Prediction and stratification for the surgical adverse events after minimally invasive esophagectomy:A two-center retrospective study

BACKGROUND Minimally invasive esophagectomy(MIE)is a widely accepted treatment for esophageal cancer,yet it is associated with a significant risk of surgical adverse events(SAEs),which can compromise patient recovery and long-term survival.Accurate preoperative identification of high-risk patients is critical for improving outcomes.AIM To establish and validate a risk prediction and stratification model for the risk of SAEs in patients with MIE.METHODS This retrospective study included 747 patients who underwent MIE at two centers from January 2019 to February 2024.Patients were separated into a train set(n=549)and a validation set(n=198).After screening by least absolute shrinkage and selection operator regression,multivariate logistic regression analyzed clinical and intraoperative variables to identify independent risk factors for SAEs.A risk stratification model was constructed and validated to predict the probability of SAEs.RESULTS SAEs occurred in 10.2%of patients in train set and 13.6%in the validation set.Patients with SAE had significantly higher complication rate and a longer hospital stay after surgery.The key independent risk factors identified included chronic obstructive pulmonary disease,a history of alcohol consumption,low forced expiratory volume in the first second,and low albumin levels.The stratification model has excellent prediction accuracy,with an area under the curve of 0.889 for the training set and an area under the curve of 0.793 for the validation set.CONCLUSION The developed risk stratification model effectively predicts the risk of SAEs in patients undergoing MIE,facilitating targeted preoperative interventions and improving perioperative management.

Impact of body mass index on adverse kidney events in diabetes mellitus patients: A systematic-review and meta-analysis

BACKGROUND The incidence of chronic kidney disease among patients with diabetes mellitus(DM)remains a global concern.Long-term obesity is known to possibly influence the development of type 2 diabetes mellitus.However,no previous meta-analysis has assessed the effects of body mass index(BMI)on adverse kidney events in patients with DM.AIM To determine the impact of BMI on adverse kidney events in patients with DM.METHODS A systematic literature search was performed on the PubMed,ISI Web of Science,Scopus,Ovid,Google Scholar,EMBASE,and BMJ databases.We included trials with the following characteristics:(1)Type of study:Prospective,retrospective,randomized,and non-randomized in design;(2)participants:Restricted to patients with DM aged≥18 years;(3)intervention:No intervention;and(4)kidney adverse events:Onset of diabetic kidney disease[estimated glomerular filtration rate(eGFR)of<60 mL/min/1.73 m2 and/or microalbuminuria value of≥30 mg/g Cr],serum creatinine increase of more than double the baseline or end-stage renal disease(eGFR<15 mL/min/1.73 m2 or dialysis),or death.RESULTS Overall,11 studies involving 801 patients with DM were included.High BMI(≥25 kg/m2)was significantly associated with higher blood pressure(BP)[systolic BP by 0.20,95%confidence interval(CI):0.15–0.25,P<0.00001;diastolic BP by 0.21 mmHg,95%CI:0.04–0.37,P=0.010],serum albumin,triglycerides[standard mean difference(SMD)=0.35,95%CI:0.29–0.41,P<0.00001],low-density lipoprotein(SMD=0.12,95%CI:0.04–0.20,P=0.030),and lower high-density lipoprotein(SMD=–0.36,95%CI:–0.51 to–0.21,P<0.00001)in patients with DM compared with those with low BMIs(<25 kg/m2).Our analysis showed that high BMI was associated with a higher risk ratio of adverse kidney events than low BMI(RR:1.22,95%CI:1.01–1.43,P=0.036).CONCLUSION The present analysis suggested that high BMI was a risk factor for adverse kidney events in patients with DM.

Prediabetes: An overlooked risk factor for major adverse cardiac and cerebrovascular events in atrial fibrillation patients

BACKGROUND Prediabetes is a well-established risk factor for major adverse cardiac and cerebrovascular events(MACCE).However,the relationship between prediabetes and MACCE in atrial fibrillation(AF)patients has not been extensively studied.Therefore,this study aimed to establish a link between prediabetes and MACCE in AF patients.AIM To investigate a link between prediabetes and MACCE in AF patients.METHODS We used the National Inpatient Sample(2019)and relevant ICD-10 CM codes to identify hospitalizations with AF and categorized them into groups with and without prediabetes,excluding diabetics.The primary outcome was MACCE(all-cause inpatient mortality,cardiac arrest including ventricular fibrillation,and stroke)in AF-related hospitalizations.RESULTS Of the 2965875 AF-related hospitalizations for MACCE,47505(1.6%)were among patients with prediabetes.The prediabetes cohort was relatively younger(median 75 vs 78 years),and often consisted of males(56.3%vs 51.4%),blacks(9.8%vs 7.9%),Hispanics(7.3%vs 4.3%),and Asians(4.7%vs 1.6%)than the non-prediabetic cohort(P<0.001).The prediabetes group had significantly higher rates of hypertension,hyperlipidemia,smoking,obesity,drug abuse,prior myocardial infarction,peripheral vascular disease,and hyperthyroidism(all P<0.05).The prediabetes cohort was often discharged routinely(51.1%vs 41.1%),but more frequently required home health care(23.6%vs 21.0%)and had higher costs.After adjusting for baseline characteristics or comorbidities,the prediabetes cohort with AF admissions showed a higher rate and significantly higher odds of MACCE compared to the non-prediabetic cohort[18.6%vs 14.7%,odds ratio(OR)1.34,95%confidence interval 1.26-1.42,P<0.001].On subgroup analyses,males had a stronger association(aOR 1.43)compared to females(aOR 1.22),whereas on the race-wise comparison,Hispanics(aOR 1.43)and Asians(aOR 1.36)had a stronger association with MACCE with prediabetes vs whites(aOR 1.33)and blacks(aOR 1.21).CONCLUSION This population-based study found a significant association between prediabetes and MACCE in AF patients.Therefore,there is a need for further research to actively screen and manage prediabetes in AF to prevent MACCE.

Predicting major adverse cardiovascular events after orthotopic liver transplantation using a supervised machine learning model:A cohort study

BACKGROUND Liver transplant(LT)patients have become older and sicker.The rate of post-LT major adverse cardiovascular events(MACE)has increased,and this in turn raises 30-d post-LT mortality.Noninvasive cardiac stress testing loses accuracy when applied to pre-LT cirrhotic patients.AIM To assess the feasibility and accuracy of a machine learning model used to predict post-LT MACE in a regional cohort.METHODS This retrospective cohort study involved 575 LT patients from a Southern Brazilian academic center.We developed a predictive model for post-LT MACE(defined as a composite outcome of stroke,new-onset heart failure,severe arrhythmia,and myocardial infarction)using the extreme gradient boosting(XGBoost)machine learning model.We addressed missing data(below 20%)for relevant variables using the k-nearest neighbor imputation method,calculating the mean from the ten nearest neighbors for each case.The modeling dataset included 83 features,encompassing patient and laboratory data,cirrhosis complications,and pre-LT cardiac assessments.Model performance was assessed using the area under the receiver operating characteristic curve(AUROC).We also employed Shapley additive explanations(SHAP)to interpret feature impacts.The dataset was split into training(75%)and testing(25%)sets.Calibration was evaluated using the Brier score.We followed Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis guidelines for reporting.Scikit-learn and SHAP in Python 3 were used for all analyses.The supplementary material includes code for model development and a user-friendly online MACE prediction calculator.RESULTS Of the 537 included patients,23(4.46%)developed in-hospital MACE,with a mean age at transplantation of 52.9 years.The majority,66.1%,were male.The XGBoost model achieved an impressive AUROC of 0.89 during the training stage.This model exhibited accuracy,precision,recall,and F1-score values of 0.84,0.85,0.80,and 0.79,respectively.Calibration,as assessed by the Brier score,indicated excellent model calibration with a score of 0.07.Furthermore,SHAP values highlighted the significance of certain variables in predicting postoperative MACE,with negative noninvasive cardiac stress testing,use of nonselective beta-blockers,direct bilirubin levels,blood type O,and dynamic alterations on myocardial perfusion scintigraphy being the most influential factors at the cohort-wide level.These results highlight the predictive capability of our XGBoost model in assessing the risk of post-LT MACE,making it a valuable tool for clinical practice.CONCLUSION Our study successfully assessed the feasibility and accuracy of the XGBoost machine learning model in predicting post-LT MACE,using both cardiovascular and hepatic variables.The model demonstrated impressive performance,aligning with literature findings,and exhibited excellent calibration.Notably,our cautious approach to prevent overfitting and data leakage suggests the stability of results when applied to prospective data,reinforcing the model’s value as a reliable tool for predicting post-LT MACE in clinical practice.

Stock Volatility Increases the Mortality Risk of Major Adverse Cardiovascular Events and Suicide:A Case-Crossover Study of 12 Million Deaths

Stock volatility constitutes an adverse psychological stressor,but few large-scale studies have focused on its impact on major adverse cardiovascular events(MACEs)and suicide.Here,we conducted an individual-level time-stratified case-crossover study to explore the association of daily stock volatility(daily returns and intra-daily oscillations for three kinds of stock indices)with MACEs and suicide among more than 12 million individual decedents from all counties in the mainland of China between 2013 and 2019.For daily stock returns,both stock increases and decreases were associated with increased mortal-ity risks of all MACEs and suicide.There were consistent and positive associations between intra-daily stock oscillations and mortality due to MACEs and suicide.The excess mortality risks occurred at the cur-rent day(lag 0 d),persisted for two days,and were greatest for suicide and hemorrhagic stroke.Taking the present-day Shanghai and Shenzhen 300 Index as an example,a 1%decrease in daily returns was associated with 0.74%-1.04%and 1.77%increases in mortality risks of MACEs and suicide,respectively;the corresponding risk increments were 0.57%-0.85%and 0.92%for a 1%increase in daily returns and 0.67%-0.77%and 1.09%for a 1%increase in intra-daily stock oscillations.The excess risks were more pro-nounced among individuals aged 65-74 years,males,and those with lower education levels.Our findings revealed considerable health risks linked to sociopsychological stressors,which are helpful for the gov-ernment and general public to mitigate the immediate cardiovascular and mental health risks associated with stock market volatility.

Performance of the EDACS-ADP incorporating high-sensitivity troponin assay:Do components of major adverse cardiac events matter?

BACKGROUND:The accelerated diagnostic protocol(ADP)using the Emergency Department Assessment of Chest pain Score(EDACS-ADP),a tool to identify patients at low risk of a major adverse cardiac event(MACE)among patients presenting with chest pain to the emergency department,was developed using a contemporary troponin assay.This study was performed to validate and compare the performance of the EDACS-ADP incorporating high-sensitivity cardiac troponin I between patients who had a 30-day MACE with and without unstable angina(MACE I and II,respectively).METHODS:A single-center prospective observational study of adult patients presenting with chest pain suggestive of acute coronary syndrome was performed.The performance of EDACS-ADP in predicting MACE was assessed by calculating the sensitivity and negative predictive value.RESULTS:Of the 1,304 patients prospectively enrolled,399(30.6%;95%confidence interval[95%CI]:27.7%–33.8%)were considered low-risk using the EDACS-ADP.Among them,the rates of MACE I and II were 1.3%(5/399)and 1.0%(4/399),respectively.The EDACS-ADP showed sensitivities and negative predictive values of 98.8%(95%CI:97.2%–99.6%)and 98.7%(95%CI:97.0%–99.5%)for MACE I and 98.7%(95%CI:96.8%–99.7%)and 99.0%(95%CI:97.4%–99.6%)for MACE II,respectively.CONCLUSION:EDACS-ADP could help identify patients as safe for early discharge.However,when unstable angina was added to the outcome,the 30-day MACE rate among the designated lowrisk patients remained above the level acceptable for early discharge without further evaluation.

Value of improved nursing measures and enhanced nursing management to reduce the occurrence of adverse events in pediatric infusion

BACKGROUND Intravenous infusion is a common method of drug administration in clinical practice.Errors in any aspect of the infusion process,from the verification of medical orders,preparation of the drug solution,to infusion by nursing staff,may cause adverse infusion events.AIM To analyzed the value of improving nursing measures and enhancing nursing management to reduce the occurrence of adverse events in pediatric infusion.METHODS The clinical data of 130 children who received an infusion in the pediatric department of our hospital from May 2020 to May 2021 were analyzed and divided into two groups according to the differences in nursing measures and nursing management:65 patients in the control group received conventional nursing and nursing management interventions,while 65 patients in the observation group received improved nursing measure interventions and enhanced nursing management.The occurrence of adverse events,compliance of children,satisfaction of children’s families,and complaints regarding the transfusion treatment were recorded in both groups.RESULTS The incidence of fluid extravasation and infusion set dislodgement in the observation group were 3.08%and 1.54%,respectively,which were significantly lower than 12.31%and 13.85%in the control group(P<0.05),while repeated punctures and medication addition errors in the observation group were 3.08%and 0.00%,respectively,which were lower than 9.23%and 3.08%in the control group,but there was no significant difference(P>0.05).The compliance rate of children in the observation group was 98.46%(64/65),which was significantly higher than 87.69%(57/65)in the control group,and the satisfaction rate of children’s families was 96.92%(63/65),which was significantly higher than 86.15%(56/65)in the control group(P<0.05).The observation group did not receive any complaints from the child’s family,whereas the control group received four complaints,two of which were due to the crying of the child caused by repeated punctures,one due to the poor attitude of the nurse,and one due to medication addition errors,with a cumulative complaint rate of 6.15%.The cumulative complaint rate of the observation group was significantly lower than that of the control group(P<0.05).CONCLUSION Improving nursing measures and enhancing nursing management can reduce the incidence of fluid extravasation and infusion set dislodgement in pediatric patients,improve children’s compliance and satisfaction of their families,and reduce family complaints.

Neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio:Markers predicting immune-checkpoint inhibitor efficacy and immune-related adverse events

We conducted a comprehensive review of existing prediction models pertaining to the efficacy of immune-checkpoint inhibitor(ICI)and the occurrence of immune-related adverse events(irAEs).The predictive potential of neutrophil-to-lymphocyte ratio(NLR)and platelet-to-lymphocyte ratio(PLR)in determining ICI effectiveness has been extensively investigated,while limited research has been conducted on predicting irAEs.Furthermore,the combined model incor-porating NLR and PLR,either with each other or in conjunction with additional markers such as carcinoembryonic antigen,exhibits superior predictive capabilities compared to individual markers alone.NLR and PLR are promising markers for clinical applications.Forthcoming models ought to incorporate established efficacious models and newly identified ones,thereby constituting a multifactor composite model.Furthermore,efforts should be made to explore effective clinical application approaches that enhance the predictive accuracy and efficiency.

Biomarkers associated with immune-related adverse events induced by immune checkpoint inhibitors

Immune checkpoint inhibitors(ICIs)constitute a pivotal class of immunotherapeutic drugs in cancer treatment.However,their widespread clinical application has led to a notable surge in immune-related adverse events(irAEs),significantly affecting the efficacy and survival rates of patients undergoing ICI therapy.While conventional hematological and imaging tests are adept at detecting organ-specific toxicities,distinguishing adverse reactions from those induced by viruses,bacteria,or immune diseases remains a formidable challenge.Consequently,there exists an urgent imperative for reliable biomarkers capable of accurately predicting or diagnosing irAEs.Thus,a thorough review of existing studies on irAEs biomarkers is indispensable.Our review commences by providing a succinct over-view of major irAEs,followed by a comprehensive summary of irAEs biomarkers across various dimensions.Furthermore,we delve into innovative methodologies such as machine learning,single-cell RNA sequencing,multiomics analysis,and gut microbiota profiling to identify novel,robust biomarkers that can facilitate precise irAEs diagnosis or prediction.Lastly,this review furnishes a concise exposition of irAEs mechanisms to augment understanding of irAEs prediction,diagnosis,and treatment strategies.

Endoscopic ultrasound-guided therapies in the treatment of gastric varices:An in-depth examination of associated adverse events

The Baveno VII consensus,released in 2023,recommends that the endoscopic treatment of choice for managing bleeding gastric varices(GV)is endoscopic ultrasound(EUS)-guided treatment,specifically EUS-guided cyanoacrylate(CYA)glue injection.This approach has been endorsed due to its efficacy in controlling bleeding while reducing rebleeding rates,compared to other endoscopic techniques.Despite its efficacy,CYA injection for GV has been linked to rare but serious adverse events,such as glue embolization leading to pulmonary embolism,infection/bacteremia,splenic infarction,intra-procedural and post-procedural complications.The technique for endoscopic obliteration of GV was subsequently refined using EUS guidance,aiming to more accurately direct the injection into the varix,reduce the volume of injected glue,target the perforating vein when possible,and confirm obliteration of GV via Doppler examination.

Predictive Effect of CA125 on Adverse Cardiovascular Events in Patients with Chronic Heart Failure

Objective: To study the expression of CA125 in the serum of patients with CHF and the relationship between CA125 level and the occurrence of adverse cardiovascular events. Methods: The clinical data of 132 patients with CHF admitted to Shizuishan Second People’s Hospital from January 2023 to December 2023 were collected and divided into heart function II group, heart function III group, heart function IV group according to cardiac function. 44 healthy subjects who underwent physical examination during the same period were selected as the control group. The clinical data of CA125, NT-proBNP, echocardiography and other clinical data of the four groups were compared, and the incidence of major adverse cardiovascular events was followed up for 12 months. Results: Compared with the control group, the CA125 level in the CHF group was significantly increased (P Conclusion: Serum CA125 level is related to the cardiac function level in CHF patients and increases with the deterioration of cardiac function. The increase of the index is related to the mortality rate and re-hospitalization rate, suggesting that CA125 can be used as an indicator to reflect the severity of heart failure and prognosis monitoring.

Contemporary nationwide trends in major adverse cardiovascular events in young cannabis users without concomitant tobacco,alcohol,cocaine use

BACKGROUND Cannabis use has increased among young individuals in recent years.Although dependent cannabis use disorder(CUD)has been associated with various cardiac events,its effects on young adults without concurrent substance use remain understudied.AIM To examine trends in hospitalizations for major adverse cardiac and cerebrovascular events(MACCE)in this cohort.METHODSWe used the National Inpatient Sample(2016-2019)to identify hospitalized young individuals(18-44 years),excluding those with concurrent substance usage(tobacco,alcohol,and cocaine).They were divided into CUD+and CUD-.Using International Classification of Diseases-10 codes,we examined the trends in MACCE hospitalizations,including all-cause mortality(ACM),acute myocardial infarction(AMI),cardiac arrest(CA),and acuteischemic stroke(AIS).RESULTSOf 27.4 million hospitalizations among young adults without concurrent substance abuse,4.2%(1.1 million)hadco-existent CUD.In CUD+group,hospitalization rates for MACCE(1.71%vs 1.35%),AMI(0.86%vs 0.54%),CA(0.27%vs 0.24%),and AIS(0.49%vs 0.35%)were higher than in CUD-group(P<0.001).However,rate of ACMhospitalizations was lower in CUD+group(0.30%vs 0.44%).From 2016 to 2019,CUD+group experienced arelative rise of 5%in MACCE and 20%in AMI hospitalizations,compared to 22%and 36%increases in CUDgroup(P<0.05).The CUD+group had a 13%relative decrease in ACM hospitalizations,compared to a 10%relative rise in CUD-group(P<0.05).However,when adjusted for confounders,MACCE odds among CUD+cohort remain comparable between 2016 and 2019.CONCLUSIONThe CUD+group had higher rates of MACCE,but the rising trends were more apparent in the CUD-group overtime.Interestingly,the CUD+group had lower ACM rates than the CUD-group.

Monitoring Adverse Events during Seasonal Malaria Chemoprevention Campaigns for Children Aged 3 - 59 Months in Benin in 2023

Background: Seasonal malaria chemoprevention (SMC) is crucial for reducing the burden of malaria in children. However, adverse events (AEs) can affect treatment adherence and efficacy. This study assesses the prevalence of AEs associated with SMC and identifies factors associated with treatment discontinuation. Methods: A cross-sectional study of 3115 children receiving SMC was conducted. The study was conducted in two departments in northern Benin. The prevalence of AEs and factors associated with discontinuation of treatment were analyzed. Results: Among the children, 578 (18.6%, 95% CI: 17.2 - 19.9) reported AEs, mainly vomiting (63.5%), fever (43.8%) and diarrhea (23.0%). Boys (51.9%) had slightly more AEs than girls (48.1%). The prevalence of AEs was higher in rural areas (64.0%) than in urban areas (36.0%). Only 2.8% of children stopped taking SMC because of AEs. There was no significant association between AEs and discontinuation of SMC (p = 0.608). Children referred to health centers for management of AEs were less likely to discontinue treatment (p = 0.015). Conclusion: AEs were common, but the rate of discontinuation of SMC due to AEs was low, indicating good treatment tolerance. Effective management of AEs in health centers reduces treatment interruptions.

Adverse Events following AstraZeneca COVID-19 Vaccination: A Case Study in Abidjan, Côte d’Ivoire

Introduction: Pharmaceutical companies have boosted vaccine production following the global COVID-19 pandemic. In Côte d’Ivoire, the first vaccination campaign with the AstraZeneca vaccine began on March 1, 2021, as part of the Covax program. Despite the positive benefit/risk balance, the adverse effects of vaccination should not be minimized. Objective: To identify adverse events of AstraZeneca’s COVID-19 vaccination for better management. Materials and Methods: This is a case of a 57-year-old obese (BMI = 39 kg/m2) female health care worker who experienced adverse events in March 2021 after the second dose of AstraZeneca vaccine administered 4 weeks apart. These were subject to mandatory case reporting. Results: Major post-vaccination events occurred in a noisy systemic picture with parameters showing significant disturbances. Biological surveillance remains costly and makes the accountability of the vaccine complex. Conclusion: Vaccination remains the ultimate weapon in the fight against endemic diseases but should not overshadow the reporting of adverse events.

Adverse events with bismuth salts for Helicobacter pylori eradication:Systematic review and meta-analysis

AIM： To assess the safety of bismuth used in Helicobacter pylori （H pylorl） eradication therapy regimens. METHODS： We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched （up to October 2007） to identify randomised controlled tri- als comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppresion. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals （CI）.RESULTS： We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth rrelative risk （RR） = 1.01; 95% CI： 0.87-1.16], specific individual adverse events, with the exception of dark stools （RR = 5.06; 95% CI： 1.59-16.12）, or adverse events leading to withdrawal of therapy （RR = 0.86; 95% CI： 0.54-1.37）. CONCLUSION： Bismuth for the treatment of H py/ori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.

Postoperative biliary adverse events following orthotopic liver transplantation: Assessment with magnetic resonance cholangiography

Biliary adverse events following orthotopic liver transplantation (OLT) are relatively common and continue to be serious causes of morbidity, mortality, and transplant dysfunction or failure. The development of these adverse events is heavily influenced by the type of anastomosis during surgery. The low specificity of clinical and biologic findings makes the diagnosis challenging. Moreover, direct cholangiographic procedures such as endoscopic retrograde cholangiopancreatography and percutaneous transhepatic cholangiography present an inadmissible rate of adverse events to be utilized in clinically low suspected patients. Magnetic resonance (MR) maging with MR cholangiopancreatography is crucial in assessing abnormalities in the biliary system after liver surgery, including liver transplant. MR cholangiopancreatography is a safe, rapid, non-invasive, and effective diagnostic procedure for the evaluation of biliary adverse events after liver transplantation, since it plays an increasingly important role in the diagnosis and management of these events. On the basis of a recent systematic review of the literature the summary estimates of sensitivity and specificity of MR cholangiopancreatography for diagnosis of biliary adverse events following OLT were 0.95 and 0.92, respectively. It can provide a non-invasive method of imaging surgical reconstruction of the biliary anastomoses as well as adverse events including anastomotic and non-anastomotic strictures, biliary lithiasis and sphincter of Oddi dysfunction in liver transplant recipients. Nevertheless, conventional T2-weighted MR cholangiography can be implemented with T1-weighted contrast-enhanced MR cholangiography using hepatobiliary contrast agents (in particular using Gd-EOB-DTPA) in order to improve the diagnostic accuracy in the adverse events&#x02019; detection such as bile leakage and strictures, especially in selected patients with biliary-enteric anastomosis.

Analysis of characteristics and predictive factors of immune checkpoint inhibitor-related adverse events

Objective:We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events(irAEs)as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpoint inhibitors(ICIs)in patients with advanced pan-cancer in a real-world setting.Methods:We retrospectively analyzed data from 105 patients with advanced pan-cancer treated with multi-type ICIs at the First Hospital of Jilin University between January 1,2016 and August 1,2020.We used logistic regression analyses to investigate the associations of irAEs with clinical baseline characteristics,blood count parameters,and biochemical indicators during treatment.Receiver operating characteristic curves were used to determine cutoff values for parameters and area under the curve values.Kaplan–Meier and Cox multivariate regression analyses were performed to estimate the relationships of baseline characteristics and irAEs with progression-free survival(PFS)and overall survival(OS).Results:A lower relative lymphocyte count(cutoff=28.5%),higher albumin level(cutoff=39.05 g/L),and higher absolute eosinophil count(AEC)(cutoff=0.175×10^(9)/L)were significantly associated with the occurrence of irAEs,among which a higher AEC(cutoff=0.205×10^(9)/L)was strongly associated with skin-related irAEs[odds ratios(ORs)=0.163,P=0.004].Moreover,a higher lactate dehydrogenase level(cutoff=237.5 U/L)was an independent predictor of irAEs of grade≥3(OR=0.083,P=0.023).In immune cell subgroup analysis,a lower absolute count of CD8+CD28−suppressor T cells(OR=0.806;95%confidence interval:0.643–1.011;P=0.062),which are regulatory T lymphocytes,was associated with the occurrence of irAEs,although the difference was not statistically significant.Furthermore,a higher percentage of CD19+B cells was associated with the occurrence of irAEs of grade≥3(P=0.02)and grade≥2(P=0.051).In addition,patients with any grade of irAE had a significantly high PFS(8.37 vs.3.77 months,hazard ratios(HR)=2.02,P=0.0038)and OS(24.77 vs.13.83 months,HR=1.84;P=0.024).Conclusions:This retrospective study reports clinical profile data for irAEs in unselected patients in a real-world setting and explored some parameters that may be potential predictive markers of the occurrence,type,or grade of irAEs in clinical practice.Evidence of a correlation between safety and efficacy may facilitate a complete assessment of the risk-benefit ratio for patients treated with ICIs.

Novel endoscopic papillectomy for reducing postoperative adverse events(with videos)

BACKGROUND Pancreatic adenoma can potentially transform into adenocarcinoma, so it is recommended to be resected surgically or endoscopically. Endoscopic papillectomy is one of the main treatments for papillary adenoma, and bleeding, perforation, and pancreatitis are the most frequent and critical adverse events that restrict its wider use. There is no standard procedure for endoscopic papillectomy yet. The procedure is relevant to postoperative adverse events.AIM To reduce the postoperative adverse event rates and improve patients' postoperative condition, we developed a standard novel procedure for endoscopic papillectomy.METHODS The novel endoscopic papillectomy had two main modifications based on the conventional method: The isolation of bile from pancreatic juice with a bile duct stent and wound surface protection with metal clips and fibrin glue. We performed a single-center retrospective comparison study on the novel and conventional methods to examine the feasibility of the novel method for reducing postoperative adverse events.RESULTS A total of 76 patients, of whom 23 underwent the novel procedure and 53 underwent the conventional procedure, were retrospectively evaluated in this study. The postoperative bleeding and pancreatitis rates of the novel method were significantly lower than those of the conventional method(0 vs 20.75%, P = 0.028, and 17.4% vs 41.5%, P = 0.042, respectively). After applying the novel method, the most critical adverse event, perforation, was entirely prevented, compared to a prevalence of 5.66% with the conventional method. Several postoperative symptoms, including fever, rapid pulse, and decrease in hemoglobin level, were significantly less frequent in the novel group(P = 0.042, 0.049, and 0.014, respectively). Overall, the total adverse event rate of the novel method was lower(0 vs 24.5%, P = 0.007) than that of the conventional method.CONCLUSION Patients who underwent the novel procedure had lower postoperative adverse event rates. This study demonstrates the potential efficacy and safety of the novel endoscopic papillectomy in reducing postoperative adverse events.

Left atrial area index predicts adverse cardiovascular events in patients with unstable angina pectoris

Background The left atrial size has been considered as a useful marker of adverse cardiovascular outcomes. However, it is not well known whether left atrial area index （LAAI） has predictive value for prognosis in patients with unstable angina pectoris （UAP）. This study was aimed to assess the association between LAAI and outcomes in UAP patients. Methods We enrolled a total of 391 in-hospital patients diag- nosed as UAP. Clinical and echocardiographic data at baseline were collected. The patients were followed for the development of ad- verse cardiovascular （CV） events, including hospital readmission for angina pectoris, acute myocardial infarction （AMI）, congestive heart failure （CHF）, stroke and all-cause mortality. Results During a mean follow-up time of 26.3±8.6 months, 98 adverse CV events occurred （84 hospital readmission for angina pectoris, four AMI, four CHF, one stroke and five all-cause mortality）. In a multivariate Cox model, LAAI [OR： 1.140, 95% CI： 1.01±1.279, P = 0.026], diastolic blood pressure （OR： 0.976, 95% CI： 0.956-0.996, P = 0.020） and pulse pressure （OR 1.020, 95% CI： 1.007-1.034, P = 0.004） were independent predictors for adverse CV events in UAP patients. Conclusions LAAI is a predictor of adverse CV events independent of clinical and other echocardiographic parameters in UAP patients.

Postoperative adverse cardiac events in acute myocardial infarction with high thrombus load and best time for stent implantation

BACKGROUND Myocardial infarction is one of the most common types of coronary heart disease.It is mainly caused by the rupture of coronary atherosclerotic plaque,which leads to platelet agglutination and thrombosis.The occlusion of coronary arteries and vessels leads to insufficient myocardial blood supply,subsequently causing cardiac interstitial fibrosis,gradual enlargement of ventricles,and heart failure,which affects the quality of life and safety of patients.AIM To investigate the effects of emergency percutaneous interventional therapy(PCI)and delayed stenting in acute myocardial infarction with high thrombotic load and identify factors related to major adverse cardiovascular events(MACE).METHODS A total of 164 patients with acute myocardial infarction and high thrombotic load who received PCI were included.Of them,92 patients were treated with delayed stent implantation(delayed group)and 72 patients received emergency PCI(immediate group).Myocardial perfusion after stent implantation was compared between the two groups.Patients were followed up for 12 mo,and the occurrence of MACE was used as the endpoint.Univariate and multivariate models were used to analyze the factors affecting MACE occurrence.RESULTS After stent implantation,66(71.74%)patients in the delayed group and 40(55.56%)patients in the immediate group had thrombolysis in myocardial infarction(TIMI)flow grade 3(P<0.05),while 61(66.30%)patients in the delayed group and 39(54.17%)patients in the immediate group reached TIMI myocardial perfusion grade 3(P>0.05).MACE occurred in 29 patients.There were statistically significant differences between the MACE and non-MACE groups in diabetes rate,TIMI grading,stent implantation timing,intraoperative use of tirofiban,and the levels of white blood cells(WBC),neutrophils,red blood cell distribution width(RDW),and uric acid,and high-sensitivity C-reactive protein(hs-CRP)at admission(P<0.05).Logistic regression analysis showed that TIMI grade 3 and intraoperative use of tirofiban effectively reduced the risk of MACE(P<0.05),while immediate stent implantation,increased WBC,hs-CRP and RDW on admission increased the risk of MACE(P<0.05).CONCLUSION Delayed stent implantation outweighs emergency PCI in improving postoperative myocardial perfusion in acute myocardial infarction with high thrombotic load,and effectively reduces MACE in these patients.