MARSHFIELD CLINIC FIRST TO TREAT PATIENT WITH "WATCHMAN" DEVICE IN WISCONSIN
A Stevens Point man is the first person in Wisconsin to participate in a research study regarding an investigational implantable device that is being studied to prevent strokes in patients suffering from atrial fibrillation.
Milind Shah, M.D., an interventional cardiologist at Marshfield Clinic, recently performed a procedure to implant the "Watchman" device in Richard Boldt of Stevens Point.
Shah explained that this investigational device is currently being studied at the Marshfield Clinic, which is one of only 40 medical centers in the United States and the only site in Wisconsin participating in this research protocol.
"This device was tested in Europe and has achieved the CE Mark, which is equivalent to Food and Drug Administration (FDA) approval," Shah said. "Now it is being studied in the United States. So far, research results in Europe have shown the device to be equivalent to using Warfarin, also known as Coumadin, to prevent strokes."
Atrial fibrillation is a condition that affects about 3 million Americans, including 10 percent who are adults age 75 and older. About 20-25 percent of the 750,000 people in this country who suffer from stroke each year do so because of atrial fibrillation.
In atrial fibrillation, the upper heart chambers beat too fast, sometimes just quivering. This can lead to blood clots forming in an area of the heart called the left atrial appendage, a small, thumb-sized pouch on the top of the heart.
The "Watchman" device, which looks like an inverted umbrella, seals off the mouth of the left atrial appendage, preventing formation of blood clots and thus preventing strokes.
"It's a major, major issue that we are dealing with because stroke is the third most common cause of death after heart attack and cancer, but the No.1 cause of long-term adult disability with an economic impact of $50 billion a year," Shah said.
Coumadin is highly effective in preventing blood clots, but many people cannot use the drug or do not want to use it because of the limitations it places on their lives. Its use requires frequent blood tests - every two to four weeks - to determine appropriate dosage. If too much is given, the patient could die from uncontrolled bleeding. If too little is given, blood clots could form. Taking Coumadin also requires changes in diet. For example, green leafy vegetables like salads can affect the body's response to the drug. Also, there is an impact on a patient's travel because of the need to not only have the frequent blood work but also to have a doctor revise dosage in response to blood tests.
"Coumadin has a lot of baggage to carry with it," Shah said, "and that is the very reason Mr. Boldt wanted to try another form of treatment."
Shah implanted the device during a two-hour procedure in the Cardiac Catheterization Lab at Saint Joseph's Hospital in Marshfield. The device was threaded into Boldt's heart through a catheter inserted into his upper leg. Cardiologist Charles McCauley, M.D., performed a trans-esophageal echocardiogram, where a tube is passed down the throat for a heart ultrasound to confirm proper positioning of the device.
Boldt is recovering well from the procedure and was thrilled to have the device.
"You have to be so careful about what you do and how you do it with Coumadin," Boldt said. "The least cut and you bleed and bleed and bleed. Even a bump to the stomach could cause bleeding internally. I just didn't care to take it for the rest of my life. I wanted to see if there was something out there because Coumadin is such a hassle. Now I feel great," Boldt said.