Biological function of Amplatzer occluder and transcatheter
treatment for atrial septal detect

Abstract

AIM： To evaluate the efficiency of transcatheter closure of secundum atrial septal defect (ASD) by using Amplatzer occluder device.

METHODS：① 65 inpatients with ASD were selected from the Department of Cardiac Surgery, Lanzhou First People's Hospital from August 2002 to April 2006, including 26 males and 39 females with a mean age of (18±8) years and a mean ASD diameter of (19.3±7.2) mm. All enrolled patients knew and agreed with the operation. ② Amplatzer ASD occluder was adopted in the operation, which was a new device suitable for secundum ASD. It was composed of self-stretched double-umbrella device and a connecting of umbrella. Double-umbrella could stabilize the ASD and decrease the incidence of residual shunt. ③ Patients were divided into balloon group (n =38) and transthoracic echocardiography (TTE) group (n =27) according to the size of occluder (i.e. measurement by TTE or by balloon). Each case was treated with Amplatzer occluder device through the percutaneous procedure under fluoroscopy and TEE. Meanwhile, the stretched diameter and size of occluder of defects were measured, and the X-ray examination as well as the time of operation were recorded. ④ TTE, electrocardiogram (ECG) and X-ray examination were performed immediately after the surgery, and 24 hours, 3 months, one years after the operation to evaluate the effects. ⑤ Transesophageal echocardiography (TEE) was performed to find whether there were any residual shunt remained. It was taken as microamount of shunt as the width of residual shunt ≤ 1 mm, small shunt as between 1.0 and 2.0 mm, middle shunt as between 2 and 4 mm, and large shunt as greater than 4 mm. ⑥ Differences among groups were compared with t test, and comparison in the efficiency of operation was conducted with rank-sum test of ranked data.

RESULT:① The achievement ratio: Of 65 ASD patients, 64 cases succeeded in occluder implant with an achievement ratio of 98%. ② The mean balloon stretched diameter of the 38 ASDs was (20.4±6.1) mm. The mean diameter of the occluder selected was (21.6±5.7) mm, which was similar to the measurement of TTE group [(22.5±4.3)，(25.1±4.9) mm, P > 0.05]. ③ Residual shunt postoperation: TTE at the postoperative instant showed that no residual shunt was found in 35 patients in the balloon group, neither in 23 patients in TTE group, and the differences were not significant (P > 0.05). No residual shunt was found in 36 patients in the balloon group and 24 patients in TTE group at 24 hours after the surgery, and the difference was not remarkable (P > 0.05); No residual shunt was found in 37 patients in the balloon group and 25 patients in TTE group at 3 months after the surgery, and the difference was not remarkable (P > 0.05); No residual shunt or recanalization was found in 52 patients in one-year follow-up. ④ X-ray examination showed that both pulmonary vascularity and heart size were improved.

CONCLUSION:The diameter of Amplatzer septal occluder device is 1.0－2.0 mm larger than the diameter of ASD measured by balloon, and the effect is better than that of ECG (2－6) mm with a higher achievement ratio.

摘要
目的：评价经导管置入Amplatzer封堵器治疗继发孔房间隔缺损的治疗效果。
方法：①选择2002－08/2006－04在兰州市第一人民医院心外科住院的继发孔型房间隔缺损 65例，男26例，女39例；平均年龄(18±8)岁；平均房间隔缺损直径(19.3±7.2) mm。纳入患者对手术方案知情同意。②手术所用封堵器为美国公司的Amplatzer 房间隔缺损封堵器，是一种新型的适于关闭二孔型房间隔缺损的装置,它由具有自膨胀性的双盘及连接双盘的腰部三部分组成。双盘状结构恢复记忆形状后可以稳定封堵房间隔缺损的边缘部分，降低残余分流的发生率。③根据选择封堵器大小的方式（即球囊测量或经胸超声心动图直接观察）将患者分为球囊测量组38例和经胸超声心动图测量组27例。均在透视及经胸超声心动图监视下经导管置入Amplatzer封堵器封堵房间隔缺损。同时测量患者缺损扩张直径、封堵器大小，记录X射线透视时间和手术时间。④术后即刻、24 h、3个月及1年分别行经胸超声心动图、心电图及X射线检查评价治疗效果。⑤超声心动图显示完全无分流为无分流；残余分流血流宽度≤1 mm为微量分流；血流宽度1.0~2.0 mm为少量残余分流；血流宽度2~4 mm为中量残余分流；血流宽度> 4 mm为大量残余分流。⑥组间计量资料差异比较采用两个独立样本t检验，组间手术效果比较采用两个独立样本的等级资料秩和检验。
结果：①技术成功率：65例房间隔缺损患者，64例封堵器置入成功，技术成功率为98%。②选择封堵器直径：球囊测量组缺损扩张直径为(20.4±6.1) mm，选择的封堵器直径为(21.6±5.7) mm，与经胸超声心动图测量组相近[(22.5±4.3)，(25.1±4.9) mm,P > 0.05]。③ 术后残余分流情况:术后即刻经胸超声心动图显示，球囊测量组35例完全无分流，经胸超声心动图组有23例，差异不明显（P > 0.05）；术后24 h，球囊测量组36例完全无分流，经胸超声心动图组有24例，差异不明显（P > 0.05）；术后3个月，球囊测量组37例完全无分流，经胸超声心动图组有25例，差异不明显（P > 0.05）；术后1年完成随访的52例患者均未见封堵器移位及房间隔缺损再通。④X射线平片检查：全部显示肺血减少，右心房、室缩小。
结论：封堵器直径比球囊测量的房间隔缺损扩张直径大1.0~2.0 mm，比超声心动图测量的大2~6 mm封堵效果好，成功率高。
关键词：封堵器；房间隔缺损；心导管术；先天性心脏病

王延震，谢静，谢定雄，于涛，郑叙锋，郭建强，任荣，靳建建.Amplazter封堵器的生物学性能及经导管介入治疗房间隔缺损[J].中国组织工程研究与临床康复，2007，11(1):25-28,32 [www.zglckf.com/zglckf/ejournal/upfiles/07-1/1k-25(ps).pdf]