Data from a trial of Keystone Heart‘s TriGuard anti-stroke device showed a lower rate of neurologic deficits after transcatheter aortic valve implantation, according to research presented last month at EuroPCR 2015 in Paris.
The 85-patient Deflect 3 study found that TAVI patients treated with the Israeli company’s TriGuard, which is designed to allow blood to pass through while catching potentially dangerous embolic debris, showed a 3.1% rate of new neurologic deficits at 30 days, compared to 15.4% in patients treated without the device.
The TriGuard cohort showed a 26.1% rate of major adverse cardiac and cerebrovascular events at 30 days, compared to 31.2% in the control group, according to Bristol University Hospital’s Dr. Andreas Baumbach, who presented data from the study at EuroPCR. The Deflect 3 results were also published in the European Heart Journal.
"This device and the principle of embolic protection have a great potential to become a major part of adjunctive treatment during TAVI. If safety can be demonstrated and the positioning of the device is very easy, I guess it should have a role in all TAVI procedures," Baumbach told heartwire.
The study showed a 45% lower rate of ischemic lesions and a 40% lower average brain lesion volume in patients treated with the device. Patients treated with TriGuard also showed double-fold improvement in recovering cognitive function after 30 days.
"What that means is, almost half of the patients who had protection had a normalized neurocognitive assessments score as opposed to only 20% in controls," Baumbach said, noting that he’s slated to be co-principal investigator for an upcoming pivotal trial of the device as the company seeks FDA approval.
