Eleven days after we reported the FDA clearance of the Sentinel device, Claret Medical® tells us that several of the largest specialist centers have performed the first U.S. cases of protected TAVR.
Transcatheter Aortic Valve Replacement (TAVR) is one of the fastest growing procedures worldwide with estomates suggesting that close to 300,000 patients may have undergone treatment by 2025.
As we’ve reported elsewhere though, the procedure is still associated with a reported ten percent risk of clinically-apparent stroke. The majority of strokes are likely to have been caused by debris that breaks loose from the native heart valve or aortic wall and travels towards the brain, leading to potential neurological damage. This is where the Sentinel device finds its utility, effectively filtering out the hazardous debris released ruing valve implantation. Use of the Sentinel has been shown to reduce procedural related strokes by 63 percent in the first 72 hours after TAVR, when most strokes occur.
Among the first centers to utilize the Sentinel to protect patients from the risk of TAVR-related procedural stroke are Cedars-Sinai in Los Angeles, Cleveland Clinic in Cleveland, Ohio, NewYork-Presbyterian in New York City, and Mount Sinai Heart in New York City. Other major centers, such as Emory Healthcare in Atlanta and Gates Vascular Institute in Buffalo, New York, plan cases in the coming days.
“All patients are concerned about the risk of stroke. In our conversations about treatment options, patients and their families seem reassured about having an added layer of protection during their TAVR procedure,” said Samir Kapadia, MD, interventional cardiologist with the Miller Family Heart and Vascular Institute, Cleveland Clinic, Ohio.
“This device has the potential to become a standard of care for protecting patients from the risk of stroke during TAVR, just as embolic protection is commonly used for safeguarding patients during carotid stenting,” said Susheel Kodali, MD, director of the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center, New York City.
“We have seamlessly integrated the device into our TAVR workflow as we have found it intuitive to use and fast to deploy, and it does not interfere with the TAVR procedure itself,” said Raj Makkar, MD, associate director of the Interventional Technologies in the Heart Institute, Cedars-Sinai, Los Angeles. “We are now able to universally remove debris that otherwise had the potential to travel to patients’ brains. This is a meaningful step in enhancing the safety of TAVR for our patients.”
Source: Claret Medical