Atrial fibrillation is a common heart disease involving electrical disturbances in the atria (the top two chambers) of the heart, which can reduce the heart’s ability to pump blood efficiently. Nonvalvular atrial fibrillation (atrial fibrillation that does not involve the heart valves) is the most common form of atrial fibrillation and can lead to stroke. To prevent stroke, people with nonvalvular atrial fibrillation often take oral anticoagulants (medications that prevent the blood from clotting) daily for life. However, on occasion, patients may be unable to take these medications owing to side effects. A new device, the left atrial appendage closure device with delivery system (LAAC device), may be able to prevent stroke in people with nonvalvular atrial fibrillation without the need for lifelong treatment with oral anticoagulants.
In this health technology assessment, we compared the effectiveness and cost-effectiveness of the LAAC device versus novel oral anticoagulants and oral antiplatelet medications in patients with nonvalvular atrial fibrillation.
We found moderate-quality evidence suggesting that the LAAC device and novel oral anticoagulants are similarly effective in preventing stroke. To date, no randomized controlled evidence is available regarding the effectiveness of the device in people with nonvalvular atrial fibrillation with contraindications to oral anticoagulants. However, some evidence suggests that the device may be effective in this patient population; if so, our results indicate that the device would be cost-effective in this patient population. People with nonvalvular atrial fibrillation with whom we spoke reported positive support for the LAAC device and reported valuing having access to the LAAC device if it were shown to be safe, effective, and recommended by their health care providers.