The Left Atrial Appendage is a small sac in the muscle wall of the left atrium. It is unclear what function, if any, the LAA performs.

In normal hearts, the heart contracts with each heartbeat, and the blood in the left atrium and Left Atrial Appendage is squeezed out. In Atrial Fibrillation – which is an irregular and chaotic heart beat. Those beats do not allow the atria to contract and effectively squeeze the blood out. This is how the blood collects inside the LAA and forms a clot which then can cause a stroke. Studies have shown that, in patients who do not have valve disease, the majority of blood clots that occur in the left atrium start in the Left Atrial Appendage. Anticoagulation such as warfarin or the NOACs (Eliquis, Xarelto, Pradaxa) are used to reduce the risk of clot formation.

The Left Atrial Appendage Closure Device
There is help for patients with atrial fibrillation who require an alternative to long-term anticoagulation (warfarin or NOAC) therapy through a minimally invasive procedure. This involves closing the Left Atrial Appendage.

LAA INTENDED USE and INDICATIONS FOR USE

The LAA closure device such as the WATCHMAN FLX or AMULET Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:

• Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;
• Are deemed by their physicians to be not suitable for anticoagulation therapy; and/or
• Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.

PATIENT SELECTION FOR TREATMENT

In considering the use of the LAA Closure Device, the rationale for seeking an alternative to long-term anticoagulation therapy and the safety and effectiveness of the device compared to anticoagulation should be taken into account.

The presence of indication(s) for long-term anticoagulation therapy, other than non-valvular atrial fibrillation (e.g. mechanical heart valve, hypercoagulable states, recurrent deep venous thrombosis) deems the device unsuitable for those conditions.

Watchman Device Sizes