CLINICAL QUESTION

For patients who have undergone catheter ablation for atrial fibrillation (AF), is left atrial appendage closure with a device superior to oral anticoagulation?

BOTTOM LINE

Following catheter ablation for AF, implantation of a device that occludes the left atrial appendage obviates the need for oral anticoagulation after 3 months, reduces the risk of non-major bleeding (number needed to treat [NNT] = 10), and is noninferior to oral anticoagulation for mortality and vascular events. The device company estimates the out-of-pocket cost of device implantation for a Medicare patient is $2,600. (Level of Evidence = 1b)

SYNOPSIS

Left atrial appendage occlusion is an effective way to reduce the risk of stroke in patients with AF but has primarily been compared with warfarin. In this study, researchers identified 1,600 adults who had undergone catheter ablation for AF and a CHA₂DS₂-VASc (congestive heart failure, hypertension, age 75 years and older [doubled], diabetes, stroke [doubled], vascular disease, age 65 to 74 years, sex [female]) score of 2 or higher for men or 3 or higher for women. This indicated a moderate or greater stroke risk and, therefore, the patient was a candidate for oral anticoagulation. Patients were randomized to receive implantation of a left atrial appendage closure device (Watchman FLX) or oral anticoagulation chosen by their physician (59% apixaban [Eliquis], 27% rivaroxaban [Xarelto], 8.5% other, and 5% none). The device group received 3 months of oral anticoagulation plus aspirin, and then aspirin alone for 9 months (the aspirin dose was not given). Groups were balanced at baseline. Mean age was 69 years, 66% were male, 40% had persistent AF, and 60% had paroxysmal AF. Analysis was by intention to treat. Patients were followed up for a total of 36 months, during which time 41% of participants required additional catheter ablation. At 36 months, there were significantly more clinically relevant major or nonmajor bleeds in the anticoagulation group (18.1% vs 8.5%; P < .001; NNT = 10 over 3 years). The left atrial appendage closure was noninferior to oral anticoagulation for the composite efficacy outcome of death, stroke, or systemic embolism (5.3% vs 5.8% for anticoagulation; P < .001 for noninferiority) and for major bleeding events (3.9% vs 5.0%; P < .001). Complications related to the device occurred in 23 patients (3.0%).