HARRISBURG, Pa., Aug. 29, 2017 /PRNewswire/ -- PinnacleHealth is the first hospital in Pennsylvania and one of the first 10 in the country to introduce new technology shown to help protect patients from the risk of stroke during transcatheter aortic valve replacement (TAVR).
Minimally invasive TAVR is proven effective in treating aortic stenosis without open heart surgery for patients at too high of a risk for surgery. However, during TAVR, calcium deposits from the heart valve or tissue can be dislodged and may travel to the brain, which can create a stroke risk. Based on clinical trial results and major TAVR registry data, the reported risk of stroke for TAVR patients varies between 1-5 percent1-4.
PinnacleHealth is implementing the Sentinel Cerebral Protection System, the first FDA-cleared device available in the U.S., to capture and remove this debris before it reaches the brain. The device has been shown to reduce strokes by 63 percent during the procedure and in the first 72 hours post-procedure, when most strokes occur5.
In the U.S. clinical trial of the technology, the device captured debris in 99 percent of TAVR cases,6 with no added risk for the overall procedure. The Sentinel device is inserted through the catheter before the TAVR device and comes out after the valve is deployed. It is shaped like a butterfly net, collapsing around the debris and allows the debris to be removed from the body after the procedure.
"Any stroke is one stroke too many," says Hemal Gada, MD, MBA, medical director of structural heart at PinnacleHealth CardioVascular Institute.
"We are proud to be on the vanguard of offering the most advanced medical technology to keep our patients safe and value the added layer of protection this device brings to our patients," says Mubashir Mumtaz, MD, FACS, FACC, chief of cardiothoracic surgery and surgical director of structural heart at PinnacleHealth CardioVascular Institute.
More than 3,500 patients worldwide have been protected with the innovative technology to-date.
About PinnacleHealth System
PinnacleHealth is a nationally recognized leader in providing high-quality, patient-centered healthcare services in central Pennsylvania and surrounding rural communities. Its more than 2,600 physicians and allied health professionals and approximately 9,000 employees serve a 10-county area at outpatient facilities and seven acute care hospitals with 1,267 licensed beds: Carlisle Regional Medical Center, Community General Osteopathic Hospital, Harrisburg Hospital, Heart of Lancaster, Lancaster Regional Medical Center, Memorial Hospital of York, and West Shore Hospital. The not-for-profit system anticipates caring for more than 1.2 million area residents in FY 2018. For more information, visit www.pinnaclehealth.org.
- Leon MB, Smith CR, Mack M, et al. PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010; 363: 1597-607.
- Mack MJ, Brennan J, Brindis R, et al. STS/ACC TVT Registry. Outcomes following transcatheter aortic valve replacement in the United States. JAMA. 2013; 310: 2069-77.
- Thomas M, Schymik G, Walther T, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011; 124: 425-33.
- Möllman H, Besteheorn K, Bestehorn M, et al. In-hospital outcomes of transcatheter vs. surgical aortic valve replacement with aortic valve replacement in patients with aortic valve stenosis; complete dataset of patients treated in 2013 in Germany. Clin Res Cardiol. 2016; 105: 553-9.
- Data from SENTINEL Trial, included in device's Instructions for Use (IFU).
- Kapadia S, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. JACC. 2017 Jan 31; 69(4): 367-377
Contact: Kelly McCall, Public Relations Manager, PinnacleHealth System, 717-231-8104 (office), [email protected]