(RxWiki News) A new device may offer an alternative to anti-clotting medication for patients with atrial fibrillation (AF).
They found that the device — called an LAA-closure device — may be able to prevent strokes, blood clots and death from heart disease as well as or possibly better than warfarin.
Vivek Y. Reddy, MD, of the Icahn School of Medicine at Mount Sinai, NY, and colleagues studied the long-term effectiveness and safety of an implanted device for treating patients with AF.
For many patients with AF, blood clots start in the left atrial appendage (LAA). This is a small pouch-like sac in the muscle wall of the top-left chamber of the heart. Blood can collect there and form clots. Typically, patients take anti-clotting medication like warfarin to help.
An LAA-closure device can be implanted to seal off the left atrial appendage. This may reduce the risk of clots forming and possibly eliminate the need to take blood-thinning medications.
Dr. Reddy and team looked at 707 patients with nonvalvular AF. Valvular AF occurs when there is a narrowing of the heart’s mitral valve, while nonvalvular AF is not related to valves.
A total of 463 patients received an LAA-closure device, while 244 received warfarin. Patients came from 59 hospitals in the US and Europe.
The study authors followed patients for an average of around four years. In the group who received the device, 8.4 percent had a stroke or blood clot or died from heart problems (cardiovascular death). In the warfarin group, about 14 percent had such an event.
Dr. Reddy and colleagues calculated that those who received the implant had a lower rate of cardiovascular death (3.7 percent versus 9 percent of warfarin patients). They also had lower death rates in general (12.3 percent versus 18 percent of warfarin patients).
Warfarin has been used for many years to prevent strokes in patients with AF. The medication often requires close monitoring. Diet, other medications and illness can affect how warfarin works in the body.
Compared to someone without AF, a patient with AF has more than five times the risk of having a stroke, according to the American Heart Association. A stroke occurs when a blood clot blocks blood flow to the brain.
The American Heart Association estimates that 2.7 million Americans have AF.
This study was published online Nov. 16 in JAMA.
The manufacturer of the device, Atritech (now owned by Boston Scientific), funded the study and provided the LAA-closure devices used in this trial. Some of the study authors received support from Boston Scientific.