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Safety and Efficacy of Biodegradable Patent Foramen Ovale Occluder in Patients with Migraine: A Clinical Trial

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单位: [1]Wuhan Univ Sci & Technol, Congenital Heart Dis Ctr, Wuhan Asia Heart Hosp, Wuhan 430022, Peoples R China [2]Wuhan Univ, Zhongnan Hosp, Struct Heart Dis Ctr, Wuhan 430071, Peoples R China [3]Huazhong Univ Sci & Technol,Tongji Med Coll,Tongji Hosp,Dept Cardiothorac & Vasc Surg,Wuhan 430030,Peoples R China [4]Huazhong Univ Sci & Technol,Tongji Med Coll,Tongji Hosp,Dept Med Ultrasound,Wuhan 430030,Peoples R China
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关键词: Patent foramen ovale biodegradable occluder transcatheter closure migraine complications

摘要:
Background: Transcatheter closure of patent foramen ovale (PFO) has been widely accepted as a highly effective way to treat high-risk PFO-related diseases. However, traditional non-degradable occluders made of metal alloys will permanently exist in the body, resulting in thrombosis, valve damage, hemolysis, arrhythmia, or other complications. The biodegradable PFO occluder developed by Shanghai Mallow Medical Instrument Co., Ltd., China can be fully absorbed and degrade into nontoxic ingredients, reducing postoperative complications. Objectives: To study the safety and efficacy of biodegradable PFO occluders in treating PFO. Methods: This single-center clinical trial collected 30 patients treated with a biodegradable PFO occluder. The follow-up period lasted 12 months to analyze the echocardiographic characteristics and headache relief through HIT-6 scores. Results: The immediate success rate was 100%, with no intraoperative severe occlusion-related complications. The contrast transcranial Doppler (cTCD) at 12 months showed that all patients' right-to-left shunts (RLS) were grade I or 0 with no serious postoperative complications, indicating the overall success rate was 100%. The biodegradable PFO occluder mostly degraded six months after the occlusion. Conclusion: PFO closure with a Mallow biodegradable occluder is safe and effective and has no severe complications.

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出版当年[2022]版:
大类 | 3 区 医学
小类 | 3 区 心脏和心血管系统
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 心脏和心血管系统
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出版当年[2021]版:
Q3 CARDIAC & CARDIOVASCULAR SYSTEMS
最新[2023]版:
Q4 CARDIAC & CARDIOVASCULAR SYSTEMS

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第一作者单位: [1]Wuhan Univ Sci & Technol, Congenital Heart Dis Ctr, Wuhan Asia Heart Hosp, Wuhan 430022, Peoples R China
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