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PubMed2000

Five-loop coil occlusion of patent ductus arteriosus prevents recurrence of shunt at follow-up.

Recent reports suggest reopening of the patent ductus arteriosus (PDA) after complete occlusion with three-loop Gianturco coils. We hypothesize that five-loop coils may produce a larger thrombus than three-loop coils, which will result in no or less probability of recanalization of PDA during follow-up. This study is designed to test this hypothesis. Follow-up echocardiographic and Doppler data of 30 patients who underwent five-loop coil occlusion of small to medium-sized PDA during a 33-month period ending December 1998 were examined. Thirty patients had no residual shunt on echo Doppler study on the day following the procedure and were followed for 6 to 30 months (median, 12) after coil implantation. At the last follow-up study, none of the patients had a residual shunt and left atrial size decreased. Careful pulsed, continuous wave, and color Doppler interrogation of left/main pulmonary artery junction and proximal descending aorta did not reveal any evidence for obstruction. The follow-up data suggest that complete occlusion of small- to medium-sized PDAs is feasible with five-loop coils without evidence for recanalization at a mean follow-up of 12 months. Much longer (2 to 5 years) follow-up data may be necessary to confirm these observations. We speculate that a greater degree of thrombosis is produced within the ductus by the five-loop coils, which in turn may be responsible for lack of shunt recurrence. We recommend use of five-loop instead of three-loop coils for transcatheter occlusion of small- to medium-sized PDAs.

Child↗
PubMed2004

Prolonged versus short course of indomethacin for the treatment of patent ductus arteriosus in preterm infants.

BACKGROUND: Indomethacin is a prostaglandin inhibitor used to treat patent ductus arteriosus (PDA) in preterm infants. Although indomethacin produces ductal closure in the majority of cases, it is ineffective in up to 40% of patients. Furthermore, the ductus will re-open in up to 35% of infants who initially respond to the drug. A more prolonged course of indomethacin has been studied regarding the potential to achieve higher rates of ductal closure. OBJECTIVES: To determine if a prolonged course of indomethacin (compared to a short course) reduces the rate of treatment failure in preterm infants with PDA without unwanted side-effects. SEARCH STRATEGY: The search included review of personal files, abstracts of conferences, and the following electronic databases: MEDLINE (1966 to April 2003), EMBASE (1974 to April 2003), and Oxford Database of Perinatal Trials, Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2003). No language restrictions were applied. SELECTION CRITERIA: 1) DESIGN AND POPULATION: Randomized or quasi-randomized controlled trials including preterm infants with PDA diagnosed on clinical and/or echocardiographic examination.2) INTERVENTION: Indomethacin treatment by any route given as a long course (four or more doses) vs a short course (three or fewer doses). 3) OUTCOMES: Report of at least one of the following outcomes: failure of PDA to close, need for re-treatment, PDA re-opening, PDA ligation, mortality, duration of assisted ventilation, chronic lung disease (CLD), duration of supplemental oxygen dependence, intraventricular hemorrhage (IVH) (all and severe), diminished urine output, increased serum creatinine, necrotizing enterocolitis (NEC), bleeding diathesis, retinopathy of prematurity (ROP), and duration of hospital stay. DATA COLLECTION AND ANALYSIS: The three reviewers independently abstracted data from each study. Relative risk (RR) and Risk Difference (RD) with 95% confidence intervals (CI) using the fixed effect model for meta-analysis are reported. When a statistically significant RD was found, the number needed to treat (NNT) or number needed to harm (NNH) was also calculated with 95% CIs. A chi-square test was used to test for heterogeneity of results among included trials. MAIN RESULTS: Prolonged indomethacin treatment when compared to the short course resulted in a borderline statistically significant difference in PDA re-opening rate favoring the prolonged course [RR 0.54 (95% CI 0.3, 0.99); RD -0.12 (95% CI -0.24, -0.01); NNT = 8 (4, 100). There was no statistically significant treatment effect on PDA closure, re-treatment, or ligation rates. The prolonged course was associated with a decreased incidence of severe IVH [RR 0.49 (95% CI 0.25, 0.98); RD -0.12 (95% CI -0.24, -0.01); NNT 8 (4, 100)] and renal function impairment, as evidenced by a lower proportion of infants having an increased creatinine level [RR 0.52 (95% CI 0.34, 0.81); RD -0.20 (95% CI -0.33, -0.08); NNT 5 (3, 13)]. However, there was a trend for the prolonged course to increase the proportion of infants with CLD in the one trial reporting this outcome [RR 2.24 (95% CI 0.98, 5.12); RD 0.24 (95% CI 0.01, 0.47)]. REVIEWER'S CONCLUSIONS IMPLICATIONS FOR PRACTICE: Prolonged as compared to short course of indomethacin for the treatment of PDA in preterm infants has a borderline effect on reducing the rate of PDA re-opening and it may be associated with an increased risk for CLD. However, prolonged course of indomethacin appears to reduce the risk of severe intracranial hemorrhage and renal impairment in this population. Definitive recommendations about the preferred duration of indomethacin therapy, i.e. prolonged versus short course, for the treatment of PDA in premature infants cannot be made based on the current findings of this review. IMPLICATIONS FOR RESEARCH: There is a paucity of data on optimal duration of indomethacin therapy for the treatment of PDA, in particular for ELBW premature infants. Future randomized clinical trials should include this high risk population and investigate the premature infants. Future randomized clinical trials should include this high risk population and investigate the possibility of tailoring duration of therapy (prolonged versus short) to individual response in terms of echocardiographic findings and/or prostaglandin levels, focusing on clinically significant outcomes and potential complications associated with either strategy. In addition, factors which may influence treatment effect need to be taken into account when designing such studies.

Ductus Arteriosus, Patent↗
PubMed2003

Ibuprofen for the treatment of a patent ductus arteriosus in preterm and/or low birth weight infants.

BACKGROUND: A patent ductus arteriosus (PDA) complicates the clinical course of preterm infants, increasing their risks of developing chronic lung disease (CLD), necrotizing enterocolitis (NEC), and intraventricular hemorrhage (IVH). Indomethacin is used as standard therapy to close a PDA, but is associated with reduced blood flow to the brain, kidneys and gut. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective with fewer side effects. OBJECTIVES: To determine the effectiveness and safety of ibuprofen compared to placebo or no intervention for closing a PDA in preterm and/or low birth weight infants. To determine the effectiveness and safety of ibuprofen compared to other cyclo-oxygenase inhibitors (including indomethacin, mefenamic acid) for closing a PDA in preterm and/or low birth weight infants. SEARCH STRATEGY: Randomized (or quasi-randomized) controlled trials (RCTs) comparing ibuprofen to placebo or indomethacin or mefenamic acid for therapy of PDA were identified by searching the Cochrane Controlled Trials Register (Issue 4, 2002), MEDLINE (1996 - January 2003), CINAHL (1982 - November 2002), EMBASE (1980 - January 2002), reference lists of published RCTs and abstracts from the Pediatric Academic Societies and the European Society for Pediatric Research meetings published in Pediatric Research (1991 - 2002). No language restrictions were applied. SELECTION CRITERIA: 1) DESIGN: Randomized or quasi-randomized controlled trials 2) POPULATION: Preterm (< 37 weeks gestational age) or low birth weight infants (< 2500 grams) with a clinically or echocardiographically diagnosed PDA 3) INTERVENTION: Administration of ibuprofen for the closure of PDA 4) OUTCOMES: At least one of the following outcomes were reported: failure to close a PDA, mortality, surgical ligation, intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), NEC, decreased urine output, retinopathy of prematurity (ROP), CLD, sepsis, days on supplementary oxygen. DATA COLLECTION AND ANALYSIS: At least two reviewers worked independently at each step of the review, then compared results and resolved differences. Methodological quality of eligible studies was assessed according to blinding of randomization, of intervention and of outcome assessment, and completeness of followup. Weighted treatment effects, calculated using Revman 4.1, included typical relative risk (RR), typical risk difference (RD), number needed to treat (NNT) or harm (NNH), and weighted mean difference (WMD), all with 95% confidence intervals (CI). A fixed effect model was used for meta-analyses. Heterogeneity tests were performed to assess the appropriateness of pooling the data. MAIN RESULTS: Eight studies including 509 patients were included. All studies compared the effectiveness of ibuprofen to indomethacin for the closure of a PDA. There was no statistically significant heterogeneity of treatment effect for any of the outcomes. For the primary outcome (failure of ductal closure), there was no statistically significant difference between ibuprofen and indomethacin groups [RR 0.92 (95% CI 0.69, 1.22)]. There were no statistically significant differences in mortality, surgical duct ligation, duration of ventilator support, IVH, PVL, NEC, time to full enteral feeds, ROP, sepsis, duration of hospital stay or gastrointestinal bleed. For many of these outcomes the sample size was small and the estimates imprecise. The incidence of decreased urine output (< 1cc/kg/hr) was lower in the ibuprofen group as compared to the indomethacin group [NNT 9 (95% CI 5-14)]. This was the only statistically significant clinical finding favouring ibuprofen. Chronic lung disease defined as oxygen requirement at 28 days post-natally was statistically significantly more likely to occur in the ibuprofen group [RR 1.37 (95% CI 1.01, 1.86); NNH 7 (95% CI 3 - 100)]. No studies comparing ibuprofen versus placebo for the closure of PDA were identified. REVIEWER'S CONCLUSIONS: We found no statistically significant difference in the effectiveness of ibuprofen compared to indomethacin in closing the PDA. Ibuprofen reduces the risk of oliguria. However, ibuprofen may increase the risk for chronic lung disease, and pulmonary hypertension has been observed in three infants after prophylactic use of ibuprofen. Based on currently available information ibuprofen does not appear to confer a net benefit over indomethacin for the treatment of a PDA. We conclude that indomethacin should remain the drug of choice for the treatment of a PDA. Future research may include a four arm trial where infants are randomized at birth, either to a prophylaxis arm starting at birth or to an arm in which treatment starts after a PDA is diagnosed by echocardiography within the first seven days of life. Within the prophylaxis and treatment arms, the infants would be randomized to either ibuprofen or indomethacin. The primary outcome should be intact survival (survival without handicap) at 18 months corrected age.

Cyclooxygenase Inhibitors↗
PubMed2005

Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight infants.

BACKGROUND: A patent ductus arteriosus (PDA) complicates the clinical course of preterm infants, increasing their risks of developing chronic lung disease (CLD), necrotizing enterocolitis (NEC), and intraventricular hemorrhage (IVH). Indomethacin is used as standard therapy to close a PDA, but is associated with reduced blood flow to the brain, kidneys and gut. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective with fewer side effects. OBJECTIVES: To determine the effectiveness and safety of ibuprofen compared to placebo or no intervention for closing a PDA in preterm and/or low birth weight infants. To determine the effectiveness and safety of ibuprofen compared to other cyclo-oxygenase inhibitors (including indomethacin, mefenamic acid) for closing a PDA in preterm and/or low birth weight infants. SEARCH STRATEGY: Randomized or quasi-randomized controlled trials (RCTs) comparing ibuprofen to placebo or indomethacin or mefenamic acid for therapy of PDA were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2005), MEDLINE (1996 - July 2005), CINAHL (1982 - July 2005), EMBASE (1980 - July 2005), reference lists of published RCTs and abstracts from the Pediatric Academic Societies and the European Society for Pediatric Research meetings published in Pediatric Research (1991 - April 2005). No language restrictions were applied. SELECTION CRITERIA: 1) DESIGN: Randomized or quasi-randomized controlled trials 2) POPULATION: Preterm (< 37 weeks gestational age) or low birth weight infants (< 2500 grams) with a clinically or echocardiographically diagnosed PDA 3) INTERVENTION: Administration of ibuprofen for the closure of PDA 4) OUTCOMES: At least one of the following outcomes were reported: failure to close a PDA, mortality, surgical ligation, intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), NEC, decreased urine output, retinopathy of prematurity (ROP), chronic lung disease (CLD), sepsis, days on supplementary oxygen. DATA COLLECTION AND ANALYSIS: At least two authors worked independently at each step of the original review, then compared results and resolved differences. The current update was conducted by one author (AO). Methodological quality of eligible studies was assessed according to blinding of randomization, of intervention and of outcome assessment, and completeness of follow up. Weighted treatment effects, calculated using RevMan 4.2, included typical relative risk (RR), typical risk difference (RD), number needed to treat (NNT) or harm (NNH), and weighted mean difference (WMD), all with 95% confidence intervals (CI). A fixed effect model was used for meta-analyses. Heterogeneity tests including I(2 )were performed to assess the appropriateness of pooling the data. MAIN RESULTS: No study using mefenamic acid was identified. One study compared ibuprofen to placebo but results were not reported unblinded to group. Eleven studies including 620 patients compared the effectiveness of ibuprofen to indomethacin for the closure of a PDA. There was no statistically significant heterogeneity of treatment effect for any of the outcomes. For the primary outcome (failure of ductal closure), there was no statistically significant difference between ibuprofen and indomethacin groups [typical RR 0.96 (95% CI 0.74, 1.25)]. There were no statistically significant differences in mortality, surgical duct ligation, duration of ventilator support, IVH, PVL, NEC, time to full enteral feeds, ROP, sepsis, duration of hospital stay or gastrointestinal bleed. For many of these outcomes the sample size was small and the estimates imprecise. The incidence of decreased urine output (< 1cc/kg/hr) was lower in the ibuprofen group as compared to the indomethacin group [NNT 9 (95% CI 5-14)]. This was the only statistically significant clinical finding favouring ibuprofen. CLD defined as oxygen requirement at 28 days post-natally was statistically significantly more likely to occur in the ibuprofen group [typical RR 1.37 (95% CI 1.01, 1.86); NNH 7 (95% CI 3 - 100)]. There was a similar trend for CLD at 36 weeks corrected gestational age. AUTHORS' CONCLUSIONS: We found no statistically significant difference in the effectiveness of ibuprofen compared to indomethacin in closing the PDA. Ibuprofen reduces the risk of oliguria. However, ibuprofen may increase the risk for CLD, and pulmonary hypertension has been observed in three infants after prophylactic use of ibuprofen. Based on currently available information ibuprofen does not appear to confer a net benefit over indomethacin for the treatment of a PDA. We conclude that indomethacin should remain the drug of choice for the treatment of a PDA. The most urgent research question to be answered is weather ibuprofen compared to indomethacin confers an improved rate of intact survival (survival without impairment) at 18 months corrected age.

Cyclooxygenase Inhibitors↗
PubMed2003

Indomethacin for asymptomatic patent ductus arteriosus in preterm infants.

BACKGROUND: Patent Ductus Arteriosus (PDA remains a significant cause of mortality and morbidity in premature infants. Indomethacin is an effective treatment to close a PDA, and has been used for many years with several treatment regimes, including prophylactic use in all at risk premature infants. There are however concerns regarding adverse side effects of indomethacin. By targeting a group of infants with an asymptomatic PDA, rather than treating all VLBW infants prophylactically, indomethacin use would be restricted, limiting the possibility of significant side effects to those with greater chance of benefit. OBJECTIVES: To assess whether in premature neonates with asymptomatic PDA, treatment with indomethacin improves short and long term outcomes; in particular: incidence of symptomatic PDA, mortality, chronic neonatal lung disease (CLD), intraventricular haemorrhage (IVH), retinopathy of prematurity (ROP), neurodevelopmental outcome, length of ventilation. SEARCH STRATEGY: Standard strategies of the Cochrane Neonatal Review Group were used. Searches were made of the Oxford Database of Perinatal Trials, MEDLINE and EMBASE from 1966 to September 2002, CINAHL from 1982 to September 2002, and the Cochrane Controlled Trials Register (CENTRAL/CCTR) in The Cochrane Library, Issue 3, 2002. Searches were also made of previous reviews including cross-referencing, abstracts, and conference and symposia proceedings published in Pediatric Research. SELECTION CRITERIA: All randomised controlled trials of indomethacin compared with placebo or no intervention for the treatment of asymptomatic PDA in premature infants were eligible. DATA COLLECTION AND ANALYSIS: Standard methods of the Cochrane Neonatal Review Group were used. Trials identified by the search strategy were independently reviewed by each author and assessed for eligibility and trial quality. Data were then extracted independently by each author and compared, with any differences resolved following discussion. Any additional information required was requested from trial authors. Only published data was available for review. Results are expressed as typical relative risk and typical risk difference for dichotomous outcomes, and weighted mean difference for continuous variables. MAIN RESULTS: Three small trials involving a total of 97 infants were included. Meta analysis of combined data was possible for seven outcomes. Treatment of an asymptomatic PDA with indomethacin significantly reduced the incidence of symptomatic PDA (RR 0.36, 95% CI 0.19, 0.68) and duration of supplemental oxygen (WMD -12.5, 95% CI -23.8, -1.26). There was no evidence of effect on mortality (RR 1.32, 95% CI 0.45, 3.86), CLD (RR 0.91, 95% CI 0.62, 1.35), IVH (RR 1.21, 95% CI 0.62, 2.37), ROP (RR 0.68, 95% CI 0.26, 1.78), or length of ventilation (WMD -7.00 days, 95%CI -17.33, 3.34). Long term neurodevelopmental outcomes were not reported. One trial reported a significant reduction in the duration of supplemental oxygen following treatment with indomethacin in the subgroup of infants with birth weight less than 1000g. REVIEWER'S CONCLUSIONS: This review demonstrates a significant decrease in the incidence of symptomatic PDA following treatment of an asymptomatic PDA with indomethacin. There is also a small but statistically significant decrease in the duration of requirement for supplemental oxygen. There are no reported long term outcomes in the included trials, and so it is not possible to comment on possible long term effects. Further studies are required to determine the long term benefits or harms of closing a PDA prior to the onset of symptoms.

Cyclooxygenase Inhibitors↗
PubMed2003

Surgical versus medical treatment with cyclooxygenase inhibitors for symptomatic patent ductus arteriosus in preterm infants.

BACKGROUND: Patent ductus arteriosus (PDA) with significant left to right shunt in preterm infants increases morbidity and mortality. Early closure of the ductus arteriosus may be achieved pharmacologically using cyclooxygenase inhibitors, or by surgery. The efficacy of both treatment modalities is well established. However, the preferred initial treatment of a symptomatic PDA in a preterm infant, surgical ligation or trial of indomethacin, has not been well established. OBJECTIVES: To compare the effect of surgical ligation of PDA versus medical treatment with cyclooxygenase inhibitors (using indomethacin, ibuprofen, or mefenamic acid), each used as the initial treatment, on neonatal mortality in preterm infants with a symptomatic PDA. SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group was used. This included search of electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2002), MEDLINE (1966 - December 2002), CINAHL (1982 - December 2002), EMBASE (1980 - December 2002); and hand search of abstracts of Pediatric Academic Societies annual meetings published in Pediatric Research (1990 - April 2002). No language restrictions were applied. SELECTION CRITERIA: All trials 1) using randomized or quasi-randomized patient allocation, 2) in preterm infants < 37 weeks gestational age or low-birth-weight infants (< 2500 grams) with symptomatic PDA in the neonatal period (< 28 days) and 3) comparing surgical ligation with medical treatment with cyclooxygenase inhibitors, each used as the initial treatment for closure of PDA. DATA COLLECTION AND ANALYSIS: Assessment of methodological quality and extraction of data for included trials was undertaken independently by the authors. RevMan 4.1 was used for analysis of the data. MAIN RESULTS: Only one study, trial B in the report of Gersony 1983, was found eligible. The trial compared the effect of surgical ligation of PDA versus medical treatment with indomethacin, each used as the primary treatment. No trials comparing surgery to other cyclooxygenase inhibitors (ibuprofen, mefenamic acid) were found. Trial B of Gersony 1983 enrolled 154 infants. The study found no statistically significant difference between surgical closure and indomethacin treatment in mortality during hospital stay, chronic lung disease, other bleeding, necrotizing enterocolitis, sepsis, creatinine level, or intraventricular hemorrhage. There was a statistically significant increase in the surgical group in incidence of pneumothorax [RR 2.68 (95% CI 1.45, 4.93); RD 0.25 (95% CI 0.11, 0.38); NNH 4 (95% CI 3, 9)] and retinopathy of prematurity grade III and IV [RR 3.80 (95% CI 1.12, 12.93); RD 0.11 (95% CI 0.02, 0.20), NNH 9 (95% CI 5, 50] compared to the indomethacin group. There was as expected a statistically significant decrease in failure of ductal closure rate in the surgical group as compared to the indomethacin group: [RR 0.04 (95% CI 0.01, 0.27); RD -0.32 (95% CI -0.43, -0.21), NNT 3 (95% CI 2, 4)]. REVIEWER'S CONCLUSIONS: The data regarding net benefit/harm are insufficient to make a conclusion as to whether surgical ligation or medical treatment with indomethacin is preferred as initial treatment for symptomatic PDA in preterm infants.

Cyclooxygenase Inhibitors↗
PubMed2003

Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants.

BACKGROUND: A patent ductus arteriosus (PDA) often complicates the clinical course of preterm infants and increases the risk of intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), chronic lung disease (CLD) and death. The standard treatment to close a PDA is indomethacin. Its use is associated with renal, gastrointestinal and cerebral side-effects. Ibuprofen has been shown to be effective in closing a PDA without reducing blood flow velocity to the brain, gut or kidneys. OBJECTIVES: To determine the effectiveness and safety of prophylactic ibuprofen compared to placebo/no intervention or other cyclo-oxygenase inhibitor drugs (indomethacin, mefenamic acid, etc) in the prevention of PDA in preterm infants. SEARCH STRATEGY: Randomized controlled trials comparing prophylactic ibuprofen use with placebo/no intervention/indomethacin were identified by searching the Cochrane Controlled Trial Register (The Cochrane Library, Issue 4, 2002), MEDLINE (1966-November 2002), CINAHL (1982-November 2002), EMBASE (1980-November 2002), reference lists of published trials and abstracts published in Pediatric Research (1990-2002). No language restrictions were applied. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials comparing use of ibuprofen with placebo/no intervention or other cyclo-oxygenase inhibitor drugs (indomethacin, mefenamic acid, etc) for the prevention of PDA in preterm and/or low birth weight infants. DATA COLLECTION AND ANALYSIS: Data regarding the clinical outcomes including presence of PDA on day three and day seven, need for surgical ligation, need for rescue treatment with cyclo-oxygenase inhibitors, IVH, mortality, renal and gastrointestinal complications were extracted. Meta-analyses were performed using RevMan 4.1 and treatment estimates were reported as weighted mean difference (WMD), typical relative risk (RR), typical risk difference (RD) and, if statistically significant, number needed to treat (NNT) or number needed to harm (NNH), along with their 95% confidence intervals (CI). MAIN RESULTS: Four trials (n = 623) were included in the review. There was a statistically significant decrease in the incidence of PDA on day three in the ibuprofen group [typical RR 0.36 (95% CI 0.26, 0.49); typical RD -0.29 (95% CI -0.37, -0.21); NNT 3 (95% CI 3, 5); 3 trials, n = 488]. There was a significant increase in the serum creatinine levels in the ibuprofen group [WMD 0.11 mg/dl (95% CI 0.06, 0.17); 2 trials, n = 438]. There were no statistically significant differences in mortality, grade 3 or 4 IVH, CLD at 28 days or 36 weeks, need for surgical closure of PDA, NEC, GI hemorrhage, time to reach full feeds and urine output. One trial (Gournay 2002) (n = 135) reported on three infants in the ibuprofen group who developed pulmonary hypertension responsive to nitric oxide treatment. REVIEWER'S CONCLUSIONS: Prophylactic use of ibuprofen reduces the incidence of PDA. However, further trials, which address potential adverse effects including pulmonary hypertension, are needed. Such trials should include long-term neurodevelopmental outcomes. Trials comparing the effectiveness of prophylactic use of indomethacin versus ibuprofen may be warranted with particular reference to IVH, need for surgical ligation and neurodevelopmental outcome.

Cyclooxygenase Inhibitors↗
PubMed2006

Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants.

BACKGROUND: A patent ductus arteriosus (PDA) often complicates the clinical course of preterm infants and increases the risk of intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), chronic lung disease (CLD) and death. The standard treatment to close a PDA is indomethacin. Its use is associated with renal, gastrointestinal and cerebral side-effects. Ibuprofen has been shown to be effective in closing a PDA without reducing blood flow velocity to the brain, gut or kidneys. OBJECTIVES: To determine the effectiveness and safety of prophylactic ibuprofen compared to placebo/no intervention or other cyclo-oxygenase inhibitor drugs (indomethacin, mefenamic acid, etc) in the prevention of PDA in preterm infants. SEARCH STRATEGY: Randomized controlled trials comparing prophylactic ibuprofen use with placebo/no intervention/indomethacin were identified by searching the Cochrane Central Register of Controlled Trial (CENTRAL, The Cochrane Library, Issue 3, 2005), MEDLINE (1966-July 2005), CINAHL (1982-July 2005), EMBASE (1980-July 2005), reference lists of published trials and abstracts published in Pediatric Research (1990-July 2005). No language restrictions were applied. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials comparing use of ibuprofen with placebo/no intervention or other cyclo-oxygenase inhibitor drugs (indomethacin, mefenamic acid, etc) for the prevention of PDA in preterm and/or low birth weight infants. DATA COLLECTION AND ANALYSIS: Data regarding the clinical outcomes including presence of PDA on day three and day seven, need for surgical ligation, need for rescue treatment with cyclo-oxygenase inhibitors, IVH, mortality, renal and gastrointestinal complications were extracted. Meta-analyses were performed using RevMan 4.2 and treatment estimates were reported as weighted mean difference (WMD), typical relative risk (RR), typical risk difference (RD) and, if statistically significant, number needed to treat (NNT) or number needed to harm (NNH), along with their 95% confidence intervals (CI). MAIN RESULTS: Four trials (n = 672) were included in the review. There was a statistically significant decrease in the incidence of PDA on day three in the ibuprofen group [typical RR 0.37 (95% CI 0.29, 0.49); typical RD -0.29 (95% CI -0.35, -0.22); NNT 3 (95% CI 3, 5); 4 trials, n = 672], in the need for rescue treatment with cyclo-oxygenase inhibitors [typical RR 0.17 (95% CI 0.11, 0.27), typical RD -0.27 (95% CI -0.35, -0.22); NNT 4 (95%CI 3, 5), and in the need for surgical ligation [typical RR 0.34 (95% CI 0.14, 0.81), typical RD -0.04 (95% CI -0.07, -0.01); NNT 25 (95% CI 14, 100). The PDA had closed spontaneously by day three in 60% of the neonates in the control group. There was a significant increase in the serum creatinine levels in the ibuprofen group [WMD 0.13 mg/dl (95% CI 0.08, 0.17); 2 trials, n = 495]. Ibuprofen reduces urine output. There were no statistically significant differences in mortality, grade 3/4 intraventricular hemorrhage, chronic lung disease at 28 days or 36 weeks, necrotizing enterocolitis , gastrointestinal hemorrhage, intestinal perforation or time to reach full feeds. One trial (Gournay 2002) (n = 135) reported on three infants in the ibuprofen group who developed pulmonary hypertension responsive to nitric oxide treatment. AUTHORS' CONCLUSIONS: Prophylactic use of ibuprofen reduces the incidence of PDA, the need for rescue treatment with cyclo-oxygenase inhibitors and surgical closure. However, in the control group, the PDA had closed spontaneously by day three in 60% of the neonates. Prophylactic treatment therefore exposes a large proportion of infants unnecessarily to a drug that has important side effects (mainly involving the kidneys) without conferring any important short term benefits. Prophylactic treatment with ibuprofen is not recommended. Until long-term follow-up results are published from the trials included in this review, no further trials of prophylactic ibuprofen are recommended.

Cyclooxygenase Inhibitors↗
PubMed2000

Closure of the patent ductus arteriosus with the amplatzer PDA device: immediate results of the international clinical trial.

The purpose of this article is to present the immediate and short-term results of the international registry of transcatheter closure of patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO). Three hundred sixteen patients (221 females) in various centers with clinical and/or echocardiographic evidence of PDA underwent an attempt of catheter closure at a median age of 2.1 years and median weight of 10.7 kg. The median Qp/Qs ratio was 2.3, the median length of the PDA was 6.7 mm and the median diameter of the PDA at its narrowest point (usually the pulmonic end) was 3.8 mm. Immediately after closure and by angiography, the PDA was completely closed in 177/311 patients (56%) and within 24 hr the complete closure rate increased to 76% (235/308). Complications were encountered in 15 patients, including 1 major complication due to device embolization and subsequent death, 6 moderate complications, and 8 minor complications. The median fluoroscopy time was 12 min and the median total procedure time was 70 min. One hundred fourteen patients reached the 6-month follow-up. Color Doppler echocardiography demonstrated complete closure in 109 patients (94.6%). Thirty-eight patients reached the 1-year follow-up mark. There was complete closure in 100% of the patients as documented by color Doppler echocardiography. So far there has been no episodes of delayed device migration, endocarditis, thromboembolism, and wire fracture or device disruption. We conclude that the ADO is safe and effective in most patients with PDA up to a diameter of 10.6 mm. Further clinical trials are underway to assess its long-term safety and efficacy.

Adolescent↗
PubMed1995

Familial occurrence of patent ductus arteriosus.

We describe 7 relatives with patent ductus arteriosus (PDA) and a slightly unusual facial appearance with prominent midface with nose elongation and flattening of the nasal bridge, wide-set eyes, downturned palpebral fissures, mild ptosis, thickened lips, and apparently slightly low-set ears. Autosomal dominant inheritance is suggested in this family. Other families where affected members have PDA and a similar facial appearance and autosomal dominant inheritance were described previously by Char [1978: BD:OAS XIV (6B):303-305] and Temple [1992: Clin Dysmorphol 1:17-21].

Child↗
PubMed2002

Severe intravascular hemolysis after transcatheter closure of a large patent ductus arteriosus using the Amplatzer duct occluder: successful resolution by intradevice coil deployment.

A 21-year-old female developed severe unremitting intravascular hemolysis following closure of a large patent ductus arteriosus using an Amplatzer duct occluder. Percutaneous deployment of fibered platinum coils within the nitinol wire cage of the Amplatzer duct occluder abolished the residual shunt through the device and resulted in cessation of intravascular hemolysis and reversal of its adverse sequelae.

Adult↗
PubMed2003

Transcatheter occlusion of patent ductus arteriosus using a new angled Amplatzer duct occluder: initial clinical experience.

In the present study, we report the initial clinical experience with the new angled Amplatzer duct occluder (ADO) for the percutaneous closure of patent ductus arteriosus (PDA). Percutaneous closure of PDA using standard ADO in infants and in patients with small PDA ampulla is difficult, or even impossible, due to protrusion of the aortic disk into the descending thoracic aorta. The aortic disk of an angled ADO is angled at 32 degrees to the body of the device and concave toward the aorta to prevent protrusion of the disk into the aorta. Percutaneous closure of PDA was attempted in nine patients with a median age of 5.2 years (range, 0.5-12.7) and median weight of 20 kg (range, 4.9-55). Selection of the occluder and the implantation technique were similar to the standard ADO. The minimal PDA diameter ranged from 2.1 to 3.7 mm (median, 2.5 mm). Occluders were successfully implanted in all patients. Immediate complete PDA closure was achieved in all patients. There were no complications. The new angled ADO is a safe and effective device for PDA closure, particularly suitable for infants and patients with small PDA ampulla. Further studies and long-term follow-up are necessary to confirm our initial experience.

Aortography↗
PubMed2003

Simultaneous treatment of native coarctation of the aorta combined with patent ductus arteriosus using a covered stent.

A 19-year-old girl with coarctation of the aorta and patent ductus arteriosus underwent simultaneous treatment of native coarctation and closure of ductus arteriosus using a covered Cheatham-Platinum stent. This technique may be used as an alternative to other forms of interventional therapy or surgery for this combination of lesions in adolescents and adults.

Abnormalities, Multiple↗
PubMed2003

One-step treatment of patent ductus arteriosus and pulmonary artery stenosis by cardiac catheterization.

Coexistence of pulmonary artery (PA) stenosis and patent ductus arteriosus (PDA) may lead to overestimating the relative importance of these malformations. This article reports on a patient with a trivial PDA and severe PA stenosis erroneously diagnosed as moderate PDA. He was successfully submitted to simultaneous PA stenting and PDA embolization.

Blood Vessel Prosthesis Implantation↗
PubMed2003

Clinical course and management strategies for hemolysis after transcatheter closure of patent arterial ducts.

Residual flows following transcatheter coil or device closure of the patent ductus arteriosus (PDA) can result in hemolysis. Of 611 patients who underwent transcatheter PDA closure at our institution, 5 patients (age, 6-63 years) developed overt hemolysis (after coil occlusion in 4 and Amplazter device closure in 1). All had ducts > 3 mm and residual flows after the procedure. In one patient, hemolysis occurred 3 months after coil occlusion following a period of uncontrolled hypertension. The occurrence of hemolysis correlated significantly with both age as well as duct size (P < 0.00001). Hemolysis was associated with a fall in hemoglobin of 3-6 g/100 ml (n = 3), jaundice (n = 2), and renal failure (n = 1). Hemolysis subsided spontaneously in one patient and four patients required flow elimination. Deploying additional coils in three patients eliminated residual flows. In one patient (after Amplatzer device closure for 12.5 mm duct with aneurysm), flow persisted after 25 additional coils, transient balloon occlusion, and gel foam instillation. Flow elimination was eventually achieved through thrombin instillation after balloon occlusion of the ampulla. All patients recovered completely and were well on follow-up. Although hemolysis after duct occlusion is rare (0.8% in this series), residual flow at the end of the procedure merits careful monitoring. Aggressive elimination of residual flows is often necessary to control hemolysis.

Adult↗
PubMed2004

Stent implantation in right-sided patent ductus arteriosus to relieve severe cyanosis in adult patient with pulmonary atresia and ventricular septal defect.

Patients with unrepaired pulmonary atresia and ventricular septal defect may develop stenosis of collaterals or shunts to the pulmonary arteries leading to hypoperfusion of lungs and systemic hypoxemia. A 25-year-old female with pulmonary atresia and ventricular septal defect presented with progressively increasing cyanosis and exercise intolerance. A restrictive right-sided patent ductus arteriosus was identified as the main source of pulmonary blood flow. We report transcatheter implantation of a balloon-expandable stent across the stenosed duct to augment the pulmonary blood flow as a palliative management option. Patient had immediate improvement in arterial oxygen saturation from 66% to 85% with excellent clinical improvement and stable oxygen saturation on 8 months of follow-up.

Adult↗
PubMed2004

Angiographic and hemodynamic predictors for successful outcome of transcatheter occlusion of patent ductus arteriosus in infants less than 8 kilograms.

Transcatheter occlusion of patent ductus arteriosus (PDA) using Gianturco coils (GCs) has been performed for the past decade. However, little has been written regarding anatomical and hemodynamic predictors for successful occlusion of the PDA in infants. This report is to evaluate the outcome of transcatheter occlusion of PDA in symptomatic infants less than 8 kg and to assess predictors of successful occlusion. Retrospective review of catheterization charts and cineangiograms of 42 symptomatic infants who underwent cardiac catheterization for attempted transcatheter occlusion of their PDA was conducted. The hemodynamic and angiographic data evaluated included the length/diameter (L/D) ratio, defined as the length divided by the narrowest diameter of the ductus arteriosus, and preocclusion pulmonary artery pressures. Thirty-one out of 42 patients (74%) had successful occlusion. Twenty-nine out of 42 infants had an L/D ratio > 3. Of these, 26 (90%) had successful occlusion of their PDA. Thirteen out of 42 patients had an L/D ratio < or = 3. Of these, 8 (62%) had unsuccessful occlusion. Complications encountered were transient loss of femoral arterial pulse (n = 6), coil embolization (n = 5), hemolysis (n = 2), and mild left pulmonary artery obstruction (n = 2). No permanent loss of femoral arterial pulse was noted. These complications resulted in no mortality and minimal morbidity. The L/D ratio was the strongest predictor of successful outcome, with an L/D ratio greater than 3.0 being more amenable to transcatheter occlusion (odds ratio of 4.6). Other predictors for success included lower preocclusion systolic, diastolic, and mean pulmonary artery pressure and smaller ductal diameter. Our conclusion was that infants less than 8 kg with an L/D ratio > 3.0 can safely and successfully undergo transcatheter occlusion of their PDA using transcatheter coils.

Body Weight↗
PubMed2001

Transcatheter closure of a 16 mm hypertensive patent ductus arteriosus with the Amplatzer muscular VSD occluder.

There is little experience with transcatheter closure of very large, hypertensive patent ductus arteriosus. We present a case of successful closure of a 16 mm ductus with the Amplatzer VSD occluder, a device originally designed for transcatheter closure of congenital muscular ventricular septal defects. To our best knowledge this is the largest ductus ever closed by an interventional technique.

Adolescent↗