摘要

目的：经导管置入Amplatzer封堵器治疗二孔型心房间隔缺损(ASD，中央型)，并对其疗效进行初步评价。

方法：全组34例，年龄31.00±15.74岁(5～53岁)，体重50.69±16.62 kg(18～79 kg),术前经食管超声心动图(TEE)检查示ASD直径平均为16.94±5.38 mm(6～28 mm)。所有病例均在透视及经食管超声心动图(TEE)监视下经导管置入Amplatzer封堵器封堵ASD。术后24小时、1个月、3个月及1年分别行经胸超声心动图(TTE)、心电图及X线胸片检查评价治疗效果。

结果：34例ASD直径的球囊测量值为21.82±5.31 mm(8～32 mm),选择的封堵器直径为23.62±5.52 mm(10～34 mm)。34例封堵器置入均获得成功，技术成功率为100%，术中未发生任何并发症，无急诊手术病例。34例术后即刻TEE显示10例(29.4%)存在微量～少量残余分流。术后24小时行TTE检查示3例(8.8%,残余少量左向右分流；术后1个月TTE示2例(5.9%)存在少量分流。X线胸片检查：全部显示肺血减少、右心房室缩小。34例完成术后3个月随访，TTE显示所有ASD(100%)均完全闭合，无残余分流；6例完成术后1年随访，ASD均完全闭合，未见ASD残余分流及再通。

结论：经导管置入Amplatzer封堵器治疗ASD是一种有效的非手术方法，具有操作简便、安全、技术成功率高及封堵效果好等诸多优点，尤其适合于直径较大的ASD介入治疗，其临床应用的远期疗效尚需继续观察。

Transcatheter Closure Secundum Atrial Septal Defect with Amplatzer Septal Occluder Device: A Priliminary Results of Clinical Application

Department of Radiology， Cardiovascular Institute and Fu Wai Hospital, CAMS and PUMC, Beijing (100037)

Zhang Gejun, Liu Yanling, Dai Ruping, et al.

Abstract

Objective: To evaluate the efficiency and priliminary results of transcatheter closure of secundum atrial septal defect (ASD) using Amplatzer occluder device.

Methods: There was 34 patients. The mean age was 31.00±15.74 years (ranging from 5 to 53 years) and the mean weight was 50.69±16.62 kg (raning from 18 to 79 kg). Transesophageal echocardiography (TEE) before the interventions confirmed the ASD with a diameter of 16.94±5.38 mm (ranging from 6 to 28 mm). Each case with ASD was treated using Amplatzer occluder device through the percutaneous procedure. The procedures were carried out under guiding fluoroscopy and TEE. After the procedure, TEE were performed immediately to find whether there was residual shunt. Transthoracic echocardiography (TTE), ECG and X-ray examination were done 24 hours, 1 month, 3- month and 1 year after the procedure to evaluate the efficiency.

Results: The mean balloon stretched diameter of the ASDs was 21.82±5.31 mm (ranging from 8 to 32 mm). The mean diameter of the occluder selected was 23.62±5.52 mm (ranging from 10 to 34 mm). The successful rate of placement of the Amplatzer occluder was 100%. No any complication occurred during the procedures, and no needed for emergency surgery. Trivial to small residual shunts were found in 10 cases (29.4%) immediately after the procedures, in 3 cases (8.8%) 24 hours after the procedures and in 2 cases (5.9%) 1 month after the procedures. All of 34 patients completed 3-month follow-up and there was no residual shunt found. Six patients carried out 1 year follow-up and no residual shunt and recanalization were found.

Conclusion: Transcatheter closure of secundum ASD using Amplatzer septal occluder device was an efficient nonsurgical method, especially to the ASDs with a larger size diameter. It had a high successful rate of placement and satisfied immediate and short and mid- term results, but the and long term follow-up was needed.

Key wordsCongenital heart disease; Atrial septal defect; Transcatheter closure

心房间隔缺损(ASD)是常见的先天性心脏病，既往手术是其唯一的治疗方法。1974年King等^［1］首先应用介入治疗技术闭合二孔型ASD获得成功，随着介入医学的发展，先后设计出若干种用于ASD介入治疗的封堵器并用于临床^［2～4］。 我院于1997年9月在国内率先引进Amplatzer封堵器治疗二孔型ASD，并对其疗效进行观察，现报告如下。

1材料和方法

病例来源全组共34例，男7例，女27例，年龄31.00±15.74岁(5～53岁)，身高156.85±12.29 cm(115～178 cm),体重50.69±16.62 kg(18～79 kg),均经临床、心电图(ECG)、X线胸片及经胸超声心动图(TTE)检查诊断为二孔型ASD。TTE显示ASD直径为16.49±4.27 mm(7.5～25.0 mm),右心房、右心室呈不同程度增大；ECG正常者11例，电轴右偏3例，不完全性右束支传导阻滞11例，完全性右束支传导阻滞2例，右心室肥厚5例，Ⅰ度房室传导阻滞1例，ST-T改变1例；X线胸片显示肺血呈不同程度增多。

34例术前均行经食管超声心动图(TEE)检查，示ASD直径为16.94±5.38 mm(6～28 mm),ASD边缘距腔静脉、肺静脉、冠状静脉窦及房室瓣的距离均大于4 mm,未见其它并发畸形。

心导管检查示肺循环血流量/体循环血流量(QP/QS)为1.95±0.65(1.11～3.95),肺动脉平均压23.12±6.64 mmHg(14～38 mmHg，1 mmHg=0.133 kPa)。

介入治疗方法Amplatzer封堵器：美国AGA公司制造，由具有自膨胀特性的双盘及连续双盘的“腰部”三部分组成。双盘及“腰部”均系镍钛记忆合金编织成的密集网状结构，双盘及“腰部”内充三层高分子聚合材料；“腰部”的直径决定可封堵的ASD的大小；根据腰部的直径分为4～34 mm等27种型号。输送系统由输送器和鞘管组成，鞘管外径为6～11F。

治疗过程10岁以下患者采用气管插管下全身麻醉，10岁以上患者采用局部浸润麻醉，均穿刺右股静脉，行常规右心导管检查获得血液动力学资料。将7F侧孔导管先端置于右上肺静脉，于左前斜45°行左心房造影，观察ASD形态特点。经7F端孔导管置入260 cm的置换导丝，将其先端置于左上肺静脉，沿该导丝送入8F Medi-tech测量球囊(最大膨胀直径为33 mm)导管至左心房，以稀释造影剂(造影剂：生理盐水=2∶1)充盈球囊，在TEE及透视监测下调整球囊大小，使其从左心房撤向右心房时与ASD边缘充分接触，在回撤球囊导管时应感到少许阻力，确定此时球囊内的造影剂总量后完全回抽造影剂，将球囊导管撤至体外。再以同样剂量的造影剂在体外充盈球囊并测量其直径，此即为ASD直径的球囊测量值。按该直径或比其大1～2 mm选择好封堵器，将其安装于输送器的先端。沿260 cm置换导丝送相应直径的输送鞘管进入左心房，使其先端位于左心房中央。再经其将封堵器送入左心房，待封堵器的左心房侧盘及“腰部”张开后，回撤输送器内芯，在TEE监视下使左心房盘与左心房壁充分相贴，“腰部”完全卡于ASD内；固定输送器，同时回撤鞘管使右心房盘张开，经TEE证实封堵器位置合适后，逆时针旋转输送器末端的旋钮将封堵器释放；撤出所有输送装置完成操作。

术后24小时内应进行肝素化(100 IU/kg),24小时后开始口服肠溶阿司匹林(每日2～4 mg/kg),共服用3个月；术后静脉给予抗生素3天预防感染。术后即刻行TEE检查，术后24小时、1个月、3个月及1年行TTE、心电图及X线胸片检查进行随访。超声心动图显示残余分流血流宽度≤2 mm定义为少量残余分流，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。ECG记录的任何不能用其它疾病或治疗方法解释的心律失常视为并发症。以X线胸片观察肺血情况、封堵器的位置及其金属结构有无变化。

2结果

34例ASD直径的球囊测量值为21.82±5.31 mm(8～32 mm),选择的封堵器直径为23.62±5.52 mm(10～34 mm),封堵器/ASD直径比值为1.1∶1。34例封堵器置入均获得成功，技术成功率为100%，术中透视时间为19.52±5.84分(10.3～37.2分)。术中未发生任何并发症，无急诊手术病例。

术后即刻TEE显示24例(70.6%)ASD封堵完全，10例(29.4%)存在微量～少量残余分流，封堵器形态位置良好，未对毗邻解剖结构产生影响。

34例患者术后24小时均行TTE检查，示31例(91.2%)房水平分流消失，3例(8.8%)残余少量左向右分流，所有病例右心房及右心室内径均较术前缩小且均未见封堵器对心房壁及二尖瓣、三尖瓣运动产生影响；术后1个月TTE显示32例(94.1%)ASD完全闭合，2例(5.9%)存在少量分流；34例均完成术后3个月随访，TTE显示所有ASD(100%)均完全闭合，无残余分流，右心房、室内径均恢复至正常范围。6例完成术后1年随访，均未见封堵器移位及ASD再通，右心房、室内径基本属正常。

34例X线胸片检查显示术后24小时肺血较术前均有不同程度减少，封堵器形态良好；随访中肺血改变未再发生明显变