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The implant, called “WATCHMAN FLX,” was approved in July by the U.S. Food and Drug Administration. It represents a new generation of its technology, with safety and performance upgrades. The device provides an alternative for patients who cannot take long-term blood thinners, the standard treatment for atrial fibrillation, or “AFib,” a heart rhythm disorder that increases the risk of stroke.
WATCHMAN FLX is implanted into the heart to close off the left atrial appendage, a blind pouch of heart tissue where blood clots form in patients with AFib. These clots can break off, travel in the bloodstream to the brain, and cause strokes. In this non-surgical procedure, the implant is inserted through a vein in the leg during a one-time, catheter-based procedure in the Electrophysiology Laboratory.
Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for the Mount Sinai Health System, led a team of physicians including Srinivas Dukkipati, MD, and Martin Goldman, MD, for their first WATCHMAN FLX procedure at The Mount Sinai Hospital. They successfully implanted the device in an 81-year-old AFib patient who had a stroke in July while off anticoagulants due to a large leg hematoma.
“We are delighted for The Mount Sinai Hospital to be the first institution on the East Coast to offer this therapy to our atrial fibrillation patients who are not good candidates for taking blood thinners over the long term,” Dr. Reddy said. “While the older generation of the WATCHMAN device was quite good, the improved safety profile and closure rates of this newer Watchman FLX device is an even better option for our patients.”
Atrial fibrillation affects nearly 6 million Americans and makes them five times more likely to have a stroke than those with a regular heartbeat. Some patients have AFib that’s not caused by a heart valve problem, and in this population, at least 90 percent of stroke- causing clots that come from the heart are formed in the left atrial appendage. WATCHMAN FLX permanently closes off the left atrial appendage to keep blood clots from escaping and causing the stroke. This upgraded version comes in five sizes to treat a greater variety of atrial appendage sizes compared to the previous WATCHMAN device. It also includes advanced performance and safety features.
Blood-thinning medications have been the standard of care for reducing the risk for stroke in patients with atrial fibrillation, but many patients cannot tolerate these medications because of the incidence of bleeding. While these therapies have been demonstrated to be efficacious, their effectiveness is contingent upon patient adherence, as gaps in treatment can lead to stroke.
Mount Sinai was part of PINNACLE-FLX, a national clinical trial in which this new generation device was tested in 400 AFib patients. This trial completed its one-year follow-up earlier this year, and the primary data were reported at the Late-Breaking Clinical Trials Sessions of the Heart Rhythm Society in May 2020. The device proved to be both safe (with a complication rate of only 0.5 percent) and 100 percent effective in closing the left atrial appendage.
Dr. Reddy published research on the previous version of WATCHMAN in multiple journals including JAMA, The Lancet, American Heart Association’s Circulation, and the Journal of the American College of Cardiology, and demonstrated the safety/efficacy of the device, as well as showing that it is more cost effective than some anticoagulants for Medicare and Medicaid patients.
So far 30 hospitals across the country have implanted the new WATCHMAN FLX devices. More than 100,000 WATCHMAN procedures (with the pervious device) have been performed worldwide. Boston Scientific makes WATCHMAN devices and Dr. Reddy has received research grants from and serves as an unpaid consultant to the company.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report’s “Honor Roll” of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.
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