WATCHMAN: Finally, An Alternative to Your Blood Thinners

Implantable device helps minimize stroke risk
Wiping Out Heart Arrhythmias

Patients with atrial fibrillation (afib), the most common type of irregular heart rhythm, are five times more likely to suffer a stroke than those without afib.

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“Therefore, the most important aspect of afib management is the prevention of stroke,” says cardiologist Oussama Wazni, MD.

Traditional treatments and a new alternative

Traditionally, stroke prevention in patients with afib has focused on anticoagulant therapy such as warfarin (also known as Coumadin®) to thin the blood and prevent clots caused by chaotic heart rhythms. These blood clots can break loose, travel through the bloodstream, and block a blood vessel in the brain. If this occurs, the part of the brain that is supplied by that blood vessel can become permanently damaged within minutes, which is known as a stroke.

Warfarin therapy requires close monitoring and blood tests, along with dietary restrictions. Newer blood thinners have been developed that do not require regular blood tests and dietary restrictions, however all blood thinners can cause harmful bleeding — most notably gastrointestinal (stomach/digestive system) bleeding; or even bleeding in the brain, which also can cause a stroke, Dr. Wazni explains. This can be of particular concern for patients who are at risk for bleeding to begin with. Therefore, researchers — including those at Cleveland Clinic — have been investigating alternatives to anticoagulant therapy.

In an exciting breakthrough, the U.S. Food and Drug Administration (FDA) recently approved one such alternative: the WATCHMAN® device, which is implanted percutaneously (through the skin) in the electrophysiology lab.

Dr. Wazni explains more about the WATCHMAN device and how it works in the video below.

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Minimally invasive procedure

The device is implanted in the left atrial appendage (LAA) of the heart, the small, ear-shaped sac in the muscle wall of the left atrium (the top left chamber of the heart) where most blood clots caused by afib occur. The parachute-shaped, self-expanding device seals off the LAA to prevent any clots that may form from entering the bloodstream and potentially causing a stroke.

“This is actually a simple procedure, where we go in with catheters into the heart through a vein in the leg and implant the WATCHMAN device,” Dr. Wazni says. “If there’s a good seal, there’s a very high likelihood of coming off any anticoagulants.”

The WATCHMAN device has been approved by the FDA to reduce the risk of thromboembolism from the LAA in patients with atrial fibrillation that is not caused by heart valve disease who:

  • Are at increased risk of stroke and systemic embolism and for whom long term anticoagulation therapy is recommended;
  • Have physician approval to take warfarin; and
  • Have an appropriate reason to want treatment with a non-medication alternative to warfarin, taking into account the safety and effectiveness of the device compared with warfarin.

Cleveland Clinic electrophysiologists participated in clinical studies of the WATCHMAN prior to FDA approval, so they have more experience than most centers with the device.

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Finding out if the WATCHMAN is for you

While the WATCHMAN device is an innovative new treatment that can benefit many patients, Dr. Wazni explains that appropriate patient evaluation and selection are extremely important.

If you or a family member are interested in treatment with the WATCHMAN device, you will need an evaluation by the physicians in Cleveland Clinic’s Atrial Fibrillation Stroke Prevention Center.

Some important information about the WATCHMAN procedure includes:

  • You will stay in the hospital overnight after the procedure.
  • You will need to take aspirin and warfarin until you have your follow-up appointment.
  • You will have a transesophageal echo (TEE) within 48 hours of the procedure.
  • Your first follow-up appointment is 45 days after the procedure. Another TEE will be done at this appointment. If the TEE shows that the LAA is blocked, you will be able to stop taking warfarin and start taking clopidogrel (Plavix) for 6 months. After 6 months, you will stop taking clopidogrel, unless you need to take it for another reason. You will continue daily treatment with aspirin.
  • If the TEE shows that the LAA is not blocked, you will continue taking warfarin and have another TEE and follow-up appointment after 6 months.
  • Once the LAA is blocked, you will have a yearly follow-up appointment in the clinic.
  • You will need an echocardiogram (echo) within 60 days of your procedure.

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