The WATCHMAN™ Procedure

New hope for patients with Atrial Fibrillation

Patients with atrial fibrillation (Afib) being treated with blood thinners now have an alternative. The Watchman Implant, a one-time, minimally invasive procedure is an FDA-approved device that can reduce stroke risk and bleeding worries for people with non-valvular Afib (not caused by a heart valve problem).

More than a third of people with Afib are caught between the fear of having a stroke and the risks of being on a blood thinner. Watchman can reduce the risk of stroke, without the risk of bleeding that comes from long-term use of blood thinners.

What is WATCHMAN™

The WATCHMAN™ left atrial appendage (LAA) closure implant is a permanent heart implant used to treat atrial fibrillation (afib) not caused by a heart valve problem. With afib, the heart’s two upper chambers (atria) beat irregularly. An irregular heartbeat can result in slower blood flow in the heart, which can cause blood clots to form. They typically form in a small sac called the left atrial appendage. If a clot gets into the bloodstream and blocks blood flow to the brain, it can cause a stroke. Doctors typically treat people who have afib with a blood thinner called warfarin (brand name Coumadin) to prevent clots from forming and reduce the risk of stroke.

In 2015, the Food and Drug Administration approved the WATCHMAN LAA closure device for afib. It’s a parachute-shaped device that expands to the size of a quarter when implanted. The device has a mesh membrane that acts as a filter at the opening of the LAA to prevent blood clots from entering the bloodstream. After the nonsurgical WATCHMAN procedure, the device replaces the need for prescription blood thinners in most patients.

Animation - What is WATCHMAN?

Is WATCHMAN™ right for me?

You may be a candidate for Watchman if you answer yes to the following:

  • Do you have atrial fibrillation (Afib) not caused by a heart valve problem?
  • Have you ever been prescribed a blood thinner due to your Afib (even if you are no longer taking it)?
  • Do you have a history of serious bleeding while taking blood thinners?
  • Do you have a lifestyle or occupation that puts you at risk of serious bleeding?

How does the procedure work?

The Watchman FLX device is inserted over a catheter through a recipient's vein accessed through the groin. It is designed to seal off the heart's left atrial appendage (LAA), a windsock-like pouch within the upper left chamber. For patients with AFib, over 95% of stroke-causing clots are formed in the LAA. This procedure takes approximately 1-2 hours.

Animation of the WATCHMAN LAAC Device implant.

Why the Procedure Is Performed

The WATCHMAN FLX device is intended to be used in patients who have atrial fibrillation (AFib) not related to heart valve disease (non-valvular atrial fibrillation).

Risks

As with many medical procedures, implanting a WATCHMAN device comes with some risks. These may include:

  • Side effects from general anesthesia, such as an allergic reaction, confusion, or nausea
  • Bleeding due to heart catheterization
  • Serious bleeding due to the device, typically within the first six months

You can reduce your risk of complications by:

  • Informing your healthcare providers if you are allergic to anesthetics or have had complications from anesthesia in the past
  • Lying flat for several hours after the procedure to prevent bleeding at the catheter insertion site
  • Taking care to research the cardiac electrophysiologist carefully, considering his or her experience implanting the WATCHMAN device
  • Notifying your doctor immediately of any concerns, such as bleeding or pain

Before the Procedure

Once you are in the procedure room, your day will typically include these events:

  • A nurse will start an intravenous (IV) line to administer an anesthetic and any other medicines you may need.
  • The doctor will numb your groin area with an anesthetic and insert a catheter into a blood vessel.
  • The doctor will guide the catheter to your heart’s upper right chamber and then across the septum (the muscular wall that divides the two sides of the heart) to the opening of the LAA.
  • You may get a transesophageal echocardiography (TEE) imaging test to ensure the device is in the right place before implantation.
  • To permanently implant the device, the doctor will push the WATCHMAN out of the catheter into the opening of the LAA where it will open—much like a parachute or umbrella.

After the Procedure

  • You may stay overnight in the hospital.
  • You may need to have another TEE within 48 hours after the implantation.
  • After the procedure, heart tissue will grow over the implant within about 45 days. About this time, you will follow up with your doctor to make sure the device has sealed off the LAA and to discuss discontinuing blood thinner medications.

How do I prepare?

  • Don’t eat or drink after midnight the night before your procedure.
  • Ask your doctor what medications you’re allowed to be taking before the procedure and whether you should stop taking anything.
  • Tell your doctor about any allergies you may have, such as to an anesthetic or latex.
  • Make sure someone can drive you home when you’re ready to leave the hospital (usually the next day).

When Should I call my doctor?

Your leg or foot becomes numb or turns blue, which may be a sign of a blood clot.

The catheter insertion site swells or drains fluid.

If bleeding from the insertion site won’t stop, call 911.

How will the WATCHMAN implant affect my everyday life?

The WATCHMAN device does not cure nonvalvular atrial fibrillation, but you may be able to stop taking blood thinners like warfarin if the LAA seals properly. It usually takes about 45 days. Your doctor may prescribe another blood thinner for a few months to make sure the implant is working properly.

With your doctor’s approval, you will eventually be able to stop taking all prescription blood thinners unless you need them to treat a different medical condition. Check with your doctor before you stop taking blood thinners. Your doctor may want you to continue taking aspirin every day.

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