Early clinical experience with the new amplatzer ductal occluder II for closure of the persistent arterial duct

Objectives : To describe the early single‐center clinical experience with the Amplatzer Ductal Occluder II (ADO II). Methods : All patients undergoing attempted transcatheter closure of persistent arterial duct (PDA) with the ADO II were included. Data collected included demographic, clinical, and echocardiographic parameters. Results : From March until September 2008, 29 procedures were undertaken in 27 patients (21 female). Median age was 1.4 years (range 0.4–76 years) with median weight 9.4 kg (range 4.7–108 kg). A transarterial approach was used in 2 patients. The median minimum ductal diameter was 2.7 mm (range 1.7–5). ADO II was released in 25 patients (92.5%). Two patients had significant residual shunting following deployment of ADO II and underwent closure with Amplatzer ductal occluder (ADO I). Postprocedural echocardiography identified one occluder had changed position with development of a significant leak and one occluder had embolized to the left pulmonary artery. Both occluders were retrieved successfully at a second catheter procedure. Complete occlusion was noted predischarge in 22 of the remaining 23 occluders (96%). One patient had mild flow acceleration in the left pulmonary artery which has resolved. Conclusions : The ADO II is highly effective at providing rapid occlusion of morphologically varied PDAs. Occluder design allows closure with arterial or venous approach and delivery with 4 or 5 F delivery catheters. Stable occluder position is dependent on correct positioning of both aortic and pulmonary discs. A larger range of sizes and configurations of this occluder may be required to successfully occlude all ductal sizes and morphologies. © 2009 Wiley‐Liss, Inc.     

Transcatheter occlusion of patent ductus arteriosus using a new angled Amplatzer duct occluder: initial clinical experience.

In the present study, we report the initial clinical experience with the new angled Amplatzer duct occluder (ADO) for the percutaneous closure of patent ductus arteriosus (PDA). Percutaneous closure of PDA using standard ADO in infants and in patients with small PDA ampulla is difficult, or even impossible, due to protrusion of the aortic disk into the descending thoracic aorta. The aortic disk of an angled ADO is angled at 32 degrees to the body of the device and concave toward the aorta to prevent protrusion of the disk into the aorta. Percutaneous closure of PDA was attempted in nine patients with a median age of 5.2 years (range, 0.5-12.7) and median weight of 20 kg (range, 4.9-55). Selection of the occluder and the implantation technique were similar to the standard ADO. The minimal PDA diameter ranged from 2.1 to 3.7 mm (median, 2.5 mm). Occluders were successfully implanted in all patients. Immediate complete PDA closure was achieved in all patients. There were no complications. The new angled ADO is a safe and effective device for PDA closure, particularly suitable for infants and patients with small PDA ampulla. Further studies and long-term follow-up are necessary to confirm our initial experience.     

The Amplatzer duct occluder: experience in 209 patients

OBJECTIVES: The aim of the study was to assess the safety and efficacy of the Amplatzer ductal occluder (ADO) in transcatheter occlusion of patent ductus arteriosus (PDA). BACKGROUND: Transcatheter closure of small to moderate sized PDAs is an established procedure. The ADO is a self-expandable device with a number of salutary features, notably its retrievability, ease of delivery via small 5F to 7F catheters and a range of sizes suitable even for the larger PDAs. METHODS: Between November 1997 and August 1999, the ADO was successfully implanted in 205 of 209 patients with PDA. The inclusion criteria for this device occlusion method were patients with clinical and echocardiographic features of moderate to large PDA, weighing > or =3.5 kg as well as asymptomatic adolescents and adults with PDA measuring > or =5.0 mm on two-dimensional (2D) echocardiogram. Occlusion was achieved via the antegrade venous approach. Follow-up evaluations were performed with 2D echocardiogram, color-flow mapping and Doppler measurement of the descending aorta and left pulmonary artery velocity at 24 h and 1, 3, 6 and 12 months after implantation. RESULTS: Two hundred and five patients had successful PDA occlusion using this device. The patients were between two months and 50 years (median 1.9) and weighed between 3.4 kg and 63.2 (median 8.4). Infants made up 26% of the total patients. The PDA measured from 1.8 to 12.5 mm (mean 4.9) at the narrowest diameter. Forty-four percent of patients achieved immediate complete occlusion. On color Doppler the closure rates at 24 h and 1 month after implant were 66% and 97%, respectively. At 6 and 12 months all except one patient attained complete occlusion. Device embolization occurred in three patients; in two this was spontaneous, and in the other it was due to catheter manipulation during postimplant hemodynamic measurement. Mild aortic narrowing was seen in an infant. CONCLUSIONS: Patent ductus arteriosus occlusion using ADO is safe and efficacious. It is particularly useful in symptomatic infants and small children with relatively large PDA. Embolization can be minimized by selection of appropriate sized devices, and caution should be exercised in infants <5 kg.     

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.     

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.     

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 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.     

Stent angioplasty to relieve left pulmonary artery obstruction caused by patent ductus arteriosus device occlusion

A 7‐month‐old patient in congestive heart failure due to a moderate sized patent ductus arteriosus (PDA) underwent uncomplicated implantation of an Amplatzer Ductal Occluder (ADO1). Two months after percutaneous device PDA closure, left pulmonary artery (LPA) stenosis was discovered. Rather than spontaneous improvement as reported in previous cases, our patient's LPA stenosis progressed in severity 7 months after ADO1 placement. A catheterization demonstrated a 32 mm Hg peak gradient from her main pulmonary artery to her LPA. She underwent successful stent angioplasty of her LPA with an excellent result and preserved PDA closure. This case demonstrates that stent angioplasty is a feasible an effective method of relieving LPA obstruction caused by a PDA occluder device. Additionally, despite slight deflection by the stent, the ADO1 device continued to provide complete ductal closure. Stent angioplasty should be considered in patients who have LPA stenosis caused by ADO1 occluder device that does not improve over time. © 2013 Wiley Periodicals, Inc.     

Trans‐catheter closure of patent ductus arteriosus—What is the best device?

Background : Over the past three decades, transcatheter occlusion of patent ductus arteriosus (PDA) has evolved to be the procedure of choice. Gianturco and Flipper coils are the most commonly used coils in the United States for closure of small and moderate size PDAs. For larger PDAs, interventionalists in the United States commonly use the Amplatzer Duct Occluder (ADO) and those in Europe use the ADO or the Nit‐Occlud Coils (NOC). A comparison between Gianturco coils, Flipper coils, ADO, and NOC has never been made. Objective : To compare the success and complication rate associated with the four different devices used for transcatheter closure of PDA. Success was defined as complete closure of PDA with absence of a residual shunt (R.S.) at six months follow‐up. Methods : Two institutions collaborated in combining their data to evaluate the results of transcatheter closure of PDA. Results : Totally, 546 patients underwent successful PDA occlusion at both institutions. Gianturco and Flipper coils were used in 120 (22%) and 119 (22%) patients respectively. A total of 152 (28%) patients received ADO and 155 (28%) patients received NOC. Immediate R.S. were noted in 226 (41.4%) patients in the entire study group with the NOC group having the highest percentage of R.S. (80/155, 51.6%, P = 0.004). Of the 484 patients with follow‐up echocardiograms at 6 months, 35 (7.2%) patients had persistent R.S. The NOC (3/143, 2.1%) and ADO (5/150, 3.3%) groups had the least R.S. at six months follow‐up. Conclusion : Per our definition of success, the Nit‐Occlud coils and the Amplatzer duct‐occluder devices had significantly higher success rate for PDA occlusion versus the coils. © 2010 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.     

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.     

Clinical evaluation of the new Amplatzer duct occluder II for patent arterial duct occlusion

Background: Several devices such as coils and Amplatzer duct occluder (ADO) are used for catheter closure of patent arterial ducts (PDA). These carry a high success rate but residual shunts, suboptimal device orientation, and technical problems are encountered. The Amplatzer duct occluder II (ADO II) is designed to address these limitations. Objectives: To evaluate the technical features of the new ADO II device for PDA closure and document the immediate/early closure rate, complications and device behavior during implantation. Methods: Prospective, two center study from February 2008 to January 2009. Twenty‐seven patients (18 females) received the ADO II. The median age was 22 months (range: 7 months–68 years) and the median weight was 11.7 kg (range: 6.9–108). The median PDA diameter was 2.6 mm (range: 1–4.4). The approach was arterial in 13 and venous in 14 patients. Follow‐up included echocardiography at 1 day and 1 month postimplantation. Results: All implantations were technically successful with immediate complete angiographic closure in 21 and trivial contrast flow in six patients. The median procedure time was 43 min (range: 15–82) and the fluoroscopy time was 6 min (range: 2.2–26.5). Echocardiography confirmed no residual shunts on the following day. There were no complications. Conclusion: The new ADO II is a versatile and very effective device for closure of PDAs of various shapes, lengths, and up to diameters of 5.5 mm. The disc articulations, high early closure rate, arterial or venous approach options, and small diameter delivery catheter are all beneficial features. © 2009 Wiley‐Liss, Inc.     

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.     

Closure of the patent ductus arteriosus with the amplatzer PDA device: immediate results of the international clinical trial.

The purpose of this article is to present the immediate and short-term results of the international registry of transcatheter closure of patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO). Three hundred sixteen patients (221 females) in various centers with clinical and/or echocardiographic evidence of PDA underwent an attempt of catheter closure at a median age of 2.1 years and median weight of 10.7 kg. The median Qp/Qs ratio was 2.3, the median length of the PDA was 6.7 mm and the median diameter of the PDA at its narrowest point (usually the pulmonic end) was 3.8 mm. Immediately after closure and by angiography, the PDA was completely closed in 177/311 patients (56%) and within 24 hr the complete closure rate increased to 76% (235/308). Complications were encountered in 15 patients, including 1 major complication due to device embolization and subsequent death, 6 moderate complications, and 8 minor complications. The median fluoroscopy time was 12 min and the median total procedure time was 70 min. One hundred fourteen patients reached the 6-month follow-up. Color Doppler echocardiography demonstrated complete closure in 109 patients (94.6%). Thirty-eight patients reached the 1-year follow-up mark. There was complete closure in 100% of the patients as documented by color Doppler echocardiography. So far there has been no episodes of delayed device migration, endocarditis, thromboembolism, and wire fracture or device disruption. We conclude that the ADO is safe and effective in most patients with PDA up to a diameter of 10.6 mm. Further clinical trials are underway to assess its long-term safety and efficacy.     

Successful transcatheter closure of a residual patent ductus arteriosus with complex anatomy after surgical ligation using an amplatzer ductal occluder guided by live three-dimensional transesophageal echocardiography

Residual patent ductus arteriosus (PDA) after surgical ligation is not common, but the anatomy of the residual duct may be distorted by the surgical ligation resulting in a difficult transcatheter closure. Such distorted anatomy of the duct may not be demonstrated by the two-dimensional transesophageal echocardiography (2D TEE). Fortunately, live 3D TEE provided the precise anatomy of the elongated distorted residual duct, and as in the case presented herein, guided the Amplatzer ductal occluder (ADO). We concluded that live 3D TEE provided novel images of complex residual ducts and successful guidance of a ductal occluder.     

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.     

Percutaneous transcatheter closure of patent ductus arteriosus: Initial experience of Sohag University

ObjectivesInitial experience with transcatheter closure of patent ductus arteriosus (PDA) using different types of devices is reported in Sohag University Hospital. We evaluated the outcome, complications, and also assessed the need of surgical backup for such interventional procedures.MethodsFrom March 2011 to September 2012, 51 patients who underwent transcatheter closure of PDA, were retrospectively identified and studied. Aortic angiogram was performed to evaluate the size, position, and shape of the duct for appropriately choosing the occluder device type and size. A second aortic angiogram was performed 10 min after device deployment. Echocardiography was repeated at intervals of 24 h, then at 1, 3, and 6 months after the procedure to assess complications. The PDA was closed by Amplatzer Duct Occluder (ADO) in 40 patients, Nit occlude PFM coil in five patients, Amplatzer muscular VSD in two patients and Detachable Cook coil in four patients .ResultsOf 51 cases, one patient had left pulmonary artery embolization of ADO that required surgical intervention. The PDA was successfully closed in 98.04% of the study population without any residual PDA shunting. All the patients were alive. Infants made up 29% of the total patients. 45 patients were children and six patients were adults.ConclusionOur initial results show that transcatheter occlusion of PDA using different types of devices is safe and effective with good midterm outcome alternative to surgery. Complications occurred in those with unfavorable duct anatomy and presence of pulmonary hypertension. Surgical backup was not important for such interventional procedures.     

Multicenter USA Amplatzer patent ductus arteriosus occlusion device trial: initial and one-year results

OBJECTIVES: We sought to review and report initial and one-year efficacy and safety results of the multicenter USA Amplatzer ductal occluder (ADO) device trial. BACKGROUND: Transcatheter closure of a moderate to large patent ductus arteriosus (PDA) using conventional techniques is challenging. The ADO can close a PDA up to 12 mm in diameter. METHODS: From September 1999 to June 2002, 484 patients were enrolled in 25 U.S. centers. Forty-five (9%) of 484 patients did not have ADO implantation, because the PDA was too small or because of elevated pulmonary resistance. The median age of the patients at catheterization was 1.8 years (range 0.2 to 70.7 years), and weight was 11 kg (range 4.5 to 164.5 kg). RESULTS: The median PDA minimal diameter was 2.6 mm (range 0.9 to 11.2 mm); 76 (17%) of 439 were larger than 4.0 mm. Median pulmonary artery mean pressure was 20 mm Hg (range 7 to 80 mm Hg). The ADO was implanted successfully in 435 (99%) of 439 patients, with a median fluoroscopy time of 7.1 min (range 2.9 to 138.4 min). Angiographic demonstration of occlusion was seen in 329 (76%) of 435. This increased to 384 (89%) of 433 on post-catheterization day 1, with occlusion documented in 359 (99.7%) of 360 at one year. At the last evaluation in all patients at any time, PDA closure was documented in 428 (98%) of 435 patients. There have been two cases of partial left pulmonary artery occlusion after ADO implantation and no cases of significant aortic obstruction. CONCLUSIONS: Moderate to large PDAs can be effectively and safely closed using the ADO device, with excellent initial and one-year results. This device should obviate the need for multiple coils or surgical intervention for these defects.     

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 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.