Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study

• Published in: EuroIntervention Vol. 11; no. 1; pp. 75 - 84
• Main Authors: 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.
• Format: Journal Article
• Language: English
• Published: France 01.05.2015
• Subjects: Aged; Aged, 80 and over; Alloys; Aortic Valve - physiopathology; Aortic Valve Stenosis - diagnosis; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - therapy; Brain Ischemia - etiology; Brain Ischemia - prevention & control; Brazil; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Cardiac Catheterization - methods; Cardiac Catheterization - mortality; Cognition; Cognition Disorders - etiology; Cognition Disorders - prevention & control; Diffusion Magnetic Resonance Imaging; Embolic Protection Devices; Europe; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - methods; Heart Valve Prosthesis Implantation - mortality; Humans; Intracranial Embolism - diagnosis; Intracranial Embolism - etiology; Intracranial Embolism - mortality; Intracranial Embolism - prevention & control; Male; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Severity of Illness Index; Stroke - etiology; Stroke - prevention & control; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Transcranial
• ISSN: 1774-024X; 1969-6213
• DOI: 10.4244/EIJY15M04_01

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). 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). 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.