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.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Aortic Valve / Aortic Valve Stenosis / Heart Valve Prosthesis / Cardiac Catheterization / Heart Valve Prosthesis Implantation / Intracranial Embolism / Embolic Protection Devices Type of study: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies Limits: Aged80 Country/Region as subject: America do sul / Brasil / Europa Language: En Journal: EuroIntervention Journal subject: ANGIOLOGIA / CARDIOLOGIA / TERAPEUTICA Year: 2015 Type: Article Affiliation country: United kingdom

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Aortic Valve / Aortic Valve Stenosis / Heart Valve Prosthesis / Cardiac Catheterization / Heart Valve Prosthesis Implantation / Intracranial Embolism / Embolic Protection Devices Type of study: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Prognostic_studies Limits: Aged80 Country/Region as subject: America do sul / Brasil / Europa Language: En Journal: EuroIntervention Journal subject: ANGIOLOGIA / CARDIOLOGIA / TERAPEUTICA Year: 2015 Type: Article Affiliation country: United kingdom