Debris Heterogeneity Across Different Valve Types Captured by A Cerebral Protection System During TAVR - Tobias Schmidt

Written by Katrina Mountford, Medical Editor.
19th March 2018


Cerebral injury after transcatheter valve replacement (TAVR) has an impact on clinical outcomes, and the use of the Sentinel cerebral protection device (CEP, Claret Medical, Santa Rosa, CA) has been found to reduce all-cause mortality and stroke within one week of TAVR.1 However, the potential differences between transcatheter heart valve (THV) types and cerebral injury are not well understood. Dr Schmidt presented a study that aimed to investigate differences between THV types and debris captured by the Sentinel CEP. Patients from the SENTINEL IDE (n=100) and SENTINEL-H (n=146) clinical studies were included in the analysis. Analyses of debris were performed for histopathology and histomorphometry, which was performed by automated (particle size, particle count, total particle area) and manual (maximum dimension) measurement. Only commercially available types of THVs were included: Evolut R (EvR, 16 %), Lotus (15 %), SAPIEN 3 (59 %), and SAPIEN XT (10 %).

Results showed that debris was captured in 99 % of patients. Around half (53 %) of all patients had particles of debris larger than 1 mm, irrespective of valve type. The quantity of debris, measured by different methods and techniques, revealed more debris in patients receiving an EvR or Lotus THV than in patients receiving a SAPIEN 3 or SAPIEN XT prosthesis. Since patient and procedural characteristics differed significantly between THV types, multivariate analysis was performed to assess interaction with the amount of debris captured. This showed that THV type was the only significant predictor for the morphometric findings. Dr Schmidt concluded that the capture of embolic debris was universal across different THV types and these findings support the need for cerebral embolic protection (CEP) devices.


1. Latib A, Pagnesi M, Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement: A Disconnect Between Logic and Data?, J Am Coll Cardiol, 2017;69:378-80.