Mount Sinai experts were the first in the Eastern United States on March 23 to implant a newly FDA-approved device that prevents stroke in patients with arrhythmia.
The new device is designed to address atrial fibrillation, a malfunction that throws the heart out of rhythm, causing the upper chambers to beat too quickly. Often seen in aging patients, it interferes with electrical signals that drive the heartbeat. Patients with the condition have a five times greater risk of stroke, and a greater chance of having a more serious stroke.
The WATCHMAN device, the size of a quarter and shaped like a parachute, is implanted into the heart to close off the left-atrial appendage, a blind pouch of heart tissue where blood clots form and can then break off and travel in the blood stream to the brain and cause strokes. The device is inserted into the heart through a vein in the leg during a one-time, minimally invasive, catheter-based procedure in the Electrophysiology Laboratory.
“Blood-thinning medications like warfarin or Coumadin are quite effective in reducing the risk for stroke in patients with atrial fibrillation. However, many of our patients cannot, or will not, tolerate these medications because of the incidence of bleeding. The WATCHMAN device is a solution for such atrial fibrillation patients, since it similarly reduces their stroke risk, but averts their need for a lifetime of blood-thinners,” says the electrophysiologist who led the procedure, Vivek Reddy, MD, Director of Arrhythmia Services at The Mount Sinai Hospital and the Mount Sinai Health System.
Dr. Reddy served as co-principal investigator for national clinical trials testing the WATCHMAN device. The recently published results of these trials revealed that the device offers an efficient alternative to warfarin, and prevents strokes just as well. Patients with the device implanted also had a 60 percent reduction in cardiovascular mortality and 34 percent reduction in all-cause mortality.
Warfarin is the most common treatment currently used to reduce stroke risk in patients with atrial fibrillation. However, warfarin is not well-tolerated by all patients and has significant risk for bleeding complications, and patients need to be closely monitored with bi-weekly blood tests.
“This advanced technology will be truly life-changing for many atrial fibrillation patients freeing them from not only the dangers of stroke risk, but also the daily challenges of long-term blood-thinning medication therapy,” says Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital.
The newly U.S. FDA-approved WATCHMAN, made by Boston Scientific, Inc., is approved in more than 70 countries worldwide.
Dr. Reddy has served as a consultant to Boston Scientific, Inc., the manufacturer of the WATCHMAN device.
About the Mount Sinai Health System
The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven member hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community‐based facilities to tertiary and quaternary care.
The System includes approximately 6,600 primary and specialty care physicians, 12‐minority‐owned free‐standing ambulatory surgery centers, over 45 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island, as well as 31 affiliated community health centers. Physicians are affiliated with the Icahn School of Medicine at Mount Sinai, which is ranked among the top 20 medical schools both in National Institutes of Health funding and by U.S. News & World Report.