The TriGuard filter, an investigational device designed to protect the brain from hazardous debris released during transcatheter aortic valve replacement (TAVR) and other procedures was found to improve in-hospital safety outcomes and cognitive scores at discharge.
The TriGuard filter, an investigational device designed to protect the brain from hazardous debris released during transcatheter aortic vale replacements (TAVR) and other procedures was found to improve in-hospital safety outcomes and cognitive scores at discharge.
Alexandra Lansky, MD, Yale University School of Medicine, said during a presentation at the 2015 American College of Cardiology annual meeting that TriGuard, studied in the DEFLECT III trial, worked by covering the 3 main arteries leading to the brain with a temporary mesh shield.
From the preliminary data currently available for 83 patients with complete in-hospital safety and efficacy measures, the researchers found TriGuard to “demonstrate benefit on several endpoints in this small patient population”. For in-hospital procedure safety, the rates were 22.2% for patients with the device and 31.6% for patients in the control group.
Death rates for the device group from all causes were 2.2% and 5.3% for the control group. Both groups experienced the same rates for both stroke and disabling bleeding, respectively.
The researchers noted, no safety concerns were seen in two categories: rates of acute kidney injury in the device group were 2.2%, but 0% in the control group, one patient vs. none. Both groups saw fairly similar rates of major vascular complications — 15.6% and 15.8%, respectively.
Lansky stated, “protecting the brain has become a priority to improve our patients’ outcomes, and this is a new focus in interventional cardiology.”
DEFLECTION III is the first multicenter randomized clinical trial of a brain-protection device. Lansky found improved performance results on two cognitive tests — the Montreal Cognitive Assessment and the Cogstate test – in the protected group. More importantly, diffusion weighted MRI indicated that fewer patients in the device group developed new brain lesions and the control group saw a lower volume of lesions.
The researchers acknowledged that all neurocognition and weighted imaging measures would be repeated after 30- day follow-up to determine whether to continue early benefits.