BlueCross BlueShield of Tennessee Medical Policy Manual

Percutaneous Left-Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation


Left-atrial appendage (LAA) closure devices (e.g. Watchman™) consist of a permanently implanted device in the left atrial appendage of the heart. The device is delivered via catheter through a vein in the leg. The catheter advances through the bloodstream until it reaches the right atrium, advances through an incision in the septum and opens like an umbrella in the left atrium. Once in place a thin layer of tissue grows over the device and keeps clots from entering the bloodstream, thus preventing strokes.

Strokes associated with atrial fibrillation are primarily embolic in nature and tend to be more severe than the typical ischemic stroke, causing higher rates of mortality and disability. The lack of atrial contractions in atrial fibrillation leads to blood stasis in the left atrium, and this low flow state increases the risk for thrombosis. It has been estimated that 90% of thrombi occur in the LAA.

The main treatment for stroke prevention in atrial fibrillation is anticoagulation medications. While anticoagulation is effective for stroke prevention, increased risk of bleeding is present. Until therapeutic anticoagulation is achieved, frequent monitoring and adjustments, as well as lifestyle changes, are required. The balance of risks and benefits associated with implantation of this device for stroke prevention as an alternative to systemic anticoagulation must be made on an individual basis.

Only one percutaneous LAA closure device, to date, has received FDA approval as a non-pharmacologic alternative to anticoagulation for stroke prevention in atrial fibrillation (Watchman™). Other devices (e.g., Lariat® Loop Applicator, Amplatzer Amulet, and Cardioblate® closure device) are in development or undergoing clinical trials.





The CHADS2 score is a clinical prediction rule for estimating the risk of stroke in individuals with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke. The CHA2DS2-VASc score is a refinement of CHADS2 score and extends the latter by including additional common stroke risk factors, that is, age 65-74, female gender and vascular disease. A higher score corresponds to a greater risk.





Congestive heart failure



Hypertension (140/90)



Age ≥ 75 years



Diabetes Mellitus



Prior Stroke or TIA



Vascular disease



Age 65-74 years



Sex category (female)



American College of Cardiology, American Heart Association Task Force, Heart Rhythm Society. (2019). 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. Retrieved October 23, 2019 from

American Heart Association/American Stroke Association. (2014). Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack. Retrieved October 23, 2017 from

Bajaj, N., Parashar, A. Agarwal, S., MD, Sodhi, N., Poddar, K., Garg A., el al. (2014). Percutaneous left atrial appendage occlusion for stroke prophylaxis in nonvalvular atrial fibrillation. Cardiologic Interventions, 7 (3), 296-304. (Level 2 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (6:2019). Percutaneous left atrial appendage closure devices for stroke prevention in atrial fibrillation (2.02.26). Retrieved October 23, 2019 from (63 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. NCD for percutaneous left atrial appendage closure (LAAC) (20.34). Retrieved October 23, 2017 from

Lakkireddy, D., Afzal, M., Lee, R., Nagaraj, H., Tschopp, D., Gidney, B., et al. (2016). Short and long-term outcomes of percutaneous left atrial appendage suture ligation: results from a US multicenter evaluation. Heart Rhythm. 13 (5), 1030-1036. Abstract retrieved October 21, 2016 from PubMed database.

National Institute for Health and Clinical Excellence (NICE). (2010, June). Percutaneous occlusion of the left atrial appendage in non-valvular atrial fibrillation for the prevention of thromboembolism. Retrieved October 21, 2016 from

Sahay, S., Nombela-Franco, L., Rodes-Cabau, J., Jimenez-Quevedo, P., Salinas, P., Biagioni, C., et al. (2017). Efficacy and safety of left atrial appendage closure versus medical treatment in atrial fibrillation: a network meta-analysis from randomized trials. Heart, 103, 139-147. (Level 1 evidence)

Winifred S. Hayes, Inc. (2018, February; last update search March 2019). Percutaneous left atrial appendage closure to reduce stroke risk in patients with atrial fibrillation. Retrieved October 23, 2019 from (110 articles and/or guidelines reviewed)




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