Percutaneous closure of patent ductus arteriosus with the Amplatzer duct occluder

BACKGROUND AND METHODS: Percutaneous closure of a moderate-to-large sized patent ductus arteriosus using multiple coils or a Rashkind double-umbrella may be technically demanding and raises a significant rate of embolization and residual shunting. This is why we tried a new self-expandable device called Amplatzer Duct Occluder to close transvenously large ductuses in eighteen patients at a median age of 2.8 years (range: 0.7 to 34). They had a patent ductus arteriosus with a minimal diameter > 3 mm (mean: 5 +/- 2 mm). The device had a mean diameter of 9 +/- 2 mm and was delivered through a 6F venous sheath. Aortography was done 5 to 10 minutes after the release and follow-up evaluation was performed with color Doppler echocardiography within 24 h, 1 and 3 to 6 months after the procedure. RESULTS: Placement was successful in all but the first patient (95%). Complete closure was achieved immediately in 4/17 patients (24%) and in 13/17 (76%) 24 h later. Two patients were lost for follow-up. Complete closure was confirmed in 14 of the 15 (93%) reviewed patients at 1 and 3 months. In all patients with a ductal diameter < or = 7.5 mm the closure was complete at 1 month. Embolization occurred in one patient with a 9.7 mm duct and surgery was undertaken. A mild and transient hematuria was observed in one patient. No pulmonary artery stenosis nor aortic obstruction were observed on follow-up. CONCLUSION: The Amplatzer Duct Occluder device offers a safe and effective option to treat patients with a ductus arteriosus which minimal diameter is up to 7.5 mm.     

应用Amplatzer封堵器治疗动脉导管未闭

目的　采用Amplatzer封堵器经皮穿刺静脉治疗动脉导管未闭 ,并对其疗效、安全性及并发症进行评价。方法　 31例患者 ,年龄 0 8～ 38 0 (8 1± 6 0 )岁 ,体重 7 0～ 6 9 5 (2 7 7± 2 0 2 )kg。经静脉使用 6F传送器置入Amplatzer堵闭器 ,听诊无杂音后 10min行胸主动脉造影。术前、术后均行血流动力学测定 ,术后 2 4h、3个月、6个月行超声心动图及X线平片检查。结果　全组技术成功率10 0 %。术后即刻所有患者心前区双期连续性杂音消失 ,10min后胸主动脉造影示 2 9例完全堵闭(93 5 % ) ,仅 2例存在极少量残余分流 ,且 48h后超声心动图示该分流消失。动脉导管最窄径 1 5～8 2 (4 4± 1 7)mm ,透视时间 3 0～ 14 5 (6 7± 2 3)min。除 1例患者术后短暂胸部不适外均无任何并发症。随访 3～ 17(9 3± 3 7)个月未发生装置移位、再通或肺动脉狭窄。结论　应用Amplatzer方法经导管治疗动脉导管未闭安全简便 ,创伤小 ,适应证广 ,成功率高 ,疗效可靠 ,可用于新生儿 ,是目前治疗动脉导管未闭最理想的方法。     

Transcatheter closure of moderate to large patent ductus arteriosus with the Amplatzer duct occluder.

OBJECTIVES: To investigate the acute and follow-up results of transcatheter closure of moderate to large patent ductus arteriosus (PDA) with the Amplatzer duct occluder. METHODS: Between April 2000 and June 2005, 237 patients underwent attempted transcatheter closure of PDA, of whom Amplatzer duct occluder was used in 68 patients with moderate-to-large-sized PDA (45 females, with ages ranging from 56 days to 75 years, median 3.3 years). Moderate to large PDA is defined as ductus diameter > or =2.5 mm (> or =3 mm in early phase of this study) in infants and young children, or > or =4 mm in adolescents and adults. The size of device selected was generally at least 1-2 mm larger than ductus diameter. RESULTS: The ductus diameter ranged from 2.5 to 8.5 mm (4.1 +/- 1.3 mm). Amplatzer duct occluder was successfully deployed in 66 out of 68 patients. The size of device deployed ranged from 4 to 12 mm (6.3 +/- 1.6 mm). The causes of failure in the 2 patients included calcification of ductus resulting, in failure in advancing a sheath to descending aorta in 1 and kinking of a Cook sheath in the other. Distal embolization of the device occurred several hours later in one. After the device was retrieved percutaneously, the patient was sent to surgery. No other significant complications occurred. In the 3-month follow-up, complete occlusion was achieved in all patients. No patient had left pulmonary artery stenosis. CONCLUSIONS: Transcatheter closure of moderate-to-large-sized ductus with Amplatzer ductus occluder is effective and safe.     

Transcatheter closure of patent ductus arteriosus with the Amplatzer duct occluder: short-term follow-up

BACKGROUND: Transcatheter closure of the patent ductus arteriosus is a well established procedure. The objective of this study was to assess the effectiveness and the safety of the Amplatzer duct occluder. METHODS AND RESULTS: Occlusion of the patent ductus arteriosus was attempted in 23 patients. The median weight was 11.7 Kg (range, 5 kg - 42.4 kg) with a mean ductus diameter of 3.7 mm (range, 1.6 - 7.2 mm). The immediate closure rate was 86% with a closure rate of 100% at 6 months, 1 year and 2 years following device placement. There was one device embolization that occurred immediately following device placement. No patient had aortic narrowing or pulmonary artery stenosis following the procedure. CONCLUSIONS: The Amplatzer duct occluder is safe and effective in the closure of a patent ductus arteriosus up to 7.2 mm in diameter. Selecting a device at least 12 mm larger than the minimal ductal diameter can minimize embolization.     

高原地区用Amplatzer封堵器介入治疗动脉导管未闭

目的 :应用 Amplatzer封堵器在高原地区治疗动脉导管未闭 （PDA）并评价其疗效。方法 :本组 2 0例 ,年龄 1.5～ 44 （2 2± 14）岁 ,PDA最窄处内径 5～ 14（9± 3） m m,均用 Am platzer封堵器介入治疗。结果 :19例成功 ,1例严重阻力性肺动脉高压不适宜封堵。术后即刻降主动脉造影显示 15例封堵完全无残余分流 ,4例少量残余分流。 1例术后 1h封堵器脱落入右肺动脉 ,第三小时急诊外科手术关闭 PDA并取出封堵器。 2 4h彩色多普勒检查显示封堵 18例患者均无分流 ,随访 2月～ 1.5年 ,无 1例分流。结论 :用 Amplatzer封堵器治疗 PDA是高原地区 1种适应性强 ,安全有效的介入治疗方法。     

Further experience with transcatheter closure of the patent ductus arteriosus using the Amplatzer duct occluder

OBJECTIVE: The aim of this study was to report further experience with transcatheter closure of the patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO). BACKGROUND: The design of previously used devices is not ideal for this purpose, and their use has been associated with several drawbacks, especially in large PDAs. METHODS: Forty-three patients, aged 0.3 to 33 years (mean 6.4+/-6.7 years), with a moderate to large, type A to E PDA, underwent attempted transcatheter closure using the ADO. The device is a plug-shaped repositionable occluder made of 0.004-in. nitinol wire mesh. It is delivered through a 5F to 6F long sheath. The mean PDA diameter (at the pulmonary end) was 3.9+/-1.2 mm (range 2.2 to 8 mm). All patients had color flow echocardiographic follow-up (6 to 24 months) at 24 h, 1 and 3 months after closure, and at 6-month intervals thereafter. RESULTS: The mean ADO diameter was 6.1+/-1.4 mm (range 4 to 10 mm). Complete angiographic closure was seen in 40 of 43 patients (93%; 95% confidence interval [CI] 85.4% to 100%). The remaining three patients had a trivial angiographic shunt through the ADO. At 24 h, color flow mapping revealed no shunt in all patients. A 9F long sheath was required for repositioning of a misplaced 8-mm device into the pulmonary artery. The mean fluoroscopy time was 7.9+/-1.6 min (range 4.6 to 12 min). There were no complications. No obstruction of the descending aorta or the pulmonary artery branches was noted on Doppler follow-up studies. Neither thromboembolization nor hemolysis or device failure was encountered. CONCLUSIONS: Transcatheter closure using the ADO is an effective and safe therapy for the majority of patients with patency of the arterial duct. Further studies are required to establish long-term results in a larger patient population.     

Transcatheter closure of the patent ductus arteriosus using an Amplatzer duct occluder in adults.

Patent ductus arteriosus (PDA) is a congenital heart disease that frequently escapes detection until the patient reaches adulthood. Percutaneous closure of the PDA has been established as a safe alternative to surgery, the Amplatzer duct occluder (ADO) is a new device that has been recently reported in paediatric patients. Our initial experience with an of ADO in an adult population appears to be encouraging and as good as in paediatric patients.     

应用Amplatzer封堵器治疗动脉导管未闭的疗效评价

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Transcatheter closure of patent ductus arteriosus using the Amplatzer duct occluder: initial results and mid-term follow-up

INTRODUCTION AND OBJECTIVES: Transcatheter closure of patent ductus arteriosus is a well-established procedure. The aim of this study was to assess the initial and mid-term results of the treatment of PDA with the Amplatzer duct occluder. PATIENTS AND METHODS: From October 1999 to December 2001, 30 children underwent transcatheter closure of persistent ductus arteriosus at a mean SD age of 5 4.02 years (range: 3 months to 14 years) and weight of 20.3 10.3 kg (range: 4.5-45 kg). Infants under 10 kg weight made up 46% of total patients. A lateral view aortogram was made to determine the morphology of the ductus and select the size of the device. Occlusion was achieved using the anterograde venous approach. Follow-up evaluations were made with chest X-ray and echocardiogram at 24 hours and 1, 4 and 12 months after implantation. RESULTS: Twenty-eight patients (93.3%) immediately achieved complete occlusion, and on color Doppler examination the closure rate was 100% within 24 hours of implantation. There was no device embolization. In the follow-up, a 19-month-old patient developed a 20 mmHg gradient across the aortic arch. CONCLUSIONS: Patent ductus arteriosus can be easily occluded with the Amplatz Duct Occluder, which is effective and particularly useful in infants and children with relatively large PDA. Further experience and long-term follow-up are still needed to assess the safety of this device in smaller children.     

高原地区用Amplatzer封堵器治疗动脉导管未闭

目的:应用Amplatzer封堵器在高原地区治疗动脉导管未闭(PDA)并评价其疗效。方法:本组40例,年龄1.5～44(22.5±14.2)岁,PDA最窄处内径5～14(9.3±3.3)mm,均用Amplatzer封堵器介入治疗。结果:19例成功,1例严重阻塞性肺动脉高压不适宜封堵。术后即刻降主动脉造影显示35例封堵完全无残余分流,4例少量残余分流。1例术后1h封堵器脱落入右肺动脉,第3小时急诊外科手术关闭PDA并取出封堵器。24 h彩色多普勒检查显示封堵36例患者均无分流,随访2个月～1年半,无一例分流。结论:高原地区PDA发病率高,并发肺动脉高压早且多,巨大PDA(内径>0.8 cm)比率高,用Amplatzer封堵器治疗PDA是高原地区一种适应性强、安全有效的介入治疗方法。     

Early experience with the Amplatzer ductal occluder for closure of the persistently patent ductus arteriosus

Using an Amplatzer duct occluder, 106 patients (weight 21 +/- 18 kg) underwent an attempt at catheter closure of a persistently patent ductus arteriosus (PDA). Their age ranged from 22 days to 48 years. The PDA measured between 1.2 to 8.1 mm at its narrowest diameter. The device was successfully implanted in 105 patients. The immediate closure rate was 70% and gradually increased to 100% at 1-month follow-up. There was no clinical evidence of hemolysis and no incidence of device embolization or bacterial arteritis. Doppler evaluation showed no evidence of aortic arch or pulmonary artery obstruction. The device, which is currently undergoing multicenter clinical trial in the United States, is proving to be a safe and effective device for closure of the persistently PDA.     

Transcatheter closure of persistent ductus arteriosus in infants using the Amplatzer duct occluder

AIM—To evaluate whether transcatheter closure with the Amplatzer duct occluder offers an alternative to surgical treatment in infants with a persistent ductus arteriosus.
METHODS—12 patients under 1 year of age (age 1-11 months, body weight 2.6-8.7 kg) with clinical and echocardiographic findings of a significant duct were considered for transcatheter closure with the Amplatzer occluder. The device is made of a Nitinol and polyester fabric mesh and provides occlusion by stenting the duct. Measured angiographically, the narrowest diameter of the ducts ranged from 1.5-5 mm; in six patients pulmonary hypertension was also present.
RESULTS—The devices were implanted and complete duct occlusion was demonstrated during follow up in 10 patients. Procedure related difficulties occurred in nine of the 12 cases and led to relatively long procedure and fluoroscopy times (procedure time 50-180 minutes, median 80 minutes; fluoroscopy time 4.9-49 minutes, median 16 minutes). In two infants transcatheter closure could not be achieved and surgical duct ligation had to be carried out.
CONCLUSIONS—In small infants with a persistent ductus arteriosus the Amplatzer duct occluder offers an alternative to surgical treatment, but further improvement of the implantation system is necessary before the procedure can be recommended as the treatment of choice.


Keywords: persistent ductus arteriosus; transcatheter closure; infants; Amplatzer duct occluder     

Transradial approach for percutaneous closure of patent ductus arteriosus with the Amplatzer duct occluder II: A case report

Percutaneous patent ductus arteriosus (PDA) closure is a safe and feasible treatment, and it is recommended over surgical approach in the majority of cases. Amplatzer duct occluder (ADO—AGA Medical Corporation, Golden Valley, MN) is the preferred device for transcatheter treatment of PDA. Recently, the ADO II (AGA Medical Corporation, Golden Valley, MN), allowing PDA closure through a small delivery catheter from an antegrade or retrograde approach, received the European Community mark approval. Here, we report, for the first time, successful PDA closure in a 66‐year‐old female with the ADO II device, using a transradial approach. © 2010 Wiley‐Liss, Inc.     

Comparison of percutaneous closure of large patent ductus arteriosus by multiple coils versus the Amplatzer duct occluder device

This study compared the efficacy and costs of the most used approaches for percutaneous closure of large patent ductus arteriosus, that is, multiple coils and the Amplatzer duct occluder (ADO) device. From April 2000 to September 2003, 47 patients underwent closure of large, symptomatic patent ductus arteriosus (diameter 4.6 +/- 3.0 mm/m(2); QP/QS 2.1 +/- 1.9) with multiple Cook detachable coils (n = 19) or the ADO device (n = 28). The multiple coil approach was significantly cheaper (1,389 +/- 168 vs 3,811 +/- 38, p <0.0001) but as effective as the ADO device over a mid-term follow-up (occlusion rate 89.5% vs 96.4%, p = NS).     

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。     

Transcatheter closure of patent ductus arteriosus in adults using the Amplatzer duct occluder: initial results and follow-up

BACKGROUND: Surgical closure of patent ductus arteriosus in adult patients may be problematic. Transcatheter closure of patent ductus arteriosus is an established procedure. Recently, transcatheter closure of patent ductus arteriosus using the Amplatzer duct occluder has been shown to be safe and efficacious. We present our experience with this device in adults. METHODS AND RESULTS: Between January 2000 and January 2002,41 adult patients (31 females and 10 males) with a patent ductus arteriosus were referred for closure with the Amplatzer duct occluder. The median age was 35.6 years (range 18-70.7 years) and the median weight was 65.8 kg (range 32.7-164.5 kg). Of these 41 patients, 37 underwent attempted closure of the patent ductus arteriosus using the Amplatzer duct occluder. The device was successfully deployed in all patients except 1. Complete angiographic closure was seen Immediately after device deployment in 29 out of 36 patients (81%). Complete echocardiographic closure was demonstrated within 24 hours post-procedure in 34 out of 36 patients (94%), and at 6-month follow-up in 35 out of 36 patients (97%). No complications related to device implantation occurred in any patient. CONCLUSIONS: Closure of patent ductus arteriosus using the Amplatzer duct occluder is safe and effective in adults.     

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.     

Lung perfusion studies after transcatheter closure of persistent ductus arteriosus with the Amplatzer duct occluder

Background : Reduced left lung perfusion has been described after transcatheter closure of the patent ductus arteriosus (PDA) with several prostheses. Although the Amplatzer ductal occluder (ADO) device is currently the most widely used occluder for closure of large‐sized PDAs, the potential consequences of flow distribution to the lungs of this device have not been completely clarified. We evaluated lung perfusion following occlusion of PDA with the ADO device. Methods : Forty‐seven patients underwent successful transcatheter PDA occlusion using the ADO device were included in this study. Lung perfusion scans were performed 6 months after the procedure. Results : Decreased perfusion to the left lung (defined as < 40% of total lung flow) was observed in 17 patients (36%), 5 of whom were low‐weight symptomatic infants. Ductal ampulla length was significantly shorter and minimal ductal diameter to ampulla diameter ratio was significantly higher in patients with decreased left lung perfusion and correlated well with left lung perfusion values (r = 0.516 and r = ?0.501, respectively). A cut‐off value of ≤5.8 mm for the ductal ampulla length and ≥1.9 for ampulla diameter to ampulla length ratio showed high sensitivity and specificity for reduced lung perfusion. Conclusions : The incidence of abnormal left lung perfusion is high 6 months after transcatheter closure of PDA with the ADO, more likely in the low weight symptomatic infants and in patients with a short duct or a relatively shallow duct having abrupt narrowing of a large ampulla. © 2010 Wiley‐Liss, Inc.     

Transcatheter closure of a 16 mm hypertensive patent ductus arteriosus with the Amplatzer muscular VSD occluder.

There is little experience with transcatheter closure of very large, hypertensive patent ductus arteriosus. We present a case of successful closure of a 16 mm ductus with the Amplatzer VSD occluder, a device originally designed for transcatheter closure of congenital muscular ventricular septal defects. To our best knowledge this is the largest ductus ever closed by an interventional technique.