ORLANDO, Fla. — A novel device to treat a common heart problem that can lead to stroke showed promise in testing, but not without risk, new research shows.
The experimental device, the Watchman, is the first to try to permanently fix atrial fibrillation, a heartbeat problem afflicting more than 2 million Americans. A federal Food and Drug Administration panel will consider it next month.
In the study presented Saturday at the American College of Cardiology Conference, the Watchman was at least as good at preventing strokes as warfarin, sold as Coumadin and other brands. The drugs pose hazards of their own.
Atrial fibrillation occurs when the upper chambers of the heart quiver instead of beating properly. That lets blood pool in a pouch-like appendage. Clots can form and travel to the brain, causing a stroke.
The usual treatment is the anti-clotting drug warfarin, but getting the right dose is tricky — too little means a risk of stroke, and too much can cause fatal bleeding. Patients must go to the doctor often for blood tests to monitor the dose.
The Watchman device is a fabric-covered metal cage that plugs the pouch. Doctors pass a hollow tube through a leg vein into the heart’s right atrium, puncture the wall separating it from the left atrium, and implant the device through the tube.
About 90 percent of device patients were able to go off warfarin. However, complications were twice as common — 8 percent in the device group and 4 percent on warfarin. Five strokes were triggered by implanting the device, and about 5 percent of device patients developed serious fluid buildup around the heart.
