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
When 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
Reducing AFib Stroke Risk with Blood Thinners
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®
- Savaysa®
However, some people need an alternative to blood thinners because they can increase the risk of bleeding.5 In some cases, bleeding events are minor and easily treated, like a cut taking longer than normal to stop bleeding. But in others, 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 device.
WATCHMAN Device Offers 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 needs an alternative to blood thinners.
The WATCHMAN device is about the size of a quarter and made from very light and compact materials commonly used in many other medical implants.
More than 150,000 people have left blood thinners behind with WATCHMAN.
How the WATCHMAN Device Works
In people with AFib not caused by a heart valve problem, more than 90% of stroke-causing clots that come from the heart form in the LAA.3 That’s why closing off this part of the heart is an effective way to reduce stroke risk.
The WATCHMAN device 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 Device 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.
WATCHMAN Procedures
The procedure is done under general anesthesia and takes about an hour. Patients commonly stay in the hospital overnight and leave the next day.
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
Hear from a WATCHMAN Device Patient
Watch Camille’s Story
“I feel more at ease going where I want to go.”
Camille was an avid traveler, but fear of having a bleed while far from home – and far from medical help – interrupted her plans. Hear how WATCHMAN paved the way for a life of adventure with her family.
Watch Cliff’s Story
“It put me back to being who I was.”
Cliff lived an active life cycling and riding motorcycles until the fear of bleeding from blood thinners stopped him in his tracks. Hear how WATCHMAN put him back on the road to enjoying retirement to the fullest.
Watch Suzanne’s Story
“My quality of life improved 100%.”
For Suzanne, blood thinners came with the burden of having to rely on pills she didn’t want to have to take. Hear how WATCHMAN freed her from medication, along with stroke and bleeding worries.
WATCHMAN Device FAQs
The most common questions about WATCHMAN, answered by patients.
What’s the procedure like? Can you have WATCHMAN if you also have a stent? How is life different after WATCHMAN? Seven people who left blood thinners behind answer questions like these.
Important Safety Information
WATCHMAN is for people with atrial fibrillation not caused by a heart valve problem who need an alternative to blood thinners.
This website is intended to provide patients and caregivers with some information about the WATCHMAN Implant. It may help prepare you for talking to your doctor about your options for reducing stroke risk.
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
- Transient ischemic attack
- In rare cases, death
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.
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Sources
- 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.
- 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.
- Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755-759.
- Cleveland Clinic. Atrial fibrillation (Afib). http://my.clevelandclinic.org/services/heart/disorders/arrhythmia/atrial-fibrillation-afib. Published May 2015. Accessed August 25, 2016.
- 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.
- PINNACLE FLX 12-month primary safety and efficacy endpoint results, Doshi, SK. presented at HRS 2020 Science.