Double-umbrella closure of atrial defects. Initial clinical applications

Forty patients were catheterized for closure of atrial septal defects with the Rashkind patent ductus arteriosus umbrella device, a modified Rashkind umbrella device, and the newly designed Lock Clamshell Occluder. Patients weighed 8 kg or more (a requirement for transvenous access with the 11F delivery sheath) and had defects suitable for closure based on two-dimensional echocardiography. The new device was at least 1.6 times the diameter of the atrial septal defect as determined by balloon sizing at catheterization. Patients were followed up by telephone, clinical examination, and echocardiography at 6 months. We attempted closure in 34 patients, with atrial septal defects ranging in diameter from 3 to 22 mm; device sizes ranged from 17 to 33 mm. Initial device position immediately after release was correct in all patients. A cerebral embolus occurred in one elderly patient before device placement--the patient died 1 week later. Two instances of early device embolization occurred, and devices were retrieved by catheter without complication. Follow-up of 31 patients discharged with devices in place, for a total of 31 patient-years, has yielded no umbrella-related complications. Adequate imaging studies in 19 patients 6.5 months after device placement revealed no atrial shunt in 12; residual flow through separate, previously unrecognized atrial septal defects occurred in two; and small residual leaks (less than 3 mm) around devices were present in five patients. This initial success indicates that double-umbrella closure of atrial septal defects will aid in the treatment of intracardiac defects.     

Transcatheter closure of multiple atrial septal defects. Initial results and value of two- and three-dimensional transoesophageal echocardiography.

AIMS: To examine the feasibility of transcatheter closure of multiple atrial septal defects using two Amplatzer devices simultaneously and to describe the importance and the role of two- and three-dimensional transoesophageal echocardiography in the selection and closure of such defects. METHODS: Twenty-two patients with more than one atrial septal defect underwent an attempt at transcatheter closure of their atrial septal defects at a mean+/-SD age of 30. 8+/-18.6 years (range 3.7-65.9 years) and mean weight of 56.6+/-25.5 kg (range 12.9-99 kg) using two Amplatzer devices implanted simultaneously via two separate delivery systems. During catheterization, two dimensional transoesophageal echocardiography was performed in all but one patient, during and after transcatheter closure, while three dimensional transoesophageal echocardiography was performed in six patients before and after transcatheter closure. RESULTS: Forty-four devices were deployed in all patients to close 45 defects (one patient with three defects closed by two devices). Two dimensional transoesophageal echocardiography was helpful in selection and in guiding correct deployment of the devices. The mean size of the larger defect, as measured by transoesophageal echocardiography was 12.8+/-5.9 mm and the mean size of the smaller defect was 6.6+/-3.0 mm. The mean size of the larger devices was 15+/-7.5 mm, and 8.4+/-3.7 mm for the smaller. Three dimensional transoesophageal echocardiography provided superior imaging and demonstrated the number, shape and the surrounding structures of the atrial septal defects in one single view. The median fluoroscopy time was 28.7 min. Device embolization with successful catheter retrieval occurred in one patient. Forty-four devices were evaluated by colour Doppler transoesophageal echocardiography immediately after the catheterization with a successful closure rate of 97.7%. On follow-up colour Doppler transthoracic echocardiography demonstrated successful closure in 97.5% at 3 months. CONCLUSIONS: The use of more than one Amplatzer septal occluder to close multiple atrial septal defects is safe and effective. The use of two- and three-dimensional transoesophageal echocardiography provided useful information for transcatheter closure of multiple atrial septal defects using two devices. Three-dimensional transoesophageal echocardiography enhanced our ability to image and understand the spatial relationship of the atrial septal defect anatomy.     

超声心动图检查继发孔型房间隔缺损封堵术后并发症的诊断价值

目的:研究超声心动图检查继发孔型房间隔缺损封堵术后并发症的应用价值。方法:选取我院2009年7月至2018年7月确诊继发孔型房间隔缺损并行经导管或经胸封堵术的患者3910例,所有患者术前经胸超声心动图(TTE)或经食管超声心动图(TEE)诊断筛选适应证,术中经经胸超声心动图或经食管超声心动图监测,术后复查经胸超声心动图,观察评价封堵器形态位置,评估相关并发症。结果:3910例行房间隔封堵术的患者中,封堵器脱落8例(0.20%),均急诊转外科修补治疗。心脏穿孔/磨蚀事件共8例,其中主动脉窦-右心房瘘1例(0.03%),经皮封堵治疗成功;二尖瓣前叶穿孔2例(0.05%),予随诊观察7年未特殊处理;心脏穿孔或心房壁损伤5例(0.13%),其中1例死亡(0.03%),4例行心包穿刺引流后好转(0.10%)。术后心包积液102例(2.61%),其中8例为少中量-中量心包积液,术后随访无明显变化或有所增多,患者血流动力学稳定,予随诊观察;94例为微量-少量心包积液,随诊观察积液量未见增加。术后残余分流167例(4.27%),其中多发房间隔缺损共102例;另外残余分流束宽度大于等于5 mm共17例,残余分流束小于5 mm或少量分流共150例,复查后分流均减少或消失。结论:房间隔缺损封堵术相关严重并发症包括封堵器脱落、心脏穿孔/磨蚀,发生率极低但危害大,常见并发症包括心包积液和残余分流,发生率低且预后好,超声心动图在及时诊断并发症和随访观察方面起到了不可替代的作用。     

Transcatheter closure of secundum atrial septal defects with the new self-centering Amplatzer Septal Occluder.

AIMS: The study was set up to find out whether a new self-centering prosthesis for transcatheter closure of secundum atrial septal defects could overcome the disadvantages of previously described devices. METHODS AND RESULTS: Fifty-two consecutive patients with a significant atrial septal defect were considered for transcatheter closure with the Amplatzer Septal Occluder. The device, made of a Nitinol and polyester fabric mesh, provides a different approach to defect occlusion by stenting the atrial septal defect up to a stretched diameter of 26 mm. Three infants whose large defects were demonstrated on a transthoracic echocardiogram were excluded from transcatheter treatment. On transoesophageal echocardiography, 49 defects ranged from 6-26 mm, in one adult the defect measured 28 mm and this patient was excluded from attempted transcatheter closure. At cardiac catheterization in five further patients, devices were not implanted, in two because the stretched diameter exceeded 26 mm and in three the device was withdrawn because it was unstable or compromised the mitral valve. Thus, device closure was performed in 43 patients. At follow-up after 3 months the complete closure rate was 97%. CONCLUSION: The self-centering Amplatzer Septal Occluder is very efficient and user-friendly and offers interventional closure in 83% of an unselected group of patients presented with an atrial septal defect.     

Transcatheter closure of patent foramen ovale using the Amplatzer septal occluder to prevent recurrence of neurological decompression illness in divers

OBJECTIVE: Large flap valve patent foramens may cause paradoxical thromboembolism and neurological decompression illness in divers. The ability of a self expanding Nitinol wire mesh device (Amplatzer septal occluder) to produce complete closure of the patent foramen ovale was assessed. PATIENTS: Seven adults, aged 18-60 years, who had experienced neurological decompression illness related to diving. Six appeared to have a normal atrial septum on transthoracic echocardiography, while one was found to have an aneurysm of the interatrial septum. METHODS: Right atrial angiography was performed to delineate the morphology of the right to left shunt. The defects were sized bidirectionally with a precalibrated balloon filled with dilute contrast. The largest balloon diameter that could be repeatedly passed across the septum was used to select the occlusion device diameter. Devices were introduced through 7 F long sheaths. All patients underwent transthoracic contrast echocardiography one month after the implant. RESULTS: Device placement was successful in all patients. Device sizes ranged from 9-14 mm. The patient with an aneurysm of the interatrial septum had three defects, which were closed with two devices. Right atrial angiography showed complete immediate closure in all patients. Median (range) fluoroscopy time was 13.7 (6-35) minutes. Follow up contrast echocardiography showed no right to left shunting in six of seven patients and the passage of a few bubbles in one patient. All patients have been allowed to return to diving. CONCLUSION: The Amplatzer septal occluder can close the large flap valve patent foramen ovale in divers who have experienced neurological decompression illness. Interatrial septal aneurysms with multiple defects may require more than one device.     

Transcatheter closure of a large residual shunt after deployment of the Das-Angel Wings device using the Amplatzer septal occluder.

A 35-year-old female patient with a large residual shunt following transcatheter closure of a large secundum atrial septal defect using the Das-Angel Wings device underwent successful complete closure of the residual shunt using a 15-mm Amplatzer Septal Occluder. Transesophageal (two- and three-dimensional) echocardiography was of great help during the closure procedure. Cathet. Cardiovasc. Intervent. 48:184-187, 1999.     

Percutaneous closure of atrial septal defects: midterm results of a new therapeutic strategy

OBJECTIVE: To evaluate the midterm results of percutaneous closure of the atrial septal defect using two new devices. PATIENTS AND METHODS: Nine children (weight 19.7 +/- 7 kg, age 5.1 +/- 1.9 years) underwent percutaneous type II atrial septal defect closure through the antegrade pathway under general anaesthesia, and monitored by transesophageal echocardiography. The closing devices used were DAS-Angel Wings and Ampaltzer. RESULTS: The hemodynamic results were: mean diameter of the defects was 11.4 +/- 2 mm by TEE measurement and 12.3 +/- 2.6 mm using balloon occlusion reference. Mean pulmonary artery pressure was 12.7 +/- 2 mmHg and mean pulmonary vascular resistance 1.5 +/- 0.5 U/m2. A total of 13 devices were used: 9 Amplatzer and 4 DAS-Angel Wings. Four Amplatzer through the introducer were retrieved without complications. Two of which because of lack of sufficient stability in the atrial septum because they were too small inappropriate and the other two because of inappropriate expansion of distal disk of the device. Finally in all patients the device was a successfully deployed. The angiographic evaluation immediate post-procedure showed a minimal shunt in five patients that was no longer present by color Doppler echocardiography 24 hours later. The children were discharged 38 +/- 12 hours after the procedure and at a mean follow up of 9.6 +/- 2.2 months they remain asymptomatic without any clinical or technical problems. CONCLUSION: With the right selection of patients percutaneous closure of atrial septal defects can obtain a very high success rate without complications.     

Embolization of Atrial Septal Occluder Device into the Pulmonary Artery: A Rare Complication and Usefulness of Live/Real Time Three-Dimensional Transthoracic Echocardiography

Percutaneous closure of atrial septal defects (ASD) in adults has emerged as an alternative to surgery. We report a rare complication of an atrial septal occluder device embolization into the pulmonary artery which was detected by fluoroscopy and echocardiography. The potential usefulness of live/real time three-dimensional transthoracic echocardiography in the management of patients undergoing percutaneous ASD occlusion is described.     

Catheter closure of atrial septal defects and patent foramen ovale in patients with an atrial septal aneurysm using different devices

BACKGROUND: Atrial septal aneurysm is frequently associated with patent foramen ovale (PFO) and atrial septal defects (ASD). Moreover, a relationship between atrial septal aneurysm and embolic cerebrovascular events has been suggested. The aims of this study were to analyze morphological and functional characteristics of atrial septal aneurysm in PFO and ASD patients and to assess the feasibility and efficacy of different devices for transcatheter closure and the influence of atrial septal aneurysm. METHODS: Between March 1997 and May 2000 transcatheter ASD or PFO closure was attempted in 63 patients (mean age 47 +/- 13 years) with an atrial septal aneurysm using one of the following devices: Angelwings (n = 3), Cardioseal (n = 5), Cardioseal-Starflex (n = 7), Amplatzer (n = 11), Amplatzer-PFO (n = 5), PFO-Star (n = 25), or Helex (n = 7). RESULTS: Implantation was primarily successful (after the first or second attempt) in all patients. One PFO-Star device embolized 12 hours after the procedure. During follow-up (0.6-37 months, mean 10.4 +/- 9.2) a residual shunt could be detected by transesophageal echocardiography after 2 weeks in four patients and after 6 months in one patient. Three PFO patients had cerebrovascular events after implantation. Two patients had a transient ischemic attack (TIA) and one patient a stroke. A thrombus formation on the device detected in three patients disappeared after antithrombotic therapy. CONCLUSION: We conclude that ASDs and PFOs with an associated atrial septal aneurysm can be closed with different available devices. There seem to be no additional risks compared with patients without atrial septal aneurysm.     

Transcatheter closure of congenital muscular ventricular septal defect

The success with occlusion devices for the closure of atrial septal defects and patent ductus arteriosus prompted the transcatheter closure of single and multiple muscular ventricular septal defects (VSD). The procedure for VSD was first attempted by Lock et al. in 1988 and devices originally designed for the closure of other intracardiac defects (Rashkind umbrella device, Lock clamshell, Cardioseal, coils, Sideris buttoned device etc.) were used with a variable success rate and a residual shunt. Recently, specially designed Amplatzer muscular VSD occluder and Sideris device are in use. The Amplatzer muscular VSD occluder has been undergoing clinical trial since 1998 after the animal experiments had shown 100% occlusion and complete endothelization at 3 months. The procedure was first attempted in August 1995 using the Rashkind umbrella device and since April 1998 only the Amplatzer muscular VSD occluder has been used. Of the149 patients who underwent transcatheter closure of VSD, 50 had muscular trabecular defects in various locations: mid-muscular, anterior, posterior, or apical. All cases were selected by detailed transthoracic and/or transesophageal echocardiography (TTE) and aneurysm of the muscular septum was observed in three of them. The age range was 3-28 years and the diameter of VSD was 4-11 mm. In all but one patient, the device was deployed from the venous side. Simultaneous TTE was done for proper positioning of the device and continuous electrocardiographic monitoring was also done for any arrhythmia/conduction defects. All patients were followed up every 3 months and received 3-5 mg/kg aspirin for 6 months. The procedure was successful in all patients. The Rashkind umbrella device (17 mm) was used in two and Amplatzer muscular VSD occluder (6-14 mm) in 48 patients. Forty-four devices were delivered by antegrade transvenous approach and six by the transjugular route. None had residual shunt, new aortic regurgitation, or tricuspid regurgitation. Transient complete heart block after 24 hours was noticed in one patient. On a follow-up of 2-90 months, the device was in position in all patients. There was no embolization of the device, and no late-conduction defects, infective endocarditis, or hemolysis. Transcatheter closure of muscular VSD is safe and efficacious, and should be considered as a procedure of choice as an alternative to surgery that avoids cardiopulmonary bypass.     

经胸超声心动图在Amplatzer封堵器治疗成人巨大房间隔缺损中的应用

目的　评价经胸超声心动图监测 (TTE)Amplatzer封堵器介入治疗巨大房间隔缺损(ASD)的安全性和可行性。方法　 2 1例住院患者 ,男 12例 ,女 9例 ;年龄 17～ 4 5岁 ;均经临床及超声心动图证实的继发孔型ASD ,以充盈球囊最大伸展直径加 2～ 4mm为原则选择封堵器型号 ,TTE监测下放置Amplatzer封堵器。随访有无残余分流及是否影响周围瓣膜和静脉功能 ,记录临床事件 (血栓栓塞、心功能不全、心律失常等 )。结果　 2 1例全部封堵成功 ,TTE监测放置Amplatzer封堵成功 ,手术成功率 10 0 % ;术后即刻及 1天、3天、3个月、6个月、1年复查TTE观察无明显残余分流及影响周围瓣膜功能 ,也无腔、肺静脉狭窄 ,无血栓栓塞事件发生 ,无封堵器移位和脱落 ,心功能有不同程度的好转。1例发生频发房性心律失常 ,经心律平 4 5 0mg d治疗 1个月后消失 ,无其他并发症发生。结论　Amp latzer封堵器介入治疗成人巨大ASD是一种安全、有效的治疗方法 ,TTE监测ASD介入封堵治疗整个过程 ,可以提高一次释放成功率     

房间隔缺损并发心房纤颤患者应用Amplatzer伞封堵房缺后心房纤颤的电复律治疗

目的 :初步评价房间隔缺损并发心房纤颤患者应用 Am platzer伞封堵房间隔缺损后心房纤颤的电复律疗效。方法 :2例患者 （5 1～ 5 3岁 ）。在透视及食管超声心动图监视下经导管置入 Amplatzer伞封堵房间隔缺损。术后即时行超声心动图 ,术后 2 4h,和 1,3,6月 ,分别行经胸超声心动图评价房间隔缺损治疗效果。术后 6月行电复律。结果 :2例患者疗效均佳 ,房间隔未见残余分流 ,电复律成功 ,患者转为窦性心律 ,复律后无并发症及 Amplatzer伞移位。结论 :应用 Am platzer伞封堵房间隔缺损并发心房纤颤患者 ,电复律易成功 ,是一种安全有效的复律方法。     

Transcatheter closure of secundum atrial septal defect with a new self-expanding nitinol double disk device (Amplatzer device): experience in Nanjing

PURPOSE: Various devices have been developed for the transcatheter closure of secundum atrial septal defect (ASD II) to avoid the morbidity, discomfort, and thoracotomy scar associated with surgical closure. The purpose of this study was to evaluate the safety and efficacy of the Amplatzer septal occluder for transcatheter closure of ASD II. PATIENTS AND METHODS: Only patients who were clinically diagnosed with ASD II were selected. The anatomy of ASD had to meet certain echocardiographic criteria. Under the guidance of echocardiography and fluoroscopy, the implantation of the device was accomplished as recommended by the manufacturer. RESULTS: Thirty patients (median age 18.4 years) with an ASD II underwent transcatheter closure. Procedure time ranged from 30-200 minutes and fluoroscopy time from 10-50 minutes. The diameter of the ASD measured by echocardiography ranged from 13-25 mm, while both the stretched diameters of the ASDs and the sizes of the devices ranged from 18-34 mm. The successful placement rate was 100%. The residual shunt rate was 100% immediately after device implantation and 10% after 24 hours. After 3 months, 3.3% of the patients had a (trivial) residual shunt. The device did not affect the surrounding structures of ASD. No embolization of the device occurred. CONCLUSION: The Amplatzer device designed for the closure of ASD II can be implanted easily and also is retrievable. Due to a low ratio of residual shunt and few complications, this device is a good choice for transcatheter closure of ASD II. Long-term follow-up will be required for widespread clinical use.     

Interventional occlusion of atrial septum defects larter than 20 mm in diameter

Over the last few years, various devices for the interventional closure of atrial septal defects (ASD) up to a diameter of 20 mm have been developed. We report our clinical experience in closing ASD with a diameter larger than 20 mm diameter with the Amplatzer Septal Occluder (ASO). METHOD: The stretched diameter of the ASD was measured by inflating a sizing balloon within the defect until an indentation in the circumference in the balloon could be observed. An ASO with a stent diameter 2-4 mm larger than the indentation in the circumference of the balloon was chosen and implanted via 9-12 French sheaths. In contrast to the closure of smaller defects, pullback of the device onto the atrial septum was only performed when the connecting stent of the ASO was completely deployed in order to achieve maximal centering characteristics and optimal support of the retention skirt of the left atrial disc on the edges of the defect. Only then was the right atrial disc deployed and actively configured by advancing the sheath and the delivery cable against the atrial septum. Implantation was only attempted if the atrial septal rims (except the anterior rim around the aorta) measured more than 7 mm by echocardiography to avoid injury or disturbance of sensitive intracardiac structures. After placement, the fixation of the device and the mechanical stability was proven by an extensive "Minnesota wiggle". The ASO was released only when TEE showed no or a trivial residual color flow through the connecting stent; otherwise repositioning was performed. RESULTS: Out of 352 patients (P) with successful closure of interatrial defects, 70 P (age: 1.1-77.3 years) had stretched defects larger than 20 mm diameter (median 22 mm diameter (20-36), 25/75% quartiles = 20/26 mm). Mean shunt size was Qp:Qs 2.1:1 (0.7-3.9:1), mean fluoroscopy time 10.9 min (0-63). Complete closure could be achieved in 85.7/93.1/100% after 3 months, 1 and 2 years, respectively. Besides 3 P with persistent atrial fibrillation, only 5 P showed transient atrial tachyarrhythmias, 2 only periprocedural and 3 within the first 3 months after implantation were treated with beta-blocker. In one patient, an acute embolization of the device occurred because a diminished posterior rim was not visualized by a monoplane TEE probe necessitating surgical explantation and defect occlusion. Despite oversizing the device, no "mushrooming" misconfiguration were observed. CONCLUSION: Transcatheter closure of large atrial septal defects with the Amplatzer Septal Occluder is feasible, safe and effective. Risk of complications do not seem to occur more frequently than after closure of smaller defects if one adheres to certain sizing and implantation measures. The incidence of transient atrial tachyarrhythmias seems to be low.     

Simultaneous Transcatheter Closure of Two Secundum Atrial Septal Defects Using the Amplatzer™ Septal Occluder

Transcatheter closure of a single secundum atrial septal defect (ASD) is performed routinely using various investigational devices. A 37-year-old patient with two large secundum ASDs underwent successful simultaneous transcatheter closure using an 18-mm and 20-mm Amplatzer™ septal occluder device. At 3-month follow-up, transesophageal color Doppler echocardiography revealed one defect to be completely closed, and the other had trivial residual shunt with significant improvement in symptoms.     

彩色多普勒超声心动图在老年房间隔缺损封堵术中的价值

目的探讨彩色多普勒超声心动图(CDE)在老年房间隔缺损(ASD)封堵术中的价值。方法选择老年ASD患者64例,封堵术前应用二维超声心动图观察ASD位置,测量ASD大小和残余边缘,彩色多普勒血流显像观察过房间隔分流束血流信号和过心脏瓣膜反流束血流信号,连续多普勒估测肺动脉压,合并心房颤动和多发ASD经食管超声心动图检查,筛选ASD封堵术适应证。ASD封堵术中应用二维超声心动图监视封堵器位置,用彩色多普勒血流显像监视有无过房间隔残余分流。ASD封堵术后应用CDE判断疗效。结果 64例老年ASD患者实施ASD封堵术全部获得成功,ASD封堵术后CDE判断疗效满意。结论 CDE在老年ASD封堵术中有重要价值。ASD封堵术前应用二维超声心动图观察ASD位置、大小和残余边缘,连续多普勒估测肺动脉压,合并心房颤动和多发ASD行经食管超声心动图检查是筛选老年ASD封堵术适应证的关键。     

Transesophageal echocardiographic predictors for successful transcatheter closure of defects within the oval fossa using the CardioSEAL septal occlusion device

OBJECTIVES: To define the utility of transesophageal echocardiography in predicting the likelihood of a successful procedure and residual shunting in patients undergoing transcatheter closure of defects within the oval fossa using the CardioSEAL device. BACKGROUND: Transesophageal echocardiography is used to monitor transcatheter closure of interatrial defects within the the oval fossa, but predictors of successful closure and residual shunting have yet to be determined. METHODS: We reviewed transesophageal echocardiograms obtained from 26 consecutive patients undergoing attempted transcatheter closure of interatrial defects within the oval fossa between January, 1997 and May, 1998. Assessment of the atrial septum, the septal defect, and the rims of the oval fossa bordering the defect was performed in 3 planes: longitudinal, 4-chamber, and basal short-axis. RESULTS: Closure proved successful in 24 patients (92%). The defect was significantly larger, and the anterosuperior rim of the defect smaller, in the 2 patients in whom occlusion was not successful. Residual shunting 24 hrs after closure was detected in 14 patients. Significant predictors of leakage included smaller posterior and superior rims, a larger shunt prior to closure, and herniation of a one left atrial arm of the device into the right atrium. In all cases, the sites of leakage were the superior rim of the defect at the superior cavo-atrial junction, and the anterosuperior rim behind the aortic root. Herniation of a left atrial arm into the right atrium was seen in 7 patients (29%). In all, it was the anterosuperior arm which herniated Doppler color flow was suboptimal in detecting residual leaks, and was enhanced substantially with the use of contrast echocardiography. CONCLUSIONS: Transesophageal echocardiography allows excellent assessment of the oval fossa and deficiencies of its floor in all of their dimensions. It is an important tool for guiding the deployment of the occlusion device in patients undergoing attempted transcatheter closure of defects within the fossa. Contrast echocardiography should be used for optimal detection of residual shunting.     

Transcatheter Closure of Secundum Atrial Septal Defects Using the Amplatzer Septal Occluder: Initial Experience in Taiwan

We assessed the safety and efficacy of closure of secundum-type atrial septal defects (ASDs) using the Amplatzer septal occluder (ASO) in a sample of Taiwanese patients. Between June 2000 and April 2002, 25 patients underwent transcatheter closure of their secundum-type atrial septal defect/s using the ASO device. The procedures were performed under general anesthesia with access through the femoral vein using guidance provided by transoesophageal echocardiography (TEE) and fluoroscopy. Twenty-two patients had larger defects with right cardiac dilatation and paradoxical interventricular septal motion, while family concerns were the primary indications for closure for the other three. Twenty-five ASO devices were successfully implanted in 24 patients, with a lone individual referred for surgery due to implantation failure. The mean age of the patients was 12.5 years. The male-female ratio was 12:13. The mean pulmonary-systemic blood flow ratio (Qp:Qs) was 2.5:1. The ASD size (mean 20.2 mm; range 8–28.5) was measured using transoesophageal echocardiography, with a balloon-stretched diameter of 8–29.5 mm (mean 20.5). The size of the implanted devices ranged from 9–36 mm (mean 23.1). Fluoroscopy duration ranged from 9.7–41.2 minutes (mean 23.5). A residual shunt, assessed not significant from transoesophageal echocardiography, was detected in one patient who had received two ASO devices for multiple ASDs. Follow-up intervals ranged from 0.1–2 years (median 1.0), with no late complications determined for any patient. Transcatheter closure of secundum ASDs using the Amplatzer septal occluder is a safe and effective alternative to the surgical analog. With careful selection of patients, secundum ASDs can be successfully closed, with minimal procedural morbidity and excellent early results. Long-term follow up is necessary for evaluation, however, if this procedure is to be as effective as surgery.     

Closure of Atrial Septal Defects With the Amplatzer Occlusion Device: Preliminary Results

Objectives. This study reports our clinical experience with transcatheter closure of secundum atrial septal defects (ASDs) in children, using the Amplatzer, a new occlusion device.Background. None of the devices previously used for transcatheter closure of interatrial communications has gained wide acceptance.Methods. We examined the efficacy and safety of the Amplatzer, a new self-centering septal occluder that consists of two round disks made of Nitinol wire mesh and linked together by a short connecting waist. Sixteen patients with secundum ASD met established two- and three-dimensional echocardiographic and cardiac catheterization criteria for transcatheter closure. The Amplatzer’s size was chosen to be equal to or 1 mm less than the stretched diameter. The device was advanced transvenously into a 7F long guiding sheath and deployed under fluoroscopic and ultrasound guidance. Once its position was optimal, it was released.Results. The mean ASD diameter by transesophageal echocardiography was 14.1 ± 2.3 mm and was significantly smaller (p < 0.001) than the stretched diameter of the ASD (16.8 ± 2.4 mm). The mean device diameter was 16.6 ± 2.3 mm. No complications were observed. After deployment of the prosthesis, there was no residual shunt in 13 (81.3%) of 16 patients. In three patients there was trivial residual shunt immediately after the procedure that had disappeared in two of them at the 3-month follow-up.Conclusions. The Amplatzer is an efficient prosthesis that can be safely applied in children with secundum ASD. However, a study including a large number of patients and a longer follow-up period are required before this technique can be widely used.     

First experience With the biostar‐device for various applications in pediatric patients With congenital heart disease

Background: Interventional closure of atrial septal defects (ASD) and surgical tunnel fenestrations in Fontan patients has become the procedure of choice for many years. Recently, the BioSTAR Occluder, a modification of the Starflex device with a resorbable matrix has become available. Patients: Ten Biostar devices were implanted in nine children with interatrial septal defects, one within a fontan baffle, eight with secundum atrial septal defects. The age of the patients ranged from 11 months to 17 years, the body weight ranged from 12.9–78 kg. Results: 10 BioSTAR devices were implanted in nine patients. In one patient, two BioSTAR devices were used to occlude multiple defects within the oval fossa. All defects were successfully and uneventfully occluded. Mean procedure time was 56 (range 28–125). Mean fluoroscopy time was 4.8 (range 1.1 to 13.0) min. None of the nine patients showed residual shunts after device implantation. After 30 days no shunt was seen in the control transthoracic echocardiography. No adverse effects like allergic reactions, tachyarrhythmia or thrombembolic events occurred in any of the patients. Conclusion: The BioSTAR closure device is a safe and effective device for the closure of a variety of interatrial shunts in children including multifenestrated interatrial defects and fontan fenestrations, however, possible long term consequences (e.g., fractures, recurrent shunts after scaffold degradation) remain to be studied. © 2009 Wiley‐Liss, Inc.