Pansy生物可降解封堵器治疗卵圆孔未闭的远期疗效:36个月随访的单中心临床研究  

Long-term results of patent foramen ovale occlusion with the Pansy®biodegradable occluder:a single-center clinical trial with 36-month follow-up

作　　者：李子昂 郑晓舟[1] 苗强 雷印胜 王明华[1] 刘现坤 郭志刚[3] Li Ziang;Zheng Xiaozhou;Miao Qiang;Lei Yinsheng;Wang Minghua;Liu Xiankun;Guo Zhigang(Department of Cardiac Surgery,the First Affiliated Hospital of Shandong First Medical University&Shandong Provincial Qianfoshan Hospital,Jinan 250014,China;Graduate College,Tianjin Medical University,Tianjin 300070,China;Department of Cardiac Surgery,Tianjin Chest Hospital,Tianjin 300222,China)

机构地区：[1]山东第一医科大学第一附属医院、山东省千佛山医院心外科,济南250014 [2]天津医科大学研究生院,天津300070 [3]天津市胸科医院心外科,天津300222

出　　处：《中华胸心血管外科杂志》2024年第11期664-671,共8页Chinese Journal of Thoracic and Cardiovascular Surgery

摘　　要：目的随访Pansy®生物可降解封堵器(PBO)治疗卵圆孔未闭(PFO)术后1、3、6、12、24和36个月,评估使用PBO经皮闭合PFO的可行性、有效性和安全性。方法本研究属于单中心前瞻性临床试验研究。我们招募了15例符合卵圆孔未闭封堵条件的PFO患者,均接受PBO封堵治疗,封堵器尺寸24~34 mm等。患者于术后第1、3、6、12、24、36个月返回医院行经胸超声心动图(TTE)或经食管超声心动图(TEE)、经颅多普勒超声造影(cTCD)或经胸超声心动图造影(cTTE)检查,记录临床数据。结果15例患者年龄27~68(44.0±16.4)岁。封堵指征为隐源性卒中6例,偏头痛9例。技术成功率100%(15/15),术中TTE显示封堵器的位置和形状满意。3例合并房间隔膨出瘤(ASA)患者分别在术后1、6个月行TTE检查发现小残余分流。1例隐源性卒中患者在封堵后8个月复发卒中。随访12个月,卵圆孔闭合11例。随访36个月,完全闭合13例。12例不合并ASA的患者完全闭合,3例合并ASA患者,完全闭合1例。随访期间无器械相关并发症发生。结论PBO具有良好的生物相容性和适宜的降解时间,对于不合并ASA的患者有较高的技术成功率和完全闭合率。使用PBO经皮闭合PFO是可行、有效和安全的。Objective To test the feasibility,efficacy and safety of percutaneous patent foramen ovale(PFO)closure utilizing the Pansy biodegradable occluder(PBO)at 1-,3-,6-,12-,24-,and 36-month follow-up.Methods In this single-center prospective clinical study,we enrolled 15 patients with PFO eligible for closure,all treated with the PBO,with device sizes ranging 24-34 mm.All clinical data were recorded in a 36-month follow-up period.Patients were summoned to the hospital in the 1,3,6,12,24,and 36 months after closure for transthoracic echocardiography(TTE),or transesophageal echocardiography(TEE),contrast transcranial doppler(cTCD)or contrast transthoracic echocardiography(cTTE),and a routine fasting blood sample.Results The mean age was 27-68(44.0±16.4)years old.Indications for closure were cryptogenic stroke in 6 patients and migraine in 9 patients.Procedures were technically successful in 100%(15/15),in which course TTE showed that the position and shape of occluders were satisfactory.Small residual shunt was found by TTE in 2 patients with ASA in 1 month and 6 months after closure,respectively.1 patient with cryptogenic stroke had another recurrent stroke 8 months after closure.At 12-month follow-up,11 cases were closure.At 36-month follow-up,13 cases were closure.12 patients without atrial septal aneurysm(ASA)were closure.1 patients with ASA was complete closure.No device-related complications occurred during the follow-up.Conclusion PBO has good biocompatibility and suitable degradation time.A high technical success rate and closure rate can be achieved in those patients without ASA.Percutaneous closure of PFO using PBO is feasible,effective,and safe.

关 键 词：卵圆孔未闭 新型生物可降解封堵器 封堵治疗 临床试验 

分 类 号：R654.2[医药卫生—外科学]