Major Gastrointestinal Complications Research Articles

Severe Gastrointestinal Complications After IVIG Infusion in Newborns: A Two-Center Study and Literature Review

Background: There are several studies regarding perforations after intravenous immunoglobulin (IVIG) infusion; however, the risk factors are not defined yet. Objectives: The present study aimed to investigate gastrointestinal complications in newborns regarding the reported immunoglobulin A (IgA) levels in IVIG preparations. Methods: This retrospective chart review was conducted on term newborns who received IVIG therapy in two centers in Istanbul. The study included patients with IVIG-associated gastrointestinal bleedings, necrotizing enterocolitis (NEC), and intra-abdominal perforations without any underlying diseases and recorded demographic data (gestational age, birth weight, and gender) and the IgA levels in the IVIG preparations. Infants born below 35 gestational weeks were excluded as they were more likely to have NEC. Results: A total of 71 patients received IVIG therapy, and 15.5% (n = 11) developed major gastrointestinal system (GIS) complications. A total of 36 patients were born ≥ 35 gestational weeks, and gastrointestinal perforation or bleeding occurred in 22.2% (n = 8) of these patients. Two patients died before surgery due to aggressive disease progression. None of these patients had any gastrointestinal symptoms before IVIG therapy or any predisposing factors for gastrointestinal perforation. All patients were on spontaneous breathing and enteral feeding without intolerance. The IgA level content of the IVIG preparations was related to the major GIS complications with strong evidence, and the safe threshold resulted in 14 mg/dL in receiver operating characteristic (ROC) analysis in the present study group. Conclusions: Higher IgA levels in IVIG preparations might be a risk factor for gastrointestinal perforation and bleeding in term newborns. Clinicians should be aware of this potential complication when using IVIG therapy in term newborns and closely monitor for signs and symptoms of major gastrointestinal complications.

Comparison of gastrointestinal adverse events between fast release tablets and regular acetylsalicylic acid (aspirin) galenics after short-term use: a meta-analysis of randomized clinical trials.

This study aimed at determining whether there is a difference in the safety profile between fast release (FR) aspirin tablets and regular galenic formulations of aspirin. This study was based on a clinical study database pool (Bayer HealthCare) including 84clinical studies and 16,095human subjects. The meta-analysis included 72studies applying a single dose of aspirin of at most 1000mg and was, therefore, based on individual data from 9288subjects. Of these, 6029subjects took aspirin and 3259subjects took placebo. Endpoints were adverse events (AEs) of any kind and, especially of gastrointestinal (GI) nature. Event incidence and odds ratios (OR) based on Mantel-Haenszel risk estimates were calcuated. Subjects on aspirin FR had a significantly decreased OR of 0.65 [0.48, 0.90] [95% confidence interval] for all AEs and of 0.39 [0.20, 0.79] for drug-related all AEs versus placebo. The risk of all GI AEs tended to be reduced for subjects on aspirin FR (0.65 [0.41; 1.03]), but not for drug-related GI AEs. Subject on aspirin mono and aspirin mono (plain only, w/o FR) showed an increased risk of drug-related all AEs compared to placebo (1.34 [1.11; 1.62] and 1.43 [1.13; 1.80]). However, subjects on aspirin FR and those on regular aspirin had almost the same risk of all determined AEs. In conclusion, aspirin FR tablets showed a comparable GI tolerability to regular galenic formulations of aspirin after short-term treatment. Major GI complication did not occur after intake of any galenic formulation of aspirin.

Impact of Controlling Nutritional Status score on short-term outcomes after carotid endarterectomy: a retrospective cohort study.

Malnutrition and impaired immune responses significantly affect the clinical outcomes of patients with atherosclerotic stenosis. The Controlling Nutritional Status (CONUT) score has recently been utilized to evaluate perioperative immunonutritional status. This study aimed to evaluate the relationship between immunonutritional status, indexed by CONUT score, and postoperative complications in patients undergoing carotid endarterectomy (CEA). We retrospectively evaluated 188 patients who underwent elective CEA between January 2010 and December 2019. The preoperative CONUT score was calculated as the sum of the serum albumin concentration, total cholesterol level, and total lymphocyte count. The primary outcome was postoperative complications within 30 days after CEA, including major adverse cardiovascular events, pulmonary complications, stroke, renal failure, sepsis, wounds, and gastrointestinal complications. Cox proportional hazards regression analysis was used to estimate the factors associated with postoperative complications during the 30-day follow-up period. Twenty-five patients (13.3%) had at least one major complication. The incidence of postoperative complications was identified more frequently in the high CONUT group (12 of 27, 44.4% vs. 13 of 161, 8.1%; p<0.001). Multivariate analyses showed that a high preoperative CONUT score was independently associated with 30-day postoperative complications (hazard ratio, 5.98; 95% confidence interval, 2.56-13.97; p<0.001). Our results showed that the CONUT score, a simple and readily available parameter using only objective laboratory values, is independently associated with early postoperative complications.

Prospective national audit of major gastrointestinal complications of transesophageal echocardiography studies in children.

Background:Perioperative trans-esophageal echocardiography ('TEE') is widely used for the assessment of anatomy/repair of congenital cardiac defects. It is recognised that there are risks associated with its use.Aims:We wished, by means of a contemporaneous prospective national audit over a six-month period, to establish what proportion of TEE studies in children are complicated by major upper gastrointestinal or upper aerodigestive tract trauma.Methods:After obtaining appropriate local institutional ethics committee approval, a national prospective audit of the rate and severity of gastrointestinal complications of trans-esophageal echocardiography studies in anaesthetised adult cardiology and cardiac surgical patients was conducted by the Association of Cardiothoracic Anaesthesia and Critical Care in the United Kingdom and Ireland during the twelve months of 2017. During the second six months of the audit, the Congenital Cardiac Anaesthesia Network (an organisation including anaesthetists with a paediatric cardiac anaesthetic practice in all the United Kingdom cardiac surgical centres) prospectively audited the incidence of such complications of TEE studies in children.Results:A total of 1,059 studies were included in this six-month paediatric audit. There were no reports of the specified major complication.Statistical Analysis:The zero incidence of the major complication is consistent with a worst possible incidence of five per thousand TEE examinations.Conclusions:Such potentially reassuring information could be included in discussions with patients or families about the risk of trans-esophageal studies in children.

Endoscopy at Bedside in Isolated Patients with Severe COVID-19: Our Approach during the Pandemic

The COVID-19 pandemic changed the management of emergency medicine and those complications that needed interventional procedures, such as endoscopy or other radiological procedures. At the beginning of the outbreak, there were no exploitable recommendations regarding the proper policy to apply for limiting the virus spread during endoscopy. Between the first and the second wave, the approach regarding interventional procedures changed, due to higher awareness and newly defined protocols, even if different among the health centers. Patients with severe COVID-19 may develop major gastrointestinal complications or require nutritional support, so interventional procedures are required at bedside, even if patients are in isolated rooms. Our tertiary center admitted 95 patients with severe COVID-19 at our ICU-dedicated department until May 2021, and 56% of them died. Among them, 61 endoscopic procedures were performed, mainly gastroscopies (81.96%) followed by colonoscopies (11.47%) and other more advanced procedures (6.55%). Our approach aimed to adapt and create COVID-related protocols, dedicated itineraries, and rooms in a separate department with the prospect to easily organize complete and safe endoscopic theaters at the COVID-ICU department.

Systematic Review and Meta-analysis: The Effects of Prophylactic Proton Pump Inhibitor Treatment in Patients With Coronary Heart Disease Receiving Dual Antiplatelet Therapy.

Dual antiplatelet therapy (DAPT) and proton pump inhibitors (PPIs) are widely used in clinical treatment. However, the pharmacokinetic interaction between PPIs and DAPT is still unclear in patients with cardiovascular disease. This systematic review and meta-analysis aimed to evaluate the risks and benefits of the combination of PPI and DAPT in patients with coronary heart disease. The PubMed, EMBASE, Cochrane, and Web of Science databases were systematically searched from inception to April 1, 2020, for eligible studies. The outcomes investigated in this study included major adverse cardiovascular events, myocardial infarction, all-cause death, gastrointestinal complications, and platelet function testing. Studies were excluded from the review if other gastrointestinal medication or aspirin or P2Y12 receptor inhibitor monotherapy was administered. The review included 52 studies, and data from 40 studies were extracted for meta-analysis. No association was found between the risk of adverse clinical outcomes and the combination of PPI and DAPT based on the randomized controlled trial data (risk ratio: 0.98; 95% confidence interval: 0.87-1.09; P = 0.877; I2 = 0%). However, an increased risk of adverse clinical outcomes due to the use of PPIs was observed in patients treated with DAPT based on the data from observational studies (risk ratio: 1.259; 95% confidence interval: 1.079-1.468; P = 0.003; I2 = 67.8%), although the heterogeneity of these studies was high. In conclusion, this systematic review and meta-analysis demonstrated that pharmacokinetic interactions between PPI and DAPT do not lead to adverse clinical outcomes.

S1513 Liver Biopsy Leading to Hemobilia Complicated by Cholangitis, Biliary Pancreatitis, and Massive Gastrointestinal Hemorrhage

INTRODUCTION: Percutaneous liver biopsies (PLB) are performed routinely to investigate liver masses, unexplained hepatomegaly or abnormal liver chemistries and are relatively safe in the absence of coagulopathy. Here, we present a rare complication of PLB: arterio-biliary fistula presenting with delayed onset of hemobilia, massive gastrointestinal hemorrhage, acute cholangitis and acute biliary pancreatitis requiring emergent embolization and antimicrobial therapy. CASE DESCRIPTION/METHODS: A 62-year-old female recently diagnosed primary biliary cholangitis presented with hematemesis, hematochezia and jaundice 1 week after percutaneous liver biopsy. On admission, she was febrile, hypotensive and tachycardic. Physical exam was notable for scleral icterus, jaundice and right upper quadrant abdominal tenderness with voluntary guarding. Rectal exam revealed a large amount of bright red blood. Laboratory data was significant for hemoglobin of 7.7 g/dL from 11.1 g/dL prior to liver biopsy, total bilirubin 7.5 mg/dL (1.0 unconjugated/4.5 conjugated), ALP 587 U/L, GGT 504 U/L, AST 98 U/L, ALT 83 U/L, lipase 3017 U/L. CT angiography of the abdomen showed contrast throughout the proximal hepatic and common bile ducts concerning for active bleeding from an arterio-biliary fistula resulting in hemobilia, moderate biliary dilation, and bowel contents concerning for intraluminal bleeding from the biliary system. She was treated with broad-spectrum antibiotics and successfully resuscitated with IV crystalloids and blood products. She underwent emergent mesenteric angiography with left hepatic artery and arterioportal fistula coil embolization which resulted in hemostasis and rapid normalization of liver chemistries. DISCUSSION: Major gastrointestinal bleeding complications due to iatrogenic arterio-biliary fistula formation after PLB are exceedingly rare, occurring less than 1% of the time due to needle intersection with the portal triad, resulting in epithelialized shunt formation between the hepatic artery and bile duct. This case represents a later presentation of hemobilia, which typically occurs within 24 hours of PLB. The accumulation of blood clots in the biliary tree can lead to life threatening cholangitis and biliary pancreatitis. Early recognition of this complication is essential as urgent embolization and aggressive antimicrobial therapy can lead to a significant reduction in mortality.Figure 1.: CT angiogram abdomen/pelvis: contrast visible in the common hepatic duct.Figure 2.: Pre-embolization: segment 3 branch of hepatic artery.Figure 3.: Post-embolization: segment 3 branch of hepatic artery.

Ancient Chinese Medicine Herbal Formula Huanglian Jiedu Decoction as a Neoadjuvant Treatment of Chemotherapy by Improving Diarrhea and Tumor Response.

BackgroundDiarrhea is a major gastrointestinal complication in cancer patients receiving chemotherapy. Prognosis and treatment of chemotherapy-induced diarrhea (CID) remain unsatisfactory. This study aims to explore the potential of an ancient Chinese Medicine herbal formula Huanglian Jiedu Decoction (HLJDD) as an adjuvant treatment on CID.MethodHLJDD extract was prepared by GMP manufacturing standard with quality and stability being checked. 5-fluorouracil (5-Fu) and irinotecan (CPT-11)-induced diarrhea model in mice was established and pre-, co- and post-treatment of HLJDD was implemented. Mechanism of action was explored by detecting related protein expression. In addition, the effect of HLJDD on diarrhea and tumor response induced by clinical regimens FOLFOX and FOLFIRI was measured in murine orthotopic colorectal cancer model.ResultsHLJDD exhibited consistency in quality and stability after 24-month storage. Pre-treatment of HLJDD, but not co-treatment or post-treatment, could significantly improve the diarrhea score, body weight loss and intestinal damage in 5-Fu- and CPT-11-treated mice. Pre-treatment of HLJDD reduced cell apoptosis in the intestine of chemotherapy-treated mice, and promoted renewal of intestinal cell wall. CD44 was predicted as the potential target of HLJDD-containing compounds in CID. HLJDD pre-treatment induced presentation of CD44-postive cells in the intestine of chemotherapy-treated mice, and initiated expression of stemness-associated genes. Transcriptional products of the downstream Wnt signaling of CD44 were elevated. Furthermore, pre-treatment of HLJDD could significantly improve the tumor response of clinical chemotherapy regimens FOLFOX and FOLFIRI in orthotopic colorectal cancer, and reduce diarrhea and intestinal damage. Conclusion: Our study suggests the potential of HLJDD as a neoadjuvant treatment of chemotherapy by reducing diarrhea and improving tumor response.

Fast-track off-pump coronary artery bypass: single-center experience.

The primary goal of the study was to perform retrospective analysis of fast-track coronary artery bypass grafting at our institute to identify risk factors for prolonged hospital stay. A secondary goal was to identify and compare survival statistics with those published in literature. We performed a retrospective analysis of patients enrolled in our fast-track coronary artery bypass protocol. There were 709 patients with a mean age of 58.85 ± 8.9 years; 572 were men. The mean EuroSCORE II was 2.02% ± 2.64%. Of these 709 patients, 538 (76%) met the requirements for discharge within 100 hours. Prolonged ventilation or reintubation, major pulmonary complications, gastrointestinal and neurological complications were the strongest predictors of fast-track failure. Persistent atrial fibrillation, postoperative transient renal impairment, requirement for noninvasive ventilation > 3 times, sternal wound infection, insulin-dependent diabetes mellitus, preoperative intraaortic balloon pump for chest pain or ST changes, preoperative severe left ventricular dysfunction, preoperative severe renal impairment, and peripheral arterial disease were also found to be significant risk factors for fast-track failure. Cumulative survival at 66 months of follow-up was 90.2% ± 0.02%. The risk factors listed above were associated with fast-track failure. Smoking cessation helps to nullify the factor of chronic obstructive pulmonary disease. Intraoperative elective insertion of a balloon pump does not affect the fast-track protocol. Survival was comparable to that described in the literature.

Major complications of jejunal feeding in children

Aim of the studyThe aim of the study was to identify major gastrointestinal complications associated with direct jejunal feeding. We hypothesized that jejunal feeding may cause life-threatening surgical complications in a minority of patients. MethodsAll patients undergoing jejunal feeding between 1/2008 and 1/2018 at a pediatric surgical unit were identified retrospectively. Data sought from records included demographics, comorbidities, indications, feeding strategies, adverse events, and follow-up. Major surgical complications were defined by Clavien–Dindo grade ≥ IIIb and involving the GI tract (excluding changes of jejunal tube). Main results197 patients were identified (110 female). Median age (IQR) at initiation of jejunal feeding months was 5.6 (6–164) months. 122 were neurologically impaired. The most frequent indications were: GERD/gastroparesis (n = 114), prophylaxis/treatment of Superior Mesenteric Artery (SMA) syndrome (N.B. our center is a national spinal deformity unit) (n = 47), congenital anomalies of aerodigestive anatomy (n = 17), and malignancy (n = 7). 125 patients were managed with nasojejunal feeding alone: gastrojejunal tube (n = 51) and via Roux-en-Y jejunostomy (n = 21). There were 14 significant gastrointestinal complications (n = 11 grade > IIIb) identified among 12 patients, of whom 8 required bowel resections, and 2 died as a result: nonmechanical bowel ischemia (n = 7), intussusception (n = 4), and volvulus (n = 3). ConclusionThis series highlights the major complications of jejunal feeding, including a significant yet underreported risk of gut compromise. Patients undergoing jejunal feeding had a 6.1% risk of developing major surgical complications (of note, 3.6% developed bowel ischemia of unknown etiology). Susceptible children were comorbid, fragile, and neurologically impaired. These findings should influence parental discussions and informed consent before embarking upon jejunal feeding. Level of evidenceLevel IV prognosis study.

PROGRAM OF INTESTINAL REHABILITATION AND EARLY POSTOPERATIVE ENTERAL NUTRITION: A PROSPECTIVE COHORT STUDY.

ABSTRACTBackground: Some factors can act on nutritional status of patients operated for a gastrointestinal cancer. A timely and appropriate nutritional intervention could have a positive effect on postoperative outcomes. Aim: To determine the effect of a program of intestinal rehabilitation and early postoperative enteral nutrition on complications and clinical outcomes of patients underwent gastrointestinal surgery for cancer. Methods: This is a prospective study of 465 patients underwent gastrointestinal surgery for cancer consecutively admitted in an oncological intensive care unit. The program of intestinal rehabilitation and early postoperative enteral nutrition consisted in: 1) general rules, and 2) gastrointestinal rules. Results: The mean age of analysed patients was 63.7±9.1 years. The most frequent operation sites were colon-rectum (44.9%), gynaecological with intestinal suture (15.7%) and oesophagus-gastric (11.0%). Emergency intervention was performed in 12.7% of patients. The program of intestinal rehabilitation and early postoperative enteral nutrition reduced major complication (19.2% vs. 10.2%; p=0.030), respiratory complications (p=0.040), delirium (p=0.032), infectious complications (p=0.047) and gastrointestinal complications (p<0.001), mainly anastomotic leakage (p=0.033). The oncological intensive care unit mortality (p=0.018), length of oncological intensive care unit (p<0.001) and hospital (p<0.001) stay were reduced as well. Conclusions: Implementing a program of intestinal rehabilitation and early postoperative enteral nutrition is associated with reduction in postoperative complications and improvement of clinical outcomes in patients undergoing gastrointestinal surgery for cancer.

Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial

Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55-0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55-1·53; p=0·76). Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication [corrected]. Boehringer Ingelheim and Canadian Institutes of Health Research.

Incidence and Risk Factors for Deliberate Self-harm, Mental Illness, and Suicide Following Bariatric Surgery: A State-wide Population-based Linked-data Cohort Study.

Assess the incidence and determinants of hospitalization for deliberate self-harm and mental health disorders, and suicide after bariatric surgery. Limited recent literature suggests an increase in deliberate self-harm following bariatric surgery. A state-wide, population-based, self-matched, longitudinal cohort study over a 5-year period between 2007 and 2011. Utilizing the Western Australian Department of Health Data Linkage Unit records, all patients undergoing bariatric surgery (n = 12062) in Western Australia were followed for an average 30.4 months preoperatively and 40.6 months postoperatively. There were 110 patients (0.9%) hospitalized for deliberate self-harm, which was higher than the general population [incidence rate ratio (IRR) 1.47, 95% confidence interval (CI) 1.11-1.94, P = 0.005]. Compared with before surgery, there was no significant increase in deliberate self-harm hospitalizations (IRR 0.79, 95% CI 0.54-1.16; P = 0.206) and a reduction in overall mental illness related hospitalizations (IRR 0.76, 95% CI 0.63-0.91; P = 0.002) after surgery. Younger age, no private-health insurance cover, a history of hospitalizations due to depression before surgery, and gastrointestinal complications after surgery were predictors for deliberate self-harm hospitalizations after bariatric surgery. Three suicides occurred during the follow-up period, a rate comparable to the general population during the same time period (IRR 0.61, 95% CI 0.11-2.27, P = 0.444). Hospitalization for deliberate self-harm in bariatric patients was more common than the general population, but an increased incidence of deliberate self-harm after bariatric surgery was not observed. Hospitalization for depression before surgery and major postoperative gastrointestinal complications after bariatric surgery are potentially modifiable risk factors for deliberate self-harm after bariatric surgery.

Effect of hypocaloric enteral nutrition on acute severe traumatic brain injury

Objective To evaluate the clinical efficacy of hypocaloric enteral nutrition in patients with acute severe traumatic brain injury (TBI). Methods A total of 100 patients with severe TBI [Glasgow Coma Scale (GCS) 3-8 points] were enrolled and randomly divided into hypocaloric enteral nutrition group (hypocaloric group, 41.86-62.79 kJ·kg-1·d-1) and traditional caloric enteral nutrition group (traditional caloric group, 104.65-125.58 kJ·kg-1·d-1), 50 patients per group. The enteral nutrition was given at 24-72 hours postoperatively. The changes of total serum protein (TP), serum-albumin (ALB), plasma hemoglobin (Hb), fasting blood glucose (Glu) and major gastrointestinal tract complications were observed and compared at 7 and 14 days after enteral nutrition support. Results Levels of TP, ALB and Hb were lowered in both groups at 7 and 14 days after nutritional support but showed no statistical difference (P>0.05). Glu was (6.37±1.02)mmol/L in hypocaloric calorie group, significantly lower than (7.35±1.70)mmol/L in traditional caloric group at day 7 after nutritional support (P 0.05), but abdominal distension, diarrhea and stomach retention rate in hypocaloric group were significantly lower than those in traditional caloric group (P<0.05). Conclusion Hypocaloric enteral nutrition can significantly reduce the stress hyperglycemia, abdominal distention, diarrhea, gastric retention and other gastrointestinal symptoms in patients with acute severe TBI. Key words: Craniocerebral trauma; Enteral nutrition; Complications

Incidence and Risk Factors of Abdominal Complications After Lung Transplantation.

Due to the underlying diseases and the need for immunosuppression, patients after lung transplantation are particularly at risk for gastrointestinal (GI) complications that may negatively influence long-term outcome. The present study assessed the incidences and impact of GI complications after lung transplantation and aimed to identify risk factors. Retrospective analysis of all 227 consecutively performed single- and double-lung transplantations at the University hospitals of Lausanne and Geneva was performed between January 1993 and December 2010. Logistic regressions were used to test the effect of potentially influencing variables on the binary outcomes overall, severe, and surgery-requiring complications, followed by a multiple logistic regression model. Final analysis included 205 patients for the purpose of the present study, and 22 patients were excluded due to re-transplantation, multiorgan transplantation, or incomplete datasets. GI complications were observed in 127 patients (62%). Gastro-esophageal reflux disease was the most commonly observed complication (22.9%), followed by inflammatory or infectious colitis (20.5%) and gastroparesis (10.7%). Major GI complications (Dindo/Clavien III-V) were observed in 83 (40.5%) patients and were fatal in 4 patients (2.0%). Multivariate analysis identified double-lung transplantation (p = 0.012) and early (1993-1998) transplantation period (p = 0.008) as independent risk factors for developing major GI complications. Forty-three (21%) patients required surgery such as colectomy, cholecystectomy, and fundoplication in 6.8, 6.3, and 3.9% of the patients, respectively. Multivariate analysis identified Charlson comorbidity index of ≥3 as an independent risk factor for developing GI complications requiring surgery (p = 0.015). GI complications after lung transplantation are common. Outcome was rather encouraging in the setting of our transplant center.

Prophylactic use of aspirin: systematic review of harms and approaches to mitigation in the general population.

A careful assessment of benefits and harms is required to assess suitability of aspirin as a prophylactic public health measure. However, comprehensive population-level data on harms are lacking. We collected and synthesized age and sex-specific data on harms relevant to aspirin use in average-risk individuals aged 50 years or older. We conducted systematic literature searches to identify baseline rates of gastrointestinal (GI) bleeding, peptic ulcer, major extra-cranial bleeding, and case-fatality rates due to GI bleeding or peptic ulcer in general population. The magnitude of aspirin-associated increase, the prevalence and attributable risk of Helicobacter pylori infection on these events in aspirin users was also assessed. Baseline rates of major extracranial bleeding events and GI complications increase with age; an almost threefold to fourfold increase is observed from age 50-54 to 70-74 years. Low or standard-dose aspirin use increases GI bleeding events by 60% leading to an annual excess of 0.45 and 0.79 GI bleeding events per 1,000 women and men aged 50-54 years respectively. 5-10% of major GI complications are fatal; a clear age dependence--higher fatality in older individuals, is seen. Eradication of H. pylori infection before aspirin use could reduce the incidence of upper GI complications by 25-30%. GI complications are increased by about 60% due to aspirin use but are fatal only in a very small proportion of individuals younger than 70 years of age. Major bleeding events that are comparable in severity to cancer or CVD, are infrequent. Screening and eradication of H. pylori infection could substantially lower aspirin-related GI harms.

Exchange transfusion for neonatal hyperbilirubinemia: an 8-year single center experience at a tertiary neonatal intensive care unit in Turkey

Objective: The aim of present study was to evaluate the indications and the complications associated with neonatal exchange transfusion (ET) performed for hyperbilirubinemia.Methods: This study included overall 306 neonates who underwent ET between 2005 and 2012. The demographic characteristics of patients, causes of jaundice and adverse events occurred during or within 1 week after ET were recorded from their medical files. Those newborns that underwent ET were classified as either “otherwise healthy” or “sick” group.Results: Of the 306 patients who underwent ET, 244 were otherwise healthy and had no medical problems other than jaundice. The remaining 62 patients were classified as sick that had medical problems other than jaundice ranging from mild to severe. The mean gestational age was 37.6 ± 2.5 weeks and the mean peak total bilirubin levels was 25.8 ± 6.6 mg/dl. The mean age at presentation was 5.4 ± 3.8 d for all infants. The most common cause of hyperbilirubinemia was ABO isoimmunization (27.8%). None of newborns died secondary to ET. Three infants had had necrotizing enterocolitis, and also three infants had had acute renal failure. The most common encountered complications of ET procedure were hyperglycemia (56.5%), hypocalcaemia (22.5%) and thrombocytopenia (16%).Conclusions: Our data showed that ABO isoimmunization was the most common cause of hyperbilirubinemia. Even mortality was not seen, very rare but major gastrointestinal and renal complications were associated with ET. The majority of adverse events associated with ET were laboratory abnormalities mainly hyperglycemia, hypocalcaemia and thrombocytopenia which were asymptomatic and treatable.

Remote ischaemic pre-conditioning in cardiac surgery: benefit or not?

This editorial refers to ‘Does remote ischaemic pre-conditioning with post-conditioning improve clinical outcomes of patients undergoing cardiac surgery? Remote Ischaemic Preconditioning with Postconditioning Outcome Trial’†, by D.M. Hong et al. , doi:10.1093/eurheartj/eht346. Hong et al. 1 report the results of a randomized controlled trial in which 1280 patients who underwent elective cardiac surgery were randomized into a group who received remote ischaemic pre-conditioning (RIPC) combined with remote ischaemic post-conditioning (RIPostC) or a control group. In the group who received remote pre-conditioning, four cycles of 5 min of ischaemia and 5 min of reperfusion were administered twice to the upper limb, before cardiopulmonary bypass or coronary anastomoses in patients who had beating heart surgery, and after cardiopulmonary bypass or coronary anastomoses. As compared with the control group, RIPC with RIPostC did not reduce the primary endpoint, a composite of major adverse outcomes, including death, myocardial infarction, arrhythmia, stroke, coma, renal damage, respiratory failure, gastrointestinal complications, and multiorgan failure. There was no difference in each major adverse outcome. Lengths of intensive care unit and hospital stays were similar in the two groups. Furthermore, in the off-pump subgroup, RIPC with RIPostC was associated with a significantly increased composite endpoint. These results are of importance in the debate regarding the potential interest in RIPC in cardiac surgery. This clinical study has several strengths, including the randomization of a rather large population over a relatively short period of time and the inclusion of patients undergoing different cardiac surgical procedures, encompassing coronary artery bypass grafting, cardiac valve surgery, combined coronary and valvular procedures, ascending or transverse aortic surgery, and congenital heart defect repair, making it, to some extent, an ‘all-comer’ study. However, this heterogeneity probably introduced bias, as the authors correctly pointed out. Also, exclusion criteria were numerous; in particular, patients with poor left ventricular function who …

Getting to the heart of the matter: a trialist’s approach to the use of nonsteroidal anti‑inflammatory drugs for patients with chronic pain syndromes

In this editorial, I refer to the relative risks associated with different interventions. To provide a perspective of what it means, please consider the risks of particular events in the placebo group of controlled trials of cyclooxygenase-2 inhibitors: major vascular events (0.82%) including nonfatal myocardial infarction (MI; 0.29%) or any MI (0.33%), any stroke (0.36%), heart failure (0.26%), upper gastrointestinal (GI) bleeding (0.14%) with any major GI complication (0.19%).

Reply to the letter regarding “Comparison of gastrointestinal adverse effects between cyclooxygenase-2 inhibitors and non-selective, non-steroidal anti-inflammatory drugs plus proton pump inhibitors: a systematic review and meta-analysis”

To the Editor:We thank Dr. Lai and his colleagues for their commentsrelated to our article ‘‘Comparison of gastrointestinaladverse effects between cyclooxygenase-2(COX-2) inhib-itors and non-selective, non-steroidal anti-inflammatorydrugs (ns-NSAID) plus proton pump inhibitors (PPI)’’ [1].According to our analyses, the risk of major gastrointesti-nal (GI) complications was lower in COX-2 inhibitors, ascompared to ns-NSAIDs plus PPI. We agree that patientswho take COX-2 inhibitors are still at risk for GI adverseevents, when compared to patients who do not take thesemedications. As shown in a metaanalysis by Rostrom et al.[2], high-dose COX-2 inhibitors insignificantly increasedthe risk of gastric (relative risk or RR 1.22; 95% CI0.83–1.80) and duodenal (RR, 1.29; 95% CI 0.63–2.66)ulcers, as compared to placebo. However, when comparedto ns-NSAIDs, the risk of major GI complications includ-ing perforation, ulceration, bleeding, and obstruction werelower in COX-2 inhibitors.The increased risk of peptic ulcer in a cohort studyneeds to be cautiously interpreted because this study designis susceptible to selection bias resulting in imbalancedprognostic characteristics at baseline. In daily practice,physicians usually prescribe COX-2 inhibitors for patientswho are at high risk of developing GI complications, e.g.,old age, prior GI ulcer or bleeding, aspirin or anti-coagu-lant user, and steroid use, whereas patients with low riskare usually treated with ns-NSAIDs. Therefore, the risk ofGI complications between COX-2 inhibitors vs. ns-NSA-IDs may be comparable or even higher in COX-2inhibitors.We totally agree that COX-2 inhibitors are associatedwith increased risk of GI complication. Patients requiringNSAID therapy who are at high risk should receive COX-2inhibitor and GI protective therapy (e.g., misoprostol orPPI) or alternative therapy for pain control.Reference