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| Thrombus prevention device shows promise in AF patients |
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15 March 2006
German researchers report initial success with a device designed to prevent thrombi in the left atrial appendage (LAA) of patients with atrial fibrillation (AF).
"The WATCHMAN LAA system is placed in the LAA via transseptal puncture to prevent the occurrence of thromboembolism," Dr Peter Sick and colleagues from the University of Leipzig in Germany explained to delegates at the 55th American College of Cardiology annual scientific sessions in Atlanta, Georgia.
Since its clinical introduction in 2002, the system has been implanted in 66 AF patients worldwide, with follow-up assessments carried out at 45 days and 6 months, and annually thereafter. The average age of the patients was 69 years, ranging from 47 to 85 years, and 66% were men. The baseline CHAD score in the patients was 1.7, from a possible range of 0-5, with a higher score indicating a greater risk of stroke. The average procedure duration was 59 minutes, from a range of 35 to 157 minutes. Procedure-related adverse events included five pericardial effusions, two of which required percutaneous puncture, one major air embolism, and two instances of device embolisation.
Enhancement of the fixation barbs of the device prevented further occurrences of embolisation. After 6 months, warfarin treatment was stopped in the majority of the patients, except for four whose 6-month examination revealed a flat thrombus on the device. Warfarin was therefore continued until removal of the thrombus, but one patient nevertheless suffered a transient ischaemic attack (TIA). During a cumulative total of 101.4 implant years, no ischaemic strokes or systemic embolisms have occurred, the team said. One patient suffered a TIA, but had no evidence of a LAA thrombus, and one patient died of non-cerebrovascular causes.
The researchers therefore concluded: "Preliminary data suggest the WATCHMAN LAA system to be safe and feasible."
Reference:
ACC 2006
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