Abstract 18207: A Prospective, Single Arm Feasibility Study to Evaluate the Safety and Performance of a Novel Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement: Results From the Deflect I Study
Background: Stroke associated with transcatheter aortic valve replacement (TAVR) is primarily due to intra-procedural mechanical embolization of calcific atherosclerotic plaque. Filter-based embolic protection devices may address this devastating complication.
Objectives: : The results of the novel TriGardTM embolic deflection device used in conjunction with (TAVR) in 20 consecutive patients in the DEFLECT I clinical trial.
Methods: DEFLECT I is a prospective, multi-center, single arm study designed to demonstrate the safety and performance of the TriGardTM Embolic Deflection Device (EDD) (Keystone Heart, Caesarea Business Park, Israel), among patients undergoing TAVR. The EDD is designed to be positioned across all major cerebral arteries in the aortic arch. Primary endpoints were device performance and in-hospital device-related safety. A powered secondary endpoint was the number and volume of new diffusion-weighted magnetic resonance imaging (DW MRI) brain lesions from pre-procedure to 4±2 days post-procedure compared to historic controls.
Results: : 20 consecutive patients undergoing TAVR were enrolled at 5 sites. All devices were positioned and retrieved successfully. The device performed as intended with complete vessel coverage until completion of the valve implant in 80% of cases. There were no in-hospital EDD-related adverse events. In-hospital procedure-related MACCE was 10% due to major disabling strokes in 2/20 patients occuring the day after the procedure. Compared with historical controls, the number of new ischemic brain lesions detected on DW MRI (70% vs. 76%) were similar; however, patients undergoing TAVR with the EDD demonstrated 94% reductions in the maximum lesion volume (p<0.01) and maximum total lesion volume (p<0.01) and a 65% reduction in mean lesion volume (p<0.01) compared with historical controls.
Conclusions: The DEFLECT I study demonstrated safety and feasibility of the TriGardTM device in patients undergoing TAVR. The TriGardTM device significantly reduced the total and maximum volume of cerebral ischemic brain lesions compared to historic controls.This study established proof of concept of the TriGardTM device and justifies further evaluation in a planned randomized clinical trial.
- © 2013 by American Heart Association, Inc.