Dr. John Day, Cardiologist

A New Blood Thinner Alternative is FDA Approved! The Watchman Device

I recently saw a new patient, Lisa, who was stuck in a very difficult situation.  Last year while at dinner with her daughter she suddenly lost her ability to speak.  She told me that she knew what she wanted to say but the words just came out all garbled.

Fortunately, her daughter immediately recognized the signs of a stroke and dialed 911 from the restaurant.  Even though Lisa protested, the call was made.  She was rushed to the hospital, a clot busting medication was immediately given, and Lisa had a complete recovery from her atrial fibrillation (A-Fib) stroke.

She was then put on warfarin and did well until last month when she was hospitalized again.  This time it was a massive gastrointestinal bleed requiring 4 blood transfusions.  She now was in my office wondering what she should do.

She definitely did not want another stroke nor did she want any more life-threatening bleeding episodes.  At the time of this visit, my options were limited.  Now, hope is available!

The Watchman device was finally FDA approved after the FDA struggled with this decision for 6 long years.  Now that the Watchman device is finally available for A-Fib patients in the U.S., what is it and is it right for you?

The Left Atrial Appendage

Before we can discuss the Watchman device, we need to back up and talk about the left atrial appendage.  The left atrial appendage is a pouch in the left atrium of the heart.  Every heart has a left atrial appendage.

In atrial fibrillation (A-Fib),  the upper chambers of the heart (right and left atrium) just “quiver” and don’t pump any blood.  When this happens, the stagnant blood in this dead-end pouch can clot.  If one of these blood clots breaks free from the left atrial appendage and travels through the bloodstream to the brain it is called a stroke.

The purpose of blood thinners in atrial fibrillation is to thin the blood enough so that this stagnant blood in the left atrial appendage won’t clot.  The problem is that these blood thinners not only thin the blood in the appendage but they also thin the blood throughout the rest of the body as well.  For this reason, many blood thinner patients suffer from bleeding problems.

Surgical Removal of the Left Atrial Appendage

For decades now, cardiac surgeons have been surgically removing the left atrial appendage in A-Fib patients who require cardiac surgery.  The difference is that the Watchman device can accomplish the same thing without surgery. The Watchman device is a small umbrella that is used to plug up the left atrial appendage.  If the appendage is plugged, then blood cannot get in and blood clots generally don’t form in the heart.

This X-ray image shows us inserting the Watchman device in the left atrial appendage with a catheter.  This small device is inserted through a vein in the leg.

The entire procedure takes about an hour to perform and patients usually go home from the hospital the next day.  The goal of the Watchman device is to plug up the left atrial appendage so patients don’t have to take blood thinners and can still be protected from A-Fib strokes.

Why Did the FDA Struggle with Watchman?

You may be wondering why the FDA struggled for 6 years in approving the Watchman device.  Let me quickly recount the history.

In the first major study to evaluate Watchman, the Watchman device was shown to be as effective as warfarin in preventing strokes in A-Fib patients.  Where Watchman really shined was in the very low risk of bleeding.  This is likely due to the 3% annual risk of a life-threatening bleed with warfarin.

Sounds like an easy decision for the FDA, right?  Where the FDA struggled is that when cardiologists first started to implant Watchman in this study, there was a high risk of cardiac tamponade or bleeding around the heart.  Fortunately, later studies showed that most of this risk could be eliminated with experience.

As the FDA was not convinced with the first study, they asked for another study.  In this second study, not only was the risk of bleeding again low but the risk of cardiac tamponade was also low.  The concern with this second study was that after the study was published, there were a number of strokes in the Watchman group which tipped the balance of stroke prevention toward warfarin.

This left the FDA with a difficult decision.  Here is a new device that is difficult to learn.  Also, while it is much safer than warfarin, when it comes to bleeding, it may not be as good as warfarin when it comes to stroke prevention.

If you want to read more about this 6 year journey through the FDA, here is an excellent article from the Wall Street Journal.

The New Blood Thinners versus Watchman

At the time the Watchman was first submitted to the FDA, our only blood thinner for A-Fib was warfarin.  While the late night TV lawyers would have us believe that the new blood thinners (dabigatran/Pradaxa, rivaroxaban/Xarelto, apixaban/Eliquis, and endoxaban/Savaysa) are the most dangerous medications ever created, the truth is that they are much safer than warfarin.

Indeed, studies have shown that the risk of life-threateining bleeding with the new blood thinners is about 50% lower than warfarin.  The sad thing is that thousands of Americans have likely already suffered an A-Fib stroke because the lawyers scared them away from these potentially life-saving medications.

The reason why I bring up the new blood thinners versus Watchman issue is because the primary benefit of Watchman is a lower bleeding risk when compared to warfarin.  As the new blood thinners have a much lower risk of bleeding than warfarin as well, this bleeding reduction benefit with Watchman may not be as clear with the new blood thinners.

Our Experience with Watchman

At our center we have been implanting the Watchman device for most of the last decade as part of clinical studies.  We have implanted this device in hundreds of patients with minimal complications.  We have found Watchman to be extremely effective in preventing strokes and are excited to again offer this as an alternative to blood thinners for our high risk A-Fib patients.

What Should Lisa Do?

Lisa is the perfect Watchman candidate.  She has already had an A-Fib stroke and has had a life-threatening bleed from blood thinners.  For her, the decision is quite simple.

Is Watchman Right for You?

At the end of the day, is Watchman something you should consider?  First of all, I would only consider the Watchman device for patients at high risk of an A-Fib stroke.  To learn if you are at high risk of an A-Fib stroke, please read this article I wrote.

In addition to being at high risk of an A-Fib stroke, patients should also meet one of the following situations:

1. Unable to take blood thinners due to a previous life-threatening bleed.

2. Patients at high risk of a life-threatening bleed with blood thinners.

3. Patients with high risk occupations or lifestyles which would make blood thinners dangerous for them.

Are you considering the Watchman Device?

Disclosure

If you feel like you might be a good candidate for Watchman, please discuss this with your cardiologist.  Together, the two of you can decide if the potential benefits of Watchman outweigh the risks of this procedure.  Also, you can have an in-depth discussion about Watchman versus blood thinners.  Please, do not self diagnose or treat based on anything that you have read in this article.