Study shows safety, effectiveness of heart filter device in stroke prevention
A study involving Beaumont Hospital cardiologists, published in the April 3 Journal of the American College of Cardiology, shows the WATCHMAN left atrial appendage device to be as good or better than the standard blood thinning treatment in preventing stroke.
The device is designed to free people with the heart rhythm condition known as atrial fibrillation from relying on blood thinning medications such as coumadin.
The pilot study, conducted at Beaumont and three other sites in the U.S., evaluated the safety of the WATCHMAN device, designed to prevent blood clots from traveling from the heart to the brain where they can lead to a stroke.
In all, 66 patients took part in the pilot study with an average age of 69.7 years old. Two-thirds of the patients were men and one-third were women. There were no ischemic strokes reported in patients with the device and 97.1 percent of patients were able to discontinue the use of blood thinning medication within six months of implant.
The next phase of research is the Protect AF Clinical Study, a multi-centered, randomized trial, which may lead to Food and Drug Administration approval. In it, researchers will look at implanting the device vs. standard treatment that involves the use of coumadin. Coumadin, although an effective medication, has many potential side effects and is utilized by less than 50 percent of patients that are eligible for it.
Atrial fibrillation, the rapid irregular twitches of the wall of the atrium of the heart, is the primary cardiac abnormality associated with stroke. It affects about 7 million people worldwide. Approximately 700,000 Americans have a stroke each year. It is the third most common cause of death. Atrial fibrillation may be responsible for up to 25 percent of all strokes.