INTRODUCTION: Two and a half million Americans with atrial fibrillation are at an elevated risk for embolic stroke. Warfarin therapy is standard treatment for high-risk patients, yet 40-65% of elderly patients do not receive anticoagulation therapy due to bleeding complications. To address this clinical need, we are evaluating a minimally invasive stent-based stroke prevention device to divert emboli from entering the arterial supply of the brain. METHODS: The feasibility of a J-shaped stroke prevention device was tested in a mock circulatory loop. Sixteen sets of 100 simulated emboli (1-5 mm(3)) were injected into the left atrium with and without J stents protecting the aortic arch vessels. To determine efficacy, emboli were trapped in filters in the aortic arch vessels and distal aorta for manual counting. RESULTS: J stents decreased the number of emboli that entered the brachiocephalic trunk by 93.7% (p < 0.0001), left common carotid artery by 79.8% (p < 0.0001), and left subclavian artery by 89.7% (p < 0.0001). CONCLUSIONS: In a mock circulation, J stents positioned in the aortic arch vessels and oriented downstream of aortic flow significantly decreased the number of emboli that entered the aortic arch vessels. These results warrant further investigation to determine the safety and efficacy of this prophylactic intervention to reduce embolic events, and chronic large animal studies are underway.
INTRODUCTION: Two and a half million Americans with atrial fibrillation are at an elevated risk for embolic stroke. Warfarin therapy is standard treatment for high-risk patients, yet 40-65% of elderly patients do not receive anticoagulation therapy due to bleeding complications. To address this clinical need, we are evaluating a minimally invasive stent-based stroke prevention device to divert emboli from entering the arterial supply of the brain. METHODS: The feasibility of a J-shaped stroke prevention device was tested in a mock circulatory loop. Sixteen sets of 100 simulated emboli (1-5 mm(3)) were injected into the left atrium with and without J stents protecting the aortic arch vessels. To determine efficacy, emboli were trapped in filters in the aortic arch vessels and distal aorta for manual counting. RESULTS: J stents decreased the number of emboli that entered the brachiocephalic trunk by 93.7% (p < 0.0001), left common carotid artery by 79.8% (p < 0.0001), and left subclavian artery by 89.7% (p < 0.0001). CONCLUSIONS: In a mock circulation, J stents positioned in the aortic arch vessels and oriented downstream of aortic flow significantly decreased the number of emboli that entered the aortic arch vessels. These results warrant further investigation to determine the safety and efficacy of this prophylactic intervention to reduce embolic events, and chronic large animal studies are underway.