Minimally invasive ‘Watchman’ device new option for A-Fib


Atrial fibrillation (A-Fib) is the most common kind of arrhythmia or irregular heartbeat. For many years, the standard treatment for A-Fib was anti-coagulation blood thinners that needed to be taken for the rest of the patient’s life. But more recently, a minimally invasive procedure/device called Watchman has given patients and doctors another option, according to Dr. Mistyann-Blue Miller, an interventional cardiologist with Cleveland Clinic Indian River Hospital.

A-Fib results from electrical impulses that misfire, causing the chambers, or atria, to quiver or flutter. It can lead to blood clots, stroke and heart failure. Statistics show that a patient with A-Fib has five times greater risk of stroke than a person with a regular heartbeat.

During atrial fibrillation, the heart’s upper chambers (the atria) beat irregularly and are not in sync with the lower chambers (the ventricles) of the heart. For many, there are no symptoms, but in other cases A-fib may cause a fast pounding heartbeat (palpitations,) shortness of breath or weakness. A-Fib caused by valve disorder or prosthetic heart valve is called valvular A-Fib, while non-valvular A-Fib refers to the condition caused by other factors such as high blood pressure or stress.

Before Watchman came along, the standard treatment for A-Fib was anti-coagulation blood thinners that needed to be taken for the rest of the patient’s life.

Unfortunately, in some cases, those blood thinners are dangerous to patients with a history of excessive bleeding or falling. They can also be expensive, which is a barrier for some to get the medication and take it as prescribed, leading to noncompliance.

In addition, some of these medications require weekly and monthly blood tests, which is an inconvenience and lifestyle hindrance. But the Watchman has made it possible to permanently reduce the risk of blood clots in the heart and free patients from a lifetime of blood-thinning medication.

The Watchman device is approved for patients who have an indication to be on anti-coagulation,” said Dr. Miller. “These patients are put on blood thinners because they can develop blood clots in the heart that sometimes travel to the brain and cause strokes.”

Dr. Miller described the Watchman as a metal device covered in polyurethane cloth around the top. “The purpose of the device is to plug up the left atrium appendage, which is an outpouching of the left atrium,” she explained. “That appendage really has no function and is where most of the blood clots can form and there’s a chance those blood clots can leave the heart and travel to the brain. The pouch is an anatomy you don’t really need and there are other procedures that allow us to clip the pouch, lasso the pouch or surgically cut the pouch out, but the best device is the Watchman.”

The Watchman implant fits right into the pouch, closing it off so blood clots can’t form there and lead to a stroke. The procedure doesn’t require open heart surgery and is exceptionally safe, with complications in only a small fraction of patients, according to Boston Scientific, which makes the device.

As in a stent procedure, your doctor accesses the heart through a vein in the groin and guides the Watchman implant with a narrow tube into the heart and then into the appendage or pouch. The procedure is done under general anesthesia and generally takes less than an hour.

Over time the heart tissue grows over the Watchman implant, forming a barrier against blood clots.

“Because the Watchman procedure is done with a catheter there is no cutting, and no scalpels,” Dr. Miller continued. “We take a lot of steps prior to the insertion to make sure it’s the right size since one size does not fit all. We utilize a Tranesophageal Echocardiogram (TEE) which gives us a clear image of the heart to measure the shape and size of the appendage to make sure it will fit and check for any existing blood clots.

“If there is a blood clot, we can’t insert the Watchman. During the procedure we will do another TEE which allows us to check the fit of the device from different angles. Because of that prescreening and measuring, the Watchman has a 96 percent success rate globally and some studies say it’s 100 percent successful.

“Typically, the patient is on blood thinners going into the procedure and after the implant the patient will still take anti-coagulation for 45 days, along with a baby aspirin daily. After 45 days we do another TEE to ensure the device is still implanted and fitted well and there is no flow going into the device or any leakage.

“If all looks good, we stop the blood thinner and advise the patient to take a baby aspirin and medicine called Plavix for six months. After six months the patient can take just one baby aspirin a day indefinitely.”

Patients can expect to spend one night in the hospital and get a final echocardiogram in the morning. Then they can go home and go about their normal lives. There are no limitations to daily activities and the risk is very minimal since the access is through a vein and not an artery.

“I was on Eliquis, and it was extremely expensive,” said Linda Volo, a Watchman patient. “I didn’t like taking blood thinners and had to be careful every time I banged into something.

When I learned that having the Watchman implant would help prevent the possibility of stroke and get me off the medication, I was ready.

“The team of cardiologists were all there around the bed, and I could talk to them all at once. Since the implant was done with a catheter, it was a simple procedure and I was back to normal activities the next day.”

“This procedure has been FDA-approved since 2015 but since the introduction of the Watchman, which is a newer, better device, more centers are starting to use it,” Dr. Miller concluded. “We started doing the procedure at Cleveland Clinic Indian River Hospital just last November and we’ve done eight or 10 already. There are a lot of patients who qualify for this procedure, so we are getting the word out. It truly can be a life altering alternative to taking blood thinners.”

Dr. Miller graduated from Morehouse School of Medicine in Atlanta and completed her residency in internal medicine at the University of Miami School of Medicine in Atlantis, Fla. She completed a fellowship in cardiovascular disease at Drexel University College of Medicine in Philadelphia, and a second fellowship in interventional cardiology at Harvard Medical School-Beth Israel Deaconess Medical Center in Boston. She is board-certified by the American Board on Internal Medicine in Interventional Cardiology, Cardiovascular Disease and Internal Medicine.

Dr. Mistyann-Blue Miller sees patients at Cleveland Clinic Indian River Hospital primarily on a referral basis. If you think you may be a candidate for the Watchman, talk to your cardiologist or primary care physician. Or call the general cardiology department at 772-563-4580.

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