Objective To evaluate the safety and efficacy of the Amplatzer septal occluder for transcatheter closure in patients with secundum atrial septal defect (ASD n). Methods Patients with clinically confirmed ASD n were recommended for transcatheter closure of ASD II. Results 30 ASD n patients(20 females)underwent transcatheter closure at a median age of 18.4 years (5-55 years). Both the stretched diameters of ASDs and the sizes of the devices were from 18 to 34mm (25+7mm).The successful placement rate was 100%. The rest shunt documented by color Doppler, was immediately after implantation in 40% of patients,in 9.9% after 24 hours,and in 3.3% trace at 3months. No serious complications were observed.There was improvement in symptoms and in cardiac size. Septal motion abnormalities normalized in all patients after 3 months follow-up. Conclusion The Amplatzer septal occluder is a safe and effective device for transcatheter closure of ASD n.Long-term follow-up is still required before widespread clinical use can be recommended.

Anti-thrombogenicity and rapid endothelialisation are prerequisites for the use of closure devices of intra-atrial communications in order to reduce the risk of cerebral embolism. The purpose of this study was therefore to assess the effect of bioactive coatings on biocompatibility of Nitinol coils designed for the closure of intra-atrial communications. Nitinol coils (n=10, each) andflat Nitinol bands(n=3, each)were treatedby basic coating with poly(amino-p-xylylene-co-p-xylylene)andthen coated with either heparin, rhirudin or fibronectin. Antithrombogenicity was studied in vitro in a dynamic model with whole blood by partial thromboplastin time(PTT), platelet binding and thrombin generation, respectively, and cytotoxicity by hemolysis. Endothelialisation was studied on Nitinol bands with human umbilical venous endothelial cells(HUVEC)by 3-(4, 5-dimethylthiazole-2yl)-2, 5-triphenyl tetrazolium (MTT)assay andimmnuofluorescence analysis of Ki67, vinculin, fibronectin andvon Willebrand Factor. Uncoatedor coated devices did not influence hemolysis and PTT. r-Hirudin (but not heparin)and fibronectin coating showed lower platelet binding than uncoatedNitinol (p<0. 05, respectively). Heparin and r-hirudin coating reduced thrombin formation (p<0. 05 versus Nitinol, respectively). HUVEC adhesion, proliferation, and matrix formation decreased in the order: fibronectin coating>uncoated Nitinol>r-hirudin coating>heparin coating>basic coating. MTT assay corroborated these findings. In conclusion, r-hirudin and fibronectin coating, by causing no acute cytotoxicity, decreasing thrombogenicity and increasing endothelialisation improve in vitro biocompatibility of Nitinol devices designed for the closure of intra-atrial communications.

观察Amplatzer双面伞堵闭器关闭继发孔房间隔缺损（ASD II）的临床疗效及安全性。方法 超声心动图及临床诊断为ASD II病人30例，选择经导管Amplatzer双面伞隔缺损关闭治疗。结果 超声测定ASD II直径为13～25mm，ASD II最大伸展径及所选Amplatzer房间隔堵闭器为18～38mm。成功率为100%，超声心动图示术后即刻、24小时后及3个月后残余分流分别为40%、9.9%和3.3%。手术中除一过性房性心动过速和房室传导阻滞外，无其他并发症。3个月随访，所有病人临床症状及心脏大小改善，未发现并发症。结论 Amplatzer双面伞房间隔堵闭器关闭ASDII临床疗效及安全性均好。

1971年Mills报道采用单个蝶形球囊导管封堵室间隔缺损的动物实验，旨在探索急性心肌梗死合并室间隔穿孔渡过危险期的临时措施，但未在临床实验。1988 年Lock首先报道应用.Rashkind双伞闭合器关闭室间隔缺损成功[1],选择的病例是肌部室间隔缺损和外科手术后补片周边残余缺损的病例。根据Lock的163例室间隔缺损介入治疗报告，54%为肌部室间隔缺损，34%为手术后残余缺损，11%为心肌梗死后室间隔缺损。采用的器械为CardioSEAL和Clamshell封堵伞，成功率高达100%。1990年国内任森根等应用Rashkind双伞闭合器介入闭合膜周部室间隔缺损，但术后短时间内出现一过性左束支传导阻滞（LBBB）。由于Rashkind双伞闭合器仅有12和17mm2种型号，仅能关闭8mm以内的室间隔缺损，临床适应证局限，限制了此闭合器的应用。Lock在Rashkind17mm双伞闭合器的基础上又衍生出17、23、28、33 和44mm的蛤壳闭合器（clamshell）和改良的CardioSEAL闭合器，但伞状闭合器的中心连接点小，可在闭合的缺损范围内移动，而且伞面直径需大于缺损直径的! 倍，植入过大的伞状闭合器，容易影响主动脉瓣的正常活动和左心室收缩功能，因而也限制了它的临床应用。另外从蛤壳闭合器应用的随诊中发现40%的病例有1支以上的伞臂断裂，尤其是较大型号的闭合器，所以这两种方法在介入治疗室间隔缺损上并不十分理想，也未在临床推广应用。1994年Sideris应用钮扣式补片关闭室间隔缺损[2]，术后出现一过性LBBB较少，但由于正、反补片之间的空隙大、扣合不够紧密，术后残余分流率较高，甚至有补片移位。1998年Amplatzer肌部室间隔缺损封堵器介入闭合肌部室间隔缺损开始在临床应用。1999年Thanopoulos报道应用Anokatzer肌部室间隔缺损封堵器介入闭合肌部室间隔缺损，取得满意临床效果[3]。但肌部室间隔缺损较少见，所以目前国内外介入治疗的例数不多。目前国外应用Amplatzer膜周部室间隔缺损封堵器的动物实验已完成[4]，进入临床使用阶段。2002年6月起Amplatzer膜周部室间隔缺损的介入治疗装置开始在临床上应用[5]，国内近500例的临床应用结果令人鼓舞。

观察Amplatzer膜部室间隔缺损封堵器关闭膜部室间隔缺损的临床疗效及安全性。方法经超声心动图及临床表现诊断为膜部室间隔缺损患者，如有临床症状但没有右向左分流，且膜部室间隔缺损的局部解剖结构满足以下条件：（1）膜部室间隔缺损离主动脉瓣至少1mm，离三尖瓣隔瓣至少3mm；（2）室间隔缺损的最窄直径小于14mm；（3）伴膜部室间隔瘤彤成时，瘤体未影响右心室流出道；（4）外科手术关闭膜部室间隔缺损后遗留的室间隔缺损，且对心脏的血流动力学有影响。在局部或全身麻醉下对患者行经导管Amplatzer双面伞膜部室间隔缺损的关闭治疗，手术中连续经胸或经食管超声心动图和X线监测。术后随访3个月。结果自2002年6月至2003年3月共有32例患者行经导管Amplatzer双面伞膜部室间隔缺损的关闭治疗，其中男17例，女15例。超声测定膜部室间隔缺损直径为3～8mm（平均5.1mm），左心室造影测定膜部室间隔缺损的直径为3～8mm（平均4.4mm），所选Amplatzer膜部室间隔缺损封堵器直径为4～12mm（平均7.6mm）。堵闭操作技术成功率为100%。超声心动图示术后即刻残余分流为11.5%（少量分流3.8%，微量7.7%），24 h后残余分流为7.7%（为微量），3个月后有3.8%的微量分流。手术中出现一过性房性心动过速、一过性室性心动过速、一过性房室传导阻滞及一过性束支传导阻滞均恢复。手术过程中1例患者主动脉瓣关闭不全加重，但没有引起明显的血流动力学改变，也完成了堵闭治疗。没有急性栓塞并发症。手术后24～48h有一例患者笈生轻度三尖瓣关闭不全，考虑与手术过程中的动静脉轨道建立有关，已经随访3个月，没有发现三尖瓣关闭不全加重和引起右心功能不全的表现，正在随访中。有1例患者手术后2d发生间隙性Ⅲ度房室传导阻滞，发生心源性晕厥，安装临时起搏器3d后未再发生Ⅲ度房室传导阻滞，而遗留有一间隙性左束支传导阻滞，患者出院，在随访中。1例患者手术后当天发生溶血，对症处理7d后溶血消失。结论超声心动图是筛选膜部室间隔缺损患者进行介入治疗的有效手段。经导管关闭膜部室间隔缺损的操作简单、方便，并发症少，残余分流少见，是经导管关闭膜部室间隔缺损的理想装置之一。