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DESCRIPTIONStroke is the most serious complication of atrial fibrillation. The estimated incidence of stroke in non-treated patients with atrial fibrillation is 5% per year. 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.
Stroke occurs primarily as a result of 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 area of the left atrium with the lowest blood flow in atrial fibrillation, and, therefore, the highest risk of thrombosis, is the left-atrial appendage (LAA). It has been estimated that 90% of left-atrial thrombi occur in the LAA.
The main treatment for stroke prevention in atrial fibrillation is anticoagulation, which has proven efficacy. Warfarin is the predominant agent in clinical use. Dabigatran (Pradaxa®, Boehringer-Ingelheim) has recently received U.S. Food and Drug Administration (FDA) approval for this indication and has demonstrated noninferiority to warfarin in clinical trials. While anticoagulation is effective for stroke prevention, there is an increased risk of bleeding. Also, warfarin requires frequent monitoring and adjustments as well as lifestyle changes. Dabigatran does not require monitoring. However, unlike warfarin, the antithrombotic effects of dabigatran are not reversible with any currently available hemostatic drugs.
Surgical removal, or exclusion, of the LAA is often performed in patients with atrial fibrillation who are undergoing open heart surgery for other reasons. Percutaneous LAA closure devices have been developed as a nonpharmacologic alternative to anticoagulation for stroke prevention in atrial fibrillation. The devices may prevent stroke by occluding the LAA and thus preventing thrombus formation.
Several versions of the devices have been developed. The WATCHMAN® left atrial appendage system (Atritech, Plymouth, MN) is a self-expanding nickel titanium device. It has a polyester covering and fixation barbs for attachment to the endocardium. Implantation is performed percutaneously through a catheter delivery system, utilizing venous access and transeptal puncture to enter the left atrium. Following implantation, patients are anticoagulated with warfarin or alternate agents for approximately 1-2 months. After this period, patients are maintained on antiplatelet agents (i.e., aspirin and/or clopidrogel) indefinitely. The Cardioblate® closure device developed by Medtronic Corp. is currently being tested in clinical studies. The Amplatzer® septal closure device, manufactured by AGA Medical Corp, Plymouth, MN, is FDA-approved for closure of atrial septal defects. This device has also been used as a LAA closure device.
There are currently no LAA closure devices with FDA approval. The WATCHMAN® device was considered for FDA approval in 2009 based on the results of the PROTECT-AF randomized controlled trial. While the FDA advisory panel for this topic voted in favor of approval, the FDA did not grant final approval after concluding that further studies of efficacy and safety were necessary.
POLICYThe use of percutaneous left-atrial appendage closure devices for the prevention of stroke in atrial fibrillation is considered investigational.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/29/2011: Approved by Medical Policy Advisory Committee.
04/26/2012: Policy reviewed; added "percutaneous" to the policy title and policy statement.
07/19/2013: Policy reviewed; no changes to policy statement. Added CPT code 0281T to the Code Reference section.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.26
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.