Therefore, another treatment is needed to prevent strokes in people with AF.
Researchers selected 15 patients whose AF was not caused by rheumatic fever. All of the patients were at high risk of stroke because they could not take warfarin for long periods. Participants ranged in age from 59 to 78.
Using an ultrasound technique called transesophageal echocardiography to guide them, the researchers threaded a catheter containing the PLAATO device to the entrance of the atrial appendage.
If the initial placement was not adequate, the researchers collapsed the device and repositioned it. Once inserted properly into the mouth of the atrial appendage, the nitinol cage expanded to its proper shape.
Tiny spikes attached to the alloy cage that protrude through its covering anchored the device in place.
The left atrial appendage was successfully blocked in all 15 patients, Sievert says.
Each patient received a device that was 20 percent to 40 percent larger than the opening of his or her left atrial appendage. During the procedure, four patients had the device removed and replaced with one of a different size with no problems. One patient had a complication during the procedure, so four weeks later the procedure was repeated, this time successfully.
The patients implants, when fixed in place, ranged in diameter from 18 to 32 millimeters. The average time for the procedure was 92.7 minutes.
As promising as the new findings appear, Sievert emphasizes that additional studies are needed to confirm the successful implantation of the PLAATO device and to show that the therapy will prevent strokes.
This initial study supports the concept that implanting a mechanical device to block the left atrial appendage can be done safely and with relative ease,
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Contact: Carole Bullock
carole.bullock@heart.org
214-706-1279
American Heart Association
8-Apr-2002