Yandao Medical Voice Network 20200708
In addition to causing symptoms such as chest tightness and palpitations, atrial fibrillation can also lead to stroke in 20-30% of patients. Compared to general stroke, the mortality and recurrence rates of atrial fibrillation stroke are significantly increased. 90% of the blood clots that cause stroke in patients with atrial fibrillation originate from the left atrial appendage, so it is necessary to intervene in the left atrial appendage to prevent stroke. Left atrial appendage occlusion is one of the effective intervention methods. At the CIT2020 Online Phase II conference on July 4th, Professor Xu Yawei's team from Shanghai Tenth People's Hospital shared the latest clinical research results of the domestically produced LEFTEAR left atrial appendage occluder. The results were recently announced in the Hot Line/Date Breaking Trials session of EuroPCRe Course.
The conference was chaired by Academician Ge Junbo from Zhongshan Hospital affiliated with Fudan University and Professor Xu Bo from Fuwai Hospital of the Chinese Academy of Medical Sciences. Professor Chen Wei from Professor Xu Yawei's team at Shanghai Tenth People's Hospital shared the research design, organizational implementation, and latest results of LEFTEAR.
Professor Chen Wei first provided a detailed introduction to the basic structure and usage of the LEFTEAR occluder. The LEFTEAR occluder includes a sealing device and a delivery system. The sealing device includes a newly designed trapezoidal sealing disc and a fixed disc with a barbed structure, while the delivery system is a 12/10F double bend structure. The new design structure can adapt to various ear shape structures.
Professor Chen Wei also introduced the experimental design and implementation principles of the study. This study is a multicenter prospective single arm study conducted prior to listing, jointly initiated by Academician Ge Junbo from Zhongshan Hospital affiliated with Fudan University and Professor Xu Yawei from Shanghai Tenth People's Hospital. The purpose of the study is to evaluate the safety and efficacy of using LEFTEAR for left atrial appendage occlusion in atrial fibrillation patients with long-term oral anticoagulation contraindications and high risk of anticoagulation therapy, and to assess its comprehensive outcomes within 12 months.
Subsequently, Professor Fan Youqi from the Second Affiliated Hospital of Zhejiang University School of Medicine shared his single center experience on the LEFTEAR left atrial appendage occluder.
It is reported that the research is being conducted in 9 famous heart centers across the country, including Zhongshan Hospital affiliated with Fudan University, Shanghai Tenth People's Hospital, Second Affiliated Hospital of Zhejiang University School of Medicine, Xiamen University Cardiovascular Hospital, Tongji University Affiliated Oriental Hospital, West China Hospital of Sichuan University, General Hospital of Tianjin Medical University, First Affiliated Hospital of Xi'an Jiaotong University, and First Hospital of Peking University.
The research results indicate that the use of LEFTEAR for left atrial appendage occlusion is safe and effective, and the "one-stop" surgery of atrial fibrillation ablation combined with left atrial appendage occlusion may increase the incidence of adverse events.
This study is the first to investigate the novel LAAC occluder LEFTEAR and is innovative. LEFTEAR is friendly to both the left atrial appendage and endothelium, but further RCT trials are needed to provide higher-level evidence to validate its effectiveness and safety.
During the discussion and summary stage, renowned experts such as Academician Ge Junbo expressed their recognition and comments on the LEFTEAR research.
Academician Ge Junbo believes that the incidence of atrial fibrillation in China is increasing year by year, and how to deal with the series of complications caused by fibrillation is a question worth considering. The LEFTEAR occluder has been improved on the basis of existing occluders, with a hook and wedge design that is more friendly to domestic patients.
Professor Huo Yong from Peking University First Hospital also expressed his views and congratulated on the experimental results. Professor Huo Yong believes that the LEFTEAR research has been very successful, and LEFTEAR is also a very distinctive instrument with good adaptability to different patients. The successful implantation rate of LEFTEAR in the study reached over 98%, indicating that this is a very mature technology and device. Under the current mature technology and equipment, how to develop the correct strategy for using left atrial appendage occluder to prevent atrial fibrillation embolism risk will be a further issue worthy of consideration and research.
Professor Zhang Yushun from the First Affiliated Hospital of Xi'an Jiaotong University commented that the LEFTEAR occluder has absorbed many advantages of left atrial appendage occlusion devices and overcome the disadvantages of early bifurcation and multi lobulation of the original occluder, so its indications will be more extensive. ”Professor Zhang Yushun believes that further promotion of LEFTEAR occluders can benefit more patients.
The LEFTEAR left atrial appendage occluder system is an innovative product independently developed and optimized by Professor Xu Yawei's team at the Tenth People's Hospital of Shanghai, targeting the morphological characteristics of the left atrial appendage in Asia, especially in China. This product is created in China, has independent intellectual property rights, and has received widespread attention from domestic and foreign media. In the current context of developing the country through science and technology and becoming an innovative powerhouse, the LEFTEAR left atrial appendage occluder system, a Chinese innovation in the cardiovascular field, is of great significance.
