The Journal of the American College of Cardiology (JACC) has published a paper showing reductions in early occurrence of stroke associated with transcatheter aortic valve replacement (TAVR) when the Sentinel Cerebral Protection System (CPS) system is employed.
Claret Medical’s Sentinel CPS is the first and only FDA-cleared device that captures and removes debris that is dislodged ubiquitously during TAVR. The objective is to prevent debris travelling to the brain and potentially causing neurological and neurocognitive damage.
The study also shows, for the first time, a significantly lower mortality rate associated with use of the Sentinel CPS device.
The large-scale, all-comers, real-world study was conducted at the University of Ulm, Germany and led by Professor Jochen Wöhrle, MD, FESC. Between 2014 and 2016, it prospectively enrolled 802 consecutive TAVR patients, 280 that were protected by the Sentinel and 522 that had unprotected TAVR. Propensity Score Matching (PSM) Analysis was utilized to reduce any potential bias in outcomes of the study. Two groups of matched patients with 280 protected and 280 unprotected in each arm were established. All patients were evaluated by a neurologist, with stroke defined according to VARC-2 standard criteria.
Sentinel-protected patients showed a three times lower rate of all-cause mortality or all-stroke at seven days – the primary endpoint – than patients who had unprotected TAVR (2.1 percent vs. 6.8 percent, p=0.01). This result translates into one stroke or death being avoided for every 21 TAVR patients protected with Sentinel, which is consistent with earlier published studies.
Independent of all other factors, the use of Sentinel was shown to be the strongest predictor in reducing the rate of all strokes in the first seven days post-TAVR by 70 percent (1.4 percent vs. 4.6 percent, p=0.03). These data corroborate the finding of 63 percent reduction in early TAVR strokes that was shown in the SENTINEL pivotal trial.
There were no major adverse events associated with Sentinel use. Device placement success (both filters deployed) was achieved in 99.6 percent of cases, with no increase in contrast amount needed during the TAVR procedure when the Sentinel was used.
The authors stated: “In patients undergoing TAVR, use of (the Sentinel) cerebral embolic protection device demonstrated a significantly higher rate of stroke-free survival compared with unprotected TAVR… In addition, there are no safety issues with use of the protection device… Hence, cerebral embolic protection should become standard of care for the TAVR procedure, as there are no pre-procedural independent predictors identified for selection of patients at high risk for stroke.”
Claret Medical Chief Executive Officer Azin Parhizgar said: “The study adds to the extensive body of evidence covering more than 1,000 patients and demonstrating that Sentinel is safe, removes debris from virtually every patient, and results in significant reduction in early procedural stroke after TAVR.
“U.S. centers of excellence that have adopted the Sentinel as an integral part of the TAVR treatment algorithm are using it in nearly two-thirds of their eligible patients. Additionally, we have had productive discussions with the Centers for Medicare and Medicaid Services (CMS) about a new technology add-on payment, with the aim of bridging the gap to a future positive DRG classification.”
Source: Claret Medical, Inc