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Year : 2020  |  Volume : 8  |  Issue : 2  |  Page : 80-84

Safety and efficacy of transcatheter device closure of patent ductus arteriosus in pediatric patients: Long-term outcomes

Department of Cardiology, U. N. Mehta Institute of Cardiology and Research Centre, B. J. Medical College, Ahmedabad, Gujarat, India

Date of Submission05-Feb-2020
Date of Decision09-Feb-2020
Date of Acceptance30-Apr-2020
Date of Web Publication4-Aug-2020

Correspondence Address:
Dr. Jayal Hasmukhbhai Shah
Bungalow No. 3, Riviera 30 Society, Near Prahladnagar Auda Garden, Satellite, Ahmedabad - 380 015, Gujarat
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/heartindia.heartindia_6_20

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Aims: Patent ductus arteriosus (PDA) is among the most prevalent congenital heart diseases in current times. The aim of this study is to evaluate contemporarily the safety and efficacy of transcatheter device closure of PDA at long-term follow-up.
Materials and Methods: Transcatheter closure of PDA was attempted in 205 children between 2008 and 2015 using the Amplatzer duct occlude (ADO). Ductal anatomy was accurately delineated on lateral and right anterior oblique view on aortic angiogram. All children underwent complete clinical evaluation, electrocardiography, chest X-rays, and echocardiography prior to discharge and at 1-month, 6-month, and annual follow-up thereafter.
Results: Of a total of 205 cases, 64% were females; the mean age was 7.92 ± 3.61 years (1–17 years), while the mean weight was 16.68 ± 10.82 (5–41 kg). ADOs-I were used in all the cases. The procedure was successful in 99.03% of patients with excellent results. Two patients required surgical closure due to device-induced aortic obstruction and left pulmonary stenosis. There were no cases of procedural deaths, device embolization, device infection, and infective endocarditis. All children fared well at a median follow-up of 94 months with no complications.
Conclusion: The long-term data showed that percutaneous transcatheter closure of PDA using ADO was safe and effective in pediatric population with minimal complications.

Keywords: Long-term follow-up, patent ductus arteriosus, pediatric patients, transcatheter device closure

How to cite this article:
Shah JH, Bhalodiya DK, Pravinchandra AR, Saraiya SP. Safety and efficacy of transcatheter device closure of patent ductus arteriosus in pediatric patients: Long-term outcomes. Heart India 2020;8:80-4

How to cite this URL:
Shah JH, Bhalodiya DK, Pravinchandra AR, Saraiya SP. Safety and efficacy of transcatheter device closure of patent ductus arteriosus in pediatric patients: Long-term outcomes. Heart India [serial online] 2020 [cited 2020 Oct 31];8:80-4. Available from: https://www.heartindia.net/text.asp?2020/8/2/80/291362

  Introduction Top

Patent ductus arteriosus (PDA) accounts for 5%–10% of all congenital heart diseases with an incidence of approximately 1/2000 live births.[1],[2] Transcatheter closure of PDA with Amplatzer occluder was first depicted in 1998.[3] It has emerged as the leading approach for closure of most cases of PDA with excellent results and minimal morbidity.[4],[5],[6],[7],[8],[9],[10],[11],[12],[13],[14],[15] We evaluated the long-term outcomes of percutaneous PDA closure with Amplatzer occluder at our center.

  Materials and Methods Top


A total of 205 children diagnosed with PDA underwent percutaneous device closure between 2008 and 2015 at our center. All the patients had undergone clinical examination, electrocardiography, chest X–rays, and echocardiography prior to ductus closure. Data were collected prospectively from all patients with due informed consent. Transcatheter device closure of PDA was done in any of following: signs of left atrial and left ventricular (LV) volume overload, small defects with continuous murmurs, and patients with pulmonary arterial hypertension but with pulmonary artery pressure <2/3 of systemic pressure. Patients with complex congenital heart disease and those weighing <5 kg were excluded from the study.


All patients underwent the procedure under general anesthesia with inspiratory oxygen regulated between 40% and 55%. The procedure was performed in older children under local anesthesia and mild sedation. All patients were given preprocedural antibiotics and intravenous heparin at a dose of 100 IU/kg (maximum: 5000 IU). After taking hemodynamic recordings, aortic angiography was done in lateral, right anterior oblique and/or left anterior oblique to accurately delineate the ductal anatomy. Transcatheter closure of PDA was done following the standard procedure. The procedure was performed with snare-assisted retrograde technique, in which the conventional antegrade approach failed. The device occluder sizes were at least 2 mm larger than the narrowest ductal diameter. Descending aortic angiography was done 10 min after defect closure with occluder to evaluate residual shunt and device positioning. We also measured the withdrawal pressure in the left pulmonary artery and descending aorta to negate the possibility of obstruction. Hemostasis at access site was achieved with manual compression after the procedure.


The ADO and release system (AGA Medical, Golden Valley, Minnesota, USA) has been widely described.[16],[17],[18]


All patients were discharged on the next day after complete clinical examination, chest X-ray, and transthoracic echocardiography. They were evaluated at 24 h, 1 month, 6 months, and annually thereafter with complete clinical, X-ray, and echocardiography evaluation. Meticulous attention was paid to left pulmonary or aortic obstruction and residual shunting.

Data analysis

Statistical analysis was done with statistical software (IBM SPSS Statistics for Windows, version 19.0. IBM Corp., Armonk, NY, USA). A paired t-test was done to compare two mean values. P < 0.05 was considered as the level of statistical significance. Quantitative data were expressed as mean ± standard deviation.

  Results Top

Demographic data

Transcatheter closure of PDA was attempted in a total of 205 children, which was successful in 99% of patients. A total of 131 female and 74 male patients underwent the procedure. The mean age of patients was 7.92 ± 3.61 years (1–17 years), while the mean weight was 16.68 ± 10.82 (5–41 kg). The New York Heart Association (NYHA) class was I in 76 (37.07%) cases, II in 124 (60.49) cases, and III in 5 (2.44) cases [Table 1].
Table 1: General characteristics

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Procedure data

The mean smallest ductal diameter on aortic angiogram was 5.6 ± 2.43 mm (4–13). ADO-I (AGA Medical, Golden Valley, Minnesota, USA) occluder was used in all the patients with maximum size of 16/14 mm and minimum being 6/4 mm. The mean preprocedural systolic aortic and pulmonary pressures were 123.12 ± 16.12 mmHg and 47.03 ± 13.21 mmHg, respectively. A total of 9 patients had residual shunting at the time of final descending aortic angiography which got diminished during follow-up evaluation. The mean fluoroscopy time was 6.43 ± 3.06 min (4–15), while the mean preprocedural Qp/Qs ratio was 2.96 ± 0.4 (1.5–4.5). The procedure was carried out by a conventional antegrade approach in 92.68% of patients, while snare-assisted retrograde closure was done in the remaining patients [Table 2].
Table 2: Procedural data and devices used

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Two patients suffered notable major complications, namely left pulmonary artery stenosis and aortic obstruction. Deployment of large 16/14 mm ADO-I occluder in the first patient led to impingement and resulting obstruction of the left pulmonary arterial branch with a significant pullback gradient which ultimately required device retrieval and surgical closure. Other patient had significant narrowing of the descending aorta due to large retention skirt of device which led to hypotension and hemodynamic compromise. The patient was successfully managed with surgical removal of the device and closure of the defect. Minor complications such as fever, transient vascular complications, hemolysis, and transient LV dysfunction were also recorded. Transient loss of peripheral pulse at the access site was recorded in 27 (13.17%) patients, which was managed conservatively with heparin infusion. Five patients developed transient LV dysfunction immediately after the procedure which recovered with diuretics and angiotensin-converting enzyme inhibitors. None of the patients had worsened of pulmonary hypertension, device embolization, or mortality after the procedure. There was transient hemolysis in six patients after the procedure which recovered by the following day [Table 3].
Table 3: Complications

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With few exceptions of procedure failure, all children were clinically asymptomatic at long-term follow-up with no worsening of pulmonary vascular disease. None had residual shunting, device embolization, device infection, and infective endocarditis at follow-up evaluation. The procedure was successful in 99.03% of patients with excellent results. There was a significant improvement in patients with postprocedural residual shunting which was not detected on long-term follow-up evaluation [Table 4]. All children were in NYHA class I on follow-up barring one child with bronchial asthma.
Table 4: Follow-up

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  Discussion Top

Since the first successful case of transcatheter PDA closure by Porstmann in 1967, there has been ample amount of progress that been made in device technology and catheter-based therapies for percutaneous closure of PDA.[19] Barring some few cases of ductus with complex anatomy where surgery is the prime modality of closure, all small-to-moderate-sized ductus are amenable to various catheter therapies such as detachable coils, vascular plugs, and occluder devices. This study aims to provide contemporary data related to the safety and efficacy of transcatheter device closure of PDA in children in a large referral center, spanning over a period of over 7 years. Percutaneous device closure of PDA was done in young children with phenomenal success rate and minimal morbidity and no mortality. There are many decisive factors such as vascular accessibility, ductal anatomy, underlying pulmonary hypertension, associated congenital defects, and type of device that predict the successful percutaneous closure of the defect. In the present study, Amplatzer ductal occluders were used in all the patients for transcatheter closure of PDA. The presence of very large defects mandates use of other occluders because 16/14 mm is the largest Amplatzer duct occluder (ADO) available. Due to the failed antegrade approach and the presence of inferior vena caval interruption in one patient, snare-assisted retrograde approach was used in 7.32% of patients. Sometimes, ADO-II devices and coils are also very useful in transcatheter closure of PDA via retrograde aortic approach. As compared to surgery, transcatheter PDA closure has many advantages such as avoidance of cardiopulmonary bypass, reducing hospital stay, no need of blood transfusions, and no patient discomfort. Documented dreaded complications of transcatheter PDA closure include device embolization, device infection, aortic obstruction, hemolysis, and left pulmonary artery stenosis.[20],[21],[22] There was one case in the present study with left pulmonary stenosis and significant pullback gradient after device deployment which was successfully managed with surgical retrieval and closure. Diligent clinical and echocardiographic follow-up is vital to the successful management of such patients. Transient hemolysis following device deployment is rare but can occur probably due to malposition of the device.[23] Trivial-to-mild residual shunting after device deployment is very common, as noted in nine patients in the present study, which disappears in most cases within 24 h of procedure. This incidence is comparable favorably with all major studies.[24],[25] Peculiar problems such as sheath kinking during percutaneous PDA closure are commonly observed in younger individuals due to the presence of a sharp angle between the right ventricular outflow tract and pulmonary artery.[26] This can be avoided using stiffer Cook sheath (Cook Medical, Bloomington, USA) or by snaring the sheath from the retrograde approach. Transient LV systolic dysfunction occurred in five patients in the present study, which recovered successfully with conservative management. Certain factors such as the presence of large shunts, severe pulmonary hypertension, mitral regurgitation, and preexisting LV dysfunction predispose the patients of PDA to postprocedure LV dysfunction. Probable underlying mechanisms include sudden unloading of LV and increased afterload leads to LV systolic dysfunction. Patients with PDA and severe pulmonary hypertension pose unique dilemma in the selection of an optimal strategy for closure. Percutaneous closure in these subsets of patients can be performed after thorough evaluation and under specific conditions after ruling irreversible pulmonary vascular occlusive disease. Transcatheter occlusion of PDA in patients with interrupted inferior vena cava poses extremely challenging difficulty in negotiating the delivery system through the pulmonary artery. In the present study, we encountered a similar problem in one patient which was mitigated successfully by device deployment from the retrograde aortic approach.

  Conclusion Top

Our data suggest that transcatheter closure of PDA is equally safe and efficacious in pediatric patients at long-term follow-up. Expertise and knowledge about different devices including retrieval techniques is paramount to successful ductal closure.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

Ethical Approval

All the procedures in this study were approved by the institutional ethics committee and were in accordance with guidelines provided by the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research involving human beings. All the procedures were in accordance with the Helsinki Declaration of 1975, as revised in 2000.

  References Top

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  [Table 1], [Table 2], [Table 3], [Table 4]


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