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Ann Thorac Surg 1997;63:434-437
© 1997 The Society of Thoracic Surgeons
King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
Accepted for publication August 22, 1996.
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Abstract |
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 TopFootnotes Abstract IntroductionMaterial and MethodsResultsCommentReferences |
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Methods. All 354 patients with PDA referred to our center in a 5-year period were included in this report. Of the 354 patients, 236 underwent cardiac catheterization with the intent of transcatheter PDA closure, and 118 had surgical intervention.
Results. In 46 (19.5%) of the 236 patients having cardiac catheterization, the procedure either was abandoned or failed. Color Doppler echocardiography demonstrated total occlusion of the ductus after 24 hours in 97 patients (41%) in the cardiac catheterization group. An additional 20 patients had no residual leaks at follow-up. Twenty other patients underwent reocclusion because of a residual shunt. Thus, of the 236 patients, 137 (58%) had successful complete closure of the PDA. Surgical PDA ligation was performed in 118 patients as the initial procedure and in 26 of the 46 patients in whom transcatheter closure was abandoned. If the remaining 20 patients in whom transcatheter closure failed are added to the 144 patients who underwent PDA ligation, the percentage having surgical intervention versus transcatheter occlusion is higher than 46%.
Conclusions. Our data suggest that surgery plays a major role in the management of patients with PDA despite the advent of new interventional catheterization techniques.
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Introduction |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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We report here the impact of the availability of the Rashkind device in the management of patients with the diagnosis of PDA referred to King Faisal Specialist Hospital and Research Center. Our aim was not to compare the outcome of the transcatheter technique with the surgical results but to assess the role of surgery in the current era. We believe that surgery still plays a significant role in the management of patients with persistent ductus arteriosus despite the advent of new interventional catheterization techniques.
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Material and Methods |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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The diagnosis of PDA was confirmed by color Doppler echocardiography. If the cardiac echo demonstrated a PDA larger than 8 mm or if a 17-mm device was thought to be indicated in a patient weighing less than 10 kg, the patient was allocated to the surgical group. If the PDA was thought to be suitable for transcatheter closure, the patient was classified in the cardiac catheterization group. Right and left cardiac catheterization was performed using standard percutaneous techniques for hemodynamic measurements, shunt calculations, and aortography. The size of the ductus was measured again on the aortogram, and the appropriate size of Rashkind device was chosen according to standard recommendations [2]. As before, if the PDA was larger than 8 mm at its narrowest diameter or if a 17-mm device was needed in a patient weighing less than 10 kg, the patient was not considered a candidate for transcatheter PDA closure and was referred for surgical intervention. This decision was made on the basis of our experience and the experiences of others in regard to the success rates and complications, in particular left pulmonary artery (LPA) stenosis, after transcatheter closure of large PDAs in small children [8].
Transcatheter Closure Technique
Transcatheter closure of the ductus arteriosus was performed by the technique previously described [2, 4]. In the case of embolization of a 12-mm device, retrieval was attempted first through the venous approach. Only if this attempt failed or if a 17-mm device embolized did the patient undergo operation to retrieve the device and ligate the PDA during the same admission. The procedure was done under the usual premedication with a mixture containing demerol (14 mg•mL-1), promethazine (6.25 mg•mL-1), and chlorpromazine (6.25 mg) in a dose of 0.1 mL•kg-1 and a maximum dose of 2 mL, and additional sedation with ketamine hydrochloride, midazolam hydrochloride, or morphine was used as necessary. Thirteen percent of the patients required endotracheal intubation and general anesthesia.
Surgical Technique
The procedure was performed in the operating room under general endotracheal anesthesia and through a left thoracotomy. A right thoracotomy was required in patients with dextrocardia. The ductus arteriosus was identified, dissected, and isolated. Interruption of ductal flow was performed by direct ligation, clipping, or both, by pursestring sutures on the aortic end and the pulmonary end with a clip or a transfixion suture in between, or, in the case of a large ductus, by division and oversuturing of both divided ends. The chest usually was closed without a chest drain. Unless the patient was ventilator dependent before the closure, he or she usually was extubated in the operating room, allowed to recover, and returned to the ward.
Follow-up
Before discharge and at clinical follow-up, most patients in both groups underwent a complete two-dimensional echocardiographic study and a color-flow Doppler study to identify residual flow across the closed arterial duct.
Statistical Analysis
Statistical analysis was performed using the Student t test for comparison between the surgical and nonsurgical groups.
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Results |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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. The groups were not comparable in age and weight. In addition, the patients in the surgical group were in congestive heart failure, and the majority had pulmonary hypertension as judged by Doppler echocardiographic evaluation.
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The implantation success rate when PDA closure was attempted using the Rashkind device was 92.2%. Complications included embolization of the device to the LPA or right pulmonary artery in 9 patients (4.34%), femoral artery occlusion requiring systemic heparinization or thrombolysis with streptokinase in 7 (3.4%), transient chest pain a few hours after the procedure without electrocardiographic or echocardiographic abnormalities in 4 (1.9%), and stenosis (gradient greater than 15 mm Hg) of the LPA caused by the device in 5 (2.4%). Two children required operation to relieve the LPA stenosis.
Color Doppler echocardiography demonstrated total occlusion of the ductus after 24 hours in 97 (41%) of the 236 patients who underwent cardiac catheterization with intent to treat. An additional 20 patients have shown no residual leaks at follow-up outpatient visits. In 20 other patients, the shunt was considered major, and they underwent a second attempt at closure in the catheterization laboratory. A second device was implanted successfully and without complications in all of them. Therefore, the interventional cardiac catheterization procedure using one or two Rashkind double umbrella devices for PDA closure was completely successful, ie, no residual left-to-right shunt noted by color Doppler echocardiography, in 137 (58%) of the 236 patients at the first or second attempt. Thus, on an intent-to-treat basis, 42% of the patients continued to have a residual flow.
Surgical Group
Surgical PDA ligation was performed as the primary treatment in 144 patients through a left thoracotomy. Included among the 144 patients are the 118 originally designated for surgical therapy and 26 of the 46 patients who were considered candidates for transcatheter PDA closure but in whom the PDA was too large for a 17-mm device or in whom device implantation failed. If the 20 patients from the cardiac catheterization group who are awaiting surgical intervention are added to the surgical group, 46.3% of the 354 patients referred to our center for PDA management underwent surgical closure.
There were three deaths (2%, 3/144) in the surgical group. These patients were 8 days, 1 month, and 12 months old. They weighed 3.5 kg, 2.2 kg, and 5.4 kg, respectively. The first 2 patients were very sick and had been ventilator dependent since birth. The third patient had Down's syndrome, severe pulmonary hypertension with right ventricular failure, and severe hepatomegaly and ascites. There was considerable controversy as to whether he was a candidate for operation or not. Hemodynamic studies on 100% oxygen and ventilation indicated some reversibility of the vascular resistance. Surgical intervention was thought to be the last option, as the child was critically ill. He eventually died postoperatively of irreversible pulmonary vascular disease. In contrast, there were no deaths in the interventional catheterization group. Follow-up echocardiography revealed residual leaks in 9 (6%) of the 144 surgical patients.
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Comment |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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The success rate of Rashkind device implantation was high (92.2%), similar to that in previous reports [3, 5]. Complications were uncommon and of minimal clinical importance except for stenosis of the LPA caused by the device [8]. This observation supports our strict selection criteria for use of the Rashkind device in small children with a large ductus. As device implantation failed in 16 patients and 20 additional patients required a second device for residual leaks, a total of 226 devices were used for 190 successful implants. Rashkind device waste and the need to implant a second device pose an additional economic problem for its worldwide use because it has been reported that the surgical approach [9] and new devices such as coils are far less expensive [10, 11].
Also of concern is the high percentage of patients with residual leaks (42%) detected by color Doppler echocardiography at discharge after Rashkind device implantation. The reported incidence of residual leaks after surgical closure is lower, ranging from 6% to 23% [12–14]. In our series, it was about 6% and hence at the low end of the scale. Many of the residual flows were detected only by color Doppler echocardiography and are not of clinical significance. This 6% rate of residual leaks in the surgical group is significantly lower than that in the catheterization group. Ligation and concomitant division of the PDA seems to have a 0% recurrence rate [15].
The rate of residual shunts in the surgical group assumes more importance when it is combined with the 2% mortality rate for the group compared with the 0% mortality rate in the catheterization group. However, the surgical group was significantly younger and their weight was significantly lower than in the other group, which per se represent a higher risk for any intervention. In addition, many of the surgical patients were ventilator dependent and had either pulmonary hypertension as estimated by Doppler or cardiac catheterization or long-standing signs of congestive heart failure, as was true for the 3 patients who died after surgical ligation. Their deaths, therefore, were probably not due to the surgical procedure itself but rather to other factors such as chronic congestive heart failure and lung damage. These reasons might also explain why our surgical death rate is higher than the rates in other series [14–16].
Although long-term follow-up studies are necessary to learn about the incidence of infection in these patients, the presence of residual leaks, especially if through a foreign body inside the ductus, is likely to represent a persistent high risk for endovascular infection. The goals of PDA closure are to achieve interruption of the left-to-right shunt and to avoid the risk of bacterial endocarditis. Hence, the presence of residual leaks should be considered a failure of the procedure.
Our results suggest that a small PDA can be treated with the transcatheter approach using the Rashkind device. A large PDA, especially in a patient with pulmonary hypertension, seems to require surgical intervention. For a moderate-sized PDA, we would usually try the transcatheter technique first, and if it fails, we would perform a surgical procedure. Recently the use of coil deployment techniques has proved successful for PDA closure, but long-term follow-up studies are still needed [10, 11, 17, 18]. A study [10] done at our center indicates that coil occlusion has a much higher occlusion rate but a worse embolization rate compared with the Rashkind device. Although bigger devices such as the clamshell device [19] may be effective in closing a large PDA, they may also cause major problems with obstruction of the LPA [8] or the descending aorta [20]. Closure of a PDA using thoracoscopy techniques is another new alternative that is being explored [21], but again long-term follow-up is necessary.
These concerns along with the substantial number of patients referred for surgical closure of the PDA at initial presentation are indicators of the important role that surgery still plays in the treatment of patients with PDA.
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Footnotes |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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References |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentReferences |
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