Band ligation versus sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis.

BACKGROUND: Portal hypertension commonly accompanies advanced liver disease and often gives rise to life-threatening complications, including bleeding (haemorrhage) from oesophageal and gastrointestinal varices. Variceal bleeding commonly occurs in children and adolescents with chronic liver disease or portal vein thrombosis. Prevention is, therefore, important. Randomised clinical trials have shown that non-selective beta-blockers and endoscopic variceal band ligation decrease the incidence of variceal bleeding in adults. In children and adolescents, band ligation, beta-blockers, and sclerotherapy have been proposed as primary prophylaxis alternatives for oesophageal variceal bleeding. However, it is unknown whether these interventions are of benefit or harm when used for primary prophylaxis in children and adolescents. OBJECTIVES: To assess the benefits and harms of band ligation compared with sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, PubMed, Embase, and two other databases (April 2020). We scrutinised the reference lists of the retrieved publications, and we also handsearched abstract books of the two main paediatric gastroenterology and hepatology conferences from January 2008 to December 2019. We also searched clinicaltrials.gov, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) for ongoing clinical trials. We imposed no language or document type restrictions on our search. SELECTION CRITERIA: We aimed to include randomised clinical trials irrespective of blinding, language, or publication status, to assess the benefits and harms of band ligation versus sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis. If the search for randomised clinical trials retrieved quasi-randomised and other observational studies, then we read them through to extract information on harm. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology to perform this systematic review. We used GRADE to assess the certainty of evidence for each outcome. Our primary outcomes were all-cause mortality, serious adverse events and liver-related morbidity, and quality of life. Our secondary outcomes were oesophageal variceal bleeding and adverse events not considered serious. We used the intention-to-treat principle. We analysed data using Review Manager 5. MAIN RESULTS: One conference abstract, describing a feasibility multi-centre randomised clinical trial, fulfilled our review inclusion criteria. We judged the trial at overall high risk of bias. This trial was conducted in three hospital centres in the United Kingdom. The aim of the trial was to determine the feasibility and safety of further larger randomised clinical trials of prophylactic band ligation versus no active treatment in children with portal hypertension and large oesophageal varices. Twelve children received prophylactic band ligation and 10 children received no active treatment. There was no information on the age of the children included, or about the diagnosis of any child included. All children were followed up for at least six months. Mortality was 8% (1/12) in the band ligation group versus 0% (0/10) in the no active intervention group (risk ratio (RR) 2.54, 95% confidence interval (CI) 0.11 to 56.25; very low certainty of evidence). The abstract did not report when the death occurred, but we assume it happened between the six-month follow-up and one year. No child (0%) in the band ligation group developed adverse events (RR 0.28, 95% CI 0.01 to 6.25; very low certainty of evidence) but one child out of 10 (10%) in the no active intervention group developed idiopathic thrombocytopaenic purpura. One child out of 12 (8%) in the band ligation group underwent liver transplantation versus none in the no active intervention group (0%) (RR 2.54, 95% CI 0.11 to 56.25; very low certainty of evidence). The trial reported no other serious adverse events or liver-related morbidity. Quality of life was not reported. Oesophageal variceal bleeding occurred in 8% (1/12) of the children in the band ligation group versus 30% (3/10) of the children in the no active intervention group (RR 0.28, 95% CI 0.03 to 2.27; very low certainty of evidence). No adverse events considered non-serious were reported. Two children were lost to follow-up by one-year. Ten children in total completed the trial at two-year follow-up. There was no information on funding.  We found two observational studies on endoscopic variceal ligation when searching for randomised trials. One found no harm, and the other reported E nterobacter cloacae septicaemia in one child and mild, transient, upper oesophageal sphincter stenosis in another. We did not assess these studies for risk of bias. We did not find any ongoing randomised clinical trials of interest to our review. AUTHORS' CONCLUSIONS: The evidence, obtained from only one feasibility randomised clinical trial at high risk of bias, is very scanty. It is very uncertain about whether prophylactic band ligation versus sham or no (active) intervention may affect mortality, serious adverse events and liver-related morbidity, or oesophageal variceal bleeding in children and adolescents with portal hypertension and large oesophageal varices. We have no data on quality of life. No adverse events considered non-serious were reported. The results presented in the trial need to be interpreted with caution. In addition, the highly limited data cover only part of our research question; namely, children with portal hypertension and large oesophageal varices. Data on children with portal vein thrombosis are lacking. Larger randomised clinical trials assessing the benefits and harms of band ligation compared with sham treatment for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis are needed. The trials should include important clinical outcomes such as death, quality of life, failure to control bleeding, and adverse events.

Short-Term Complications Associated with Surgical Ligation of Patent Ductus Arteriosus in ELBW Infants: A 25-Year Cohort Study.

OBJECTIVE: This article aims to determine the incidence of short-term complications of surgical patent ductus arteriosus (PDA) ligations, the factors associated with those complications, and whether complications are associated with poor long-term outcomes. STUDY DESIGN: Retrospective cohort study of all extremely low birth weight (ELBW, < 1,000 g) infants who underwent surgical PDA ligation at a single-center neonatal intensive care unit from 1989 to 2015. Demographic, clinical, and laboratory data were reviewed. The primary outcome was development of a short-term (< 2 weeks from ligation) surgical complication. Secondary outcomes include bronchopulmonary dysplasia (BPD), length of stay, and mortality. RESULTS: A total of 180 ELBW infants were included; median gestational age and birth weight was 24 weeks and 683 g, respectively, and 44% of infants had at least one short-term complication. Need for vasopressors (33%) was the most common medical complication and vocal cord paralysis (9%) was the most common surgical complication. Younger corrected gestational age at time of repair was associated with increased risk for complications. Mortality, length of stay, and BPD rates were similar between infants with and without complications. CONCLUSION: Serious complications were seen in a minority of infants. Additional research is needed to determine if short-term complications are associated with long-term adverse outcomes.

Liver regeneration after performing associating liver partition and portal vein occlusion for staged hepatectomy (ALPPS) is histologically similar to that occurring after liver transplantation using a small-for-size graft.

PURPOSE: Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) can achieve marked future liver remnant (FLR) hypertrophy but this procedure is associated with a risk of mortality due to liver failure because of an insufficient FLR functional increase, a situation comparable to small-for-size syndrome (SFSS) after living-donor liver transplantation (LDLT). METHODS: The clinical data, morphologic volume changes, and histopathologic and immunohistochemical findings in hepatocytes and bile ductules were compared between ALPPS (n = 10) and LDLT with a risk for SFSS (n = 12). RESULTS: Although the patient characteristics and short-term outcome differed between the groups, the mean hypertrophy ratios with respect to liver volume for the FLR after performing the first-stage ALPPS procedures resembled those in small-for-size grafts after similar time intervals: 1.702 ± 0.407 in ALPPS vs. 1.948 ± 0.252 in LDLT (P = 0.205). The histologic grades for sinusoidal dilation (P = 0.896), congestion (P = 0.922), vacuolar change (P = 0.964), hepatocanalicular cholestasis (P = 0.969), and ductular reaction (P = 0.728) within the FLR at the second-stage operation during ALPPS or implanted graft were all similar between the groups. CONCLUSIONS: The hepatic regenerative process may be similar in ALPPS and LDLT using a small-for-size graft. Reducing the hepatic vascular inflow that may be excessive for the FLR volume during the first stage of ALPPS might enhance the functional recovery since measures with a similar effect appear to lessen the likelihood of SFSS.

Hypogastric artery ligation in postpartum haemorrhage: a ten-year experience at a tertiary care centre.

This study investigated patients who underwent bilateral hypogastric artery ligation (BHAL) due to postpartum haemorrhage (PPH). Patients who underwent BHAL because of PPH following a conservative treatment were included in this study. Placental abnormalities were referred to as placenta accreta. A total of 130 BHAL procedures took place at the study hospital as a result of PPH. Of these, 39 (30%) were referred to the hospital. The rate of BHAL requirement was 62 out of 10,000 births. Among the 130 patients, the most frequent indication for BHAL was placenta accreta (58.5%). Haematological parameters were poorer among the referral patients. Four of the exitus patients (80%) were referral patients. The mortality rate among the referral patients was 10.25%, whereas this rate was only 1.01% among the patients who gave birth at the hospital. PPH is a life-threatening condition that requires immediate medical attention. BHAL, with its fertility-preserving features, is a good option that can be employed in all PPH patients. BHAL not only preserves patients' fertility, but it also gives them a higher chance of survival.IMPACT STATEMENTWhat is already known on this subject? PPH is a life-threatening condition. Due to the worldwide increase in caesarean sections, placenta accreta has also increased. BHAL is a vital treatment method for PPH.What do the results of this study add? Placenta accreta is one of the most common causes of PPH. Traditional hysterectomy rates can be reduced by replacing this treatment with BHAL in this group of patients. Without early intervention in PPH, a patient's mortality risk can increase by up to 10 times. As research and surgeons' experience grows, PPH can be controlled with treatments with less complex modalities without the need for BHAL.What are the implications of these findings for clinical practice and/or further research? The need for BHAL should be kept in mind when addressing PPH, especially in cases of placenta accreta. The need for hypogastric artery ligation, which is a more aggressive treatment for the surgical correction of the pathology, can be reduced as surgeons' experience increases. Early intervention and/or referral in cases of PPH is of great importance.

Impact of inferior vena cava ligation on mortality in trauma patients.

OBJECTIVE: Inferior vena cava (IVC) injuries are potentially lethal and require prompt intervention. Repair of complex IVC injuries may require the use of a prosthetic graft or a complicated panel or spiral vein graft reconstruction to avoid the need for ligation. Collateral venous drainage may be sufficient to allow acceptable results from IVC ligation; however, previous studies have suffered from low numbers and have differing results. The aims of this study were to assess the outcomes of isolated IVC injuries overall and to compare IVC ligation with repair. METHODS: Patients in the National Trauma Data Bank from 2007 to 2014 with an IVC injury were evaluated. Isolated IVC injury was defined as patients with nonvascular Abbreviated Injury Scale scores <4 and no other named vascular injury. The primary outcome was mortality; secondary outcomes were in-hospital amputation-free survival, major lower extremity amputation, lower extremity compartment syndrome, acute kidney injury (AKI), deep venous thrombosis (DVT), and pulmonary embolism (PE). RESULTS: Overall, 1075 (0.018%) patients had IVC injuries and 443 met inclusion criteria. On univariate analysis, in comparing IVC ligation and primary repair, ligation was not associated with mortality (23% vs 16%; P = .102) but was associated with blunt mechanism (22% vs 11%; P = .009), higher fasciotomy rate (11% vs 0%; P < .001), trend toward lower in-hospital amputation-free survival (76% vs 84.4%, P = .056), and higher rates of AKI (9% vs 4%; P = .060) and PE (3% vs 1%, P = .087). Similarly, major lower extremity amputation, compartment syndrome, and DVT were not different between groups. IVC ligation was not independently associated with mortality (adjusted odds ratio [AOR], 1.54; P = .197), in-hospital amputation-free survival (AOR, 0.61; P = .141), major amputation (AOR, Inf; P = .99), lower extremity compartment syndrome (AOR, 0.82; P = .827), or PE (AOR, 6.72; P = .052), but it was independently associated with fasciotomy (AOR, 31.4; P = .002), AKI (AOR, 2.7; P = .048), and DVT (AOR, 2.3; P = .021). CONCLUSIONS: IVC ligation was not independently associated with mortality or lower extremity amputation, but it was associated with AKI and need for fasciotomy.

Band ligation versus no intervention for primary prevention of upper gastrointestinal bleeding in adults with cirrhosis and oesophageal varices.

BACKGROUND: The presence of oesophageal varices is associated with the risk of upper gastrointestinal bleeding. Endoscopic variceal ligation is used to prevent this occurrence but the ligation procedure may be associated with complications. OBJECTIVES: To assess the beneficial and harmful effects of band ligation versus no intervention for primary prevention of upper gastrointestinal bleeding in adults with cirrhosis and oesophageal varices. SEARCH METHODS: We combined searches in the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, and Science Citation Index with manual searches. The last search update was 9 February 2019. SELECTION CRITERIA: We included randomised clinical trials comparing band ligation verus no intervention regardless of publication status, blinding, or language in the analyses of benefits and harms, and observational studies in the assessment of harms. Included participants had cirrhosis and oesophageal varices with no previous history of variceal bleeding. DATA COLLECTION AND ANALYSIS: Three review authors extracted data independently. The primary outcome measures were all-cause mortality, upper gastrointestinal bleeding, and serious adverse events. We undertook meta-analyses and presented results using risk ratios (RRs) with 95% confidence intervals (CIs) and I2 values as a marker of heterogeneity. In addition, we calculated the number needed to treat to benefit (NNTTB) for the primary outcomes . We assessed bias control using the Cochrane Hepato-Biliary domains; determined the certainty of the evidence using GRADE; and conducted sensitivity analyses including Trial Sequential Analysis. MAIN RESULTS: Six randomised clinical trials involving 637 participants fulfilled our inclusion criteria. One of the trials included an additional small number of participants (< 10% of the total) with non-cirrhotic portal hypertension/portal vein block. We classified one trial as at low risk of bias for the outcome, mortality and high risk of bias for the remaining outcomes; the five remaining trials were at high risk of bias for all outcomes. We downgraded the evidence to moderate certainty due to the bias risk. We gathered data on all primary outcomes from all trials. Seventy-one of 320 participants allocated to band ligation compared to 129 of 317 participants allocated to no intervention died (RR 0.55, 95% CI 0.43 to 0.70; I2 = 0%; NNTTB = 6 persons). In addition, band ligation was associated with reduced risks of upper gastrointestinal bleeding (RR 0.44, 95% CI 0.28 to 0.72; 6 trials, 637 participants; I2 = 61%; NNTTB = 5 persons), serious adverse events (RR 0.55, 95% CI 0.43 to 0.70; 6 trials, 637 participants; I2 = 44%; NNTTB = 4 persons), and variceal bleeding (RR 0.43, 95% CI 0.27 to 0.69; 6 trials, 637 participants; I² = 56%; NNTTB = 5 persons). The non-serious adverse events reported in association with band ligation included oesophageal ulceration, dysphagia, odynophagia, retrosternal and throat pain, heartburn, and fever, and in the one trial involving participants with either small or large varices, the incidence of non-serious side effects in the banding group was much higher in those with small varices, namely ulcers: small versus large varices 30.5% versus 8.7%; heartburn 39.2% versus 17.4%. No trials reported on health-related quality of life.Two trials did not receive support from pharmaceutical companies; the remaining four trials did not provide information on this issue. AUTHORS' CONCLUSIONS: This review found moderate-certainty evidence that, in patients with cirrhosis, band ligation of oesophageal varices reduces mortality, upper gastrointestinal bleeding, variceal bleeding, and serious adverse events compared to no intervention. It is unlikely that further trials of band ligation versus no intervention would be considered ethical.

Transjugular intrahepatic portosystemic shunt prevents rebleeding in cirrhotic patients having cavernous transformation of the portal vein without improving their survival.

OBJECTIVE: To compare the efficacy of transjugular intrahepatic portosystemic shunts (TIPS) and endoscopic variceal ligations (EVL) plus propranolol in decreasing rebleeding and improving survival rates in cirrhotic patients with cavernous transformation of the portal vein (CTPV). METHODS: Cirrhotic patients with CTPV and a history of variceal bleeding who were treated for recurrent variceal bleeding between June 2010 and July 2016 were identified and classified based on the treatment they received (TIPS or EVL plus propranolol). Their characteristics and clinical data were recorded. The rebleeding and long-term survival rates between the two groups were analyzed. RESULTS: A total of 51 patients were included, of whom 25 were treated with TIPS and 26 with EVL plus propranolol. The mean duration of follow up was 21 months (range 1-47 months) in the former group and 27 months (range 6-73 months) in the latter group. The recurrent variceal bleeding-free rate increased remarkably in the TIPS group compared with the EVL + propranolol group (P = 0.047). Three (14.3%) patients died in the TIPS group, and one (3.8%) in the EVL plus propranolol group (P = 0.305). Hepatic encephalopathy occurred in 14.3% (3/21) of the patients in the TIPS group and in 3.8% (1/26) in the EVL + propranolol group (P = 0.202). CONCLUSION: TIPS appeared to be more effective in preventing rebleeding in cirrhotic patients with CTPV compared with EVL plus propranolol, without improving survival.

Effects of practice change on outcomes of extremely preterm infants with patent ductus arteriosus.

AIM: To determine whether a decrease in patent ductus arteriosus (PDA) treatment or ligation in extremely preterm (EP) infants was associated with changes in rates of mortality and/or morbidities. METHODS: Observational study on EP infants admitted from 2008 to 2015. The small baby guidelines do not mandate ligation, however, in late 2010 the guidelines were amended based on new literature suggested that ligation may increase rates of morbidities. RESULTS: There were 717 EP infants admitted during the study period. There were no significant changes in gestational age, birthweight or annual admissions during the study period. The annual rate of PDA medical treatment declined significantly (R = 0.83, p = 0.01), while the annual rate of PDA ligation declined substantially (R = 0.88, p = 0.004). The annual mortality rate also declined significantly (R = 0.81, p = 0.014). The annual rates of bronchopulmonary dysplasia (BPD), necrotising enterocolitis and intraventricular haemorrhage did not change significantly. CONCLUSION: In this cohort of EP patients, the rate of PDA ligation decreased substantially since 2010, with no apparent adverse effects on mortality or rates of BPD. These data are consistent with the concept that ligation does not improve outcomes in EP infants.

Association of Patent Ductus Arteriosus Ligation With Death or Neurodevelopmental Impairment Among Extremely Preterm Infants.

Importance: Observational studies have associated patent ductus arteriosus (PDA) ligation among preterm infants with adverse neonatal outcomes and neurodevelopmental impairment in early childhood, with a resultant secular trend away from surgical treatment. However, to our knowledge, studies have inadequately addressed sources of residual bias, including survival bias and major neonatal morbidities arising before exposure to ligation. Objective: Evaluate the association between PDA ligation vs medical management and neonatal and neurodevelopmental outcomes. Design, Setting, and Participants: This retrospective cohort study of preterm infants younger than 28 weeks gestational age born between January 1, 2006, and December 31, 2012, with clinical and echocardiography diagnoses of hemodynamically significant PDA was conducted at 3 tertiary neonatal intensive care units and affiliated follow-up programs. Exposure: Surgical ligation vs medical management. Main Outcomes and Measures: The primary outcome was a composite of death or neurodevelopmental impairment (NDI) at 18 to 24 months corrected age. Secondary outcomes included death before discharge, NDI, moderate-severe chronic lung disease, and severe retinopathy of prematurity. Multivariable logistic regression analysis was used to adjust for perinatal and postnatal confounders. Results: Of 754 infants with hemodynamically significant PDA (mean [standard deviation] gestational age 25.7 [1.2] weeks and birth weight 813 [183] grams), 184 (24%) underwent ligation. Infants who underwent ligation had a higher frequency of morbidities before PDA closure, including sepsis, necrotizing enterocolitis, and a dependence on mechanical ventilation. After adjusting for perinatal characteristics and preligation morbidities, there was no difference in the odds of death or NDI (adjusted odds ratio (aOR), 0.83; 95% CI, 0.52-1.32), NDI (aOR, 1.27; 95% CI, 0.78-2.06), chronic lung disease (aOR, 1.36; 95% CI, 0.78-2.39) or severe retinopathy of prematurity (aOR, 1.61; 95% CI, 0.85-3.06). Ligation was associated with lower odds of mortality (aOR, 0.09; 95% CI, 0.04-0.21). Conclusions and Relevance: Patent ductus arteriosus ligation among preterm neonates younger than 28 weeks gestational age was not associated with the composite outcome of death or NDI, and there were no differences in chronic lung disease, retinopathy of prematurity, or NDI among survivors. Mortality was lower among infants who underwent ligation, though residual survival bias could not be excluded. Previously reported associations of ligation with increased morbidity may be because of bias from confounding by indication.

Long-Term Causes of Death and Excess Mortality After Carotid Artery Ligation.

OBJECTIVE: Carotid artery ligation (CAL) is used to treat large and complex intracranial aneurysms. However, little is known about long-term survival and causes of death in patients who undergo the procedure. This study was intended to evaluate if patients who have undergone CAL have long-term excess mortality and what the causes of death are. METHODS: All patients were treated at Helsinki University Hospital between 1937 and 2009. Patients who had undergone CAL and survived ≥1 year after the procedure were included in the cohort. Follow-up was until death or 2015 (2711 patient-years). Causes of death were reviewed and relative survival ratios calculated using the Ederer II method and a matched population. RESULTS: There was 12% excess mortality in all patients 20 years after CAL and 22% after 30 years. A higher proportion of the patients who had subarachnoid hemorrhage (SAH) died during follow-up compared with unruptured patients undergoing CAL. Cardiovascular disease and cerebrovascular accident were the leading causes of death. CONCLUSIONS: Patients with unruptured aneurysms did not experience as much excess mortality as those who had an SAH. The higher proportion of deaths observed in ruptured patients may be partly because of long-term excess mortality conferred by the SAH itself or SAH risk factors. Although the entire population did display excess mortality compared with the general population, this may be because of shared risk factors for aneurysm development and rupture and the cause of death.

High ligation of the inferior mesenteric artery in rectal cancer surgery.

In rectal cancer surgery, it is unclear whether the inferior mesenteric artery (IMA) should be ligated as high as possible, at its origin, or low, below the origin of the left colic artery. We reviewed all relevant articles identified from MEDLINE databases and found that despite a trend of improved survival among patients who underwent high ligation, there is no conclusive evidence to support this. High ligation of the IMA is beneficial in that it allows for en bloc dissection of the node metastases at and around the origin of the IMA, while enabling anastomosis to be performed in the pelvis, without tension, at the time of low anterior resection. High ligation of the IMA does not represent a source of increased anastomotic leak in rectal cancer surgery and postoperative quality of life is improved by preserving the hypogastric nerve without compromising the radicality of the operation. More importantly, high ligation of the IMA improves node harvest, enabling accurate tumor staging. Although the prognosis of patients with node metastases at and around the origin of the IMA is poor, the survival rate of patients with rectal cancer may be improved by performing high ligation of the IMA combined with neoadjuvant and adjuvant therapy.

Outcomes following the surgical ligation of the patent ductus arteriosus in premature infants in Scotland.

OBJECTIVE: To determine morbidity, mortality and associated risk factors following patent ductus arteriosus (PDA) ligation in premature infants. METHODS: Retrospective case note audit of premature infants referred to a national paediatric cardiothoracic surgical service (2001-2007) with univariate and multivariate analysis of potential risk factors for mortality and morbidity. RESULTS: 125 infants were enrolled (median gestational age 26 weeks (IQR 25-27 weeks), median birth weight 840 g (IQR 730-1035 g)). Referral characteristics were median LA:Ao 1.8 (IQR 1.5-2.0), 80% ventilated, 18.4% continuous positive airway pressure, 70% diuretics and 58% prior treatment with cyclooxygenase inhibitors (COIs). Median age at PDA ligation was 31 days (IQR 25-41 days). Postoperative characteristics were median time to extubation 5 days (IQR 3-10 days), 36.0% corticosteroids, 46.8% domiciliary oxygen and 4.8% vocal cord palsy. The 30-day and 1-year mortality rates were 4.8% and 12.8%, respectively, with neurodisability in 32% of survivors. All deaths occurred in the ventilated group and were mainly attributable to bronchopulmonary dysplasia (BPD). Gestation and fractional inspired oxygen (FiO(2))>60% were significantly associated with 30-day mortality. FiO(2), ventilation, lack of prior COIs and postoperative corticosteroids were significantly associated with 1-year mortality. Preoperative FiO(2)>40% and lack of prior COIs retained independent significance for death at 1 year. CONCLUSIONS: PDA ligation is well tolerated, with evidence of early benefit. The incidence of neurodisability or death from BPD at 1 year remains high. Increasing preoperative FiO(2) and lack of prior treatment with COIs are associated with increased mortality at 1 year.

What happens when the patent ductus arteriosus is treated less aggressively in very low birth weight infants?

OBJECTIVE: It remains unclear whether indomethacin (INDO) and/or surgical ligation (LIGATE) are necessary to improve outcomes in premature infants with a patent ductus arteriosus (PDA). We have adopted a conservative approach to PDA management that emphasizes waiting for spontaneous closure unless certain cardiorespiratory distress criteria are met. STUDY DESIGN: This was a before-after observational study in infants born 501 to 1,500 g in two distinct epochs. Era 1 (January 2005 to December 2007) featured traditional management with INDO and LIGATE used early to close all moderate and large PDAs in infants receiving any respiratory support. Era 2 (January 2008 to June 2009) emphasized modest fluid restriction, watchful waiting and limited INDO and LIGATE to only those infants with large PDAs who met certain cardiorespiratory distress criteria. RESULT: Era 1 included 139 infants with a PDA, mean (s.d.) gestational age 27.5 (2) weeks; Era 2 72 infants, mean (s.d.) gestational age 27.5 (2) weeks. In Era 2, INDO use significantly decreased (79% of infants to 26%, P<0.001), and 28 day total fluids decreased (140 vs. 130 ml kg(-1) day(-1), P<0.001). LIGATE rate was 45% in Era 1, 33% in Era 2 (P=0.11). There were no significant differences in supplemental oxygen, nasal continuous positive airway pressure, or mechanical ventilation days. There were no significant differences in mortality or individual morbidities. The combined outcome of chronic lung disease (CLD) or mortality after Day 7 significantly increased (Era 1, 40%, Era 2, 54%, P=0.04). More infants were discharged home with a PDA in Era 2, but most resolved spontaneously and the need for closure therapy after discharge from the neonatal intensive care unit (NICU) did not increase. Multiple regression analysis demonstrated Era 2 management did not predict an increased risk of one or more interlinked morbidities. CONCLUSION: Tolerance of the PDA with watchful waiting for spontaneous closure, modest fluid reduction, and less INDO use is a reasonable treatment strategy that is not associated with significant changes in NICU mortality or individual morbidities. We did note an increase in the combined outcome of CLD or mortality after Day 7, thus our investigation supports the urgency of a randomized controlled trial comparing traditional PDA management with a true control group similar to our Era 2 management to answer important questions of short and long-term outcomes.

Surgical ligation of patent ductus arteriosus in premature infants.

INTRODUCTION: The objective was to evaluate the mortality and the morbidity in neonates operated for persistent ductus arteriosus at Copenhagen University Hospital in the 10-year period from 1 January 1998 to 31 December 2007, and to compare the results with results reported in extant literature. MATERIAL AND METHODS: Patient data were collected by retrospective audit of medical charts. Infants with complex heart disease were excluded. The outcomes were mortality, necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), paresis of the recurrent laryngeal nerve and chylothorax. For statistical analyses, we used Fisher's exact test and Mann-Whitney U test. RESULTS: We included 46 neonates among an initial 60 candidates. Gestational age was from 23 + 6 to 34 + 0 weeks (mean 26 + 6.5) and the birth weight ranged from 535 g to 1,793 g (mean 943.5 g). In 93% of the cases, the left atrium diameter (LAD)/aorta diameter (Ao)-ratio measured by echocardiography was greater than or equal to 1.5, and medical closure had been attempted in 93% of the cases. After surgical ligation, there were three cases of paresis of the recurrent laryngeal nerve, two cases of chylothorax, eight cases of NEC, four cases of IVH and seven deaths (15.2%). The deaths occurred between three and 119 days postoperatively. Those who died were operated at an earlier age than the remaining patients (p < 0.05) and they tended to be of lower gestational age and to have a lower birth weight (p > 0.05) than those who survived. CONCLUSION: The need for ligation of a patent arterial duct in preterm neonates is subject to considerable risk. Total mortality in this vulnerable group of patients was 15%. Although no obviously procedure-related deaths were observed, severe complications and postoperative morbidity occurred.

Differences in bleeding behavior after endoscopic band ligation: a retrospective analysis.

BACKGROUND: Endoscopic band ligation (EBL) is generally accepted as the treatment of choice for bleeding from esophageal varices. It is also used for secondary prophylaxis of esophageal variceal hemorrhage. However, there is no data or guidelines concerning endoscopic control of ligation ulcers. We conducted a retrospective study of EBL procedures analyzing bleeding complications after EBL. METHODS: We retrospectively analyzed data from patients who underwent EBL. We analyzed several data points, including indication for the procedure, bleeding events and the time interval between EBL and bleeding. RESULTS: 255 patients and 387 ligation sessions were included in the analysis. We observed an overall bleeding rate after EBL of 7.8%. Bleeding events after elective treatment (3.9%) were significantly lower than those after treatment for acute variceal hemorrhage (12.1%). The number of bleeding events from ligation ulcers and variceal rebleeding was 14 and 15, respectively. The bleeding rate from the ligation site in the group who underwent emergency ligation was 7.1% and 0.5% in the group who underwent elective ligation. Incidence of variceal rebleeding did not vary significantly. Seventy-five percent of all bleeding episodes after elective treatment occurred within four days after EBL. 20/22 of bleeding events after emergency ligation occurred within 11 days after treatment. Elective EBL has a lower risk of bleeding from treatment-induced ulceration than emergency ligation. CONCLUSIONS: Patients who underwent EBL for treatment of acute variceal bleeding should be kept under medical surveillance for 11 days. After elective EBL, it may be reasonable to restrict the period of surveillance to four days or even perform the procedure in an out-patient setting.

Early or late surgical ligation of medical refractory patent ductus arteriosus in premature infants.

Optimal time to surgical ligation of patent ductus arteriosus (PDA) in very-low-birth-weight (< 1500 g) premature infants remains an area of controversy. We compared the outcomes of early or late ligation of medical refractory PDA in very-low-birth-weight premature infants. Fifty-six infants underwent surgical closure of PDA after failure of or having contraindications to medical treatment. Thirteen infants were in the early ligation (< or = 14 days) and 43 in the late ligation (> 14 days) groups. Basic clinical features, major morbidity of prematurity and mortality were compared. Clinical features and major outcomes were similar. The early ligation group had earlier onset of symptomatic PDA (5.7 +/- 1.6 days vs. 8.1 +/- 3.6 days, p = 0.024), and fewer days of total parenteral nutrition (TPN) (39.6 +/- 13.9 days vs. 60.4 +/- 31.4 days, p = 0.025) and ventilator use (11.1 +/- 6.7 days vs. 18.6 +/- 10.5 days, p = 0.019). Early ligation of medical refractory PDA in very-low-birth-weight premature infants improves enteral feeding tolerance and reduces TPN and ventilator use, but long-term benefits need further investigation.

Short-term outcomes following total minimally invasive oesophagectomy.

BACKGROUND: Minimally invasive oesophagectomy (MIO; thoracoscopy, laparoscopy, cervical anastomosis) is a complex procedure and few substantial series have been published. This study documented the morbidity, mortality and challenges of adopting MIO in a specialist unit in the UK. METHODS: A prospective group of 77 patients was listed consecutively with the intention of performing MIO. Three other patients underwent open oesophagectomy during the study period. RESULTS: MIO was attempted in 77 patients, completed successfully in 70, abandoned in six patients (8 per cent) with unsuspected metastatic disease, and converted to a thoracoscopic anastomosis in one patient. There was one in-hospital death (1 per cent). Complications occurred in 33 patients (47 per cent), including nine gastric conduit-related complications (13 per cent). Median lymph node harvest was 21 (range 7-48) nodes. Mean overall and disease-free survival times were 35 and 33 months respectively. Median disease-free survival for patients with stage III disease was 26 months. CONCLUSION: MIO can be performed with acceptable mortality and morbidity rates in an unselected series of patients. There was more morbidity related to gastric tube ischaemia than was expected.

Prophylactic surgical ligation of patent ductus arteriosus for prevention of mortality and morbidity in extremely low birth weight infants.

BACKGROUND: Patent ductus arteriosus (PDA) is associated with increased mortality and morbidity in preterm infants. Prophylactic indomethacin results in favorable intermediate outcomes such as reduction of significant PDA, need for surgical ligation, severe intraventricular hemorrhage and serious pulmonary hemorrhage without modifying long-term neurosensory outcomes. Little is known about the effectiveness and safety of prophylactic surgical closure of the PDA in extremely low birth weight (ELBW) infants. OBJECTIVES: To identify and summarize evidence from randomized controlled trials investigating the effectiveness and safety of prophylactic surgical ligation of the PDA on mortality and morbidities of preterm infants less than 1000 g at birth as compared to no prophylaxis or prophylactic cyclooxygenase inhibitors. SEARCH STRATEGY: The standard search strategy for the Cochrane Neonatal Review Group was performed by two review authors. Searches were made of MEDLINE (1966 to December 2006), EMBASE (1980 to December 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2006), and abstracts of annual meetings of the Society for Pediatric Research (1995 - 2006). Contacts were made with the authors of published articles. SELECTION CRITERIA: Randomized or quazi-randomized controlled trials that enrolled infants less than 28 weeks gestation or less than 1000 g at birth who are on assisted ventilation and/or supplemental oxygen without clinical signs of hemodynamic significance of the ductus arteriosus were considered. Trials addressing prophylactic surgical ligation of the patent ducts arteriosus (i.e. procedure done during the first 72 hours of life) versus no intervention or cyclooxygenase inhibitor prophylaxis were included. The primary outcome was bronchopulmonary dysplasia (BPD). Other important short and long-term neonatal outcomes were also considered. DATA COLLECTION AND ANALYSIS: Standard methods of the Cochrane Collaboration and its Neonatal Review Group were used to assess the methodologic quality of the trials. Retrieved articles were assessed for eligibility and data was abstracted independently by two reviewer authors. Where data were incomplete, the primary investigators were contacted for further information and clarifications. For dichotomous outcomes, relative risk (RR) and its associated confidence interval were calculated. For continuous outcomes, treatment effect was expressed as mean difference and its calculated standard deviation. When appropriate, meta-analysis of pooled data was performed assuming a fixed effect model MAIN RESULTS: Only one eligible study that enrolled 84 ELBW infants was identified. The prophylactic group had ductal ligation performed within 24 hours of life following a pre-specified protocol, while the control group received standard care without indomethacin. Prophylactic surgical ligation of the PDA resulted in a statistically significant reduction of severe stage II or III necrotizing enterocolitis (NEC), [RR 0.25, 95% CI (0.08,0.83), p value 0.02, NNT 5]. The study found no statistically significant difference in mortality, severe grade III and IV intraventricular hemorrhage (IVH), BPD, and retinopathy of prematurity (ROP). Of note, the study was unblinded and underpowered to detect clinically important differences in the above mentioned outcomes. AUTHORS' CONCLUSIONS: Prophylactic surgical ligation of the PDA did not decrease mortality or BPD in ELBW infants. A significant reduction of stage II or III NEC was noted. Based on the current evidence, the high rate of spontaneous closure, availability of effective safe medical therapies, and the potential short and long-term complications of surgical ligation, the use such prophylactic surgical therapy is not indicated in the management of the preterm infants.

Pediatric and adolescent strangulation deaths.

The incidence of pediatric and adolescent deaths due to unnatural means is increasing. Fatal strangulation constitutes a significant group of violent deaths. The characteristics of pediatric and adolescent involvement has been rarely studied. In the present study, a cohort of 28 cases of pediatric and adolescent strangulation deaths was analyzed. The data for the study were collected from inquest papers, post-mortem reports and other departmental records for the period 1993-2004 (12 years). Female victims were more than male with male, female ratio of 3:4. Ligature strangulation was three times more frequent than manual strangulation. Ninety three percent were homicidal and the remaining 7% accidental. Fracture of neck structures was found in 25% of the cases and other associated injuries on different body parts were observed in more than half of the cases. Clothing and personal belongings were the most common ligature materials and in the majority of cases the exact reason for strangulation was not known at the time of postmortem.