IJCA-25528; No of Pages 6 International Journal of Cardiology xxx (2017) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
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Article history: Received 18 March 2017 Received in revised form 23 July 2017 Accepted 5 October 2017 Available online xxxx
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Ozge Pamukcu a,⁎, Aydin Tuncay b, Nazmi Narin a, Ali Baykan a, Levent Korkmaz c, Mustafa Argun a, Abdullah Ozyurt a, Suleyman Sunkak a, Kazim Uzum a Erciyes University School of Medicine, Division of Pediatric Cardiology, Kayseri, Turkiye, Erciyes University School of Medicine, Division of Cardiovascular Surgery, Kayseri, Turkiye Erciyes University School of Medicine, Division of Neonatology, Kayseri, Turkiye
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Patent Ductus Arteriosus closure in preterms less than 2 kg: Surgery versus transcatheter☆
Background: As new devices come into the market, percutaneous techniques improve and interventionalists become more experienced; percutaneous closure gets more common in preterms. In this study we aimed to compare efficacy and safety of Patent Ductus Arteriosus closure surgically versus transcatheter method in preterms b2 kg. Best of our knowledge this study is the first one that compares outcomes of surgery and percutaneous Patent Ductus Arteriosus closure in preterms. Methods & results: Between the dates July 1997 to October 2014 in our center Patent Ductus Arteriosus of 26 patients b2 kg were closed percutaneously (Group A) and 31 less than 2 kg operated (Group B). Weight of patients in percutaneous Patent Ductus Arteriosus closure group was significantly more than the surgery group. Mean gestational age of the patients in Group A was 30 ± 1.8 weeks, in group B was 28.6 ± 3.5 weeks. In group A; all cases were closed successfully except 4 cases: device embolization in 2, cardiac tamponade and iatrogenic aortic coarctation were seen. Pneumomediastinum and chylothorax were the major complications of the surgery group. There was no statistically significance between complication and success rates between two groups. Conclusion: Percutaneous Patent Ductus Arteriosus closure is the candidate for taking the place of surgery in preterms. However, it is not applied routinely; can only be done in fully equipped large centers by experienced interventionalists. © 2017 Published by Elsevier Ireland Ltd.
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Keywords: Patent Ductus Arteriosus Percutaneous Surgery Infant
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1. Introduction
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Symptomatic patients who have Patent Ductus Arteriosus (PDA) should be treated as soon as possible, but the treatment method in preterm infants is a highly controversial topic. Surgical ligation is used for the definitive treatment if medical treatment fails [1,2]. However, in recent years, new devices have come onto the market, percutaneous techniques have improved and interventionalists have become more experienced, which have all led to percutaneous PDA closure gets more common in preterms. In this study, we aimed to compare the success rate, complications in preterms weighing b2 kg whose PDA was closed surgically versus percutaneously.
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☆ All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. ⁎ Corresponding author at: Erciyes University School of Medicine, Division of Pediatric Cardiology, Kayseri 38039, Turkiye. E-mail address: [email protected] (O. Pamukcu).
To the best of our knowledge, this study is the first to compare the 58 outcomes of surgery and percutaneous PDA closure in preterms. 59 2. Patients and methods
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2.1. Patient population
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From March 2012 to April 2016, transcatheter PDA closure was attempted in 26 patients weighing b2 kg in our center. Within this period, only 31 patients weighing b2 kg were operated on for PDA. The study was approved by the local research ethics committee. The data of all patients were reviewed retrospectively. A comparison was made between the data from patients whose PDA were closed percutaneously (Group A) and surgically (Group B). The main inclusion criteria for patients regarding PDA closure (transcatheter or surgical) were: 1) patients who were symptomatic, required intensive care because of the complications of prematurity; 2) patients in whom PDA was thought to be a possible contributor to the medical state of the patient by the consulting neonatologist; 3) patients whose left chambers were enlarged, 4) significant left to right shunt was detected by echocardiography; and 5) persistence of PDA after medical closure. The main exclusion criteria were: 1) to be asymptomatic; 2) to weigh b2 kg; 3) to have bleeding diathesis; and 4) to have sepsis. The decision regarding the way of closure (whether transcatheter or surgical) was made according to the size and shape of the PDA. Large window types were usually referred to surgery. Also, the decision-making
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https://doi.org/10.1016/j.ijcard.2017.10.020 0167-5273/© 2017 Published by Elsevier Ireland Ltd.
Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
O. Pamukcu et al. / International Journal of Cardiology xxx (2017) xxx–xxx
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2.2.1. Percutaneous closure and catheterization Cardiac catheterization was performed under sedation and local anesthesia. Access to a femoral artery was obtained using the Seldinger technique; in some patients, the femoral vein or umbilical vein was used. We did not have routine arterial access in all patients. In recent years, as the devices were improved and as we obtained more experience, only venous access was used. According to the age and weight of the patient, size of sheath differed. All patients were heparinized after the insertion of sheaths. The ones who had arterial sheath were heparinized 100 IU/kg, the ones who only had venous sheath were heparinized 50 IU/kg. The activated clotting time (ACT) was maintained at N250 s during the procedure with iv heparin. Therefore, when the duration of procedure gets longer we check ACT and additional heparin dosages are applied in order to keep ACT N 250 s. Following heparinization and a dose of intravenous antibiotics, angiography was performed. Hemodynamic evaluations (ratio of pulmonary to systemic blood flow (Qp/Qs) and pressure recordings) were not done in all patients because all patients were premature and we wanted to keep the procedure time to a minimum. Angiography was performed in descending aorta using pigtail catheter (Merit Medical, South Jordan, UT), typically using Right Anterior Oblique and lateral projections to profile PDA. Aortography was performed to determine the morphology and size of ductus. In patients without arterial access, we performed aortography after passing through PDA from the pulmonary artery to aorta. According to morphology, ducti were categorized according to Kritchenko et al. [3] classification. The width of aortic, pulmonary sides and length of ductus were measured and appropriate device with appropriate size was chosen. The main types of devices used in our study for percutaneous PDA closure were Amplatzer Ductal Occluders (ADO) (St. Jude Medical, St. Paul, MN). As time progressed during the study period, technology improved new versions of ADO were produced, such as the ADO II and ADO II-Additional size (AS) was used for small ducts as well. The ADO diameter is about 1–1.5 mm larger than the diameter of the narrowest point of the duct. The PDA was closed from the pulmonary or aortic side using the Amplatzer™ TorqVue™ 90° Curve LP (St. Jude Medical, St. Paul, MN) delivery system for all ADO II AS device and Amplatzer™ TorqVue™ 180° Curve (St. Jude Medical, St. Paul, MN) delivery system for ADO 1 device. The stability of the device was assessed by gentle pulling and pushing of the delivery cable. Correct positioning of the device was confirmed by radiocontrast injection through the delivery sheath prior to device release. Angiography was repeated after the device was released to evaluate the presence of residual shunts. After implantation of device, it was checked as to whether there was a pressure gradient on pullback from the ascending aorta to the descending aorta to exclude the presence of an obstruction on aortic side. In patients without arterial access, pressure gradient on aortic side was checked by TTE. Transthoracic Echocardiography was performed to determine whether there was an obstruction of the left pulmonary artery (LPA) and descending aorta immediately after implantation. Follow-up echocardiography was performed on the next day, then 1, 3, 6 months after implantation and yearly thereafter. At each follow-up visit, complications related to ADO implantation were noted.
151 152
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94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137
In the percutaneous group: 10 (38.5%) of 26 patients were female and 16 (61.5%) were male. In the surgery group, 11 (35.5%) of the patients were male and 20 (64.5%) were female. The mean patient age was 27.6 ± 17.9 days in Group A and 31.3 ± 13 days in Group B. The median weight of the patients in Group A was 1455 g (967–1770 g), in Group B was 1254 g (920–1755 g) (Tables 1 and 2). The mean PDA diameter in the percutaneous group was 2 ± 0.62 mm and 2.9 ± 0.49 mm in the surgery group (Table 1). There were no associated heart defects in the percutaneous group; however, 9.6% of patients (n:3) in Group B had additional heart problems like a ventricular septal defect (VSD), atrial septal defect (ASD), or bicuspid aortic valve (BAV). These additional heart defects did not require surgery: VSD was muscular and hemodynamically stable, ASD was 7 mm in size, and there was no aortic insufficiency in patient with BAV. Patients who had other cardiac surgical procedures were excluded from the study. In the percutaneous group, the morphology of PDA was assessed angiographically; 11 of them were Type A and 15 of them were Type C. The types of devices used were: ADO I in 1 patient and ADO II - AS in 25 patients. In the surgery group, we did not perform morphological classification since we did not perform angiography in these cases routinely. The vascular routes used were: umbilical vein in 2 patients, femoral vein in 16, both femoral vein and artery in 8 patients. We performed closure from a femoral venous access in 24 patients, and in 2 patients from umbilical vein. We did not use arterial site for closure as this was usually used for control angiograms. We did not obtain femoral arterial access in 18 patients, which may explain why we did not face with clinical vascular complications. The size of sheaths that we used for venous sites was 4 F in 14, 5 F in 8, 6 F in 1, and 3 F in 3 patients. For arterial sites, 5 patients had 4 F, 1 had 5 F, and 2 had a 3 F sized sheath. The mean procedure time was: 39.3 ± 10.9 min, the mean scopy duration was 15.19 ± 6.46 min, and the mean radiation dosage was 267 ± 17 8 cGy/cm2 (Table 3). The mean amount of contrast used in the percutaneous group was 1.96 ± 0.915 ml. There was no statistically significance between two groups in terms of age, defect size. Only weight of patients in percutaneous Patent Ductus Arteriosus closure group was significantly more than the surgery group (p = 0.004). The mean gestational age of patients in the percutaneous group was 28.3 ± 2.8 weeks and in the surgery group was 28.8 ± 3.46 weeks (Table 4). In the percutaneous group; all PDA were closed successfully in the percutaneous group except 4 cases. Major complications are categorized into 3 groups: a) device embolizations: two had large PDA 4 mm and 3 mm in width. In the patient with 3 mm PDA, 4 × 2 mm ADO II - AS device had been used. Then the device embolized to LPA. 24 h after implantation. The embolized device was captured with a snare catheter and withdrawn. Then, 4 × 4 mm ADO II - AS device was delivered percutaneously. We had no other problems in 12months follow-up interval. In another patient, 4 mm PDA was closed with 6 × 6 mm ADO II - AS device; however, it embolized to the pulmonary artery. Therefore, the patient was referred to surgery and PDA ligation was done. b) cardiac tamponade: during device implantation, TTE was performed. In one patient, we recognized a pericardial effusion before the delivery of the device. As it was increasing, there was a risk of cardiac tamponade and we called the surgeons for evaluation. The surgeons determined that there was a right atrial perforation. They fixed it and PDA ligation was done. c) iatrogenic aortic coarctation: the discs of the ADOII-AS are not large, so risk of aorta and pulmonary artery closure are small; still, iatrogenic aortic coarctation occurred in one patient. The device was removed surgically and the PDA was ligated. No major complications like procedure - related death, clinical vascular complications, hemolysis, thromboembolism, or infective endocarditis were reported during the study period. There were minor complications such as device-related left pulmonary stenosis in 2
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process has changed over time. In earlier days, when we did not have enough experience in transcatheter closure and before the new devices came into the market, we used to perform surgery most often. Nowadays, as we have gained more experience and with the use of improved devices, we prefer transcatheter closure in suitable cases. Patent Ductus Arteriosus shape and diameter were assessed with aortogram. However, angiography was not done routinely in cases that surgery was planned. Therefore, in such cases, the PDA size and shape were determined by transthoracic echocardiography (TTE). The following patient characteristics were recorded: age, weight, sex, non-cardiac medical problems, gestational week, duration of hospitalization, and complications in both groups. The duration of mechanical ventilation, procedure time, fluoroscopy duration, and radiation dosage were also recorded in the percutaneous group. Physical examination, chest radiography, electrocardiography, and TTE were done before each procedure. All the parents were informed about the procedure and its complications, and written consent was obtained before the procedure.
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78 79 80 81 82 83 84 85 86 87 88 89 90 91 92
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2.2.2. Surgery PDA ligation was performed in the operating room. Post-operative follow-up was done by the neonatal intensive care specialist. The ductus was identified and ligated with two strands of 2–0 silk or 3–0 Ticron (Sherwood, Davis & Geck, St. Louis, MO, USA). Hemoclips were used in two patients. A 8-10 French chest tube was inserted routinely in all cases.
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2.3. Statistical analysis
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SPSS for Windows 15.0 program was used for statistical analysis. Distribution of variables was determined using the Shapiro–Wilkstest. Data are expressed as a frequency or percentage for nominal variables, as the median (25th–75th quartile) for categorical variables and as the mean ± SD for continous variables. In all statistical analyses, values of p b 0.05 were considered to be significant.
Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
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O. Pamukcu et al. / International Journal of Cardiology xxx (2017) xxx–xxx t1:1 t1:2
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Table 1 Demographic features of patients in the percutaneous group. Patient No
Weight (gr)
Age (days)
Gestational Week
Diameter of ductus (mm)
Ductus type
Device type
Size of device (mm)
Vascular access
Site of closure
t1:5 t1:6 t1:7 t1:8 t1:9 t1:10 t1:11 t1:12 t1:13 t1:14 t1:15 t1:16 t1:17 t1:18 t1:19 t1:20 t1:21 t1:22 t1:23 t1:24 t1:25 t1:26 t1:27 t1:28 t1:29 t1:30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
850 1450 1600 1460 1000 960 750 970 2000 1500 1300 2000 2000 820 1000 978 1400 1760 910 940 1800 2000 1650 2000 1600 1600
24 15 13 15 24 15 25 10 75 6 21 24 23 23 23 10 18 30 11 30 30 30 45 60 60 60
27 29 28 29 26 26 26 27 29 28 30 32 32 27 26 27 27 32 26 25 33 37 28 27 27 26
2 2.00 2.50 1.60 1.80 1.2 1.80 2.50 1.80 1.60 2.30 3.00 3.00 1.60 2.3 1.7 2.00 4.00 2.60 1.8 2.50 2.20 1.00 1.50 2.00 1.70
Tubular Tubular Conical Tubular Conical Tubular Tubular Conical Conical Conical Conical Tubular Tubular Conical Conical Conical Conical Conical Conical Tubular Tubular Tubular Conical Tubular Conical Conical
ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADO 1 ADOIIAS ADOIIAS ADOIIAS ADOIIAS
5×2 5×2 5×4 3×2 4×2 3×2 3×4 4×2 4×2 5×6 5×4 4×4 4×2 4×2 5×6 3×2 4×4 6×6 5×2 4×2 5×2 5×4 3×4 4×2 3×4 3×4
Venous Venous Venous Venous Venous, Arterial Venous Venous Venous Venous Venous Venous Venous, Arterial Venous Venous Umbilical Venous Venous Venous, Arterial Umbilical Venous, Arterial Venous Venous, Arterial Venous, Arterial Venous Venous, Arterial Venous, Arterial
Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Umblikal Venous Venous Venous Umblikal Venous Venous Venous Venous Venous Venous Venous
t2:1 t2:2
Table 2 Demographic features and length of hospital stay of patients in the surgery group. Patient no
Age (days)
Weight (gr)
Diameter of ductus (mm)
Gestational week
t2:4 t2:5 t2:6 t2:7 t2:8 t2:9 t2:10 t2:11 t2:12 t2:13 t2:14 t2:15 t2:16 t2:17 t2:18 t2:19 t2:20 t2:21 t2:22 t2:23 t2:24 t2:25 t2:26 t2:27 t2:28 t2:29 t2:30 t2:31 t2:32 t2:33 t2:34
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
34 19 28 29 32 24 25 33 23 31 31 43 21 15 33 41 44 63 48 39 26 21 34 27 4 23 33 20 66 23 30
810 2000 1400 1000 990 940 1900 600 970 810 1150 1300 1990 1940 830 700 890 1300 780 1320 630 2000 930 800 1000 1210 1525 1254 800 1750 1760
2 2.3 1.9 4 2.8 3.2 3.5 3.6 3.5 2.7 3 2.7 2.7 3 3 3 2.7 2.5 2 3.2 3.4 3 2.5 3 2.7 3 3 3 2 2.3 4
26 37 38 24 28 28 32 28 28 24 27 30 33 34 26 26 28 30 24 29 25 31 26 28 30 28 30 28 26 30 32
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Length of hospital stay (days) 60 48 48 30 90 56 12 32 72 33 62 74 54 20 60 150 150 99 119 52 300 96 77 146 5 68 44 86 102 48
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We faced with major complications in 2 patients in the surgery group, including pneumomediastinum and chylothorax which were resolved with appropriate treatment. No minor complications were reported. When success rate of percutaneous PDA closure was compared with the surgery group, no statistically significant difference was found between them, indicating that surgery and percutaneous PDA closure do not have superiority over one another in preterms weighing b2 kg. All cases in the percutaneous group, except 3 (because of necrotizing enterocolitis or thrombocytopenia) were given 3 courses of ibuprofen treatment. Thirty-one patients in the surgery group had taken ibuprofen for PDA (1 of them took 3 courses; 3 of them had 2 courses). Twentyeight patients had undergone decongestive treatment before surgery. Since the patients weighed b2 kg, most of them required additional medical support because of the complications of prematurity. In the percutaneous group, 20 patients were on mechanical ventilation and 14 of them were extubated after PDA closure. One of the patients was on nasal continuous positive airway pressure and weaned after PDA closure. One patient died 1 month after PDA closure because of severe lung problems, sepsis and multiorgan failure. There were no procedurerelated deaths. Six patients in the percutaneous group suffered from Respiratory Distress Syndrome (RDS) Type1 or 3 and had intraventricular hemorrhage (IVH), one had hydrocephaly secondary to intraventricular bleeding, and one had necrotizing enterocolitis (NEC). Retinopathy of prematurity (ROP) was found in 6 patients. Additionally, one had congenital pneumonia and one had inguinal hernia. The length of hospital stay in the percutaneous group was 60 ± 38 days. Four patients were referred to our center for percutaneous closure. After the procedure, they were followed for 48 h in our center, and then sent back to their hospital. In the surgery group, most of the patients (n:26) had other health problems related to prematurity such as RDS (n:13), IVH (n:1), hydrocephaly (n:2), both NEC and RDS (n:1), pneumothorax (n:2), ROP (n:2); in addition, 5 patients had RDS, pneumothorax and ROP. These additional health problems prolonged the duration of hospital stay. The mean length of hospital stays in the surgery group was 76 ± 56 days. Five of the patients (16.6%) in the surgery group died because of additional health problems, including sepsis in 2, RDS in 1, and heart and respiratory failure in 2. Only 1 patient died in the percutaneous
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patients. The pressure gradient in LPA was checked before deployment of the device in each case. Even through there was no pressure gradient detected initially, LPA stenosis was detected in 2 patients after implantation of the device by Doppler; this was 14 mm Hg atmost. After 6 months of follow-up, stenosis had resolved spontaneously in all cases.
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Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
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O. Pamukcu et al. / International Journal of Cardiology xxx (2017) xxx–xxx
Table 3 Catheterization data, complications, length of hospital stay, Follow-up duration of patients in the percutaneous group. Procedure Time (min)
Scopy duration (min)
Dosage Of radiation (cGycm2)
Major complications
Minor Complications
Length of hospital stay
Duration of follow-up (months)
t3:5 t3:6 t3:7 t3:8
1 2 3 4
45 30 30 39
19 20 20 16
294 130 130 402
None None None None
Still In Hospital Still In Hospital Still In Hospital Unknownb
1 2 2 3
t3:9 t3:10 t3:11 t3:12 t3:13 t3:14 t3:15 t3:16 t3:17
5 6 7 8 9 10 11 12 13
26 50 45 36 42 30 50 50 40
8 13 19 7 19 14 10 33 8
49.1 115 294 151 636 108 326 709 302
None None None LPAa stenosis None None None None None
57 10 43 43 62 72 52 4 4
did not come to controls 5 5 6 12 10 11 12 12
t3:18 t3:19 t3:20 t3:21 t3:22
14 15 16 17 18
45 70 30 40 40
10 22 12 11 26
60 285 67 123 491
None None None None None
Unknownb 146 Unknownb 53 48
did not come to controls 16 19 18 19
t3:23 t3:24 t3:25 t3:26 t3:27 t3:28 t3:29 t3:30
19 20 21 22 23 24 25 26
59 39 30 32 32 34 43 26
8 20 11 20 16 12 22 9
65 409 422 409 248 291 314 167
None None None Operated for cardiac tamponade and PDA was ligated None None None None None Operated for Coarctation of aorta None None Embolised to Pulmonary artery, new device implanted None None None None Embolised to Pulmonary artery, surgical closure was done None None None None None None None None
25 53 Unknownb 35 76 85 142 93
Exitus 24 18 38 60 37 42 48
t3:31 t3:32
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4. Discussion
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Surgical PDA closure in preterms is thought to be the definitive treatment if medical therapy fails. Percutaneous PDA closure has not been frequently mentioned as a treatment option for preterms, because it was not well-known, is technically challenging and interventionalists do not have a great deal of experience with it. Transcatheter closure of the PDA was first described in1967 and preferred as a method of treatment for children beyond the neonatal period [4]. As the interventionalists get more experienced and new techniques, devices were developed; it becomes much more common and accepted
t4:1 t4:2
Table 4 Comparison of demographic features of 2 groups.
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266 267
261 262
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LPA: left pulmonary artery. Unknown: patients were sent to their hospitals where they were referred to us for the procedure. We can not gather data for their rest hospitalization period from those hospitals.
group. He died 5 days after angiography, as his lungs did not ventilate well even with high frequency ventilation. The mean follow-up period of the patients in the percutaneous group was 18.8 ± 16.3 months (minimum: 1 month, maximum: 60 months). One patient died, 2 patients were still in hospital, and one patient was living in a different city so did not come to our center for follow-up. Most of the patients in the surgery group did not attend regular follow-up appointments. The follow-up records were not good, so we could not gather enough information to assess these data.
259 260
None None None None None None LPAa stenosis None
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Patient No
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t3:3 t3:4
t4:3 t4:4 t4:5 t4:6 t4:7 t4:8
Female/male Age (days) (mean ± SD) Gestational week Weight (gr) (median, range) PDAb diameter (mm)
t4:9 t4:10
a b
a
Percutaneous group (n = 26)
Surgery group (n = 31)
P value
10/16 27.6 ± 17.9 days 30 ± 1.8 1455 g (967–1770) 2 ± 0.62 mm
11/20 31.3 ±13 days 28.6 ± 3.5 1254 g (920–1755) 2.9 ± 0.49 mm
N0.05 N0.05 N0.05 =0.004 N0.05
P value b 0.05 is accepted as statistically significant. PDA: Patent Ductus Arteriosus.
as a third treatment option for PDA closure. A few case reports were reported concerning percutaneous closure in low birth weight infants [5–7]. Major problem in preterms is that they usually suffer from the complications of prematurity like bronchopulmonary dysplasia (BPD), NEC, ROP, cerebral hypoperfusion, and IVH. PDA itself also has a contribution to these complications like adversely affects the regional blood flow, resulting in NEC, hypoperfusion to kidney, increases oxygen requirement, prolongs the ventilation and increases the risk for BPD [8]. Although PDA ligation is the definitive treatment, there are few comparisons between early surgical ligation and other treatment modalities for symptomatic PDA in the available literature. But up to our knowledge, there is no study that compares the outcomes of surgery and percutaneous PDA closure in preterms. It is by sure that surgical ligation minimizes the hazardous effects of PDA in preterms however; the benefits or side effects of surgical ligation in preterm infants are not known well. Surgery is accepted as a safe procedure for mature infants. Mavroudis et al. reported the surgical procedural success rate to be 100% with a morbidity rate of 4.4% and mortality rate of 0% in a singleinstitution cohort over a 46-year period [9]. However, the conditions are different for infants weighing b2 kg who have additional health problems due to the complications of prematurity and are therefore too risky for surgery. Patients are at risk postoperatively for a significant decrease in left ventricular output and hypoperfusion, because of decreased left ventricle preload and increased systemic vascular resistance [10]. It has also been proposed that surgical ligation may contribute to brain injury due to the intraoperative compromise of cerebral oxygen saturation and postoperative hemodynamic instability. In the literature, there are the reports suggesting that surgery impedes lung growth [11], increases the risk for poor neurodevelopmental outcome, BPD, and severe ROP as compared to medically treated infants [12]. Kabra et al. [13] studied surgical PDA ligation in 110 extremely low birth weight infants with symptomatic PDA. They showed that surgery was a strong risk factor for neurosensory impairment at 18 months, also
Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
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coils were used for closure. Nowadays, with the improvement of devices, the residual shunt rate has significantly decreased. In our study, the PDA of all 23 patients was closed successfully without a residual shunt. No signs of protrusion or obstruction of the discs were observed in the echocardiographic examination. There was no procedure-related major complication in our patients. However, left pulmonary stenosis was detected in two patients after implantation of the device. In the follow-up, stenosis was resolved spontaneously in all cases within six months. Wang et al. compared catheterization therapy with surgical closure of PDA in a meta-analysis. They found that there was not a significant difference in the success rate, post-procedure complications, or blood transfusion between surgical and percutaneous PDA closure. In addition, the incidence of post-procedure residual shunts was higher in the catheterization group, but the length of hospital stay was shorter when compared to the surgical closure group [21]. Cost effectiveness plays an important role in making decisions regarding PDA closure, whether by surgery or transcatheter. Recently, due to the development of transaxillary muscle-sparing thoracotomy and the technique of video-assisted thoracoscopic ligation of a PDA, the morbidity rate has been reduced, the hospital stay has been shortened, and the cost-effectiveness of surgery has increased. Although surgery seems to be less expensive than the device closure technique, because of its lower mortality and morbidity rates, the latter technique remains preferable [22]. Percutaneous PDA closure should be the candidate of choice for this surgery in preterms. However, it is still not applied routinely, and can only be done in fully equipped large centers by experienced interventionalists.
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C
321 322
E
319 320
R
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contrary to popular belief it had increased the risks of bronchopulmonary dysplasia and of severe retinopathy of prematurity. However, it had beneficial effects on survival. There are also some researchers who believe that these morbidities can occur before, during, or after PDA treatment and thus may be confounders in some infants. It was found that it is necessary to obtain data on the timing and severity of respiratory failure, interventricular hemorrhage, necrotizing enterocolitis, and sepsis relative to surgical ligation, to correct for possible bias due to these potential confounders in multivariable analyses examining the impact of surgical PDA ligation [14]. Tashiro et al. [15] emphasized that morbidity and mortality are not affected by the timing of surgery. Body weight, rather than gestational age, determines the survival of infants undergoing surgery. The possible risks of surgery of preterm infants direct clinicians to search for alternative treatment modalities, like transcatheter closure. Percutaneous PDA closure in preterms used to be considered a difficult and challenging procedure. Previously, Francis et al. reported the occlusion of PDA in eight preterms with coils. They demonstrated the feasibility and safety of transcatheter occlusion in selected sick preterm newborns. They claim that procedural risks can be minimized and the success rate can be increased by paying attention to anatomic details and planning the hardware before starting the procedure [16]. In our study, we implemented appropriate planning before the procedure. Before percutaneous closure, we evaluated the size and shape of the PDA by aortography and then chose the device. Proper device selection for appropriate patients plays an important role. There are various devices available, including coils and Amplatzer ductal occluders. The use of coils, when compared to other devices, is potentially cheaper for ductal closure. However, the procedure may be complicated by a significant residual leak rate, which may require a second procedure, although this may be less likely with a smaller ductus [17]. In addition, larger ducti often require additional coils with increased procedure time, complexity, and radiation exposure, as well as migration problems [18,19]. Amplatzer ductal occluders are apropriate for larger ducti. The Amplatzer Ductal Occluder I and Amplatzer Ductal Occluder II are commonly used. In preterm and low birth weight infants, the main problem is the size of the sheath and protrusion of the disc into the aorta and pulmonary artery. Therefore, new devices were produced to decrease this protrusion, like the Amplatzer Ductal Occluder II additional size (St. Jude Medical, Plymouth, MN), with smaller angled retention disks. The removal of the occlusive material made for a flexible device with a smaller profile that could be delivered from the aortic or pulmonary side. Compatible with the literature, initially we used Amplatzer duct occluders; more recently, we prefer Amplatzer Ductal Occluder II additional size devices. The advantages of catheterization-based PDA closure include a high success rate, shorter length of hospital stay, reduced blood loss, low morbidity rate, and no traumatic scars. Since the length of hospital stay decreases with catheterization, it is much more cost effective than surgery. In this retrospective study, percutaneous PDA closure in infants weighing b2 kg was found to be as effective as surgery. There was no statistically significant difference between the two groups in terms of age and PDA diameter so we excluded the bias relating to them. However, bodyweight and gestational age of the patients in the surgery group were significantly lower than the percutaneous group. This probably affects the success rate of the surgical procedure in a negative way which was also mentioned in the study limitations. In our study major complications of surgery: pneumomediastinum and chylothorax which delayed the extubation time. The period of mechanical ventilator support of these patients also duration of hospital stay was increased because of these complications. These complications did not resolve spontaneously but with appropriate treatment. But, we found no statistically significant differences in major and minor complication rates between the percutaneous and surgery groups. In previous studies that compared the results of PDA ligation with percutaneous PDA closure, the residual shunt rates were higher in the catheter group [20]. However, these data are from earlier times when
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This was a retrospective study. It would be better to compare 2 groups in terms of post procedure extubation time, ventilator settings etc. however; medical follow-up records were not obtained for the patients who underwent surgery, so we could not compare these data. Moreover, our hospital conditions are not suitable for bedside surgical closure. Therefore, all the operations were done in the surgical suite, which increases the rate of morbidity and mortality associated with the surgery. Bodyweight and gestational ages of the patients in the surgery group were significantly lower than the percutaneous group. This probably affects the success rate of the surgical procedure in a negative way. Moreover; the number of patients included in the study was limited. Perhaps by increasing the number of patients in both groups healthier results we can gather.
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In conclusion, transcatheter closure of PDA in preterms weighing b2 kg is a safe, effective treatment option and an alternative to surgery. We do not claim that it is safer or more effective than surgery, but we want to emphasize that, in experienced centers, these methods are equivalent.
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None. References [1] J.L. Grosfeld, M. Chaet, F. Molinari, W. Engle, S.A. Engum, K.W. West, F.J. Rescorla, et al., Increased risk of necrotizing enterocolitis in premature infants with patent ductus arteriosus treated with indomethacin, Ann. Surg. 224 (3) (1996) 350–357. [2] G. Cassady, D.R. Crouse, J.W. Kriklin, M.J. Strange, C.H. Joiner, G. Godoy, G.T. Odrezin, et al., A randomized controlled trial of very early prophylactic ligation of the ductus arteriosus in babies who weighed 1000 g or less at birth, N. Engl. J. Med. 320 (23) (1989) 1511–1516.
Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
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weight infants: results from the trial of indomethacin prophylaxis in preterms, J. Pediatr. 150 (3) (2007) 229–234. D.E. Weisz, P.J. McNamara, Patent ductus arteriosus ligation and adverse outcomes: causality or bias? J. Clin. Neonatol. 3 (2) (2014) 67–75, https://doi.org/10.4103/ 2249-4847.134670. J. Tashiro, B. Wang, J.E. Sola, A.R. Hogan, H.L. Neville, E.A. Perez, Patent ductus arteriosus ligation in premature infants in the United States, J. Surg. Res. 190 (2) (2014) 613–622, https://doi.org/10.1016/j.jss.2014.02.003. E. Francis, A.K. Singhi, S. Lakshmivenkateshaiah, R.K. Kumar, Transcatheter occlusion of patent ductus arteriosus in pre-term infants, J. Am. Coll. Cardiol. Intv. 3 (5) (2010) 550–555. F.F. Ing, R.J. Sommer, The snare-assisted technique for transcatheter coil occlusion of moderate to large patent ductus arteriosus: immediate and intermediate results, J. Am. Coll. Cardiol. 33 (6) (1999) 1710–1718. Z.M. Hijazi, R.L. Geggel, Transcatheter closure of large patent ductus arteriosus (N or = 4 mm) with multiple Gianturco coils: immediate and mid-term results, Heart 76 (6) (1996) 536–540. H.T. Patel, Q.L. Cao, J. Rhodes, Z.M. Hijazi, Long-term outcome of transcatheter coil closure of small to large patent ductus arteriosus, Catheter. Cardiovasc. Interv. 47 (4) (1999) 457–461. P. Roberts, S. Adwani, N. Archer, N. Wilson, Catheter closure of arterial duct in preterm infants, Arch. Dis. Child. Fetal Neonatal Ed. 92 (4) (2007) 248–250. K. Wang, X. Pan, Q. Tang, Y. Pang, Catheterization therapy vs. surgical closure in pediatric patients with patent ductus arteriosus: a meta-analysis, Clin. Cardiol. 37 (3) (2014) 188–194, https://doi.org/10.1002/clc.22238. A. Ahmadi, M. Sabri, H. Bigdelian, B. Dehghan, M. Gharipour, Comparison of costeffectiveness and postoperative outcome of device closure and open surgeryclosure techniques for treatment of patent ductus arteriosus, Atherosclerosis 10 (1) (2014) 37–40.
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[3] A. Krichenko, L.N. Benson, P. Burrows, C.A. Moes, P. McLaughlin, R.M. Freedon, Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion, Am. J. Cardiol. 63 (1989) 877–879. [4] W. Porstmann, L. Wierny, H. Warnke, Closure of persistent ductus arteriosus without thoracotomy, Ger. Med. Mon. 12 (6) (1967) 259–261. [5] Z.M. Hijazi, T.R. Lloyd, R.H. Beekman, R.L. Geggel, Transcatheter closure with single or multiple Gianturco coil of patent ductus arteriosus in infants weighing b8 kg: retrograde versus anterograde approach, Am. Heart 132 (4) (1996) 827–835. [6] N. Haneda, F. Kato, S.-H. Kim, Coil closure of a large patent arterial duct in a lowbirthweight infant, Pediatr. Int. 44 (3) (2002) 317–320. [7] R. Thukaram, W.A. Suarez, S. Sundararaghavan, Transcatheter closure of the patent arterial duct using the flipper coil in a premature infant weighing 1,400 g: a case report, Catheter. Cardiovasc. Interv. 66 (1) (2005) 18–20. [8] H.J. Lee, G.H. Sim, K.E. Jung, J.A. Lee, C.W. Choi, E.K. Kim, H.S. Kim, et al., Delayed closure effect in preterm infants with patent ductus arteriosus, Korean J. Pediatr. 51 (1) (2008) 1065–1070. [9] C. Mavroudis, C.L. Backer, M. Gevitz, Forty-six years of patient ductus arteriosus division at Children's Memorial Hospital of Chicago. Standards for comparison, Ann. Surg. 220 (3) (1994) 402–409. [10] A.F. El-Khuffash, A. Jain, P.J. McNamara, Ligation of the patent ductus arteriosus in preterm infants: understanding the physiology, J. Pediatr. 162 (6) (2013) 1100–1106. [11] L.Y. Chang, D. McCurnin, B. Yoder, P.W. Shaul, R.I. Clyman, Ductus arteriosus ligation and alveolar growth in preterm baboons with a patent ductus arteriosus, Pediatr. Res. 63 (3) (2008) 299–302. [12] J.C. Madan, D. Kendrick, J.I. Hagadorn, I.D. Frantz 3rd, Patent ductus arteriosus therapy: impact on neonatal and 18-month outcome, Pediatrics 123 (2) (2009) 674–681. [13] N.S. Kabra, B. Schmidt, R.S. Roberts, Doyle, L. Papile, A. Fanaroff, Neurosensory impairment after surgical closure of patent ductus arteriosus in extremely low birth
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Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
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Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
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Article history: Received 18 March 2017 Received in revised form 23 July 2017 Accepted 5 October 2017 Available online xxxx
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Ozge Pamukcu a,⁎, Aydin Tuncay b, Nazmi Narin a, Ali Baykan a, Levent Korkmaz c, Mustafa Argun a, Abdullah Ozyurt a, Suleyman Sunkak a, Kazim Uzum a Erciyes University School of Medicine, Division of Pediatric Cardiology, Kayseri, Turkiye, Erciyes University School of Medicine, Division of Cardiovascular Surgery, Kayseri, Turkiye Erciyes University School of Medicine, Division of Neonatology, Kayseri, Turkiye
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Patent Ductus Arteriosus closure in preterms less than 2 kg: Surgery versus transcatheter☆
Background: As new devices come into the market, percutaneous techniques improve and interventionalists become more experienced; percutaneous closure gets more common in preterms. In this study we aimed to compare efficacy and safety of Patent Ductus Arteriosus closure surgically versus transcatheter method in preterms b2 kg. Best of our knowledge this study is the first one that compares outcomes of surgery and percutaneous Patent Ductus Arteriosus closure in preterms. Methods & results: Between the dates July 1997 to October 2014 in our center Patent Ductus Arteriosus of 26 patients b2 kg were closed percutaneously (Group A) and 31 less than 2 kg operated (Group B). Weight of patients in percutaneous Patent Ductus Arteriosus closure group was significantly more than the surgery group. Mean gestational age of the patients in Group A was 30 ± 1.8 weeks, in group B was 28.6 ± 3.5 weeks. In group A; all cases were closed successfully except 4 cases: device embolization in 2, cardiac tamponade and iatrogenic aortic coarctation were seen. Pneumomediastinum and chylothorax were the major complications of the surgery group. There was no statistically significance between complication and success rates between two groups. Conclusion: Percutaneous Patent Ductus Arteriosus closure is the candidate for taking the place of surgery in preterms. However, it is not applied routinely; can only be done in fully equipped large centers by experienced interventionalists. © 2017 Published by Elsevier Ireland Ltd.
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Keywords: Patent Ductus Arteriosus Percutaneous Surgery Infant
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1. Introduction
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Symptomatic patients who have Patent Ductus Arteriosus (PDA) should be treated as soon as possible, but the treatment method in preterm infants is a highly controversial topic. Surgical ligation is used for the definitive treatment if medical treatment fails [1,2]. However, in recent years, new devices have come onto the market, percutaneous techniques have improved and interventionalists have become more experienced, which have all led to percutaneous PDA closure gets more common in preterms. In this study, we aimed to compare the success rate, complications in preterms weighing b2 kg whose PDA was closed surgically versus percutaneously.
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☆ All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. ⁎ Corresponding author at: Erciyes University School of Medicine, Division of Pediatric Cardiology, Kayseri 38039, Turkiye. E-mail address: [email protected] (O. Pamukcu).
To the best of our knowledge, this study is the first to compare the 58 outcomes of surgery and percutaneous PDA closure in preterms. 59 2. Patients and methods
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2.1. Patient population
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From March 2012 to April 2016, transcatheter PDA closure was attempted in 26 patients weighing b2 kg in our center. Within this period, only 31 patients weighing b2 kg were operated on for PDA. The study was approved by the local research ethics committee. The data of all patients were reviewed retrospectively. A comparison was made between the data from patients whose PDA were closed percutaneously (Group A) and surgically (Group B). The main inclusion criteria for patients regarding PDA closure (transcatheter or surgical) were: 1) patients who were symptomatic, required intensive care because of the complications of prematurity; 2) patients in whom PDA was thought to be a possible contributor to the medical state of the patient by the consulting neonatologist; 3) patients whose left chambers were enlarged, 4) significant left to right shunt was detected by echocardiography; and 5) persistence of PDA after medical closure. The main exclusion criteria were: 1) to be asymptomatic; 2) to weigh b2 kg; 3) to have bleeding diathesis; and 4) to have sepsis. The decision regarding the way of closure (whether transcatheter or surgical) was made according to the size and shape of the PDA. Large window types were usually referred to surgery. Also, the decision-making
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https://doi.org/10.1016/j.ijcard.2017.10.020 0167-5273/© 2017 Published by Elsevier Ireland Ltd.
Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
O. Pamukcu et al. / International Journal of Cardiology xxx (2017) xxx–xxx
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2.2.1. Percutaneous closure and catheterization Cardiac catheterization was performed under sedation and local anesthesia. Access to a femoral artery was obtained using the Seldinger technique; in some patients, the femoral vein or umbilical vein was used. We did not have routine arterial access in all patients. In recent years, as the devices were improved and as we obtained more experience, only venous access was used. According to the age and weight of the patient, size of sheath differed. All patients were heparinized after the insertion of sheaths. The ones who had arterial sheath were heparinized 100 IU/kg, the ones who only had venous sheath were heparinized 50 IU/kg. The activated clotting time (ACT) was maintained at N250 s during the procedure with iv heparin. Therefore, when the duration of procedure gets longer we check ACT and additional heparin dosages are applied in order to keep ACT N 250 s. Following heparinization and a dose of intravenous antibiotics, angiography was performed. Hemodynamic evaluations (ratio of pulmonary to systemic blood flow (Qp/Qs) and pressure recordings) were not done in all patients because all patients were premature and we wanted to keep the procedure time to a minimum. Angiography was performed in descending aorta using pigtail catheter (Merit Medical, South Jordan, UT), typically using Right Anterior Oblique and lateral projections to profile PDA. Aortography was performed to determine the morphology and size of ductus. In patients without arterial access, we performed aortography after passing through PDA from the pulmonary artery to aorta. According to morphology, ducti were categorized according to Kritchenko et al. [3] classification. The width of aortic, pulmonary sides and length of ductus were measured and appropriate device with appropriate size was chosen. The main types of devices used in our study for percutaneous PDA closure were Amplatzer Ductal Occluders (ADO) (St. Jude Medical, St. Paul, MN). As time progressed during the study period, technology improved new versions of ADO were produced, such as the ADO II and ADO II-Additional size (AS) was used for small ducts as well. The ADO diameter is about 1–1.5 mm larger than the diameter of the narrowest point of the duct. The PDA was closed from the pulmonary or aortic side using the Amplatzer™ TorqVue™ 90° Curve LP (St. Jude Medical, St. Paul, MN) delivery system for all ADO II AS device and Amplatzer™ TorqVue™ 180° Curve (St. Jude Medical, St. Paul, MN) delivery system for ADO 1 device. The stability of the device was assessed by gentle pulling and pushing of the delivery cable. Correct positioning of the device was confirmed by radiocontrast injection through the delivery sheath prior to device release. Angiography was repeated after the device was released to evaluate the presence of residual shunts. After implantation of device, it was checked as to whether there was a pressure gradient on pullback from the ascending aorta to the descending aorta to exclude the presence of an obstruction on aortic side. In patients without arterial access, pressure gradient on aortic side was checked by TTE. Transthoracic Echocardiography was performed to determine whether there was an obstruction of the left pulmonary artery (LPA) and descending aorta immediately after implantation. Follow-up echocardiography was performed on the next day, then 1, 3, 6 months after implantation and yearly thereafter. At each follow-up visit, complications related to ADO implantation were noted.
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In the percutaneous group: 10 (38.5%) of 26 patients were female and 16 (61.5%) were male. In the surgery group, 11 (35.5%) of the patients were male and 20 (64.5%) were female. The mean patient age was 27.6 ± 17.9 days in Group A and 31.3 ± 13 days in Group B. The median weight of the patients in Group A was 1455 g (967–1770 g), in Group B was 1254 g (920–1755 g) (Tables 1 and 2). The mean PDA diameter in the percutaneous group was 2 ± 0.62 mm and 2.9 ± 0.49 mm in the surgery group (Table 1). There were no associated heart defects in the percutaneous group; however, 9.6% of patients (n:3) in Group B had additional heart problems like a ventricular septal defect (VSD), atrial septal defect (ASD), or bicuspid aortic valve (BAV). These additional heart defects did not require surgery: VSD was muscular and hemodynamically stable, ASD was 7 mm in size, and there was no aortic insufficiency in patient with BAV. Patients who had other cardiac surgical procedures were excluded from the study. In the percutaneous group, the morphology of PDA was assessed angiographically; 11 of them were Type A and 15 of them were Type C. The types of devices used were: ADO I in 1 patient and ADO II - AS in 25 patients. In the surgery group, we did not perform morphological classification since we did not perform angiography in these cases routinely. The vascular routes used were: umbilical vein in 2 patients, femoral vein in 16, both femoral vein and artery in 8 patients. We performed closure from a femoral venous access in 24 patients, and in 2 patients from umbilical vein. We did not use arterial site for closure as this was usually used for control angiograms. We did not obtain femoral arterial access in 18 patients, which may explain why we did not face with clinical vascular complications. The size of sheaths that we used for venous sites was 4 F in 14, 5 F in 8, 6 F in 1, and 3 F in 3 patients. For arterial sites, 5 patients had 4 F, 1 had 5 F, and 2 had a 3 F sized sheath. The mean procedure time was: 39.3 ± 10.9 min, the mean scopy duration was 15.19 ± 6.46 min, and the mean radiation dosage was 267 ± 17 8 cGy/cm2 (Table 3). The mean amount of contrast used in the percutaneous group was 1.96 ± 0.915 ml. There was no statistically significance between two groups in terms of age, defect size. Only weight of patients in percutaneous Patent Ductus Arteriosus closure group was significantly more than the surgery group (p = 0.004). The mean gestational age of patients in the percutaneous group was 28.3 ± 2.8 weeks and in the surgery group was 28.8 ± 3.46 weeks (Table 4). In the percutaneous group; all PDA were closed successfully in the percutaneous group except 4 cases. Major complications are categorized into 3 groups: a) device embolizations: two had large PDA 4 mm and 3 mm in width. In the patient with 3 mm PDA, 4 × 2 mm ADO II - AS device had been used. Then the device embolized to LPA. 24 h after implantation. The embolized device was captured with a snare catheter and withdrawn. Then, 4 × 4 mm ADO II - AS device was delivered percutaneously. We had no other problems in 12months follow-up interval. In another patient, 4 mm PDA was closed with 6 × 6 mm ADO II - AS device; however, it embolized to the pulmonary artery. Therefore, the patient was referred to surgery and PDA ligation was done. b) cardiac tamponade: during device implantation, TTE was performed. In one patient, we recognized a pericardial effusion before the delivery of the device. As it was increasing, there was a risk of cardiac tamponade and we called the surgeons for evaluation. The surgeons determined that there was a right atrial perforation. They fixed it and PDA ligation was done. c) iatrogenic aortic coarctation: the discs of the ADOII-AS are not large, so risk of aorta and pulmonary artery closure are small; still, iatrogenic aortic coarctation occurred in one patient. The device was removed surgically and the PDA was ligated. No major complications like procedure - related death, clinical vascular complications, hemolysis, thromboembolism, or infective endocarditis were reported during the study period. There were minor complications such as device-related left pulmonary stenosis in 2
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process has changed over time. In earlier days, when we did not have enough experience in transcatheter closure and before the new devices came into the market, we used to perform surgery most often. Nowadays, as we have gained more experience and with the use of improved devices, we prefer transcatheter closure in suitable cases. Patent Ductus Arteriosus shape and diameter were assessed with aortogram. However, angiography was not done routinely in cases that surgery was planned. Therefore, in such cases, the PDA size and shape were determined by transthoracic echocardiography (TTE). The following patient characteristics were recorded: age, weight, sex, non-cardiac medical problems, gestational week, duration of hospitalization, and complications in both groups. The duration of mechanical ventilation, procedure time, fluoroscopy duration, and radiation dosage were also recorded in the percutaneous group. Physical examination, chest radiography, electrocardiography, and TTE were done before each procedure. All the parents were informed about the procedure and its complications, and written consent was obtained before the procedure.
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2.2.2. Surgery PDA ligation was performed in the operating room. Post-operative follow-up was done by the neonatal intensive care specialist. The ductus was identified and ligated with two strands of 2–0 silk or 3–0 Ticron (Sherwood, Davis & Geck, St. Louis, MO, USA). Hemoclips were used in two patients. A 8-10 French chest tube was inserted routinely in all cases.
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SPSS for Windows 15.0 program was used for statistical analysis. Distribution of variables was determined using the Shapiro–Wilkstest. Data are expressed as a frequency or percentage for nominal variables, as the median (25th–75th quartile) for categorical variables and as the mean ± SD for continous variables. In all statistical analyses, values of p b 0.05 were considered to be significant.
Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
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Table 1 Demographic features of patients in the percutaneous group. Patient No
Weight (gr)
Age (days)
Gestational Week
Diameter of ductus (mm)
Ductus type
Device type
Size of device (mm)
Vascular access
Site of closure
t1:5 t1:6 t1:7 t1:8 t1:9 t1:10 t1:11 t1:12 t1:13 t1:14 t1:15 t1:16 t1:17 t1:18 t1:19 t1:20 t1:21 t1:22 t1:23 t1:24 t1:25 t1:26 t1:27 t1:28 t1:29 t1:30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
850 1450 1600 1460 1000 960 750 970 2000 1500 1300 2000 2000 820 1000 978 1400 1760 910 940 1800 2000 1650 2000 1600 1600
24 15 13 15 24 15 25 10 75 6 21 24 23 23 23 10 18 30 11 30 30 30 45 60 60 60
27 29 28 29 26 26 26 27 29 28 30 32 32 27 26 27 27 32 26 25 33 37 28 27 27 26
2 2.00 2.50 1.60 1.80 1.2 1.80 2.50 1.80 1.60 2.30 3.00 3.00 1.60 2.3 1.7 2.00 4.00 2.60 1.8 2.50 2.20 1.00 1.50 2.00 1.70
Tubular Tubular Conical Tubular Conical Tubular Tubular Conical Conical Conical Conical Tubular Tubular Conical Conical Conical Conical Conical Conical Tubular Tubular Tubular Conical Tubular Conical Conical
ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADOIIAS ADO 1 ADOIIAS ADOIIAS ADOIIAS ADOIIAS
5×2 5×2 5×4 3×2 4×2 3×2 3×4 4×2 4×2 5×6 5×4 4×4 4×2 4×2 5×6 3×2 4×4 6×6 5×2 4×2 5×2 5×4 3×4 4×2 3×4 3×4
Venous Venous Venous Venous Venous, Arterial Venous Venous Venous Venous Venous Venous Venous, Arterial Venous Venous Umbilical Venous Venous Venous, Arterial Umbilical Venous, Arterial Venous Venous, Arterial Venous, Arterial Venous Venous, Arterial Venous, Arterial
Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Venous Umblikal Venous Venous Venous Umblikal Venous Venous Venous Venous Venous Venous Venous
t2:1 t2:2
Table 2 Demographic features and length of hospital stay of patients in the surgery group. Patient no
Age (days)
Weight (gr)
Diameter of ductus (mm)
Gestational week
t2:4 t2:5 t2:6 t2:7 t2:8 t2:9 t2:10 t2:11 t2:12 t2:13 t2:14 t2:15 t2:16 t2:17 t2:18 t2:19 t2:20 t2:21 t2:22 t2:23 t2:24 t2:25 t2:26 t2:27 t2:28 t2:29 t2:30 t2:31 t2:32 t2:33 t2:34
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
34 19 28 29 32 24 25 33 23 31 31 43 21 15 33 41 44 63 48 39 26 21 34 27 4 23 33 20 66 23 30
810 2000 1400 1000 990 940 1900 600 970 810 1150 1300 1990 1940 830 700 890 1300 780 1320 630 2000 930 800 1000 1210 1525 1254 800 1750 1760
2 2.3 1.9 4 2.8 3.2 3.5 3.6 3.5 2.7 3 2.7 2.7 3 3 3 2.7 2.5 2 3.2 3.4 3 2.5 3 2.7 3 3 3 2 2.3 4
26 37 38 24 28 28 32 28 28 24 27 30 33 34 26 26 28 30 24 29 25 31 26 28 30 28 30 28 26 30 32
R
N C O
U
R
t2:3
Length of hospital stay (days) 60 48 48 30 90 56 12 32 72 33 62 74 54 20 60 150 150 99 119 52 300 96 77 146 5 68 44 86 102 48
O
R O
P
D
We faced with major complications in 2 patients in the surgery group, including pneumomediastinum and chylothorax which were resolved with appropriate treatment. No minor complications were reported. When success rate of percutaneous PDA closure was compared with the surgery group, no statistically significant difference was found between them, indicating that surgery and percutaneous PDA closure do not have superiority over one another in preterms weighing b2 kg. All cases in the percutaneous group, except 3 (because of necrotizing enterocolitis or thrombocytopenia) were given 3 courses of ibuprofen treatment. Thirty-one patients in the surgery group had taken ibuprofen for PDA (1 of them took 3 courses; 3 of them had 2 courses). Twentyeight patients had undergone decongestive treatment before surgery. Since the patients weighed b2 kg, most of them required additional medical support because of the complications of prematurity. In the percutaneous group, 20 patients were on mechanical ventilation and 14 of them were extubated after PDA closure. One of the patients was on nasal continuous positive airway pressure and weaned after PDA closure. One patient died 1 month after PDA closure because of severe lung problems, sepsis and multiorgan failure. There were no procedurerelated deaths. Six patients in the percutaneous group suffered from Respiratory Distress Syndrome (RDS) Type1 or 3 and had intraventricular hemorrhage (IVH), one had hydrocephaly secondary to intraventricular bleeding, and one had necrotizing enterocolitis (NEC). Retinopathy of prematurity (ROP) was found in 6 patients. Additionally, one had congenital pneumonia and one had inguinal hernia. The length of hospital stay in the percutaneous group was 60 ± 38 days. Four patients were referred to our center for percutaneous closure. After the procedure, they were followed for 48 h in our center, and then sent back to their hospital. In the surgery group, most of the patients (n:26) had other health problems related to prematurity such as RDS (n:13), IVH (n:1), hydrocephaly (n:2), both NEC and RDS (n:1), pneumothorax (n:2), ROP (n:2); in addition, 5 patients had RDS, pneumothorax and ROP. These additional health problems prolonged the duration of hospital stay. The mean length of hospital stays in the surgery group was 76 ± 56 days. Five of the patients (16.6%) in the surgery group died because of additional health problems, including sepsis in 2, RDS in 1, and heart and respiratory failure in 2. Only 1 patient died in the percutaneous
E
T
218 219
patients. The pressure gradient in LPA was checked before deployment of the device in each case. Even through there was no pressure gradient detected initially, LPA stenosis was detected in 2 patients after implantation of the device by Doppler; this was 14 mm Hg atmost. After 6 months of follow-up, stenosis had resolved spontaneously in all cases.
C
216 217
E
215
F
t1:3 t1:4
Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
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4 t3:1 t3:2
O. Pamukcu et al. / International Journal of Cardiology xxx (2017) xxx–xxx
Table 3 Catheterization data, complications, length of hospital stay, Follow-up duration of patients in the percutaneous group. Procedure Time (min)
Scopy duration (min)
Dosage Of radiation (cGycm2)
Major complications
Minor Complications
Length of hospital stay
Duration of follow-up (months)
t3:5 t3:6 t3:7 t3:8
1 2 3 4
45 30 30 39
19 20 20 16
294 130 130 402
None None None None
Still In Hospital Still In Hospital Still In Hospital Unknownb
1 2 2 3
t3:9 t3:10 t3:11 t3:12 t3:13 t3:14 t3:15 t3:16 t3:17
5 6 7 8 9 10 11 12 13
26 50 45 36 42 30 50 50 40
8 13 19 7 19 14 10 33 8
49.1 115 294 151 636 108 326 709 302
None None None LPAa stenosis None None None None None
57 10 43 43 62 72 52 4 4
did not come to controls 5 5 6 12 10 11 12 12
t3:18 t3:19 t3:20 t3:21 t3:22
14 15 16 17 18
45 70 30 40 40
10 22 12 11 26
60 285 67 123 491
None None None None None
Unknownb 146 Unknownb 53 48
did not come to controls 16 19 18 19
t3:23 t3:24 t3:25 t3:26 t3:27 t3:28 t3:29 t3:30
19 20 21 22 23 24 25 26
59 39 30 32 32 34 43 26
8 20 11 20 16 12 22 9
65 409 422 409 248 291 314 167
None None None Operated for cardiac tamponade and PDA was ligated None None None None None Operated for Coarctation of aorta None None Embolised to Pulmonary artery, new device implanted None None None None Embolised to Pulmonary artery, surgical closure was done None None None None None None None None
25 53 Unknownb 35 76 85 142 93
Exitus 24 18 38 60 37 42 48
t3:31 t3:32
a
268
4. Discussion
269 270
277
Surgical PDA closure in preterms is thought to be the definitive treatment if medical therapy fails. Percutaneous PDA closure has not been frequently mentioned as a treatment option for preterms, because it was not well-known, is technically challenging and interventionalists do not have a great deal of experience with it. Transcatheter closure of the PDA was first described in1967 and preferred as a method of treatment for children beyond the neonatal period [4]. As the interventionalists get more experienced and new techniques, devices were developed; it becomes much more common and accepted
t4:1 t4:2
Table 4 Comparison of demographic features of 2 groups.
273 274 275 276
E
R
R
O
C
271 272
N
265
U
263 264
C
266 267
261 262
O
R O
P
E
LPA: left pulmonary artery. Unknown: patients were sent to their hospitals where they were referred to us for the procedure. We can not gather data for their rest hospitalization period from those hospitals.
group. He died 5 days after angiography, as his lungs did not ventilate well even with high frequency ventilation. The mean follow-up period of the patients in the percutaneous group was 18.8 ± 16.3 months (minimum: 1 month, maximum: 60 months). One patient died, 2 patients were still in hospital, and one patient was living in a different city so did not come to our center for follow-up. Most of the patients in the surgery group did not attend regular follow-up appointments. The follow-up records were not good, so we could not gather enough information to assess these data.
259 260
None None None None None None LPAa stenosis None
T
258
b
F
Patient No
D
t3:3 t3:4
t4:3 t4:4 t4:5 t4:6 t4:7 t4:8
Female/male Age (days) (mean ± SD) Gestational week Weight (gr) (median, range) PDAb diameter (mm)
t4:9 t4:10
a b
a
Percutaneous group (n = 26)
Surgery group (n = 31)
P value
10/16 27.6 ± 17.9 days 30 ± 1.8 1455 g (967–1770) 2 ± 0.62 mm
11/20 31.3 ±13 days 28.6 ± 3.5 1254 g (920–1755) 2.9 ± 0.49 mm
N0.05 N0.05 N0.05 =0.004 N0.05
P value b 0.05 is accepted as statistically significant. PDA: Patent Ductus Arteriosus.
as a third treatment option for PDA closure. A few case reports were reported concerning percutaneous closure in low birth weight infants [5–7]. Major problem in preterms is that they usually suffer from the complications of prematurity like bronchopulmonary dysplasia (BPD), NEC, ROP, cerebral hypoperfusion, and IVH. PDA itself also has a contribution to these complications like adversely affects the regional blood flow, resulting in NEC, hypoperfusion to kidney, increases oxygen requirement, prolongs the ventilation and increases the risk for BPD [8]. Although PDA ligation is the definitive treatment, there are few comparisons between early surgical ligation and other treatment modalities for symptomatic PDA in the available literature. But up to our knowledge, there is no study that compares the outcomes of surgery and percutaneous PDA closure in preterms. It is by sure that surgical ligation minimizes the hazardous effects of PDA in preterms however; the benefits or side effects of surgical ligation in preterm infants are not known well. Surgery is accepted as a safe procedure for mature infants. Mavroudis et al. reported the surgical procedural success rate to be 100% with a morbidity rate of 4.4% and mortality rate of 0% in a singleinstitution cohort over a 46-year period [9]. However, the conditions are different for infants weighing b2 kg who have additional health problems due to the complications of prematurity and are therefore too risky for surgery. Patients are at risk postoperatively for a significant decrease in left ventricular output and hypoperfusion, because of decreased left ventricle preload and increased systemic vascular resistance [10]. It has also been proposed that surgical ligation may contribute to brain injury due to the intraoperative compromise of cerebral oxygen saturation and postoperative hemodynamic instability. In the literature, there are the reports suggesting that surgery impedes lung growth [11], increases the risk for poor neurodevelopmental outcome, BPD, and severe ROP as compared to medically treated infants [12]. Kabra et al. [13] studied surgical PDA ligation in 110 extremely low birth weight infants with symptomatic PDA. They showed that surgery was a strong risk factor for neurosensory impairment at 18 months, also
Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
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O
R O
331 332
P
329 330
D
327 328
E
325 326
coils were used for closure. Nowadays, with the improvement of devices, the residual shunt rate has significantly decreased. In our study, the PDA of all 23 patients was closed successfully without a residual shunt. No signs of protrusion or obstruction of the discs were observed in the echocardiographic examination. There was no procedure-related major complication in our patients. However, left pulmonary stenosis was detected in two patients after implantation of the device. In the follow-up, stenosis was resolved spontaneously in all cases within six months. Wang et al. compared catheterization therapy with surgical closure of PDA in a meta-analysis. They found that there was not a significant difference in the success rate, post-procedure complications, or blood transfusion between surgical and percutaneous PDA closure. In addition, the incidence of post-procedure residual shunts was higher in the catheterization group, but the length of hospital stay was shorter when compared to the surgical closure group [21]. Cost effectiveness plays an important role in making decisions regarding PDA closure, whether by surgery or transcatheter. Recently, due to the development of transaxillary muscle-sparing thoracotomy and the technique of video-assisted thoracoscopic ligation of a PDA, the morbidity rate has been reduced, the hospital stay has been shortened, and the cost-effectiveness of surgery has increased. Although surgery seems to be less expensive than the device closure technique, because of its lower mortality and morbidity rates, the latter technique remains preferable [22]. Percutaneous PDA closure should be the candidate of choice for this surgery in preterms. However, it is still not applied routinely, and can only be done in fully equipped large centers by experienced interventionalists.
T
323 324
C
321 322
E
319 320
R
318
R
316 317
N C O
314 315
contrary to popular belief it had increased the risks of bronchopulmonary dysplasia and of severe retinopathy of prematurity. However, it had beneficial effects on survival. There are also some researchers who believe that these morbidities can occur before, during, or after PDA treatment and thus may be confounders in some infants. It was found that it is necessary to obtain data on the timing and severity of respiratory failure, interventricular hemorrhage, necrotizing enterocolitis, and sepsis relative to surgical ligation, to correct for possible bias due to these potential confounders in multivariable analyses examining the impact of surgical PDA ligation [14]. Tashiro et al. [15] emphasized that morbidity and mortality are not affected by the timing of surgery. Body weight, rather than gestational age, determines the survival of infants undergoing surgery. The possible risks of surgery of preterm infants direct clinicians to search for alternative treatment modalities, like transcatheter closure. Percutaneous PDA closure in preterms used to be considered a difficult and challenging procedure. Previously, Francis et al. reported the occlusion of PDA in eight preterms with coils. They demonstrated the feasibility and safety of transcatheter occlusion in selected sick preterm newborns. They claim that procedural risks can be minimized and the success rate can be increased by paying attention to anatomic details and planning the hardware before starting the procedure [16]. In our study, we implemented appropriate planning before the procedure. Before percutaneous closure, we evaluated the size and shape of the PDA by aortography and then chose the device. Proper device selection for appropriate patients plays an important role. There are various devices available, including coils and Amplatzer ductal occluders. The use of coils, when compared to other devices, is potentially cheaper for ductal closure. However, the procedure may be complicated by a significant residual leak rate, which may require a second procedure, although this may be less likely with a smaller ductus [17]. In addition, larger ducti often require additional coils with increased procedure time, complexity, and radiation exposure, as well as migration problems [18,19]. Amplatzer ductal occluders are apropriate for larger ducti. The Amplatzer Ductal Occluder I and Amplatzer Ductal Occluder II are commonly used. In preterm and low birth weight infants, the main problem is the size of the sheath and protrusion of the disc into the aorta and pulmonary artery. Therefore, new devices were produced to decrease this protrusion, like the Amplatzer Ductal Occluder II additional size (St. Jude Medical, Plymouth, MN), with smaller angled retention disks. The removal of the occlusive material made for a flexible device with a smaller profile that could be delivered from the aortic or pulmonary side. Compatible with the literature, initially we used Amplatzer duct occluders; more recently, we prefer Amplatzer Ductal Occluder II additional size devices. The advantages of catheterization-based PDA closure include a high success rate, shorter length of hospital stay, reduced blood loss, low morbidity rate, and no traumatic scars. Since the length of hospital stay decreases with catheterization, it is much more cost effective than surgery. In this retrospective study, percutaneous PDA closure in infants weighing b2 kg was found to be as effective as surgery. There was no statistically significant difference between the two groups in terms of age and PDA diameter so we excluded the bias relating to them. However, bodyweight and gestational age of the patients in the surgery group were significantly lower than the percutaneous group. This probably affects the success rate of the surgical procedure in a negative way which was also mentioned in the study limitations. In our study major complications of surgery: pneumomediastinum and chylothorax which delayed the extubation time. The period of mechanical ventilator support of these patients also duration of hospital stay was increased because of these complications. These complications did not resolve spontaneously but with appropriate treatment. But, we found no statistically significant differences in major and minor complication rates between the percutaneous and surgery groups. In previous studies that compared the results of PDA ligation with percutaneous PDA closure, the residual shunt rates were higher in the catheter group [20]. However, these data are from earlier times when
U
312 313
5
378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405
4.1. Limitations
406
This was a retrospective study. It would be better to compare 2 groups in terms of post procedure extubation time, ventilator settings etc. however; medical follow-up records were not obtained for the patients who underwent surgery, so we could not compare these data. Moreover, our hospital conditions are not suitable for bedside surgical closure. Therefore, all the operations were done in the surgical suite, which increases the rate of morbidity and mortality associated with the surgery. Bodyweight and gestational ages of the patients in the surgery group were significantly lower than the percutaneous group. This probably affects the success rate of the surgical procedure in a negative way. Moreover; the number of patients included in the study was limited. Perhaps by increasing the number of patients in both groups healthier results we can gather.
407 408
5. Conclusion
420
In conclusion, transcatheter closure of PDA in preterms weighing b2 kg is a safe, effective treatment option and an alternative to surgery. We do not claim that it is safer or more effective than surgery, but we want to emphasize that, in experienced centers, these methods are equivalent.
421
Conflict of interest
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None. References [1] J.L. Grosfeld, M. Chaet, F. Molinari, W. Engle, S.A. Engum, K.W. West, F.J. Rescorla, et al., Increased risk of necrotizing enterocolitis in premature infants with patent ductus arteriosus treated with indomethacin, Ann. Surg. 224 (3) (1996) 350–357. [2] G. Cassady, D.R. Crouse, J.W. Kriklin, M.J. Strange, C.H. Joiner, G. Godoy, G.T. Odrezin, et al., A randomized controlled trial of very early prophylactic ligation of the ductus arteriosus in babies who weighed 1000 g or less at birth, N. Engl. J. Med. 320 (23) (1989) 1511–1516.
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[3] A. Krichenko, L.N. Benson, P. Burrows, C.A. Moes, P. McLaughlin, R.M. Freedon, Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion, Am. J. Cardiol. 63 (1989) 877–879. [4] W. Porstmann, L. Wierny, H. Warnke, Closure of persistent ductus arteriosus without thoracotomy, Ger. Med. Mon. 12 (6) (1967) 259–261. [5] Z.M. Hijazi, T.R. Lloyd, R.H. Beekman, R.L. Geggel, Transcatheter closure with single or multiple Gianturco coil of patent ductus arteriosus in infants weighing b8 kg: retrograde versus anterograde approach, Am. Heart 132 (4) (1996) 827–835. [6] N. Haneda, F. Kato, S.-H. Kim, Coil closure of a large patent arterial duct in a lowbirthweight infant, Pediatr. Int. 44 (3) (2002) 317–320. [7] R. Thukaram, W.A. Suarez, S. Sundararaghavan, Transcatheter closure of the patent arterial duct using the flipper coil in a premature infant weighing 1,400 g: a case report, Catheter. Cardiovasc. Interv. 66 (1) (2005) 18–20. [8] H.J. Lee, G.H. Sim, K.E. Jung, J.A. Lee, C.W. Choi, E.K. Kim, H.S. Kim, et al., Delayed closure effect in preterm infants with patent ductus arteriosus, Korean J. Pediatr. 51 (1) (2008) 1065–1070. [9] C. Mavroudis, C.L. Backer, M. Gevitz, Forty-six years of patient ductus arteriosus division at Children's Memorial Hospital of Chicago. Standards for comparison, Ann. Surg. 220 (3) (1994) 402–409. [10] A.F. El-Khuffash, A. Jain, P.J. McNamara, Ligation of the patent ductus arteriosus in preterm infants: understanding the physiology, J. Pediatr. 162 (6) (2013) 1100–1106. [11] L.Y. Chang, D. McCurnin, B. Yoder, P.W. Shaul, R.I. Clyman, Ductus arteriosus ligation and alveolar growth in preterm baboons with a patent ductus arteriosus, Pediatr. Res. 63 (3) (2008) 299–302. [12] J.C. Madan, D. Kendrick, J.I. Hagadorn, I.D. Frantz 3rd, Patent ductus arteriosus therapy: impact on neonatal and 18-month outcome, Pediatrics 123 (2) (2009) 674–681. [13] N.S. Kabra, B. Schmidt, R.S. Roberts, Doyle, L. Papile, A. Fanaroff, Neurosensory impairment after surgical closure of patent ductus arteriosus in extremely low birth
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6
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494
Please cite this article as: O. Pamukcu, et al., Patent Ductus Arteriosus closure in preterms less than 2kg: Surgery versus transcatheter, Int J Cardiol (2017), https://doi.org/10.1016/j.ijcard.2017.10.020
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