The low-dose colchicine in patients after non-CABG cardiac surgery: a randomized controlled trial.

BACKGROUND: Recent high-quality trials have shown that the anti-inflammatory effects of colchicine reduce the risk of cardiovascular events in patients suffering post-myocardial infarction and chronic coronary disease. The effect of colchicine in patients undergoing non-coronary artery bypass grafting (non-CABG) with cardiopulmonary bypass remains unclear. We aim to evaluate the effect of colchicine on myocardial protection in patients who underwent non-CABG cardiac surgery. METHOD: Patients were randomly assigned to colchicine or placebo groups starting 72 h before scheduled cardiac surgery and for 5 days thereafter (0.5 mg daily).The primary outcome was the level of cardiac troponin T (cTnT) at postoperative 48 h. The secondary outcomes included troponin I (cTnI) and creatine kinase-MB (CK-MB), inflammatory biomarkers (procalcitonin and interleukin-6, etc.), and adverse events (30-day mortality, stroke, ECMO and IABP use, etc.). RESULTS: A total of 132 patients underwent non-CAGB cardiac surgery, 11were excluded because of diarrhea (n = 6) and long aortic cross-clamp time > 2 h (n = 5), 59 were assigned to the colchicine group and 62 to the placebo group. Compared with the placebo group, cTnT (median: 0.3 µg/L, IQR 0.2-0.4 µg/L vs. median: 0.4 µg/L, IQR 0.3-0.6 µg/L, P < 0.01), cardiac troponin I (median: 0.9 ng/ml, IQR 0.4-1.7 ng/ml vs. median: 1.3 ng/ml, IQR 0.6-2.3 ng/ml, P = 0.02), CK-MB (median: 1.9 ng/ml, IQR 0.7-3.2 ng/ml vs. median: 4.4 ng/ml, IQR 1.5-8.2 ng/ml, P < 0.01), and interleukin-6 (median: 73.5 pg/ml, IQR 49.6-125.8 pg/ml vs. median: 101 pg/ml, IQR 57.5-164.7 pg/ml, P = 0.048) were significantly reduced in colchicine group at postoperative 48 h. For safety evaluation, the colchicine (n = 65) significantly decreased post-pericardiotomy syndrome (3.08% vs. 17.7%, P < 0.01) and increased the rate of diarrhea (9.23% vs. 0, P = 0.01) compared with the placebo group (n = 62). No significant difference was observed in other adverse events between the two groups. CONCLUSION: A short perioperative course of low-dose colchicine was effective to attenuate the postoperative biomarkers of myocardial injury and inflammation, and to decrease the postoperative syndrome compared with the placebo. Trial registration ChiCTR2000040129. Registered 22nd Nov. 2020. This trial was registered before the first participant was enrolled. http://www.chictr.org.cn/showproj.aspx?proj=64370 .

Nomogram for individualised prediction of liver failure risk after hepatectomy in patients with resectable hepatocellular carcinoma: the evidence from ultrasound data.

OBJECTIVES: This study sought to develop a clinical nomogram for predicting post-hepatectomy liver failure (PHLF) among patients with resectable hepatocellular carcinoma (HCC). METHODS: The nomogram was established based on data obtained from a prospective study on 136 consecutive patients with resectable HCC undergoing hepatectomy from January 2015 to December 2015 in our centre. Another 80 patients in our centre served as an independent internal validation set. The predictive accuracy and discriminative ability of the nomogram were determined by concordance index (C-index), calibration curve and compared with commonly predictive systems. RESULTS: PHLF occurred in 30.9% of patients in the derivation set, including 36 and six patients with Grades A and B, respectively. The statistical nomogram built on the basis of platelet count, serum bilirubin, serum GGT, clinical signs of portal hypertension and shear wave elastography had good calibration and discriminatory abilities, with C-indices of 0.85. These models showed satisfactory goodness-of-fit and discrimination abilities in the independent validation set with C-indices of 0.824 for PHLF. The areas under the receiver-operator characteristic (ROC) curve using our methods were greater than those of conventional predictive systems in the validation patients (corresponding C-indices, 0.572-0.701). CONCLUSIONS: This novel nomogram provides good preoperative prediction of PHLF in patients with resectable HCC. KEY POINTS: • The nomogram was built by platelet count, bilirubin, GGT, CSPH and SWE. • The nomogram showed good calibration and discriminatory abilities in the different sets. • Compared with other models, the nomogram indicated better discriminatory capability.

Diagnosis of Early Bacterial Pneumonia and Sepsis After Cardiovascular Surgery: A Diagnostic Prediction Model Based on LASSO Logistic Regression.

Background: Early postoperative bacterial pneumonia and sepsis (ePOPS), which occurs within the first 48 hours after cardiovascular surgery, is a serious life-threatening complication. Diagnosis of ePOPS is extremely challenging, and the existing diagnostic tools are insufficient. The purpose of this study was to construct a novel diagnostic prediction model for ePOPS. Methods: Least Absolute Shrinkage and Selection Operator (LASSO) with logistic regression was used to construct a model to diagnose ePOPS based on patients' comorbidities, medical history, and laboratory findings. The area under the receiver operating characteristic curve (AUC) was used to evaluate the model discrimination. Results: A total of 1203 patients were recruited and randomly split into a training and validation set in a 7:3 ratio. By early morning on the 3rd postoperative day (POD3), 103 patients had experienced 133 episodes of bacterial pneumonia or sepsis (15 patients had both). LASSO logistic regression model showed that duration of mechanical ventilation (P=0.015), NYHA class ≥ III (P=0.001), diabetes (P<0.001), exudation on chest radiograph (P=0.011) and IL-6 on POD3 (P<0.001) were independent risk factors. Based on these factors, we created a nomogram named DICS-I with an AUC of 0.787 in the training set and 0.739 in the validation set. Conclusion: The DICS-I model may be used to predict the risk of ePOPS after cardiovascular surgery, and is also especially suitable for predicting the risk of IRAO. The DICS-I model could help clinicians to adjust antibiotics on the POD3.

The relationship between time to a high COVID-19 response level and timing of peak daily incidence: an analysis of governments' Stringency Index from 148 countries.

BACKGROUND: The transmission dynamics and severity of coronavirus disease 2019 (COVID-19) pandemic is different across countries or regions. Differences in governments' policy responses may explain some of these differences. We aimed to compare worldwide government responses to the spread of COVID-19, to examine the relationship between response level, response timing and the epidemic trajectory. METHODS: Free publicly-accessible data collected by the Coronavirus Government Response Tracker (OxCGRT) were used. Nine sub-indicators reflecting government response from 148 countries were collected systematically from January 1 to May 1, 2020. The sub-indicators were scored and were aggregated into a common Stringency Index (SI, a value between 0 and 100) that reflects the overall stringency of the government's response in a daily basis. Group-based trajectory modelling method was used to identify trajectories of SI. Multivariable linear regression models were used to analyse the association between time to reach a high-level SI and time to the peak number of daily new cases. RESULTS: Our results identified four trajectories of response in the spread of COVID-19 based on when the response was initiated: before January 13, from January 13 to February 12, from February 12 to March 11, and the last stage-from March 11 (the day WHO declared a pandemic of COVID-19) on going. Governments' responses were upgraded with further spread of COVID-19 but varied substantially across countries. After the adjustment of SI level, geographical region and initiation stages, each day earlier to a high SI level (SI > 80) from the start of response was associated with 0.44 (standard error: 0.08, P < 0.001, R2 = 0.65) days earlier to the peak number of daily new case. Also, each day earlier to a high SI level from the date of first reported case was associated with 0.65 (standard error: 0.08, P < 0.001, R2 = 0.42) days earlier to the peak number of daily new case. CONCLUSIONS: Early start of a high-level response to COVID-19 is associated with early arrival of the peak number of daily new cases. This may help to reduce the delays in flattening the epidemic curve to the low spread level.

Diagnosis of infection after cardiovascular surgery (DICS): a study protocol for developing and validating a prediction model in prospective observational study.

INTRODUCTION: Postoperative infection (PI) is one of the main severe complications after cardiovascular surgery. Therefore, antibiotics are routinely used during the first 48 hours after cardiovascular surgery. However, there is no effective method for early diagnosis of infection after cardiovascular surgery, particularly, to determine whether postoperative patients need to prolong the use of antibiotics after the first 48 hours. In this study, we aim to develop and validate a diagnostic model to help identify whether a patient has been infected after surgery and guide the appropriate use of antibiotics. METHODS AND ANALYSIS: In this prospective study, we will develop and validate a diagnostic model to determine whether the patient has a bacterial infection within 48 hours after cardiovascular surgery. Baseline data will be collected through the electronic medical record system. A total of 2700 participants will be recruited (n=2000 for development, n=700 for validation). The primary outcome of the study is the newly PI during the first 48 hours after cardiovascular surgery. Logistic regression penalised with elastic net regularisation will be used for model development and bootstrap and k-fold cross-validation aggregation will be performed for internal validation. The derived model will be also externally validated in patients who are continuously included in another time period (N=700). We will evaluate the calibration and differentiation performance of the model by Hosmer-Lemeshow good of fit test and the area under the curve, respectively. We will report sensitivity, specificity, positive predictive value and negative predictive value in the validation data-set, with a target of 80% sensitivity. ETHICS AND DISSEMINATION: Ethical approval was obtained from Medical Ethics Committee of Affiliated Nanjing Drum Tower Hospital, Nanjing University Medical College (2020-249-01). TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Register (www.chictr.org.cn, ChiCTR2000038762); Pre-results.

Corrigendum to "Ethnic differences in the association between angiotensin-converting enzyme gene insertion/deletion polymorphism and peripheral vascular disease: A meta-analysis" [CDTM 3/4 (2017) 230-241].

[This corrects the article DOI: 10.1016/j.cdtm.2017.07.002.].

Ethnic differences in the association between angiotensin-converting enzyme gene insertion/deletion polymorphism and peripheral vascular disease: A meta-analysis.

BACKGROUND: Several studies have investigated the association of angiotensin-converting enzyme (ACE) gene insertion/deletion (I/D) polymorphism with peripheral vascular disease (PVD); however, the results remain controversial. Therefore, we conducted the current meta-analysis to evaluate this relationship in the general population of different ethnicities. METHODS: We searched PubMed, Embase, Web of Science, Wanfang Database, and CNKI to identify eligible studies. Random-effect models were applied to estimate the pooled odds ratio (OR) with a 95% confidence interval (CI), regardless of between-study heterogeneity. RESULTS: A total of 13 studies with 1966 cases and 6129 controls were included in this meta-analysis. The pooled ORs for the association between ACE I/D polymorphism and PVD risk were not statistically significant in the overall population under all genetic models. In further ethnicity-stratified analyses, we found a statistically significant association of ACE I/D polymorphism with PVD susceptibility in Asians under most models. However, the association among Caucasians did not reach statistical significance. CONCLUSION: ACE I/D polymorphism might be associated with susceptibility to PVD in the Asian population, but there was no clear evidence indicating a similar significant relationship among Caucasians.

Prognostic nomogram for post-surgical treatment with adjuvant TACE in hepatitis B virus-related hepatocellular carcinoma.

OBJECTIVE: This study sought to establish an effective and reliable prognostic nomogram to guide the decision for post-surgical adjuvant transarterial chemoembolization (PA-TACE) in patients with hepatitis B virus-related (HBV) hepatocellular carcinoma (HCC). RESULTS: The 1, 3, 5-year overall survival rates were, respectively, 87.7%, 52.1% and 28.3% in the patients from the derivation set and 91.7%, 57.1% and 34.1% in those from the validation set. Five risk factors (HBV-DNA level, platelet count, vascular invasion, change of Child-Pugh score, and tumor diameter) in the multivariate analysis were significantly associated with prognosis. The statistical nomogram incorporated these five factors achieved good calibration and discriminatory abilities with c-index of 0.75 (95% CI 0.67 to 0.83). The findings were supported by the independent external validation set (c-index, 0.69; 95% CI 0.56 to 0.83). Patients who had a nomogram score of less than 180 was considered to have higher survival benefit from PA-TACE. METHODS: The nomogram was established based on data obtained from a retrospective study on 235 consecutive patients with HBV HCC who received PA-TACE as an initial therapy from 2006 to 2010 in our center. 84 patients who were collected at another institution between 01/2008 and 12/2010 served as an external validation set. The prognostic nomogram was developed based on the data obtained before the PA-TACE procedure. Predictive accuracy and discriminative ability of the nomogram were assessed by concordance index (C-index), calibration curves, and validation set. CONCLUSIONS: The novel nomogram may achieve an optimal prognostic prediction for PA-TACE in HBV-related HCC.

Postsurgical treatment with adjuvant transarterial chemoembolization in patients with hepatitis B-related hepatocellular carcinoma: A strobe-compliant article.

This study sought to develop a reliable and easy-to-use scoring model to guide the decision to perform postsurgical adjuvant transarterial chemoembolization (PA-TACE) in patients with hepatitis B-related hepatocellular carcinoma (HCC).The study included 235 consecutive patients with hepatitis B-related HCC undergoing PA-TACE at our medical center. Patients were assigned to 2 sets according to the PA-TACE date: initial (2005-2007; n = 130) and internal validation (2008-2009; n = 105) sets. With the aid of a Cox regression model, we developed a risk-scoring model from the independent predictive factors of our initial set designed as a guide for PA-TACE, and the performance of the model was validated with an internal set. External validation was also performed with an independent dataset (n = 84) to assess the discriminatory power of the scoring model.In the multivariate analysis, 4 risk factors (an increase in Child-Pugh score of at least 1 point, hepatitis B virus deoxyribonucleic acid [HBV-DNA] level >10 IU/mL, tumor diameter ≥5 cm, and the presence of vascular invasion) were significantly associated with prognosis. These factors were incorporated into a novel clinicopathological scoring model (assessment for PA-TACE [APT] risk-scoring model) ranging from 0 to 8 that was correlated with prognosis. Different survival outcomes were identified in three groups (0-2 points, 3-6 points, and 7-8 points). The risk-scoring model was further confirmed with 2 independent sets.The novel APT risk-scoring model, merging 4 prognostic factors, may achieve an optimal postsurgical prediction of PA-TACE in HBV-related HCC. The risk for an individual patient with an APT score of ≥7.0 prior to the PA-TACE, who may not profit from further PA-TACE, can be determined, and this may lead to a more appropriate choice of treatment.