Journal of Pediatric Surgery 49 (2014) 363–366
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Outcomes of thoracoscopic clipping versus transcatheter occlusion of patent ductus arteriosus: Randomized clinical trial Nguyen Thanh Liem a,⁎, Cao Viet Tung b, Nguyen Van Linh c, To Manh Tuan c, Le Hong Quang b, Tran Thanh Tu d a
Vinmec International Hospital, Hanoi, Vietnam Cardiology Department, National Hospital of Pediatrics, Hanoi, Vietnam, Hanoi, Vietnam Department of Surgery, National Hospital of Pediatrics, Hanoi, Vietnam d Research Institute for Child Health, National Hospital of Pediatrics, Hanoi, Vietnam b c
a r t i c l e
i n f o
Article history: Received 22 March 2013 Accepted 13 September 2013 Key words: Patent ductus arteriosus Thoracoscopic Transcatheter occlusion
a b s t r a c t Aim: To compare outcomes of thoracoscopic clipping (TC) versus transcatheter occlusion (TO) for patent ductus arteriosus (PDA). Patients and methods: One hundred patients were enrolled in the study from May 2010 to December 2011. Those patients were randomized into 2 groups: group one received TC, group two received TO. Result: There were no significant differences concerning width or length of the ductus (P N 0.05). However the median age and median weight of patients in the TO group were greater than in the TC group (P b 0.05). Mean operative time was 32 ± 12 min in the TC group versus 20 ± 3 min in the TO group (P b 0.05). There were no deaths in either group. There were no complications in the TC group whereas three patients in the TO group had complications and required subsequent operation. Median postoperative stay was 3.5 days (IQR: 3.0–4.3) in the TC group versus 3 days (IQR: 2.0–4.0) in the TO group (P b 0.05). There was no residual shunting in either group. Average cost for one patient was $645 ± 232 in the TC group versus $1260 ± 204 in the TO group (P b 0.001). Conclusion: Thoracoscopic clipping is safer than transcatheter occlusion for PDA repair, with the same effectiveness and lower cost. © 2014 Elsevier Inc. All rights reserved.
PDA is a common type of congenital heart disease [1]. Division of the ductus via thoracotomy has been a standard treatment for many years [2]. However long term morbidities such as chest wall and spinal deformity associated with thoracotomy have been reported [3,4]. Transcatheter occlusion (TO) of PDA was first introduced in 1967 [5] and has become a common procedure [6–10]. In 1993, Laborde first introduced the technique of thoracoscopic clipping (TC) for PDA [11]. This approach has been applied successfully in many centers [12–17]. Both TC and TO have many advantages in comparison with classic thoracotomy. However, which procedure is better and preferable for PDA repair? So far no randomized clinical trial has been carried out to compare outcomes of these two methods. The aim of this study was to compare outcomes of TC versus TO for PDA with a randomized study.
1. Patients and methods One hundred patients with PDA admitted at the National Hospital of Pediatrics in Hanoi, Vietnam from May 2010 to December 2011 met the inclusion criteria and were enrolled in this study. Patients were randomized into two groups: group 1 underwent TC, group 2 underwent TO. Randomization was done by shuffled sealed envelopes, opened by a cardiologist after confirming the diagnosis. TC was performed by one of two experienced thoracoscopic surgeons. TO was performed by one of two experienced cardiac interventionists. Inclusion criteria: − − − −
Sex: Both sexes Ages: 3 months–3 years old Diameter of PDA ≤ 8 mm Weight N 4 kg Exclusion criteria:
⁎ Corresponding author. National Hospital of Pediatrics, Hanoi, Vietnam. Fax: +84 4 6273 8648. E-mail address: [email protected] (N.T. Liem). 0022-3468/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpedsurg.2013.09.007
− Diameter of PDA N 8 mm − Weight ≤ 4 kg − Associated cardiac anomalies
364
N.T. Liem et al. / Journal of Pediatric Surgery 49 (2014) 363–366
Outcome variables: Duration of intervention, complications during and after intervention, need for subsequent open surgery, residual shunt after intervention evaluated by echocardiography before discharge and 3 months after discharge, postoperative stay and postintervention hospital stay, hospital cost including lab tests, consumable materials, medicines, bed charges, etc. The PDA inside diameter was measured by Echo in both groups. The duration of intervention was calculated from the insertion of cannulation to the removal of cannulation. The operative time was calculated from skin incision to skin closure. Recurrent laryngeal injury was defined if patient’s voice was postoperatively changed during crying evaluated by patient’s parent. Costs were calculated based on regulations of Vietnam Ministry of Finance including the cost for lab tests, imaging examinations, consumable materials, and hospital stay fee. Fig. 2. The ductus was pulled forward with a thread of Vicryl.
1.1. Follow-up and end point 1.3. Technique of transcatheter occlusion All patients were checked by clinical examination and echocardiography before discharge and 3 months after discharge.
1.2. Technique of thoracoscopic clipping The patient was anesthetized with single lung ventilation then placed in the right lateral position. The surgeon and assistant stood at the patient’s feet. A monitor was placed at the patient’s head. The operation was performed using 4 trocars. The initial 5 mm trocar was inserted through the 8th intercostal space in the midaxillary line for the scope. The second trocar (5 mm for instrument and clip applier) was introduced through the 7th intercostal space in the postaxillary line. The third trocar (3 mm for instruments) was inserted through the 7th intercostal space in the anterioaxillary line, and the fourth trocar (3 mm for lung retractor) in the third intercostal space in the anterioraxillary line (Fig. 1). CO2 pressure was maintained between 4 and 6 mmHg with a flow rate of 1–2 L/min. The pleura was incised and dissected to expose the ductus, the vagal nerve, and recurrent laryngeal nerve. The ductus was detached from surrounding tissue, isolated, and pulled forward with a thread (Fig. 2). The ductus was clipped with one or two clips (Weck He-mo-lock) (Fig. 3).
Fig. 1. Patient and trocar position.
With the patient under general anesthesia, both the femoral artery and vein of the right groin were cannulated using a 4 Fr sheath in the artery and a 6 Fr sheath for the vein. A 4 Fr pigtail was used for left heart study and aortography. The selected Amplatzer device size (the pulmonary end) was at least 2 mm larger than the narrowest PDA diameter. If the pulmonary end diameter was less than 2 mm, the duct was occluded with Flipper coil. A 4 Fr multi- purpose catheter was advanced from the venous side through the PDA into the descending aorta and then was changed for the delivery sheath and dilator over a 0.035 inch exchange guide wire. The dilator was then removed, leaving the sheath in the descending aorta. Under fluoroscopy, the device was implanted. Aortography was carried out to verify the position of the device. If the position was satisfactory, the device was then released. The pigtail catheter was replaced by a 4 Fr right coronary catheter when Flipper coil occlusion was attempted. The ductus was first crossed with a guide wire, then with the catheter and the guide wire was removed. The tip of the catheter was left in the main pulmonary artery. The Flipper coil and the delivery system were loaded into the catheter. The delivery system was advanced to protrude a full loop of the coil into the main pulmonary artery. The catheter and delivery system were pulled back through the ductus, until the extruded loop of the coil was resisted at the pulmonary end of the ductus. The delivery catheter was carefully withdrawn across the ductus into the descending aorta. The catheter was withdrawn proximally to an attachment point of the coil. The delivery system was advanced to form remaining loops in the aortic end of the ductus. The coil was positioned but attached to the delivery system. One loop of the coil in
Fig. 3. A clip is passed through the lower port of the ductus.
N.T. Liem et al. / Journal of Pediatric Surgery 49 (2014) 363–366
the pulmonary artery and the remaining loops in the aortic end of the ductus were accepted as the optimal coil position and then the Flipper Coil was detached. Aortography was performed 10 min after detachment of the coil. 1.4. Ethics The study protocol was approved by the hospital ethic committee. A written consent was obtained from the family of each patient. 1.5. Statistical analysis Average and Student’s t test were used for normally distributed data and median and Mann–Whitney were used for abnormally distributed data. Significance was defined as P value less than 0.05. 2. Results The patients’ main characteristics are seen in Table 1. There were no significant differences between the two groups concerning width or length of the ductus (P N 0.05). However patient age and patient weight in the TC group were significantly higher than in TO. Clinical outcomes for each group are presented in Table 2. Devices were dislodged in three patients in the TO group requiring open surgery. The devices were slipped into the aorta near the location of PDA in two patients. The devices were retrieved and PDA was divided on the same time via thoracotomy. The device was dislodged to the femoral artery in one patient. PDA was managed via thoracotomy and the device was removed via arteriotomy. All three patients recovered well after surgery. Average cost for one patient was $645 ± 232 in the TC group versus $1260 ± 204 in the TO group (P b 0.001) (costs are expressed in US dollars). 3. Discussion This is the first randomized clinical trial to compare outcomes of TC and TO. In our study, the mean time for TC is 12 min longer than in the TO group (32 min ± 12 versus 20 min ± 3). The difference is significant from a statistical point of view, but of little practical importance. In the series of Dutta, the mean operative time in the TC group was 94 min ± 34 versus 50 min ± 23 in the TO group [18]. Chen also noticed that the operative time was longer in the TC group in comparison with the TO group (90.9 min versus 60.4 min) [19]. The mean operative time for TC in our series was much shorter than in other series. The volume of patients could be an important factor to reduce the operative time. The operative time for TC was also short in other reports with big volume of patients [15,17]. Injury of the recurrence nerve was a common complication in the thoracoscopic approach. However this complication was not encountered in our series. Careful dissection and pulling the ductus forward with a portion of Vicryl before clipping could be an important factor to avoid this complication. TC is a safe approach for PDA. There were no deaths. The rate of complication was lower than the TO group. No patient in the TC group
Table 1 Patient characteristics. Characteristic
TC group
TO group
Age (month)
8.0 (IQR: 5.0–14.3) 6.0 (IQR: 5.0–8.2) 6.79 ± 1.69 7.14 ± 1.88
12.0 (IQR: 7.0–21.3) 8.0 (IQR: 6.0–9.6) 7.12 ± 2.32 7.28 ± 1.86
Weight (kg) Duct size (mm) Duct length (mm)
P 0.028 b0.001 0.43 0.71
365
Table 2 Clinical outcomes and cost in TC and TO.
Operative time (min) Need for subsequent open surgery Occluder dislodged Thromboembolism Complications or death Death Bleeding Blood transfusion Recurrent laryngeal dysfunction Pleural effusion or pneumothorax Residual shunt Postoperative hospital stay (days)
TC group (n = 50)
TO group (n = 50)
P
32 ± 12 0
20 ± 3 3
b0.001
0 0
2 1
0 0 0 0
0 0 0 0
0
0
0 3.5 (IQR: 3.0–4.3)
0 3.0 (IQR: 2.0–4.0)
0.02
required a second operation whereas three patients with severe complications in the TO group required an open surgery. Chen also showed that the rate of complications was higher in the TO group than the TC group (10.2% versus 1.5%) [19]. Our results also revealed that TC is an effective procedure for PDA. There was no residual shunting in any patient. TC effectiveness was equal or higher when compared to the TO technique. The rate of residual shunt was 0% in the TC group and 4.1% in the TO group in the Chen study [19]. The postoperative stay in both groups is short. However, it was lightly longer in the TC group (3.5 vs 3.0 days). Intervention cost in the TO group was twice that of the TC group. Chen also mentioned that the cost was more expensive for the TO procedure in comparison with the TC operation (3415.8$ ± 637.3 versus $1309.4 ± 312.2) [19]. Our results revealed that TC is superior to TO in the management of PDA. However there is a limitation in our study. The sample size of the study is not great enough according to statistical calculation. This may explain some differences between the two groups concerning patient age and patient weight. In conclusion with experienced surgeons, TC is safer than TO for PDA repair. It has the same effectiveness but lower cost. Moreover, it avoids radiation for both medical staff and the patient.
References [1] Schneider DJ, Moore JW. Patent ductus arteriosus. Circulation 2006;114(17): 1873–82. [2] Gross RE. Surgical management of the patent ductus arteriosus with summary of four surgical treated cases. Ann Surg 1939;110(3):321–56. [3] Jaureguizar E, Vazquez J, Murcia J, et al. Morbid musculoskeletal sequelae of thoracotomy for tracheoesophageal fistula. J Pediatr Surg 1985;20(5):511–4. [4] Westfelt JN, Nordwall A. Thoracotomy and scoliosis. Spine 1991;16(9):1124–5. [5] Porstmann W, Wierny L, Warnke H, et al. Catheter closure of patent ductus arteriosus. 62 cases treated without thoracotomy. Radiol Clin North Am 1971;9: 203–18. [6] Park YA, Kim NK, Park SJ, et al. Clinical outcome of transcatheter closure of patent ductus arteriosus in small children weighting 10 kg or less. Korean J Pediatr 2010;53:1012–7. [7] Forsey J, Kenny D, Morgan G. Early clinical experience with the new Amplatzer Ductal Occluder II for closure of the persistent arterial duct. Catheter Cardiovasc Interv 2009;74:615–23. [8] Dua J, Chessa M, Piazza L, et al. Initial experience with the new Amplazer Duct Occluer II. J Invasive Cardiol 2009;21:401–5. [9] Dimas VV, Takao C, Ing FF, et al. Outcomes of transcatheter occlusion of patent ductus arteriosus in infants weighing ≤ 6 kg. J Cardio Vasc Interv 2010;3(12): 1295–9. [10] Azhar AS, Abd El-Azim AA, Habib HS. Transcatheter closure of patent ductus arteriosus: evaluating the effect of the learning curve on the outcome. Ann Pediatr Cardiol 2009;2:36–40. [11] Laborde F, Noirhomme P, Karam J, et al. A new video-assisted thoracoscopic surgical technique for interruption of patient ductus arteriosus in infants and children. J Thorac Cardiovasc Surg 1993;105:278–80.
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[12] Rothenberg SS. Thoracoscopic closure of patent ductus arteriosus: a less traumatic and more costeffective technique. J Pediatr Surg 1995;30:1057–60. [13] Burke RP, Jacobs JP, Cheng W, et al. Video-assisted thoracoscopic surgery for patent ductus arteriosus in low birth weight neonates and infants. Pediatrics 1999;104:227–30. [14] Nezafati MH, Mahmoodi E, Hashemian SH, et al. Video-assisted thoracoscopic surgical (VATS) closure of Patent Ductus Arteriosus: report of three-hundred cases. Heart Surg Forum 2002;5:57–9. [15] Villa E, Vanden Eynden F, Le Bret E, et al. F.Paediatric video-assisted thoracoscopic clipping of patent ductus arteriosus: experience in more than 700 cases. Eur J Cardiothorac Surg 2004;25:387–93.
[16] Vanamo K, Berg E, Kokki H, et al. Video-assisted thoracoscopic versus open surgery for persistent ductus arteriosus. Eur J Cardiothorac Surg 2004;25:387–93. [17] Nezafati MH, Soltani G, Vedadian A. Video-assisted ductal closure with new modifications: minimally invasive, maximally effective, 1,300 cases. J Pediatr Surg 2006;41:1226–9. [18] Dutta S, Mihailovic A, Benson L, et al. Thoracoscopic ligation versus coil occlusion for patent ductus arteriosus: a matched cohort study of outcomes and cost. Surg Endosc 2008;22(7):1643–8. [19] Chen H, Weng G, Chen Z, et al. Comparison of long-term clinical outcomes and costs between videoassisted thoracoscopic surgery and transcatheter amplatzer occlusion of the patent ductus arteriosus. Pediatr Cardiol 2012;33:316–21.
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Outcomes of thoracoscopic clipping versus transcatheter occlusion of patent ductus arteriosus: Randomized clinical trial Nguyen Thanh Liem a,⁎, Cao Viet Tung b, Nguyen Van Linh c, To Manh Tuan c, Le Hong Quang b, Tran Thanh Tu d a
Vinmec International Hospital, Hanoi, Vietnam Cardiology Department, National Hospital of Pediatrics, Hanoi, Vietnam, Hanoi, Vietnam Department of Surgery, National Hospital of Pediatrics, Hanoi, Vietnam d Research Institute for Child Health, National Hospital of Pediatrics, Hanoi, Vietnam b c
a r t i c l e
i n f o
Article history: Received 22 March 2013 Accepted 13 September 2013 Key words: Patent ductus arteriosus Thoracoscopic Transcatheter occlusion
a b s t r a c t Aim: To compare outcomes of thoracoscopic clipping (TC) versus transcatheter occlusion (TO) for patent ductus arteriosus (PDA). Patients and methods: One hundred patients were enrolled in the study from May 2010 to December 2011. Those patients were randomized into 2 groups: group one received TC, group two received TO. Result: There were no significant differences concerning width or length of the ductus (P N 0.05). However the median age and median weight of patients in the TO group were greater than in the TC group (P b 0.05). Mean operative time was 32 ± 12 min in the TC group versus 20 ± 3 min in the TO group (P b 0.05). There were no deaths in either group. There were no complications in the TC group whereas three patients in the TO group had complications and required subsequent operation. Median postoperative stay was 3.5 days (IQR: 3.0–4.3) in the TC group versus 3 days (IQR: 2.0–4.0) in the TO group (P b 0.05). There was no residual shunting in either group. Average cost for one patient was $645 ± 232 in the TC group versus $1260 ± 204 in the TO group (P b 0.001). Conclusion: Thoracoscopic clipping is safer than transcatheter occlusion for PDA repair, with the same effectiveness and lower cost. © 2014 Elsevier Inc. All rights reserved.
PDA is a common type of congenital heart disease [1]. Division of the ductus via thoracotomy has been a standard treatment for many years [2]. However long term morbidities such as chest wall and spinal deformity associated with thoracotomy have been reported [3,4]. Transcatheter occlusion (TO) of PDA was first introduced in 1967 [5] and has become a common procedure [6–10]. In 1993, Laborde first introduced the technique of thoracoscopic clipping (TC) for PDA [11]. This approach has been applied successfully in many centers [12–17]. Both TC and TO have many advantages in comparison with classic thoracotomy. However, which procedure is better and preferable for PDA repair? So far no randomized clinical trial has been carried out to compare outcomes of these two methods. The aim of this study was to compare outcomes of TC versus TO for PDA with a randomized study.
1. Patients and methods One hundred patients with PDA admitted at the National Hospital of Pediatrics in Hanoi, Vietnam from May 2010 to December 2011 met the inclusion criteria and were enrolled in this study. Patients were randomized into two groups: group 1 underwent TC, group 2 underwent TO. Randomization was done by shuffled sealed envelopes, opened by a cardiologist after confirming the diagnosis. TC was performed by one of two experienced thoracoscopic surgeons. TO was performed by one of two experienced cardiac interventionists. Inclusion criteria: − − − −
Sex: Both sexes Ages: 3 months–3 years old Diameter of PDA ≤ 8 mm Weight N 4 kg Exclusion criteria:
⁎ Corresponding author. National Hospital of Pediatrics, Hanoi, Vietnam. Fax: +84 4 6273 8648. E-mail address: [email protected] (N.T. Liem). 0022-3468/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpedsurg.2013.09.007
− Diameter of PDA N 8 mm − Weight ≤ 4 kg − Associated cardiac anomalies
364
N.T. Liem et al. / Journal of Pediatric Surgery 49 (2014) 363–366
Outcome variables: Duration of intervention, complications during and after intervention, need for subsequent open surgery, residual shunt after intervention evaluated by echocardiography before discharge and 3 months after discharge, postoperative stay and postintervention hospital stay, hospital cost including lab tests, consumable materials, medicines, bed charges, etc. The PDA inside diameter was measured by Echo in both groups. The duration of intervention was calculated from the insertion of cannulation to the removal of cannulation. The operative time was calculated from skin incision to skin closure. Recurrent laryngeal injury was defined if patient’s voice was postoperatively changed during crying evaluated by patient’s parent. Costs were calculated based on regulations of Vietnam Ministry of Finance including the cost for lab tests, imaging examinations, consumable materials, and hospital stay fee. Fig. 2. The ductus was pulled forward with a thread of Vicryl.
1.1. Follow-up and end point 1.3. Technique of transcatheter occlusion All patients were checked by clinical examination and echocardiography before discharge and 3 months after discharge.
1.2. Technique of thoracoscopic clipping The patient was anesthetized with single lung ventilation then placed in the right lateral position. The surgeon and assistant stood at the patient’s feet. A monitor was placed at the patient’s head. The operation was performed using 4 trocars. The initial 5 mm trocar was inserted through the 8th intercostal space in the midaxillary line for the scope. The second trocar (5 mm for instrument and clip applier) was introduced through the 7th intercostal space in the postaxillary line. The third trocar (3 mm for instruments) was inserted through the 7th intercostal space in the anterioaxillary line, and the fourth trocar (3 mm for lung retractor) in the third intercostal space in the anterioraxillary line (Fig. 1). CO2 pressure was maintained between 4 and 6 mmHg with a flow rate of 1–2 L/min. The pleura was incised and dissected to expose the ductus, the vagal nerve, and recurrent laryngeal nerve. The ductus was detached from surrounding tissue, isolated, and pulled forward with a thread (Fig. 2). The ductus was clipped with one or two clips (Weck He-mo-lock) (Fig. 3).
Fig. 1. Patient and trocar position.
With the patient under general anesthesia, both the femoral artery and vein of the right groin were cannulated using a 4 Fr sheath in the artery and a 6 Fr sheath for the vein. A 4 Fr pigtail was used for left heart study and aortography. The selected Amplatzer device size (the pulmonary end) was at least 2 mm larger than the narrowest PDA diameter. If the pulmonary end diameter was less than 2 mm, the duct was occluded with Flipper coil. A 4 Fr multi- purpose catheter was advanced from the venous side through the PDA into the descending aorta and then was changed for the delivery sheath and dilator over a 0.035 inch exchange guide wire. The dilator was then removed, leaving the sheath in the descending aorta. Under fluoroscopy, the device was implanted. Aortography was carried out to verify the position of the device. If the position was satisfactory, the device was then released. The pigtail catheter was replaced by a 4 Fr right coronary catheter when Flipper coil occlusion was attempted. The ductus was first crossed with a guide wire, then with the catheter and the guide wire was removed. The tip of the catheter was left in the main pulmonary artery. The Flipper coil and the delivery system were loaded into the catheter. The delivery system was advanced to protrude a full loop of the coil into the main pulmonary artery. The catheter and delivery system were pulled back through the ductus, until the extruded loop of the coil was resisted at the pulmonary end of the ductus. The delivery catheter was carefully withdrawn across the ductus into the descending aorta. The catheter was withdrawn proximally to an attachment point of the coil. The delivery system was advanced to form remaining loops in the aortic end of the ductus. The coil was positioned but attached to the delivery system. One loop of the coil in
Fig. 3. A clip is passed through the lower port of the ductus.
N.T. Liem et al. / Journal of Pediatric Surgery 49 (2014) 363–366
the pulmonary artery and the remaining loops in the aortic end of the ductus were accepted as the optimal coil position and then the Flipper Coil was detached. Aortography was performed 10 min after detachment of the coil. 1.4. Ethics The study protocol was approved by the hospital ethic committee. A written consent was obtained from the family of each patient. 1.5. Statistical analysis Average and Student’s t test were used for normally distributed data and median and Mann–Whitney were used for abnormally distributed data. Significance was defined as P value less than 0.05. 2. Results The patients’ main characteristics are seen in Table 1. There were no significant differences between the two groups concerning width or length of the ductus (P N 0.05). However patient age and patient weight in the TC group were significantly higher than in TO. Clinical outcomes for each group are presented in Table 2. Devices were dislodged in three patients in the TO group requiring open surgery. The devices were slipped into the aorta near the location of PDA in two patients. The devices were retrieved and PDA was divided on the same time via thoracotomy. The device was dislodged to the femoral artery in one patient. PDA was managed via thoracotomy and the device was removed via arteriotomy. All three patients recovered well after surgery. Average cost for one patient was $645 ± 232 in the TC group versus $1260 ± 204 in the TO group (P b 0.001) (costs are expressed in US dollars). 3. Discussion This is the first randomized clinical trial to compare outcomes of TC and TO. In our study, the mean time for TC is 12 min longer than in the TO group (32 min ± 12 versus 20 min ± 3). The difference is significant from a statistical point of view, but of little practical importance. In the series of Dutta, the mean operative time in the TC group was 94 min ± 34 versus 50 min ± 23 in the TO group [18]. Chen also noticed that the operative time was longer in the TC group in comparison with the TO group (90.9 min versus 60.4 min) [19]. The mean operative time for TC in our series was much shorter than in other series. The volume of patients could be an important factor to reduce the operative time. The operative time for TC was also short in other reports with big volume of patients [15,17]. Injury of the recurrence nerve was a common complication in the thoracoscopic approach. However this complication was not encountered in our series. Careful dissection and pulling the ductus forward with a portion of Vicryl before clipping could be an important factor to avoid this complication. TC is a safe approach for PDA. There were no deaths. The rate of complication was lower than the TO group. No patient in the TC group
Table 1 Patient characteristics. Characteristic
TC group
TO group
Age (month)
8.0 (IQR: 5.0–14.3) 6.0 (IQR: 5.0–8.2) 6.79 ± 1.69 7.14 ± 1.88
12.0 (IQR: 7.0–21.3) 8.0 (IQR: 6.0–9.6) 7.12 ± 2.32 7.28 ± 1.86
Weight (kg) Duct size (mm) Duct length (mm)
P 0.028 b0.001 0.43 0.71
365
Table 2 Clinical outcomes and cost in TC and TO.
Operative time (min) Need for subsequent open surgery Occluder dislodged Thromboembolism Complications or death Death Bleeding Blood transfusion Recurrent laryngeal dysfunction Pleural effusion or pneumothorax Residual shunt Postoperative hospital stay (days)
TC group (n = 50)
TO group (n = 50)
P
32 ± 12 0
20 ± 3 3
b0.001
0 0
2 1
0 0 0 0
0 0 0 0
0
0
0 3.5 (IQR: 3.0–4.3)
0 3.0 (IQR: 2.0–4.0)
0.02
required a second operation whereas three patients with severe complications in the TO group required an open surgery. Chen also showed that the rate of complications was higher in the TO group than the TC group (10.2% versus 1.5%) [19]. Our results also revealed that TC is an effective procedure for PDA. There was no residual shunting in any patient. TC effectiveness was equal or higher when compared to the TO technique. The rate of residual shunt was 0% in the TC group and 4.1% in the TO group in the Chen study [19]. The postoperative stay in both groups is short. However, it was lightly longer in the TC group (3.5 vs 3.0 days). Intervention cost in the TO group was twice that of the TC group. Chen also mentioned that the cost was more expensive for the TO procedure in comparison with the TC operation (3415.8$ ± 637.3 versus $1309.4 ± 312.2) [19]. Our results revealed that TC is superior to TO in the management of PDA. However there is a limitation in our study. The sample size of the study is not great enough according to statistical calculation. This may explain some differences between the two groups concerning patient age and patient weight. In conclusion with experienced surgeons, TC is safer than TO for PDA repair. It has the same effectiveness but lower cost. Moreover, it avoids radiation for both medical staff and the patient.
References [1] Schneider DJ, Moore JW. Patent ductus arteriosus. Circulation 2006;114(17): 1873–82. [2] Gross RE. Surgical management of the patent ductus arteriosus with summary of four surgical treated cases. Ann Surg 1939;110(3):321–56. [3] Jaureguizar E, Vazquez J, Murcia J, et al. Morbid musculoskeletal sequelae of thoracotomy for tracheoesophageal fistula. J Pediatr Surg 1985;20(5):511–4. [4] Westfelt JN, Nordwall A. Thoracotomy and scoliosis. Spine 1991;16(9):1124–5. [5] Porstmann W, Wierny L, Warnke H, et al. Catheter closure of patent ductus arteriosus. 62 cases treated without thoracotomy. Radiol Clin North Am 1971;9: 203–18. [6] Park YA, Kim NK, Park SJ, et al. Clinical outcome of transcatheter closure of patent ductus arteriosus in small children weighting 10 kg or less. Korean J Pediatr 2010;53:1012–7. [7] Forsey J, Kenny D, Morgan G. Early clinical experience with the new Amplatzer Ductal Occluder II for closure of the persistent arterial duct. Catheter Cardiovasc Interv 2009;74:615–23. [8] Dua J, Chessa M, Piazza L, et al. Initial experience with the new Amplazer Duct Occluer II. J Invasive Cardiol 2009;21:401–5. [9] Dimas VV, Takao C, Ing FF, et al. Outcomes of transcatheter occlusion of patent ductus arteriosus in infants weighing ≤ 6 kg. J Cardio Vasc Interv 2010;3(12): 1295–9. [10] Azhar AS, Abd El-Azim AA, Habib HS. Transcatheter closure of patent ductus arteriosus: evaluating the effect of the learning curve on the outcome. Ann Pediatr Cardiol 2009;2:36–40. [11] Laborde F, Noirhomme P, Karam J, et al. A new video-assisted thoracoscopic surgical technique for interruption of patient ductus arteriosus in infants and children. J Thorac Cardiovasc Surg 1993;105:278–80.
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[12] Rothenberg SS. Thoracoscopic closure of patent ductus arteriosus: a less traumatic and more costeffective technique. J Pediatr Surg 1995;30:1057–60. [13] Burke RP, Jacobs JP, Cheng W, et al. Video-assisted thoracoscopic surgery for patent ductus arteriosus in low birth weight neonates and infants. Pediatrics 1999;104:227–30. [14] Nezafati MH, Mahmoodi E, Hashemian SH, et al. Video-assisted thoracoscopic surgical (VATS) closure of Patent Ductus Arteriosus: report of three-hundred cases. Heart Surg Forum 2002;5:57–9. [15] Villa E, Vanden Eynden F, Le Bret E, et al. F.Paediatric video-assisted thoracoscopic clipping of patent ductus arteriosus: experience in more than 700 cases. Eur J Cardiothorac Surg 2004;25:387–93.
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