First of its Kind Life-saving Heart Device Studied in Utah to be Available to all Eligible Utah Heart Patients, Doctors to announce Today

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The WATCHMAN left atrial appendage closure device, which is about the size of a quarter, is the first and only device of its kind in the United States. 

The Intermountain Medical Center Heart Institute has been one of the leading national research sites (one of about 60 centers in the United States). It is the only Utah hospital authorized to implant the WATCHMAN device at this point. Of the 2,400 WATCHMAN patients enrolled in national clinical trials, the Intermountain Medical Center Heart Institute enrolled more than 130 patients. 

The medical team at the Intermountain Medical Center Heart Institute will make this announcement and outline the important ways this will benefit Utah heart patients today. Three patients who received the device, as part of the clinical trials, including a well-known Utah actor, will also talk about how the device helped them.

The WATCHMAN is a small, parachute-like device that is permanently 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 non-valvular atrial fibrillation, one of the most common heart rhythm disorders in the world. 

The WATCHMAN prevents blood clots that form in the left atrial appendage from entering the bloodstream and potentially causing a stroke. The procedure is minimally invasive, typically requiring an overnight stay in the hospital so doctors can monitor recovery.

Clinical trials of the WATCHMAN device have shown to significantly reduce the risk of stroke in patients with atrial fibrillation. Approval for widespread clinical use of WATCHMAN is good news for patients with atrial fibrillation, a disorder found in about 2.2 million Americans.

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 is designed for patients who cannot tolerate blood-thinning medication, such as warfarin, which is the most common treatment option for atrial fibrillation to reduce stroke risk. Approximately 45% of patients who are eligible for warfarin are not being treated, due to tolerance or adherence issues. This applies particularly to the elderly. 

After reviewing data from long-term studies that the Intermountain Medical Center Heart Institute and 60+ other centers in the United States completed of the WATCHMAN, an FDA panel of medical experts recommended approval of the heart device for general use. Medicare payment approval is expected in the coming days.
 
Intermountain Medical Center Heart Institute cardiologist Brian Whisenant, MD, has implanted the WATCHMAN in many patients with atrial fibrillation since 2005, and has monitored their progress over the years. 

Dr. Whisenant says the results are outstanding. “It’s a home-run opportunity to reduce patients’ stroke risk and avoid warfarin,” he says. 
 
Intermountain Medical Center was one of a select group of research sites participating in early national clinical trials of the WATCHMAN.  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.