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The Watchman is a Device That Can Help Certain Patients with Atrial Fibrillation

By Matthew Nojiri, Reading Eagle
Bern Township, PA –

Charlotte Moyer had no fears about getting a new heart procedure at Penn State Health St. Joseph. The 71-year-old St. Lawrence resident had bigger fears about having a stroke. “I decided to have it done just to be cautious,” Moyer said. “I don’t want to worry about having a blood clot in the head. It was nothing to have it done.”

watchman-lg

Moyer was one of the first patients in Berks County to have a new procedure to insert a device called the Watchman. The device from Boston Scientific Corp. was approved by the Food and Drug Administration in 2015.

The Watchman has been approved for certain patients with atrial fibrillation who are at a higher risk for a stroke and do not want to be on a blood thinner for the long term due to concerns about bleeding and other side effects.

Cardiologists at St. Joe’s say the new procedure fills an important niche. Many patients with an abnormal heartbeat are at a higher risk of stroke, but can’t take a blood-thinning medicine, such as Coumadin.

The Watchman could be emerging as an alternative for those patients, said Dr. Christopher Rogers, a cardiologist with Berks Cardiologists. “It kind of technically eliminates the part of the heart where clots form to eliminate the risk of having a stroke,” Rogers said.

Abnormal heartbeat

At St. Joe’s, Rogers and his colleague Dr. Troy Trayer have been performing the procedure since August, and it’s taken a bit of legwork to get ready.

The two doctors have been watching for nearly a decade as the device moved through the process of clinical trials and regulation. They said there has always been a need for such a device.

Patients who have an irregular heartbeat can be at higher risk for blood clots and strokes.

Most of those blood clots develop in the left atrial appendage in the heart and then travel through the bloodstream. That can ultimately lead to a stroke in the brain.

Blood thinners have been the gold standard for stroke prevention, but some patients have problems with bleeding while on those drugs. “There’s a population of patients who need to be protected from having stroke that are not good candidates to be on blood thinners,” Rogers said. “This is the only FDA-approved device that’s approved and available that shows it’s at least as protective as being on blood thinners.”

How it works

The device is implanted through a catheter that runs all the way up from a leg vein to the left side of the heart. Rogers and Trayer work with a team of caregivers during the procedure, which can last between 45 minutes and three hours. The device is pushed through the catheter and opens up like a flower once it reaches its destination in the heart. It’s made of a self-expanding, nickel-titanium frame with an attached woven plastic cap.

The key is to position the device in just the right spot, making sure it’s secure and there are no leakages, the doctors said. “It’s like putting an umbrella in this pouch, and that umbrella is catching and preventing blood from coming out there where that clot could form,” Trayer said.

Feedback

Patients are put under general anesthetic and only have to stay at the hospital for a day before being released. Moyer said the whole process could not have been simpler. She was a perfect candidate for the procedure because she has atrial fibrillation but couldn’t be on blood thinners for the long term due to the bleeding problems in her stomach.

“I feel fine, and I have no problems,” she said of her recovery. “I’m just glad I had it done. It’s one less worry I have.” Moyer was on Coumadin for 45 days and now takes Plavix, but eventually she’ll just need to take a daily aspirin.

Rogers said it’s possible the device could be expanded to help more people one day, but that is likely years down the line. For now, the doctors are happy to offer the service to the patients who need it in Berks County.

“They have an alternative to blood thinners if they have high risk of stroke and high risk of bleeding,” Trayer said. “They don’t have to go on living their life crossing their fingers and hoping they don’t have a stroke.”

About the Watchman

What: The device is implanted via a catheter into the left atrial appendage of the heart. It prevents blood clots from entering the bloodstream and causing a stroke.

How it works: The device is implanted through a catheter through a vein in the leg. The physician makes a small hole through the wall between the two upper chambers of the heart. The device is pushed in the left atrial appendage and then opens up like an umbrella.

When it’s used: The device is an option for patients who have atrial fibrillation not related to heart valve disease. Those abnormal heart beat patients should also be at increased risk for stroke, recommended for blood thinners and have appropriate reason to seek an alternative to those blood thinners.

Clinical results: The device was evaluated in four studies, comparing how it compared against blood-thinning medicines to prevent strokes caused by a blood clot in the brain. In two of the studies, the blood thinners were better than the Watchman in preventing strokes caused by a blocked blood vessel in the brain. However, the number of strokes caused by bleeding in the brain was lower in the device patients compared to the blood thinner patients. The rate of serious bleeding was similar in the device and blood-thinner patients.

In one study, 99 percent of patients were able to stop taking the blood thinner Coumadin after a year.

Approved: March 2015

Source: Food and Drug Administration

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