The WATCHMAN™ Left Atrial Appendage Closure Device is more cost-effective than warfarin and non-warfarin oral anticoagulants (NOACs) for stroke reduction in patients with non-valvular atrial fibrillation, according to a study led by Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and the Mount Sinai Health System, and published online and in the December 22 issue of the Journal of American College of Cardiology (JACC), the world's leading peer-reviewed journal on cardiovascular disease.
Atrial fibrillation, a heart rhythm malfunction that affects nearly six million Americans, puts patients at a significantly greater risk of stroke, which can be both debilitating and costly. With nearly $8 billion spent annually on atrial fibrillation-associated strokes, researchers aimed to determine the cost effectiveness of three atrial fibrillation treatments: warfarin, NOACs and the WATCHMAN device.
"By its very nature, the WATCHMAN device is not subject to patient adherence issues, since once implanted, the device provides lifelong stroke prophylaxis without the risk of complications associated with blood thinners," said Dr. Reddy. "This is crucial both in improving patient outcomes by reducing disabling strokes, as well as reducing health care costs."
Blood-thinning medications like warfarin and NOACs have long been the standard of care for reducing the risk for stroke in patients with atrial fibrillation; however, many patients cannot tolerate these medications because of the incidence of bleeding and need for bi-weekly blood tests. While these therapies have been demonstrated to be efficacious, their effectiveness is contingent upon patient adherence, as gaps in treatment can lead to stroke.
The WATCHMAN device, approved by the U.S. Food and Drug Administration in March 2015, 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 bloodstream to the brain and cause strokes. It is inserted through a vein in the leg during a one-time, minimally invasive, catheter-based procedure in the Electrophysiology Laboratory.
Researchers used a Markov model constructed from the perspective of the Centers for Medicare & Medicaid Services (CMS) with a lifetime horizon defined as 20 years and 3-month cycle length to evaluate the cost effectiveness of the three treatment strategies. Cost effectiveness was assessed annually to determine if there was an observable time horizon over which treatment options reached accepted levels of cost effectiveness.
The researchers found:
- The WATCHMAN device achieved cost effectiveness relative to warfarin at seven years ($42,994/QALY) and NOACs achieved cost effectiveness relative to warfarin at 16 years ($48,446/QALY) when assessing Medicare beneficiaries over a 20-year period.
- The WATCHMAN device became dominant (more effective and less costly) to warfarin at 10 years and dominant to NOACs at five years, with cost savings generated annually thereafter.
The WATCHMAN device, made by Boston Scientific, is approved in more than 70 countries worldwide. Mount Sinai experts were the first to use the device in the eastern United States.
Dr. Reddy served as co-principal investigator for national clinical trials testing the WATCHMAN device, and has served as a consultant to Boston Scientific.
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 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 6,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is ranked as one of the nation's top 10 hospitals in Geriatrics, Cardiology/Heart Surgery, and Gastroenterology, and is in the top 25 in five other specialties in the 2015-2016 "Best Hospitals" issue of U.S. News & World Report. Mount Sinai's Kravis Children's Hospital also is ranked in seven out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 11th nationally for Ophthalmology, while Mount Sinai Beth Israel is ranked regionally.
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