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New Device May Prevent Strokes In Those With Atrial Fibrillation
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Published: March 14, 2008
Gloria Carastro of Tampa didn't know she had a serious heart problem.
The 76-year-old was rushed to the hospital two years ago for an unrelated ailment, and paramedics discovered an irregular heartbeat. Further testing revealed a condition known as atrial fibrillation, or AFIB.
In some people, AFIB can cause fainting, dizziness, fatigue, breathlessness, a fluttering feeling in the chest or racing in the heart. But it also can have no symptoms at all.
According to St. Joseph's Hospital cardiologist James Irwin, millions of Americans have AFIB and don't know it. Trouble is, it significantly increases the risk of stroke.
In atrial fibrillation, an upper chamber of the heart beats erratically, or quivers, instead of contracting in a strong, steady rhythm. This irregular heartbeat allows blood to pool in the heart, where it can form clots. The danger is that a clot will pass out of the heart and travel to the brain, causing a stroke.
To reduce the risk of stroke, most AFIB patients are put on what is commonly known as blood-thinning medication, such as Coumadin, which actually increases the time it takes the blood to clot. That can be a problem if you cut yourself or are seriously injured in a car accident. People on blood thinners must make frequent trips to the doctor to check the anticoagulant level of their blood, and they must avoid certain foods that cause the blood to clot. But most bothersome, at least according to Carastro, is the increased bruising all over her body. She says atrial fibrillation never really caused her any problems, but the treatment did.
"The problem is the Coumadin that you have to take. It's terrible stuff," she says.
Indeed, Carastro's arms are a patchwork of red, brown, black and blue marks of all shapes and sizes — all caused by Coumadin.
"Coumadin is a lifelong hassle that patients are forced to deal with," says Irwin, co-director of the Advanced Center for Atrial Fibrillation at St. Joseph's.
He is involved in the clinical trial of a new device meant to prevent strokes in AFIB patients and get them off Coumadin. The device, called the Watchman, is a flexible wire and mesh device shaped like a jellyfish and small enough to fit on the eraser of a pencil. It's placed at the entrance to a small pocket in the lower part of the left atrium, called the left atrial appendage, where blood likes to pool and clots can form.
The Watchman requires only a small puncture in the leg to thread a catheter up to the heart and deploy the device. Patients are kept in the hospital overnight. They must return after 45 days for a test to confirm that the Watchman is fully blocking the left atrial appendage and no blood is leaking out. Eventually, tissue grows over the Watchman and patients are taken off Coumadin.
At Carastro's first checkup after the Watchman placement, doctors found she still had some leakage, so she was sent home, disappointed, to wait another 45 days. But Irwin assured her, "We'll get you there. I promise."
Irwin expects the Watchman to receive FDA approval and become widely available in the next year or two. Right now it's available only through a clinical trial. For information on the St. Joseph's trial, call research coordinator and registered nurse Maureen Jacob-Waleski at (813) 870-4760.
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