The use of a device with U.S. Food and Drug Administration (FDA) approval for percutaneous left atrial appendage closure (e.g., the Watchman or Amplatzer Amulet) may be considered medically necessary for the prevention of stroke in patients with atrial fibrillation when the following criteria are met:
There is an increased risk of stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc score and systemic anticoagulation therapy is recommended; and
The long-term risks of systemic anticoagulation outweigh the risks of the device implantation (see Policy Guidelines).
The use of a device with FDA approval for percutaneous left atrial appendage closure (e.g., the Watchman or Amplatzer Amulet) for stroke prevention in patients who do not meet the above criteria is considered investigational.
The use of other percutaneous left atrial appendage closure devices, including but not limited to the Lariat and Amplatzer Cardiac Plug devices, for stroke prevention in patients with atrial fibrillation is considered investigational.
