Experience With Left Atrial Appendage Closure Device
What is the acute procedural outcome among patients undergoing implantation of a left atrial appendage (LAA) occlusion device in a “real-world” setting?
All patients undergoing implantation of a LAA occlusion device (Watchman, Boston Scientific) in the United States after its approval by the Food and Drug Association (FDA) were included in this study. The manufacturer required the presence of a clinical specialist to be present at the time of the procedure in part to record procedural parameters and complications in a standardized fashion. The procedure was performed by either an electrophysiologist or interventional cardiologist. After implantation, warfarin and aspirin were recommended until follow-up imaging (at 45 days) failed to reveal a significant leak, at which time, warfarin was discontinued for clopidogrel. After 6 months of dual antiplatelet therapy, clopidogrel was discontinued.
Demographic data were not available. A total of 3,822 patients underwent implantation of a LAA occlusion device. The procedure was performed by 382 physicians from 169 centers. About one-third of the physicians had previously implanted the device in the clinical trial setting, with the remainder being “naïve” operators, who performed 50% of the procedures. The acute success rate was 96%, and the mean procedure duration was 50 minutes. Pericardial tamponade occurred in 39 patients (1%), 24 of whom responded to pericardiocentesis. Twelve patients required cardiac surgery for refractory tamponade. Three patients died related to pericardial tamponade, and another died of pulmonary embolism. Procedure-related stroke occurred in three patients (0.08%) and device embolization occurred in nine patients (0.24%).
The authors concluded that the post-approval experience with the Watchman LAA occlusion device was associated with a high procedural success rate and a low rate of complications.
The Watchman LAA occlusion device has been shown to be noninferior to warfarin in terms of thromboembolism, and superior to oral anticoagulation with respect to hemorrhagic stroke. In addition, when the impact disability related to stroke is considered, LAA occlusion has also been shown to be cost-effective. Quality of life of patients is also improved. This study demonstrates a high success rate and a low risk of complications, despite extending the experience to novice operators. The possibility of serious complications, albeit low, underscores the need for judicious patient selection, rigorous training, and ongoing improvements in product design. A prospective registry may help identify risk factors for adverse outcomes.
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