A new device implanted in the heart to stop blood clots from triggering strokes (from the rhythm disorder atrial fibrillation) may be soon an alternative to blood thinner heparin, according to a study presented at the American College of Cardiology scientific meeting in Orlando, Florida on Saturday. However, the device implantation is not without risks, the researchers cautioned.

 

“The take-home message is that although there are complications associated with implantation of the device, patients can avoid the need for chronic warfarin therapy, with all its attendant risks.” Dr. David Holmes, professor of medicine at the \mayo Graduate School of Medicine in Minnesota, said.

 

The device called “Watchman” is made by privately held Atritech Inc. of Plymouth, Minnesota, which sponsored the study named Protect AF. The company has already filed an application seeking Food and Drug Administration approval.

 

The study involved 707 patients with a type of atrial fibrillation, a condition that can lead to palpitations, fainting, fatigue or congestive heart failure. It can also lead to blood clots and stroke. The condition becomes more common with age. About 1 in 100 people, and nearly 9 in 100 over the age of 80 have atrial fibrillation. Some 70,000 Americans a year have embolic strokes, which can be caused by atrial fibrillation where the blood "pools" and sometimes clots in the atria (chambers of the heart), from which a piece breaks off and causes the stroke.

 

Atrial fibrillation had been treated with blood thinning medication, and in certain severe cases, with open heart surgery. But the new study showed that patients with the new device had a 32 percent lower risk of stroke and cardiovascular death compared with warfarin therapy. This was especially true for hemorrhagic stroke, which causes bleeding in the brain and is usually fatal.

 

“Efficacy was dramatically better with the device, and stopping the warfarin,” Holmes said.

 

Additionally, the study found fewer complications with the device, once it was implanted, compared to the blood thinner. Most of them occurred when placing it in the heart, but these complications got better in time as doctors improved their technique.

 

The findings of the study were highly appreciated by experts in the field. Dr. Gregg C. Fonarow, professor of cardiology at the University of California, Los Angeles said the new device will benefit many patients with atrial fibrillation, whose only option before this study was warfarin.

 

“The findings from this clinical trial are very impressive,” Fonarow said, adding that, despite some procedure-related complications, “treatment with this novel device will be very attractive and provide patients with atrial fibrillation effective, long-term protection from stroke and systemic embolization without the bleeding risks associated with warfarin.”

 

James Bullock, Atritech’s Chief executive officer, said an FDA advisory panel will meet next month to consider the company’s application to sell the device in the US. The device is already approved in Europe and is due on the market there in May, he added.