Left Atrial Appendage Closure
What is WATCHMAN?
The WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Implant offers patients with non-valvular atrial fibrillation (AF) an alternative to long-term warfarin (Coumadin®) medication. For patients with AF who are considered suitable for blood thinners by their physicians but who have reason to seek a non-drug alternative, the WATCHMAN Implant is an alternative to reduce their risk of AF-related stroke. The implant device closes off an area of the heart called the left atrial appendage (LAA) to keep harmful blood clots that can form in the LAA from entering the blood stream and potentially causing a stroke. By closing off the LAA, the risk of stroke may be reduced and, over time, patients may be able to stop taking their blood thinner. This next-generation technology has a new design to help treat more patients safely and effectively to ensure the best long-term outcomes. According to Boston Scientific, 100 percent of subjects demonstrated effective LAA closure at 12 months.*
People with atrial fibrillation have a five times greater risk of stroke.1 Atrial fibrillation can cause blood to pool and form clots in the LAA. For patients with non-valvular AF, the LAA is believed to be the source of the majority of stroke-causing blood clots.2 If a clot forms in the LAA, it can increase one’s risk of having a stroke. Blood clots can break loose and travel in the blood stream to the brain, lungs, and other parts of the body.
What is Atrial Fibrillation?
Atrial fibrillation is a heart condition where the upper chambers of the heart (atrium) beat too fast and with irregular rhythm. AF is the most common cardiac arrhythmia, currently affecting up to 6 million Americans.3,4 Stroke is the most common complication of AF and AF-related strokes are also more frequently fatal and disabling.1,2 In people with nonvalvular AF, more than 90 percent of all stroke-causing clots that come from the heart form in the LAA.5 The most common treatment to reduce stroke risk in patients with AF is blood-thinning medication. While very effective at reducing the risk of stroke, blood thinners increase the risk of serious bleeding over time and come with certain requirements and restrictions.
Is WATCHMAN Right For You?
You may be a candidate for Watchman if you can answer yes to the following questions:
- Do you have atrial fibrillation not caused by a heart valve problem?
- Has your doctor recommended that you take a blood thinner for your AFib?
- Can you take coumadin but need an alternative to long-term blood thinners for one of the reasons below?
- You have a history of serious bleeding while taking blood thinners.
- You have a lifestyle, occupation or condition that puts you at risk for serious bleeding.
- You’re taking coumadin and having trouble with your treatment plan, and a different type of blood thinner isn’t an option for you.
Cost and Coverage
WATCHMAN is covered for eligible Medicare patients who meet certain national coverage criteria. It’s also covered by an increasing number of commercial insurers.
Potential Risks
According to Boston Scientific, the WATCHMAN FLX Device can be successfully and safely implanted in 99 percent of patients.** The risk of complication is 0.5 percent, which is lower than the original WATCHMAN implant device.
About the WATCHMAN Procedure
WATCHMAN is implanted into your heart in a one-time procedure. It’s a permanent device that doesn’t have to be replaced and can’t be seen outside the body.
To implant WATCHMAN, your doctor makes a small cut in your upper leg and inserts a narrow tube, as done in a standard stent procedure. Your doctor then guides WATCHMAN into the left atrial appendage (LAA) of your heart. The procedure is done under general anesthesia and takes about an hour. Patients commonly stay in the hospital overnight and leave the next day.
How WATCHMAN Works
WATCHMAN™ is a trademark of Boston Scientific. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties.
* LAA closure at 12 months is defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE
**Implant success defined as successful delivery and release of a WATCHMAN FLX device into the LAA)
- Hart RG, Halperin JL., Ann Intern Med. 1999; 131:688–695.
- McGrath ER, Neurology 2013; 81:825-832.
- Benjamin EJ, Muntner P, Alonso A, et al. Heart disease and stroke statistics—2019 update: a report from the American Heart Association. Circulation. 2019;137:e1-e473.
- “Atrial Fibrillation Fact Sheet.” Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm.
- Price MJ, Reddy VY, Valderrábano M, et al. Bleeding outcomes after left atrial appendage closure compared with long-term warfarin. JACC Cardiovasc Interv. 2015;8(15):1925-1932.
