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。     

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 occlusion of gigantic persistent ductus arteriosus (PDA) using a custom‐made persistent ductus arteriosus occluder

We reported transcatheter closure of gigantic persistent ductus arteriosus (PDA) complicated by severe pulmonary hypertension (PH) using a custom‐made PDA occluder. A 19‐year‐old lady weighing 45 kg visited to our Heart Saving Project in Mongolia with a chief complaint of shortness of breath. Contrast CT scan showed ellipsoidal section of PDA whose long axis being 28 mm, and the short axis of 21 mm. A custom‐made PDA occluder, whose retention skirt, the aortic side, and the pulmonic side diameter of the body were 54, 36, 34 mm, respectively, was successfully deployed using 14‐Fr sheath. Pulmonary pressure decreased around a half compared to before closure. A custom‐made duct occluder could be a reasonable and cost‐effective choice for transcatheter closure of gigantic PDA complicated by severe PH. © 2015 Wiley Periodicals, Inc.     

Safety and feasibility of transcatheter closure of large patent ductus arteriosus measuring >or=4 mm in patients weighing

Kothandam Sivakumar  Edwin Francis  Prasad Krishnan 《Journal of interventional cardiology》2008,21(2):196-203

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.     

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.     

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。     

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     

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.     

动脉导管未闭合并重度肺动脉高压Amplatzer法封堵治疗的临床应用--12例初步报告

目的评价Amplatzer封堵器治疗动脉导管未闭(PDA)合并重度肺动脉高压(SPH)的初步疗效.方法对12例(女9例,男3例)PDA合并SPH患者实施封堵治疗.其中10例采用Amplatzer动脉导管未闭封堵器,2例采用Amplatzer房间隔缺损封堵器.结果全组12例PDA封堵器均放置成功.11例PDA封堵后30分至1小时肺动脉收缩压、肺动脉平均压均明显降低.1例封堵术后即刻肺动脉压无变化.术后36小时彩色多普勒估测肺动脉压明显下降,封堵术后30分降主动脉造影,无残余分流9例,微量残余分流2例,少量残余分流1例.全组术后24～48小时彩色多普勒检查,动脉水平左向右分流均完全消失.无重要并发症发生.随访1～24个月(平均8个月),患者症状改善,11例心脏缩小,无1例发生再通.结论采用Amplatzer法封堵治疗PDA合并SPH,近期疗效满意.     

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.     

Patent ductus arteriosus equipment and technique. Amplatzer duct occluder: intermediate-term follow-up and technical considerations

Between May 1997 and June 2000, 69 patients, ages 0.1 to 34 years, underwent attempted anterograde transcatheter closure of a patent ductus arteriosus (PDA) using the Amplatzer Duct Occluder (ADO). The ADO is a cone-shaped, self-centering, and repositionable occluder made of nitinol wire mesh. A 5Fr to 7Fr sheath was used for the delivery of the device. The mean PDA diameter (at the pulmonary end) was 4.6 +/- 1.9 mm (range 1 mm-8.5 mm). Sixty-seven of the 69 patients had successful device placement. The mean ADO smallest diameter was 6.9 +/- 1.8 mm (range 4 mm-12 mm). Complete angiographic closure occurred in 62 (92.5%) of 67 patients (95% confidence interval, 88.22%-98.77%). In five patients, there was a trivial residual shunt immediately after the procedure. At 24 hours, color Doppler flow imaging revealed complete closure in all 67 (100%) patients. The unsuccessful attempts occurred in two patients with a small, 1-mm diameter native PDA and residual PDA after surgical occlusion. Fluoroscopy time was 7.6 +/- 1.8 minutes (4 min-18 min). No complications were observed. At a median follow-up of 1.5 years (range 0.25 to 3.2 years), all patients had complete closure without complications. We conclude that transcatheter closure using the ADO is a highly effective and safe treatment for most patients with PDA.     

Advances in interventional occlusion of persistent ductus arteriosus: comparison of results using different occlusion devices

This report describes our results with transcatheter closure of patent ductus arteriosus between March 1993 and May 2000 including our early experience with the Amplatzer duct occluder. One hundred and sixty-six consecutive procedures were performed in 160 patients. The mean age was 6.8 years (range 0.8 to 26.2), mean weight 24.3 kg (range 7.7 to 84.0). Single or multiple coils were implanted successfully in 114 cases, a Rashind double umbrella in 35 patients, and an Amplatzer duct occluder in 16 patients. After failure to implant coils in one patient, a second attempt with a Rashkind double umbrella was successful. Complete closure of the patent ductus arteriosus was achieved in a total of 148 patients (92.5%), mean fluoroscopy time was 13.7 min (range 3.1 to 126 min). In 144 patients (90.0%), occlusion without residual shunting was achieved by the first interventional approach. Angiography showed immediate closure in 44%, echocardiography within 48 h revealed complete closure in additional 28%. In a further 18%, a residual shunt disappeared spontaneously in the following months. In five patients a second procedure was performed to terminate residual shunting after placement of a Rashkind occluder system by coils. In three patients, the residual shunt resolved. In 12 patients (7.5%) echocardiography showed a residual shunt 2-1259 days after interventional approach. Occlusion rates of the different devices were 83% for the Rashkind occluder, 92% for detachable coils, and 100% for the Amplatzer duct occluder. Coil embolisation into the pulmonary artery occurred in two patients, interventional removal was successful in one of them. There were no further complications. According to our experience interventional occlusion of patent ductus arteriosus is highly effective and associated with a low complication rate. Transcatheter closure using the Amplatzer duct occluder seems to be safe and effective also in small children with a body weight of 8 kg and a large ductus diameter. Compared to the total group of patients, the occlusion rate of the Amplatzer duct occluder was significantly higher (p = 0.005), and of the Rashkind occluder system significantly lower (p = 0.026). Therefore, we recommend the use of detachable coils in patients with small ductus (diameter < or = 2 mm) and the Amplatzer duct occluder in those with a larger ductus. Transcatheter closure of the patent ductus arteriosus according to this regimen should achieve occlusion rates above 95%.     

Clinical Outcomes After Percutaneous Patent Ductus Arteriosus Closure in Adults

BackgroundThere is little published data regarding percutaneous patent ductus arteriosus (PDA) closure in adults. We aim to describe the outcomes of adult patients undergoing PDA closure at a single tertiary referral centre.MethodsAll adults who underwent device PDA closure at our centre from 2001 to 2017 were identified and enrolled in the study. Available clinical data and imaging data were reviewed.ResultsAt total of 141 patients were identified, with a mean age of 43 ± 15 years. Left ventricular dilation was present in 27% and pulmonary hypertension in 36% of the patients. Most ducts (74%) were of type A morphology. Mean ductal diameter at the pulmonary artery end was 4.1 ± 1.9 mm and mean length was 10.0 ± 4.7 mm. Wire passage from the pulmonary artery was achieved in 79%. Procedural success rate was 100%, and an Amplatzer duct occluder was deployed in all successful cases (ADO1 device in 97%). There was a small residual shunt in 6% at the time of closure, and only 2 patients had a residual leak on echocardiography at a median 3 months’ follow-up. No major complications occurred.ConclusionsTranscatheter PDA closure with the use of an Amplatzer duct occluder is very effective in adults across all duct morphologies and associated with a very low complication rate.     

Transcatheter closure of patent ductus arteriosus using Gianturco coils in adolescents and adults.

We present the short- and intermediate-term results of transcatheter closure of patent ductus arteriosus with Gianturco coils in adolescents and adults. During a 5-year period, 55 patients (44 females, 11 males) with ages ranging from 14 to 72 years (median, 23) underwent attempted transcatheter closure of patent ductus with the Gianturco coils. The diameter of the narrowest segment of the ductus ranged from 0.8 to 7.6 mm (3.9 +/- 1.3 mm). The 55 patients were divided into three groups. Group I consisted of nine patients with a ductal diameter < or = 3 mm, group II consisted of 27 patients with a ductal diameter > 3 mm but < or = 4 mm, and group III consisted of 19 patients with a ductal diameter > 4 mm. Four- to five-loop Gianturco coils were used, which were deployed via retrograde aortic route. Multiple-coil technique was generally applied in group II patients. Balloon occlusion technique in combination with multiple-coil technique was generally used in group III patients. Deployment of coil was successful in 51 patients (93%) but failed in 4. The success rate of coil deployment in group I, II, and III were 100% (9/9), 96% (26/27), and 84% (16/19), respectively. A mean of 1.9 +/- 0.7 coils was deployed per patient. Of the four patients with unsuccessful coil deployment, three underwent surgery and one received implantation with Amplatzer duct occluder. Distal embolization of 21 coils occurred in 10 patients (3 in group II and 7 in group III), from whom 20 coils were retrieved with a gooseneck snare and 1 coil was removed during surgery. The mean diameter of ductus in the 10 patients with distal embolization was significantly larger than that in those without (5.2 +/- 1.4 vs. 3.7 +/- 1.1 mm; P < 0.01). Among the 51 patients with successful coil deployment, immediate complete closure was achieved in 20 (39%), while trivial to mild leak was present in 31 (61%). No significant complications were encountered. After a follow-up period ranging from 5 to 42 months, four patients had a small residual shunt and three underwent a second intervention with complete occlusion. None had left pulmonary artery stenosis documented with Doppler echocardiography. Transcatheter closure of ductus with the Gianturco coils is safe and feasible in the majority of adolescents and adults. Taking high embolization rate in patients with a ductus diameter > 4 mm into consideration, controlled-release coils, Buttoned device, or Amplatzer duct occluder can be a better choice.     

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.     

Safety and Feasibility of Transcatheter Closure of Large Patent Ductus Arteriosus Measuring ≥4 mm in Patients Weighing ≤6 kg

Objectives: The study aims to find safety of transcatheter closure of large patent ductus arteriosus (PDA) ≥4 mm in patients weighing ≤6 kg.
Background: Large PDA ≥4 mm in patients ≤6 kg challenge the interventionist due to need for large delivery sheath, kink of delivery sheath, and encroachment of aorta or pulmonary artery (PA) by the device. Many institutions refer them for surgery.
Methods: Preterm neonates and ducts with coarctation were excluded. All other patients were taken for catheter closure. Ducts with roomy ampulla were closed with multiple coils aided by bioptome, and others with Amplatzer duct occluders.
Results: Twenty-eight patients aged 2–18 months (median 5.5 months) and weighing 3.8–6 kg (median 4.7 kg) had large PDA (mean diameter 6.3 ± 2 mm) with hyperkinetic pulmonary hypertension. Four patients had bioptome-aided coil closure. Twenty-two other ducts were closed with devices. Two procedures failed due to sheath kink in one patient and device pulling through a duct in the other patient. Four infants needed blood transfusions. The mean procedural time was 42 ± 20 minutes. On a mean follow-up of 25.5 ± 14.8 months, there were no residual flows and no gradients across aorta or pulmonary artery.
Conclusions: Transcatheter closure of large ducts ≥4 mm might be considered safe and effective in infants weighing ≤6 kg also. Decision on coils versus devices depends on ductal morphology. On midterm follow-up with somatic growth, there was no occurrence of aortic or PA gradients.     

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。     

Catheter Closure of Moderate- to Large-Sized Patent Ductus Arteriosus Using the New Amplatzer Duct Occluder: Immediate and Short-Term Results

Objectives. The aim of this study was to assess the immediate and short-term results of anterograde catheter closure of a moderate- to large-sized patent ductus arteriosus (PDA) using the new self-expandable, respositionable Amplatzer duct occluder (ADO) device.Background. Transcatheter closure of a PDA using devices or coils is technically challenging and may be accompanied by a 38% incidence of residual shunts.Methods. Twenty-four patients (6 male, 18 female) underwent attempted transcatheter closure of a PDA using the ADO at a median age of 3.8 years (range 0.4 to 48) and a median weight of 15.5 kg (range 6 to 70). The mean PDA diameter at its narrowest segment was 3.7 ± 1.5 mm. A 6F long sheath was used for delivery of the ADO. Follow-up evaluation was performed with color flow mapping of the main pulmonary artery within 24 h and at 1 and 3 months after closure.Results. Twenty three of the 24 patients had successful device placement. Angiography showed that 7 patients had complete immediate closure, 14 had a trace shunt (foaming through the device with no jet), and 2 had a small residual shunt (with a jet). Within 24 h, color Doppler revealed complete closure in all patients. The unsuccessful attempt was during an initial trial with a prototype that has been modified. The median fluoroscopy time was 13.5 min (range 6.3 to 47). All patients were discharged home the next day. There were no complications. Of the 23 patients, 21 completed the 1-month follow-up, all (95% confidence interval [CI] 86% to 100%) with complete closure, and 18 of 23 patients completed the 3-month follow-up, also all (95% CI 83% to 100%) with complete closure.Conclusions. Anterograde transcatheter closure using the new ADO is an effective therapy for patients with a PDA diameter up to 6 mm. Further clinical trials are underway.