Innovative Procedure Under Study May Reduce Blood Thinner Use and Lower Severe Stroke Risk For Some Heart Patients

Mike Noble
Marketing and Communications
December 16, 2011

BURLINGTON VT; A new device being studied in a clinical trial that is implanted in the heart may reduce the need for blood thinners and reduce severe stroke risk for patients who have atrial fibrillation. The Watchman Left Atrial Appendage Closure device, as it is known, is being studied by the Cardiology Division at Fletcher Allen Health Care as part of a national clinical trial. This is the only study location north of Boston in New England.

Atrial fibrillation (AF) is irregular electrical activity of the upper chambers of the heart, the atria, resulting in ineffective pumping action.  AF is the most common heart rhythm disorder, affecting over 5 million people worldwide.

AF can cause blood to pool in a portion of the left atrium known as the left atrial appendage, providing an environment for blood to clot.  These clots can then break lose and migrate through the bloodstream and up to the brain causing an embolic stroke.

An embolic stroke refers to the blockage of an artery by an embolism from another part of the body, such as the heart chamber.  Because the blockage is sudden, initial symptoms are usually severe. Embolic strokes can leave patients with serious lasting effects. Patients with AF have a 6-fold increased risk of severe stroke versus patients who have normal heart rhythm. 

The device looks like a miniature umbrella. It is inserted into the atrial appendage using a catheter that is placed in a procedure that is similar to the use of a catheter to implant a stent in a blocked coronary artery. With the device in place, it is opened much like an umbrella, and the curved surface blocks the entrance to the appendage, trapping existing embolisms in the pooled blood inside. Subsequently, the catheter used to deliver the device is removed from the patient. After a few weeks, tissue grows over the device’s curved surface, preventing blood from pooling.

 “The potential of being able to close off the left atrial appendage without major surgery may offer many clinical advantages to our patients with atrial fibrillation who are at risk of having a stroke,” said Dan Lustgarten, M.D. Ph.D., associate professor, Medicine, University of Vermont Medical Group at Fletcher Allen.  If successful, the adoption of this procedure and technology may reduce the need for blood thinning medications and decrease the number of strokes in this at risk patient population.”

Currently, blood thinners are considered to be the best preventive therapy for those patients.

To obtain additional information about this study, please contact Joe Miller, M.S., clinical research coordinator at Fletcher Allen, (802) 847-4746.

Watch a video animation of the device being used
Click on this link: http://www.atritech.net/animation.html