新型单铆双盘状封堵器治疗房间隔缺损的安全性和疗效观察

New type single-rivet double-plate occluder device for the treatment of atrial septal defect:its clinical safety and therapeutic observation

目的评价新型单铆双盘状封堵器治疗房间隔缺损(ASD)的安全性及疗效。方法选取继发孔ASD患者49例,按选用封堵器的类型不同分为试验组34例,植入新型单铆双盘状封堵器(Sunflower封堵器),对照组15例,植入双盘状封堵器(SHSMA封堵器)。记录两组患者的ASD直径、肺动脉收缩压(PASP)、右室收缩压(RVSP)、封堵器腰部直径、手术时间、透视时间及并发症发生率,术后随访心电图及1、3和6个月的经胸超声心动图。结果 49例手术全部成功,手术成功率为100%。试验组34例植入封堵器腰部直径为6～32 mm,对照组为14～34 mm。两组患者术中均无严重并发症,术后即刻超声心动图检查示,对照组1例可见残余分流,术后6个月残余分流消失,其他患者均未见心房水平分流,封堵器未影响右房室瓣返流。术前、术后心电图变化两组间差异无统计学意义(P>0.05)。结论Sunflower封堵器与SHSMA封堵器治疗ASD同样安全和有效。

Objective To assess the clinical safety and efficiency of new type single-rivet double- plate occluder device in treating atrial septal defect （ASD）. Methods A total of forty-nine patients with ASD （18 males and 31 females, aged 4 - 70 years） were collected for this study. According to the occluder type used in the treatment, the patients were divided into study group （n = 34） and control group （n = 15）. Implantation of new type single-rivet double-plate occluder device （sunflower occluder） was carried out in the patients of study group, while SHSMA occluder was employed in the patients of control group. The diameter of ASD, the systolic pressure of the pulmonary artery, the systolic pressure of the right ventricle, the waist diameter of the occluder, the operation time, the fluoroscopic time and the occurrence of complications were recorded. The results were analyzed. Follow-up checkups with electrocardiogram （ECG） and trans- thoracic echocardiography at one, 3 and 6 months after the treatment were conducted. Results Technical success was obtained in all patients. In the study group, the waist diameter of the implanted occluder was （6 - 32） mm. In the control group, the waist diameter of the implanted occluder was （14 - 34） mm. During the procedure no serious complications occurred in both groups. Ultrasound echocardiography performed immediately after the treatment showed that residual shunt was seen in one patient of the control group, and the residual shunt disappeared 6 months later. No shunt at atrial level was found in all other patients, and the occluder did not produce any influence on the tricuspid valve regurgitation. The postoperative ECG findings were not significantly different from the preoperative ECG manifestations in both groups （P 〉 0.05）. Conclusion For the treatment of ASD, the use of the new type single-rivet double- plate occluder device （sunflower occluder） carries the same safety and effectiveness as SHSMA occluder does.