Burlington, Vermont - December 15, 2011
Doctors inside the electrophysiology lab at Fletcher Allen Health Care in Burlington are prepping their patient for surgery. He's part of a clinical trial for a device called a Watchman. The 74-year-old man has atrial fibrillation-- a potentially fatal heart arrhythmia that puts him at risk for a stroke.
"In atrial fibrillation what's happening is that instead of a pulse that is discharged and then a moment of rest and then re-initiation, you have continuous electrical activation of the atrial chambers. So they never get a rest," Dr. Dan Lustgarten explained.
So blood then pools in an appendage off the left atrium. Blood clots can form, break off, and travel to the head, causing the stroke.
To date, the only treatment has been to thin the blood with medication; an attempt to prevent a clot from forming. It's a cumbersome regimen with risks of its own. Barry Stone took blood thinners for more than two years.
"The Coumadin has a lot of really horrible side effects. You bruise very easily and you bleed very easily and the testing part of it is awful. So I was not a very happy camper being on Coumadin, which I was on for quite a while," Stone said.
But not anymore. Stone was the very first A-Fib patient in Vermont to receive the Watchman device in February. The patient on this day is the 10th. They are both part of a clinical trial at Fletcher Allen Health Care; the final phase before FDA approval.
Here's how it works: Doctors begin by sending the umbrella like device-- in compact form-- to the heart via a vein in the leg. The goal is to seal off the opening of the appendage so blood clots cannot escape. To date, 90 percent of those in the study nationwide have been successful.
"Potentially revolutionary," Lustgarten said. "So the idea again of this device is that it closes off this appendage. It makes it so that the appendage doesn't go away, but it essentially gets sealed off, or walled off from the main body of the left atrium."
It's the only alternative to lifelong blood thinners, and for patients like Stone, that means a dramatic improvement in his quality of life.
"I had a cabinet full of Coumadin of all different doses because you never know what you're going to be on. And it's really taken a great load off my mind. I live a normal life. I play in tennis tournaments all summer. I'm skiing... Had my first day of skiing this winter yesterday," Stone said.
He'll be checked one more time in February, but to date, Stone's left atrial appendage is completely sealed off and he's off all blood thinners. Doctors at Fletcher Allen expect to wrap up their study of the Watchman next spring.
The Watchman device is already approved in Europe and doctors here fully expect it to be approved by the FDA, perhaps next year.
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