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.
More than 90% of stroke-causing clots that come from the heart are formed
in the LLA
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.
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.
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
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
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.
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