Posted by Lisa O'Neill Hill Feb 23 2016
A medical device about the size of a quarter could help prevent stroke in people with atrial fibrillation (AFib) who are looking for an option to commonly-prescribed blood thinners. AFib is a significant risk factor for stroke.
The FDA approved the WATCHMAN device last year to be used in people whose AFib isn’t related to heart valve disease.
The WATCHMAN closes a small sack of tissue that comes off the heart. More than 90 percent of blood clots that form in the heart develop in that sack of tissue, called the left atrial appendage (LAA.) Those clots can break loose, travel through the blood stream and cause a stroke. The WATCHMAN stops clots from getting into the blood stream.
Blood thinners are considered the gold standard for treatment of AFib to prevent strokes, said Dr. Erik Altman, Chief of Electrophysiology at Southside Hospital in Bay Shore, New York. But some patients, including older people prone to falls, aren’t good candidates for long-time use of blood thinners, he said.
“The LAA occlusion is a major advancement in the field of device therapy as another option to anti-coagulation and our ability to reduce the risk of stroke,” Dr. Altman said.
Dr. Altman has already performed 10 of these surgeries.
“All have done beautifully afterwards,” he said of his patients. “A handful are off blood thinners and over time, more will come off blood thinners.”
For 45 days after the procedure, patients have to take Coumadin (warfarin.) Patients then have a transesophageal echocardiogram to make sure the LAA is sealed off. If the results are positive, the patient can stop Coumadin.
“This offers a new opportunity to reduce the risk of stroke and offer a safe alternative through a minimally invasive procedure that takes less than an hour,” Dr. Altman said.
People with Afib are at a higher risk of stroke because they have irregular heartbeats that can cause blood to pool in the heart and possibly form a clot. People who have AFib are usually prescribed blood thinners such as warfarin.
The FDA says doctors should consider the risks and benefits of blood thinners compared to the device for each patient. The WATCHMAN is only recommended for patients who have an appropriate reason to seek a non-drug alternative to warfarin and who fit certain other criteria.
The WATCHMAN isn’t appropriate for several groups of people, including people with a blood clot in the heart, anyone who can’t tolerate blood thinners or anyone with nickel or titanium sensitivity, the FDA says.
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