To provide evidence for the surgical feasibility of high-risk stroke patients, the "one-stop" cardiac surgery research results release thrombosis | patients | surgery
The world's top academic conference on cardiac intervention, Euro-PCR, was recently held in Paris. Shanghai Enterprise Minimally Invasive Medical Science Co., Ltd. announced the latest results of pre market clinical research on AnchorMan left atrial appendage occluder at the conference. This is a randomized controlled clinical study on the one-stop surgery of atrial fibrillation ablation and left atrial appendage occlusion, providing new evidence-based medicine evidence for the feasibility of this surgery in high-risk stroke patients.
Atrial fibrillation is the most common arrhythmia disease in clinical practice. The incidence rate of atrial fibrillation in the general population is 0.5% -1.5%, and the incidence rate of atrial fibrillation in the population with hypertension, coronary heart disease, obesity, diabetes, etc. is significantly increased. When a patient experiences atrial fibrillation, the myocardium in various parts of the heart "act independently" and cannot contract in a regular manner, making it difficult for the heart to promote normal blood flow, which may lead to the formation of blood clots. Research has shown that the risk of stroke in patients with atrial fibrillation is five times higher than in non atrial fibrillation patients, and the consequences are more severe. Therefore, in the treatment of atrial fibrillation, restoring normal heart rhythm is equally important as preventing stroke.
Atrial fibrillation ablation and left atrial appendage closure are both minimally invasive surgeries aimed at treating atrial fibrillation. The former is to treat the patient's atrial fibrillation disease itself, while the latter is to prevent the formation of blood clots and the risk of stroke in atrial fibrillation patients. In the past, patients with atrial fibrillation usually needed to take anticoagulants for a long time to prevent stroke. However, long-term anticoagulation may cause a decrease in coagulation function in patients, and for elderly patients, especially those in East Asia, there is a risk of major bleeding. In addition, lifelong medication is also an economic burden for patients.
In response to this situation, left atrial appendage occlusion surgery has emerged. It blocks the left atrial appendage, which is the most prone site for thrombus formation in patients with atrial fibrillation, so that even if a thrombus forms, it will not fall off and block the blood supply vessels of important organs with the flow of blood. Research has shown that more than 90% of thrombosis in non valvular atrial fibrillation patients originates from the left atrial appendage. Therefore, theoretically, as long as the left atrial appendage can be blocked and isolated from the systemic blood circulation, the vast majority of atrial fibrillation thrombosis and related problems can be prevented and treated from the source.
Schematic diagram of AnchorMan left atrial appendage occluder implantation
The left atrial appendage is located on the left anterior lateral side of the left atrium, and is a small ear shaped sac that extends from the left atrium. Its internal shape is extremely irregular, with many grooves and undulations, making it more prone to blood stasis and the formation of blood clots. The left atrial appendage occlusion procedure involves inserting a catheter through the femoral vein on the thigh to deliver the occluder to the left atrial appendage. The occluder that reaches the left atrial appendage automatically expands, blocking it like a plug, blocking the connection between the left atrium and the left atrial appendage, preventing the thrombus formed in the left atrial appendage from dislodging and flowing throughout the blood vessels, thus avoiding the risk of thromboembolism.
Both left atrial appendage occlusion and catheter ablation belong to interventional minimally invasive surgeries, and they both require the use of catheters to puncture the femoral vein and pass through the atrial septum of the heart, forming a one-stop surgical solution for atrial fibrillation ablation and left atrial appendage occlusion.
The research findings presented at the International Cardiovascular Congress provide new evidence-based medicine evidence for the feasibility of this surgical approach. As one of the chief researchers, Professor He Ben, Director of Cardiology at Shanghai Chest Hospital, said, "In this clinical trial, the proportion of 'one-stop' surgery exceeded 70%. The research data proved the feasibility of 'one-stop' surgery in such high-risk patients, without increasing the risk of perioperative and late adverse events such as systemic embolism and instrument related thrombosis. Using one surgery can achieve the dual purpose of treating atrial fibrillation and preventing stroke, not only providing patients with double insurance, but also helping to reduce treatment costs."
AnchorMan is developed by Shanghai Zuoxin Medical Technology Co., Ltd., a minimally invasive subsidiary, and innovatively adopts a distal rounded design to reduce damage to the ear tissue; The dense nickel titanium alloy mesh and the axial support design along the auricle allow it to better conform to the auricle and improve the sealing effect; The 12 3D folding units at the tail form a semi closed structure with a mesh frame, which combines the advantages of both open and closed occluders. This solves the clinical pain point of traditional plug occluder sheaths that must penetrate deep into the ear, and also makes instrument anchoring more stable.
In the future, Zuoxin Medical will continue to promote AnchorMan related research, while promoting the early launch of the product, continuously accumulating clinical data, and further exploring the role of left atrial appendage occluder in stroke prevention therapy for non valvular atrial fibrillation patients, bringing good news to more atrial fibrillation patients.
