Keystone Heart today released data from transcatheter aortic valve replacement patients treated with its TriGuard cerebral embolic protection device, touting a significant reduction in brain lesions.
TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR procedures, by allowing blood to pass through while catching potentially dangerous embolic debris.
Preliminary results from a real-world study of 51 patients who underwent TAVR procedures were presented at the PCR London Valves 2016 Conference this week, Keystone Heart said.
“These data, together with previously reported positive safety, and clinically meaningful outcomes, reinforce the importance of using TriGuard to protect the brain from damage potentially incurred during TAVR procedures. Neurologic damage due to TAVR is overlooked, and protecting the brain has become a priority to improve our patients’ outcomes. Consensus-driven definitions of neurologic measures will facilitate more informed benefit-risk assessments for all procedures and devices, and improve our care of patients,” Dr. Alexandra Lansky of the Yale School of Medicine said in a press release.
Patients treated with the TriGuard embolic deflection device showed a 20% rate of new brain lesion developments, compared with 68% for patients treated without the TriGuard, Keystone Heart said.
No strokes were reported during the study and there was a 100% rate of successful device placement, the company said. The MRI arm of the study reported a “clear improvement” in the mean number of new lesions, mean total lesion time and mean single lesion volume for patients treated with TriGuard.
In June, data from the Deflect 3 trial indicated a lower rate of neurologic deficits after TAVR procedures.
The 85-patient study found that TAVR patients treated with TriGuard showed a 3.1% rate of new neurologic deficits at 30 days, compared to 15.4% in patients treated without the device.