Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial.

BACKGROUND: The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement. METHODS: ORBITA-COSMIC was a double-blind, randomised, placebo-controlled trial conducted at six UK hospitals. Patients aged 18 years or older with angina, stable coronary artery disease, ischaemia, and no further options for treatment were eligible. All patients completed a quantitative adenosine-stress perfusion cardiac magnetic resonance scan, symptom and quality-of-life questionnaires, and a treadmill exercise test before entering a 2-week symptom assessment phase, in which patients reported their angina symptoms using a smartphone application (ORBITA-app). Patients were randomly assigned (1:1) to receive either CSR or placebo. Both participants and investigators were masked to study assignment. After the CSR implantation or placebo procedure, patients entered a 6-month blinded follow-up phase in which they reported their daily symptoms in the ORBITA-app. At 6 months, all assessments were repeated. The primary outcome was myocardial blood flow in segments designated ischaemic at enrolment during the adenosine-stress perfusion cardiac magnetic resonance scan. The primary symptom outcome was the number of daily angina episodes. Analysis was done by intention-to-treat and followed Bayesian methodology. The study is registered with ClinicalTrials.gov, NCT04892537, and completed. FINDINGS: Between May 26, 2021, and June 28, 2023, 61 patients were enrolled, of whom 51 (44 [86%] male; seven [14%] female) were randomly assigned to either the CSR group (n=25) or the placebo group (n=26). Of these, 50 patients were included in the intention-to-treat analysis (24 in the CSR group and 26 in the placebo group). 454 (57%) of 800 imaged cardiac segments were ischaemic at enrolment, with a median stress myocardial blood flow of 1·08 mL/min per g (IQR 0·77-1·41). Myocardial blood flow in ischaemic segments did not improve with CSR compared with placebo (difference 0·06 mL/min per g [95% CrI -0·09 to 0·20]; Pr(Benefit)=78·8%). The number of daily angina episodes was reduced with CSR compared with placebo (OR 1·40 [95% CrI 1·08 to 1·83]; Pr(Benefit)=99·4%). There were two CSR embolisation events in the CSR group, and no acute coronary syndrome events or deaths in either group. INTERPRETATION: ORBITA-COSMIC found no evidence that the CSR improved transmural myocardial perfusion, but the CSR did improve angina compared with placebo. These findings provide evidence for the use of CSR as a further antianginal option for patients with stable coronary artery disease. FUNDING: Medical Research Council, Imperial College Healthcare Charity, National Institute for Health and Care Research Imperial Biomedical Research Centre, St Mary's Coronary Flow Trust, British Heart Foundation.

Exploring the relationship between insomnia and depression: a cross-sectional prospective study.

This is a cross-sectional prospective study aimed to examine the association between insomnia and depression among individuals attending an outpatient psychiatric clinic. Methods: A total of 416 participants were recruited from the psychiatric and mental health outpatient clinic using a cross-sectional design. The participants completed the Pittsburgh Sleep Quality Index (PSQI) and the Beck Depression Inventory (BDI) to measure sleep disturbances and depressive symptoms, respectively. Ethical approval was obtained from the Institutional Review Board at Ninevah University. Descriptive statistics, bivariate correlations, and multivariate regression analysis were used to analyze the data. The data collected in the study was analyzed using SPSS v0.26. Results: A total of 416 participants were recruited from the psychiatric and mental health outpatient clinic in Iraq through convenience sampling. The sample included 227 (54.6%) females and 189 (45.4%) males, with a mean age of 35.4 years (SD=9.8, range=18-65). Participants had a mean PSQI score of 11.6 (SD=3.7, range=2-21) and a mean BDI score of 21.8 (SD=11.1, range=0-54). Bivariate correlations showed a significant positive relationship between sleep disturbances (as measured by the PSQI) and depressive symptoms (as measured by the BDI) (r=0.67, P<0.001). Conclusions: The study provides valuable insights into the relationship between insomnia and depression in a sample of individuals from Iraq. These findings could contribute to the development of interventions to improve mental health outcomes among this population.

Acquired Factor X Deficiency without Amyloidosis Presenting with Massive Hematuria: A Case Report and Review of the Literature.

Acquired factor X deficiency is a rare diagnosis, especially without the association of other co-existing conditions such as amyloidosis. The authors report the case of a 34-year-old male with severe frank hematuria found to have markedly prolonged prothrombin time and activated partial thromboplastin time. A mixing study showed correction utilizing normal plasma and a coagulation panel testing revealed decreased factor X activity. The patient was treated with multiple blood transfusions, fresh frozen plasma, high-dose pulse steroids, and rituximab. The patient's condition improved during his 21-day hospital stay and was followed up every 2 weeks for 3 months. The patient's factor X level recovered after two weeks of discharge with no other hemorrhagic episodes.

Comparison of Migraine Characteristics in Patients With and Without Inflammatory Bowel Disease: A Retrospective Cohort Study.

BACKGROUND: Survey studies have found an increased prevalence of migraine in patients with inflammatory bowel disease (IBD). However, the clinical characteristics of migraines in this population are unknown. We conducted a retrospective medical record review study to characterize migraines in the IBD population. METHODS: Six hundred seventy-five migraine patients (280 with IBD, 395 without IBD) who were evaluated at Mayo Clinic Rochester, Mayo Clinic Arizona, or Mayo Clinic Florida between July 2009 and March 2021 were included. Patients with ICD codes for migraine and either Crohn's disease (CD) or ulcerative colitis (UC) were selected. Electronic health care records were reviewed. Patients confirmed to have IBD and migraine were included. Demographic, IBD, and migraine characteristics were collected. Statistical analysis was completed using SAS. RESULTS: Patients with IBD were less often male (8.6% vs 21.3%, P < .001) and had a higher Charlson Comorbidity Index (>2: 24.6% vs 15.7%, P = .003); 54.6% had CD and 39.3% had UC. Patients with IBD had migraine with aura and without aura more frequently ( OR 2.20, P < .001 and OR 2.79, P < .001, respectively) than non-IBD patients. Additionally, those with IBD less commonly had chronic migraine (OR 0.23, P < .001) and less commonly had chronic migraine or treatment for migraine (ORs 0.23-0.55, P ≤ .002). CONCLUSIONS: Migraine with and without aura have increased prevalence in IBD patients. Further study of this topic will be helpful to clarify the prevalence of migraine, establish this population's response to treatment, and better understand the reason(s) for a low rate of treatment.

Post-hepatectomy liver failure: A timeline centered review.

BACKGROUND: Post-hepatectomy liver failure (PHLF) is a leading cause of postoperative mortality after liver surgery. Due to its significant impact, it is imperative to understand the risk stratification and preventative strategies for PHLF. The main objective of this review is to highlight the role of these strategies in a timeline centered way around curative resection. DATA SOURCES: This review includes studies on both humans and animals, where they addressed PHLF. A literature search was conducted across the Cochrane Library, Embase, MEDLINE/PubMed, and Web of Knowledge electronic databases for English language studies published between July 1997 and June 2020. Studies presented in other languages were equally considered. The quality of included publications was assessed using Downs and Black's checklist. The results were presented in qualitative summaries owing to the lack of studies qualifying for quantitative analysis. RESULTS: This systematic review with 245 studies, provides insight into the current prediction, prevention, diagnosis, and management options for PHLF. This review highlighted that liver volume manipulation is the most frequently studied preventive measure against PHLF in clinical practice, with modest improvement in the treatment strategies over the past decade. CONCLUSIONS: Remnant liver volume manipulation is the most consistent preventive measure against PHLF.

Effect of seasons on delirium in postoperative critically ill patients: a retrospective analysis

Abstract Background and objectives Postoperative delirium is common in critically ill patients and is known to have several predisposing and precipitating factors. Seasonality affects cognitive function which has a more dysfunctional pattern during winter. We, therefore, aimed to test whether seasonal variation is associated with the occurrence of delirium and hospital Length Of Stay (LOS) in critically ill non-cardiac surgical populations. Methods We conducted a retrospective analysis of adult patients recovering from non-cardiac surgery at the Cleveland Clinic between March 2013 and March 2018 who stayed in Surgical Intensive Care Unit (SICU) for at least 48 hours and had daily Confusion Assessment Method Intensive Care Unit (CAM-ICU) assessments for delirium. The incidence of delirium and LOS were summarized by season and compared using chi-square test and non-parametric tests, respectively. A logistic regression model was used to assess the association between delirium and LOS with seasons, adjusted for potential confounding variables. Results Among 2300 patients admitted to SICU after non-cardiac surgeries, 1267 (55%) had postoperative delirium. The incidence of delirium was 55% in spring, 54% in summer, 55% in fall and 57% in winter, which was not significantly different over the four seasons (p= 0.69). The median LOS was 12 days (IQR = [8, 19]) overall. There was a significant difference in LOS across the four seasons (p= 0.018). LOS during summer was 12% longer (95% CI: 1.04, 1.21; p= 0.002) than in winter. Conclusions In adult non-cardiac critically ill surgical patients, the incidence of postoperative delirium is not associated with season. Noticeably, LOS was longer in summer than in winter.

Effect of seasons on delirium in postoperative critically ill patients: a retrospective analysis.

BACKGROUND AND OBJECTIVES: Postoperative delirium is common in critically ill patients and is known to have several predisposing and precipitating factors. Seasonality affects cognitive function which has a more dysfunctional pattern during winter. We, therefore, aimed to test whether seasonal variation is associated with the occurrence of delirium and hospital Length Of Stay (LOS) in critically ill non-cardiac surgical populations. METHODS: We conducted a retrospective analysis of adult patients recovering from non-cardiac surgery at the Cleveland Clinic between March 2013 and March 2018 who stayed in Surgical Intensive Care Unit (SICU) for at least 48 hours and had daily Confusion Assessment Method Intensive Care Unit (CAM-ICU) assessments for delirium. The incidence of delirium and LOS were summarized by season and compared using chi-square test and non-parametric tests, respectively. A logistic regression model was used to assess the association between delirium and LOS with seasons, adjusted for potential confounding variables. RESULTS: Among 2300 patients admitted to SICU after non-cardiac surgeries, 1267 (55%) had postoperative delirium. The incidence of delirium was 55% in spring, 54% in summer, 55% in fall and 57% in winter, which was not significantly different over the four seasons (p = 0.69). The median LOS was 12 days (IQR = [8, 19]) overall. There was a significant difference in LOS across the four seasons (p = 0.018). LOS during summer was 12% longer (95% CI: 1.04, 1.21; p = 0.002) than in winter. CONCLUSIONS: In adult non-cardiac critically ill surgical patients, the incidence of postoperative delirium is not associated with season. Noticeably, LOS was longer in summer than in winter.

Cardiovascular disease and mortality sequelae of COVID-19 in the UK Biobank.

OBJECTIVE: To examine association of COVID-19 with incident cardiovascular events in 17 871 UK Biobank cases between March 2020 and 2021. METHODS: COVID-19 cases were defined using health record linkage. Each case was propensity score-matched to two uninfected controls on age, sex, deprivation, body mass index, ethnicity, diabetes, prevalent ischaemic heart disease (IHD), smoking, hypertension and high cholesterol. We included the following incident outcomes: myocardial infarction, stroke, heart failure, atrial fibrillation, venous thromboembolism (VTE), pericarditis, all-cause death, cardiovascular death, IHD death. Cox proportional hazards regression was used to estimate associations of COVID-19 with each outcome over an average of 141 days (range 32-395) of prospective follow-up. RESULTS: Non-hospitalised cases (n=14 304) had increased risk of incident VTE (HR 2.74 (95% CI 1.38 to 5.45), p=0.004) and death (HR 10.23 (95% CI 7.63 to 13.70), p<0.0001). Individuals with primary COVID-19 hospitalisation (n=2701) had increased risk of all outcomes considered. The largest effect sizes were with VTE (HR 27.6 (95% CI 14.5 to 52.3); p<0.0001), heart failure (HR 21.6 (95% CI 10.9 to 42.9); p<0.0001) and stroke (HR 17.5 (95% CI 5.26 to 57.9); p<0.0001). Those hospitalised with COVID-19 as a secondary diagnosis (n=866) had similarly increased cardiovascular risk. The associated risks were greatest in the first 30 days after infection but remained higher than controls even after this period. CONCLUSIONS: Individuals hospitalised with COVID-19 have increased risk of incident cardiovascular events across a range of disease and mortality outcomes. The risk of most events is highest in the early postinfection period. Individuals not requiring hospitalisation have increased risk of VTE, but not of other cardiovascular-specific outcomes.

Exocrine pancreatic insufficiency after bariatric surgery.

BACKGROUND: Exocrine pancreatic insufficiency (EPI) is a known complication of upper gastrointestinal surgery and has recently been associated with bariatric surgery. Our objectives were to determine the incidence of EPI in patients who underwent bariatric surgery and to identify the type of bariatric procedure most associated with EPI. METHODS: This retrospective cohort analysis included patients age ≥18 years who underwent bariatric surgery at Mayo Clinic between 2010 and 2020. Patients with a history of other gastrointestinal or hepatobiliary resection, revision of bariatric surgery, EPI prior to surgery, and surgery greater than >10 years earlier were excluded from the study. Characteristics were compared between two groups based on type of bariatric surgery including Roux-en-Y gastric bypass (RYGB) or gastric sleeve (GS). Characteristics were also analyzed between patients with RYGB who developed post-operative steatorrhea and those who did not. RESULTS: Of 150 patients, 126 underwent RYGB while 24 patients had GS. Thirty-one (20.6%) patients developed post-operative steatorrhea and 14 (9.3%) were diagnosed with EPI. Mean pancreatic elastase level was 287 ± 156 mcg/g and fecal fat level 31 ± 22 g/d. There was a significantly higher proportion of post-operative steatorrhea in patients who underwent RYGB compared to gastric sleeve surgery (p = 0.029). CONCLUSION: The incidence of EPI after bariatric surgery in our cohort was 9.3%. Overall, patients who underwent RYGB had higher rates of EPI (10.3%) than those who had GS (4.2%). Clinicians should be aware of EPI as a cause for steatorrhea in patients who underwent bariatric surgery and consider treatment with enzyme replacement therapy.

Syntheses of Gold and Silver Nanocomposite Contact Lenses via Chemical Volumetric Modulation of Hydrogels.

Integration of nanomaterials into hydrogels has emerged as a prominent research tool utilized in applications such as sensing, cancer therapy, and bone tissue engineering. Wearable contact lenses functionalized with nanoparticles have been exploited in therapeutics and targeted therapy. Here, we report the fabrication of gold and silver nanocomposite commercial contact lenses using a breathing-in/breathing-out (BI-BO) method, whereby a hydrated contact lens is shrunk in an aprotic solvent and then allowed to swell in an aqueous solution containing nanoparticles. The morphology and optical properties of the gold and silver nanoparticles were characterized through transmission electron microscopy and ultraviolet-visible spectroscopy. The transmission spectra of nanocomposite contact lenses indicated that the nanoparticles' loading amount within the lens depended primarily on the number of BI-BO cycles. Nanocomposites were stable for a minimum period of 1 month, and no nanoparticle leaching was observed. Wettability and water content analysis of the nanocomposites revealed that the contact lenses retained their intrinsic material properties after the fabrication process. The dispersion of the nanoparticles within the contact lens media was determined through scanning electron microscopy imaging. The nanocomposite lenses can be deployed in color filtering and antibacterial applications. In fact, the silver nanocomposite contact lens showed blue-light blocking capabilities by filtering a harmful high-energy blue-light range (400-450 nm) while transmitting the visible light beyond 470 nm, which facilitates enhanced night vision and color distinction. The ease of fabricating these nanocomposite contact lenses via the BI-BO method could enable the incorporation of nanoparticles with diverse morphologies into contact lenses for various biomedical applications.

Cancer Incidence in the Kurdistan Region of Iraq: Results of a Seven-Year Cancer Registration in Erbil and Duhok Governorates.

INTRODUCTION: There are limited published data regarding the recent incidence trends of cancer in Iraqi Kurdistan. METHODS: The present study assessed the epidemiological estimates of cancer incidence, as well providing a projection of future cancer trends in the upcoming decade by analysing the population-based cancer registry between 2013 and 2019, in both the Erbil and Duhok governorates. A retrospective analysis was performed on data retrieved from the Medical Statistics Department at the Ministry of Health, Kurdistan Regional Government (KRG). RESULTS: The total number of female cancer patients was higher in both governorates, and the total incidence of patients with cancer increased by over 2x between 2013 and 2019 in Erbil and Duhok, from 73 to 174 patients/100,000 individuals for women, and 36 to 85 patients/100,000 individuals for men. Analysis indicated that the percentage of patients with cancer is projected to increase by >2x in the current decade, from 3,457 cases to 4,547 and 4,449 cases in the Erbil governorate; and from 1,365 to 2,633 and 2,737 cases in 2028 based on LSTM and bi-LTSM analysis in the Duhok governorate. Lung cancer (LC) and female breast cancer (BC) were the most prominent types of cancers diagnosed since 2013 in both the Erbil and Duhok governorates. CONCLUSION: The striking pattern of trends for both present and future cancer incidence rates require urgent solutions and comprehensive efforts to control risk factors that promote the increasing incidence of cancer in these two KRG governorates.
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Abnormal findings on abdominopelvic cross-sectional imaging in patients with microscopic colitis: a retrospective, multicenter study.

OBJECTIVES: Patients with microscopic colitis may have subtle macroscopic findings on colonoscopy such as erythema, edema, or altered vascular pattern; however, radiographic abnormalities on cross-sectional imaging have not been investigated. We aimed at identifying the abdominopelvic radiographic abnormalities in patients with microscopic colitis, as well as possible correlation with endoscopic findings and the need for extended duration of treatment. MATERIALS AND METHODS: This was a retrospective study of patients with biopsy-proven microscopic colitis at two tertiary centers between 1 January 2010 and 30 April 2020. Patients underwent computed tomography scan or magnetic resonance imaging within 30 days of a diagnostic flexible sigmoidoscopy or colonoscopy. Patients with colon ischemia and other causes of colitis were excluded. Radiographic abnormalities from imaging reports included bowel wall thickening, mucosal hyperenhancement and mesenteric fat stranding. Univariate and multivariable logistic regression models were used to identify predictors of radiographic abnormalities. RESULTS: 498 patients with microscopic colitis underwent abdominopelvic cross-sectional imaging within 30 days of flexible sigmoidoscopy/colonoscopy. Lymphocytic colitis was diagnosed in 54.6% of patients, and collagenous colitis in 45.4%. Endoscopic and radiographic abnormalities were identified in 16.1% and 12.4% of patients, respectively. Radiographic abnormalities were associated with the need for budesonide therapy (p = .029) and budesonide therapy long-term (p = .0028). Budesonide therapy long-term (p = .047) was associated with radiographic abnormalities in multivariate analysis. CONCLUSIONS: Radiographic abnormalities may be present on abdominopelvic cross-sectional imaging in a minority of patients with biopsy-proven microscopic colitis, suggesting cross-sectional imaging has low clinical value in the evaluation and treatment of this disease.

Diabetic Ketoacidosis as the Initial Presenting Symptom of Pancreatic Adenocarcinoma: A Discussion about Screening Utilizing ENDPAC Scoring Coupled with CT Scans and Endoscopic Ultrasound.

Pancreatic adenocarcinoma is often discovered at an advanced stage due to a lack of early symptomology, resulting in this being the fourth leading cause of cancer-related death in the USA. The relationship between diabetes mellitus and pancreatic cancer has been known for many years; however, it is not well understood. Studies have suggested that long-standing type 2 diabetes mellitus can increase the risk of pancreatic cancer by 1.5-2.0-fold. However, patients with new-onset diabetes over 50 years of age have an 8-fold higher risk of pancreatic cancer. Evidence has shown that pancreatic cancer causes diabetes, with the majority being new onset. Diabetic ketoacidosis, which occurs in long-term hyperglycemia, as an initial presentation of pancreatic adenocarcinoma is rare, and only a few cases have been reported. It is postulated that pancreatic cancer prevents insulin-producing cells of the pancreas from responding to insulin resistance. The enriching new-onset diabetes for pancreatic cancer (ENDPAC) score may be utilized as a screening tool for pancreatic carcinomas as an early diagnosis may lead to cure by surgery instead of the grave prognosis associated with it. In this case report, we discuss a 52-year-old female presenting with symptoms of diabetic ketoacidosis who was then subsequently found to have stage-4 pancreatic adenocarcinoma. We concluded that if a patient presents with new-onset diabetes, abdominal imaging with CT scans and endoscopic ultrasound may be warranted to rule out pancreatic carcinoma.

Hyperleukocytosis and Pseudohyperkalemia in a Patient With Severe SARS-COVID 19 Unmasks Chronic Lymphocytic Leukemia.

Coronavirus disease 2019 (COVID-19) has caused significant morbidity and mortality in a vast majority of the patient population, especially those with malignancies. Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults and is often an indolent disease. High white blood cell counts greater than 120 k/cumm in chronic lymphocytic leukemia may be implicated in cases of COVID-19. Hyperleukocytosis leads to falsely elevated potassium levels due to cell fragility. Pseudohyperkalemia occurs when elevated potassium is present due to potassium movement out of cells during or after a blood sample is drawn. Pseudohyperkalemia may be suspected when elevated potassium is present in asymptomatic patients with no corresponding electrocardiogram findings. The authors present a case of hyperleukocytosis and pseudohyperkalemia in a patient whose COVID-19 infection unmasked CLL.

Massive Hemoperitoneum Secondary to Splenic Laceration After Extracorporeal Shockwave Lithotripsy.

Extracorporeal shock wave lithotripsy (ESWL) is considered a safe technique, but not without complications, though the vast majority are minor complications. We describe a rare case of splenic injury after ESWL. A 33-year-old male presented to the emergency department (ED) after three weeks experiencing severe intermittent left-sided flank pain that he contributed to a previous motor vehicle accident. Then computerized tomography (CT) revealed a left renal stone. ESWL was performed after three weeks. After being discharged home, he returned the same day to the ED with persistent, worsening abdominal pain, hypotension, and multiple syncopes. CT demonstrated the presence of active contrast extravasation from the spleen likely due to active bleeding. Initial resuscitation was with intravenous fluids and blood products. The following day, the embolization of the splenic artery was done. The patient was discharged home after nine days of conservative management. After one month, he had shortness of breath due to a large left-sided pleural effusion and lung collapse managed with thoracocentesis and thoracoscopic surgery. Subsequent follow-up reveals much improvement and successful conservative management. Splenic injury is a rare complication of ESWL, and all of the 11 reported cases in the literature were managed with splenectomy. Our case is unique in being successfully managed conservatively.

Ethnic Differences in Analgesic Efficacy and Safety of Liposomal Bupivacaine Among Asian and Caucasian Surgical Patients: A Retrospective Matched-Cohort Analysis.

BACKGROUND: Extended-release local anesthetics allow for prolonged analgesia after a single administration. Although Asians demonstrate different pain thresholds than Caucasians, whether they have different postoperative local anesthetic analgesic effects has not been elucidated. OBJECTIVE: We aimed to compare the postoperative analgesic efficacy of liposomal bupivacaine on Asian and Caucasian adults, and the incidence of local anesthetic systemic toxicity (LAST) syndrome. METHODS: We conducted a retrospective, assessor-blinded cohort study of adult patients who received liposomal bupivacaine for surgery between 2012 and 2018. Asians and Caucasians were matched in a 1:1 ratio by clinical characteristics and surgery type. The primary outcome was pain management, defined as average pain score and opioid consumption during the initial 72 postoperative hours. The secondary outcome was the incidence of LAST syndrome. Reviewers were blinded to the ethnicity of the patient. RESULTS: After 1:1 propensity score matching, 130 Asians and 129 Caucasians were analyzed. All confounding variables were balanced, except for higher body mass index in the Asian group. Pain scores were lower (adjusted mean difference of -0.50 [97.5% CI, -0.98, -0.01]; superiority p = 0.011) and opioid consumption was not greater (geometric means ratio, 0.61 [97.5% CI, 0.36, 1.04]; non-inferiority p ＜ 0.001) in Asian patients compared to Caucasian patients. Only one Caucasian patient was judged as having a potential case of LAST syndrome. The length of hospital stay and the incidence of additional complications were not different between the groups. CONCLUSION: Asian adults receiving liposomal bupivacaine as part of multimodal perioperative analgesia demonstrated lower pain scores compared to matching Caucasians, despite not having greater opioid consumption.

Incidence of adverse events attributable to bupivacaine liposome injectable suspension or plain bupivacaine for postoperative pain in pediatric surgical patients: A retrospective matched cohort analysis.

BACKGROUND: Surgical wound infiltration with local anesthetics is common as part of multimodal analgesia and enhanced recovery pathways in pediatric surgical patients. Liposomal bupivacaine can provide up to 92 hours of pain relief, and was approved by the U.S Food and Drug Administration for local infiltration in adults. It is also commonly used by pediatric surgeons, but its safety profile in this age group has not been described. AIMS: The aim of this study was to describe the incidence of local anesthetic systemic toxicity syndrome in pediatric surgical patients receiving liposomal bupivacaine compared to plain bupivacaine for surgical wound infiltration. METHODS: We conducted a retrospective, single center, assessor blinded cohort study of pediatric surgical inpatients having open or laparoscopic surgery in the Cleveland Clinic between 2013 and 2017 and receiving wound infiltration with local anesthetics. We compared the incidence of local anesthetic systemic toxicity among those who received any dose of liposomal bupivacaine and those who received plain bupivacaine. Groups were matched 1:2 according to procedure type, age, and physical status score. Local anesthetic systemic toxicity was primarily defined as at least two signs or symptoms possibly related to anesthetic toxicity, as judged by two independent adjudicators blinded to the type of local anesthetic. A sensitivity analysis compared the incidence of a single sign/symptom possibly related to anesthetic toxicity. RESULTS: A total of 924 surgical cases were included in the final analysis (356 liposomal bupivacaine and 568 plain bupivacaine cases). The primary outcome did not occur in any patient. The sensitivity analysis found three cases in the liposomal bupivacaine group and two cases in the plain bupivacaine group having a single sign/symptom possibly related to local anesthetic administration (relative risk 2.4, 95% CI 0.4-14.0, P = 0.38). CONCLUSION: In a cohort of pediatric surgical patients receiving wound infiltration with either plain or liposomal bupivacaine, we identified no cases of local anesthetic systemic toxicity syndrome, and only few patients with any sign or symptom that could potentially be related to local anesthetic toxicity.