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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.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

04/26/2012: Policy reviewed; added "percutaneous" to the policy title and policy statement.

Non-Covered Codes

This is not an all-inclusive list of non-covered procedure codes.

All codes billed for this procedure are considered investigational and not eligible for coverage. 

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