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  • Open Access

    ARTICLE

    2025 Chinese Expert Consensus on Clinical Applications of Biodegradable Patent Foramen Ovale Occluders

    Caojin Zhang1,#, Haibo Hu2,#, Gangcheng Zhang3,#, Qiguang Wang4, Xiaobin Chen5, Yingzhang Cheng6, Qunshan Shen7, Jie Yuan8, Wenqi Zhang9, Yuanshi Li10, Xuan Zheng3, Xiangbin Pan2,*, Professional Committee of National Quality Management and Control Center for Structural Heart Diseases, Professional Committee of Structural Heart Diseases of the National Cardiovascular Disease Expert Committee

    Congenital Heart Disease, Vol.20, No.4, pp. 403-420, 2025, DOI:10.32604/chd.2025.071050 - 18 September 2025

    Abstract Compared with traditional nickel-titanium alloy patent foramen ovale occluders, which are widely used in clinical practice, biodegradable patent foramen ovale occluders have obvious differences in material characteristics, interventional operation mode and postoperative management strategy. This article gives expert consensus on the selection of clinical indications and standardized operating procedures, so as to standardize the clinical application of biodegradable patent foramen ovale occluders. More >

  • Open Access

    ARTICLE

    A Novel Transcatheter Suture Closure System for Patent Foramen Ovale: An Experimental Study in Swine

    Su Ye1, Luxi Guan1, Dong Luo1, Fengwen Zhang1, Jianhua Lv1, Qizong Xie2, Qiao Huang2, Haiming Wu2, Haibo Hu1,*, Xiangbing Pan1,*

    Congenital Heart Disease, Vol.20, No.2, pp. 181-193, 2025, DOI:10.32604/chd.2025.063297 - 30 April 2025

    Abstract Objectives: This study aimed to evaluate the feasibility, safety, and efficacy of a novel transcatheter suture closure system (HaloStitch®) for patent foramen ovale (PFO) closure in a swine model. Methods: Thirteen swine underwent experimental PFO model creation. All animals received implantation of the transcatheter suture closure system to evaluate procedural success. Comprehensive follow-up over six months included serial ultrasound imaging, histopathological analysis, and gross anatomical examination of cardiac specimens. Results: Successful HaloStitch® device implantation was achieved in 11 of 13 swine. Gross anatomical examination confirmed secure positioning of all sutures in the atrial septum, with no redundancy or… More >

  • Open Access

    RETRACTION

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

    Xingbang Li1,#, Xuan Zheng2,#, Bowen Jin1, Yunyan Li1, Yongyu Shao1, Xiaoxian Deng1, Dingyang Li1, Shanshan Li1, Hongmei Zhou1, Jie Zhang3, Xianya Zhang4, Qunshan Shen1, Gangcheng Zhang2,*

    Congenital Heart Disease, Vol.18, No.4, pp. 489-489, 2023, DOI:10.32604/chd.2023.031413 - 15 September 2023

    Abstract This article has no abstract. More >

  • Open Access

    ARTICLE

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

    Xingbang Li1,#, Xuan Zheng2,#, Bowen Jin1, Yunyan Li1, Yongyu Shao1, Xiaoxian Deng1, Dingyang Li1, Shanshan Li1, Hongmei Zhou1, Jie Zhang3, Xianya Zhang4, Qunshan Shen1, Gangcheng Zhang2,*

    Congenital Heart Disease, Vol.18, No.3, pp. 373-385, 2023, DOI:10.32604/chd.2023.028979 - 09 June 2023

    Abstract 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 More > Graphic Abstract

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

  • Open Access

    ARTICLE

    Percutaneous Closure of Patent Foramen Ovale and Secundum Atrial Septal Defects with the GORE® CARDIOFORM Septal Occluder: Incidence and Implications of Device Wire Frame Fracture

    Biagio Castaldi1,*, Giulio Cabrelle1, Massimo Padalino2, Vladimiro Vida2, Ornella Milanesi1, Giovanni Di Salvo1

    Congenital Heart Disease, Vol.15, No.5, pp. 347-360, 2020, DOI:10.32604/CHD.2020.012750 - 23 September 2020

    Abstract Background: Trans-catheter closure has become the treatment of choice for patent foramen ovale (PFO) and ostium secundum atrial septal defects (ASD). A wide variety of devices are commercially available, however, concerns have been raised about the risk of cardiac erosion associated with stiff/rigid devices. The GORE® CARDIOFORM Septal Occluder (GSO) is a double-disc, soft and conformable device with no reported incidence of cardiac erosions. However, wire frame fracture (WFF) have been reported. Aim: To assess the incidence and clinical significance of WFF after GSO implantation in paediatric patients. Methods: Seventy-seven consecutive patients were enrolled. Periprocedural and follow-up… More >

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