(RxWiki News) An investigational device may help prevent stroke in patients with atrial fibrillation, a common heart arrhythmia that increases the risk of stroke.
Investigators from Atritech, now part of Boston Scientific, developed the Watchman device, a tiny mesh umbrella inserted into part of the heart cavity to prevent the formation of blood clots that cause strokes.
"Ask your doctor about the best stroke prevention measures for arrhythmias."
Warfarin, an anti-coagulant, is usually used to prevent strokes, but the drug has risks and patients must be regularly monitored while taking it.
Dr. Sven Mobius-Winkler, author of the paper from the University of Leipzig Heart Center in Germany, noted that Warfarin has many side effects such as the risk of bleeding events. He said as a result only about half of the patients who should be taking the drug actually do.
The Watchman was designed to offer another option. The device received investigational approval from the U.S. Food and Drug Administration in 2009, though it already is in use in the European Union and Australia.
Hoping to train doctors to use the experimental device, Dr. Mobius-Winkler published a detailed paper along with a full video detailing placement of the Watchman device in the Journal of Visualized Experiments, the only peer-reviewed science and medicine video journal on Feb. 28.
“Intervention and closure of the left atrial appendage is a complex procedure,” said Dr. Mobius- Winkler. “For inexperienced physicians, it is hard to learn this procedure and therefore the video can help by doing step-by-step the implantation.”
An initial study pertaining to the device published in the Lancet in 2008 showed the device could reduce the risk of stroke by 31 percent. The 2010 Protect AF trial found that 87 percent of successfully implanted Watchman patients could discontinue Warfarin at 45 days. That number increased to 92 percent at six months. The FDA had asked for additional trials prior to full approval of the device.
“The WATCHMAN device will give patients with atrial fibrillation another option rather than anti-coagulant drugs,” said JoVE Editor Dr. Robert Dolan. “This article demonstrates the implantation of the device and will help clinicians gain expertise with the procedure, helping many of the patients who are unable or unwilling to take warfarin.”