Image: The TriGuard Cerebral Protection Device (Photo courtesy of Keystone Heart).
An innovative cerebral protection device (CPD) reduces the volume of new brain lesions, especially during protected transcatheter aortic valve replacement (TAVR).
The TriGuard CPD is a Nitinol mesh embolic debris deflection device designed to cover all three aortic cerebral branches to minimize the risk of brain damage during cardiovascular (CV) procedures, and accommodates most anatomical variations of the aortic arch. The Nitinol frame and mesh are designed to be flexible and atraumatic, yet robust and sturdy, thus providing simple placement and retrieval.
The device is placed via one of two femoral artery access ports typically used in TAVR, eliminating the need for a third puncture site, and deploys rapidly, self-positioning through a 3-mm catheter. Studies have shown that compared with historical data on unprotected TAVR procedures, use of the TriGuard CPD decreased maximum total lesion volume by 95%, while average total lesion volume was 57% smaller, when compared with historical references. The TriGuard Cerebral Protection Device is a product of Keystone Heart (Caesarea, Israel), and has received the European community CE marking of approval.
“Cerebral function is the essence of quality of life. Its preservation throughout medical procedures is a key component to procedural success and patient care. TriGuard is the most sophisticated cerebral embolic protection device currently available,” said Andreas Baumbach, MD, consultant cardiologist at University Hospitals Bristol (United Kingdom). “The device has the potential to become a routine preventive measure in TAVR and other cardiovascular procedures associated with embolic lesions.”
Cerebral emboli are commonly associated with left-sided cardiac procedures. During CV procedures, debris from the aortic valve, ascending aorta, and other sources may embolize and cause cerebral infarction. Cerebral damage may not be clinically evident after CV procedures and can take months or years for symptoms to manifest, often as devastating stroke, dementia, and cognitive decline. Embolic brain lesions can be objectively and consistently detected by diffusion-weighted magnetic resonance imaging (DW-MRI).
University Hospitals Bristol