Atrial fibrillation, or AFib, is a cardiovascular disease that causes abnormal
heart rhythm. AFib is caused by a combination of factors, but principally
its development is attributed to overactive electrical signals from the
top chambers of the heart. These signals are disorganized, causing the
atria to “fibrillate” or “flutter.” A small percentage
of AFib is caused by heart valve problems. The most dangerous consequence
of atrial fibrillation is stroke—the average person with AFib is
about five times more likely to suffer a stroke than someone with a regular
heartbeat with a risk ranging from 2 to 20 percent a year.
Most people with AFib are treated with a blood thinning medication such
as warfarin (brand name Coumadin) to reduce the risk of forming blood
clots in the heart that cause a stroke. For some, though, these medications
cannot be taken long-term. Until recently, there was no FDA -approved
alternative to blood thinners. Now there is: a tiny device implanted into
the heart itself to block off the area where most of these clots form.
It’s called the Watchman. The team of David Dobesh, M.D., cardiac
electrophysiologist; Constantinos Costeas, M.D., director of Cardiac Electrophysiology
at Saint Barnabas Medical Center; and Susan Simandl, M.D., director of
the Saint Barnabas Medical Center Echocardiography Laboratory, implanted
the first four of them at the medical center in January. “There
is long-term data showing that the Watchman is equivalent to or superior
to using Coumadin,” Dr. Dobesh says. “It reduces the risk
of stroke without the increasing risk of internal bleeding from blood
thinners. It’s a game changer in how we treat this disease.”
The reason AFib can lead to stroke is because it decreases the heart’s
pumping capacity in the top chambers, the atria. When blood isn’t
pumped out efficiently, blood cells can pool in a part of the heart’s
top left chamber called the left atrial appendage (LAA ), where it forms
clots that can travel to the rest of the body, including the brain. More
than 90 percent of the clots that cause a stroke in patients with this
type of AFib come from the LAA.
“The main preventive therapy is blood thinners, but for many patients
these are not suitable,” Dr. Dobesh says. They can cause bleeding
in the gastrointestinal or urinary tracts, or lead to excessive surface
bleeding and bruising, especially in the elderly, who make up a substantial
portion of those with AFib. Those with other health conditions that raise
the risk of bleeding, such as kidney or liver disease, or blood disorders,
are also poor candidates for blood thinners. “Millions of people
in the United States have AFib, so a large number of people are at risk,” he says.
For them, the Watchman may be the answer. The device is less than the size
of a quarter. It is composed of a self-expanding, nickel-titanium frame,
with a polyester fabric cover. To implant it, the surgeon makes a small
cut in the upper leg and inserts a catheter, similar in many ways to procedures
to implant a cardiac stent. In this case, the doctor guides the Watchman
into the LAA. It expands to block off the LAA, and the heart grows its
own new tissue over the device over the next 45 days to create a permanent
seal, preventing blood from pooling and forming clots there. The LAA has
no known role in normal heart function; it is a vestigial appendage, much
like the appendix. “In fact in the original Grey’s Anatomy
text it is called the left atrial appendix,” Dr. Dobesh says. “It
plays a role in fetal heart development, but you don’t need it after
The procedure is done under general anesthesia and takes about an hour.
Patients commonly stay in the hospital overnight and leave the next day.
“The recovery is very quick, and most patients will be back to normal
that week,” Dr. Dobesh says. Patients are required to remain on
blood thinners for 45 days, until the Watchman has permanently sealed
the LAA . An echocardiogram will be performed to make sure the device
is working properly. The device is permanent, and never needs to be replaced.
Patients will need to take a different medicine called clopidogrel (known
by the brand name Plavix) and aspirin for six months. After six months
they are encouraged to continue aspirin on an ongoing basis. A very small
number of patients may be encouraged to keep taking blood thinners long
term, Dr. Dobesh says, but more than 90 percent of patients can stop taking
the drug. What’s more, those patients will no longer need regular
blood tests or to restrict their eating and drinking habits, as is required
when on some blood thinners.
More than 20,000 Watchman procedures have been performed worldwide since
2005, with more than 10 years of clinical trials and registry data proving
its safety and efficacy. It’s the only device of its kind approved
by the FDA for reducing stroke risk in people with AFib not caused by
heart valve problems.
To find out more about Cardiac Services available at Saint Barnabas Medical
Center, please call 973.322.5244 or visit