Evaluation of the AMPLATZER vascular plug for embolization of peripheral vascular malformations associated with congenital heart disease.

OBJECTIVE: The purpose of this study is to evaluate the recently FDA-approved AMPLATZER Vascular Plug in the embolization of vascular lesions associated with congenital heart disease (CHD). BACKGROUND: Fistulas and arteriovenous malformations have been occluded using various devices. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device, used for embolization in the peripheral vasculature. METHODS: A total of 84 vessels in 52 patients with CHD from 11 centers were occluded with 89 AMPLATZER Vascular Plugs, delivered through a coronary guide catheter in various vascular sites, including collaterals, pulmonary arterio-venous and coronary artery fistulas, transhepatic tracts, central shunts, patent ductus arteriosus (PDA), and excluded hepatic vein. Complete vessel occlusion was demonstrated within 10 min in 94% of patients. RESULTS: There was no device embolization, vascular disruption, or procedure-related complication. One vascular plug implanted in a large type C PDA required surgical removal followed by PDA ligation, after 5 weeks from successful implant because of significant residual flow through the device. CONCLUSIONS: The AMPLATZER Vascular Plug is an effective transcatheter occlusion device in the embolization of a wide variety of vascular lesions associated with CHD. Based on our early experience, caution should be used when considering the Vascular Plug as a closure device for large PDA.     

Transcatheter closure of a patent ductus arteriosus in a preterm infant with an Amplatzer Vascular Plug IV device

Rapid advances in paediatric interventional cardiology allow transcatheter closure of patent ductus arteriosus (PDA) in increasingly smaller patients. We describe a successful transcatheter closure of a large tubular PDA in a symptomatic preterm infant of 2,210 g using an Amplatzer Vascular Plug IV device. © 2010 Wiley‐Liss, Inc.     

Use of the Amplatzer Vascular Plug for treatment of coronary steal

The left internal mammary artery (LIMA) is a widely used conduit during coronary artery bypass graft surgery because of its excellent long-term patency. Although large LIMA side branches are typically ligated during the surgery, the occurrence of a coronary steal phenomenon related to these side branches following surgery remains controversial. A variety of devices, including coil embolization and gelatin sponge particles, have been used in the percutaneous treatment of LIMA side branch induced coronary steal. The Amplatzer Vascular Plug has recently been applied in variety of clinical situations, including the occlusion of aortopulmonary collaterals, patent ductus arteriosus and pulmonary arteriovenous malformations. The Amplatzer Vascular Plug is a self-expandable, cylindrical device made from nitinol that offers several potential advantages in this setting including ease of delivery, a wide range of device sizes and the ability to safely remove the device if placement location in not optimal. In this case report, we present a patient with objective ischemia in the left anterior descending artery distribution secondary to coronary steal from a large LIMA side branch that was successfully treated using the Amplatzer Vascular Plug.     

Late coil migration due to thrombolysis after successful implantation of a coil for persistent ductus arteriosus.

Transcatheter coil occlusion of persistent ductus arteriosus (PDA) is now a widely accepted treatment for PDA. However, late complication might occur due to thrombolytic treatment during the interventional period. We discuss a case with late coil migration due to thrombolysis after successful implantation of a coil. It should be emphasized that early thrombus formation is important for successful closure of PDA shunt using coil.     

Comparison and results of transcatheter closure of patent ductus arteriosus using the swivel-disk device versus plug occluder in children

The transcatheter closure of certain types of patent ductus arteriosus (PDA) remains a challenge. The investigators report initial clinical experience with 25 patients who underwent PDA occlusion with the use of a swivel-disk device (SDD) or a plug occluder (PO). The patients were divided into 2 groups: in the SDD group, 12 patients aged 1 to 2 years with type A PDA underwent attempted closure using the SDD, a modified Amplatzer duct occluder with a very low profile retention disk that can adapt itself at different PDA insertion angles. The mean PDA diameter was 4.8 +/- 1.5 mm (range 3.8 to 8). In the PO group, 13 patients aged 0.5 to 3 years with type C, D, or E PDA underwent attempted occlusion with the PO, a tubular occluder made of Nitinol wire mesh. The mean PDA diameter was 4.2 +/- 3.5 mm (range 1.2 to 9). The 2 occluders are filled with Dacron patches. The mean device diameters were 6.5 +/- 1.2 and 6.8 +/- 2.2 mm (range 4 to 11) in the SDD and PO groups, respectively. Complete angiographic closure was seen in 24 of 25 patients. The deployment of 4 5-PDA5 coils abolished a residual shunt associated with hemolysis in a 5-month-old patient with a large type C PDA after the implantation of an 11-mm PO. No other complications were observed. In conclusion, the SDD and the PO are promising additions to the armamentarium for PDA closure.     

Amplatzer封堵器介入治疗动脉导管未闭疗效分析

目的 评价Amplatzer封堵器介入治疗动脉导管未闭(PDA)的临床疗效。方法 对10例管型PDA患儿用Amplatzer PDA封堵器进行堵闭，2例窗型PDA用Amplatzer房间隔双伞封堵器堵闭。在透视下经6F输送器置入封堵器，术后10分钟，行右心导管检查及主动脉弓降部造影，术后24小时、1、3个月分别行彩色多普勒超声心动图、血常规及肝肾功能检查，评价治疗效果。结果 本组技术成功率为100％，患儿心脏双期连续性杂音均消失，术后10分钟主动脉弓降部造影显示少量残余分流2例，均为窗型PDA。术后24小时超声心动图示上述2例仍有微量分流。术后24小时、1、3个月行彩色多普勒超声心动图检查，均未发现残余分流、PDA再通及封堵器移位，血常规及肝肾功能检查均正常。2例有分流的患儿术后均出现急性溶血，经积极内科治疗后好转。其余10例无并发症发生。结论 应用Amplatzer封堵器介入治疗PDA安全有效，近中期疗效满意，远期疗效尚待进一步观察。对窗型PDA可试用Amplatzer房间隔封堵器堵闭。对术后发生急性溶血者可采用内科治疗。     

Percutaneous closure of an aneurysmal patent ductus arteriosus in an adult

We report a case of a 24 year old woman with an aneurysmal patent ductus arteriosus (PDA) that was percutaneously closed using an Amplatzer Vascular Plug II. This is the first report of the successful use of an Amplatzer Vascular Plug II for a PDA, and suggests the feasibility and safety of its utilization in select cases. © 2010 Wiley‐Liss, Inc.     

Transcatheter closure of a 22 mm patent ductus arteriosus with an Amplatzer atrial septal occluder.

Transcatheter techniques for closure of patent ductus arteriosus (PDA) have been used for almost 40 years. We report a case of a 24-year-old female with a 22 mm PDA, congestive heart failure, and atrial fibrillation. She underwent transcatheter PDA closure with an Amplatzer atrial septal occluder (ASO). Following the procedure, she developed hemolysis due to a large residual shunt. However, the shunt gradually resolved until complete closure was achieved within 8 months. An attempt to restore sinus rhythm with electrical cardioversion was successful and the patient is now, 2 years after procedure, in New York Heart Association functional class I. Off-label use of an ASO for closure of a very large PDA yielded an excellent clinical result.     

Percutaneous treatment of moderate-to-large patent ductus arteriosus with different devices: early and mid-term results.

BACKGROUND: Transcatheter closure is now accepted as the first-choice therapeutic option in patients with patent ductus arteriosus (PDA). However, this procedure is still challenging in large PDA and/or younger patients. This study evaluated feasibility and results of this approach in large, symptomatic PDA using different devices. METHODS: Between April 2000 and July 2004, 57 patients underwent attempt of transcatheter closure of a large PDA at our Institution. Nineteen patients (33.3 %) were on pharmacologic therapy for congestive heart failure. PDA diameter was 3.2+/-1.2 mm (range 1.8-9 mm), resulting in a pulmonary to systemic flow ratio of 2.1+/-1.8 (range 1.4-5). RESULTS: The procedure was successfully performed in 54 patients (94.7%), using the Amplatzer duct occluder (ADO) device (34 patients) or a multiple detachable coil approach (20 patients). Complete PDA occlusion was recorded in 77.8% of patients at 24 hours, 92.6% at 1 month, and 94.4% at last follow-up control (23+/-12 months). PDA morphology and pulmonary to systemic flow ratio did not influence the success rate of the procedure or the residual shunt. A trend toward a higher occlusion rate at any follow-up point was recorded in the ADO group (79.5 vs 75.0% at 24 hours, 97.1 vs 85.0% at 1 month, and 97.1 vs 90% at last follow-up control, p = NS for all comparisons). CONCLUSIONS: Percutaneous closure might be considered effective and safe also in large, clinically significant PDA, by tailoring the device choice to the patient size and ductal morphology. In this setting, the multiple coil option revealed as effective as the ADO device over a mid-term follow-up.     

应用Amplatzer封堵器经导管治疗直径≥8mm动脉导管未闭的疗效评价

目的 :应用 Amplatzer封堵器经导管治疗直径≥ 8mm的大型动脉导管未闭 （PDA）并对其疗效进行评价。方法 :全组 5 0例 ,年龄 2 6 .4± 2 3.2 （4.0～ 6 0 .0 ）岁。 PDA最窄处直径为 10 .2± 2 .3（8.0～ 15 .0 ） mm。封堵 10 m in后行侧位降主动脉造影 ,术后 1d及 1月行超声心动图检查 ,观察有无残余分流及 PDA再通。结果 :47例 PDA采用Amplatzer PDA封堵器治疗 ,2例采用 Amplatzer ASD封堵器治疗 ,1例 PDA伴有阻力性肺动脉高压未行介入治疗。术后 10 min降主动脉造影显示 ,19例存在微～少量残余分流 ,30例封堵完全无残余分流。术后 2 4h、术后 1月超声心动图未见残余分流及再通。结论 :应用 Am platzer封堵器治疗直径≥ 8mm的大型动脉导管未闭是一种安全有效的介入方法。     

Patent ductus arteriosus closure using the new Amplatzer Duct Occluder. Preliminary results and review of the literature.

BACKGROUND: Patent ductus arteriosus (PDA) is the second most common congenital heart disease. A large number of surgical and transcatheter techniques for the interruption or closure of PDA has been reported. The aim of this study was to assess the immediate and short-term results of transcatheter closure of PDA using the new, self-expandable, self-centering, and repositionable Amplatzer Duct Occluder device. METHODS: We attempted occlusion of PDA with the Amplatzer Duct Occluder in seven consecutive patients, one child and six adults, four females and three males, between September 1999 and January 30th 2000. All PDAs but one were approached from the femoral venous site; the Amplatzer Duct Occluder size was selected in order to be 2 mm larger than the duct's diameter at its narrowest site and the mean PDA diameter was 5.4+/-2.5 mm (range 3-9). All patients underwent physical examination, chest X-ray and echocardiography within 48 hours and on first and third month after PDA occlusion. RESULTS: Four patients had a megaphone type (type A), and three had an elongated, conical type (type E) PDA. Four patients had immediate, complete angiographic closure of the ductus 10 minutes after the procedure, one had a trace shunt and two had small shunts which all disappeared within 48 hours. The average fluoroscopy time and procedural time were 34.4+/-10.6 min (range 21-50) and 105+/-38.9 min (range 75-190) respectively. There were no complications at follow-up. CONCLUSIONS: Transcatheter closure of PDA using the new Amplatzer Duct Occluder is an easy and effective technique. Moreover it is safe even in the presence of wide PDAs.     

Failure of the Amplatzer ductal occluder II

Since March 2008, the new Amplatzer duct occluder II (ADO II) has been used clinically for PDA closure in Europe. We report an interesting case of a 2½‐year‐old girl with a 3‐mm conical shape PDA (type A PDA) who underwent uneventful implantation of 3/4 ADO II with complete closure by angiography and echocardiographic control at the end of the procedure. To our surprise, echocardiography 24 hr later revealed a moderate secondary shunt due to kinking of the aortic retention disk of the device with the central waist and the pulmonary retention disk still in correct position. The persistent shunt was closed 1 year later in the cath lab with a 9/6 Nit‐Occlud device. To our knowledge, this is the first reported late complication directly related to the device. © 2010 Wiley‐Liss, Inc.     

Device Closure of Patent Ductus Arteriosus in Marfan Patients: Safety and Effect on the Aortic Root Diameter

Objectives. There is little evidence in the medical literature about safety of PDA device closure and its effects on aortic root diameter in Marfan patients. We reported on nine Marfan patients whose ducts were occluded by coil or Amplatzer Duct Occluder. Patients and Interventions. Two patients had aneurismal type E ducts which were closed by a single coil, respectively. The others had conical ducts for which even Amplatzer occluder, stiff, or double coils were used. Results. No untoward consequence was found during a median follow up period of 18.5 months (range 3 months to 6.33 years). Two patients had small residual shunts. The observed change in the mean ratio of aortic root diameter to its estimated value was statistically insignificant in seven patients who had complete data on their aortic root diameter before PDA closure and during the follow up. Conclusions. We concluded that PDA device closure in Marfan patients is safe. Risk of residual shunt is higher even after closure of small ducts.     

经导管介入治疗冠状动脉瘘

目的：探讨经导管介入治疗冠状动脉瘘的方法及临床疗效。方法：经导管堵塞冠状动脉瘘14例，平均年龄7．1岁。结果：13例应用弹簧圈堵塞，平均瘘口大小为3．65mm，除3例失败外均获成功；1例（瘘口6．6mm）应用Amplatzer动脉导管未闭堵塞器堵塞成功。所有病例随访1个月－4年，均无残余分流及任何并发症。结论：经导管介入治疗冠状动脉瘘具有良好的临床疗效及安全性。可控弹簧圈一般用于堵塞瘘口较小的冠状动脉瘘，而瘘口较大的冠状动脉瘘可选用Amplatzer动脉导管未闭堵塞器。     

Transcatheter Closure of a Coronary Fistula with an Amplatzer? Vascular Plug: Should a Retrograde Approach Be Standard?

Coronary artery fistulae are rare disorders. Only 2 reports in the medical literature discuss the use of vascular plugs to occlude coronary fistulae, and the same device-the Amplatzer Vascular Plug-was deployed via different techniques to treat those patients. The safety, the feasibility, and the standard approach to deployment have yet to be established. Herein, we describe the case of a 15-year-old boy who presented with a continuous murmur at the left sternal border. The patient was diagnosed with a large coronary fistula that originated from the right coronary artery and emptied into the right atrium. He underwent transcatheter closure of the fistula. We placed a 14-mm Amplatzer Vascular Plug into the narrowest part of the fistula, which resulted in complete occlusion and an excellent outcome. Our retrograde approach is simple and obviates the need to establish arteriovenous loops or to insert additional devices, such as coils. In this report, we compare our results with those of the 2 previous reports. To our knowledge, this is only the 2nd report that describes the closure of a coronary fistula in an adolescent patient by use of an Amplatzer Vascular Plug.     

Comparison of two transcatheter device strategies for occlusion of the patent ductus arteriosus

Objectives: The present study evaluates two transcatheter closure strategies utilized at a single center and makes recommendations for device selection when occluding the patent ductus arteriosus. Background: A variety of devices are available for transcatheter closure of the patent ductus arteriosus (PDA) but no guidelines exist to guide operator device choice. Methods: A total of 132 patients underwent attempted transcatheter PDA closure utilizing one of two consecutive closure strategies between January 2000 and June 2005. Strategy A (n = 64; January 2000–May 2003) utilized Gianturco coils only. Strategy B (n = 68; June 2003–June 2005) utilized a single Gianturco coil for the PDA with a minimal diameter ≤1 mm (n = 28) or an Amplatzer Duct Occluder (ADO) if the PDA diameter exceeded 1 mm (n = 40). Success was defined as complete occlusion on a follow up echocardiogram. Results: 58 of 64 (90.6%) patients treated utilizing strategy A had successful coil implantation. 68 of 68 (100%) patients treated utilizing strategy B had successful coil/device implantation. At follow up echocardiography, 32 of 44 (72.7%) strategy A patients had complete ductal closure, as compared with 57 of 58 (98.3%) strategy B patients (P < 0.0001). Stepwise logistic regression analysis identified closure strategy as the most powerful predictor of procedural success (OR = 85.9; CI 5.6–9.99). Conclusions: A transcatheter PDA closure strategy consisting of a single Gianturco coil for PDA ≤ 1 mm or an ADO for larger sized PDA (strategy B) achieves superior outcomes compared to the use of coils alone. © 2008 Wiley‐Liss, Inc.     

Rare case of persistent left superior vena cava to left upper pulmonary vein: pathway for paradoxical embolization and development of transient ischemic attack and subsequent occlusion with an amplatzer vascular plug

We report the successful transcatheter closure of a large persistent left superior vena cava draining into a left upper pulmonary vein in a patient who suffered 2 transient ischemic attacks after intravenous (IV) injection of saline flush solution into a left arm peripheral IV line utilizing an Amplatzer Vascular Plug.     

Percutaneous closure of congenital and acquired ventricular septal defects--considerations on selection of the occlusion device

Nonsurgical closure of congenital and acquired ventricular septal defects (VSD) has become increasingly acceptable with the availability of various occlusion systems that allow percutaneous treatment of muscular and membranous defects. This study describes a series of 12 patients (0.2-74-years-old) who underwent defect closure with six different occlusion systems. Device selection according to anatomy and outcome is highlighted. Seven VSDs were located in the membranous part of the septum, five in the mid-muscular septum. Complex heart lesions were present in five postmyocardial infarction VSD in one and residual postsurgical defects in three patients. The size of the VSD ranged from 2.6 to 10 mm. The applied devices were: Amplatzer muscular VSD occluder (n=4), Amplatzer septal occluder (n=2), Amplatzer duct occluder (n=1), Amplatzer membranous VSD occluder (n=2), Nit-Occlud coil (n=2), and Cook PDA coil (n=1). The devices were implanted successfully in nine patients. There was complete VSD closure in eight patients within the first 24 hours. In one patient, a trivial residual shunt disappeared at 6 months follow-up. Because of device instability, two occluders were removed during catheterization. In two other cases, tricuspid valve tissue was entrapped in the occluder and had to be removed surgically, one of them during the consecutive Rastelli operation. Neither significant arrhythmia, nor thromboembolism or hemolysis occurred in out patients during follow-up. Transcatheter closure of VSD is an attractive alternative to surgery. In complex congenital heart disease, surgical-interventional hybrid therapy may improve morbidity and total outcome. The recently developed Amplatzer VSD devices allow closure of muscular and membranous VSDs. Implantation and short-term follow-up are superior to the formerly used devices. Long-term effects have to be evaluated in further studies.     

Amplatzer蘑菇伞器治疗儿小动脉导管未闭的临床应用

目的：探讨应用Amplatzer蘑菇伞器治疗小儿动脉导管未闭（PDA）的临床疗效及价值。方法：本组共68例,年龄8个月－12岁（平均6．4岁）,体重6．5－30（平均18．2）kg,PDA直径为3－8mm,术中行右心导管检查取血,测压,术后5－15min行隆主动脉造影,测肺动脉压,主动脉压。术后1月,3月,6月分别行X线及超声心动图检查,了解有无残余分流及封堵器位置。结果：本组68例均应用AmplatzerPDA蘑菇伞器治疗,成功率100％,疗效满意,无并发症,术后3d行超声心动图检查显示无1例分流。结论：应用Amplatzer蘑菇伞器治疗PDA创伤小,操作简单,使用广泛,成功率高,临床疗效满意。     

Amplatzer vascular plug closure of a subclavian arteriovenous fistula associated with implantable cardioverter‐defibrillator implantation

Subclavian arteriovenous fistula (AVF) is a rare complication of implantable cardioverter‐defibrillator (ICD) implantation. This report illustrates the case of a subclavian AVF after ICD implantation in a patient with nonischemic cardiomyopathy and the successful closure of this AVF using an Amplatzer vascular occlusion plug. Given the increasing number of ICD implantations, physicians should be made aware of this uncommon complication. In addition, as more percutaneous endovascular techniques are developed to treat peripheral vascular and structural heart disease, iatrogenic AVFs may occur more frequently. The Amplatzer vascular plug should be considered as a potential treatment strategy for AVFs alongside other endovascular and surgical techniques. © 2011 Wiley‐Liss, Inc.