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New device helpful in preventing strokes
Source: Agencies |
March 29, 2009, Sunday
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Print Edition
Print Edition
A new device implanted in the heart proved to be a potential alternative to a standard blood thinner for helping patients with irregular heart beats prevent stroke, researchers who conducted the large American clinical study said yesterday.
The cage-like device reduced the risk of stroke and cardiovascular death by 32 percent compared to warfarin, a widely used blood thinner that is notoriously difficult to manage and carries a high bleeding risk.
The Watchman device, made by Atritech Inc, had twice as many procedure-related complications ?? most of them related to its implantation ?? but researchers concluded it is an effective alternative to warfarin.
"Although there are complications associated with implantation of the device, patients can avoid the need for chronic warfarin therapy, with all its attendant risks," said Dr David Holmes, professor of medicine at the Mayo Graduate School of Medicine in Minnesota, who presented the study at the American College of Cardiology scientific meeting in Orlando.
Atrial fibrillation is a common heart rhythm disorder that creates blood clots and increases the risk of stroke. The disorder is found in about 2.2 million Americans and about 15 percent of strokes occur in people with atrial fibrillation, according to the American Heart Association.
The Watchman is an expandable cage designed to keep harmful blood clots that form in the left atrial appendage of the heart from entering the blood stream and causing a stroke.
The device is guided to the heart through a catheter inserted through a vein in the upper leg.
It is placed just behind or at the opening of the left atrial appendage, where the vast majority of clots are formed, according to Atritech.
In the 707-patient study, 463 atrial fibrillation patients were randomly assigned to the Watchman and 244 patients to warfarin.
The combined rate of stroke and cardiovascular death ?? the primary effectiveness measure ?? was 3.4 per 100 patient years in the device group, compared to five per 100 patient years in the warfarin group.
The cage-like device reduced the risk of stroke and cardiovascular death by 32 percent compared to warfarin, a widely used blood thinner that is notoriously difficult to manage and carries a high bleeding risk.
The Watchman device, made by Atritech Inc, had twice as many procedure-related complications ?? most of them related to its implantation ?? but researchers concluded it is an effective alternative to warfarin.
"Although there are complications associated with implantation of the device, patients can avoid the need for chronic warfarin therapy, with all its attendant risks," said Dr David Holmes, professor of medicine at the Mayo Graduate School of Medicine in Minnesota, who presented the study at the American College of Cardiology scientific meeting in Orlando.
Atrial fibrillation is a common heart rhythm disorder that creates blood clots and increases the risk of stroke. The disorder is found in about 2.2 million Americans and about 15 percent of strokes occur in people with atrial fibrillation, according to the American Heart Association.
The Watchman is an expandable cage designed to keep harmful blood clots that form in the left atrial appendage of the heart from entering the blood stream and causing a stroke.
The device is guided to the heart through a catheter inserted through a vein in the upper leg.
It is placed just behind or at the opening of the left atrial appendage, where the vast majority of clots are formed, according to Atritech.
In the 707-patient study, 463 atrial fibrillation patients were randomly assigned to the Watchman and 244 patients to warfarin.
The combined rate of stroke and cardiovascular death ?? the primary effectiveness measure ?? was 3.4 per 100 patient years in the device group, compared to five per 100 patient years in the warfarin group.
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