Study Supports Claret Medical's Sentinel Cerebral Protection System for TAVR
September 18, 2017—Claret Medical announced findings demonstrating the role of the company's Sentinel cerebral protection system (CPS) in significantly reducing the early occurrence of stroke associated with transcatheter aortic valve replacement (TAVR). The study also shows, for the first time, a significantly lower mortality rate associated with the 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. The study was published by Julia Seeger, MD, et al and is available online in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
According to Claret Medical, the Sentinel captures and removes debris that is dislodged ubiquitously during TAVR before it can travel to the brain and potentially cause neurologic and neurocognitive damage. The Sentinel device is cleared for use by the US Food and Drug Administration.
As reported in the company's press release, the investigators 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 the use of the protection device. Hence, cerebral embolic protection should become the standard of care for the TAVR procedure, as there are no preprocedural independent predictors identified for selection of patients at high risk for stroke.”
Between 2014 and 2016, the study investigators prospectively enrolled 802 consecutive TAVR patients. Of these, 280 were protected by the Sentinel and 522 underwent unprotected TAVR. A propensity-score matching analysis was used 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.
In the study's primary endpoint, Sentinel-protected patients showed a three-times lower rate of all-cause mortality or all-stroke at 7 days than patients who had unprotected TAVR (2.1% vs 6.8%; P = .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, noted the company.
Independent of all other factors, use of the Sentinel device was shown to be the strongest predictor in reducing the rate of all strokes in the first 7 days after TAVR by 70% (1.4% vs 4.6%; P = .03). These data corroborate the finding of 63% reduction in early TAVR strokes that was shown in the SENTINEL pivotal trial.
The company noted that there were no major adverse events associated with Sentinel use. Device placement success (both filters deployed) was achieved in 99.6% of cases, with no increase in the amount of contrast agent needed during the TAVR procedure when the Sentinel was used.
Claret Medical advised that in an accompanying editorial, also published online in JACC: Cardiovascular Interventions, Samir Kapadia, MD, commented, “Stroke risk with TAVR, although comparable to that of surgical aortic valve replacement, remains to be a serious complication of TAVR. That risk is still in the 4%–10% range for all strokes, and 2%–3% for major strokes. Although this risk is considered ‘acceptable’ when compared with the gold standard therapy of surgical aortic valve replacement, the question remains whether such a risk is really acceptable to patients."
Dr. Kapadia continued, “In the study from Ulm, systematic use of the Sentinel device resulted in a 1.4% stroke rate. If TAVR is performed without an emboli prevention strategy and the patient has a procedural stroke, one could argue that this adverse event could have been potentially prevented with the use of this device. With TAVR advancing to intermediate-risk and younger patients, preventing cerebral ischemic events and protecting the brain from embolic burden is crucial.”