Image: The Sentinel Cerebral Protection (SCP) device (Photo courtesy of Claret Medical).
A novel device provides cerebral protection during endovascular procedures such as transcatheter aortic valve replacement (TAVR).
The Sentinel Cerebral Protection (SCP) device consists of a catheter with deployable proximal and distal filters, an articulating sheath, and an integral handle assembly. Prior to the endovascular procedure, the SCP delivers a proximal embolic filter to the brachiocephalic artery, and a distal embolic filter to the left common carotid artery. Delivery is facilitated by the articulating sheath, which allows the curvature of the device to be adjusted for anatomic variations of the aortic arch, and by radiopaque markers that enable visualization under fluoroscopy during placement.
The filters collect debris released during the procedure, such as valve tissue, calcification, thrombii, or other material, and prevent it from traveling to the brain. At the completion of the procedure, the filters and collected debris are recaptured into the 6 French-compatible catheter and subsequently removed. The Sentinel CPS is a product of Claret Medical (Santa Rosa, CA, USA), and is available in one universal size that adjusts to the majority of vascular anatomies.
“Any occurrence of stroke is one too many, and results from this clinical trial may give us the evidence needed to make cerebral protection a standard of care during TAVR, as it is in carotid artery stenting,” said Samir Kapadia, MD, of the Cleveland Clinic (CC, OH, USA) cardiac catheterization laboratories, who participated in the clinical trial of the device. “By both capturing and removing embolic debris released during TAVR, the Sentinel CPS may offer a unique neuroprotective benefit.”
New ischemic brain lesions, or “silent” infarcts, occur in more than 90% of TAVR and other endovascular procedures, according to recent research. These ischemic lesions are associated with adverse neurologic and cognitive consequences, as well as dementia, and have also been shown to increase the risk of stroke by two to four times.