A new experimental device to treat atrial fibrillation had mixed results in a recent study but still shows promise as a treatment option, the Associated Press reports. The Watchman is the first device designed to permanently treat atrial fibrillation, a heart condition in which blood stagnates in a small pouch called the left atrial appendage. Clots can form and travel to the brain, eventually causing a stroke. The study found that the Watchman device was as good at preventing stroke as blood-thinning drugs Coumadin or warfarin. However, the procedure to implant the Watchman led to strokes in some patients. Complications, including fluid buildup around the heart, were two times higher compared to warfarin. The Watchman device, designed by Atritech, is an expandable cage that blocks clots from entering the bloodstream. It is implanted in the heart via a catheter inserted into a leg vein.
Warfarin is typically used to treat AF, but the drug has significant drawbacks. Finding the right dose is tricky (too much causes bleeding), the medication frequently interacts with other drugs and foods, and patients have to be closely monitored. Although the Watchman device caused twice as many complications as warfarin in the study, these problems declined as the study progressed, suggesting that doctors improved their technique as they gained experience with the device. The FDA has scheduled an expert panel to review the Watchman in late April. If the device is approved, doctors and patients will have to decide whether the upfront risks associated with implanting it are better than the ongoing risks associated with warfarin, a Duke doctor told the AP.