Debris captured in Sentinel CPS
Bioprosthetic heart valves typically last 10-15 years, and when they fail, they require replacement. The emergence of transcatheter heart valve procedures has enabled “valve-in-valve” procedures, where a transcatheter aortic valve is implanted within the existing implanted valve.
The Sentinel Cerebral Protection System (CPS) has been initially studied1 in 21 patients undergoing transcatheter aortic valve-in-valve procedures, where histopathological analysis of captured debris was performed on a sub-set of nine patients.
The histology showed that debris was captured and removed in 100% of the procedures. Acute thrombus was the most common type of debris, found in 89% of procedures, while calcification was found in 56% of procedures.
The investigators concluded that the company’s Cerebral Protection System can protect the brain from embolic debris with a 0% stroke rate for valve-in- valve procedures.
- Schmidt, T, et al. Cerebral protection device for transcatheter valve-in- valve procedures — the ALSTER data. TCT 2015.
The Sentinel CPS has received the CE Mark and is commercially available in Europe. It is limited to investigational use in the United States.