DESCRIPTION
Stroke associated with atrial fibrillation is primarily embolic in nature, tends to be more severe than the typical ischemic stroke and causes higher rates of mortality and disability. As a result, stroke prevention is one of the main goals of atrial fibrillation treatment. Strokes occur primarily as a result of a thromboembolism from the left atrium. 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. The highest risk of thrombosis is the left-atrial appendage (LAA) and it has been estimated that 90% of thrombi occur in the LAA.
The main treatment for stroke prevention in atrial fibrillation is anticoagulation, which has proven efficacy. While anticoagulation is effective for stroke prevention there is the increased risk of bleeding, so until therapeutic anticoagulation is achieved, frequent monitoring and adjustments, as well as lifestyle changes are required.
A surgical procedure of the LAA is often performed in individuals with atrial fibrillation who are undergoing open heart surgery for other reasons. Percutaneous LAA closure devices are being developed as a non-pharmacologic alternative to anticoagulation for stroke prevention in atrial fibrillation. Some of these devices (e.g., WATCHMAN® left atrial appendage system, Cardioblate® closure device) are being developed and are undergoing clinical trials.
POLICY
The use of left-atrial appendage closure devices for the prevention of stroke in atrial fibrillation is considered investigational.
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ADDITIONAL INFORMATION
According to the U.S. Food and Drug Administration (FDA), there are no approvals for left atrial appendage (LAA) closure devices. In 2009, the FDA advisory panel for the LAA technology voted in favor of approval, however the FDA did not grant final approval after concluding that further studies of efficacy and safety were necessary.
There is a lack of published evidence-based data to determine whether the use of the left-atrial appendage (LAA) closure devices for stroke prevention in atrial fibrillation impacts net health outcomes.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Left-atrial appendage closure devices for stroke prevention in atrial fibrillation (2.02.26). Retrieved June 1, 2011 from BlueWeb. (5 articles and/or guidelines reviewed)
Contractor, T., & Khasnis, A. (2011). Left atrial appendage closure in atrial fibrillation: A world without anticoagulation? Cardiology Research and Practice, 2011, 1-7.
Dawson, A. G., Asopa, S., & Dunning, J. (2010). Should patients undergoing cardiac surgery with atrial fibrillation have left atrial appendage exclusion? Interactive CardioVascular and Thoracic Surgery, 10 (2), 306-311.
Fuller, C. & Reisman, M. (2011). Stroke prevention in atrial fibrillation: Atrial appendage closure. Current Cardiology Reports, 13 (2), 159-166.
Furie, K. L., Kasner, S. E., Adams, R. J., Albers, G. W., Bush, R. L., Fagan, S. C., et al. (2011). Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke, 42 (1), 227-276.
Holmes, D. R., Reddy, V. Y., Turi, Z. G., Doshi, S. K., Sievert, H., Buchbinder, M., et al. (2009). Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: A randomised non-inferiority trial. Lancet, 374 (9689), 534-542. (Level 1 Evidence - Industry sponsored)
Khasnis, A., & Thakur, R. K. (2009) Atrial fibrillation: A historical perspective. Cardiology Clinics, 27 (1), 1-12.
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 June 2, 2011 from http://www.nice.org.uk/nicemedia/live/11216/49407/49407.pdf.
Onalan, O., & Crystal, E. (2007). Left atrial appendage exclusion for stroke prevention in patients with nonrheumatic atrial fibrillation. Stroke, 38 (2 Suppl), 624-630.
Park, J. W., Leithauser, B., Gerk, U., Vrsansky, M., & Jung, F. (2009). Percutaneous left atrial appendage transcatheter occlusion (PLAATO) for stroke prevention in atrial fibrillation: 2-year outcomes. The Journal of invasive Cardiology, 21 (9), 446-450. (Level 3 Evidence - Independent study)
Reddy, V. Y., Holmes, D., Doshi, S. K., Neuzil, P., & Kar, S. (2011). Safety of percutaneous left atrial appendage closure: Results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation, 123 (4), 417-424. (Level 1 Evidence - Industry sponsored)
Wrigley, B. J. (2009). Can the WATCHMAN device truly PROTECT from stroke in atrial fibrillation? Lancet Neurology, 8 (10), 877-878.
ORIGINAL EFFECTIVE DATE: 10/8/2011
MOST RECENT REVIEW DATE: 10/8/2011
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