Innovative device for surgical wound irrigation: a preclinical testing and pilot clinical validation study.

INTRODUCTION: Surgical site infection (SSI) poses a substantial postoperative challenge, affecting patient recovery and healthcare costs. While surgical wound irrigation is pivotal in SSI reduction, consensus on the optimal method remains elusive. We developed a novel device for surgical wound irrigation and conducted preclinical and clinical evaluations to evaluate its efficacy and safety. METHODS: Two preclinical experiments using swine were performed. In the washability test, two contaminated wound model were established, and the cleansing rate between the device and the conventional method were compared. In the contamination test, the irrigation procedure with a fluorescent solution assessed the surrounding contamination of drapes. Subsequently, a clinical trial involving patients undergoing abdominal surgery was conducted. RESULTS: The washability test demonstrated significantly higher cleansing rates with the device method (86.4% and 82.5%) compared to the conventional method (65.2% and 65.1%) in two contamination models. The contamination test revealed a smaller contaminated region with the device method than the conventional method. In the clinical trial involving 17 abdominal surgery cases, no superficial SSIs or adverse events related to device use were observed. CONCLUSIONS: Our newly developed device exhibits potential for achieving more effective and safe SSI control compared to conventional wound irrigation.

Estimation of the Number of Patients With Mitochondrial Diseases: A Descriptive Study Using a Nationwide Database in Japan.

BACKGROUND: To provide a better healthcare system for patients with mitochondrial diseases, it is important to understand the basic epidemiology of these conditions, including the number of patients affected. However, little information about them has appeared in Japan to date. METHODS: To gather data of patients with mitochondrial diseases, we estimated the number of patients with mitochondrial diseases from April 2018 through March 2019 using a national Japanese health care claims database, the National Database (NDB). Further, we calculated the prevalence of patients, and sex ratio, age class, and geographical distribution. RESULTS: From April 2018 through March 2019, the number of patients with mitochondrial diseases was 3,629, and the prevalence was 2.9 (95% confidence interval [CI], 2.8-3.0) per 100,000 general population. The ratio of females and males was 53 to 47, and the most frequent age class was 40-49 years old. Tokyo had the greatest number of patients with mitochondrial diseases, at 477, whereas Yamanashi had the fewest, at 13. Kagoshima had the highest prevalence of patients with mitochondrial diseases, 8.4 (95% CI, 7.1-10.0) per 100,000 population, whereas Yamanashi had the lowest, 1.6 (95% CI, 0.8-2.7). CONCLUSION: The number of patients with mitochondrial diseases estimated by this study, 3,269, was more than double that indicated by the Japanese government. This result may imply that about half of all patients are overlooked for reasons such as low severity of illness, suggesting that the Japanese healthcare system needs to provide additional support for these patients.

Analysis of the risk factors of mortality in elderly patients with hip fracture using a combined database of medical and long-term care insurance claims data.

BACKGROUND: The present study evaluated the risk of mortality in elderly hip fracture, focusing on comorbidities and nursing care levels. METHODS: The present study was an observational cohort study that used a combined database of medical and long-term care insurance (LTCI) claims data from one prefecture in Japan between 2011 and 2016. In total, 6125 patients aged 65 years and older were selected from acute care hospitals with a diagnosis of "hip fracture" between March 2011 and March 2012. The impact of long-term care insurance claim evaluation levels and comorbidities at recruitment time was investigated using this dataset. These patients were followed up monthly until March 2016. Based on this person-month dataset, survival analysis was performed with death as the endpoint. Cases in which receipt data were missing during the middle of the observation period and cases in which the patient survived at the end of the observation period were censored. RESULTS: The number of deaths during the observation period was 635 (10.4%). The impact of comorbidities and nursing care level on mortality were both significant as follows: high nursing care level before the fracture (hazard ratio: 1.09, P < 0.001), comorbidities of malignant diseases (HR: 1.45, P < 0.001), heart disease (hazard ratio: 1.20, P = 0.037), pneumonia (hazard ratio: 1.27, P < 0.001), chronic obstructive pulmonary disease (hazard ratio: 1.28, P = 0.026), renal failure (hazard ratio: 1.44, P < 0.001), and dementia (hazard ratio: 1.27, P = 0.013). CONCLUSION: The results of this study showed that a high level of nursing care and presence of comorbidities such as malignant diseases, heart diseases, pneumonia, chronic obstructive pulmonary disease, renal failure, and dementia increased mortality in elderly patients with hip fracture. Furthermore, this study showed the usefulness of a combined database of medical and LTCI claims data for clinical and health service-related research in the field of orthopedics.

Eribulin prolongs survival in an orthotopic xenograft mouse model of malignant meningioma.

Meningioma is the most common intracranial tumor, with generally favorable patient prognosis. However, patients with malignant meningioma typically experience recurrence, undergo multiple surgical resections, and ultimately have a poor prognosis. Thus far, effective chemotherapy for malignant meningiomas has not been established. We recently reported the efficacy of eribulin (Halaven) for glioblastoma with a telomerase reverse transcriptase (TERT) promoter mutation. This study investigated the anti-tumor effect of eribulin against TERT promoter mutation-harboring human malignant meningioma cell lines in vitro and in vivo. Two meningioma cell lines, IOMM-Lee and HKBMM, were used in this study. The strong inhibition of cell proliferation by eribulin via cell cycle arrest was demonstrated through viability assay and flow cytometry. Apoptotic cell death in malignant meningioma cell lines was determined through vital dye assay and immunoblotting. Moreover, a wound healing assay revealed the suppression of tumor cell migration after eribulin exposure. Intraperitoneal administration of eribulin significantly prolonged the survival of orthotopic xenograft mouse models of both malignant meningioma cell lines implanted in the subdural space (P < .0001). Immunohistochemistry confirmed apoptosis in brain tumor tissue treated with eribulin. Overall, these results suggest that eribulin is a potential therapeutic agent for malignant meningiomas.

Epidemiological Study of Hospital Admissions for Food-Induced Anaphylaxis Using the Japanese Diagnosis Procedure Combination Database.

BACKGROUND: Food allergies are common among children, and food-induced anaphylaxis (FIA) is a serious disease with a risk of death; however, there is yet to be a large-scale epidemiological study on causative foods in Japan. The purpose of this study was to identify foods that cause FIA in Japan. METHODS: We identified 9,079 patients from the Japanese Diagnosis Procedure Combination Database who were admitted for treatment for FIA from April 1, 2014 through March 31, 2017. We extracted data on patient sex, age, use of epinephrine injections on the first day, prescription for epinephrine self-injection on the day of discharge, length of stay, readmission, and causative foods. RESULTS: The most common causative food was eggs, followed by wheat, milk, peanuts, and buckwheat. The most common causative food in each age group was eggs among 0-3-year-olds, milk among 4-6-year-olds, peanuts among 7-19-year-olds, and wheat among those aged 20 years and older. Epinephrine was used at admission among about 40%, 50%, and over 60% of cases in which the causative food was eggs; wheat, milk and peanuts; and buckwheat, respectively. The proportion of cases with a prescription for epinephrine self-injection at discharge was highest among those in which the causative food was wheat, followed by peanuts, buckwheat, milk, and eggs. CONCLUSIONS: FIA due to peanuts has become as common in Japan as it is in the West. These results suggest the importance of taking measures to prevent peanut allergies because children cannot make adequate decisions regarding food.

TERT promoter mutation status is necessary and sufficient to diagnose IDH-wildtype diffuse astrocytic glioma with molecular features of glioblastoma.

The Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy (cIMPACT-NOW) update 3 recommends that histologic grade II and III IDH-wildtype diffuse astrocytic gliomas that harbor EGFR amplification, the combination of whole chromosome 7 gain and whole chromosome 10 loss (7 + /10 -), or TERT promoter (pTERT) mutations should be considered as glioblastomas (GBM), World Health Organization grade IV. In this retrospective study, we examined the utility of molecular classification based on pTERT status and copy-number alterations (CNAs) in IDH-wildtype lower grade gliomas (LGGs, grade II, and III). The impact on survival was evaluated for the pTERT mutation and CNAs, including EGFR gain/amplification, PTEN loss, CDKN2A homozygous deletion, and PDGFRA gain/amplification. We analyzed 46 patients with IDH-wildtype/pTERT-mutant (mut) LGGs and 85 with IDH-wildtype/pTERT-wildtype LGGs. EGFR amplification and a combination of EGFR gain and PTEN loss (EGFR + /PTEN -) were significantly more frequent in pTERT-mut patients (p < 0.0001). Cox regression analysis showed that the pTERT mutation was a significant predictor of poor prognosis (hazard ratio [HR] 2.79, 95% confidence interval [CI] 1.55-4.89, p = 0.0008), but neither EGFR amplification nor EGFR + /PTEN - was an independent prognostic factor in IDH-wildtype LGGs. PDGFRA gain/amplification was a significant poor prognostic factor in IDH-wildtype/pTERT-wildtype LGGs (HR 2.44, 95% CI 1.09-5.27, p = 0.03, Cox regression analysis). The IDH-wildtype LGGs with either pTERT-mut or PDGFRA amplification were mostly clustered with GBM by DNA methylation analysis. Thus, our study suggests that analysis of pTERT mutation status is necessary and sufficient to diagnose IDH-wildtype diffuse astrocytic gliomas with molecular features of glioblastoma. The PDGFRA status may help further delineate IDH-wildtype/pTERT-wildtype LGGs. Methylation profiling showed that IDH-wildtype LGGs without molecular features of GBM were a heterogeneous group of tumors. Some of them did not fall into existing categories and had significantly better prognoses than those clustered with GBM.

Diabetes severity measured by treatment control status and number of anti-diabetic drugs affects presenteeism among workers with type 2 diabetes.

BACKGROUND: The number of people with diabetes is increasing and resulting in major economic losses. Presenteeism accounts for the majority of economic losses, so measures against presenteeism are important. This study investigated the relationship between severity of type 2 diabetes and presenteeism. METHODS: A cross-sectional study was conducted among workers over 40 years of age. Participants were classified as normal group or diabetic treatment group using their medical examination results and health insurance claims data. Diabetic treatment groups were described by degree of treatment control: Good (HbA1c < 7%), Intermediate (7% ≤ HbA1c < 8%), and Poor (8% ≤ HbA1c). Therapy type was also divided into monotherapy and combination therapy. Logistic regression analysis was performed to predict presenteeism loss using the Quantity and Quality method. RESULTS: Data on 13,271 workers were analyzed. Presenteeism loss was significantly higher in all treatment control groups compared with the normal group, particularly for the intermediate and poor control groups. The monotherapy group did not differ from the normal group, but presenteeism loss was significantly higher in the combination therapy group than the normal group. CONCLUSIONS: Presenteeism loss in workers with diabetes may be affected by diabetes severity, and even if treatment control were good, presenteeism loss could occur when the number of anti-diabetic drugs was high. Therefore, it is important to provide early intervention and continuous support as a preventive measure against not only diabetes and diabetes-related complications but also presenteeism.

Clinical Outcomes of Laparoscopic Versus Laparotomic Distal Gastrectomy in Gastric Cancer Patients: A Multilevel Analysis Based on a Nationwide Administrative Database in Japan.

BACKGROUND: The present study compared the short-term outcomes and costs of laparoscopic distal gastrectomy (LDG) with those of open distal gastrectomy (ODG) for gastric cancer using a nationwide administrative database in Japan. METHOD: Overall, 37,752 patients with gastric cancer who underwent distal gastrectomy at 1074 hospitals in the fiscal year 2012-2013 were evaluated using a diagnosis procedure combination database in Japan. We performed a retrospective analysis via a multilevel analysis (MLA) of the short-term surgical results and costs of the LDG and ODG groups. The models included the age, sex, comorbid complications, smoking, body mass index (BMI), activity of daily living (ADL), stage, and the number of cases of gastrectomy per facility for adjustment. The in-hospital mortality relative to the hospital volume was also compared. RESULTS: The LDG group required postoperative blood transfusion less frequently and had fewer postoperative complications, shorter hospitalization, and lower operative mortality than the ODG group. While this stage did not correlate with the in-hospital mortality, the surgical method, age, sex, ADL, BMI, comorbidity, and yearly volume showed a correlation. A significant association in the in-hospital mortality was observed between low- and very-high-volume hospitals. CONCLUSION: In this large nationwide cohort of patients with gastric cancer using an MLA, LDG was shown to be safer with lower mortality and postoperative complication rates than ODG.

Open colectomy vs. laparoscopic colectomy in Japan: a retrospective study using real-world data from the diagnosis procedure combination database.

PURPOSE: To compare the short-term outcomes of conventional open colectomy with those of laparoscopic colectomy for colon cancer. METHODS: We retrieved data between January 2014 and March 2016 from the Diagnosis Procedure Combination database. A total of 69,418 patients who underwent colectomy for colon cancer were analyzed from among 15,901,766 cases of colorectal cancer. We applied a multilevel logistic regression model using a 2-level structure of individuals nested from 1065 hospitals. RESULTS: A total of 22,440 open colectomy and 46,978 laparoscopic colectomy procedures were performed. The in-hospital mortality rate was significantly lower in the laparoscopic group than in the open group (0.28% vs. 0.06%, odds ratio [OR] 0.40, p < 0.001). Similarly, the 30-day postoperative mortality rate (0.14% vs. 0.03%, OR 0.47, p = 0.019) and surgical morbidity rate (43.0% vs. 25.3%, OR 0.47, p < 0.001) were significantly lower in the laparoscopic group than in the open group. The postoperative length of stay was significantly longer in the open group (mean difference - 5.6 days, p < 0.001) than in the open group. The admission cost was significantly greater in the open group than in the laparoscopic group (mean difference - 95,080 yen, p < 0.001). CONCLUSIONS: Laparoscopic colectomy is safe and effective in the short term.

Eribulin penetrates brain tumor tissue and prolongs survival of mice harboring intracerebral glioblastoma xenografts.

Glioblastoma is one of the most devastating human malignancies for which a novel efficient treatment is urgently required. This pre-clinical study shows that eribulin, a specific inhibitor of telomerase reverse transcriptase (TERT)-RNA-dependent RNA polymerase, is an effective anticancer agent against glioblastoma. Eribulin inhibited the growth of 4 TERT promoter mutation-harboring glioblastoma cell lines in vitro at subnanomolar concentrations. In addition, it suppressed the growth of glioblastoma cells transplanted subcutaneously or intracerebrally into mice, and significantly prolonged the survival of mice harboring brain tumors at a clinically equivalent dose. A pharmacokinetics study showed that eribulin quickly penetrated brain tumors and remained at a high concentration even when it was washed away from plasma, kidney or liver 24 hours after intravenous injection. Moreover, a matrix-assisted laser desorption/ionization mass spectrometry imaging analysis revealed that intraperitoneally injected eribulin penetrated the brain tumor and was distributed evenly within the tumor mass at 1 hour after the injection whereas only very low levels of eribulin were detected in surrounding normal brain. Eribulin is an FDA-approved drug for refractory breast cancer and can be safely repositioned for treatment of glioblastoma patients. Thus, our results suggest that eribulin may serve as a novel therapeutic option for glioblastoma. Based on these data, an investigator-initiated registration-directed clinical trial to evaluate the safety and efficacy of eribulin in patients with recurrent GBM (UMIN000030359) has been initiated.

Impact of Body Mass Index of Japanese Gallbladder Cancer Patients on their Postoperative Outcomes.

　We investigated the relationship between body mass index (BMI) and postoperative outcomes in 450 gallbladder cancer patients in Japan. We collected patient information, including sex, age, underlying disease, BMI, stage, surgery method, postoperative time to discharge, and postoperative Medicare fees, from the Japanese administrative database associated with the Diagnosis Procedure Combination system. We classified patient BMIs as underweight (BMI<18.5 kg/m2), normal (BMI≥18.5 kg/m2 and <25 kg/m2) or overweight/obese (BMI≥25 kg/m2), then investigated the relationship between these categories and two postoperative outcomes: time to discharge and postoperative Medicare fees. The median postoperative time to discharge was 12 days in all patients, and 12 days in each of the three weight groups (p=0.62, n.s.). The median postoperative Medicare fees from surgery until discharge were (USD): all patients, $5,002; underweight, $5,875; normal weight, $4,797; and overweight/obese, $5,179 (p=0.146, n.s.). A multivariate analysis with adjustment for competing risk factors revealed that BMI was not associated with increased risk of longer postoperative time to discharge (normal weight: HR 1.17, p=0.29; overweight/obese: HR 1.17, p=0.37) or higher postoperative Medicare fees (OR 0.99, p=0.86, n.s.). Thus, high BMI was not found to be a factor for poor postoperative outcomes in Japanese patients with gallbladder cancer.

Concomitant administration of radiation with eribulin improves the survival of mice harboring intracerebral glioblastoma.

Glioblastoma is the most common and devastating type of malignant brain tumor. We recently found that eribulin suppresses glioma growth in vitro and in vivo and that eribulin is efficiently transferred into mouse brain tumors at a high concentration. Eribulin is a non-taxane microtubule inhibitor approved for breast cancer and liposarcoma. Cells arrested in M-phase by chemotherapeutic agents such as microtubule inhibitors are highly sensitive to radiation-induced DNA damage. Several recent case reports have demonstrated the clinical benefits of eribulin combined with radiation therapy for metastatic brain tumors. In this study, we investigated the efficacy of a combined eribulin and radiation treatment on human glioblastoma cells. The glioblastoma cell lines U87MG, U251MG and U118MG, and SJ28 cells, a patient-derived sphere culture cell line, were used to determine the radiosensitizing effect of eribulin using western blotting, flow cytometry and clonogenic assay. Subcutaneous and intracerebral glioma xenografts were generated in mice to assess the efficacy of the combined treatment. The combination of eribulin and radiation enhanced DNA damage in vitro. The clonogenic assay of U87MG demonstrated the radiosensitizing effect of eribulin. The concomitant eribulin and radiation treatment significantly prolonged the survival of mice harboring intracerebral glioma xenografts compared with eribulin or radiation alone (P < .0001). In addition, maintenance administration of eribulin after the concomitant treatment further controlled brain tumor growth. Aberrant microvasculature was decreased in these tumors. Concomitant treatment with eribulin and radiation followed by maintenance administration of eribulin may serve as a novel therapeutic strategy for glioblastomas.

Usefulness of Self-Selected Scenarios for Simple Triage and Rapid Treatment Method Using Virtual Reality.

BACKGROUND: Repeated triage training is necessary to maintain and improve the accuracy of simple triage and rapid treatment (START), a popular triage method. Virtual reality (VR) may be more effective than conventional training methods. This study aimed to verify the educational usefulness of START using VR originally developed for students. METHODS: A VR was initially developed with a function that allowed students to select the triage procedure and its evaluation. Triage was performed using a simple modified START method, and eight scenarios were developed. The participants included 70 paramedic students classified into VR and live lecture groups. They took a 20-question written test that evaluated their academic ability before the course. After the course, a practical test and a 20-question written test were conducted. The total score of the practical test was 43 points. Triage procedure (1 point), observation and evaluation (1-5 points), and triage categories (1 point) were evaluated in this test. RESULTS: The VR and live lecture groups consisted of 33 and 29 participants, respectively. No significant differences were observed pre- and post-test. In the practical test, the median (interquartile range) score was 29 (26-32) and 25 (23-29) for the VR and live lecture groups, respectively, with the VR group scoring significantly higher (P=0.03). CONCLUSION: Our results confirmed the educational usefulness of selective VR for active learning of START. Therefore, VR combined with live lectures and simulations would be an optimal educational technique.

Assessment of liver fibrosis with real-time tissue elastography in chronic viral hepatitis.

OBJECTIVE: The aim of this study was to assess prospectively the accuracy of measurement of liver fibrosis with real-time tissue elastography (RTE) in patients with chronic viral hepatitis. METHODS: Two hundred and forty-five patients were prospectively enrolled. Nine image features were measured from strain images, and Liver Fibrosis Index (LFI) was calculated from these features. Fibrosis stage was diagnosed from pathological specimens obtained by ultrasound-guided biopsy. LFI and serological markers were compared with pathological diagnosis, and the diagnostic performance of RTE was compared. RESULTS: LFI in stages F0-F1, F2, F3 and F4 was 1.58, 2.03, 2.40 and 2.86, respectively, demonstrating a stepwise increase with increasing severity of liver fibrosis (p < 0.001). LFI in F2 did not significantly differ from that in F3, whereas for all other combinations of stages, there were significant differences. The area under the receiver operating characteristic curve of the LFI, platelet count, aspartate/alanine aminotransferase ratio, aspartate aminotransferase-to-platelet ratio, and FibroIndex for predicting F3 stage or higher (F0-F2 vs. F3-F4) was 0.865, 0.824, 0.708, 0.789 and 0.828, respectively. CONCLUSIONS: RTE is useful for diagnosis of liver fibrosis, regardless of stage, in patients with chronic viral hepatitis.

Novel image analysis method using ultrasound elastography for noninvasive evaluation of hepatic fibrosis in patients with chronic hepatitis C.

It has been established that the long-term infection of chronic hepatitis C leads to the increased risk of hepatic fibrosis and hepatocellular carcinoma. Currently, histological diagnosis by invasive and painful liver biopsy is the gold standard for evaluating the hepatic fibrosis stage. Because of a side effect or patient inability to cope with the pain, it is difficult to assess the fibrosis stage frequently using liver biopsy. Recently, instead of liver biopsy, many articles have been published showing the usefulness of ultrasound elastography to evaluate the stage of hepatic fibrosis. We also reported the usefulness of real-time tissue elastography (RTE) for liver fibrosis staging in 2007. However, in our previous report, fibrosis classification was performed manually and the number of patients involved was also small. In the current study, the fibrosis staging is performed automatically using software by characterizing the elastography images. We have also increased the number of patients from 64 to 310. Thus, the aim of this study is to increase objectivity by using a newly developed automatic analysis method. We obtain the Liver Fibrosis Index (LFI), which is calculated from image features of RTE images, using multiple regression analysis performed on clinical data of 310 cases as the training data set. The correlation coefficient obtained between the LFI and the stage of hepatic fibrosis was r = 0.68, and significant differences exist between all stages of fibrosis (p < 0.001). Our new method seems promising since it has the ability to diagnose fibrosis even in the presence of inflammation.

JSUM ultrasound elastography practice guidelines: liver.

In diffuse liver disease, it is extremely important to make an accurate diagnosis of liver fibrosis prior to determining indications for therapy or predicting treatment outcome and malignant potential. Although liver biopsy has long been the gold standard in the diagnosis of liver fibrosis, it is still an invasive method. In addition, the sampling error is an intrinsic problem of liver biopsy. Non-invasive serological methods for the diagnosis of liver fibrosis can be affected by factors unrelated to the liver. Recently, after the introduction of FibroScan, it became possible to measure liver fibrosis directly and non-invasively by elastography, which has attracted attention as a non-invasive imaging diagnostic tool for liver fibrosis. In addition, real-time tissue elastography is currently being used to conduct clinical trials at many institutions. Moreover, virtual touch quantification enables the observation of liver stiffness at any location by simply observing B-mode images. Furthermore, the recently developed ShearWave elastography visualizes liver stiffness on a color map. Elastography is thought to be useful for all types of diffuse liver diseases. Because of its association with portal hypertension and liver carcinogenesis, elastography is expected to function as a novel prognostic tool for liver disease. Although various elastographic devices have been developed by multiple companies, each device has its own measurement principle, method, and outcome, creating confusion in clinical settings. Therefore, it is extremely important to understand the characteristics of each device in advance. The objective of this guideline, which describes the characteristics of each device based on the latest knowledge, is for all users to be able to make the correct diagnosis of hepatic fibrosis by ultrasound elastography.

Stochastic Optimal Linear Control for Generalized Cost Functions With Time-Invariant Stochastic Parameters.

This study presents the design of feedback controllers for generalized cost functions to deal with stochastic optimal control problems. Target linear systems contain time-invariant stochastic parameters that describe system uncertainty. The cost functions involve nonlinear mappings and polynomial forms of the system states and inputs to express various performance metrics. Unfortunately, these properties cause difficulties in solving the problems. Conventional methods, such as the principle of optimality, are not employed to solve such problems owing to the time-invariant parameters. As opposed to the well-known quadratic functions, handling the generalized cost functions is a complicated task. This study overcomes these challenges by deriving an explicit relation between the cost function and the linear feedback gain of a controller. The derived relation enables the feedback gain to be optimized via a gradient method. A theoretical analysis ensures the convergence of the proposed gradient method. A suboptimal feedback controller is obtained to solve the problem, even for the generalized cost. Furthermore, the controller guarantees robust stability of the feedback system even with the stochastic parameters. It is demonstrated that the proposed cost function can express an expectation of a quadratic cost, risk-sensitive cost, polynomial cost, and input-to-state gain. A numerical simulation shows the effectiveness of the proposed method.

Atrial fibrillation and mortality after ischemic stroke: An observational study using an insurance claim database.

OBJECTIVES: In this study, we aimed to examine the association between atrial fibrillation and mortality after ischemic stroke and evaluate the use of anticoagulation therapy for atrial fibrillation before stroke onset in patients who experienced stroke. METHODS: In this retrospective observational study, we used a combined database of medical and long-term care insurance claims data from one prefecture in Japan. The data of 25,352 patients aged ≥ 65 years who were hospitalized in acute care hospitals with a diagnosis of ischemic stroke between April 2012 and March 2015 were extracted. Cox proportional hazard modeling, with adjustment for age, sex, comorbidities, and long-term care dependency level (based on the activities of daily living), was performed to evaluate the relationship between mortality and atrial fibrillation. RESULTS: The prevalence of atrial fibrillation was 21.8% in the study population. A significant association was noted between mortality and atrial fibrillation (adjusted hazard ratio: 1.28, 95% confidence interval: 1.16-1.41, p < 0.001). Anticoagulant drugs were used in 32.2% of the patients with atrial fibrillation. CONCLUSIONS: These results indicate that atrial fibrillation is associated with mortality after stroke; however, the use of anticoagulation therapy for atrial fibrillation is unsatisfactory. Efforts to improve the use of atrial fibrillation therapy are required in Japan.

A Study on Points of Respiratory Assist Devices Using in Pre-Hospital Care Respiratory Assist Devices in Pre-Hospital Care.

BACKGROUND: In Japan, increasing the number of ambulance requests, the case with the use of respiratory assistance devices in prehospital care by paramedics is also increasing1. When patient experiences respiratory failure, the first responders frequently select a respiratory assist device (RAD) such as Bag Valve Mask (BVM), Jackson Rees (JR), or BVM with Gas Supply Valve® (BVM+GSV). This is based on both evaluation and experience as there is no study indicating which RAD is the best choice at the pre-hospital emergency site. This study clarified the precautions when using BVM, JR, and BVM+GSV in pre-hospital emergency medical care with healthy volunteers. METHODS: Twenty healthy adults were fitted with a RAD while breathing spontaneously, and changes in vital signs and ETCO2 were observed. RESULTS: The level of ETCO2 became elevated after each RAD was attached. The value was significantly higher in the JR group than in the others. CONCLUSIONS: The study showed that even in the presence of spontaneous breathing, ETCO2 increased markedly with the application of respiratory assist devices that are used in pre-hospital care for conditions such as hypoxemia and ventilatory disturbance. The increase in ETCO2 was particularly significant in the JR group, suggesting the need for caution when selecting JRs for pre-hospital care. As the number of subjects was only 20 for each RAD, studies with a larger sample size are needed.

Clinical characteristics in patients with non-alcoholic steatohepatitis in Japan: a case-control study using a 5-year large-scale claims database.

OBJECTIVES: To examine the clinical characteristics of patients with non-alcoholic steatohepatitis (NASH) and associated comorbidities. DESIGN: A case-control study using the national health insurance and the long-term elderly health insurance claims database. SETTING: Eligible patients diagnosed with NASH (ICD-10 K-75.8, other inflammatory liver disease or K-76.0, other fatty liver) between April 2015 and March 2020 were included. PARTICIPANTS: Patients who met the diagnostic definitions for NASH (n=545) were matched with non-NASH controls (n=185 264) and randomly selected according to sex, birth year and residential area. INTERVENTIONS: No interventions were made. PRIMARY AND SECONDARY OUTCOME MEASURES: ORs were estimated for the relationship between patient background, such as age and sex, body mass index (BMI), NASH-related comorbidities and lifestyle-related diseases. RESULTS: In total, 545 patients with NASH (38.3% men) and 185 264 non-NASH controls (43.2% men) were identified, with median ages of 68 (IQR 63.0-75.0) and 65 (IQR 44.0-74.0) years, respectively. BMI was significantly higher in patients with NASH than in controls (25.8 kg/m2 vs 22.9 kg/m2, p<0.001). The proportions of women, patients with hypertension, patients with dyslipidaemia and patients with type 2 diabetes were higher in the NASH group. In addition, NASH was associated with an increased risk of hepatic cirrhosis (OR 28.81 (95% CI 21.79 to 38.08)), followed by liver cancer (OR 18.38 (95% CI 12.56 to 26.89)). There was no significant association between NASH and risk for depression (OR 1.11 (95% CI 0.87 to 1.41)), insomnia (OR 1.12 (95% CI 0.94 to 1.34)) or chronic kidney diseases (OR 0.81 (95% CI 0.58 to 1.12)). CONCLUSIONS: In the daily medical care of patients, it is necessary to consider sex and age differences and to pay close attention to the risk of liver cancer, as well as other lifestyle-related comorbidities associated with NASH.