Regular use of fish oil supplements and course of cardiovascular diseases: prospective cohort study.

Objective: To examine the effects of fish oil supplements on the clinical course of cardiovascular disease, from a healthy state to atrial fibrillation, major adverse cardiovascular events, and subsequently death. Design: Prospective cohort study. Setting: UK Biobank study, 1 January 2006 to 31 December 2010, with follow-up to 31 March 2021 (median follow-up 11.9 years). Participants: 415 737 participants, aged 40-69 years, enrolled in the UK Biobank study. Main outcome measures: Incident cases of atrial fibrillation, major adverse cardiovascular events, and death, identified by linkage to hospital inpatient records and death registries. Role of fish oil supplements in different progressive stages of cardiovascular diseases, from healthy status (primary stage), to atrial fibrillation (secondary stage), major adverse cardiovascular events (tertiary stage), and death (end stage). Results: Among 415 737 participants free of cardiovascular diseases, 18 367 patients with incident atrial fibrillation, 22 636 with major adverse cardiovascular events, and 22 140 deaths during follow-up were identified. Regular use of fish oil supplements had different roles in the transitions from healthy status to atrial fibrillation, to major adverse cardiovascular events, and then to death. For people without cardiovascular disease, hazard ratios were 1.13 (95% confidence interval 1.10 to 1.17) for the transition from healthy status to atrial fibrillation and 1.05 (1.00 to 1.11) from healthy status to stroke. For participants with a diagnosis of a known cardiovascular disease, regular use of fish oil supplements was beneficial for transitions from atrial fibrillation to major adverse cardiovascular events (hazard ratio 0.92, 0.87 to 0.98), atrial fibrillation to myocardial infarction (0.85, 0.76 to 0.96), and heart failure to death (0.91, 0.84 to 0.99). Conclusions: Regular use of fish oil supplements might be a risk factor for atrial fibrillation and stroke among the general population but could be beneficial for progression of cardiovascular disease from atrial fibrillation to major adverse cardiovascular events, and from atrial fibrillation to death. Further studies are needed to determine the precise mechanisms for the development and prognosis of cardiovascular disease events with regular use of fish oil supplements.

Solid pseudopapillary neoplasm of the pancreas: a retrospective study of 195 cases.

Objective: Solid pseudopapillary neoplasm of the pancreas (SPN) is a rare exocrine tumor of the pancreas. The aim of our study is to summarize the clinical features of SPN and to analyze the risk factors for malignant SPN. Methods: From May 2013 to September 2022, patients who were pathologically confirmed to have SPN were retrospectively reviewed. Demographic data, clinical and pathological features, follow-up data were collected and analyzed. To investigate the factors influencing the benign or malignant nature of SPN, we employed logistic regression. Additionally, we utilized Kaplan-Meier curves to depict and analyze the overall prognosis. Results: A total of 195 patients were included, 163 of whom were female and the average age of all patients was 31.7 years old. Among 195 patients, 101 patients (51.8%) had no obvious clinical symptoms and their pancreatic lesions were detected during routine examination. The primary symptom was abdominal pain and distension in 64 cases (32.8%). The maximum diameter of SPN tumors ranged from 1-17 cm (mean 6.19 cm). Forty-eight postoperative complications developed in 43 (22.1%) patients. After a median follow-up duration of 44.5 months, the overall 5-year survival rate was 98.8% and the recurrence rate was 1.5%. Furthermore, we observed a statistically significant difference in the completeness of the tumor capsule between benign and malignant SPN. Conclusion: SPN is associated with a favorable long-term survival after surgery in our large sample size cohort. For malignant SPN, tumor capsule incompleteness is an independent risk factor.

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.

Changes in Drug Clinical Trials of Thyroid Diseases in China, 2009-2022.

Objective: The incidence rate of thyroid diseases increased worldwide. This study aims to overview the changing landscape of drug clinical trials on thyroid disease during 2009-2022. Methods: The detailed information of thyroid disease drug trials registered on the National Medical Products Administration (NMPA) Registration and Information Disclosure Platform for Drug Clinical Studies was searched and collected. The thyroid drug clinical trials were analyzed by the characteristics, time trends, indications, and geographical distribution. Results: Sixty-five thyroid disease drug clinical trials were launched from 2009 to 2022 in China, which included 21 trials in nontumorous thyroid disease and 44 trials in thyroid carcinoma. The number of registered trials of thyroid diseases including thyroid carcinoma and nontumorous thyroid disease increased steadily from 2009 to 2020. Bioequivalence studies accounted for the largest proportion (32[49.2%]), while phase I and Phase II studies both only accounted for 18.5% (12/65). A significant difference was observed in the trials phase, and randomization between thyroid carcinoma and nontumorous thyroid disease. In terms of clinical indications and drug mechanisms, the number of trials in multi-target tyrosine kinase inhibitors for thyroid carcinoma (n=35) ranked first, followed by thyroid hormone for hypothyroidism (n=7), thyrotropin for thyroid carcinoma (n=6). Sixty-five trials were led by 36 principal investigator (PI) units, and more than 30% of PI-leading units were located in Shanghai (n=7) and Beijing (n=4). Conclusion: During the past 13 years, the development of thyroid diseases drugs trials has achieved certain progress in thyroid carcinoma, especially the molecular targeted therapy, yet the development of drug trials on nontumorous thyroid disease was very slow.

Level of evidence supporting the Chinese cardiovascular disease clinical practice guidelines and its evolution in the past two decades.

Background: Clinical practice is guided by guidelines in the era of evidence-based medicine to improve healthcare. The consistency between the strength of recommendations and the underlying quality of evidence in clinical guidelines and its evolution dynamically reflects the status of medical practice in important aspects. This study aimed to evaluate the levels of evidence (LOEs) supporting different classes of recommendations (CORs) in Chinese cardiovascular disease (CVD) guidelines between 2003 and 2021, and changes over time. Methods: Clinical guideline documents on cardiovascular topics issued by leading professional organizations were retrieved in the Databases of SinoMed and Wanfang Med Online from inception to June 2021. All guidelines were screened through abstract and full-text reading, and included if satisfying the pre-specified criteria. 79 Chinese guideline documents on 12 sub-topics including a total of 5195 recommendations and the designated CORs/LOEs, were abstracted. The number of recommendations of Class Ⅰ, Class Ⅱ, Class Ⅲ, LOE A, LOE B, and LOE C were identified for each guideline document. The proportion of CORs, LOEs, and COR-LOE combinations in guidelines and the changes among those with ≥2 versions. Findings: A total of 79 guidelines were included in the analysis. When examining the status of current guidelines, among the 3325 recommendations derived from 59 documents during 2011-2021, 735 recommendations (22.1%) were classified as LOE A, 1280 (38.5%) as LOE B, and 1310 (39.4%) as LOE C. 596 recommendations (17.9%) were characterized as Class Ⅰ-LOE A, accounting for the majority of LOE A recommendations but only one-third of Class I recommendations. Evidence levels varied greatly across different sub-topics and individual guidelines. There are 9 guidelines on 5 sub-topics having ≥2 versions. When analyzing the changes over time, although an increase was observed in the total number of recommendations, the proportion of recommendations designated as Class Ⅰ-LOE A did not significantly improve (19.1% [current] vs 19.0% [prior], p = 0.97). Interpretation: In current Chinese CVD guidelines, the high level of evidence lacks, and its alignment with strong recommendations is deficient. Although it shows moderate improvements in certain major topics (e.g., coronary artery disease, interventional therapy, surgery) in the past two decades, the overall proportion of Class I-LOE A recommendations remains small, suggesting that conduction, and particularly translation, of high-quality studies like RCTs addressing CVDs-related questions are still essential and demanded, especially for areas with less attention. Funding: This study was supported by Beijing Nova Program from Beijing Municipal Science & Technology Commission (Z211100002121063, Z201100006820002); Fundamental Research Funds for the Central Universities (3332022023); National Key R&D Program of China (2020YFC2004705); CAMS Innovation Fund for Medical Sciences (2021-I2M-5-003); National Natural Science Foundation of China (81825003, 91957123, 82270376).

Mid-term outcomes of patients with subclinical hypothyroidism after coronary bypass surgery.

OBJECTIVES: Subclinical hypothyroidism (SCH) is characterized by an elevated thyroid-stimulating hormone and normal free thyroxine. This study aimed to evaluate the influence of SCH on mid-term outcomes of patients after coronary artery bypass grafting (CABG). METHODS: From January 2015 to December 2018, 548 SCH patients and 6718 euthyroid patients who underwent CABG were identified. Propensity score matching was used to create 2 cohorts with similar baseline characteristics (n = 544 in each group). The mid-term follow-up outcomes were compared. Adjusted hazard ratios (HRs) were calculated using Cox proportional hazards models. RESULTS: The mean follow-up for all patients was 39.7 ± 17.3 months. The unadjusted Kaplan-Meier estimate for mortality at 5-year follow-up was higher in patients with SCH compared with euthyroid patients (5.3% vs 1.6%, log-rank P = 0.03). After adjusting for covariates, the risk of mortality was higher in patients with SCH compared with euthyroid patients [HR, 2.40; 95% confidence interval (CI), 1.03-5.58; P = 0.04]. The adjusted risk of major adverse cardiovascular and cerebral event (HR, 2.16; 95% CI, 1.51-3.08; P < 0.001) and angina (HR, 2.44; 95% CI, 1.41-4.24; P = 0.001) was higher in patients with SCH compared with euthyroid patients. CONCLUSIONS: SCH is associated with an increased risk of mortality, major adverse cardiovascular and cerebral event and angina compared with euthyroidism in patients undergoing CABG.

The changing landscape of drug clinical trials on cardiometabolic diseases in China, 2009-2021.

BACKGROUND: Cardiometabolic disease is a clinical syndrome characterized by multiple metabolic disorders, with atherosclerosis as the core and cardiovascular and cerebrovascular events as the outcome. Drug research and development (R&D) in cardiometabolic diseases has grown rapidly worldwide. However, the development of cardiometabolic drug clinical trials in China remains unclear. This study aims to depict the changing landscape of drug clinical trials for cardiometabolic diseases in China during 2009-2021. METHODS: The detailed information of drug trials on cardiometabolic diseases registered in the National Medical Products Administration (NMPA) Registration and Information Disclosure Platform was collected between January 1, 2009, and July 1, 2021. The landscape of cardiometabolic drug clinical trials was analyzed by the characteristics, time trends, indications, pharmacological mechanisms, and geographical distribution. RESULTS: A total of 2466 drug clinical trials on cardiometabolic diseases were extracted and analyzed. The annual number of drug trials increased rapidly in the past twelve years. Among all the trials, the bioequivalence trials (1428; 58.3%) accounted for the largest proportion, followed by phase I (555; 22.5%), phase III (278; 11.3%), phase II (169; 6.9%), and phase IV (26; 1.1%). Of 2466 trials, 2133 (86.5%) trials were monomer drugs, only 236 (9.6%) trials were polypills and 97 (3.9%) were traditional Chinese medicine (TCM) compounds. In terms of pharmacological mechanisms, the number of trials in dihydropyridine (DHP) calcium antagonists 321 (11.9%) ranked first, while trials in angiotensin receptor blocker (ARB) 289 (10.7%) and dipeptidyl peptidase-4 (DPP-4) inhibitor 205 (7.6%) ranked second and third place respectively. Of 236 chemical polypills trials, 23 (9.7%) polypills were the combination of DHP calcium antagonists and statins, while others were the combination of two same pharmacological effect agents. As for the geographical distribution of leading units, 36 trials were led by principal investigators (PI) units from Beijing, followed by Jiangsu (n = 29), Shanghai (n = 19), Guangdong (n = 19), and Hunan (n = 19), showing an uneven regional distribution. CONCLUSIONS: Great progress has been made in drug clinical trials on cardiometabolic diseases, especially in antihypertensive agents, hypoglycemic agents, and hypolipidemic agents. However, the insufficient innovation of first-in-class drugs and polypills should be carefully considered by all stakeholders in drug trials.

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 .

A novel predictive model for poor in-hospital outcomes in patients with acute kidney injury after cardiac surgery.

OBJECTIVE: Patients with cardiac surgery-associated acute kidney injury are at risk of renal replacement therapy and in-hospital death. We aimed to develop and validate a novel predictive model for poor in-hospital outcomes among patients with cardiac surgery-associated acute kidney injury. METHODS: A total of 196 patients diagnosed with cardiac surgery-associated acute kidney injury were enrolled in this study as the training cohort, and 32 blood cytokines were measured. Least absolute shrinkage and selection operator regression and random forest quantile-classifier were performed to identify the key blood predictors for in-hospital composite outcomes (requiring renal replacement therapy or in-hospital death). The logistic regression model incorporating the selected predictors was validated internally using bootstrapping and externally in an independent cohort (n = 52). RESULTS: A change in serum creatinine (delta serum creatinine) and interleukin 16 and interleukin 8 were selected as key predictors for composite outcomes. The logistic regression model incorporating interleukin 16, interleukin 8, and delta serum creatinine yielded the optimal performance, with decent discrimination (area under the receiver operating characteristic curve: 0.947; area under the precision-recall curve: 0.809) and excellent calibration (Brier score: 0.056, Hosmer-Lemeshow test P = .651). Application of the model in the validation cohort yielded good discrimination. A nomogram was generated for clinical use, and decision curve analysis demonstrated that the new model adds more net benefit than delta serum creatinine. CONCLUSIONS: We developed and validated a promising predictive model for in-hospital composite outcomes among patients with cardiac surgery-associated acute kidney injury and demonstrated interleukin-16 and interleukin-8 as useful predictors to improve risk stratification for poor in-hospital outcomes among those with cardiac surgery-associated acute kidney injury.

Associations of Antibiotics, Hormonal Therapies, Oral Contraceptives, and Long-Term NSAIDS With Inflammatory Bowel Disease: Results From the Prospective Urban Rural Epidemiology (PURE) Study.

BACKGROUND & AIMS: Several medications have been suspected to contribute to the etiology of inflammatory bowel disease (IBD). This study assessed the association between medication use and the risk of developing IBD using the Prospective Urban Rural Epidemiology cohort. METHODS: This was a prospective cohort study of 133,137 individuals between the ages of 20 and 80 from 24 countries. Country-specific validated questionnaires documented baseline and follow-up medication use. Participants were followed up prospectively at least every 3 years. The main outcome was the development of IBD, including Crohn's disease (CD) and ulcerative colitis (UC). Short-term (baseline but not follow-up use) and long-term use (baseline and subsequent follow-up use) were evaluated. Results are presented as adjusted odds ratios (aORs) with 95% CIs. RESULTS: During a median follow-up period of 11.0 years (interquartile range, 9.2-12.2 y), there were 571 incident IBD cases (143 CD and 428 UC). Incident IBD was associated significantly with baseline antibiotic (aOR, 2.81; 95% CI, 1.67-4.73; P = .0001) and hormonal medication use (aOR, 4.43; 95% CI, 1.78-11.01; P = .001). Among females, previous or current oral contraceptive use also was associated with IBD development (aOR, 2.17; 95% CI, 1.70-2.77; P < .001). Nonsteroidal anti-inflammatory drug users also were observed to have increased odds of IBD (aOR, 1.80; 95% CI, 1.23-2.64; P = .002), which was driven by long-term use (aOR, 5.58; 95% CI, 2.26-13.80; P < .001). All significant results were consistent in direction for CD and UC with low heterogeneity. CONCLUSIONS: Antibiotics, hormonal medications, oral contraceptives, and long-term nonsteroidal anti-inflammatory drug use were associated with increased odds of incident IBD after adjustment for covariates.

Modifiable risk factors associated with cardiovascular disease and mortality in China: a PURE substudy.

AIMS: To examine the incidence of cardiovascular disease (CVD) and mortality in China and in key subpopulations, and to estimate the population-level risks attributable to 12 common modifiable risk factors for each outcome. METHODS AND RESULTS: In this prospective cohort of 47 262 middle-aged participants from 115 urban and rural communities in 12 provinces of China, it was examined how CVD incidence and mortality rates varied by sex, by urban-rural area, and by region. In participants without prior CVD, population-attributable fractions (PAFs) for CVD and for death related to 12 common modifiable risk factors were assessed: four metabolic risk factors (hypertension, diabetes, abdominal obesity, and lipids), four behavioural risk factors (tobacco, alcohol, diet quality, and physical activity), education, depression, grip strength, and household air pollution. The mean age of the cohort was 51.1 years. 58.2% were female, 49.2% were from urban areas, and 59.6% were from the eastern region of China. The median follow-up duration was 11.9 years. The CVD was the leading cause of death in China (36%). The rates of CVD and death were 8.35 and 5.33 per 1000 person-years, respectively, with higher rates in men compared with women and in rural compared with urban areas. Death rates were higher in the central and western regions of China compared with the eastern region. The modifiable risk factors studied collectively contributed to 59% of the PAF for CVD and 56% of the PAF for death in China. Metabolic risk factors accounted for the largest proportion of CVD (PAF of 41.7%), and hypertension was the most important risk factor (25.0%), followed by low education (10.2%), high non-high-density lipoprotein cholesterol (7.8%), and abdominal obesity (6.9%). The largest risk factors for death were hypertension (10.8%), low education (10.5%), poor diet (8.3%), tobacco use (7.5%), and household air pollution (6.1%). CONCLUSION: Both CVD and mortality are higher in men compared with women, and in rural compared with urban areas. Large reductions in CVD could potentially be achieved by controlling metabolic risk factors and improving education. Lowering mortality rates will require strategies addressing a broader range of risk factors.

Differences and agreement between two portable hand-held spirometers across diverse community-based populations in the Prospective Urban Rural Epidemiology (PURE) study.

INTRODUCTION: Portable spirometers are commonly used in longitudinal epidemiological studies to measure and track the forced expiratory volume in first second (FEV1) and forced vital capacity (FVC). During the course of the study, it may be necessary to replace spirometers with a different model. This raise questions regarding the comparability of measurements from different devices. We examined the correlation, mean differences and agreement between two different spirometers, across diverse populations and different participant characteristics. METHODS: From June 2015 to Jan 2018, a total of 4,603 adults were enrolled from 628 communities in 18 countries and 7 regions of the world. Each participant performed concurrent measurements from the MicroGP and EasyOne spirometer. Measurements were compared by the intra-class correlation coefficient (ICC) and Bland-Altman method. RESULTS: Approximately 65% of the participants achieved clinically acceptable quality measurements. Overall correlations between paired FEV1 (ICC 0.88 [95% CI 0.87, 0.88]) and FVC (ICC 0.84 [0.83, 0.85]) were high. Mean differences between paired FEV1 (-0.038 L [-0.053, -0.023]) and FVC (0.033 L [0.012, 0.054]) were small. The 95% limits of agreement were wide but unbiased (FEV1 984, -1060; FVC 1460, -1394). Similar findings were observed across regions. The source of variation between spirometers was mainly at the participant level. Older age, higher body mass index, tobacco smoking and known COPD/asthma did not adversely impact on the inter-device variability. Furthermore, there were small and acceptable mean differences between paired FEV1 and FVC z-scores using the Global Lung Initiative normative values, suggesting minimal impact on lung function interpretation. CONCLUSIONS: In this multicenter, diverse community-based cohort study, measurements from two portable spirometers provided good correlation, small and unbiased differences between measurements. These data support their interchangeable use across diverse populations to provide accurate trends in serial lung function measurements in epidemiological studies.

Impact of Overt Hypothyroidism on Early Outcomes of Coronary Artery Surgery.

BACKGROUND: The association between preoperative overt hypothyroidism and early outcomes after coronary artery bypass grafting (CABG) is unclear. This study aimed to evaluate the influence of overt hypothyroidism on the outcomes of CABG. METHODS: The series included 189 overt hypothyroid patients, who underwent CABG at Fuwai Hospital. These patients were 1:4 matched with 737 euthyroid patients using propensity score matching. The early postoperative outcomes were compared. RESULTS: After propensity score matching, the incidences of impaired wound healing, reintubation, and the total complications were higher in hypothyroid patients than euthyroid patients (11.8% vs. 0.9%, P < 0.001; 2.1% vs. 0.4%, P = 0.03; 39.6% vs. 30.3%, P = 0.015, respectively). Multivariate analysis showed overt hypothyroidism was significantly associated with the occurrence of impaired wound healing (odds ratio [OR]=12.29, P < 0.001), reintubation (OR=5.71, P = 0.047), and the total complications (OR=1.31, P = 0.049). The OR of the total complications was 1.43 (P = 0.03) in hypothyroid patients with abnormal thyroid-stimulating hormone compared with euthyroid patients. The proportions of the use of dopamine, adrenaline, milrinone, and dobutamine in hypothyroid patients were higher than euthyroid patients (75.4% vs. 67.6%, P = 0.038; 10.7% vs. 6.1%, P = 0.028; 3.2% vs. 0.3%, P = 0.001; 4.8% vs. 1.2%, P = 0.004, respectively). The total duration of inotropic support and mechanical ventilation time in hypothyroid patients were longer than euthyroid patients (median duration: 4 days vs. 3 days, P = 0.003; 17 hours vs. 15 hours, P < 0.001, respectively). CONCLUSIONS: CABG in overt hypothyroid patients is associated with a higher incidence of postoperative complications, stronger postoperative inotropic support, and longer mechanical ventilation time.

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.

Coronary Evaluation Before Heart Valvular Surgery by Using Coronary Computed Tomographic Angiography Versus Invasive Coronary Angiography.

Background Coronary computed tomography angiography (CCTA) is a noninvasive, less expensive, low-radiation alternative to invasive coronary angiography (ICA). ICA is recommended for coronary evaluation before heart valvular surgery, and the supporting evidence for CCTA is insufficient. Our study is a single-center, prospective cohort study designed to evaluate the feasibility of CCTA instead of ICA in detection of coronary artery disease before surgery. Methods and Results Heart valvular surgery candidates were consecutively enrolled between April 2017 and December 2018. Nine hundred fifty-eight patients in the CCTA group underwent CCTA primarily, and those with ≥50% coronary stenosis or uncertain diagnosis underwent subsequent ICA. One thousand five hundred twenty-five patients in the ICA group underwent ICA directly before surgery. Coronary artery bypass grafting decision was made by surgeons according to CCTA or ICA results. Most of the patients (78.8%) in the CCTA group avoided invasive angiography. Thirty-day mortality (0.7% versus 0.9%, P=0.821), myocardial infarction (6.4% versus 6.9%, P=0.680 ), and low cardiac output syndrome (4.2% versus 2.8%, P=0.085) were similar in the CCTA and ICA groups. Median duration of follow-up was 19.3 months (interquartile range, 14.2-30.0 months), cumulative rates of mortality (2.6% versus 2.6%, P=0.882) and major adverse cardiac events (9.6% versus 9.0%, P=0.607) showed no difference between the 2 groups. Coronary evaluation expense was lower in the CCTA group ($149.6 versus $636.0, P<0.001). Conclusions The strategy of using CCTA as a doorkeeper in coronary evaluation before heart valvular surgery showed noninferiority in identification of candidates for coronary artery bypass grafting and postoperative safety.

Fruit, vegetable, and legume intake and the risk of all-cause, cardiovascular, and cancer mortality: A prospective study.

BACKGROUND & AIMS: Although fruits and vegetable consumption has been shown to be associated with lower risks of mortality, cancers, and cardiovascular disease (CVD), there are limited data from China on the shape of the association. This study aimed to quantify the relationship between levels of fruit, vegetable, and legume consumption with the risk of major CVD, CVD mortality, cancer incidence, cancer mortality, and all-cause mortality. METHODS: In the baseline survey, participants attended 1 of 115 (45 urban and 70 rural) communities from 12 provinces to complete a standardized questionnaire, and undergo a physical examination between 2005 and 2009, and were followed up till 2017 (for the current analysis). Diet was assessed through in-person interviews by using validated food-frequency questionnaires. The clinical outcomes were adjudicated centrally by trained physicians using standardized definitions. Cox frailty models were used to explore the associations between fruit, vegetable, and legume consumption with the risk of all-cause, CVD, and cancer mortality. RESULTS: A total of 41 243 participants were eligible for inclusion in the analyses. The average combined average daily intake of fruit, vegetable, and legume was 2.97 [standard deviation (SD) 1.22] servings per day. During a median follow-up of 8.9 years [interquartile range (IQR) 6.7-9.9 years], we recorded 1893 major CVDs, 794 cancer events, and 1324 deaths, with 411 CVD deaths and 429 cancer deaths. In the models adjusted for age, sex, and center (random effect), a higher total intake of fruit, vegetable, and legume was inversely associated with CVD mortality, cancer incidence, cancer mortality, and all-cause mortality. After adjusting for additional covariates, the associations were evidently attenuated and only the association with all-cause mortality (hazard ratio [HR] trend 0.92, 95% CI 0.86-0.98, p trend = 0.021) remained significant, with a non-significant trend for major CVD (HR trend 1.02, 95% CI 0.97-1.08, p trend = 0.449), CVD mortality (HR trend 0.94, 95% CI 0.84-1.06, p trend = 0.301), cancer incidence (HR trend 0.97, 95% CI 0.89-1.06, p trend = 0.540), or cancer mortality (HR trend 0.92, 95% CI 0.82-1.04, p trend = 0.174). Compared with the reference group, the risk of all-cause mortality was the lowest for four to five servings of total daily intake of fruit, vegetable, and legume (HR 0.73, 95% CI 0.55-0.97), and did not show a further decrease for the higher intake group. Separately, fruit intake was associated with a lower risk of all-cause mortality (HR trend 0.92, 95% CI 0.86-0.99, p trend = 0.020) and legume intake was associated with a lower risk of major CVD (HR trend 0.95, 95% CI 0.90-0.99, p trend = 0.028) and all-cause mortality (HR trend 0.94, 95% CI 0.89-0.99, p trend = 0.020) in the fully adjusted models. CONCLUSIONS: This prospective study suggests that Chinese people with daily consumption of four to five servings (equivalent to 500-625 g/day) of fruit, vegetable, and legume demonstrated the lowest mortality, which conveys an encouraging message to the public that lifestyle modification to increase fruit, vegetable, and legume intakes may have greater beneficial effects on reducing all-cause mortality.

Comparison of healthy lifestyle behaviors among individuals with and without cardiovascular diseases from urban and rural areas in China: A cross-sectional study.

INTRODUCTION: The study aimed to explore the gap of prevalence of healthy lifestyle behaviors including smoking cessation, quitting drinking, physical activity and healthy eating between Chinese adults with and without cardiovascular diseases (CVDs). METHODS: This study is a cross-sectional component of Prospective Urban Rural Epidemiology (PURE)-China study, which recruited ~46,000 participants from 70 rural and 45 urban communities between 2005 and 2009. Participants were divided into disease (with CVDs) and control (without any diseases) groups. The adjusted rates were estimated for different strata by the generalized, linear mixed-effects model, including community as a random effect with additional adjustment for age, sex, education and income. RESULTS: Among 40,490 participants, <10% had all four healthy lifestyle behaviors (disease group versus control group: urban areas: 7.8% versus 8.1%; rural areas: 3.4% versus 3.2%). The rates of smoking cessation and quitting drinking were significantly higher in disease group for both urban and rural residents (P<0.001). In urban areas, higher rates were observed in all other three healthy lifestyle behaviors except physical activity in low-income regions (P<0.05). Similarly, the higher trends were observed for stopping smoking and drinking while opposite trends for healthy eating among rural residents from low-income regions (P<0.05). CONCLUSIONS: Our study showed that the prevalence of adopting all four behaviors was low among Chinese adults. Individuals with CVDs were more likely to follow healthy lifestyle behaviors, but it still indicated a large gap between the actual and ideal adoption of healthy lifestyle behaviors, which called for the promotion of population-wide strategies to modify lifestyle behaviors in addition to individual health-care intervention strategies.

A Meta-Analysis of Miniaturized Versus Conventional Extracorporeal Circulation in Valve Surgery.

The effects of miniaturized extracorporeal circulation in patients operated on for heart valve surgery are still inconsistent. We performed a meta-analysis of eight studies involving 1,011 patients to evaluate the comprehensive effects of miniaturized extracorporeal circulation. The results suggested its application significantly reduced the length of stay in the intensive care unit and total hospital stay after heart valve surgery, but no significant effects on reducing postoperative morbidity and mortality were observed. Further studies with long-term follow-up are needed to confirm our results.