However, for patients who are poor candidates for long-term oral anticoagu- lation (because of the propensity for bleeding or poor drug tolerance or adherence), the Watchman device provides an alternative. There are important differences in wording between the FDA approval and the Centers for Medicare & Medicaid Services (CMS) approval. In the FDA approval, the device was restricted to patients who were deemed suitable for long-term warfarin (mirroring the inclusion criteria for enrollment in the clinical trials) but had an ap- propriate rationale to seek a nonpharmacological alternative to warfarin. Conversely, CMS states that the device is an option for patients who are suitable for short-term warfarin but deemed unable to take long-term oral anticoagulation. CMS has specified that patients should have a CHADS2 score 2 or a -VASc score 3 to be considered for the device. A number of unresolved issues remain, in- cluding the optimal patient selection and peripro- cedural antithrombotic regimen. The current FDA labeling specifies that patients should be deemed suitable for anticoagulation and, in particular, a period of periprocedural anticoagulation. Patients unable to take oral anticoagulation were excluded from the Watchman RCTs. However, there is in- creasing experience outside the United States with LAA closure in oral anticoagulation ineligible pa- tients using an antiplatelet regimen only,S4.4.1-6,S4.4.1-7 and this is the focus of an ongoing RCT.S4.4.1-8 CLINICAL STATEMENTS AND GUIDELINES 4.4.2. Cardiac Surgery LAA Occlusion/Excision Recommendation for Cardiac Surgery LAA Occlusion/Excision Referenced studies that support the modified recommendation are summarized in Online Data Supplement 5. COR LOE Recommendation IIb B-NR Surgical occlusion of the LAA may be considered in patients with AF undergoing , as a component of an overall heart team approach to the management of AF. MODIFIED: LOE was updated from C to B-NR because of new evidence. Recommendation-Specific Supportive Text (Modified) 1. 