Jan. 14--NEW HAVEN -- A device that looks like a small umbrella or parachute is being used to reduce the risk of stroke caused by blood clots formed in the heart.
The device, about the size of a quarter when deployed, is called a Watchman and it allows patients to stop taking blood thinners that can hamper their lifestyle and threaten their health.
The clots form when the upper chambers of the heart, the atriums, beat in an irregular rhythm, a condition known as atrial fibrillation, and fail to pump blood effectively. "Atrial fibrillation is the most common cardiac arrhythmia and it increases your risk of stroke substantially, [a] five-fold increase of stroke on average," said Dr. James Freeman, co-director of the Atrial Fibrillation Program in Yale New Haven Hospital's Heart and Vascular Center.
"It's more quivery. It's not effectively pumping the blood," said Dr. Joseph Akar, Freeman's co-director, who also directs the electrophysiology lab at Yale New Haven.
"Most of the blood clots that form form in an appendage of tissue that hangs off the left atrium" that contains, "for a lack of a better term, nooks and crannies," Freeman said. Like the appendix, the function of the left atrial appendage is unknown, but sealing if off greatly reduces the chances of clots traveling to the brain and causing a stroke.
According to Boston Scientific, which manufactures the Watchman device, more than 90 percent of the strokes that originate in the heart are caused by clots formed in the appendage.
Freeman said that for more than 30 years the standard treatment to prevent strokes has been blood thinners, "but many people have problems with blood thinners," he said. In fact, "30 to 50 percent who are at increased risk of stroke with afib are not on blood thinners for some reason, mostly because of bleeding issues," he said.
People at risk of bleeding, such as those who work in jobs with a risk of injury or those who have a higher chance of falling, such as the elderly, are not good candidates for blood thinners. In those cases, the Watchman can take the place of warfarin (marketed as Coumadin) or other medications.
"It's a fairly straightforward procedure," Akar said. "It entails putting in a sheath in the vein in the groin area ... putting up a wire into the heart and crossing from the right atrium to the left atrium and deploying the device in the left atrial appendage."
Blood thinners continue to be given for a while, but, according to Boston Scientific, 92 percent of patients were able to get off of warfarin after 45 days and 99 percent after a year.
"The big thing ... that's good about our program is the process of patient selection," said Dr. Jeptha Curtis, director of performance improvement for the Heart and Vascular Center. "This procedure is not for everyone. ... For people who can take blood thinners there is really no reason for those people to be considered for this device."
Dr. Ben Lin, director of interventional echocardiography, oversees the ultrasound and fluoroscope imaging that lets the surgeons view the interior of the heart. "Real-time ultrasound imaging is critical to proper placement of this device," Lin said. "We start with pre-procedural imaging, which allows us to evaluate for subtle anatomy and device sizing."
The Watchman is made of a nickel titanium alloy with a mesh coating and, over time, tissue known as endothelium grows over the device, sealing off the atrial pouch.
Better quality of life
Russell Bonaccorso, 74, of Bristol was in a "terrible ... life-threatening" condition while being treated with Coumadin for more than 10 years because of his atrial fibrillation. He also has a pacemaker.
"Here lies the rub," Bonaccorso said. "Every four or five years months, I'd have an episode of bleeding internally ... which is life-threatening. I would lose 4 to 5 pints [of blood] and I would lose so much blood it would make me go blind."
His doctor referred Bonaccorso to Freeman, who performed the operation on Oct. 20, and he is now on Plavix, which acts in a less aggressive way than Coumadin and which he'll be able to stop taking soon.
"This is making the quality of my life much, much better," Bonaccorso said. "I don't have to be careful of cutting myself. ... With Coumadin, I was bleeding everywhere, all the time.
"There does not seem to be any side effects, except feeling way, way, way better," he said. "I feel 40 years old again. I've gone back to work." He had been retired for five years since his first wife died but is now a manager at a construction site.
Richard Wagner, 83, of Southbury underwent the procedure on Nov. 3 because of his risk of falling. His daughter, Susan Lyle, said that, like Bonaccorso, he'll be able to go off Coumadin and take just low-dose aspirin.
"He was getting a lot of bruising from being on the blood thinner and that is definitely better," Lyle said. "He feels he has a lot of freedom. He doesn't have to worry. If he falls, he won't have a bleeding issue or anything."
The team has performed about 350 procedures and "we're part of a research team that's leading national efforts to see how this device is performing across the U.S.," Curtis said. Each procedure -- more than 10,000 so far -- is recorded on the Left Atrial Appendage Occlusion Registry.
Akar is a member of the national steering committee for the registry. Curtis and Freeman are ad hoc members and co-directors of the registry's Data Analytic Center and the Event Adjudication Center. "Our team at Yale does all the adjudication of the major adverse events that are reported to the registry and all the data analysis for all the research that is conducted using the registry data," Freeman said.
The team's "national prominence" will produce "a lot of the science that's going to tell us about this procedure in the years to come," he said.
The risks of the procedure are small, but include the possibility of "stroke during the procedure or of perforating the heart wall inserting the device," Curtis said. There's also a one in 1,000 chance the device could fall out of place.
"The risks are low but it's important to be prepared and have all the processes in place to respond to an emergency like that," Curtis said.
Contact Ed Stannard at email@example.com or 203-680-9382.
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