MURRAY, UT (5/7/2009) – A tiny catheter-delivered "parachute" that is implanted in the heart as an alternative to the blood-thinning drug, warfarin, has been shown to significantly reduce the risk of stroke in patients with atrial fibrillation, according to new research that involved cardiac researchers from Intermountain Medical Center.
The findings are good news for patients with atrial fibrillation, a disorder found in about 2.2 million Americans, because they have led a U.S. Food and Drug Administration panel to recommend approval of the device, called The Watchman, for general use.
The Watchman is a small, parachute-like device that is inserted by catheter into a small pouch on the left side of the heart. This is the area where over 90 percent of blood clots originate in patients with atrial fibrillation. During atrial fibrillation, the heart's two small upper chambers quiver instead of beating effectively. Blood isn't pumped completely out of them, so it may pool and clot. If a piece of a blood clot leaves the heart and becomes lodged in an artery in the brain, a stroke results. About 15 percent of strokes occur in people with atrial fibrillation.
The Watchman blocks those clots from leaving that chamber and moving into the bloodstream and into the brain. The procedure is minimally invasive, typically requiring an overnight stay in the hospital so that doctors can monitor recovery.
After reviewing data from the long-term study, the FDA panel of medical experts recommended approval of the heart device for general use. While the FDA is not required to follow the advice of its panel, it does follow panel recommendations in all but rare circumstances and full FDA approval is anticipated later this year.
Intermountain Medical Center cardiologist Brian Whisenant, MD, has implanted the Watchman device in approximately 30 patients with atrial fibrillation since 2005, and has monitored their progress over four years. He says the results are outstanding.
“It’s a home run opportunity to reduce patients’ stroke risk and avoid warfarin,” says Dr. Whisenant. Warfarin, is a blood-thinning drug that can cause dangerous side effects, such as excessive bleeding.
Intermountain Medical Center was one of a select group of research sites participating in the national clinical trial. The study of 900 patients, called Protect AF, found that the combined rate of stroke and cardiovascular death was 30 percent less in patients using the device than those patients taking Coumadin to prevent stroke.
Dr. Whisenant says none of his patients using the Watchman have suffered a clot related stroke or experienced any device or procedural complications. “This device may prove to have a larger impact on the treatment of patients with atrial fibrillation than any other therapy over the last few decades,” he says.
Ed Morgan of Salt Lake City is one of Dr. Whisenant’s patients who received the device. Before receiving the Watchman device, he used Coumadin to prevent an atrial fibrillation related stroke, but suffered life-threatening bleeding related to Coumadin. Morgan, in his 70’s, works out regularly at a gym to stay healthy, but lived with the concern that blood, escaping from his heart, would create tiny strokes.
Now that the Watchman keeps blood from leaking from this appendage in the heart, he says he feels, “like there’s a light at the end of the tunnel. It’s wonderful because I don’t have to take all the medications I’ve been taking.”
The benefit for patients is not only clinical, but also financial. By reducing the need for prescription blood thinners and decreasing the risk of stroke, The Journal of Neurology estimates a savings of $2.2 trillion dollars to be achieved by 2050 on treating patients with atrial fibrillation.