One of the primary dangers for atrial fibrillation patients is the high risk of strokes. With an irregular heartbeat, which is the hallmark for afib patients, blood can pool and form a clot. The clot can then dislodge and travel to the brain and cause a stroke.
Right now medications, specifically blood thinners, are the only options doctors and patients have to combat the risk of strokes. Unfortunately, these medications come with their own potential side effects and risks.
The Watchman device may provide another option for atrial fibrillation patients who don’t do well on blood thinners.
The Watchman is a tiny wire and mesh device that looks like a parachute. It’s inserted into the heart via a catheter. Once implanted, tissue grows over it and permanently closes the area where clots would normally form.
Dr. Bill Katsiyiannis of the Minneapolis Heart Institute has repeatedly implanted the device in patients. He has no financial stake in the device, yet is a clear champion for using it on atrial fibrillation patients who have a risk of stroke, but for whom blood thinners are not a good option. This is the way to go for those people,” he said. “It fills a very specific need, and it’s a big need.”
Mary Hacker, 74, of Minneapolis, is one of those patients. She has atrial fibrillation and high blood pressure. Three years ago, she had a stroke. Nearly two years ago, her doctors recommended having the device installed to prevent another stroke. She was out of the hospital in a day and has not taken a blood thinner since.
“It’s been wonderful,” she said. “I was very pleased with the whole program.”
The device was the brain child of two cardiologists, Dr. Robert Hauser and Dr. Robert Schwartz, and was ultimately developed by Atritech, a small Minneapolis-based company. Atritech was eventually bought out by Boston Scientific, who continued the work on the Watchman device.
The implant device, which is already available in 30 countries, goes before an advisory panel of the U.S. Food and Drug Administration on December 11, 2013. It is predicted the device will get FDA approval in the first half of 2014.
If that holds true, atrial fibrillation patients with a high risk of strokes who don’t tolerate blood thinners will have another option – one that might be better than medications.
I say *might* because the research on the Watchman is mixed. According to MassDevice.com, researchers found no differences in rates of stroke between patients with the device vs. those who use warfarin only. However, other research showed that the Watchman *may* eliminate the need for long-term use of blood thinners.