NewYork-Presbyterian Hospital Participating in Trial of Device Designed to Prevent Stroke in Heart Valve-Replacement Patients
First center in the U.S. to test Sentinel device during transcatheter aortic valve replacement
Jan 14, 2015
NewYork-Presbyterian Hospital is participating in a national multicenter trial to evaluate the Sentinel Cerebral Protection System (Sentinel), a medical device designed to prevent stroke in patients undergoing transcatheter aortic valve replacement (TAVR). The trial will assess Sentinel’s ability to capture embolic debris—calcified plaque built up in the arteries that can cause brain lesions or stroke—in the bloodstream.
“Embolic debris dislodged during TAVR poses a threat to the brain,” said Dr. Susheel Kodali, director of the Heart Valve Center at NewYork-Presbyterian/Columbia University Medical Center, an assistant professor of medicine at Columbia University College of Physicians and Surgeons and National principal investigator for the trial. “The Sentinel device shows promise as an effective way to filter out harmful material and increase the safety of TAVR for our patients.” The Heart Valve Center at NewYork-Presbyterian/Columbia University Medical Center was the first in the country to use Sentinel during TAVR.
“We are excited to be participating in the Sentinel trial at NewYork-Presbyterian,” said Dr. Chiu Wong, director of cardiac catheterization laboratories at NewYork-Presbyterian/Weill Cornell Medical Center, a professor of medicine at Weill Cornell Medical College and principal investigator of the trial for NewYork-Presbyterian/Weill Cornell. “The novel cerebral protection system will potentially reduce the risk of stroke for our patients undergoing TAVR procedures.”
In recent years, TAVR has proven to be an effective treatment for aortic valve replacement. Unlike traditional aortic valve replacement surgery which requires open-heart surgery, TAVR is a minimally invasive procedure in which a replacement heart valve is inserted through the groin and advanced to the heart using a delivery catheter. The procedure is life-saving for patients who are too sick to undergo major surgery, but it does carry risks. Roughly 3 percent of TAVR patients experience stroke caused by embolic debris that becomes dislodged when the valve is replaced.
Sentinel, developed by Claret Medical, uses specially designed filters to capture this harmful debris. The device is implanted in tandem with the replacement heart valve during TAVR and can be adjusted to the precise size of a patient’s arteries. After the valve has been replaced and the procedure is complete, the filters containing the debris are recaptured into the catheter and removed from the patient.
NewYork-Presbyterian has been a pioneer in TAVR procedures since 2009. Since then, more than 1,500 TAVR procedures have been performed at the hospital.
NewYork-Presbyterian Hospital, based in New York City, is one of the nation’s largest and most comprehensive hospitals and a leading provider of inpatient, ambulatory and preventive care in all areas of medicine. With some 2,600 beds and more that 6,500 affiliated physicians and 20,000 employees, NewYork-Presbyterian had more than 2 million visits in 2013, including close to 15,000 infant deliveries and more than 310,000 emergency department visits. NewYork-Presbyterian comprises six campuses: NewYork-Presbyterian/Weill Cornell Medical Center, NewYork-Presbyterian/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian/The Allen Hospital, NewYork-Presbyterian/Westchester Division and NewYork-Presbyterian/Lower Manhattan Hospital. The hospital is also closely affiliated with NewYork-Presbyterian/Lawrence Hospital in Bronxville. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area, according to U.S. News & World Report, and consistently named to the magazine’s Honor Roll of best hospitals in the nation. Affiliated with two world-renowned medical schools, Weill Cornell Medical College and Columbia University College of Physicians and Surgeons, NewYork-Presbyterian is committed to excellence in patient care, research, education and community service. For more information, visit www.nyp.org.
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