Cardiovascular cerebral protection experts, Claret Medical™, tell us about new clinical results showing statistically significant support for the use of the Sentinel™ system during transcatheter aortic valve replacement (TAVR).
Claret Medical’s Sentinel cerebral protection system (CPS) gained CE Mark approval in 2013 since when more than 2,000 commercial cases have been performed using the technology. Now comes some interesting clinical data that appears to back up the application of the system.
An oral presentation of results from the MISTRAL-C study has been performed at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting by Principal Investigator Nicholas van Mieghem, MD, Thoraxcenter, Erasmus Medical Center, Rotterdam.
Data from the multi-center, randomized, controlled study show the first definitive cognitive benefit from use of the Sentinel™ Cerebral Protection System (CPS) during TAVR. Data show that unprotected patients have a statistically significant (p=0.017) worsening in cognition when compared to Sentinel-protected patients at five days post-TAVR, when assessed using the Mini Mental State Exam (MMSE).
There was a 52 percent reduction in the median total new lesion volume at five days post-procedure as assessed using highly sensitive 3-Tesla brain MRI. None of the protected patients had National Institute of Health Stroke Scale (NIHSS) deterioration at five days post-procedure, while five percent of unprotected patients showed deterioration.
MISTRAL-C studied 65 patients enrolled at four centers in the Netherlands that underwent TAVR using both self-expanding and balloon-expandable valves, with and without the use of the Sentinel CPS. The study compared the median total new lesion volume as detected by DW-MRI at five days post-procedure to pre-procedural baseline cerebral scans. It also included a detailed neurological and cognitive assessment of patients five days post-procedure.
The MISTRAL-C data also validates findings from the landmark CLEAN-TAVI study that showed the use of a Claret Medical cerebral protection system reduced the number and volume of brain lesions in TAVR patients.
“What is clear in MISTRAL-C is that patients not protected by the Sentinel CPS showed significant cognitive decline post-procedure when compared to those protected by the Sentinel CPS. Protected patients also showed a robust reduction in the number and volume of new cerebral lesions at five days,” said Dr. van Mieghem.
“Claret Medical is leading the way in incorporating advanced neuroimaging methodologies in its studies in order to obtain an accurate picture of patients’ brain health pre- and post-TAVR,” said Claret Medical Chief Executive Officer Azin Parhizgar, Ph.D.
“When we incorporate 3-Tesla MRI analysis at baseline in clinical studies, CLEAN-TAVI showed us that nearly 40 percent of patients present with pre-existing lesions, and 17 percent of those with volume greater than 100mm.2 Utilizing the more sensitive 3T MRI enables us to accurately quantify the number and volume of all new lesions caused by TAVR. This imaging algorithm also tells us that, while a substantial number of new lesions are measured at sub-3mm,2 the cumulative debris shower that impacts the brain may be quite large.”
Source: Claret Medical, Inc.