DEFLECT III Results Support TriGuard HDH Embolic Deflection Device

August 17, 2015—Alexandra J. Lansky, MD, et al published results from the DEFLECT III trial of the TriGuard HDH embolic deflection device (Keystone Heart, Ltd.) in the European Heart Journal (2015;36:2070–2078). DEFLECT III was conducted to evaluate the safety, efficacy, and performance of the TriGuard device compared with no cerebral protection in patients undergoing transcatheter aortic valve replacement (TAVR). 

The DEFLECT III trial included 85 patients undergoing TAVR at 13 centers in Europe and Israel from February 2014 to March 2015. The patients were randomized to TriGuard protection versus no protection. 

The investigators concluded that TriGuard cerebral protection during TAVR is safe, and complete cerebral vessel coverage was achieved in 89% of patients. In this exploratory study, the investigators found that patients undergoing protected TAVR had more freedom from ischemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and at 30 days compared with controls.

As summarized in the European Heart Journal, the patients underwent neurologic and cognitive evaluation at baseline, predischarge, and 30 days. Cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days postprocedure and at 30 days. 

The investigators found that technical success, which included complete three-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard patients and 30.8% of control patients. 

In the per treatment population (patients with complete three-vessel cerebral coverage), use of the TriGuard device versus no protection was associated with greater freedom from new ischemic brain lesions (26.9% vs 11.5%), fewer new neurologic deficits as detected by the National Institutes of Health Stroke Scale (3.1% vs 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task at discharge, and a greater than twofold increase in recovery of normal cognitive function (MoCA score > 26) at 30 days, reported the investigators in the European Heart Journal.

In March, preliminary findings from DEFLECT III were presented at the 64th annual scientific session of the American College of Cardiology in San Diego, California.