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WATCHMAN

Bay Area Regional Medical Center is among the first hospitals in the Houston Bay Area to offer patients with non-valvular atrial fibrillation (AF) an alternative to long-term warfarin medication with the newly approved WATCHMAN Left Atrial Appendage Closure (LAAC) Implant.

 

There’s an alternative to warfarin for people who need one. It’s called WATCHMAN. The only FDA-approved implant proven to reduce stroke risk in people with atrial fibrillation not caused by a heart valve problem. 

Beyond Blood Thinners

People with AFib often face the lifelong use of blood thinners to reduce their risk of stroke. WATCHMAN is a one-time procedure with a proven safety record.

WATCHMAN offers an alternative to the lifelong use of warfarin for people with atrial fibrillation not caused by a heart valve problem (also known as non-valvular AFib). 

This permanent heart implant effectively reduces the risk of stroke—without the risk of bleeding that can come with the long-term use of warfarin (the most common blood thinner). What’s more, WATCHMAN can eliminate the regular blood tests and food-and-drink restrictions that come with warfarin. (Warfarin is also known as Coumadin®.) 

In a clinical trial, 9 out of 10 people were able to stop taking warfarin just 45 days after the WATCHMAN procedure.

Why WATCHMAN?

WATCHMAN may be a life-changing alternative to the lifelong use of warfarin. In a one-time procedure, WATCHMAN effectively reduces the risk of stroke in people with atrial fibrillation not caused by a heart valve problem.

As a permanent implant, WATCHMAN doesn’t come with the same bleeding risks associated with the long-term use of warfarin.2 This makes it an important option for people with a history or risk of serious bleeding on blood thinners. Newer blood thinners (also known as novel anticoagulant drugs) offer additional options to warfarin, but they don’t take away the long-term risk of bleeding.

How WATCHMAN Works

To understand how WATCHMAN works, it helps to know more about the connection between atrial fibrillation and stroke. 

Atrial fibrillation, or AFib, affects your heart’s ability to pump blood normally. This can cause blood to pool in an area of the heart called the left atrial appendage, or LAA. There, blood cells can stick together and form a clot. 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.

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. WATCHMAN is about the size of a quarter and made from very light and compact materials commonly used in many other medical implants.

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. 

Due to the risk of having a medical procedure, patients should not be considered for WATCHMAN if they are doing well and expect to continue doing well on blood thinners.

After the Procedure

Following the WATCHMAN procedure, you’ll take warfarin (a common blood thinner) 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 warfarin. 

Your doctor will then prescribe a medicine called clopidogrel (also known as Plavix®) and aspirin for you to take for 6 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:

• 92% of patients were able to stop taking warfarin just 45 days after the procedure

• 99% of patients were able to stop taking warfarin within 1 year after the procedure

Studies of WATCHMAN

WATCHMAN is the only device of its kind approved by the U.S. Food and Drug Administration (FDA) for reducing the risk of stroke in people with atrial fibrillation not caused by a heart valve problem. 

More than 30,000 WATCHMAN procedures have been performed worldwide. And with over 10 years of U.S. clinical studies behind it, WATCHMAN has a proven safety record.

In a clinical trial, WATCHMAN was implanted successfully in 95% of patients.1 In the remaining 5%, the procedure was either not attempted or not completed. This was because a pre-procedure exam showed that the patient was not qualified to receive the implant, or because a complication occurred during the procedure before WATCHMAN was implanted.

As with any medical procedure, there are risks involved with WATCHMAN. See the Important Safety Information below for a list of possible complications, and ask your cardiologist about the risks and benefits of WATCHMAN.

Who WATCHMAN Is For

The WATCHMAN Implant may be right for people who meet the following criteria:

• They have atrial fi­brillation not caused by a heart valve problem (also known as non-valvular AFib)

• They have been recommended for blood thinning medicines by their doctor

• They can take warfarin but need an alternative

People may need an alternative to warfarin for any one of these reasons:

• They have a history of major (serious) bleeding while taking blood thinners

• They have a lifestyle, occupation, or condition that puts them at risk for major bleeding

• They take warfarin and have trouble staying within the recommended blood clotting range (a measurement known as INR*) or getting regular blood tests to confirm their INR, and they cannot take a different type of blood thinner

*INR, or International Normalized Ratio, is a measurement of how long it takes for your blood to clot. If you’re out of range, you may be at higher risk for stroke or at higher risk for bleeding.3

As with any medical procedure, there are risks involved with WATCHMAN. See the Important Safety Information below for a list of possible complications, and ask your cardiologist about the risks and benefits of WATCHMAN.

 

Who WATCHMAN Is Not For

People who should not receive the WATCHMAN Implant include but are not limited to those who:

• Cannot take warfarin (Coumadin®), aspirin, or clopidogrel (Plavix®)

• Should not or cannot undergo heart catheterization procedures

• Have an allergy or sensitivity to nitinol (nickel and titanium) or any of the other materials in the WATCHMAN Implant

• Have a left atrial appendage that is too large or too small to fi­t the WATCHMAN Implant

• Need to take blood thinners for reasons other than AFib stroke risk reduction

Ask your cardiologist if any of these conditions apply to you.

Due to the risk of having a medical procedure, patients should also not be considered for WATCHMAN if they are doing well and expect to continue doing well on blood thinners.

 

Important Safety Information
The WATCHMAN Device is a permanent implant 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 WATCHMAN™ Closure 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 WATCHMAN Device.

 

 

References

  1. Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64(1):1-12.
  2. 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.
  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. 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.
  5. Holmes DR Jr, Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis. J Am Coll Cardiol. 2015;65(24):2614-2623.
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