WATCHMAN: A One-Time Implant that Helps Reduce AFib Stroke Risk

How Does AFib Increase Stroke Risk?

The average person with atrial fibrillation (also called AFib or AF) is five times more likely to have a stroke than someone with a regular heartbeat.¹ That’s because AFib can decrease the heart’s pumping capacity by as much as 30%.² Because blood isn’t pumped out of the heart normally, it’s easier for blood cells to stick together and form clots in an area of the heart called the left atrial appendage (LAA).^{2, 3} When a blood clot escapes from the LAA and travels to another part of the body, it can cut off the blood supply to the brain, causing a stroke.^{1, 4}

In people with atrial fibrillation not caused by heart valve problems (the most common type of AFib), more than 90% of stroke-causing clots that come from the heart are formed in the LAA.³

Learn more about atrial fibrillation and stroke risk.

Reducing AFib Stroke Risk

Blood thinners, also called anticoagulants, are an effective way to lower the risk of stroke in people with atrial fibrillation not caused by heart valve problems.⁵ Common blood thinners include warfarin (also known as Coumadin^®), Eliquis^®, Pradaxa^®, Xarelto^® and Savaysa^®.

But some people need an alternative to blood thinners, because they can increase the risk of bleeding.⁵ Some bleeding events are minor and easily treated, like a cut taking longer than normal to stop bleeding. In other cases, the bleeding can be life-threatening, such as when bleeding in the brain causes a stroke.

If you have a history of bleeding or a lifestyle, occupation or condition that puts you at risk for bleeding, your doctor may consider an alternative to blood thinners, such as the WATCHMAN Implant.

An Alternative to Blood Thinners

WATCHMAN is a one-time, minimally invasive procedure for people with atrial fibrillation not caused by a heart valve problem (also known as non-valvuar AFib) who need an alternative to blood thinners. It’s about the size of a quarter and made from very light and compact materials commonly used in many other medical implants.

More than 100,000 people have left blood thinners behind with WATCHMAN.

How WATCHMAN Works

In people with AFib not caused by a heart valve problem, more than 90% of stroke-causing clots that come from the heart are formed in the LAA.³ That’s why closing off this part of the heart is an effective way to reduce stroke risk.

The WATCHMAN Implant fits right into your LAA. It’s designed to permanently close it off and keep those blood clots from escaping.

Science always looks for ways to make effective treatments even better. WATCHMAN is no exception. The WATCHMAN FLX design is an advancement that enables the implant to fit a greater number of patients, giving more people than ever a safe, effective alternative to blood thinners should they need one.

In a clinical trial, 96% of people were able to stop taking blood thinners just 45 days after the WATCHMAN procedure.⁶

How is WATCHMAN Implanted?

WATCHMAN is implanted into your heart in a minimally invasive, one-time procedure. 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 your heart’s LAA. The procedure is done under general anesthesia and takes about an hour. Patients commonly stay in the hospital overnight and leave the next day.

The procedure is done under general anesthesia and takes about an hour. Patients commonly stay in the hospital overnight and leave the next day.

See how WATCHMAN works

After the Procedure

Following the WATCHMAN procedure, your doctor will prescribe you blood thinning medication for 45 days or until your LAA is permanently closed off. During this time, heart tissue will grow over the implant to form a barrier against blood clots. Your doctor will monitor this process by taking pictures of your heart to see when you can stop taking your blood thinners.

Your doctor will then prescribe a medicine called clopidogrel (also known as Plavix^®) and aspirin for you to take for six months. After that, you’ll continue to take aspirin on an ongoing basis. A very small number of patients may need to keep taking blood thinners long term.

In a clinical trial, 96% of people were able to stop taking blood thinners just 45 days after the WATCHMAN procedure.⁶

Is WATCHMAN Right for You?

If you have a history of bleeding or a lifestyle, occupation or condition that puts you at risk for bleeding, WATCHMAN may be right for you. But like any medical procedure, WATCHMAN comes with risks, so it isn’t right for everyone. Your cardiologist will weigh your risk of a stroke against your risk of a serious bleeding problem to determine the right treatment for you.

Take the WATCHMAN Eligibility Survey to see if WATCHMAN is right for you.

Hear from a WATCHMAN Patient

• Billy's Story
• Ingrid's Story
• Majorie's Story
• Bill's Story

To find out if you are a candidate for WATCHMAN, make an appointment with a BHS cardiologist by calling 866-620-6761.

Important Safety Information

The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke.

With all medical procedures there are risks associated with the implant procedure and the use of the device. The risks include but are not limited to accidental heart puncture, air embolism, allergic reaction, anemia, anesthesia risks, arrhythmias, AV (Arteriovenous) fistula, bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, blood clot or air bubbles in the lungs or other organs, bruising at the catheter insertion site, clot formation on the device, cranial bleed, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, hypotension, infection/pneumonia, pneumothorax, pulmonary edema, pulmonary vein obstruction, renal failure, stroke, thrombosis and transient ischemic attack. In rare cases death can occur.

Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the device.

Sources

1. National Stroke Association. Making the Afib-Stroke Connection. https://www.stroke.org/sites/default/files/resources/Afib-Connection%20for%20hcp.pdf. Published 2012. Accessed September 1, 2016.

2. Harvard Health Publications. Atrial fibrillation. http://www.health.harvard.edu/heart-health/atrial-fibrillation-common-serious-treatable. Harvard University Medical School. Published November 2011. Accessed August 25, 2016.

3. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755-759.

4. Cleveland Clinic. Atrial fibrillation (Afib). http://my.clevelandclinic.org/services/heart/disorders/arrhythmia/atrial-fibrillation-afib. Published May 2015. Accessed August 25, 2016.

5. National Stroke Association. Making the Afib-Stroke Connection. https://www.stroke.org/sites/default/files/resources/Afib-Connection%20for%20hcp.pdf. Published 2012. Accessed September 1, 2016.

6. PINNACLE FLX 12-month primary safety and efficacy endpoint results, Doshi, SK. presented at HRS 2020 Science.