WATCHMAN Device Reduces Stroke Risk; Eliminates Need for Blood Thinners in Patients with Atrial Fibrillation

INDIANAPOLIS, Indiana – Franciscan Health Indianapolis is one of the few hospitals in Indiana offering patients with abnormal heart rhythm – or atrial fibrillation (Afib) – a life-changing device that greatly reduces the risk of stroke.

The newly approved WATCHMANTM Device has been used successfully in five patients at the Franciscan Health Heart Center in Indianapolis. "The device provides physicians with a breakthrough stroke-reduction alternative to treat patients with atrial fibrillation," said Saeed Shaikh, MD, FACC, FSCAI, an interventional cardiologist who first performed the procedure at the Heart Center. "This advanced technology will be life-changing for many non-valvular atrial fibrillation patients freeing them from not only the dangers of stroke risk, but also in many cases eliminates the need for long-term blood-thinning medication therapy."

Afib is a condition where the heart beats irregularly at a high rate and patients are treated with blood thinners such as warfarin (Coumadin). These drugs reduce the likelihood of experiencing potentially dangerous blood clots within the heart which may cause a stroke.

Blood thinners, however, can increase the risk of bleeding strokes, or brain strokes (hemorrhage strokes), as well as possibly cause calcium build-up in the arteries. The calcium build-up can narrow the aortic valve that helps the flow of blood, and therefore reduces the amount of oxygen that can reach body tissues.

Patients with Afib have a marked risk of stroke because blood can pool and create clots in an area of the heart called the left atrial appendage (LAA). When a clot breaks free, it can travel to other areas of the body and trigger a stroke. Poor pumping increases the risk of clots forming in the heart chambers, particularly the left atrial appendage, which is located on the top of the heart.

The WATCHMAN device is designed to prevent blood clots that frequently form in the LAA from traveling in the blood stream to the brain, lungs and other parts of the body. Clots that travel to the brain cause strokes, one of the leading causes of death and disability.

Oral blood thinners such as warfarin have been in use for a half century and used to prevent strokes. While effective, blood thinners increase the rate of bleeding. And studies have found that many patients stop taking their prescribed dosages after a year out of fear of bleeding complications and the cost of the medicine.

“Despite its proven efficacy, long-term warfarin therapy is not well-tolerated by some patients and carries a significant risk for bleeding complications, said Dr. Shaikh, managing director of Franciscan Physician Network Indiana Heart Physicians. “Nearly half of patients eligible for warfarin are currently untreated due to tolerance and adherence issues.”

Implanting the WATCHMANTM device is a one-time minimally invasive procedure that lasts 90-minutes under anesthesia. The device is inserted through a catheter in the groin area. It is then implanted in the heart to close off the left atrial appendage, the most common site where harmful blood clots form in patients with Afib. The small device then prevents clots from entering the bloodstream, where they might otherwise travel to the brain, causing a stroke.

By closing off the LAA, the risk of stroke can be reduced. Over time, heart tissue grows over the implant, permanently sealing off the LAA. And in 90 percent of cases, patients are able to discontinue use of blood thinners 45 days after the procedure.

The WATCHMANTM has been implanted in more than 10,000 patients worldwide.