Feb 29, 2020 4 min read

One hospital in West Virginia will soon be testing a device that could help prevent strokes for patients with atrial fibrillation.

Mon Health Medical Center in Morgantown was among the first hospitals chosen nationwide, and the only one in West Virginia, for a national clinical trial for an innovative device that’s being used to treat the condition. The Watchman implant is designed to help reduce the risk of stroke for atrial fibrillation patients.

What is atrial fibrillation?

Atrial fibrillation affects the heart’s ability to pump blood normally. The American Heart Association estimates up to six million Americans have the condition. This can cause blood to pool in an area of the heart called the left atrial appendage. Blood cells can stick together there and form a clot. If that clot escapes and travels to another part of the body, it can cut off blood supply to the brain causing a stroke.

Dr. Wissam Gharib, structural heart cardiologist at Mon Health Heart and Vascular Center, said atrial fibrillation is an epidemic of the elderly and that its prevalence increases as adults age.

About 10% of people over age 80 have atrial fibrillation.

“The Watchman device does not prevent (atrial fibrillation),” Gharib said. “(Atrial fibrillation) causes stagnation of the blood in the upper chamber of the heart (atria) and causes clots to form in the atrial appendage. As those clots dislodge, strokes occur.”

To prevent clots, most atrial fibrillation patients have to take blood thinners, such as Coumadin or other newer anticoagulants, to prevent strokes. However, those drugs are difficult for many patients to take since they can cause intestinal bleeding and other issues like severe bleeding after a fall or injury.

“For patients who can’t take blood thinners, the Watchman is essentially a plug for the appendage,” Gharib said.

Patients who may be a candidate for this implant are already taking blood-thinners on the recommendation of a doctor, can take warfarin (Coumadin), but also need an alternative because of history of major bleeding or if they are at risk for bleeding based on lifestyle, job or medical condition.

How does it work?

The Watchman is an FDA approved device available for use in the United States.

“The Watchman FLX device is a new device that is only available in clinical trials such as the one we are currently involved in at Mon Health,” Gharib said.

Doctors implant the device into the heart in a one-time procedure. It’s a permanent device that doesn’t have to be replaced and can’t be seen outside the body. The implant is about the size of a quarter and is made of light, compact materials. The device is positioned inside the heart in the left atrial appendage where it stays and is designed to permanently close off the left atrial appendage and keep blood clots from escaping.

The procedure is done under general anesthesia and take about one hour. The doctor makes a small cut in the upper leg, inserts a narrow tube and guides the implant into place.

Recruiting participants

It might be surprised to know that rather than a huge hospital system in a big city, Mon Health is one of the sites at the forefront of this type of research.

“We are consistently in the top 10 implanting sites in the country,” said Gharib, who implanted the first Watchman in West Virginia and has developed a reputation as an advanced implanter using minimally invasive techniques.

Gharib’s expertise is one of the reasons why Mon Health was chosen for the clinical trial.

Mon Health Medical Center was recently recognized by the American College of Cardiology as the first and only hospital in West Virginia to earn accreditation for atrial fibrillation with electrophysiology services.

Gharib said the trial will be aimed at expanding on the FDA approval of Watchman.

“In this trial, patients who have (atrial fibrillation) and have an ablation are evaluated to either continue standard practice with blood thinners or receive a Watchman FLX device,” he said. “Patients do not have to have failed blood thinner treatment to qualify for this trial.”

Mon Health Medical Center is actively recruiting patients for this clinical trial.

For more information on becoming involved with the clinical trial, call Mon Health Medical Center at 304-599-8802 or visit monhealth.com/watchman.