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Man receives new device aimed at preventing strokes

By Jonel Aleccia, The Seattle Times (Tribune News Service)
August 28, 2015

SEATTLE—A 77-year-old Lake Stevens, Washington, man with a serious history of stroke was at the front of the line this spring when the federal Food and Drug Administration finally approved a new device aimed at stopping a common cause of the often-deadly problem.

Edwin Dixon, a retired electrician and husband of 55 years, was the first post-approval patient implanted at the University of Washington Medical Center (UWMC) with the Watchman device, which stops blood clots that travel from the heart to the brain, potentially causing strokes.

“It's a new look at life,” said Dixon, who underwent the procedure July 28.

The Boston Scientific product was given the nod by the FDA in March after years of testing and two previous rejections. UWMC experts—including Dr. Mark Reisman, section head of interventional cardiology, and Liz Perpetua, associate director of the Center for Cardiovascular Emerging Therapies—are among the first in the United States to use the state-of-the-art devices in patients.

“The FDA was finally given enough information to take action,” said Reisman, who, along with Perpetua, helped conduct early trials of the Watchman up to a decade ago.

For most of that time, Dixon was suffering from atrial fibrillation, a common condition in which the heart beats rapidly and chaotically. AFib, as it's known, can allow blood to pool in the left atrial appendage of the heart, forming blood clots that account for at least 90 percent of strokes, experts say.

Many patients with AFib—which affects about one in four people older than 40—take blood thinners such as warfarin, also known as Coumadin. But some patients have bad reactions to the anticoagulants and are more prone to brain bleeds, or so-called hemorrhagic strokes, making the drugs a serious risk.

“Mr. Dixon had a problem with blood thinners,” explained Perpetua, who led his treatment. “We're always balancing that risk of stroke and that risk of bleeding.”

Dixon, who has had three strokes, already suffers some impairment on his left side.

For him and other patients, the solution appeared to be the Watchman, a walnut-sized device that looks something like a tiny Chinese lantern or badminton birdie. The device, which Perpetua said costs about $30,000, is inserted via a catheter pushed through a vein in the leg.

The catheter advances through the bloodstream until it reaches the heart, where the doctor makes a small hole and positions it into the left atrial appendage, or LAA. The doctor pushes the Watchman device into place, where it opens like an umbrella, blocking the LAA. Once it's in place, heart tissue grows over the device within six weeks, creating a permanent barrier to prevent blood clots from forming.

Previous concerns about procedural complications and potential overuse of the device available outside the United States since 2009 stymied earlier efforts. There was a question about whether warfarin was better than the Watchman at preventing certain kinds of strokes, and vice-versa.

Eventually, and after considerable debate, the FDA agreed that the Watchman may be used in patients who are at high risk when they take warfarin, the standard anticoagulant, because of possible side effects such as brain bleeds. More than 90 percent of patients who got the device were able to stop the blood thinner within 45 days, and 99 percent stopped within a year, studies found.

For Dixon and another 20 urgent UW Medicine cases waiting for treatment, the device has been a boon, Perpetua said. Four patients in addition to Dixon have been implanted so far, and more implants are planned.

She estimates the UW Medicine cardiology team will implant five to 10 of the devices every month going forward.

As a condition of approval, Boston Scientific must track patients who receive the Watchman in a registry and conduct a study of the device's clinical outcomes, the FDA said.

Perpetua said she and Reisman are happy to help patients with such an advanced intervention.

Dixon said he doesn't mind being a guinea pig, of sorts, for a new device that took three tries to gain approval.

“No, I wasn't worried,” he said. “Because I also knew I had a problem.”