国产镍钛记忆合金房间隔封堵器的实验研究

目的:通过外科创建的房间隔缺损动物模型评价国产镍钛记忆合金封堵器的封堵效果和组织学反应。方法:将犬房间隔造口建立房间隔缺损动物模型后,利用国产镍钛记忆合金房间隔封堵器进行封堵,术后4h、15h、1、2、3个月分别进行大体解剖和光镜、电镜检查。结果:5只犬成功建立了动物模型并1次封堵成功,完成4h～3个月随访。动物生长发育正常,无严重并发症出现。15d～3个月大体解剖可见封堵器与房间隔组织紧密嵌合,表面完全被一层半透明、光滑的新生组织所覆盖,光镜及透射电镜检查证实为内皮样细胞。结论:国产镍钛记忆合金封堵器封堵外科创建的房间隔缺损动物模型是可行的。     

两种不同设计的国产VSD封堵器的生物相容性评价

目的：观察国产室间隔缺损封堵器植入动物体内后的组织学反应，评价比较两种不同设计国产室间隔缺损封堵器的生物相容性和安全性。方法：选用中华小型猪9只，非体外循环下通过外科方法建立创伤性肌部室间隔缺损动物模型，直视下经导管分别植入两种设计不同的室间隔缺损封堵器(有端头型和无端头型，实验样品由北京华医圣杰科技有限公司提供)，术后1、2、3个月分别处死动物进行大体解剖、     

国产房间隔缺损封堵器的实验研究

目的　通过外科手术创建的房间隔缺损动物模型评价国产心健TM 房间隔缺损封堵器介入治疗的可行性、安全性、有效性。方法　体外循环下 ,在幼猪的房间隔剪一个缺损口形成房间隔缺损 (ASD)动物模型 ,7d后行房间隔缺损封堵术。术后进行超声心动图、大体解剖、扫描电镜和透射电镜检查。结果　共 8只猪建立了房间隔缺损模型并进行封堵术 ,封堵器放置的成功率为 10 0 % ,超声心动图随访无残余分流 ,动物生长发育正常 ,无严重并发症出现。 1～ 6个月大体解剖可见封堵器与房间隔组织紧密嵌合 ,表面被一层白色半透明组织覆盖 ,电镜证实为内皮组织。结论　国产心健TM 房间隔缺损封堵器关闭外科手术创建的ASD模型可行、安全、有效     

经胸超声心动图对室间隔缺损介入封堵治疗的价值

目的：探讨经胸超声心动图(TTE)在室间隔缺损(VSD)介入封堵术中的应用价值。方法：术前经胸超声心动图扫查选择适合封堵治疗的VSD患者，然后监测导管引导Amplatzer封堵器治疗VSD的全过程，在监测过程中要认真观察导管及封堵器的位置，配合封堵器的释放，观察封堵器是否已封堵好室间隔缺损处，周边有无残余分流。     

两种国产室间隔缺损封堵器的生物相容性评价

目的:观察国产室间隔缺损封堵器置入动物体内后的组织学反应,评价比较两种不同设计国产室间隔缺损封堵器的生物相容性和安全性。 方法:选用中华小型猪9只,非体外循环下通过外科方法建立创伤性肌部室间隔缺损动物模型,直视下经导管分别置入两种设计不同的室间隔缺损封堵器(有端头型和无端头型),术后1、2、3个月分别处死进行大体解剖、光镜和电镜观察。 结果:9只猪中3只因术中出血死亡,6只置入封堵器(无端头型和有端头型各3只)成功,均存活至各自的实验终点。大体标本显示各组封堵器表面均覆盖一层厚薄不等的、光滑的新生内膜组织,免疫组化染色证实其组织学来源于正常心内膜结构。封堵器置入处心肌组织早期有轻度炎症反应,3个月时消失并为纤维组织所代替。肺、肝、脾、肾脏等重要脏器均无血栓栓塞现象。对比研究发现,有端头型封堵器较无端头型封堵器内膜完全覆盖所需的时间稍长。 结论:两种国产室间隔缺损封堵器均有良好的生物相容性和安全性,相比之下无端头型封堵器生物相容性更佳。     

国产对称双盘状封堵器经导管治疗室间隔缺损21例

目的:分析国产对称双盘状封堵器经导管治疗室间隔缺损（VSD）的疗效。方法:21例,全部为膜部室间隔缺损,年龄3.035.0（7.6±8.4）岁。VSD左室面直径为2.212.0（6.2±4.2）mm。经6F-10F传送鞘置入国产对称双盘状封堵器,封堵后即刻行左心室造影,术后1 d、1、6及12月行超声心动图检查观察有无残余分流。结果:封堵器植入成功20例,植入技术成功率95%。术后即刻左心室造影示4例（20%）存在微少量残余分流,16例（80%）封堵完全无残余分流。术后2448 h超声心动图示分流完全消失19（95%）、微少量残余分流1例（5%）。1例封堵术后3 d发生一过性Ⅲ度房室传导阻滞,经过410 d内科保守治疗治愈。1月超声心动图所有病例未见残余分流。结论:应用国产双盘状封堵器治疗VSD是一种安全有效的介入方法,操作简便,成功率高,近期疗效可靠。     

介入治疗先天性心脏病118例近期疗效评价

目的：评价应用国产封堵器治疗动脉导管未闭（PDA）、房间隔缺损（ASD）室间隔缺损（VSD）的近期疗效及安全性。方法：118例先天性心脏病患者（PDA24例，ASD48例，VSD46例）均在X线透视及经胸超声心动图监视下经导管置入封堵器治疗PDA、ASD和VSD。结果：全组封堵成功率98．3％，所有封堵成功的患者均于术后24h、7d、1月和3月行经胸超声心动图检查，均无残余分流。结论：经导管置入封堵器是治疗PDA、ASD和VSD的一种操作简便、成功率高、疗效可靠的介入方法。     

国产双盘状封堵器经导管治疗膜部室间隔缺损疗效的初步评价

目的 :应用国产双盘状封堵器经导管治疗膜部室间隔缺损并对其疗效进行初步评价。方法 :全组 2 0例 ,年龄8± 6 （2～ 17）岁。室间隔缺损直径为 7.2± 2 .3（2 .0～ 14 .0 ） mm。经 7F或 8F传送鞘置入双盘状封堵器 ,封堵后即刻行左心室造影 ,术后 1d及 1月行超声心动图检查观察有无残余分流及再通。结果 :全组技术成功率 10 0 % ,术后左心室造影显示 ,6例存在微量～少量残余分流 ,14例封堵完全无残余分流。术后 2 4 h、术后 1月超声心动图未见残余分流及再通。结论 :应用双盘状封堵器治疗膜部室间隔缺损是一种安全有效的介入方法 ,成功率高 ,近期疗效可靠 ,中远期疗效尚需进一步观察     

生物可完全降解封堵器封堵犬卵圆孔未闭的实验研究

目的 评估生物可完全降解卵圆孔未闭（patent foramen ovale，PFO）封堵器封堵犬PFO的可行性、安全性等。方法 右胸小切口开胸卵圆窝穿刺法建立犬PFO模型，即刻在直视及经胸超声心动图（TTE）引导下用生物可完全降解型PFO封堵器封堵PFO。在植入后分别于1、3、6、9和12个月各处死2只犬，进行肉眼和组织学检查。结果 10只犬成功建立PFO模型后并植入可完全降解PFO封堵器。随访见封堵器均未发生移位，表面无赘生物及血栓形成，大体解剖见内膜组织从边缘逐渐完全覆盖封堵器表面。组织病理学提示，术后6个月封堵器骨架几乎完全降解并和周围组织融为一体。结论 应用生物可完全降解PFO封堵器封堵犬PFO，降解后在体内无任何残留物，是一种安全、有效并且可行的封堵器。     

先天性心脏病经导管封堵术后人体血清镍浓度的变化及其与IL-6、IL-10的关系

目的:观察先天性心脏病(先心病)经导管封堵术植入国产封堵器前后血清镍浓度及白细胞介素(IL)-6及IL-10的变化,探讨先心病经导管封堵术植入国产封堵器后血清镍浓度与免疫激活的关系。方法:30例先心病患者,行经导管封堵术植入国产封堵器的房间隔缺损(ASD)或室间隔缺损(VSD),为先心病组。另30例年龄及性别相匹配的正常体检成人作为对照组。检测先心病组经导管封堵术前、术后24h、1个月、3个月、6个月血清镍、IL-6与IL-10浓度,并与对照组进行比较。结果:①先心病组经导管封堵术植入国产封堵器后血清镍浓度升高,到术后1个月达到最高(P0.05),然后逐渐减低,到6个月回到术前水平;在整个观察期内无过敏反应及毒性反应病例。②经导管封堵术前IL-6与IL-10水平较对照组明显升高(均P0.05),经导管封堵术后升高,到术后1个月达到最高(P0.05),然后逐渐减低,到6个月回到对照组水平。③先心病经导管封堵术植入国产封堵器后,在术后1个月血清镍浓度与血清IL-6、IL-10呈正相关(P0.05)。结论:先心病经导管封堵术植入国产封堵器后血清镍浓度升高,到术后1个月达到最高,然后逐渐减低,到6个月回到术前水平。经导管封堵术后1个月血清镍浓度与免疫激活状况(IL-6、IL-10变化水平)呈正相关关系。     

Transcatheter closure of the perimembranous ventricular septal defect-preclinical trial of a new Amplatzer device

Objectives : This study assessed the feasibility and efficacy of implanting a new nitinol device for closure of perimembranous ventricular septal defects in a swine model. Background : Perimembranous ventricular septal defect occurs in 80% of patients requiring treatment for congenital heart disease. Methods : The Amplatzer perimembranous ventricular septal occluder device (pmVSO2 device, AGA Medical Company, Plymouth MN) is a new transcatheter Nitinol device containing polyester fabric designed to close the perimembranous ventricular septal defect (VSD). The device has 75% reduction in radial force, 45% reduction in clamping force, and increased stability as compared to the previous version. The device was implanted in six swine with naturally occurring perimembranous VSD with immediate, 1, 7, ～30, and ～90 day followup by echocardiography, angiography, and final pathological examination. Results : The device was successfully implanted in all animals and was retrievable and repositionable. There was complete occlusion of the VSD in five of six cases without embolization. There was no thrombus formation on the device or occurrence of complete heart block. A single instance of a tiny residual shunt was attributed to capture of tricuspid valve apparatus. Conclusions : The success of this animal study confirms safety and feasibility of the Amplatzer pmVSO2 device. Human trials are planned. © 2011 Wiley Periodicals, Inc.     

经食管超声心动图在微创室间隔缺损封堵治疗中的应用

目的 评价经食管超声心动图(transoesophageal echocardiography,TEE)在微创外科室间隔缺损封堵治疗中的临床价值.方法 经胸超声心动图检查粗筛27例室间隔缺损(VSD)患者,拟行微创外科非体外循环下封堵治疗.术前行TEE,根据VSD位置、类型、大小选择合适的封堵器;术中TEE引导封堵器放置,评价即刻封堵效果;术后1周内复查.结果 3例患者术前TEE剔除,20例患者封堵成功,TEE显示19例无残余分流,1例微量残余分流;4例患者转体外循环进行VSD修补,其中2例有残余分流,2例出现主动脉瓣反流;20例微创封堵成功患者术后1周内超声随访,均见封堵器位置正常,无残余分流,左心室重构改善,三尖瓣反流程度减轻,肺动脉压力下降.结论 TEE对选择适合行微创封堵的VSD患者、选择封堵器大小、协助封堵器的释放、评价疗效均有重要作用.微创VSD封堵安全、有效.     

经胸超声心动图和χ线透视下行膜部室间隔缺损封堵术

目的:探讨Am p latzer封堵器和国产封堵器的临床疗效以及经胸超声心动图和χ线透视下行膜部室间隔缺损(V SD)封堵术的安全性和有效性。方法:在经胸超声心动图和χ线指导下,对15例膜部(膜周)室缺患者行室缺封堵术,术后1 d,1月,3月,6月随访心电图和超声心动图检查。结果:左室造影测量室缺的大小为3~11 mm,经胸超声心动图测量V SD大小为3~10 mm,封堵器的大小为6~14 mm。15例患儿手术成功,其中8例选择Am p latzer封堵器,7例选择国产封堵器,二者在手术时间,手术即刻和随访的成功率无显著性差异(P>0.05),二组均无严重并发症发生。患儿住院时间为5~7 d,术后复查超声心动图未见主动脉瓣,三尖瓣的关闭不全,无残余分流,心电图无房室传导阻滞。结论:(1)Am p latzer封堵器和国产封堵器性能相同;(2)膜部室间隔缺损封堵术安全,有效。     

A case of hybrid closure of a muscular ventricular septal defect: anatomical complexity and surgical management

Complex muscular ventricular septal defect poses difficult surgical management and is associated with high morbidity and mortality despite advancements in surgical therapy. Device closure of muscular ventricular septal defect has been encouraging and has been used in hybrid approach at a few centres. However, device closure has some limitations in patients with complex muscular ventricular septal defect. We report a case of perventricular device closure of a complex muscular ventricular septal defect in a beating heart with entrapped right ventricular disc and its surgical management.     

A new method to close the gastrotomy by using a cardiac septal occluder: long-term survival study in a porcine model

INTRODUCTION: Closure of the gastrotomy when performing transgastric procedures is one of the most challenging steps to overcome. Several methods of gastric closure have been described, but a simple and safe technique is still lacking. AIM: To evaluate the technical feasibility and safety of a new method of endoscopic gastric closure using a nitinol septal occluder in a porcine survival model. DESIGN: Endoscopic animal experimental study in a porcine survival model. MATERIALS AND METHODS: In 6 male pigs under general anesthesia, a 1-cm full-thickness gastrotomy was performed on the anterior body of the stomach and closed with a nitinol septal occluder (Occlutech). Postoperative follow-up included endoscopy and laparoscopy at 1, 2, 4, and 6 weeks after the initial procedure and endoscopy alone at weeks 8, 10, and 12. RESULTS: All of the gastrotomy closures with the septal occluder were successful. At follow-up endoscopy and laparoscopy there were no signs of adhesions, peritonitis, or perigastric abscess formation at the gastrotomy site. At 12 weeks, 5 of 6 animals were thriving, with appropriate weight gain. CONCLUSIONS: Endoscopic gastrotomy closure with a septal occluder is technically feasible, safe, and effective in a survival porcine model.     

Device closure of ventricular septal defects by hybrid procedures: A multicenter retrospective study

Objective : This study reports on the feasibility, efficacy, and outcome of hybrid procedures to close ventricular septal defects (VSD), reflecting the experience of 11 centers in Germany, Austria, and Switzerland. Background : Beating heart closure of VSD has attracted interest in small infants, complex anomalies and postinfarction scenarios where patients are at high risk during surgery. Perventricular or intraoperative device placement allows access to the lesions where percutaneous delivery is limited. Methods : Between December 2001 and April 2009, placement of Amplatzer septal occluders was attempted in 26 patients. The defects were located in the perimembranous (n = 5) and muscular septum (n = 21). In 20 patients, a perventricular approach was used, and, in six, the occluders were placed under direct visualization being part of a complex heart surgery. Results : In 23 of 26 procedures, device placement was successful (88.5%). The mean defect size was 7.8 mm (range, 3.5–20). The occluder types were perimembranous VSD occluder (n = 4), muscular VSD occluder (n = 20), postinfarct VSD occluder (n = 1), and ASD occluder (n = 1) with a ratio device/defect of 0.9–2.4 (median 1.15). Device removal was necessary in three due to arrhythmia, malpositioning, and additional defects. Pericardial effusion occurred once. In the remaining 22 patients, there were no procedure or device‐related complications. During mean follow up of 1.4 years (range, 1 day–3.9 years), a residual shunt that was more than trivial was observed in one patient out of 21 successful procedures. Conclusions : Perventricular and intraoperative device closure of VSD is as effective as a surgical patch and averts the increased morbidity of conventional surgical repair in a subgroup of high‐risk patients. © 2010 Wiley‐Liss, Inc.     

Transcaval access for TAVR across a polyester aortic graft

Transcaval access to the aorta allows transcatheter aortic valve replacement in patients without other good access options. The resulting aorto‐caval fistula is closed with a nitinol cardiac occluder device. There is no experience traversing a synthetic aortic graft to perform transcaval access and closure. We describe a patient who underwent successful traversal of a polyester aortic graft using radiofrequency energy applied from the tip of a guidewire, to allow retrograde transcatheter aortic valve replacement from a femoral vein, along with details of our technique. The patient did well and was discharged home after 3 days. There was residual aorto‐caval fistulous flow immediately after implantation of a polyester‐seeded nitinol muscular ventricular septal defect occluder device, but this fistula spontaneously occluded within one month. © 2015 Wiley Periodicals, Inc.     

应用Amplatzer封堵器治疗膜周部室间隔缺损20例

目的:观察应用Amplatzer封堵器经导管介入治疗先天性心脏病膜周部室间隔缺损(PMVSD)的可行性、安全性和疗效。方法:采用Amplatzer封堵器治疗先天性心脏病膜部室间隔缺损20例患者,术前由经胸超声心动图确诊PMVSD,术中经左心室造影明确缺损位置、直径、在透视及超声心动图监视下经导管置入Amplatzer封堵器封堵PMVSD,术后3d、3个月、6个月及1年分别行经胸超声心动图、心电图和X线检查。评价治疗效果。结果:20例VSD病人成功置入Amplatzer封堵器,透视及超声心动图显示即刻完全堵闭。术后出现溶血和三度房室传导阻滞各1例,对症治疗后消失。分别手术后3个月、6个月、1年随访,超声心动图示封堵器位置良好,19例完全闭合,仅1例残余分流,无严重并发症。结论:经导管置入Amplatzer封堵器治疗PMVSD是一种成功率高、并发症少、疗效可靠的介入方法。     

Transcatheter closure of a residual postmyocardial infarction ventricular septal defect with the Amplatzer septal occluder

Acute ventricular septal rupture following myocardial infarction carries a high mortality. Early surgery improves survival but long term outcome depends on residual shunting and left ventricular function. Residual shunting is common despite apparently successful closure and may require reoperation. Transcatheter closure is an established method of treating selected congenital defects but clinical experience of transcatheter closure in postinfarction ventricular septal rupture is minimal. Transcatheter closure of a residual ventricular septal defect was successfully done using a new device, the Amplatzer septal occluder, in a 50 year old Indian man who had previously undergone emergency surgical repair for postinfarction acute ventricular septal rupture. The technique is described and its potential as a treatment in postinfarction ventricular septal rupture, its possible complications, and the important aspects of case selection and device design are discussed.

Keywords: ventricular septal defect; transcatheter closure; Amplazter septal occluder     

国产室间隔缺损封堵器与Amplatzer封堵器的疗效比较

目的比较国产室间隔缺损封堵器与Amplatzer封堵器在经导管室间隔缺损封堵术中的疗效。方法41例患儿采用Amplatzer封堵器,76例患儿采用国产封堵器进行室间隔缺损封堵术,对比两组的疗效、并发症和费用等情况。结果国产组75例封堵成功（成功率99%）,进口组40例封堵成功（成功率98%）。两组患儿术前各项临床指标、手术和X线曝光时间、封堵成功率及住院天数,术后各项并发症发生率比较差异无统计学意义,两组患儿治疗前后左室舒张末径、收缩末径及C/T值减少程度无明显差异,治疗总费用进口组明显高于国产组。结论国产室间隔缺损封堵器与Amplatzer封堵器相比较其疗效、并发症发生率无显著差异,治疗费用低,临床应用前景广泛。