Cerebral Small Vessel Disease Burden for Bleeding Risk during Antithrombotic Therapy: Bleeding with Antithrombotic Therapy 2 Study.

OBJECTIVE: This study was undertaken to determine the excess risk of antithrombotic-related bleeding due to cerebral small vessel disease (SVD) burden. METHODS: In this observational, prospective cohort study, patients with cerebrovascular or cardiovascular diseases taking oral antithrombotic agents were enrolled from 52 hospitals across Japan between 2016 and 2019. Baseline multimodal magnetic resonance imaging acquired under prespecified conditions was assessed by a central diagnostic radiology committee to calculate total SVD score. The primary outcome was major bleeding. Secondary outcomes included bleeding at each site and ischemic events. RESULTS: Of the analyzed 5,250 patients (1,736 women; median age = 73 years, 9,933 patient-years of follow-up), antiplatelets and anticoagulants were administered at baseline in 3,948 and 1,565, respectively. Median SVD score was 2 (interquartile range = 1-3). Incidence rate of major bleeding was 0.39 (per 100 patinet-years) in score 0, 0.56 in score 1, 0.91 in score 2, 1.35 in score 3, and 2.24 in score 4 (adjusted hazard ratio [aHR] for score 4 vs 0 = 5.47, 95% confidence interval [CI] = 2.26-13.23), that of intracranial hemorrhage was 0.11, 0.33, 0.58, 0.99, and 1.06, respectively (aHR = 9.29, 95% CI = 1.99-43.35), and that of ischemic event was 1.82, 2.27, 3.04, 3.91, and 4.07, respectively (aHR = 1.76, 95% CI = 1.08-2.86). In addition, extracranial major bleeding (aHR = 3.43, 95% CI = 1.13-10.38) and gastrointestinal bleeding (aHR = 2.54, 95% CI = 1.02-6.35) significantly increased in SVD score 4 compared to score 0. INTERPRETATION: Total SVD score was predictive for intracranial hemorrhage and probably for extracranial bleeding, suggesting the broader clinical relevance of cerebral SVD as a marker for safe implementation of antithrombotic therapy. ANN NEUROL 2024;95:774-787.

Dual Antiplatelet Therapy With Cilostazol for Secondary Prevention in Lacunar Stroke: Subanalysis of the CSPS.com Trial.

BACKGROUND: The effectiveness of long-term dual antiplatelet therapy (DAPT) to prevent recurrent strokes in patients with lacunar stroke remains unclarified. Therefore, this study aimed to compare and to elucidate the safety and effectiveness of DAPT and single antiplatelet therapy (SAPT) in preventing recurrence in chronic lacunar stroke. METHODS: CSPS.com (Cilostazol Stroke Prevention Study for Antiplatelet Combination) was a prospective, multicenter, randomized controlled trial. In this prespecified subanalysis, 925 patients (mean age, 69.5 years; 69.4% men) with lacunar stroke were selected from 1884 patients with high-risk noncardioembolic stroke, enrolled in the CSPS.com trial after 8 to 180 days following stroke. Patients were randomly assigned to receive either SAPT or DAPT using cilostazol and were followed for 0.5 to 3.5 years. The primary efficacy outcome was the first recurrence of ischemic stroke. The safety outcomes were severe or life-threatening bleeding. RESULTS: The DAPT group receiving cilostazol and either aspirin or clopidogrel and SAPT group receiving aspirin or clopidogrel alone comprised 464 (50.2%) and 461 (49.8%) patients, respectively. Ischemic stroke occurred in 12 of 464 patients (1.84 per 100 patient-years) in the DAPT group and 31 of 461 patients (4.42 per 100 patient-years) in the SAPT group, during follow-up. After adjusting for multiple potential confounding factors, ischemic stroke risk was significantly lower in the DAPT group than in the SAPT group (hazard ratio, 0.43 [95% CI, 0.22-0.84]). The rate of severe or life-threatening hemorrhage did not differ significantly between the groups (2 patients [0.31 per 100 patient-years] versus 6 patients [0.86 per 100 patient-years] in the DAPT and SAPT groups, respectively; hazard ratio, 0.36 [95% CI, 0.07-1.81]). CONCLUSIONS: In patients with lacunar stroke, DAPT using cilostazol had significant benefits in reducing recurrent ischemic stroke incidence compared with SAPT without increasing the risk of severe or life-threatening bleeding. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01995370. URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000012180.

Verifying the Japanese version of the Healthy Aging Brain Care Monitor self-report tool for evaluating post-intensive care syndrome.

BACKGROUND: Post-intensive care syndrome (PICS) requires the use of multiple assessment tools because it affects multiple domains: Cognitive, Functional, and Behavioural/Psychological. Therefore, this study translated the self-report (SR) version of the Healthy Aging Brain Care Monitor (HABC-M), spanning multiple domains, into Japanese and analysed its reliability and validity in a post-intensive care setting. METHODS: Patients aged 20 years or older and admitted to the adult intensive care unit from August 2019 to January 2021 were included and surveyed by questionnaire. The 21-item Dementia Assessment Sheet for the Regional Comprehensive Care System was used to validate cognitive and physical aspects, and the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, and the Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders 5th edition were used to validate emotional aspects. Reliability was assessed by Cronbach's alpha, and congruent validity by correlation analysis. Multivariate linear regression models were used to identify potential factors for PICS. RESULTS: A total of 104 patients (mean age: 64 ± 14 years) with 3 median mechanical ventilation days (interquartile range: 2-5) were enrolled. The Cognitive domain of the HABC-M SR was highly correlated with memory and disorientation (r = 0.77 for each), while the Functional domain was highly correlated with Instrumental Activities of Daily Living Scale (r = 0.75-0.79). The Behavioural/Psychological domain highly correlated with the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders 5th edition (r = 0.75-0.76). Multivariate analysis revealed longer ICU stays associated with lower Cognitive and Functional (p = 0.03 for each) domains and longer mechanical ventilation days with a lower Behavioural/Psychological domain (p < 0.01). CONCLUSION: The translated Japanese HABC-M SR showed high validity for assessment of the Cognitive, Functional, and Behavioural/Psychological domains of PICS. Therefore, we recommend that the Japanese version of the HABC-M SR be routinely used in the assessment of PICS.

Comparative Safety and Effectiveness of Apixaban vs. Warfarin in Oral Anticoagulant-Naïve Japanese Patients With Non-Valvular Atrial Fibrillation　- A Retrospective Chart Review Study.

BACKGROUND: The risk of bleeding and stroke/systemic embolism (SE) events associated with apixaban vs. warfarin among oral anticoagulant-naïve Japanese patients with non-valvular atrial fibrillation (NVAF) has not been well studied in daily clinical practice.Methods and Results:Clinical data for 12,090 patients were retrospectively extracted from the medical records of patients with NVAF (aged ≥20 years, creatinine clearance [CrCl] ≥15 mL/min) newly initiated to apixaban or warfarin treatment between January 1, 2010, and December 31, 2017, at 315 general practitioner clinics and 87 hospitals across Japan. After applying propensity score matching, patient characteristics were well-balanced between the apixaban and warfarin groups (4,523 patients each). The incidence rate (per 100 person-years) of major bleeding was lower in the apixaban vs. warfarin group (1.17 vs. 1.64; hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.54-0.93; P=0.01), as was that of stroke/SE (1.14 vs. 1.73; HR, 0.65; 95% CI, 0.50-0.85; P<0.01). When patients were stratified by CrCl (≥50 mL/min and <50 mL/min), the P value for interaction was not statistically significant between subgroups (P=0.31 for major bleeding and P=0.32 for stroke/SE). CONCLUSIONS: The benefit of apixaban over warfarin for the reduction in risk of major bleeding and stroke/SE could be generalizable to daily clinical practice and to patients with reduced renal function.

COVID-19 vaccine induced interstitial lung disease.

A 60-year-old man presented with dyspnea four days after the second dose of the coronavirus disease (COVID-19) vaccine. Imaging revealed extensive ground-glass opacification. Blood tests were notable for elevated KL-6 levels. Bronchoalveolar lavage fluid analysis showed increased lymphocyte-dominant inflammatory cells and decreased CD4/CD8 ratio. These findings were consistent with the diagnosis of drug-induced interstitial lung disease (DIILD). To the best of our knowledge, this has never been reported in previous literature. Treatment with glucocorticoids relieved his symptoms. This paper highlights that although extremely rare, COVID-19 vaccine could cause DIILD, and early diagnosis and treatment are crucial to improve patient outcomes.

Dual Antiplatelet Therapy Using Cilostazol With Aspirin or Clopidogrel: Subanalysis of the CSPS.com Trial.

Background and Purpose: Although dual antiplatelet therapy (DAPT) with aspirin and clopidogrel reduces the recurrence of ischemic stroke while significantly increasing the bleeding events compared with monotherapy, the CSPS.com trial (Cilostazol Stroke Prevention Study combination) showed that DAPT using cilostazol was more effective without the bleeding risk. In the CSPS.com trial, aspirin or clopidogrel was used as the underlying antiplatelet drug. The effectiveness and safety of each combination were examined and clarified. Methods: In the CSPS.com trial, a multicenter, open-label, randomized controlled study, patients with high-risk, noncardioembolic ischemic stroke 8 to 180 days after onset treated with aspirin or clopidogrel alone at the discretion of the physician in charge were recruited. Patients were randomly assigned to receive either monotherapy or DAPT using cilostazol and followed for 0.5 to 3.5 years. The primary efficacy outcome was first recurrence of ischemic stroke. The safety outcome was severe or life-threatening bleeding. The analysis was based on the underlying antiplatelet agents. Results: A total of 763 patients taking aspirin and 1116 taking clopidogrel were included in the intention-to-treat analysis. Although the clopidogrel group had more risk factors than the aspirin group, the primary efficacy outcome and safety outcome did not differ significantly between the 2 groups. In the aspirin group, the primary efficacy outcome and safety outcome did not differ significantly between the DAPT group and the aspirin-monotherapy group. In the clopidogrel group, the primary end point occurred at a rate of 2.31 per 100 patient-years in the DAPT group and 5.19 per 100 patient-years in the clopidogrel-monotherapy group (hazard ratio, 0.447 [95% CI, 0.258­0.774]). Safety outcome did not differ significantly between groups (0.51 per 100 patient-years versus 0.71 per 100 patient-years, respectively; hazard ratio, 0.730 [95% CI, 0.206­2.588]). Conclusions: The combination of cilostazol and clopidogrel significantly reduced the recurrence of ischemic stroke without increasing the bleeding risk in noncardioembolic, high-risk patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01995370. URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000012180.

The Validity and Reliability of the Japanese Version of the Cornell Assessment of Pediatric Delirium.

OBJECTIVES: To examine validity and reliability of the Japanese version of the Cornell Assessment of Pediatric Delirium. DESIGN: Prospective double-blinded observational cohort study. SETTING: Eight-bed mixed PICU (post-surgical and internal medicine) from May 2017 to June 2018. PATIENTS: All children between the ages of 0-13 years who were admitted to the PICU for at least 24 hours were eligible for inclusion, as long as the child was arousable to verbal stimulation. INTERVENTIONS: Two nurses simultaneously and independently assessed each patient for pediatric delirium with the Japanese version of the Cornell Assessment of Pediatric Delirium; this was compared to the gold standard of psychiatric diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition standards. MEASUREMENTS AND MAIN RESULTS: Forty-one children were enrolled and 92 assessments (ranging from one to four per subject) were completed. Congenital heart disease patients accounted for 73 enrollees (79%). Forty-three percent of observations were performed in children on invasive mechanical ventilation. Pediatric delirium prevalence (as determined by psychiatric diagnosis) was 53%. The Japanese version of the Cornell Assessment of Pediatric Delirium demonstrated an optimal scoring cutpoint of 9. Overall, area under the curve was 92%, sensitivity 90% (95% CI, 79-97%), specificity 88% (95% CI, 75-96%), positive predictive value of 90% (95% CI, 79-97%), negative predictive value of 91% (95% CI, 80-97%), and a Cohen's κ of 0.89 (95% CI, 0.8-0.98). In children on invasive mechanical ventilation, the Japanese version of the Cornell Assessment of Pediatric Delirium maintained an area under the curve 87%, sensitivity 97%, and specificity 64%. CONCLUSIONS: The Japanese version of the Cornell Assessment of Pediatric Delirium is a valid and reliable tool for use in Japanese PICUs. This will allow for detection of delirium in real-time and may lead to better identification of the population and risk factors for appropriate management and therapeutic and preventative interventions.

Development of Quality Indicators of Stroke Centers and Feasibility of Their Measurement Using a Nationwide Insurance Claims Database in Japan　­ J-ASPECT Study ­

BACKGROUND: We aimed to develop quality indicators (QIs) related to primary and comprehensive stroke care and examine the feasibility of their measurement using the existing Diagnosis Procedure Combination (DPC) database. METHODS AND RESULTS: We conducted a systematic review of domestic and international studies using the modified Delphi method. Feasibility of measuring the QI adherence rates was examined using a DPC-based nationwide stroke database (396,350 patients admitted during 2013-2015 to 558 hospitals participating in the J-ASPECT study). Associations between adherence rates of these QIs and hospital characteristics were analyzed using hierarchical logistic regression analysis. We developed 17 and 12 measures as QIs for primary and comprehensive stroke care, respectively. We found that measurement of the adherence rates of the developed QIs using the existing DPC database was feasible for the 6 QIs (primary stroke care: early and discharge antithrombotic drugs, mean 54.6% and 58.7%; discharge anticoagulation for atrial fibrillation, 64.4%; discharge antihypertensive agents, 51.7%; comprehensive stroke care: fasudil hydrochloride or ozagrel sodium for vasospasm prevention, 86.9%; death complications of diagnostic neuroangiography, 0.4%). We found wide inter-hospital variation in QI adherence rates based on hospital characteristics. CONCLUSIONS: We developed QIs for primary and comprehensive stroke care. The DPC database may allow efficient data collection at low cost and decreased burden to evaluate the developed QIs.

Two Medullary Hemorrhage Cases Complicated by Respiratory Distress in the Early Phase.

Medullary hemorrhage is quite rare among brain stem hemorrhage cases, thus the clinical course remains unclear. In the medulla oblongata, respiratory centers are located and previous reports indicate that medullary lesions have possible relationship with acute respiratory distress syndrome. This kind of respiratory failure is commonly caused by neurogenic pulmonary edema (NPE), which is defined as noncardiac noninfectious acute respiratory distress syndrome with changes in intracranial condition including cerebrovascular events. However, to date, very few reports have described cases with medullary hemorrhage accompanied by NPE. We experienced 2 patients with medullary hemorrhages. A 65-year-old man presented with sudden onset of headache, whose head computed tomography showed right medullary hemorrhage. Another 76-year-old woman was transferred because of sudden limb weakness and diagnosed with left medullary hemorrhage. Digital subtraction angiography showed the presence of arteriovenous fistula in the medulla oblongata and drainer veins in the second case. Both cases were complicated by acute pulmonary edema in the early phase, suggesting the possible association of the medullary hemorrhage with NPE.

[Transition and current state of the classification and diagnostic strategy in the ischemic stroke].

Since 1990, the classification of cerebrovascular disease released from the NINDS has been used. The subtypes of ischemic stroke have been diagnosed based on the diagnostic criteria used in the TOAST. For classifying the subtypes of ischemic stroke, we need to know the size and location of the infarcts and the presence of the stenosis or occlusion in the stem arteries. The cardiac evaluation including the long-term ECG monitor should be done for excluding the embolic source. Although the branch atheromatous disease (BAD) is not recognized in the western countries, it should be established as one clinical entity because of the high incidence rate in Japan.

Prevalence and clinical features of asymptomatic peripheral artery disease in Japanese stroke patients.

BACKGROUND: A recent worldwide disease registration study has revealed a high prevalence of polyvascular diseases in stroke patients. However, although a poor clinical outcome of patients with polyvascular disease has been reported, there have been few reports on clinical features of peripheral artery disease (PAD) in stroke patients. We assessed the prevalence, demographics, characteristics, and risk factors of PAD in Japanese stroke patients. METHODS: One hundred and one consecutive chronic stroke patients in an outpatient clinic underwent ankle-brachial index (ABI) screening tests. PAD was diagnosed when the ABI was <0.9. RESULTS: Abnormal ABI was found in 19 patients (18.8%). Eleven patients were asymptomatic, and 8 patients had symptoms of intermittent claudication. Gender, prevalence of hypertension, and dyslipidemia and alcohol intake were not different between the patients with PAD and those without PAD. Prevalence of diabetes mellitus (63.6%) was higher in the patients with asymptomatic PAD. Among the clinical subtypes of stroke, the patients with atherothrombotic infarction had a higher prevalence of PAD. CONCLUSIONS: The prevalence of PAD in stroke patients was 18.8%. Approximately 60% of the patients had no symptoms related to PAD. Diabetes mellitus was associated with higher prevalence of asymptomatic PAD among Japanese stroke patients.

Safety and Effectiveness of Apixaban Versus Warfarin in Japanese Patients with Nonvalvular Atrial Fibrillation Stratified by Renal Function: A Retrospective Cohort Study.

BACKGROUND: We previously conducted a retrospective cohort study using chart review of oral anticoagulant-naïve Japanese patients with nonvalvular atrial fibrillation (NVAF) that assessed the risk of major bleeding and stroke/systemic embolism (SE) events of apixaban versus warfarin. METHODS: In this subgroup analysis, we compared the risk of major bleeding and stroke/SE events by stratifying patients into four subgroups matched 1:1 using propensity score matching (PSM) according to baseline creatinine clearance (CrCl; mL/min): ≥ 15 to < 30, ≥ 30 to < 50, ≥ 50 to < 80, and ≥ 80. RESULTS: Of the 7074 patients in the apixaban group and 4998 in the warfarin group eligible for inclusion in the analysis, 4385 were included in each group after PSM. Incidence rates of major bleeding and stroke/SE events were generally lower with apixaban versus warfarin across the CrCl subgroups. When all patients with a CrCl change of < 0 mL/min per year during the study period (apixaban, n = 3871; warfarin, n = 2635) were stratified into four subgroups based on the magnitude of CrCl decline (median CrCl change [mL/min] per year: - 1.09, - 3.48, - 7.54, and - 36.92 for apixaban, and - 1.10, - 3.65, - 7.85, and - 40.40 for warfarin), the incidence rates of major bleeding and stroke/SE events generally increased with an increasing CrCl decline per year in both groups. CONCLUSIONS: In Japanese patients with NVAF, the safety and effectiveness of apixaban and warfarin were consistent across different renal subgroups, including those with severe renal impairment. Our results highlight the importance of monitoring renal function variations over time in patients with NVAF. GOV IDENTIFIER: NCT03765242.

Dual antiplatelet therapy with cilostazol in stroke patients with extracranial arterial stenosis or without arterial stenosis: A subgroup analysis of the CSPS.com trial.

BACKGROUND: We previously reported that dual antiplatelet therapy (DAPT) with cilostazol was superior to aspirin or clopidogrel for the prevention of recurrent stroke and vascular events in a subgroup analysis of intracranial arterial stenosis in the Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com), a randomized controlled trial. AIMS: We conducted another subgroup analysis to investigate the benefit of DAPT with cilostazol in patients with extracranial arterial stenosis (ECAS) and those without arterial stenosis. METHODS: We compared the risk of recurrent ischemic stroke, vascular events, and major bleeding between DAPT with cilostazol plus aspirin or clopidogrel and aspirin or clopidogrel alone in patients with ischemic stroke between 8 and 180 days before starting trial treatment and ECAS or without arterial stenosis. RESULTS: The median follow-up period was 1.4 years. The risk of recurrent ischemic stroke (hazard ratio (HR): 1.04, 95% confidence interval (CI): 0.42-2.57) and vascular events (HR: 0.97, 95% CI: 0.42-2.24) did not differ between the two groups for the 253 patients with ECAS, whereas they were lower (HR: 0.36, 95% CI: 0.18-0.74 and HR: 0.47, 95% CI: 0.26-0.85, respectively) in the DAPT group for the 944 patients without arterial stenosis. The risk of major bleeding did not differ between the groups in patients with ECAS (HR: 0.58, 95% CI: 0.05-6.39) or without arterial stenosis (HR: 0.79, 95% CI: 0.27-2.26). CONCLUSION: DAPT with cilostazol might be beneficial for prevention of recurrent stroke and vascular events in patients without arterial stenosis but not in those with ECAS. DATA ACCESS STATEMENT: We will make the deidentified participant data from this research available to the scientific community with as few restrictions as feasible, while retaining exclusive use until the publication of major output.

Sex Difference in the Impact of Dual Antiplatelet Therapy using Cilostazol for Secondary Stroke Prevention: A Sub-Analysis of CSPS.com.

AIM: Although some sex differences in stroke have been reported, differences in the effects of antiplatelet therapy for secondary stroke prevention have not been clarified. METHODS: In the Cilostazol Stroke Prevention Study combination trial, patients with high-risk, non-cardioembolic ischemic stroke between 8 and 180 days after onset treated with aspirin or clopidogrel alone were recruited and randomly assigned to receive either monotherapy or dual antiplatelet therapy (DAPT) using cilostazol and followed up for 0.5-3.5 years. The primary efficacy outcome was recurrence of ischemic stroke. The safety outcome was severe or life-threatening hemorrhage. Outcomes were analyzed by sex. RESULTS: A total of 1,320 male patients and 558 female patients were included. The male patients had more risk factors than the female patients. In male patients, the primary endpoint occurred at a rate of 2.0 per 100 patient-years in the DAPT group and 5.1 per 100 patient-years in the monotherapy group (hazard ratio (HR), 0.40; 95% confidence interval (CI), 0.23-0.68). In male patients, DAPT prolonged the time to recurrent stroke by 4.02-fold (95% CI, 1.63-9.96) compared with monotherapy. In female patients, the average annual event rates were 2.7 per 100 patient-years in the DAPT group and 3.3 per 100 patient-years in the monotherapy group (HR, 0.82; 95% CI, 0.37-1.84). Safety outcomes did not differ significantly in both male and female patients. CONCLUSIONS: Long-term DAPT using cilostazol reduced the recurrence of ischemic stroke and prolonged the recurrence-free time in male patients, but not in female patients.

Soluble C-type lectin-like receptor 2 in stroke (CLECSTRO) study: protocol of a multicentre, prospective cohort of a novel platelet activation marker in acute ischaemic stroke and transient ischaemic attack.

INTRODUCTION: Soluble C-type lectin-like receptor 2 (sCLEC-2) is a new biomarker for platelet activation, which can be easily measured by usual blood collection. We conducted the CLECSTRO, a prospective, observational cohort study, to evaluate the clinical implications of sCLEC-2 in patients with acute ischaemic stroke (AIS) and transient ischaemic attack (TIA). METHODS AND ANALYSIS: The participants are patients with AIS/TIA and control patients required for differentiation from AIS/TIA. The target population is 600, including the patients and controls, who would be recruited from eight stroke centres across Japan. The inclusion criteria are AIS within 24 hours of onset and a modified Rankin Scale (mRS) score of 0-2, TIA within 7 days of onset, and contemporary patients required for differentiation from AIS/TIA. Plasma sCLEC-2 will be measured by high-sensitive chemiluminescent enzyme immunoassay using residual blood samples from routine laboratory examinations at the first visit in all patients and 7 days later or at discharge in patients with AIS/TIA. The outcomes include plasma levels of sCLEC-2 in patients with AIS/TIA and controls, sCLEC-2/D-dimer ratio in non-cardioembolic and cardioembolic AIS/TIA, correlation of sCLEC-2 with recurrence or worsening of stroke, severity of stroke, infarct size, ABCD2 score in TIA and outcome (mRS) at 7 days and 3 months. ETHICS AND DISSEMINATION: This study was approved by the Ethical Committee of the University of Yamanashi as the central ethical committee in agreement with the ethical committees of all collaborative stroke centres. Informed consent will be obtained by an opt-out form from the patients at each stroke centre according to the Ethical Guidelines for Medical and Biological Research Involving Human Subjects by the Japanese Ministry of Health, Labour and Welfare. TRIAL REGISTRATION NUMBERS: NCT05579405, UMIN000048954.

National trends in the outcomes of subarachnoid haemorrhage and the prognostic influence of stroke centre capability in Japan: retrospective cohort study.

OBJECTIVES: To examine the national, 6-year trends in in-hospital clinical outcomes of patients with subarachnoid haemorrhage (SAH) who underwent clipping or coiling and the prognostic influence of temporal trends in the Comprehensive Stroke Center (CSC) capabilities on patient outcomes in Japan. DESIGN: Retrospective study. SETTING: Six hundred and thirty-one primary care institutions in Japan. PARTICIPANTS: Forty-five thousand and eleven patients with SAH who were urgently hospitalised, identified using the J-ASPECT Diagnosis Procedure Combination database. PRIMARY AND SECONDARY OUTCOME MEASURES: Annual number of patients with SAH who remained untreated, or who received clipping or coiling, in-hospital mortality and poor functional outcomes (modified Rankin Scale: 3-6) at discharge. Each CSC was assessed using a validated scoring system (CSC score: 1-25 points). RESULTS: In the overall cohort, in-hospital mortality decreased (year for trend, OR (95% CI): 0.97 (0.96 to 0.99)), while the proportion of poor functional outcomes remained unchanged (1.00 (0.98 to 1.02)). The proportion of patients who underwent clipping gradually decreased from 46.6% to 38.5%, while that of those who received coiling and those left untreated gradually increased from 16.9% to 22.6% and 35.4% to 38%, respectively. In-hospital mortality of coiled (0.94 (0.89 to 0.98)) and untreated (0.93 (0.90 to 0.96)) patients decreased, whereas that of clipped patients remained stable. CSC score improvement was associated with increased use of coiling (per 1-point increase, 1.14 (1.08 to 1.20)) but not with short-term patient outcomes regardless of treatment modality. CONCLUSIONS: The 6-year trends indicated lower in-hospital mortality for patients with SAH (attributable to better outcomes), increased use of coiling and multidisciplinary care for untreated patients. Further increasing CSC capabilities may improve overall outcomes, mainly by increasing the use of coiling. Additional studies are necessary to determine the effect of confounders such as aneurysm complexity on outcomes of clipped patients in the modern endovascular era.

Prestroke anticoagulation and paroxysmal type are correlated with favorable outcome in ischemic stroke patients with atrial fibrillation.

Paroxysmal atrial fibrillation (AF), which often precedes permanent AF, is reported to be a risk factor for milder ischemic stroke. We assessed whether the type of AF and prestroke treatment with an anticoagulant were associated with physical disabilities in patients with AF-related acute ischemic stroke. We identified 162 consecutive acute ischemic stroke patients with AF who were admitted to our hospital over a 3-year period. Disability was measured using the modified Rankin Scale (mRS) at the time of discharge and was categorized according to favorable clinical outcome (mRS score 0-2). Of the 162 patients, 71 (43.8%) had paroxysmal AF and 91 had permanent AF. Fifty-six patients (34.6%) had been treated with a prophylactic anticoagulant. A total of 103 patients (63.6%) had a favorable outcome. Multivariate logistic analysis revealed that paroxysmal AF (odds ratio [OR], 1.58; P = .0187), prestroke anticoagulation treatment (OR, 1.95; P = .0019), and noncardiogenic embolism (OR, 2.20; P = .0073) were independent factors associated with a favorable clinical outcome. Our data indicate that paroxysmal AF and prestroke anticoagulation treatment are independently associated with favorable clinical outcome at the time of hospital discharge in patients with AF.

Clinical features and neurologic severity in stroke patients with mild to moderate renal dysfunction.

BACKGROUND: To evaluate the independent effect of moderate renal dysfunction on stroke severity and to disclose the clinical features of stroke patients with moderate renal dysfunction. METHODS: We studied consecutive stroke patients presenting within 48 hours of onset. The National Institutes of Health Stroke Scale (NIHSS) score at the time of presentation was used as an index of stroke severity. Patients were categorized into 2 groups based on their estimated glomerular filtration rates (eGFRs). RESULTS: Of the 475 patients with an eGFR >15 mL per minute per 1.73 m(2), 158 patients (33.3%) had an eGFR <60 mL per minute per 1.73 m(2). These patients were older and included significantly more cases with hypertension and atrial fibrillation. The NIHSS score at the time of admission was higher among the patients with renal dysfunction. In a multivariable model with adjustments for other clinical background factors, moderate renal dysfunction was an independent predictor of the neurologic severity of stroke at the time of admission (odds ratio, 1.261; 95% confidence interval, 1.032-1.545; P = .0244). CONCLUSIONS: Stroke patients with moderate renal dysfunction had a higher prevalence of hypertension and atrial fibrillation. Moderate renal dysfunction was associated with a higher severity of stroke on admission.

PERSonality, Ehical, and PROfessional quality of life in Pediatric/Adult Intensive Nurses study: PERSEPRO PAIN study.

BACKGROUND: The World Health Organization included burnout syndrome criteria that reduce both professional quality of life and work satisfaction in its 11th Revision of the International Classification of Diseases in 2019 while nursing bodies have issued action calls to prevent burnout syndrome. Despite this, the effect of social factors, personality traits and cross-interaction on professional quality of life is still unclear. AIM: To reveal the association between ethical climate, personal trait and professional quality of life. METHOD: An online survey of registered nurses working in adult, pediatric or both ICUs. We used the ten-item personality measure based on The Big Five theory and Type-D personality Scale-14 then measured the ethical climate with the Hospital Ethical Climate Survey and the professional domains of burnout syndrome, secondary traumatic stress and compassion satisfaction by the Professional Quality of Life Scale Version 5 simultaneously. Multivariate analysis confirmed the triangular association of hospital ethical climate, personality traits and professional quality of life. RESULT: We enrolled 310 participants from September 2019 to February 2020. Mean age was 33.1 years (± 5.9) and about 70% were female. In the multivariate analysis, neuroticism (p = 0.03, p = 0.01) and Type D personality (both of p<0.01) were associated with burnout syndrome and secondary traumatic stress while agreeableness (p<0.01) was associated with secondary traumatic stress. Conversely, extraversion (p = 0.01), agreeableness (p<0.01) and openness (p<0.01) were associated with compassion satisfaction. We also observed interactions between hospital ethical climate and conscientiousness (p = 0.01) for burnout syndrome and secondary traumatic stress. Neuroticism was related to (p<0.01) BOS and compassion satisfaction while Type D personality (p<0.01) correlated with burnout syndrome and secondary traumatic stress. CONCLUSION: Hospital ethical climate strongly affects professional quality of life in nurses with specific personality traits. Therefore, it is important to maintain an ethical hospital climate, considering individual personalities to prevent burnout syndrome.