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Introduction: In out-of-hospital cardiac arrest (OHCA) patients with extracorporeal cardiopulmonary resuscitation (ECPR), the association between low-flow time, the duration between the initiation of conventional cardiopulmonary resuscitation and the establishment of ECPR, and outcomes has not been clearly determined., Methods: This was a secondary analysis of the retrospective multicenter registry in Japan. This study registered patients ≥18 years old who were admitted to the emergency department for OHCA and underwent ECPR between January, 2013 and December, 2018. Low-flow time was defined as the time from initiation of conventional cardiopulmonary resuscitation to the establishment of ECPR, and patients were categorized into two groups according to the visualized association of the restricted cubic spline curve. The primary outcome was survival discharge. Cubic spline analyses and multivariable logistic regression analyses were performed to assess the nonlinear associations between low-flow time and outcomes., Results: A total of 1,524 patients were included. The median age was 60 years, and the median low-flow time was 52 (42-53) mins. The overall survival at hospital discharge and favorable neurological outcomes were 27.8% and 14.2%, respectively. The cubic spline analysis showed a decreased trend of survival discharge rates and favorable neurological outcomes with shorter low-flow time between 20 and 60 mins, with little change between the following 60 and 80 mins. The multivariable logistic regression analyses showed that patients with long low-flow time (>40 mins) compared to those with short low-flow time (0-40 mins) had significantly worse survival (adjusted odds ratio 0.42; 95% confidence intervals, 0.31-0.57) and neurological outcomes (0.65; 0.45-0.95, respectively)., Conclusions: The survival discharge and neurological outcomes of patients with low-flow time shorter than 40 min are better than those of patients with longer low-flow time., Competing Interests: Declaration of Competing Interest This work was supported by JSPS KAKENHI Grant Number 19H03755., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background and Objectives: Clinical benefits of intracranial pressure (ICP) monitoring in the management of children with severe traumatic brain injury (TBI) are not universally agreed upon. We investigated the association between ICP monitoring and outcomes in children with severe TBI using a nationwide inpatient database., Methods: This observational study used the Japanese Diagnostic Procedure Combination inpatient database from July 1, 2010, to March 31, 2020. We included patients younger than 18 years, admitted to the intensive care unit or high-dependency unit with severe TBI. Patients who died or were discharged on the day of admission were excluded. One-to-four propensity score matching was performed to compare patients who underwent ICP monitoring on the day of admission with those who did not. The primary outcome was in-hospital mortality. Mixed-effects linear regression analysis compared outcomes and estimated the interaction between ICP monitoring and subgroups in matched cohorts., Results: Of the 2116 eligible children, 252 received ICP monitoring on the day of admission. One-to-4 propensity score matching selected 210 patients who had ICP monitoring on admission day and 840 patients who did not. In-hospital mortality was significantly lower in patients who underwent ICP monitoring than those who did not (12.7% vs 17.9%; within-hospital difference, -4.2%; 95% CI, -8.1% to -0.4%). There was no significant difference in the proportion of unfavorable outcomes (Barthel index <60 or death) at discharge, proportion of enteral nutrition at discharge, length of hospital stay, and total hospitalization cost. Subgroup analyses demonstrated a quantitative interaction between ICP monitoring and the Japan Coma Scale ( P < .001)., Conclusion: ICP monitoring was associated with lower in-hospital mortality in children with severe TBI. Our results demonstrated the clinical benefits of ICP monitoring in managing pediatric TBI. The advantages of ICP monitoring may be amplified in children who exhibit the most severe disturbances of consciousness., (Copyright © Congress of Neurological Surgeons 2023. All rights reserved.)

Background: Ischemic heart disease is a leading cause of death worldwide, and coronary artery bypass grafting (CABG) is a major treatment. Landiolol is an ultra-short-acting beta-antagonist known to prevent postoperative atrial fibrillation. However, the effectiveness of intraoperative landiolol on mortality remains unknown. This study aimed to evaluate the association between intraoperative landiolol use and the in-hospital mortality in patients undergoing CABG., Methods: To conduct this retrospective cohort study, we used data from the Japanese Diagnosis Procedure Combination inpatient database. All patients who underwent CABG during hospitalization between July 1, 2010, and March 31, 2020, were included. Patients who received intraoperative landiolol were defined as the landiolol group, whereas the other patients were defined as the control group. The primary outcome was in-hospital mortality. Propensity score matching was used to compare the landiolol and control groups., Results: In total, 118,506 patients were eligible for this study, including 25,219 (21%) in the landiolol group and 93,287 (79%) in the control group. One-to-one propensity score matching created 24,893 pairs. After propensity score matching, the in-hospital mortality was significantly lower in the landiolol group than that in the control group (3.7% vs 4.3%; odds ratio 0.85; 95% confidence interval 0.78 to 0.94; P = .010)., Conclusions: Intraoperative landiolol use was associated with decreased in-hospital mortality in patients undergoing CABG. Further randomized controlled trials are required to confirm these findings., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 International Anesthesia Research Society.)

Background: Previous studies have reported conflicting results regarding fresh frozen plasma (FFP)-to-red blood cell (RBC) ratio and platelet-to-RBC ratio on outcomes for massive transfusion for trauma. Moreover, nationwide data on massive transfusion practices for trauma in the real-world clinical setting are scarce. This study aimed to examine the nationwide practice patterns and trends in massive transfusion for trauma in Japan using a national administrative, inpatient database., Method: We identified patients who underwent emergency hospitalization for trauma and received massive transfusion, defined as administration of at least 20 units of RBC within the first 2 days of admission, using the nationwide inpatient database, which covers approximately 90% of all tertiary emergency hospitals in Japan, between 2011 and 2020. Trends in the incidence and practice patterns of massive transfusion were described by calendar year. The association of practice patterns with mortality or adverse events was tested., Results: A total of 3,530,846 trauma hospitalizations were identified, of which 5247 (0.15%) received massive transfusion. A significant declining trend was observed in the incidence of massive transfusion in trauma hospitalizations from 0.24% in 2011 to 0.10% in 2020 (P for trend < 0.001). The FFP-to-RBC ratio rose significantly from 0.77 in 2011 to 1.08 in 2020 (P for trend < 0.001), while the platelet-to-RBC ratio remained virtually unchanged from 0.71 in 2011 to 0.78 in 2020 (P for trend 0.060). Massive transfusion with lower FFP-to-RBC (< 0.75) and platelets-to-RBC ratio (< 1.00) were associated with increased in-hospital mortality compared with those ≥ 1.00, while there were linear increases in adverse events with increasing FFP and platelets ratios., Conclusions: This study demonstrated a declining trend in the incidence and a rise in higher FFP-to-RBC ratios in massive transfusion in association with patient outcomes for trauma from 2011 to 2020 in Japan., (© 2023. The Japanese Society of Intensive Care Medicine.)

Little is known about the impact of the downgrade of guideline recommendations for intra-aortic balloon pump (IABP) use and the approval of the Impella in Japan, where IABPs have been predominantly used. This study aimed to describe the annual trends in the mechanical circulatory support (MCS) use and outcomes in patients with cardiogenic shock (CS) requiring MCS. Using the Japanese Diagnosis Procedure Combination database from July 2010 to March 2021, we identified inpatients with CS requiring MCS. The patients were stratified into 3 groups: (1) IABP alone, (2) Impella alone, and (3) extracorporeal membrane oxygenation (ECMO), regardless of IABP or Impella use. The patient characteristics and outcomes were reported by the fiscal year. Of the 160,559 eligible patients, 117,599 (73.2%) used IABP alone, 1,465 (0.9%) Impella alone, and 41,495 (25.8%) ECMO. The prevalence of the use of an IABP alone significantly decreased from 80.5% in 2010 to 65.3% in 2020 (p for trend <0.001), whereas the prevalence of the use of an Impella alone significantly increased from 0.0% to 5.0% and ECMO from 19.5% to 29.6% (p for trend <0.001 for both). In-hospital mortality significantly increased from 29.3% in 2010 to 32.6% in 2020 in the overall patients with CS requiring MCS but significantly decreased in those requiring ECMO from 73.7% to 64.1% (p for trend <0.001 for both). In conclusion, there were significant annual changes in the patterns of MCS use and clinical outcomes in patients with CS requiring MCS., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Purpose: To investigate the association between annual hospital volume of endovascular therapy (EVT) and long-term outcomes in patients with lower-extremity peripheral artery disease (PAD)., Materials and Methods: We identified patients who underwent percutaneous endovascular transluminal angioplasty and thrombectomy of the extremities or percutaneous endovascular removal in the Japanese Diagnosis Procedure Combination inpatient database from April 2014 to March 2020 linked to the Survey of Medical Institutions data. A generalized linear model analysis was performed to assess 12-month amputation, all-cause death, composite outcome (amputation and death), and readmission. We also analyzed length of hospital stay and total health care costs during the first hospitalization., Results: Among 127 486 eligible patients, 31 579, 31 913, 31 999, and 31 995 were in the first (1-27 cases/year), second (28-44 cases), third (45-67 cases), and fourth (68-289 cases) quartiles, respectively. There were no significant differences in 12-month amputation among the second (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.90-1.04), third (OR, 1.00; 95% CI, 0.93-1.07), and fourth (OR, 1.00; 95% CI, 0.93-1.07) quartile volumes compared with the first quartile. Significant differences were observed in 12-month death (OR for fourth quartile with reference to the first quartile, 0.71; 95% CI, 0.65-0.76), composite outcome (OR, 0.84; 95% CI, 0.80-0.89), and readmission (OR, 1.05; 95% CI, 1.02-1.09)., Conclusions: We found that the annual hospital volume of EVT was not associated with decreased 12-month amputation in patients with lower-extremity PAD. In contrast, all-cause death and composite outcome were significantly decreased in hospitals with the highest volume., Clinical Impact: The association between hospital volume of endovascular therapy and long-term adverse clinical outcomes remains unclear. The present analyses showed no significant differences in 12-month amputation rates among the hospital volumes, whereas higher-volume quartiles were significantly associated with decreased 12-month all-cause death rates and composite outcome. There was also a positive association in the length of stay between the first quartile volume and the others, while no significant difference in total health care costs among the quartiles was observed. Further investigations are needed, including insights into operator volume and procedural characteristics, to clarify the relationship between hospital volume and long-term adverse outcomes.

Background: Most previous studies on outpatient cardiac catheterization have been conducted in Western countries, but Japanese studies are rare. We aimed to describe patient characteristics and short-term clinical outcomes of outpatient cardiac catheterization compared to those of inpatient cardiac catheterization in Japan., Methods: We conducted a retrospective cohort study using data from the JMDC Claims Database. We identified all adult patients aged ≥18 years who underwent cardiac catheterization between April 2012 and October 2021. We investigated patient characteristics and clinical outcomes (i.e. all-cause mortality, stroke, acute kidney injury, bleeding, vascular complications, percutaneous coronary intervention, and total healthcare costs) within 2, 7, and 30 days between patients who underwent outpatient cardiac catheterization (outpatient group) and those who underwent inpatient cardiac catheterization (inpatient group)., Results: Of the 37,002 eligible patients (57.6 % <60 years old, and 80.2 % male), 1853 (5.01 %) underwent outpatient cardiac catheterization. The outpatient group was more likely to be male, have more comorbidities, and be performed at non-university hospitals than the inpatient group. The proportion of patients who underwent right heart catheterization and imaging was lower in the outpatient group. There were no significant differences in 7-day major complications between the two groups (all-cause mortality, 0.0 % versus 0.0 %, p = 0.57; acute kidney injury, 0.0 % versus 0.1 %, p = 0.10, bleeding, 0.5 % versus 0.9 %, p = 0.052; vascular complication, 0.0 % versus 0.1 %, p = 0.23, respectively). The 30-day total healthcare costs were lower in the outpatient group than in the inpatient group (mean 3212 US dollars versus 3955 US dollars, p = 0.003)., Conclusions: Approximately 5 % of cardiac catheterizations were performed in an outpatient setting. Given the low adverse event risk observed in this study, it may be a reasonable option to widen outpatient cardiac catheterization to include potential populations in Japan, warranting further studies., Competing Interests: Declaration of competing interest Nao Setogawa is an employee of Terumo Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objectives: To assess the association between levels of intensive care and in-hospital mortality in patients hospitalized for sepsis, stratified by Sequential Organ Failure Assessment (SOFA) score at admission., Design: A nationwide, propensity score-matched, retrospective cohort study., Setting: A Japanese national inpatient database with data on 70-75% of all ICU and high-dependency care unit (HDU) beds in Japan., Patients: Adult patients hospitalized for sepsis with SOFA scores greater than or equal to 2 on their day of admission between April 1, 2018, and March 31, 2021, were recruited. Propensity score matching was performed to compare in-hospital mortality, and patients were stratified into 10 groups according to SOFA scores., Interventions: Two exposure and control groups according to treatment unit on day of admission: 1) ICU + HDU versus general ward and 2) ICU versus HDU., Measurements and Main Results: Of 97,070 patients, 19,770 (20.4%), 23,066 (23.8%), and 54,234 (55.9%) were treated in ICU, HDU, and general ward, respectively. After propensity score matching, the ICU + HDU group had significantly lower in-hospital mortality than the general ward group, among cohorts with SOFA scores greater than or equal to 6. There were no significant differences in in-hospital mortality among cohorts with SOFA scores 3-5. The ICU + HDU group had significantly higher in-hospital mortality than the general ward among cohorts with SOFA scores of 2. The ICU group had lower in-hospital mortality than the HDU group among cohorts with SOFA scores greater than or equal to 12. There were no significant differences in in-hospital mortality among cohorts with SOFA scores 5-11. The ICU group had significantly higher in-hospital mortality than the general ward group among cohorts with SOFA scores less than or equal to 4., Conclusions: Patients hospitalized for sepsis with SOFA scores greater than or equal to 6 in the ICU or HDU had lower in-hospital mortality than those in the general ward, as did those with SOFA scores greater than or equal to 12 in the ICU versus HDU., Competing Interests: Dr. Yasunaga’s institution received funding from the Ministry of Health, Labour and Welfare, Japan and the Ministry of Education, Culture, Sports, Science and Technology, Japan. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2023 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Objectives: We aimed to describe patient characteristics, healthcare utilization, and in-hospital mortality among patients with COVID-19 in Japan across waves., Methods: Using a large-scale hospital-based database, we identified patients hospitalized for COVID-19 in the first (January-June 2020), second (June-October 2020), third (October 2020-February 2021), fourth (March-June 2021), and fifth (June-December 2021) waves. We summarized patient characteristics, healthcare utilization, and in-hospital mortality during each wave and performed multivariable logistic regression analyses for in-hospital mortality., Results: From the first to fifth waves, the number of patients (mean age ± standard deviation, years) was 2958 (61.2 ± 22.8), 7981 (55.6 ± 25.3), 18,788 (63.6 ± 22.9), 17,729 (60.6 ± 22.6), and 23,656 (51.2 ± 22.3), respectively. There were 190 (6.4%), 363 (4.5%), 1261 (6.7%), 1081 (6.1%), and 762 (3.2%) in-hospital deaths, respectively. The adjusted odds ratios for in-hospital deaths (95% confidence interval) were 0.78 (0.65-0.95), 0.94 (0.79-1.12), 0.99 (0.84-1.18), 0.77 (0.65-0.92), in the second to fifth waves, respectively, compared with the first wave., Conclusions: In-hospital COVID-19 mortality improved from the first to the second wave; however, during the third and fourth waves, mortality was as serious as in the first wave. Although in-hospital mortality during the fifth wave improved, careful monitoring is needed for upcoming waves, considering changing patient and viral characteristics., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

Objective: Intracranial pressure (ICP) monitoring is recommended for the management of severe traumatic brain injury (TBI). The clinical benefit of ICP monitoring remains controversial, however, with randomized controlled trials showing negative results. Therefore, this study investigated the real-world impact of ICP monitoring in managing severe TBI., Methods: This observational study used the Japanese Diagnosis Procedure Combination inpatient database, a nationwide inpatient database, from July 1, 2010, to March 31, 2020. The study included patients aged 18 years or older who were admitted to an intensive care or high-dependency unit with a diagnosis of severe TBI. Patients who did not survive or were discharged on admission day were excluded. Between-hospital differences in ICP monitoring were quantified using the median odds ratio (MOR). A one-to-one propensity score matching (PSM) analysis was conducted to compare patients who initiated ICP monitoring on the admission day with those who did not. Outcomes in the matched cohort were compared using mixed-effects linear regression analysis. Linear regression analysis was used to estimate interactions between ICP monitoring and the subgroups., Results: The analysis included 31,660 eligible patients from 765 hospitals. There was considerable variability in the use of ICP monitoring across hospitals (MOR 6.3, 95% confidence interval [CI] 5.7-7.1), with ICP monitoring used in 2165 patients (6.8%). PSM resulted in 1907 matched pairs with highly balanced covariates. ICP monitoring was associated with significantly lower in-hospital mortality (31.9% vs 39.1%, within-hospital difference -7.2%, 95% CI -10.3% to -4.2%) and longer length of hospital stay (median 35 vs 28 days, within-hospital difference 6.5 days, 95% CI 2.6-10.3). There was no significant difference in the proportion of patients with unfavorable outcomes (Barthel index < 60 or death) at discharge (80.3% vs 77.8%, within-hospital difference 2.1%, 95% CI -0.6% to 5.0%). Subgroup analyses demonstrated a quantitative interaction between ICP monitoring and the Japan Coma Scale (JCS) score for in-hospital mortality, with a greater risk reduction with higher JCS score (p = 0.033)., Conclusions: ICP monitoring was associated with lower in-hospital mortality in the real-world management of severe TBI. The results suggest that active ICP monitoring is associated with improved outcomes after TBI, while the indication for monitoring might be limited to the most severely ill patients.

Background: Severe fever with thrombocytopenia syndrome (SFTS) is an emerging tick-borne infectious disease caused by the SFTS virus. Effective treatment for SFTS has not been established, but steroid pulse therapy is often used. This study aimed to verify whether steroid pulse therapy for SFTS improves prognosis or not., Methods: Data of SFTS patients were obtained from the Japanese Diagnosis Procedure Combination Database from April 2013 to March 2021. Patients treated with steroid pulse therapy were compared with untreated patients, using overlap weighting and traditional multivariable regression analysis to evaluate the impact of steroid pulse therapy on prognosis., Results: 412 SFTS patients were included in this study, and 66 (16%) underwent steroid pulse therapy within 3 days of admission and were allocated to the steroid pulse therapy group. After overlap weighting, patients in the steroid pulse therapy group had a significantly higher in-hospital mortality rate than patients in the control group (31.1% vs. 20.5%; difference: +10.6%; 95% confidence interval: +2.2% to +19.0%). There were no statistically significant differences in hospitalization cost and length of hospital stay between the two groups. The results of the sensitivity analysis using traditional multivariable regression were similar to those of the main analysis., Conclusion: In the analysis of SFTS patients using the Japanese Diagnosis Procedure Combination inpatient data, steroid pulse therapy did not improve patient prognosis. The evidence does not support the universal use of steroid pulse therapy in patients with severe SFTS., Competing Interests: Declaration of competing interest None., (Copyright © 2023 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Background: The optimal surgical procedure to reduce the recurrence rate of chronic subdural hematoma (CSDH) after burr-hole surgery remains to be established. This study aimed to investigate the association between artificial cerebrospinal fluid (ACF) use during burr-hole surgery and reoperation rate in patients with CSDH., Method: In this retrospective cohort study, we used the Japanese Diagnostic Procedure Combination inpatient database. We identified patients aged 40-90 years who were hospitalized for CSDH and had undergone burr-hole surgery within 2 days of admission, between July 1, 2010 and March 31, 2019. We performed a one-to-one propensity score-matched analysis to compare the outcomes between patients with and without ACF irrigation during burr-hole surgery. The primary outcome was reoperation within 1 year of surgery. The secondary outcome was the total hospitalization costs., Results: Of the 149,543 patients with CSDH from 1100 hospitals, ACF was used in 32,748 patients (21.9%). Propensity score matching created highly balanced 13,894 matched pairs. In the matched patients, the reoperation rate was significantly lower in the ACF users than that in the non-users group (6.3% vs. 7.0%, P = 0.015), with a risk difference of -0.8% (95% confidence interval, -1.5 to -0.2). There was no significant difference in the total hospitalization costs between the two groups (5079 vs. 5042 US dollars, P = 0.330)., Conclusions: ACF use during burr-hole surgery may be associated with lower reoperation rate in patients with CSDH., (© 2023. The Author(s).)

Background: Current guidelines recommend systemic thrombolysis as the first-line reperfusion treatment for patients with high-risk pulmonary embolism (PE) who present with cardiogenic shock but do not require venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, little is known about the optimal reperfusion treatment in high-risk PE patients requiring VA-ECMO. We aimed to evaluate whether systemic thrombolysis improved high-risk PE patients' outcomes who received VA-ECMO., Methods: This was a retrospective cohort study using the Japanese Diagnosis Procedure Combination inpatient database from July 2010 to March 2021. We identified patients who were diagnosed with PE and received VA-ECMO on the day of admission. Patients who received systemic thrombolysis with monteplase or urokinase within two days of initiating VA-ECMO were defined as the thrombolysis group and the remaining patients as the control group. The primary outcome was in-hospital mortality and secondary outcomes were favorable neurological outcomes, length of hospital stay, VA-ECMO duration, total hospitalization cost, major bleeding, and blood transfusion volume. Propensity-score inverse probability of treatment weighting (IPTW) was performed to compare the outcomes between the groups., Results: Of 1220 eligible patients, 432 (35%) received systemic thrombolysis within two days of initiating VA-ECMO. Among the unweighted cohort, patients in the thrombolysis group were less likely to have poor consciousness at admission, out-of-hospital cardiac arrest, and left heart catheterization. After IPTW, the patient characteristics were well-balanced between the two groups The crude in-hospital mortality was 52% in the thrombolysis group and 61% in the control group. After IPTW, in-hospital mortality did not differ significantly between the two groups (risk difference: - 3.0%, 95% confidence interval: - 9.6% to 3.5%). There were also no significant differences in the secondary outcomes. Sensitivity analyses showed a significant difference in major bleeding between the monteplase and control groups (risk difference: 6.9%, 95% confidence interval: 1.7% to 12.1%), excluding patients who received urokinase. There were no significant differences in the other sensitivity and subgroup analyses except for the total hospitalization cost., Conclusions: Systemic thrombolysis was not associated with reduced in-hospital mortality or increased major bleeding in the high-risk PE patients receiving VA-ECMO. However, systemic thrombolysis with monteplase was associated with increased major bleeding., (© 2023. The Author(s).)

Purpose: This study aimed to develop an ancestry-specific polygenic risk scores (PRSs) for the prediction of breast cancer events in Japanese females and validate it in a longitudinal cohort study., Methods: Using publicly available summary statistics of female breast cancer genome-wide association study (GWAS) of Japanese and European ancestries, we, respectively, developed 31 candidate genome-wide PRSs using pruning and thresholding (P + T) and LDpred methods with varying parameters. Among the candidate PRS models, the best model was selected using a case-cohort dataset (63 breast cancer cases and 2213 sub-cohorts of Japanese females during a median follow-up of 11.9 years) according to the maximal predictive ability by Harrell's C-statistics. The best-performing PRS for each derivation GWAS was evaluated in another independent case-cohort dataset (260 breast cancer cases and 7845 sub-cohorts of Japanese females during a median follow-up of 16.9 years)., Results: For the best PRS model involving 46,861 single nucleotide polymorphisms (SNPs; P + T method with P T  = 0.05 and R 2  = 0.2) derived from Japanese-ancestry GWAS, the Harrell's C-statistic was 0.598 ± 0.018 in the evaluation dataset. The age-adjusted hazard ratio for breast cancer in females with the highest PRS quintile compared with those in the lowest PRS quintile was 2.47 (95% confidence intervals, 1.64-3.70). The PRS constructed using Japanese-ancestry GWAS demonstrated better predictive performance for breast cancer in Japanese females than that using European-ancestry GWAS (Harrell's C-statistics 0.598 versus 0.586)., Conclusion: This study developed a breast cancer PRS for Japanese females and demonstrated the usefulness of the PRS for breast cancer risk stratification., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The optimal timing of antibiotic administration in patients with a liver abscess undergoing liver aspiration or drainage is unknown., Methods: This was a retrospective cohort study using the Diagnosis Procedure Combination database, a national inpatient database in Japan., Results: A total of 34,424 patients who were emergently hospitalized due to liver abscess between July 2010 and March 2020 were included. Of these, 31,248 (90.8%) received antibiotics on the day of admission (early antibiotics group), and 3176 (9.2%) did not (delayed antibiotics group). Multivariable logistic regression analyses showed that in-hospital mortality of patients in the early antibiotics group was significantly lower than that in the delayed antibiotics group (odds ratio, 0.61; 95% confidence interval, 0.52-0.72; p <0.001). Patients in the early antibiotics group had a significantly lower proportion of clinical deterioration (odds ratio, 0.73; 95% confidence interval, 0.63-0.84; p <0.001) and shorter length of stay (adjusted difference, -5.2 days; 95% confidence interval, -6.2 to -4.1 days; p <0.001) than those in the delayed antibiotics group., Conclusions: Starting antibiotic treatment on the day of admission was associated with lower mortality, a lower proportion of clinical deterioration, and a shorter length of hospital stay., Competing Interests: Declaration of competing interest All authors do not have a commercial or other association that might pose a conflict of interest., (Copyright © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Background: The coronavirus disease 2019 (COVID-19) pandemic has disrupted critical care services worldwide. Examining how critical care systems responded to the COVID-19 pandemic on a national level will be useful in setting future critical care plans. The present study aimed to describe the utilization of critical care services before and during the COVID-19 pandemic using a nationwide Japanese inpatient administrative database., Methods: All patients admitted to an intensive care unit (ICU) or a high-dependency care unit (HDU) from February 9, 2019, to February 8, 2021, in the Japanese Diagnosis Procedure Combination inpatient database were included. February 9, 2020, was used as the breakpoint separating the periods before and during COVID-19 pandemic. Hospital and patient characteristics were compared before and during the COVID-19 pandemic. Change in ICU and HDU bed occupancy before and during the COVID-19 pandemic was evaluated using interrupted time-series analysis., Results: The number of ICU patients before and during the COVID-19 pandemic was 297,679 and 277,799, respectively, and the number of HDU patients was 408,005 and 384,647, respectively. In the participating hospitals (383 ICU-equipped hospitals and 460 HDU-equipped hospitals), the number of hospitals which increased the ICU and HDU beds capacity were 14 (3.7%) and 33 (7.2%), respectively. Patient characteristics and outcomes in ICU and HDU were similar before and during the COVID-19 pandemic except main etiology for admission of COVID-19. The mean ICU bed occupancy before and during the COVID-19 pandemic was 51.5% and 47.5%, respectively. The interrupted time-series analysis showed a downward level change in ICU bed occupancy during the COVID-19 pandemic (- 4.29%, 95% confidence intervals - 5.69 to - 2.88%), and HDU bed occupancy showed similar trends. Of 383 hospitals with ICUs, 232 (60.6%) treated COVID-19 patients in their ICUs. Their annual hospital case volume of COVID-19 ICU patients varied greatly, with a median of 10 (interquartile range 3-25, min 1, max 444)., Conclusions: The ICU and HDU bed capacity did not increase while their bed occupancy decreased during the COVID-19 pandemic in Japan. There was no change in clinicians' decision-making to forego ICU/HDU care for selected patients, and there was no progress in the centralization of critically ill COVID-19 patients., (© 2022. The Author(s).)

Objectives: Although existing guidelines recommend commencing cannulation for extracorporeal cardiopulmonary resuscitation (ECPR) within 10-20 minutes of failed conventional resuscitation efforts for cardiac arrest, there is little supportive evidence. The present study aimed to determine the association of low-flow duration with survival-to-discharge rate in in-hospital cardiac arrest patients who received ECPR., Design: A nationwide retrospective cohort study analyzed a nationwide inpatient database in Japan. Low-flow duration was defined as the time interval from initiation of chest compression to termination of chest compression. We assessed the association between low-flow duration and survival-to-discharge rate by predicting estimates with covariate adjustment stratified by categories of low-flow duration., Setting: More than 1,600 acute-care hospitals in Japan., Patients: All in-hospital cardiac arrest patients greater than or equal to 18 years old who received ECPR during hospitalization from July 2010 to March 2018., Interventions: None., Measurements and Main Results: Among 303,319 in-hospital cardiac arrest patients, 9,844 (3.2%) received ECPR in 697 hospitals during the study period and 9,433 were eligible in the study. The overall survival-to-discharge rate was 20.5% (1,932/9,433). The median low-flow duration was 26.0 minutes (interquartile range, 12.0-46.0 min) in the overall cohort. The highest and lowest estimated survival-to-discharge rates were 35.1% in the group with low-flow duration 0-5 minutes and 7.9% in the group with low-flow duration greater than 90 minutes. The estimated survival-to-discharge rate dropped sharply by about 20% during the first 35 minutes of low-flow duration (decreasing by about 3% every 5 min), followed by small decreases after the first 35 minutes., Conclusions: The estimated survival-to-discharge rate was markedly decreased by approximately 20% during the first 35 minutes of low-flow duration. Whether we should wait for the first 10-20 minutes of cardiac arrest without preparing for ECPR is questionable., Competing Interests: Dr. Yasunaga’s institution received funding from the Ministry of Health, Labour, and Welfare, Japan, and the Ministry of Education, Culture, Sports, Science and Technology, Japan. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2022 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Background: Patients with traumatic brain injury associated with intracranial hemorrhage are commonly admitted to the intensive care unit (ICU); however, the need for ICU care for patients with isolated traumatic subarachnoid hemorrhage (tSAH) remains unclear. We aimed to investigate the association between the ICU admission practices and outcomes in patients with isolated tSAH., Methods: This observational study used a nationwide administrative database in Japan. We identified patients with isolated tSAH from the Japanese Diagnostic Procedure Combination inpatient database from July 1, 2010, to March 31, 2020. The primary outcome was in-hospital mortality, whereas the secondary outcomes were neurosurgical interventions, activities of daily living at discharge, and total hospitalization cost. We performed a risk-adjusted mixed-effect regression analysis to evaluate the association between hospital-level ICU admission rates and study outcomes. The ICU admission rates were categorized into quartiles: lowest, middle-low, middle-high, and highest. Moreover, we assessed the robustness of the results with a patient-level instrumental variable analysis., Results: Of the 61,883 patients with isolated tSAH treated at 962 hospitals, 16,898 (27.3%) patients were admitted to the ICU on the day of admission. Overall, 2465 (4.0%) patients died in the hospital, and 783 (1.3%) patients underwent neurosurgical interventions. There was no significant difference between the lowest and highest ICU admission quartile in terms of in-hospital mortality (3.7% vs. 4.3%; adjusted odds ratio 0.93; 95% confidence interval [CI] 0.78-1.10), neurosurgical interventions, and activities of daily living at discharge. However, the total hospitalization cost in the lowest ICU admission quartile was significantly lower than that in the highest quartile (US $3032 vs. $4095; adjusted difference US $560; 95% CI 33-1087). The patient-level instrumental variable analysis did not reveal a significant difference in in-hospital mortality between the patients who were admitted to the ICU and those who were not (risk difference 0.2%; 95% CI - 0.1 to 0.5)., Conclusions: There was no significant association between the ICU admission practices and outcomes in patients with isolated tSAH, whereas higher ICU admission rates were associated with significantly higher hospitalization costs. Our results provide an opportunity for improved health care allocation in the management of patients with isolated tSAH., (© 2022. Springer Science+Business Media, LLC, part of Springer Nature and Neurocritical Care Society.)

Objectives: This study aim to evaluate the effectiveness of fluoroquinolone (FQ) antimicrobial therapy in combination with tetracyclines (TCs) in patients with Japanese spotted fever (JSF) using a nationwide inpatient database in Japan., Methods: We identified hospitalized patients diagnosed with JSF who were enrolled in the Japanese Diagnosis Procedure Combination inpatient database from July 2010 to March 2021. Patients who received FQ plus TC on the day of admission were compared with patients who received TC alone on the day of admission, using inverse probability of treatment weighting. The primary outcome was in-hospital mortality. Secondary outcomes were in-hospital complications, total hospitalization costs, and length of hospital stay., Results: We identified 1060 eligible patients. Of these, 434 (41%) received FQ plus TC on the day of admission and 626 (59%) received TC alone on the day of admission. Inverse probability of treatment weighting showed no statistically significant differences between the groups in in-hospital mortality, in-hospital complications, total hospitalization costs, and length of hospital stay., Conclusion: This study did not show any significantly improved effectiveness using FQ antimicrobials in combination with TCs for treating JSF. Clinicians may need to be cautious in administering FQ and TC antimicrobials concomitantly in routine practice., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: The appropriate level of postoperative critical care for patients undergoing emergency surgery is unknown. We aimed to assess the outcomes of postoperative patients treated in the intensive care unit (ICU) and high dependency care unit (HDU) after emergency surgery., Methods: Analysis of national in-patient registry data in Japan from July 2010 to March 2018, including patients undergoing one of 10 emergency surgeries on the day of hospital admission. The exposures were ICU or HDU admission on the day of surgery. The primary outcome was in-hospital mortality. We performed multivariable logistic regression analysis adjusted for patient and hospital characteristics. Results are presented as n (%) and odds ratios (ORs) with 95% confidence intervals., Results: We included 158 149 patients from 646 hospitals. Crude in-hospital mortality for each procedure ranged from 168/8583 (2.0%) for cholecystectomy to 2842/12 958 (21.9%) for patients undergoing surgery for traumatic brain injury. Compared with HDU admission, ICU admission was associated with lower in-hospital mortality among the cohorts for medium-mortality risk procedures (procedure-specific mortality 5-15%) (ICU: 8834/73 616 [12.0%] vs HDU: 2586/25 262 [10.2%]; OR=0.90 [0.85-0.96]; P=0.001), and high-mortality risk procedures (procedures-specific mortality >15%) (ICU: 3445/16 334 [21.1%] vs HDU: 996/4613 [21.6%]; OR=0.86 [0.78-0.96]; P=0.005). There were no differences in mortality for low-mortality risk procedures with procedure-specific mortality <5%., Conclusions: In this national registry study, postoperative critical care in ICU was associated with lower in-hospital mortality than in HDU for patients undergoing medium-risk and high-risk emergency surgery. Further research is needed to understand the role of critical care for surgical patients., (Copyright © 2022 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

Background: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used for postpartum hemorrhage (PPH), which is one of the leading causes of maternal mortality worldwide; however, its utility in the obstetrics setting remains unclear. Thus, this study aimed to describe the characteristics, demographics, and mortality of patients with PPH who underwent REBOA., Methods: We used the Japanese Diagnosis Procedure Combination inpatient database to identify patients with PPH who underwent REBOA from April 2012 to March 2020. We examined the patients' characteristics, interventions administered, and in-hospital mortality., Results: We identified 143 patients with PPH who underwent REBOA. The most common cause of PPH was atonic postpartum hemorrhage (52.4%), followed by disseminated intravascular coagulation (29.4%) and amniotic fluid embolism documented (11.2%). Among patients who delivered at hospitals in which REBOA was performed (n = 55), 38.2% of patients experienced preterm births, and 70.9% delivered via cesarean delivery. The proportion of patients who underwent transcatheter arterial embolization and hysterectomy was 53.8% and 16.1%, respectively. In-hospital mortality was 7.0%., Conclusion: The results of the present study could be helpful in clinical decision making and providing patients and families with additional treatment options for PPH., Level of Evidence: Therapeutic/Care Management; Level IV., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Exercise immediately after aortic surgery is controversial with limited evidence. The present study aimed to assess whether early rehabilitation commencing within 3 days of aortic surgery improves physical functions at discharge more than usual care in patients after aortic surgery., Methods: We used the Japanese Diagnosis Procedure Combination database, a nationwide inpatient database from more than 1600 acute care hospitals that covers approximately 75% of all intensive care unit (ICU) beds in Japan. We identified patients who underwent open or endovascular aortic surgery and were admitted to the ICU between July 2010 and March 2018. Patients beginning rehabilitation within 3 days of aortic surgery were defined as the early rehabilitation group and the remaining patients as the usual care group. We used inverse probability of treatment weighting analyses to compare outcomes between the two groups., Results: Among 121,024 eligible patients, there were 44,746 (37.0%) in the early rehabilitation group and 76,278 (63.0%) in the usual care group. In inverse probability of treatment weighting analyses, Barthel index scores at discharge were significantly higher in the early rehabilitation group than in the usual care group (difference, 4.0; 95% confidence interval, 2.8-5.2). The early rehabilitation group had significantly lower in-hospital mortality, lower total hospitalization costs, shorter ICU stay, and shorter hospital stay than the usual care group., Conclusion: Early rehabilitation within 3 days of aortic surgery was associated with improved physical functions at discharge, shorter ICU and hospital stays, and lower hospitalization costs without increased mortality., (© 2022. The Author(s), under exclusive licence to The Japanese Association for Thoracic Surgery.)

Objective: Adjuvant medical treatment to reduce the recurrence rate after burr hole surgery for chronic subdural hematoma (CSDH) has not yet been established. This study aimed to investigate the association between tranexamic acid (TXA) use after burr hole surgery and the reoperation rate in patients with CSDH., Methods: This observational study used the Japanese Diagnostic Procedure Combination inpatient database, a nationwide inpatient database in Japan, from July 1, 2010, to March 31, 2019. The authors identified patients who were hospitalized for CSDH and underwent burr hole surgery within 2 days of admission. The primary outcome measure was reoperation within 1 year after surgery. One-to-one propensity score-matched analysis was performed to compare the outcomes between patients who started oral TXA within 2 days after surgery (TXA users) and those who did not (TXA nonusers). Robustness of the analyses was assessed using the instrumental variable analysis., Results: Of the 149,543 patients with CSDH treated at 1100 hospitals, 7366 (4.9%) were TXA users. Propensity score matching created 6564 matched pairs with highly balanced baseline characteristics. The reoperation rate was significantly lower in TXA users than in nonusers (1.9% vs 6.1%, p < 0.001) with a risk difference of -4.1% (95% CI -4.8% to -3.4%). There was no significant difference in composite adverse events (0.6% vs 0.5%, p = 0.817). Total hospitalization costs were also significantly lower in TXA users than in nonusers ($5229 vs $5344 [USD], p < 0.001). The results of the instrumental variable analysis were consistent with those of the propensity score-matched analysis., Conclusions: Findings of this study, using a nationwide inpatient database, suggest that adjuvant TXA use after burr hole surgery was associated with a reduced reoperation rate in patients with CSDH.

Background: Hormonal therapy and radiotherapy are conducted concurrently or sequentially after breast cancer surgery. It remains unclear whether concurrent or sequential treatment is safer in terms of lung complications. Using a Japanese nationwide database, this study aimed to compare the occurrence of severe lung complications between concurrent and sequential treatments., Methods: We identified patients who underwent partial mastectomy for stage 0-III breast cancer from July 2010 to March 2020 and received adjuvant hormonal therapy and radiotherapy concurrently (n = 1851) or sequentially (n = 18,429). Two propensity score analyses (1:4 matching and overlap weighting) were conducted to compare hospitalization for radiation pneumonitis and pneumonia within 1 year after surgery, and intensive care unit admission and mortality during the hospitalization. We conducted additional analyses stratified by hormonal drugs (aromatase inhibitors and tamoxifen)., Results: The propensity score-matched analysis showed no significant differences in occurrence of hospitalization for radiation pneumonitis (0.27 vs. 0.58%, p = 0.10) and pneumonia (0.16 vs. 0.58%, p = 0.05) between the concurrent and sequential treatments. The overlap propensity score-weighted analysis also showed no significant differences (0.25 vs. 0.56%, p = 0.08 and 0.15 vs. 0.44%, p = 0.06, respectively). Intensive care unit admission and in-hospital mortality did not differ significantly between the two treatments. The stratified analysis showed similar results., Conclusion: Our propensity score analyses revealed no significant differences in severe lung complications between concurrent and sequential hormonal therapy with radiotherapy following breast cancer surgery, regardless of the type of hormonal drugs. Clinicians can provide concurrent or sequential treatment with equivalent attention to early lung complications., (© 2022. The Author(s), under exclusive licence to The Japanese Breast Cancer Society.)

Rationale: In Japan, the government officially issued intensive care unit (ICU) admission criteria that require ICUs to admit patients who need a certain level of monitoring and procedures to ensure their reimbursement for ICU costs from April 2014. Objectives: To assess whether the newly issued health policy on ICU admission criteria based on financial incentives for monitoring and procedures had any impact on clinical practices, outcomes, and ICU bed occupancy. Methods: Using a nationwide inpatient health claims database in Japan, we identified patients who were admitted to the ICU from April 2012 to March 2018. Outcomes were monitoring and procedures in the ICU, clinical outcomes, and ICU bed occupancy. The outcomes of monitoring and procedures and clinical outcomes were adjusted for patient characteristics. Interrupted time-series analyses were used to compare the trends in outcomes for two separate periods before and after the issue of the new health policy on ICU admission criteria in April 2014. Results: A total of 1,660,601 patients in 259 ICU-equipped hospitals were eligible. There were significant upward slope changes between the pre- and post-issue periods for all monitoring and procedures in the ICU, including invasive arterial pressure monitoring (5.62% change in trend per year; 95% confidence interval [CI], 4.75-6.49%) and central venous pressure monitoring (1.22% change in trend per year; 95% CI, 0.78-1.67%). There was no significant slope change between the pre- and post-issue periods for in-hospital mortality, but there were significant upward slope changes for complications of pneumonia (0.27% change in trend per year; 95% CI, 0.14-0.39%) and catheter-related bloodstream infection (0.02% change in trend per year; 95% CI, 0.00-0.14%). There were also significant upward slope changes in length of hospital stay, length of ICU stay, and hospitalization costs between the pre- and post-issue periods. There was no significant slope change between the pre- and post-issue periods for ICU bed occupancy. Conclusions: The health policy on ICU admission criteria based on financial incentives for actions taken by providers was associated with increased monitoring and procedures, complications, lengths of hospital and ICU stay, and hospitalization costs without decreasing ICU bed occupancy.

Objectives: To compare the outcomes of patients with acute myocardial infarction who were treated in ICUs versus high-dependency care units (HDUs)., Design: A nationwide, propensity score-matched, retrospective cohort study of a national administrative inpatient database in Japan from July 2010 to March 2018., Setting: Six hundred sixty-six acute-care hospitals with ICU and/or HDU beds covering about 75% of all ICU beds and 70% of all HDU beds in Japan., Patients: Adult patients who were hospitalized for acute myocardial infarction and admitted to the ICU or HDU on the day of hospital admission. Propensity score-matching analysis was performed to compare the inhospital mortality between patients treated in the ICU and HDU on the day of hospital admission., Interventions: ICU or HDU admission on the day of hospital admission., Measurements and Main Results: Of 135,142 eligible patients, 89,382 (66%) were admitted to the ICU and 45,760 (34%) were admitted to the HDU on the day of admission. After propensity score matching, there was no statistically significant difference in inhospital mortality between the ICU and HDU groups (5.0% vs 5.5%; difference, -0.5%; 95% CI, -1.0% to 0.1%). In the subgroup analyses, inhospital mortality was significantly lower in the ICU group than that in the HDU group among patients with Killip class IV (25.6% vs 28.4%; difference, -2.9%; 95% CI, -5.4% to -0.3%), patients who underwent intubation (40.0% vs 46.6%; difference, -6.6%; 95% CI, -10.6% to -2.7%), and patients who received mechanical circulatory support (21.8% vs 24.7%; difference, -2.8%; 95% CI, -5.5% to -0.2%)., Conclusions: Critical care in the ICU compared with that in the HDU was not associated with reduced inhospital mortality among the entire cohort of patients with acute myocardial infarction but was associated with reduced inhospital mortality among the subsets of patients with Killip class IV, intubation, or mechanical circulatory support., Competing Interests: Dr. Yasunaga’s institution received funding from the Ministry of Health, Labour, and Welfare, Japan and the Ministry of Education, Culture, Sports, Science and Technology, Japan. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2022 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

Purpose: We aimed to develop and validate models for predicting new-onset functional impairment after intensive care unit (ICU) admission with predictors routinely collected within 2 days of admission., Methods: In this multi-center retrospective cohort study of acute care hospitals in Japan, we identified adult patients who were admitted to the ICU with independent activities of daily living before hospitalization and survived for at least 2 days from April 2014 to October 2020. The primary outcome was functional impairment defined as Barthel Index ≤ 60 at hospital discharge. In the internal validation dataset (April 2014 to March 2019), using routinely collected 94 candidate predictors within 2 days of ICU admission, we trained and tuned the six conventional and machine-learning models with repeated random sub-sampling cross-validation. We computed the variable importance of each predictor to the models. In the temporal validation dataset (April 2019 to October 2020), we measured the performance of these models., Results: We identified 19,846 eligible patients. Functional impairment at discharge was developed in 33% of patients (n = 6488/19,846). In the temporal validation dataset, all six models showed good discrimination ability with areas under the curve above 0.86, and the differences among the six models were negligible. Variable importance revealed newly detected early predictors, including worsened neurologic conditions and catabolism biomarkers such as decreased serum albumin and increased blood urea nitrogen., Conclusion: We successfully developed early prediction models of new-onset functional impairment after ICU admission that achieved high performance using only data routinely collected within 2 days of ICU admission., (© 2022. Springer-Verlag GmbH Germany, part of Springer Nature.)

Competing Interests: None

Background: Although numerous studies have investigated out-of-hospital cardiac arrest, few studies have been conducted on in-hospital cardiac arrest (IHCA). Knowledge of the nationwide epidemiology of IHCA in Japan, with its super-aging society, is important to understand the current situation of IHCA and to establish evidenced-based medicine in the future. The present study aimed to determine the incidence and outcomes of IHCA and their trends in Japan., Methods: This observational cohort study was performed using a national administrative inpatient database for more than 1600 acute-care hospitals covering about 50% of all acute-care hospital beds in Japan from April 2011 to March 2018. We defined cardiac arrest patients who received cardiopulmonary resuscitation (chest compression) during hospitalization as IHCA. We excluded out-of-hospital cardiac arrest patients from the source population. The incidence of IHCA per 1000 hospital admissions and survival to discharge rate was reported with trend analyses by calendar year 2011-2017., Results: Among 53,871,101 hospitalized patients without out-of-hospital cardiac arrest patients in 1626 hospitals, 2,136,038 (4.0%) had cardiac arrest. Of them, 274,664 (12.9%) received cardiopulmonary resuscitation at least once during hospitalization and were identified as IHCA, and 1,861,374 (87.1%) did not receive cardiopulmonary resuscitation. The incidence of IHCA per 1000 hospital admissions was 5.1, with a significant decreasing trend from 6.1 in 2011 to 4.6 in 2017 (P for trend = 0.033). Our estimated incidence can be translated to approximately 87,000 IHCA cases in Japan each year. The percentage of IHCA patients among cardiac arrest patients was 12.9%, with a significant decreasing trend from 14.0% in 2011 to 12.2% in 2017 (P for trend = 0.006). The overall rate of survival to discharge was 12.7%, with a significant increasing trend from 10.5% in 2011 to 14.0% in 2017 (P for trend < 0.001)., Conclusions: We found substantial associations between mortality and loss of health and IHCA in Japan. The incidence of IHCA showed a decreasing trend over time, the percentage of treated cardiac arrest patients also had a decreasing trend, and the overall survival to discharge rate improved over time., (© 2022. The Author(s).)

Background: COVID-19 has worse mortality than influenza in American and European studies, but evidence from the Western Pacific region is scarce., Methods: Using a large-scale multicenter inpatient claims data in Japan, we identified individuals hospitalised with COVID-19 in 2020 or influenza in 2017-2020. We compared patient characteristics, supportive care, and in-hospital mortality, with multivariable logistic regression analyses for in-hospital mortality overall, by age group, and among patients with mechanical ventilation., Findings: We identified 16,790 COVID-19 patients and 27,870 influenza patients, with the different age distribution (peak at 70-89 years in COVID-19 vs. bimodal peaks at 0-9 and 80-89 years in influenza). On admission, the use of mechanical ventilation was similar in both groups (1·4% vs. 1·4%) but higher in the COVID-19 group (3·3% vs. 2·5%; p<0·0001) during the entire hospitalisation. The crude in-hospital mortality was 5·1% (856/16,790) for COVID-19 and 2·8% (791/27,870) for influenza. Adjusted for potential confounders, the in-hospital mortality was higher for COVID-19 than for influenza (adjusted odds ratio [aOR] 1·83, 95% confidence interval [CI] 1·64-2·04). In age-stratified analyses, the aOR (95%CI) were 0·78 (0·56-1·08) and 2·05 (1·83-2·30) in patients aged 20-69 years and ≥70 years, respectively (p-for-interaction<0·0001). Among patients with mechanical ventilation, the aOR was 0·79 (0·59-1·05)., Interpretation: Patients hospitalised with COVID-19 in Japan were more likely to die than those with influenza. However, this was mainly driven by findings in older people, and there was no difference once mechanical ventilation was started., Funding: Ministry of Health, Labour and Welfare of Japan (21AA2007)., Competing Interests: Atsushi Miyawaki has a joint research project with Medical Data Vision Co., Ltd. outside of this study and received labour contributions in the financial year 2020., (© 2021 The Author(s).)

Background: A structure and staffing model similar to that in general intensive care unit (ICUs) is applied to cardiac intensive care unit (CICUs) for patients with acute heart failure. However, there is limited evidence on the structure and staffing model of CICUs. The present study aimed to assess whether critical care for patients with acute heart failure in the ICUs is associated with improved outcomes than care in the high-dependency care units (HDUs), the hospital units in which patient care levels and costs are between the levels found in the ICU and general ward., Methods: This nationwide, propensity score-matched, retrospective cohort study was performed using a national administrative inpatient database in Japan. We identified all patients who were hospitalized for acute heart failure and admitted to the ICU or HDU on the day of hospital admission from April 2014 to March 2019. Propensity score-matching analysis was performed to compare the in-hospital mortality between acute heart failure patients treated in the ICU and HDU on the day of hospital admission., Results: Of 202,866 eligible patients, 78,646 (39%) and 124,220 (61%) were admitted to the ICU and HDU, respectively, on the day of admission. After propensity score matching, there was no statistically significant difference in in-hospital mortality between patients who were admitted to the ICU and HDU on the day of admission (10.7% vs. 11.4%; difference, - 0.6%; 95% confidence interval, - 1.5% to 0.2%). In the subgroup analyses, there was a statistically significant difference in in-hospital mortality between the ICU and HDU groups among patients receiving noninvasive ventilation (9.4% vs. 10.5%; difference, - 1.0%; 95% confidence interval, - 1.9% to - 0.1%) and patients receiving intubation (32.5% vs. 40.6%; difference, - 8.0%; 95% confidence interval, - 14.5% to - 1.5%). There were no statistically significant differences in other subgroup analyses., Conclusions: Critical care in ICUs was not associated with lower in-hospital mortality than critical care in HDUs among patients with acute heart failure. However, critical care in ICUs was associated with lower in-hospital mortality than critical care in HDUs among patients receiving noninvasive ventilation and intubation., (© 2021. The Author(s).)

Background: The association of simultaneous bilateral total hip arthroplasty (THA) with postoperative deep venous thrombosis (DVT) remains controversial. The aim of the study is to determine whether simultaneous bilateral THA without chemoprophylaxis has a higher risk than unilateral THA without chemoprophylaxis., Methods: This is a population-based retrospective cohort study of all adults who underwent primary THA without any anticoagulant or antiplatelet therapy between July 2012 and March 2021 at the Department of Orthopedic Surgery, Toranomon Hospital, Tokyo, Japan. The association of simultaneous bilateral THA with postoperative DVT was examined by unadjusted analysis and overlap propensity score weighting. The primary outcome was the incidence of DVT (confirmed by ultrasonography of the lower limb veins) within 7 days postoperatively., Results: Of the 557 consecutive patients who underwent primary THA in the study period, 458 met the inclusion criteria. The mean (standard deviation) age of these patients was 67 (11.7) years, and 364 (79.5%) were women; 75 (16.4%) of the 458 patients underwent simultaneous bilateral THA, and 383 (83.6%), unilateral THA. A total of 64 patients (14.0%) developed a postoperative venous thromboembolism, all of which were a distal DVT. The overlap weighting analysis found no significant difference in the incidence of postoperative DVT complications among patients who underwent simultaneous bilateral THA and those who underwent unilateral THA (31.1 [13.6%] vs 22.9 [10.0%], respectively; risk ratio, 1.36; 95% confidence interval, 0.67 to 2.77; P  = .40)., Conclusions: Our findings indicate that the occurrence of DVT within 7 days after surgery is not significantly different between patients undergoing simultaneous bilateral THA or unilateral THA without any anticoagulant or antiplatelet therapy ., Level of Evidence: Level II-III., (© 2021 The Authors.)

Background: Daikenchuto, a Japanese herbal Kampo medicine, is used to improve gastrointestinal motility in critically ill patients with enteral feeding intolerance (EFI) in Japan. The present study aimed to investigate the effect of Daikenchuto for critically ill patients with EFI., Methods: Using the Japanese Diagnosis Procedure Combination inpatient database from July 2010 to March 2018, we identified mechanically ventilated patients in intensive care units (ICUs) who had EFI during mechanical ventilation. We defined EFI as receipt of intravenous metoclopramide during mechanical ventilation. Patients who started Daikenchuto within 2 days of EFI onset were defined as the Daikenchuto group, and the remaining patients were defined as the control group. Propensity score-matched analyses were performed to compare the outcomes between the 2 groups., Results: A total of 61,454 patients were included. Of these, 8842 patients (14%) were in the Daikenchuto group. One-to-one propensity score matching created 8701 matched pairs. After propensity score matching, the total number of days receiving enteral nutrition within 28 days of EFI onset was significantly longer in the Daikenchuto group than in the control group (risk difference, 0.9 days; 95% CI, 0.5-1.3 days). There were no significant differences in 28-day in-hospital mortality, hospital-acquired pneumonia, ventilator-free days, length of ICU stay, time to discharge alive, and adverse complications., Conclusion: This nationwide observational study suggested that use of Daikenchuto may increase the total number of days receiving enteral nutrition in mechanically ventilated patients with EFI., (© 2021 American Society for Parenteral and Enteral Nutrition.)

Background: Previous prospective studies have suggested that spouses of patients who are admitted to the intensive care unit (ICU) have a high prevalence of mental disorders, termed post-intensive care syndrome-family (PICS-F). However, it remains unclear whether the patient's ICU admission is associated with the occurrence of mental disorders in the spouse outside of the prospective study setting. We therefore investigated the proportion of ICU patients' spouses who visited medical facilities for mental disorders and the association between ICU admission of a patient and mental disorders in the spouse using real-world data., Methods: This was a retrospective matched-pair cohort study using commercially available, routinely collected administrative claims data. As the study population, we identified all married couples (both wife and husband) who were registered in the database from 1 April 2012 to 31 August 2018 using family identification codes. We identified spouses of patients who were admitted to the ICU for more than 2 days as the exposure group and defined the date of admission to the ICU as the index date. We randomly matched four individuals in the non-exposure group with one individual in the exposure group. The primary outcome was any PICS-F-related mental disorder in the spouses within 6 months from the index date. As a sensitivity analysis, we also investigated the proportion and association of individuals (excluding spouses) with a history of mental disorders., Results: Among 1,082,208 married couples, we identified 8490 spouses of ICU patients, and they were matched with 33,946 individuals. The proportion of any PICS-F-related mental disorder within 6 months from the index date was 12.8% in ICU patients' spouses and 11.3% in the matched individuals (adjusted odds ratio, 1.29; 95% confidence interval, 1.03-1.42). The sensitivity analysis showed significant associations between ICU admission and spouses' mental disorders., Conclusions: Spouses of patients who were admitted to the ICU had a slightly higher risk of mental disorders within 6 months than spouses of patients who were not admitted to the ICU., (© 2021. The Author(s).)

Introduction: In this present study, we aimed to assess whether care in resource-rich intensive care unit (ICU) was associated with lower ICU mortality compared with care in standard ICU., Methods: This retrospective cohort study used administrative data that are routinely collected in Japan. Using the Japanese Diagnosis Procedure Combination inpatient database, we identified patients aged >15 years who were admitted to the ICU from April 2016 to March 2019. We defined resource-rich ICUs as ICUs with two or more intensivists as full-time employees, ≥20 m 2 per ICU bed, and a medical engineer in the hospital 24 hours per day; other ICUs were categorized as standard ICUs. The primary outcome was ICU mortality. A generalized estimating equation approach with ICUs as the clusters was used to compare ICU mortality between the two groups., Results: Of the 789,630 eligible patients from 458 ICUs, 237,138 (30%) were treated in the 111 resource-rich ICUs, whereas 552,492 (70%) were treated in the 347 standard ICUs. The crude ICU mortality rate was 3.6% (8443/237,138) among patients admitted to resource-rich ICUs, while it was 4.3% (23,490/552,492) among those admitted to standard ICUs. The results of the generalized estimating equation analysis showed that patients treated in resource-rich ICUs tended to have lower ICU mortality compared to patients treated in standard ICUs (difference, -0.4%; 95% confidence interval, -0.8%-0.0%)., Conclusions: The findings of this nationwide study suggest that, compared with care in standard ICUs, care in resource-rich ICUs is associated with lower ICU mortality. This study showed the overall effect of treatment in hospitals with resource-rich ICUs including intensivist staffing and greater hospital resources. Further studies are required to assess the effects of organizational factors on mortality., Competing Interests: None, (Copyright © Japan Medical Association.)

Objectives: This study aimed to evaluate whether early electroconvulsive therapy (ECT) can reduce length of hospital stay and total hospitalization costs in major depressive disorder (MDD) patients., Methods: Using the Japanese Diagnosis Procedure Combination inpatient database from April 2011 to March 2018 linked with the Annual Report for Functions of Medical Institutions, we identified patients admitted for MDD. Patients who received ECT within 8 days of admission were assigned to the early ECT group and the remaining patients to the control group. The primary outcomes were length of hospital stay and total hospitalization costs. The secondary outcomes were in-hospital mortality and fatal adverse events. Propensity score-matched analyses were performed to compare the outcomes between the 2 groups., Results: We identified 41,248 eligible patients, comprising 1169 in the early ECT group and 40,079 in the control group. After 1:1 propensity score matching, patients in the early ECT group had significantly shorter length of hospital stay than those in the control group (difference: -12.6 days; 95% confidence interval: -17.4 to -7.7 days). There was no significant difference in total hospitalization costs between the 2 groups. Early ECT was not significantly associated with increased in-hospital mortality or fatal adverse events., Conclusions: Early ECT may reduce length of hospital stay without increasing total hospitalization costs or fatal adverse events in patients with MDD., Competing Interests: R.Y. reports personal fees from Inter-Riha outside the submitted work. S.K. reports grants and personal fees from Century Medical, Inter-Riha, Teijin Pharma, and Vorpal Technologies outside the submitted work. The other authors have no conflicts of interest or financial disclosures to report., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Many mechanically ventilated patients in Japan are treated in high-dependency care units (HDUs) rather than intensive care units (ICUs). HDUs can provide intermediate-level care with reduced costs; however, there is limited evidence on whether mechanically ventilated patients should be treated in the ICU or HDU., Methods: This was a comparative effectiveness study using a nationwide administrative database in Japan. We identified mechanically ventilated patients with pneumonia in ICU or HDU on the day of admission in the Japanese Diagnosis Procedure Combination inpatient database from April 2014 to March 2019. The primary outcome was 30-day in-hospital mortality. Propensity score matching analysis was performed to compare this outcome between patients treated in the ICU and HDU. The robustness of the analyses was evaluated with multivariable regression, overlap weighting, and instrumental variable analyses., Findings: Of 14,859 mechanically ventilated patients with pneumonia, 7,528 (51%) were treated in the ICU and 7,331 (49%) were treated in the HDU. After propensity score matching, patients treated in the ICU had significantly lower 30-day in-hospital mortality than did those treated in the HDU (24.0% vs. 31.2%; difference, -7.2%; 95% confidence interval, -10.0% to -4.4%). The multivariable regression, overlap weighting, and instrumental variable analyses showed a similar direction and magnitude of association., Interpretation: Critical care for mechanically ventilated patients with pneumonia in the ICU was associated with a 7.2% decrease in 30-day in-hospital mortality vs. care in the HDU. Residual confounding may still play a role in the effect estimates., Funding: This study received funding from Ministry of Health, Labour and Welfare, Japan, and Ministry of Education, Culture, Sports, Science and Technology, Japan., Competing Interests: This work was supported by grants from the Ministry of Health, Labour and Welfare, Japan (19AA2007 and H30-Policy-Designated-004) and the Ministry of Education, Culture, Sports, Science and Technology, Japan (17H04141). The authors report no potential conflicts of interest., (© 2021 The Author(s). Published by Elsevier Ltd.)

Introduction: Existing evidence on the mortality time trends of patients with disseminated intravascular coagulation (DIC) is limited, and whether the mortality trend or quality of care of DIC patients has improved remains unknown. This study aimed to investigate the temporal trend in mortality, patient outcomes, and treatment preferences of several anticoagulants in Japan., Methods: This retrospective observational study used the Japanese Diagnosis Procedure Combination inpatient database, which contains data from more than 1200 acute-care hospitals in Japan. We identified all adult patients that were diagnosed with DIC from July 2010 to March 2018 and sorted them into one of five predefined underlying conditions: sepsis, solid cancer, leukemia, trauma, or obstetric. The data collected as general outcomes were the 28-day mortality and major bleeding events. We also evaluated anticoagulant use for DIC treatment., Results: A total of 325,327 DIC patients were included in this study. Regarding the baseline characteristics, an increase in median age, worsened comorbid conditions, and higher illness severity were observed over time. The underlying conditions for DIC were largely unchanged. Over the study period, the 28-day mortality for overall DIC patients decreased from 41.8% (95% CI 41.2%-42.3%) to 36.1% (95% CI 35.6%-36.6%), which is a 14% decrease over the 8-year period ( P trend < 0.001). The downward trend in mortality was more evident in patients with sepsis and leukemia (15% and 14% decreases, respectively), whereas no clinically meaningful change in mortality occurred in trauma and obstetrics patients. Over time, major bleeding events modestly increased, and the length of hospital stay decreased. The temporal trend in the treatment preferences of anticoagulants for DIC patients clearly changed over time., Conclusions: The overall 28-day mortality for DIC patients clearly decreased from 2010 to 2017. The downward trend in mortality might have resulted from the advances made in the fundamental treatment of underlying diseases and from the changes in anti-DIC strategies., Competing Interests: None, (Copyright © Japan Medical Association.)

Introduction: Clinical guidelines state that disseminated intravascular coagulation (DIC) treatment should be based on three clinical phenotypes: the marked bleeding type (e.g. leukemia, trauma, obstetric diseases, or aortic diseases); organ failure type (sepsis or pancreatitis); and asymptomatic type of DIC (solid cancer). However, among the various underlying disorders of DIC, the clinical presentations of bleeding or organ failure have not to date been well documented. The present study aimed to evaluate whether underlying disorders of DIC would affect clinical outcome including death, organ failure, and bleeding., Methods: Using the Japanese Diagnosis Procedure Combination inpatient database, we identified all adult patients diagnosed with DIC during hospitalization from July 1, 2010, to March 31, 2018. We collected data on patient characteristics and underlying disorders of DIC including sepsis, solid cancer, leukemia, trauma, obstetric diseases, aortic diseases, pancreatitis, and miscellaneous diseases. We counted major bleeding events and calculated an organ failure score for patients during hospitalization., Results: We identified 337,132 patients with DIC. The major disorders underlying DIC were sepsis (42%) and solid cancer (31%). The average organ failure scores of patients with aortic diseases, sepsis, and trauma were 2.8, 2.2, and 2.2, respectively. The percentages with major bleeding events among patients with aortic diseases, trauma, obstetric diseases, and solid cancer were 24%, 15%, 10%, and 10%, respectively., Conclusions: This study suggests that the clinical presentations of bleeding and organ failure are not associated with the three existing clinical phenotypes of DIC or with the underlying disorders of DIC. Therefore, clinical presentation alone may not be sufficient for identifying the clinical phenotypes of DIC. Further research is necessary to develop new strategies for identifying the phenotypes of DIC and improving treatment strategies for individual patients., Competing Interests: None, (Copyright © Japan Medical Association.)