Newly-Approved Device Eliminates AFib Patients' Need For Blood Thinners

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PITTSBURGH (KDKA) - Motorcycle enthusiast Fritz Lang had the typical symptoms of the irregular heart rhythm atrial fibrillation - AFib for short.

"I could feel the heart racing," Fritz said.

He was put on medicine to thin his blood.

"You're at an increased risk of stroke off blood thinners. On blood thinners, you're at an increased risk of bleeding," explains Allegheny General Hospital cardiologist Dr. David Lasorda about the dilemma some patients face.

His daughter, Pam Lang, and the whole family were concerned.

"We all care. We all worry," Pam said.

With AFib, the upper chambers of the heart quiver irregularly -- a set up for clots.

The left atrial appendage is a pouch-like extension on the upper left part of the heart. The vast majority clots associated with atrial fibrillation are found here.

The problem is these clots can break off and get pumped up to the brain and cause a stroke. For that reason, people with AFib are often put on blood thinners.

But with these medicines, minor bumps and scrapes can be major problems. Depending on where the bleeding happens, it can even be life-threatening.

"The worst thing is when he had the brain bleed. That was probably the scariest thing we've ever gone through," Pam said.

The talkative man couldn't find his words and the medication couldn't be reversed. They had to wait it out in the hospital.

"When we got out of there," Fritz said, "I said, look, I don't want any more of this. Give me something that if you want to stop it, you can stop it."

Then, he heard about a device that could eliminate the need for any blood thinners. He wanted that device -- called the Watchman.

It's folded up and threaded up from the groin, through a major blood vessel and up to the heart.

"Now, it's not easy to get to the appendage, because it's in the left atrium," Dr. Lasorda said.

Once they reach the heart, the doctors poke a hole between the right and left atria to get to the appendage. The device pops out of the threading instrument, and opens like an umbrella and closes off the left atrial appendage. Over time, cells that make up the lining of the heart grow over the device.

This is done with ultrasound guidance. Sometimes a clot is discovered in the appendage at the time of the procedure, and in that case, the doctors cannot proceed.

Once the device is in place, the patient takes blood thinners for six weeks. If an ultrasound at that point shows everything is sealed, the medicine is stopped. If a person cannot take blood thinners at all, this device is not for them.

The first patient was enrolled in the first Watchman study in 2005, and there have been a few attempts at FDA approval, which resulted in rejection. A review of all the studies on the device was completed, and the FDA finally granted approval in 2016. The Watchman does not work better than blood thinners, but isn't any worse.

"We've done about 10 or 15 cases," Dr. Lasorda said. "There's an awful lot of patients with atrial fibrillation, and there's an awful lot of patients that have bleeding issues. And I think this is an ideal device for them."

Fritz is glad there was this option.

"No blood thinners involved, and I'm not having the nosebleeds, and the other things that I was having before," he said.

Pam is glad, too.

"Thrilled to know it existed, thrilled to know that a hospital in Pittsburgh was going to be cutting edge, and push the issue with the insurers to be able to get it covered on insurance. It's been a big deal to our family," she said.