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Over a 3-year period patent ductus arterious (PDA) ligation was performed on a day-case transfer basis on 45 premature infants. The overall survival rate was 93%. We would recommend this practice as an alternative to surgery in the neonatal intensive care unit.
Over a 5-year period ending June 1986, 183 premature infants with evidence of a hemodynamically significant patent ductus arteriosus (PDA) associated with cardiopulmonary compromise underwent pharmacologic and/or surgical ductal manipulation. One hundred seven infants underwent surgical ligation and 76 initially received indomethacin. The average birth weight was 10% less and 1 week less for the surgically treated v the indomethacin-treated infants. Among the infants undergoing ligation, there were no failures of therapy and one surgically related complication. Among the infants receiving indomethacin, 42% failed to improve, and 84% of these infants required surgical intervention. Those infants who failed indomethacin therapy in general weighed less, had a shorter gestation and required prolonged ventilatory support. In no instance was death directly attributable to either therapeutic modality. Our data suggest that surgical ligation of hemodynamically significant PDA yields a more predictable result with low morbidity and no mortality. We believe it is the preferred treatment for premature infants less than 800 g.
Over a 5-year period ending in June 1986, 234 neonates with evidence of a significant patent ductus arteriosus (PDA) underwent ductal manipulation. Thirty-four infants (15%) developed evidence of necrotizing enterocolitis (NEC). When NEC and treatment of PDA were within 72 hours of each other, there was a 71% mortality rate. When NEC and PDA ligation were greater than 72 hours apart, there were no deaths. Development of NEC prior to ductal closure was associated with a mortality of 57%, as opposed to no mortality when the development of NEC occurred after ductal closure. Our data suggest that infants who develop NEC before PDA ligation incur a high mortality.
The optimal approach to a patent ductus arteriosus (PDA) in an extremely low birth weight (ELBW) neonate, whether initial surgical ligation or a trial of indomethacin, has not been established. The authors reviewed the records of 82 ELBW premature infants who had surgical ligation of a PDA during a 2-year period. Thirty-one received indomethacin before ligation. Bronchopulmonary dysplasia (BPD) occurred in 33% of the infants. Predictors of BPD were prolonged positive pressure ventilation, severe intraventricular hemorrhage (IVH) and lower birth weight (BW). Seventy-seven percent of the infants survived. Predictors of mortality were severe IVH, lower BW, and the occurrence of necrotizing enterocolitis (NEC). The indomethacin-treated infants had a lower incidence of NEC and IVH. Overall, 16% of the patients had perioperative morbidity, and 10% of the patients died. The study shows that a trial of indomethacin therapy is not associated with increased complications in ELBW infants with PDA.
Open surgical ligation has proven to be a safe and effective method to bring about closure of the patent ductus arteriosus (PDA). Recent studies have suggested that percutaneous transcatheter and video-assisted thorascopic closure may be better and more cost-effective techniques for PDA closure. The authors reviewed their experience with open thoracotomy for the elective ligation of PDA in 42 children over a 3-year period. The male:female ratio was 1.6:1; the age of the patients (mean +/- SD) was 2.8 +/- 2.3 years and their weight was 14 +/- 7 kg. In all cases the diagnosis was confirmed preoperatively by echocardiography. Open ligation of the PDA was performed through a limited left posterolateral thoracotomy with exposure, by an extrapleural approach. Closure was established with two silk ligatures or a silk ligature and clip, and drainage of the extrapleural space was not used. The operating time was 85 +/- 12 minutes. The total duration of hospitalization was 3.1 +/- 0.8 days. There were no deaths. Successful closure was confirmed by auscultation in 39 children and by subsequent echocardiography in three patients. No surgical complications occurred, and no transfusions were required. Minor respiratory symptoms occurred in two patients postoperatively. Transient systemic hypertension was seen in two patients, and one wound infection occurred.
We tested the hypothesis that prolonged maintenance indomethacin therapy would allow more effective closure of patent ductus arteriosus (PDA) and thereby decrease the recurrence rate. Thirty-nine low birthweight neonates (less than 1500 gm) with confirmed PDA were randomly assigned in a double-blind fashion to receive standard indomethacin therapy (three doses), followed either by maintenance indomethacin therapy (0.2 mg/kg/day) for 5 days or by an equivalent volume of placebo for 5 days. Of the 20 infants who received maintenance indomethacin therapy, two (10%) required additional therapy and one of these required surgical ligation. Of the 19 infants who received only the first three indomethacin doses, nine (47%) required additional therapy for PDA (p less than 0.05) and seven of these had a ligation (p less than 0.05). We conclude that maintenance indomethacin therapy, in comparison with short-term indomethacin therapy, decreases the incidence of surgical PDA ligations, eliminates most PDA recurrences, and does not increase toxic effects of indomethacin in the low birth weight infant with PDA.
The effect of left-right shunting upon left ventricular and atrial dimensions was assessed by means of 129 serial echocardiographic studies in 37 premature infants with patent ductus arterisus. The cardiac dimensions of asymptomatic premature infants and those with pulmonary disease were similar and served as control subjects. Left cardiac dimensions were enlarged in infants with significant PDA. Dimensions were greatest in surgically treated infants (post-operatively they returned rapidly to normal) in contrast with the persistent enlargement observed in some medically treated infants. Serial echocardiography was a valuable adjunct to clinical assessment of the course of PDA in premature infants with pulmonary disease.
Daily weights and mean daily fluid volumes administered to 62 infants with birth weights of less than 2,000 gm, who required respiratory support for respiratory distress syndrome, were reviewed. In 31 infants signs of patent ductus arteriosus developed. In a comparison group of 31 infants, the mean daily fluid volume was 144 ml/kg/24 hours, and the mean body weight was 102% of expected, differing significantly from the 189 nl/kg/24 hours, and 114% of expected weight in those infants who developed PDA. Those infants who developed PDA had not differed significantly from the comparison group in either mean daily fluid volumes or expected weights prior to a period two days before clinical evidence of PDA. Seven infants developed PDA in association with increased fluid administration on more than one occasion during nursery stay. Diuresis after excessive fluid administration was associated with improvement in, or resolution of, signs of PDA in many infants. The results suggest that excessive fluid administration to premature infants with RDS may be one factor associated with the developed of PDA complicating RDS (PDA/RDS).
Thirty-one infants with clinical and radiographic evidence of a large left-to-right shunt across a patent ductus arteriosus underwent echocardiographic study to determine the magnitude of shunting. Seven patients were found to have a normal-left atrial dimensions and a normal left atrial/aortic root dimension at the time when physical and roentgenographic findings of a large PDA were most pronounced. In contrast, left ventricular end diastolic dimensions were excessive in these infants. After ductal closure (four, surgery; two, indomethacin, one, spontaneous) the left ventricular end diastolic dimension fell to the normal range. Optimal echocardiographic accuracy in infants with PDA should combine analysis of both atrial and ventricular dimensions; the former, used alone, may be misleading.
This report summarizes a consecutive experience with 59 preterm infants with clinical, radiographic, and echocardiographic findings of a large patent ductus arteriosus. Thirty-five infants who met defined criteria received indomethacin, and 24 infants underwent PDA ligation. Analysis of the clinical course of these infants revealed no selective indomethacin morbidity and suggests that infants undergoing ligation require more prolonged ventilator therapy with increased exposure to FiO2 greater than or equal to 0.3. Mortality rates between ligated and pharmacologically treated groups were similar. This study documents that inhibition of prostaglandin synthesis to constrict and close the PDA in the premature infant is an effective alternative to operative closure.
Digoxin therapy was evaluated retrospectively in a group of 30, and prospectively in a group of 16 low-birth-weight, premature infants with cardiorespiratory symptoms due to persistent patency of the ductus arteriosus. The response to decongestive therapy was equivocal. Digoxin levels in serum varied between 1.5 and 13 ng/ml. Digoxin half-life in serum exceeded three days in four patients. Fourteen of the combined group of 46 infants had signs of toxicity of digoxin. High dosage, inadvertent overadministration, and variable clearance of digoxin, as well as special characteristics of the patients studied, are postulated as explanations for the high incidence of toxicity. This study suggests that digoxin therapy in low-birth-weight, premature infants with patent ductus arteriosus is not without risk.
Renal function during indomethacin treatment was studied in 12 premature infants with patent ductus arteriosus. Decreases in urinary flow rate, GFR, and CH2O by 56, 27, and 66%, respectively, occurred during Indo therapy. Urinary excretion rates of ions were also reduced: Na by 70%, Cl by 79%, K by 40%. These changes were accompanied by slight decreases in plasma sodium concentration and osmolality. Except for GFR and urinary Na and osmolality, all these functions returned to pretreatment values one to two weeks after stopping the drug.
The course and complications of fifty-two infants with patent ductus arteriosus requiring closure were assessed prospectively. Twenty-six infants with a PDA received indomethacin for pharmacologic closure of the PDA, and 26 underwent ligation. The current study analyzes and compares the longitudinal follow-up with respect to somatic growth, neurologic function, psychomotor and mental development, and renal, ophthalmologic, and audiologic function in 21 infants in each group who entered the follow-up. No selective morbidity was attributable to PDA closure with indomethacin when compared to surgically treated infants.
A modified impedence cardiographic technique was developed using a tetrapolar apnea monitor and minicomputer system. Evaluation of this technique in premature infants with and without symptomatic patent ductus arteriosus indicates that the magnitude of the cardiac-related deflection in the impedance signal is useful in the assessment of ductus shunting. Since the infant under study is involved only by the attachment of two double electrodes to the thorax, continuous assessment of ductur shunting is possible without disturbing routine care.
A controlled clinical trial comparing early closure (mean = 48.8 hours) of the patent ductus arteriosus using indomethacin to conventional medical management, with intervention only after cardiopulmonary decompensation (mean = 167.4 hours), was undertaken in 24 preterm infants with severe respiratory distress syndrome and evidence of PDA. An interval analysis of one-half the projected sample revealed that infants undergoing early closure of the PDA had significantly reduced occurrence of BPD or mortality by 6 months of age. A comparison of birth weight, Apgar scores, gestational age, age of initial PDA diagnosis, and fluid therapy during the first seven days of life showed no significant differences between early intervention and control groups. At the time of the interval analysis, there were no differences between the groups in duration of intermittent mandatory ventilation or oxygen exposure. Studies will be required to determine whether these and other variables can be altered by early closure of the PDA.
To determine if furosemide would prevent the renal side effects of indomethacin therapy in premature infants with patent ductus arteriosus, 19 premature infants were randomized into two groups: nine received indomethacin alone, and ten received indomethacin followed immediately by furosemide. There was no significant difference between the groups in birth weight, gestational age, postnatal age, and in cardiopulmonary or renal status at the time of study. Infants who received indomethacin and furosemide had significantly higher urine output (P less than 0.05), higher FENa and FECl (P less than 0.01), and higher glomerular filtration rate (P less than 0.05) than those of infants who received indomethacin alone. Seven infants in each group responded to indomethacin therapy with disappearance of PDA murmur and improvement of cardiovascular status. The results of this study suggest that furosemide may prevent the renal side effects of indomethacin therapy and yet not affect the efficacy of indomethacin in the closure of a PDA.
To determine whether there are significant alterations in cerebral blood flow patterns in infants with a patent ductus arteriosus and whether these alterations correlate with alterations in aortic blood flow, we performed range-gated pulsed-Doppler examinations of the aorta and cerebral arteries in 20 infants. Ten infants had a PDA and ten control infants did not. We analyzed these flow patterns quantitatively by calculating the pulsatility index (peak systolic frequency minus trough diastolic frequency)/peak systolic frequency. In the ten control infants and in three infants with a small PDA, there was no significant diastolic flow in the descending aorta; flow in the cerebral arteries was antegrade throughout systole and diastole (PI = 0.75 +/- 0.03 for control infants and 0.73 +/- 0.07 for small PDA infants). In seven infants with a large PDA, there was retrograde diastolic flow in the descending aorta. This pattern was not seen after PDA closure. In the cerebral arteries of the seven infants with a large PDA, diastolic flow was retrograde in three and decreased or absent in four, and PI was significantly higher (PI = 0.96 +/- 0.06. P less than 0.001 vs controls). After PDA closure, cerebral diastolic flow was antegrade in all seven infants (PI = 0.74 +/- 0.04). We conclude that a large PDA can cause abnormal flow patterns in the descending aorta and cerebral arteries. These flow patterns may predispose these infants to CNS ischemia or intraventricular hemorrhage.
Among 3559 newborn infants with birth weight less than 1750 gm, 421 developing a hemodynamically significant patent ductus arteriosus were entered into a randomized trial to evaluate the role of indomethacin in the management of PDA. Indomethacin given concurrently with usual medical therapy at the time of diagnosis resulted in ductal closure in 79%, versus 35% with placebo (P less than 0.001). Indomethacin as backup to usual medical treatment resulted in similar closure rates. To assess overall effects through hospital discharge, three management strategies were compared. Although mortality did not differ significantly, infants given indomethacin only if usual therapy failed (strategy 2) had a lower incidence of bleeding than those to whom indomethacin was given with initial medical therapy (strategy 1) and lower rates of pneumothorax and retrolental fibroplasia than those to whom no indomethacin was administered, with surgery the only backup to medical therapy (strategy 3). Thus the administration of indomethacin only when medical treatment fails appears to be the preferable approach for the management of symptomatic PDA in premature infants.