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The WATCHMAN™ device is a medical implant designed to reduce the risk of stroke in individuals with atrial fibrillation (AFib).

What is Atrial Fibrillation (AFib)?

Atrial fibrillation (AFib), which affects millions of people worldwide, is a common heart rhythm disorder characterized by irregular and often rapid electrical impulses in the upper chambers of the heart, called the atria. During AFib, the atria quiver instead of beating properly. As a result, the blood cannot effectively move into the heart’s two lower chambers (the ventricles), potentially leading to reduced blood flow to the rest of the body.

A person with AFib is five times more likely to suffer a stroke. This is because AFib can cause blood to pool and clot and, if a blood clot enters the bloodstream, it can travel to the brain and result in a stroke. The vast majority of strokes that occur in patients with AFib are from clots that form in the left atrial appendage (LAA), a small pouch off the left atrium.

To treat AFib, many patients are prescribed blood thinners, such as warfarin, to lower the risk of stroke; however, some patients experience unwanted side effects, such as an increased risk of bleeding from long-term blood thinner therapy.

What are the symptoms a person with AFib may experience?

A person with AFib may experience symptoms that include palpitations (rapid, irregular heartbeat), shortness of breath, fatigue, dizziness or lightheadedness, chest discomfort or pain, and a sensation of fluttering or pounding in the chest. Some individuals with AFib may experience no symptoms at all, making regular medical check-ups important for early detection and appropriate management.

What are some contributing factors that can cause AFib?

Common conditions that can increase a person’s risk for AFib include age, weight, stress, family history, alcohol, illegal drugs, smoking, excessive caffeine, sedentary lifestyle, and medical conditions, such as diabetes, high blood pressure, chronic lung disease, sleep apnea, thyroid conditions, and existing heart conditions.

What is the WATCHMAN Device?

The WATCHMAN device is the first-of-its-kind alternative treatment for AFib used to reduce stroke risk without the need for blood-thinning medications. The device, which is inserted through a minimally invasive procedure, offers an alternative to long-term anticoagulant therapy, providing stroke protection while potentially reducing bleeding risks associated with blood thinners.

The device is designed to close the left atrial appendage — that small pouch area in the left atrium where blood is most likely to collect and clot — to prevent the clots from forming and entering the bloodstream. Over time, heart tissue grows over the implanted device, and it becomes a permanent part of the body.

How does the WATCHMAN Device work?

The WATCHMAN device is a small, parachute-shaped device made of nitinol (nickel-titanium), a biocompatible material, that is implanted in the heart’s left atrial appendage (LAA). As in many minimally invasive procedures, instead of open-heart surgery to access the heart, only small incisions are needed to guide the device to the organ.

The procedure includes the following steps:

  • The patient is put under general anesthesia.
  • The surgeon attaches the WATCHMAN device to a thin, flexible tube called a catheter.
  • The doctor makes a small cut in the patient’s groin and inserts the catheter.
  • The catheter is then guided through blood vessels to the heart’s left atrial appendage.
  • Once in place, the WATCHMAN device is deployed to seal off the LAA from the rest of the heart chamber so that blood doesn’t pool and clot.
  • Over time, the body’s own tissue grows over and around the WATCHMAN device, securely anchoring it in place.

It’s important to note that the WATCHMAN device procedure requires careful patient selection and assessment to determine eligibility.

Who is a good candidate for the WATCHMAN Device?

A good candidate for the WATCHMAN device is typically an individual with non-valvular atrial fibrillation (AFib) who is at high risk for stroke and has a reason to seek an alternative to long-term use of blood-thinning medications. While this procedure offers an alternative to anticoagulants, it may not be suitable for all individuals with AFib.

At MemorialCare, all candidates must undergo a thorough medical evaluation, including imaging studies and assessments of heart function, to determine their eligibility and the potential benefits of the device.

Our cardiac teams will look for specific criteria that may make someone a suitable candidate for the WATCHMAN device, such as:

  • Individuals with AFib who have a high risk of stroke based on factors, such as age, previous stroke or transient ischemic attack (TIA), diabetes, hypertension and other medical conditions.
  • Those who are at an increased risk of bleeding complications due to anticoagulant therapy.
  • Individuals who have difficulty adhering to anticoagulant medication regimens or have experienced adverse effects from these medications.
  • Candidates with a left atrial appendage (LAA) anatomy that is compatible with the WATCHMAN device placement.
  • Patients who prefer a non-medication approach to stroke prevention.

What are the benefits of the WATCHMAN Device?

The WATCHMAN device offers key advantages for high-risk atrial fibrillation (AFib) patients:

  • By blocking the left atrial appendage (LAA), it significantly reduces stroke risk.
  • It provides an alternative to blood-thinning medications, reducing bleeding risk.
  • Patients experience improved well-being without strict medication routines or bleeding concerns.
  • Once implanted, ongoing stroke prevention is achieved without constant medication adjustments.
  • The procedure is less invasive, leading to quicker recovery compared to surgery.
  • Its effectiveness becomes apparent soon after implantation.
  • Suitable for various AFib cases, especially when anticoagulants aren’t an option.
  • Clinical trials and real-world experience validate its safety and efficacy.
  • Patients gain peace of mind and the potential for more active lifestyles.

What are the risks and considerations of the WATCHMAN device?

The WATCHMAN device provides valuable benefits but also comes with certain risks. Our team of cardiac professionals at MemorialCare takes every necessary measure to ensure the safety of our patients and minimize any potential risks.

Nonetheless, one should understand the following:

  • Every medical intervention carries risks, such as infection, bleeding, fluid build-up and anesthesia-related complications.
  • Although rare, the device may move from its intended position, not completely seal off the left atrial appendage, or blood clots can form on its surface, requiring additional procedures or medication. 
  • While this device was designed for long-term use and has proven to be since it became commercially available internationally in 2009, its durability over multiple decades is still being studied.
  • Although the device reduces the need for blood thinners, some patients may still require limited anticoagulation based on their specific situation.
  • Some pre-existing heart conditions or anatomical factors may make the WATCHMAN device unsuitable.

The WATCHMAN Device Procedure

The WATCHMAN device procedure involves several stages, from pre-operative preparation to post-operative care.

Pre-Operative:

  • Patient undergoes a comprehensive evaluation to assess eligibility for the WATCHMAN device. This includes reviewing medical history, conducting imaging studies and assessing overall health.
  • Patient engages in shared decision-making discussions with their health care team to understand the procedure, potential benefits and risks.
  • Patient receives specific instructions regarding fasting, medications and any necessary preparatory steps before the procedure.

Operation:

  • Patient is administered anesthesia, either general anesthesia or conscious sedation.
  • A catheter is inserted into a blood vessel, often in the leg or groin, and guided to the heart using imaging techniques like fluoroscopy and echocardiography.
  • The WATCHMAN device is carefully guided through the catheter and positioned within the left atrial appendage (LAA) of the heart.
  • The device is deployed to effectively seal off the LAA, reducing the risk of blood clot formation and subsequent stroke.
  • Imaging tools verify the correct placement and function of the WATCHMAN device.
  • The procedure takes about one hour.

Post-Operation:

  • Patient is closely monitored in a recovery area to ensure stable vital signs and a smooth transition from anesthesia. Any immediate post-operative concerns are addressed.
  • Patient receives pain management as needed to ensure their comfort during the recovery period.
  • The patient is generally up and around within four hours.
  • Patient gradually resumes a normal diet and physical activities as instructed by health care team.
  • Medications are prescribed for pain relief and to prevent infection or clot formation.
  • Regular follow-up appointments are scheduled to monitor the effectiveness of the device, heart function and overall recovery.
  • Lifestyle recommendations and potential adjustments to medications are discussed as needed.

FAQs about the WATCHMAN Device

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How long does the WATCHMAN device last in the body?

The WATCHMAN device is designed to be a permanent implant within the body, intended to provide ongoing stroke prevention by sealing off the left atrial appendage. The FDA approved its use in 2015, but it has been commercially available internationally since 2009. During this time, its long-term durability has been studied and established to offer sustained effectiveness in reducing the risk of blood clot-related strokes in individuals with atrial fibrillation.

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How big is the WATCHMAN implant?

The WATCHMAN device is typically around 2.5 to 3.5 centimeters (1 to 1.4 inches) in size. Its compact design allows it to be delivered and positioned within the left atrial appendage of the heart using minimally invasive catheter-based techniques, reducing the risk of blood clot-related strokes in individuals with atrial fibrillation.

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How does the WATCHMAN device stop blood clots?

The WATCHMAN device prevents blood clots by effectively sealing off the left atrial appendage (LAA), a small pouch in the heart where clots often form in individuals with atrial fibrillation. Once implanted, the device forms a barrier, blocking the LAA and preventing clots from escaping into the bloodstream and causing strokes. This reduces the risk of blood clot-related strokes in patients with atrial fibrillation.

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Is the WATCHMAN device a minimally invasive procedure?

Yes, the WATCHMAN device procedure is minimally invasive. It involves the insertion of a catheter through a blood vessel, typically in the leg or groin, and the device is guided to the heart using imaging techniques. This approach reduces the need for traditional open-heart surgery and often results in shorter recovery times and fewer complications.

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What are the side effects of the WATCHMAN procedure?

The WATCHMAN procedure is generally well-tolerated, but like any medical intervention, it carries potential side effects. These can include a small risk of complications, such as bleeding, infection or anesthesia-related issues. Additionally, there might be a rare chance of device migration, blood clot formation or incomplete sealing of the left atrial appendage.

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What is the difference between the WATCHMAN device and a pacemaker?

The WATCHMAN device is designed to reduce the risk of stroke in individuals with atrial fibrillation by sealing off the left atrial appendage and preventing blood clot-related strokes. A pacemaker, on the other hand, is an implant that helps regulate the heart’s rhythm by sending electrical signals to control its beating. While both are implanted devices, their primary functions and purposes differ – the WATCHMAN device focuses on stroke prevention, while a pacemaker addresses heart rhythm abnormalities.

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