Keystone Heart's TriGuard Brain Shield Shows Promise for Use With TAVR

March 15, 2015—TriGuard (Keystone Heart, Ltd.), which is being studied in the DEFLECT III trial, was designed to reduce the risk of brain damage during transcatheter aortic valve replacement (TAVR) and other procedures that release potentially hazardous debris by covering the three arteries that lead to the brain with a temporary mesh shield. 

Preliminary findings from DEFLECT III were presented at the 64th annual scientific session of the American College of Cardiology (ACC) in San Diego California.
 
According to the ACC, the small, randomized DEFLECT III study concluded that the TriGuard seems to improve in-hospital safety outcomes and cognitive scores at discharge. 

Preliminary data are available for 83 patients with complete in-hospital safety and efficacy measures. Thirty-day data are being gathered and are expected to be reported in May. Target enrollment for the trial is 86 patients recruited from 15 centers in Europe and Israel. 

As summarized in the ACC announcement, the novel TriGuard device demonstrated benefit on several endpoints in this small patient population. For in-hospital procedure safety, defined as a hierarchical composite of major adverse cardiovascular and cerebrovascular events up to 7 days after TAVR, the rates were 22.2% for patients with the device and 31.6% for patients in the control group. 

Death rates from all causes were 2.2% for the device group and 5.3% for the control group. For both stroke and life-threatening or disabling bleeding, rates were 2.2% for the device group and 5.3% for the control group. No safety concerns were seen in two categories: rates of acute kidney injury were 2.2% for the device group compared with 0% for the control group—one patient versus none; and rates of major vascular complications were 15.6% for the device group and 15.8% for the control group. 

The ACC advised that Alexandra J. Lansky, MD, is the Lead Investigator for DEFLECT III, which is the first multicenter randomized clinical trial of a brain-protection device. Dr. Lansky is director of the Yale Cardiovascular Research Program at Yale School of Medicine in New Haven, Connecticut. 

In the ACC press release, Dr. Lansky commented, “Protecting the brain has become a priority to improve our patients’ outcomes, and this is a new focus in interventional cardiology.” Dr. Lansky noted that patients in the protected group performed better than the control on two cognitive tests, the Montreal Cognitive Assessment, which takes a broad look at all domains of neurocognition, and the Cogstate test, a computerized assessment of mental processing. Diffusion weighted magnetic resonance imaging, used as a surrogate endpoint for subclinical brain injury, showed that fewer patients in the device group had new brain lesions and that the volume of the lesions was lower than in the control group. 

The ACC advised that patients in DEFLECT III will be followed for 30 days, and all neurocognition and weighted imaging measures will be repeated at that point to determine whether the early benefits continue. Also, the US Food and Drug Administration has approved a definitive investigational device exemption trial, REFLECT, which is expected to start enrollment during the second quarter of 2015.