Validation study of age-independent fibrosis score (Fibrosis-3 index) in patients with metabolic dysfunction-associated steatotic liver disease.

BACKGROUND AND AIMS: Because the accuracy of the Fibrosis-4 (FIB-4) index for predicting liver fibrosis changes with age, the need for different cut-offs in various age groups has frequently been discussed. We developed the age-independent score, the Fibrosis-3 (FIB-3) index, and have shown its usefulness in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). This study aimed to validate the diagnostic ability of the FIB-3 index to predict fibrosis progression using a large new patient cohort. METHODS: The ability of the FIB-3 index to predict liver fibrosis was analyzed by comparing it with that of the FIB-4 index using data from 1398 patients with MASLD enrolled in the Asia-based clinical outcome NAFLD study. RESULTS: The areas under the receiver operating characteristic curves for predicting fibrosis stage F3 or higher were not different between the FIB-3 and FIB-4 indices in the entire cohort. Using the single ideal cut-offs of the indices (3.41 for FIB-3 index and 2.01 for FIB-4 index), the predictive accuracy of the FIB-3 index was not significantly different from that of the FIB-4 index among patients aged <60 years; however, the accuracy of the FIB-3 index was significantly higher than that of the FIB-4 index in those aged ≥60 years (0.645 and 0.529, respectively; p < 0.0001). CONCLUSION: The high ability of the FIB-3 index with a single cut-off to predict liver fibrosis in patients with MASLD was confirmed. The FIB-3 index could serve as a useful tool for assessing liver fibrosis regardless of age.

Hepatic inflammation and fibrosis are profiles related to mid-term mortality in biopsy-proven MASLD: A multicenter study in Japan.

AIMS: A multi-stakeholder consensus has proposed MASLD (metabolic dysfunction-associated steatotic liver disease). We aimed to investigate the pathological findings related to the mid-term mortality of patients with biopsy-proven MASLD in Japan. METHODS: We enrolled 1349 patients with biopsy-proven MASLD. The observational period was 8010 person years. We evaluated independent factors associated with mortality in patients with MASLD by Cox regression analysis. We also investigated pathological profiles related to mortality in patients with MASLD using data-mining analysis. RESULTS: The prevalence of MASH and stage 3/4 fibrosis was observed in 65.6% and 17.4%, respectively. Forty-five patients with MASLD died. Of these, liver-related events were the most common cause at 40% (n = 18), followed by extrahepatic malignancies at 26.7% (n = 12). Grade 2/3 lobular inflammation and stage 3/4 fibrosis had a 1.9-fold and 1.8-fold risk of mortality, respectively. In the decision-tree analysis, the profiles with the worst prognosis were characterised by Grade 2/3 hepatic inflammation, along with advanced ballooning (grade 1/2) and fibrosis (stage 3/4). This profile showed a mortality at 8.3%. Furthermore, the random forest analysis identified that hepatic fibrosis and inflammation were the first and second responsible factors for the mid-term prognosis of patients with MASLD. CONCLUSIONS: In patients with biopsy-proven MASLD, the prevalence of MASH and advanced fibrosis was approximately 65% and 20%, respectively. The leading cause of mortality was liver-related events. Hepatic inflammation and fibrosis were significant factors influencing mid-term mortality. These findings highlight the importance of targeting inflammation and fibrosis in the management of patients with MASLD.

Benefits of Collaboration Between the Wound, Ostomy, and Continence Nurse and Orthopedic Surgeon When Treating Skin Defects After Soft Tissue Sarcoma Resection: A Retrospective Case-Control Study.

PURPOSE: The purpose of this study was to evaluate the benefits of collaborative management between orthopedic surgery and WOC nurses in patients undergoing resection of subcutaneous sarcomas. DESIGN: Retrospective case-control study. SUBJECTS AND SETTING: The sample comprised 25 patients who underwent wide resection for soft tissue sarcoma, followed by 2-stage split-thickness skin grafting. Data collection occurred between January 2015 and April 2021 in a university hospital based in Kagoshima, Japan. For comparison, we categorized these patients into 2 groups: intervention group participants were managed by an orthopedic surgeon and a WOC nurse; nonintervention group members were managed without WOC nurse participation. METHODS: Patient background and treatment-related information was retrospectively collected from medical records and compared between the WOC nurse intervention group and the nonintervention group, including maximum tumor diameter, surgical time, maximum skin defect diameter, length of hospital stay, and time from surgery to complete wound healing. RESULTS: The average length of hospital stay was significantly shorter in the WOC nurse intervention group compared with the nonintervention group (38.3 days, SD = 8.0 vs 47.1 days, SD = 10.2; P = .023). CONCLUSION: Collaborative wound management with a WOC nurse resulted in a shorter hospital length of stay when compared to traditional management with WOC nurse involvement. Based on these findings, we assert that WOC nurses provide an important bridge between postoperative wound management in patients undergoing resection of subcutaneous sarcomas.

Association between weight gain following smoking cessation and development of hypertension in the future.

Although quitting smoking lowers the risk of developing chronic conditions, it usually leads to weight gain. Literature on the association between weight gain after quitting smoking and the future development of hypertension is scarce. Among 234 596 individuals who visited our health center, 856 who had quit smoking for whom data were available at least 6 years after smoking cessation were included. We evaluated changes in blood pressure and antihypertensive drug prescription rate at 1 and 6 years after smoking cessation. We also compared weight and blood pressure between the smoking cessation and continued smoking groups after 6 years. Multiple regression analyses were performed to identify predictors of changes in systolic and diastolic blood pressures using covariates affecting blood pressure. Since a median weight gain of 1.8 kg was observed at 1 year after smoking cessation, we divided the participants into high and low-weight gain groups. No significant intergroup difference in the antihypertensive drug prescription rate was observed after 6 years. The high weight gain group showed significant increases in systolic and diastolic blood pressures after 6 years. Multiple regression analyses revealed that systolic blood pressure was affected by age and high weight gain, while diastolic blood pressure was affected by high weight gain. Our findings suggest that weight gain following smoking cessation leads to blood pressure elevation: the smoking cessation group gained more weight and had higher blood pressure than the continued smoking group. Therefore, weight loss guidance may be useful for individuals who want to quit smoking. Participants in the high weight gain group showed significant increases in systolic and diastolic blood pressures at 6 years after smoking cessation that were significantly different from those observed in participants in the low weight gain group and the continued smoking group.

Prognosis of biopsy-confirmed metabolic dysfunction- associated steatotic liver disease: A sub-analysis of the CLIONE study.

BACKGROUND/AIMS: Metabolic dysfunction-associated steatotic liver disease (MASLD) was recently proposed as an alternative disease concept to nonalcoholic fatty liver disease (NAFLD). We aimed to investigate the prognosis of patients with biopsy-confirmed MASLD using data from a multicenter study. METHODS: This was a sub-analysis of the Clinical Outcome Nonalcoholic Fatty Liver Disease (CLIONE) study that included 1,398 patients with NAFLD. Liver biopsy specimens were pathologically diagnosed and histologically scored using the NASH Clinical Research Network system, the FLIP algorithm, and the SAF score. Patients who met at least one cardiometabolic criterion were diagnosed with MASLD. RESULTS: Approximately 99% of cases (n=1,381) were classified as MASLD. Patients with no cardiometabolic risk (n=17) had a significantly lower BMI than patients with MASLD (20.9 kg/m2 vs. 28.0 kg/m2, P<0.001), in addition to significantly lower levels of inflammation, ballooning, NAFLD activity score, and fibrosis stage based on liver histology. These 17 patients had a median follow-up of 5.9 years, equivalent to 115 person-years, with no deaths, liver-related events, cardiovascular events, or extrahepatic cancers. The results showed that the prognosis for pure MASLD was similar to that for the original CLIONE cohort, with 47 deaths and one patient who underwent orthotopic liver transplantation. The leading cause of death was extrahepatic cancer (n=10), while the leading causes of liver-related death were liver failure (n=9), hepatocellular carcinoma (n=8), and cholangiocarcinoma (n=4). CONCLUSION: Approximately 99% of NAFLD cases were considered MASLD based on the 2023 liver disease nomenclature. The NAFLD-only group, which is not encompassed by MASLD, had a relatively mild histopathologic severity and a favorable prognosis. Consequently, the prognosis of MASLD is similar to that previously reported for NAFLD.

Comparison of Discriminative Ability of Bleeding Risk Criteria and Scores for Predicting Short- and Mid-Term Major Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention.

Background: This study aimed to compare the discriminative ability of the Japanese Version of High Bleeding Risk (J-HBR), Academic Research Consortium for High Bleeding Risk (ARC-HBR), and Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) scores for predicting major bleeding events. Methods and Results: Between January 2017 and December 2020, 646 consecutive patients who underwent successful percutaneous coronary intervention (PCI) were enrolled. We scored the ARC-HBR and J-HBR criteria by assigning 1 point to each major criterion and 0.5 point to each minor criterion. The primary outcome was major bleeding events, defined as Bleeding Academic Research Consortium type 3 or 5 bleeding events. According to the J-HBR, ARC-HBR, and PRECISE-DAPT scores, 428 (66.3%), 319 (49.4%), and 282 (43.7%) patients respectively had a high bleeding risk. During the follow-up period (median, 974 days), 44 patients experienced major bleeding events. The area under the curve (AUC) using the time-dependent receiver operating characteristic curve for major bleeding events was 0.84, 0.82, and 0.83 within 30 days and 0.86, 0.83, and 0.80 within 2 years for the J-HBR, ARC-HBR, and PRECISE-DAPT scores, respectively. The AUC values did not differ significantly among the 3 bleeding risk scores. Conclusions: The J-HBR score had a discriminative ability similar to the ARC-HBR and PRECISE-DAPT scores for predicting short- and mid-term major bleeding events.

Different effects of medications for hypertension on renal function between patients with and without diabetes mellitus undergoing percutaneous coronary intervention: a retrospective single-center cohort study.

BACKGROUND: Diabetes mellitus (DM) and hypertension are well-known atherosclerosis risk factors. Furthermore, renal dysfunction is a crucial risk factor for patients with coronary artery disease (CAD), and managing renal function in these patients is complicated because of comorbid conditions and potential side effects during treatment. Therefore, this study aimed to investigate the effect of medications for hypertension on renal function after percutaneous coronary intervention (PCI) between patients with and without DM with statins. METHODS: In 297 consecutive patients undergoing PCI for stable angina pectoris, cystatin C (CysC) was evaluated at baseline and 9 months after PCI, and the percent change in CysC (%CysC) was calculated. The association of worsening renal function (WRF: %CysC ≥ 0) and baseline characteristics, including medications, was assessed. RESULTS: Among 297 hypertensive patients with statins, 196 and 101 were with and without DM, respectively. Angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker, and ß-blocker were prescribed in 56 (29%), 82 (42%), and 91 (46%) patients in the DM group, and 20 (20%), 52 (51%), and 52 (51%) in the non-DM group, respectively. The patients with WRF after PCI were 100 (51%) and 59 (58%) in the DM and non-DM groups (p = 0.261). Additionally, the %CysC had no significant differences between groups [median: 0%, interquartile range (IQR): -7.9% to 8.5% vs. median: 1.1%, IQR: -6.6% to 9.6%, p = 0.521]. Multivariate logistic analysis for WRF using relevant factors from univariate analysis showed that only ß-blocker [odds ratio (OR): 2.76, 95% confidence interval (CI): 1.03-7.90, p = 0.048] was independently associated with WRF in the DM group whereas ACEI (OR: 0.07, 95% CI: 0.01-0.47, p = 0.012) was negatively correlated with WRF in the non-DM group. CONCLUSION: The ß-blocker was the independent risk factor for WRF in patients with DM in the late phase after PCI for stable angina pectoris, while the use of ACEI had a renoprotective effect in patients without DM.

Living alone predicts poor prognosis among patients with acute myocardial infarction.

BACKGROUND: Living alone as a proxy for social isolation has been considered to increase the risk of cardiovascular disease. We thus investigated the impact of living alone on mortality in acute myocardial infarction (AMI) patients. METHODS: Subjects comprised 277 AMI patients who underwent percutaneous coronary intervention (PCI). Associations between all-cause and cardiac deaths after PCI and baseline characteristics including living alone and Global Registry of Acute Coronary Events (GRACE) risk score were assessed. RESULTS: Eighty-three patients (30%) were living alone. Thirty patients died after PCI, including 20 cardiac deaths. Patients living alone showed higher incidences of both all-cause and cardiac deaths compared with patients not living alone (18% vs. 8%, P  = 0.019 and 14% vs. 4%, P  = 0.004). Multivariate Cox proportional hazards regression analysis models showed living alone [hazard ratio (HR), 2.60; 95% confidence interval (CI), 1.20-5.62; P  = 0.016 and HR, 4.17; 95% CI, 1.60-10.84; P  = 0.003] and GRACE risk score (HR, 1.02; 95% CI, 1.01-1.03; P  = 0.003 and HR, 1.03; 95% CI, 1.01-1.04; P  < 0.001) correlated significantly with all-cause and cardiac deaths. Cox proportional hazards modeling revealed that patients living alone with GRACE risk score ≥162 derived from the receiver-operating characteristic curve showed a significantly greater risk of all-cause death than patients not living alone with GRACE risk score <162 (HR 16.57; 95% CI 6.67-41.21; P  < 0.001). CONCLUSION: Among AMI patients, living alone represents an independent risk factor for all-cause and cardiac deaths after PCI, separate from GRACE risk score. Furthermore, AMI patients living alone with high GRACE risk scores may experience an additively increased risk of mortality after PCI.

A case of cardiac metastasis of neuroendocrine tumor with 2-year follow-up.

A 55-year-old male underwent surgery for thymus gland tumors six years previously, and for lung and pancreas tumors three years previously, which were pathologically diagnosed as neuroendocrine tumors (NETs). During routine medical checkups, a giant negative T-wave was observed on the electrocardiogram. Echocardiography revealed a tumor at the apex. A surgical biopsy was performed; the tumor was diagnosed as a cardiac metastasis of NETs, and chemotherapy was initiated. Two years later, echocardiography confirmed that the tumor had not increased in size. A 2-year follow-up of NETs cardiac metastasis is rare; we therefore report this case. Learning objective: Neuroendocrine tumors are considered slowly progressing tumors, but despite the presence of cardiac metastasis, accurate diagnosis and appropriate treatment have allowed the patient to survive the disease for more than two years.

Secondary rotational atherectomy is associated with reduced occurrence of prolonged ST-segment elevation following ablation.

Elevation of the ST segment after percutaneous coronary intervention (PCI) using rotational atherectomy (RA) for severely calcified lesions often persists after disappearance of the slow-flow phenomenon on angiography. We investigated clinical factors relevant to prolonged ST-segment elevation following RA among 152 patients with stable angina undergoing elective PCI. PCI procedures were divided into two strategies, RA without (primary RA strategy) or with (secondary RA strategy) balloon dilatation before RA. Incidence of prolonged ST-segment elevation after disappearance of slow-flow phenomenon was higher in the 56 patients with primary RA strategy (13%) than in the 96 patients with secondary RA strategy (3%, p = 0.039). Univariate logistic regression analysis showed levels of low-density lipoprotein cholesterol (LDL-C) (odds ratio [OR] 0.95, 95% confidence interval [CI] 0.93-0.99; p = 0.013), levels of triglycerides (OR 0.97, 95%CI 0.94-0.99; p = 0.040), and secondary RA strategy (OR 0.23, 95% CI 0.05-0.85; p = 0.028) were inversely associated with occurrence of prolonged ST-segment elevation following ablation. However, hemodialysis, diabetes mellitus, left-ventricular ejection fraction, lesion length ≥ 20 mm, and burr size did not show significant associations. Multivariate logistic regression analysis modeling revealed that secondary RA strategy was significantly associated with the occurrence of prolonged ST-segment elevation (Model 1: OR 0.24, 95% CI 0.05-0.95, p = 0.042; Model 2: OR 0.17, 95% CI 0.03-0.68, p = 0.018; Model 3: OR 0.21, 95% CI 0.03-0.87, p = 0.041) even after adjusting for levels of LDL-C and triglycerides. Secondary RA strategy may be useful to reduce the occurrence of prolonged ST-segment elevation following RA.

Identification of clinical phenotypes associated with poor prognosis in patients with nonalcoholic fatty liver disease via unsupervised machine learning.

BACKGROUND AND AIMS: Both fibrosis status and body weight are important for assessing prognosis in nonalcoholic fatty liver disease (NAFLD). The aim of this study was to identify population clusters for specific clinical outcomes based on fibrosis-4 (FIB-4) index and body mass index (BMI) using an unsupervised machine learning method. METHODS: We conducted a multicenter study of 1335 biopsy-proven NAFLD patients from Japan. Using the Gaussian mixture model to divide the cohort into clusters based on FIB-4 index and BMI, we investigated prognosis for these clusters. RESULTS: The cohort consisted of 223 cases (16.0%) with advanced fibrosis (F3-4) as assessed from liver biopsy. Median values of BMI and FIB-4 index were 27.3 kg/m2 and 1.67. The patients were divided into four clusters by Bayesian information criterion, and all-cause mortality was highest in cluster d, followed by cluster b (P = 0.001). Regarding the characteristics of each cluster, clusters d and b presented a high FIB-4 index (median 5.23 and 2.23), cluster a presented the lowest FIB-4 index (median 0.78), and cluster c was associated with moderate FIB-4 level (median 1.30) and highest BMI (median 34.3 kg/m2 ). Clusters a and c had lower mortality rates than clusters b and d. However, all-cause of death in clusters a and c was unrelated to liver disease. CONCLUSIONS: Our clustering approach found that the FIB-4 index is an important predictor of mortality in NAFLD patients regardless of BMI. Additionally, non-liver-related diseases were identified as the causes of death in NAFLD patients with low FIB-4 index.

Association of Serum Albumin Levels and Long-Term Prognosis in Patients with Biopsy-Confirmed Nonalcoholic Fatty Liver Disease.

The relationship between baseline serum albumin level and long-term prognosis of patients with nonalcoholic fatty liver disease (NAFLD) remains unknown. This is a sub-analysis of the CLIONE (Clinical Outcome Nonalcoholic Fatty Liver Disease) study. The main outcomes were: death or orthotopic liver transplantation (OLT), liver-related death, and liver-related events (hepatocellular carcinoma [HCC], decompensated cirrhosis, and gastroesophageal varices/bleeding). 1383 Japanese patients with biopsy-confirmed NAFLD were analyzed. They were divided into 3 groups based on serum albumin: high (>4.0 g/dL), intermediate (3.5-4.0 g/dL), and low (<3.5 g/dL). Unadjusted hazard ratio [HR] of the intermediate albumin group, compared with the high albumin group, were 3.6 for death or OLT, 11.2 for liver-related death, 4.6 for HCC, 8.2 for decompensated cirrhosis, and 6.2 for gastroesophageal varices (all risks were statistically significant). After adjusting confounding factors, albumin remained significantly associated with death or OLT (intermediate vs. high albumin group: HR 3.06, 95% confidence interval [CI] 1.59-5.91, p < 0.001; low vs. high albumin group: HR 22.9, 95% CI 8.21-63.9, p < 0.001). Among biopsy-confirmed NAFLD patients, those with intermediate or low serum albumin had a significantly higher risk of death or OLT than those with high serum albumin.

Association of preoperative clinical frailty and clinical outcomes in elderly patients with stable coronary artery disease after percutaneous coronary intervention.

There are few reports on the long-term clinical outcome after percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (CAD) complicated with frailty. This novel study investigated the association between pre-PCI frailty and long-term clinical outcomes in elderly patients aged 65 years or older with stable CAD who underwent elective PCI. We assessed 239 consecutive patients aged 65 years or older with stable CAD who underwent successful elective PCI at Kagoshima City Hospital between January 1st, 2017 and December 31st, 2020. Frailty was retrospectively assessed using the Canadian Study and Aging Clinical Frailty Scale (CFS). Based on the pre-PCI CFS, patients were divided into two groups: the non-frail (CFS < 5) and the frail (CFS ≥ 5) group. We investigated the association between pre-PCI CFS and major adverse cardiovascular events (MACEs) defined as the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, and heart failure requiring hospitalization. Additionally, we assessed the association between pre-PCI CFS and major bleeding events defined as Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. The mean age was 74.8 ± 7.0 years, and 73.6% were men. According to the pre-PCI frailty assessment, 38 (15.9%) and 201 (84.1%) were classified as frail and non-frail groups, respectively. During a median follow-up of 962 (607-1284) days, 46 patients developed MACEs and 10 patients developed major bleeding events. Kaplan-Meier curves showed a significantly higher incidence of MACE in the frail group compared to those in the non-frail group (Log-rank p < 0.001). Even in multivariate analysis, pre-PCI frailty (CFS ≥ 5) was independently associated with MACE (HR 4.27, 95% CI 1.86-9.80, p-value: < 0.001). Additionally, the cumulative incidence of major bleeding events was significantly higher in the frail group than in the non-frail group (Log-rank p = 0.001). Pre-PCI frailty was an independent risk factor for MACE and bleeding events in elderly patients with stable CAD who underwent elective PCI.

Agile 3+ and Agile 4, noninvasive tests for liver fibrosis, are excellent formulae to predict liver-related events in nonalcoholic fatty liver disease.

AIM: The noninvasive tests (NITs) Agile 3+ and Agile 4 effectively identify patients with nonalcoholic fatty liver disease (NAFLD) complicated with advanced fibrosis (F3-4) and cirrhosis (F4), respectively. Little information is available on associations between Agile scores and intra-/extrahepatic events. The aim of this study was to determine the predictive performance of Agile scores for intra-/extrahepatic events in Asian patients with biopsy-proven NAFLD. METHODS: We undertook a retrospective multicenter cohort study to investigate associations between intra-/extrahepatic events and two Agile scores, Agile 3+ and Agile 4. The scores were obtained by combining clinical parameters and liver stiffness measurement using transient elastography. RESULTS: Among 403 enrolled patients, 11 had liver-related events (LREs), including seven with hepatocellular carcinoma (HCC). The incidence of LREs and HCC showed a stepwise increase in the advanced fibrosis group (F3-4), Agile 3+ rule-in (F3-4, highly suspected), and Agile 4 rule-in (F4, highly suspected) groups, compared to their counterparts. Hazard ratios for LREs in the advanced fibrosis group, Agile 3+ rule-in, and Agile 4 rule-in groups were 4.05 (p = 0.03), 23.5 (p = 0.003), and 45.5 (p < 0.001), respectively. The predictive performance results for Agile 3+ and Agile 4 were 0.780 and 0.866, respectively, which were higher than for fibrosis (0.595). Unlike for LREs, Agile scores failed to identify patients with extrahepatic events, including cardiovascular events and extrahepatic cancer. CONCLUSIONS: Agile 3+ and Agile 4 scores are excellent NITs for predicting LREs in patients with NAFLD, possibly without histological assessment.

Plastic Syringes Instead of Heparin-added Dedicated Syringes for Blood Gas Analysis: A Prospective Observational Study.

Introduction: Blood gas analysis is an important test for making quick and important clinical decisions, and it is recommended that a dedicated syringe that contains heparin be used to measure blood gas. We hypothesized that a plastic syringe could be used as a less-expensive substitute for a dedicated syringe, given that the test is performed immediately after collection. Methods: This single-center, prospective, observational study involved patients admitted to the Kanoya Medical Center (Kagoshima, Japan) between July 2020 and March 2021, who were requiring blood gas analysis using a dedicated syringe under arterial line (A-line) monitoring. There were no exclusion criteria. Two samples were collected from each patient using a dedicated syringe, and one sample was collected using a plastic syringe. To determine clinical substitutability, Bland-Altman analysis was performed. Results: A total of 60 samples from 20 consecutive patients were collected and assayed. The mean patient age was 72 years, and 75% patients were men. The 95% limit of agreement for pH, PCO2, PO2, Na, K, Ca, and SO2 were similar for both dedicated and plastic syringes. HCO3 and BE were significantly higher in the samples taken with plastic syringes, whereas Hb and Ht could not be measured accurately with any syringe. Conclusions: The use of plastic syringes in place of dedicated syringes is generally considered acceptable for most items considering that measurement is performed within 3 min of collection, and the cost of medical materials may be reduced. Regardless of the type of syringe, caution should be exercised in interpreting the results of measuring Hb and Ht using a blood gas analyzer.

Pre-Extubation Cuffed Tube Leak Test and Subsequent Post-Extubation Laryngeal Edema: Prospective, Single-Center Evaluation of PICU Patients.

OBJECTIVES: We performed our standard air leak, leak percentage, and cuff leak percentage tests in pediatric patients intubated with microcuff pediatric tracheal tubes (MPTTs) just before extubation. We examined the association between test findings and the subsequent occurrence of post-extubation laryngeal edema (PLE). DESIGN: Prospective, single-center, observational study. SETTING: PICU (June 1, 2020 to May 31, 2021). PATIENTS: Pediatric patients intubated and scheduled for extubation during the day shift in the PICU. INTERVENTIONS: Multiple pre-extubation leak tests were performed on each patient immediately before extubation. In our center, the standard leak test is positive if a leak is audible at 30 cm H 2 O applied pressure with the MPTT cuff deflated. Two other tests were calculated in the pressure control-assist control ventilator mode using the following formulas: leak percentage with deflated cuff = (inspiratory tidal volume [V t ]-expiratory V t ) × 100/inspiratory V t ; cuff leak percentage = (expiratory V t with inflated cuff-expiratory V t with deflated cuff) × 100/expiratory V t with inflated cuff. MEASUREMENTS AND MAIN RESULTS: The diagnostic criteria for PLE was made by at least two healthcare professionals and included upper airway stricture with stridor-requiring nebulized epinephrine. Eighty-five pediatric patients (< 15 yr) who had been intubated for at least 12 hours using the MPTT were included. Positive rates for the standard leak, leak percentage (cutoff 10%), and cuff leak percentage (cutoff 10%) tests were 0.27, 0.20, and 0.64, respectively. The standard leak, leak percentage, and cuff leak tests showed sensitivities of 0.36, 0.27, and 0.55, respectively; and specificities of 0.74, 0.81, and 0.35, respectively. PLE occurred in 11 of 85 patients (13%), and there were no instances of needing reintubation. CONCLUSIONS: The pre-extubation leak tests in current practice for intubated pediatric patients in the PICU all lack diagnostic accuracy for PLE.

Prediction of Liver-Related Events With a Combination of Liver Stiffness Measurements and Controlled Attenuation Parameters in Japanese Patients With Biopsy-Proven Non-alcoholic Fatty Liver Disease.

OBJECTIVE: Liver stiffness measurements (LSMs) and controlled attenuation parameters (CAPs) obtained using vibration-controlled transient elastography (VCTE) are recognized non-invasive methods of assessing liver histology. The usefulness of CAP for predicting liver-related events (LREs: hepatocellular carcinoma, decompensation, bleeding varices) is not well understood worldwide. Our aim was to re-evaluate the cutoff values of LSM/CAP in Japan and to examine whether LSM/CAP can predict LRE. METHODS: Japanese NAFLD patients (n = 403) who underwent both liver biopsy and VCTE were enrolled. We determined optimal cutoff values of LSM/CAP diagnoses for fibrosis stage and steatosis grade and investigated their clinical outcome based on LSM/CAP values. RESULTS: The LSM cutoff values for F1 to F4 are 7.1, 7.9, 10.0 and 20.2 kPa, and the CAP cutoff values for S1 to S3 are 230, 282 and 320 dB/m. During a median follow-up of 2.7 y (range: 0.0-12.5 y), 11 patients developed LREs. The incidence of LREs in the LSM Hi (≥8.7) group was significantly higher than that in the LSM Lo (<8.7) group (p = 0.003), and the incidence in the CAP Lo (<295) group was higher than that in CAP Hi (≥295) group (p = 0.018). Considering LSM and CAP together, the risk of LRE was higher in the LSM Hi CAP Lo group than in the LSM Hi CAP Hi group (p = 0.03). CONCLUSION: We set LSM/CAP cutoff values to diagnose liver fibrosis and steatosis in Japan. Our study determined that NAFLD patients with high LSM and low CAP values are at high risk for LREs.

The Kagoshima-DVT Score Is a Useful Predictive Model for Cancer-Associated Thrombosis in Patients With Gastrointestinal Cancer.

Background: Cancer-associated thrombosis (CAT) is a common complication of cancer and has received increasing attention; the Khorana Risk Score (KRS) is a recommended but insufficient risk assessment model for CAT. We propose a novel Kagoshima-DVT score (KDS) to predict preoperative deep vein thrombosis (DVT). This scoring method scores D-dimer ≥1.5 µg/mL, age ≥60 years, female sex, ongoing glucocorticoids, cancer with high risk of DVT, and prolonged immobility. The purpose of this study was to compare the performance of the KDS and KRS in predicting CAT in patients with gastrointestinal cancer. Methods and Results: In all, 250 patients without a history of thrombosis who received their first chemotherapy for gastrointestinal cancer were divided into low- (48.0%), intermediate- (38.8%), and high-risk (13.2%) groups for CAT development by the KDS. The patients' median age was 67 years and 63.2% were men. In all, 61 (27.1%) patients developed CAT (17.6%, 35.3%, and 36.4% of patients in the low-, intermediate, and high-risk groups, respectively; log-rank P=0.006). The area under the time-dependent receiver operating characteristic curve for CAT occurrence within 1 year was larger for the KDS than KRS (0.653 vs. 0.494). Conclusions: A high KDS at the start of first chemotherapy is a risk indicator for CAT development during chemotherapy. Moreover, the KDS is more useful than the KRS in predicting CAT risk.

Noninvasive tests predict liver-related events and mortality in patients with nonalcoholic fatty liver disease: sub-analysis of the CLIONE-Asia study.

BACKGROUND AND AIMS: Noninvasive tests (NITs) have prognostic potential, but whether NITs are comparable with liver biopsy is unclear. This study aimed to examine the prognostic accuracy of NITs for liver-related mortality (LRM) and events (LREs) in patients with biopsy-proven nonalcoholic fatty liver disease (NAFLD). METHODS: We investigated 1313 patients with NAFLD. Patients were assigned to low-risk, indeterminate-risk, and high-risk groups using conventional cutoff values of each FIB-4 and NAFLD fibrosis score (NFS) and to stage 0-2 and stage 3-4 groups using the fibrosis stage. Survival and Cox regression analyses of the prognostic potential of NITs for LRM/LREs were conducted. RESULTS: During a median follow-up of 4.5 years, regarding to FIB-4, the incidence rate (/1000 person-years) in the low risk was zero for LRM and 0.5 for LREs. In contrast, the rate in stage 0-2 was 1.3 for LRM and 2.8 for LRE. The adjusted hazard ratios (aHRs) for LREs in the high risk compared with the low risk were 32.85 (P < 0.01). The aHRs in stage 3-4 compared with stage 0-2 were 2.68 (P = 0.02) for LREs and 2.26 (P = 0.582) for LRM. In the same fibrosis stage, the incidence of LRM/LREs was more frequent with a higher risk stratification. The same trend was observed for NFS. CONCLUSIONS: NITs accurately predict LRM and LREs as well as a liver biopsy in Japanese patients with NAFLD. Patients in the low risk may not require close follow-up for at least 5 years. The simple NITs could be an acceptable alternative method to performing a liver biopsy for the prognosis of NAFLD.

Association between the number of Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and clinical outcomes in patients with acute coronary syndrome.

BACKGROUND: Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria have been used to identify high-risk patients undergoing percutaneous coronary intervention (PCI) in current clinical practice. This study aimed to evaluate the association between the number of ARC-HBR criteria and clinical outcomes in patients with acute coronary syndrome (ACS) after an emergent PCI. METHODS: We assessed 338 consecutive patients with ACS who underwent successful emergent PCI between January 2017 and December 2020. The ARC-HBR score was calculated by assigning 1 point to each major criterion and 0.5 points to each minor criterion. The patients were classified into low (ARC-HBR score<1), intermediate (1≤ARC-HBR score<2), and high (ARC-HBR score≥2) bleeding risk groups. We investigated the association between the ARC-HBR score and major adverse cardiovascular events (MACEs), defined as a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke. We also compared the diagnostic ability of the ARC-HBR score and Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) risk score. RESULTS: The mean age of the patients was 67.6±12.4years, and 78.4% were men. During the median follow-up of 864 (557-1309) days, 70 patients developed MACEs. Kaplan-Meier curves showed that the cumulative incidence of MACE was significantly higher as the ARC-HBR score increased in a stepwise manner (log-rank p<0.001). There were no significant differences in the area under the receiver operating characteristic curve (AUC) for predicting MACE within two years after an emergent PCI between the ARC-HBR and CADILLAC risk scores (AUC: 0.763 vs. 0.777). CONCLUSIONS: ARC-HBR score was independently associated with an increased risk of MACE in patients with ACS after an emergent PCI. Moreover, it had a similar diagnostic ability for predicting MACE within two years compared to the CADILLAC risk score.