In people with atrial fibrillation (AFib), the heart’s electrical system causes the upper chambers of the heart to beat irregularly and often, too rapidly. That irregular heartbeat affects the heart’s ability to pump blood normally. As a result, blood can collect and form clots. These blood clots can break loose and travel to other parts of the body. When a clot travels to the brain, it can cut off the blood supply to the brain—causing a stroke.

Statistics show that people with untreated atrial fibrillation (AFib) have a five times greater stroke risk compared to that of a person with a normal heart rhythm. 90% of stroke-causing blood clots that come from the heart are formed in a small pocket of the heart called the left atrial appendage. This is why most people with AFib are prescribed anti-clotting medications, also known as blood thinners.

In appropriate patients, AFib can be treated by catheter ablation. Performed by an electrophysiologist, this minimally invasive procedure destroys tiny areas of abnormal electrical tissue through freezing (cryoablation) or cauterization (radiofrequency ablation). However, in some patients, AFib can unexpectedly recur after ablation so most patients remain on blood thinners preventively after having an ablation. Unfortunately, not everyone tolerates blood thinners well, and some people have medical conditions that preclude taking them. In addition, long-term use of blood thinners is associated with a higher risk of bleeding.

A One-Time Procedure that Reduces Stroke Risk for a Lifetime

The next-generation version of the original WATCHMAN™ implant, the WATCHMAN FLX™ is a minimally invasive alternative to anticoagulation medication for the treatment of non-valvular AFib. The WATCHMAN FLX is a left atrial appendage closure (LAAC) device designed to reduce the risk of stroke. This safe, effective, and proven device is a small implantable stent used to permanently close off the left atrial appendage so that blood clots can’t form there. The WATCHMAN and WATCHMAN FLX are the only implants of this kind to be approved by the FDA.

More than 100,000 WATCHMAN procedures have been performed worldwide, with excellent outcomes. At the Haynes Cardiovascular Institute within MarinHealth Medical Center, our surgeons have built a robust left atrial appendage closure program that leads all of Northern California in volume of procedures performed. In addition, as one of the first hospitals granted access to the next generation WATCHMAN FLX device, we are actively participating in two major clinical trials that feature the WATCHMAN implant.

The WATCHMAN FLX features a new, fully rounded design that offers several advantages over the original WATCHMAN device:

  • It makes it easier for physicians to enter and maneuver within the left atrial appendage.
  • It is the first LAAC device that can be fully recaptured, re-positioned and redeployed for precise placement
  • The new frame design allows for optimal device engagement with the tissue for long- term stability and a faster, more complete seal.
  • The WATCHMAN FLX device is available in more size options to treat a broader range of patients

All patients receiving the WATCHMAN implant at MarinHealth Medical Center will get the newest generation FLX version. The WATCHMAN FLX can help more people leave blood thinners behind than ever before. In a clinical trial, 96% of people were able to stop taking blood thinners 45 days after getting WATCHMAN FLX.

The WATCHMAN Procedure

Roughly the size of a quarter, the WATCHMAN FLX fits into the left atrial appendage of the heart. The procedure does not require open-heart surgery. To implant WATCHMAN FLX, an interventional cardiologist makes a small cut in the femoral vein in the thigh. Using guided imaging, a narrow catheter is threaded up to the heart through the vein. Then, the WATCHMAN device is introduced through the catheter and positioned in place to close off the left atrial appendage. The procedure is done under general anesthesia and typically takes about an hour.

After the procedure, patients usually spend one night in the hospital and go home the next day. Over the next six weeks, heart tissue grows over the WATCHMAN implant, forming a permanent barrier against blood clots. Patients continue to take a blood thinner for about 45 days, until their left atrial appendage is permanently closed off.

Who Is a Good Candidate for WATCHMAN?

WATCHMAN is appropriate for people with AFib not caused by a heart valve problem. Traditionally, the initial treatment approach for Afib includes the use of blood thinners to prevent clots and stroke. However, some patients need an alternative to blood thinners for one of more of the following reasons:

  • A history of serious bleeding
  • A lifestyle, occupation, or condition that increases the risk of serious bleeding, such as falls
  • Desire for an alternative to blood thinners as a long-term treatment option to reduce stroke risk and bleeding risk
  • Trouble tolerating warfarin when a different type of blood thinner is not an option

If you feel that the WATCHMAN FLX Implant could be right for you, take our quiz and answer a few quick questions about your overall health so we can help you and your physician decide if you are a good candidate.

Take The WATCHMAN Quiz

Who Is NOT a Good Candidate for WATCHMAN?

WATCHMAN is an effective minimally invasive procedure that can reduce your stroke risk for a lifetime. Like all procedures certain risks are associated with left atrial appendage closure. Talk to your cardiologist to discuss the potential risks and benefits and help decide if WATCHMAN is right for you.

Clinical Trials

As one of the nation’s first hospitals to be granted use of the original WATCHMAN implant, we are involved in two ongoing clinical trials. You can click on the links below to learn more about the studies and how to enroll if you are interested.

  • The Option Trial was launched when the WATCHMAN device was still in the process of receiving FDA approval. The purpose of this study is to evaluate WATCHMAN as an effective long-term solution for replacing blood thinners in patients who have had an ablation to treat their AFib. MarinHealth was one of the first regional medical centers to participate in the Option Trial. Learn more.

  • The Champion-AF Trial was initiated more recently, after WATCHMAN was officially market-approved by the FDA. This study is to evaluate the use of WATCHMAN FLX as an upfront therapy for AFib.