DEFLECT I Results Published for Keystone Heart's EDD Used During TAVR

April 20, 2015—Results of the DEFLECT I study on the safety and performance of the TriGuard embolic deflection device (EDD; Keystone Heart, Ltd.) in patients undergoing transcatheter aortic valve replacement (TAVR) were published by Andreas Baumbach, MD, et al online ahead of print in EuroIntervention. The TriGuard EDD is 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.

The investigators concluded that use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the portions of the TAVR procedure that present the highest embolic risk. The potential of the TriGuard EDD to reduce the total cerebral ischemic burden merits further randomized investigation, advised the investigators.

As summarized in EuroIntervention, the prospective, multicenter DEFLECT I study enrolled 37 consecutive patients undergoing TAVR with the TriGuard EDD. The patients underwent clinical and cognitive follow-up to 30 days. Cerebral diffusion-weighted magnetic resonance imaging was performed preprocedurally and at 4 ± 2 days postprocedure.

The investigators found that the device performed as intended, with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolization, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of patients (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischemic lesions on postprocedure diffusion-weighted magnetic resonance imaging (n = 28) was similar to historical controls (82% vs 76%).

However, an exploratory analysis found that the per-patient total lesion volume was 34% lower than the 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), reported the investigators in EuroIntervention.