Effect of the COVID-19 pandemic on allogeneic stem cell transplantation in Japan.

The coronavirus disease 2019 (COVID-19) pandemic affected healthcare quality and access worldwide and may also have negatively affected the frequency and outcomes of allogeneic hematopoietic stem cell transplantation (HSCT). We evaluated the effect of the pandemic on allogeneic HSCT in Japan. Our subjects were patients who received allogeneic HSCT during January 2018-December 2020 in Japan. We assessed differences in yearly number of allogeneic HSCTs and 1-year outcomes in 2020 versus both 2019 and 2018. The total number of patients who received allogeneic HSCT increased from 3621 patients in 2018 and 3708 patients in 2019 to 3865 patients in 2020. Some following changes in allogeneic HSCT methods were observed: patients were older, fewer patients received bone marrow transplantation, fewer patients received transplants from unrelated donors, fewer patients received transplants from matched donors, more patients received reduced-intensity conditioning, and fewer patients received anti-thymocyte globulin in 2020 compared with previous years. HSCT outcomes were not affected, as 1-year overall survival was not significantly different (65.8% in 2020, vs. 66.5% in 2019 and 66.4% in 2018). Our results suggest that we can maintain transplant care during the pandemic by controlling the spread of COVID-19 and modifying HSCT methods.

Association between tracheostomy and survival in patients with coronavirus disease 2019 who require prolonged mechanical ventilation for more than 14 days: A multicenter cohort study.

OBJECTIVE: Tracheostomy is a common procedure with potential prognostic advantages for patients who require prolonged mechanical ventilation (PMV). Early recommendations for patients with coronavirus disease 2019 (COVID-19) suggested delayed or limited tracheostomy considering the risk for viral transmission to clinicians. However, updated guidelines for tracheostomy with appropriate personal protective equipment have revised its indications. This study aimed to evaluate the association between tracheostomy and prognosis in patients with COVID-19 requiring PMV. METHODS: This was a multicenter, retrospective cohort study using data from the nationwide Japanese Intensive Care PAtient Database. We included adult patients aged ≥16 years who were admitted to the intensive care unit (ICU) due to COVID-19 and who required PMV (for >14 days or until performance of tracheostomy). The primary outcome was hospital mortality, and the association between implementation of tracheostomy and patient prognosis was assessed using weighted Cox proportional hazards regression analysis with inverse probability of treatment weighting (IPTW) using the propensity score to address confounders. RESULTS: Between January 2020 and February 2021, 453 patients with COVID-19 were observed. Data from 109 patients who required PMV were analyzed: 66 (60.6%) underwent tracheostomy and 38 (34.9%) died. After adjusting for potential confounders using IPTW, tracheostomy implementation was found to significantly reduce hospital mortality (hazard ratio [HR]: 0.316, 95% confidence interval [CI]: 0.163-0.612). Patients who underwent tracheostomy had a similarly decreased ICU and 28-day mortality (HR: 0.269, 95% CI: 0.124-0.581; HR 0.281, 95% CI: 0.094-0.839, respectively). A sensitivity analysis using different definitions of PMV duration consistently showed reduced mortality in patients who underwent tracheostomy. CONCLUSION: The implementation of tracheostomy was associated with favorable patient prognosis among patients with COVID-19 requiring PMV. Our findings support proactive tracheostomy in critically ill patients with COVID-19 requiring mechanical ventilation for >14 days.

Impact of the COVID-19 pandemic on out-of-hospital cardiac arrest outcomes in older adults in Japan.

Aim: The coronavirus disease (COVID-19) pandemic has negatively affected access to healthcare and treatment. This study aimed to explore the impact of the COVID-19 pandemic on older adults with out-of-hospital cardiac arrest (OHCA) in Japan, a country with a super-aging society. Methods: This secondary analysis of the All-Japan Utstein Registry included patients aged 65 years and older with bystander-witnessed OHCA between January 1, 2005, and December 31, 2020. Survival outcomes were compared by time period using multivariable logistic regression analyses. The primary outcome measured was the one-month survival rate with neurologically favorable outcomes. Results: Before the COVID-19 pandemic, survival outcomes were steadily improving, and 32,024 patients in 2019 and 31,894 in 2020 were eligible for analysis. The proportions of conventional cardiopulmonary resuscitation and shock by public-access automated external defibrillators were lower in 2020 than in 2019 (6.7% versus 5.7%, p < 0.001 and 2.5% versus 2.1%, p < 0.001, respectively). Compared to 2019, the one-month survival after OHCA and prehospital return of spontaneous circulation decreased significantly in 2020 than in 2019 (7.7% versus 6.6%, adjusted odds ratio [AOR]: 0.88, 95% confidence interval [CI]: 0.83-0.94, and 16.8% versus 14.9%, AOR: 0.87, 95% CI: 0.83-0.91, respectively). The proportion of neurologically favorable outcomes also decreased, but the decrease was not statistically significant (3.4% versus 2.8%, AOR: 0.92, 95% CI: 0.83-1.01). Conclusion: In this population-focused, bystander-witnessed study regarding OHCA, the analysis of nationwide registry data revealed that the COVID-19 pandemic was associated with reduced survival among older adults with OHCA in Japan.

Association of the COVID-19 Pandemic With Prehospital Characteristics and Outcomes of Pediatric Patients With Out-of-Hospital Cardiac Arrest in Japan, 2005-2020.

This cohort study investigates the association of the COVID-19 pandemic with prehospital characteristics and outcomes of pediatric patients with out-of-hospital-cardiac arrest in Japan.

Clinical epidemiology and outcomes of COVID-19 patients with extracorporeal membrane oxygenation support in Japan: a retrospective study.

Objective: To elucidate the clinical epidemiology and outcomes of patients with COVID-19 who received extracorporeal membrane oxygenation (ECMO) in the Osaka Prefecture, Japan. Methods: We conducted a retrospective study of COVID-19 patients who received ECMO. Among patients diagnosed with COVID-19 between January 29 and November 9, 2020, we targeted patients who received ECMO. The outcome was all-cause mortality. The baseline characteristics of the COVID-19 patients who received ECMO were summarized according to the outcome. A univariable logistic regression model was applied to evaluate the association of each factor (sex, age group, city of residence, presence of comorbidities, presence of close contact, use of dialysis, and wave) with all-cause mortality. Odds ratios (ORs) with 95% confidence intervals were calculated. Results: Among the 14,864 patients diagnosed with COVID-19 during the study period, 39 patients received ECMO. Fourteen patients (35.9%) died. All patients aged 30-39 years survived, whereas all patients aged ≥80 years died. Higher mortality was observed among patients in the higher age group, and the P value for trend was significant (P value for trend: 0.04). Conclusions: Of the 14,864 COVID-19 patients in Osaka Prefecture until November 2020, 39 underwent ECMO. Of these, 14 died.

Characteristics and Outcomes of COVID-19 in Reproductive-Aged Pregnant and Nonpregnant Women in Osaka, Japan.

OBJECTIVE: To describe the clinical characteristics and outcomes of reproductive-aged female patients with coronavirus disease 2019 (COVID-19). METHODS: We conducted a retrospective study of female patients aged 10-49 years, diagnosed with COVID-19 in Osaka, Japan, between January and November 2020. We assessed their epidemiological and clinical characteristics according to their pregnancy status. RESULTS: A total of 4,156 patients were enrolled, of whom 29 (0.7%) were pregnant. Most patients exhibited mild symptoms, and 10.8% of the cases were asymptomatic. No moderate or severe cases were observed in pregnant women, whereas only 0.1% of the nonpregnant women had severe disease at diagnosis. No clusters were observed in the pregnant patients; however, most acquired the infection from a family member. Of the 29 pregnant women, 22 (75.9%) were hospitalized; whereas among the nonpregnant women, 579 (14.0%) were hospitalized (p < 0.001). No patients were admitted to the intensive care unit, and there were no deaths among women aged 10-49 years. CONCLUSIONS: Pregnant women accounted for 0.7% of the total cases of COVID-19 among women aged 10-49 years. Pregnant women were more likely to be hospitalized but generally had mild disease.

The background occurrence of selected clinical conditions prior to the start of an extensive national vaccination program in Japan.

INTRODUCTION: The COVID-19 pandemic caused by SARS-CoV-2 has now affected tens of millions of people globally. It is the hope that vaccines against SARS-CoV-2 will deliver a comprehensive solution to this global pandemic; however, this will require extensive national vaccination programs. Ultimately, clinical conditions and even sudden unexplained death will occur around the time of vaccination, thus a distinction needs to be made between events that are causally related to the vaccine or temporally related to vaccination. This study aimed to estimate the background occurrence of 43 clinical conditions in the Japanese population. METHODS: A retrospective cohort study was conducted from 2013 to 2019 using data from two large healthcare claims databases (MDV and JMDC) in Japan. The estimated number of new cases and incidence were calculated based on the actual number of new cases identified in the databases. The PubMed and Ichushi-web databases, as well as grey literature such as guidelines and government statistics, were also searched to identify any publications related to incidence of these conditions in Japan. RESULTS AND CONCLUSION: The estimates of the number of total cases and incidence were similar for the MDV and JMDC databases for some diseases. In addition, some estimates were similar to those in the scientific literature. For example, from the MDV and JMDC databases, estimates of incidence of confirmed Bell's palsy in 2019 were 41.7 and 47.9 cases per 100,000 population per year, respectively. These estimates were of the same order from the scientific publication. Determining whether clinical conditions occurring around the time of vaccination are causally or only temporally related to vaccination will be critical for public health decision makers as well as for the general public. Comparison of background occurrence at the population level may provide some additional objective evidence for the evaluation of temporality or causality.

Characteristics and outcomes of older patients with coronavirus disease 2019 in Japan.

AIM: The epidemiological characteristics, in-hospital treatments and outcomes of coronavirus disease 2019 among older patients have not been fully evaluated in Japan. METHODS: In this retrospective observational study carried out in Osaka Prefecture, Japan, we enrolled patients aged ≥60 years with laboratory-confirmed coronavirus disease 2019 from January to November 2020. The main outcome was mortality during the observation period, based on the Infectious Diseases Control Law. Cox regression analysis was used to evaluate the association between epidemiological factors and mortality among older patients with coronavirus disease 2019. RESULTS: Older patients accounted for 21.5% (3192/14 846) of the registered patients with coronavirus disease 2019. The number of patients according to age was as follows: 60-69 years, 1140 (35.7%); 70-79 years, 1058 (33.1%); 80-89 years, 749 (23.5%); and ≥90 years, 245 (7.7%). The proportion of deaths during the observation period was 8.5% (271/3192). The proportion of deaths increased with increasing age category (from 1.9% to 20.4%, P for trend <0.001). In multivariable Cox regression analysis, patients aged 70-79, 80-89 and ≥90 years had higher hazard ratios and 95% confidence intervals of death (2.62 [1.63-4.23], 5.99 [3.77-9.50] and 10.24 [6.03-17.40], respectively) than those aged 60-69 years. Factors such as male sex, presence of comorbidities, cluster cases in medical institutions and moderate/severe symptoms at diagnosis were also associated with mortality. CONCLUSIONS: This study shows the epidemiological characteristics of older patients with coronavirus disease 2019 in Osaka Prefecture, Japan. The proportion of deaths was 8.5% in total and increased with increasing age. Geriatr Gerontol Int 2021; 21: 629-635.

Characteristics and Survival of Intensive Care Unit Patients with Coronavirus Disease in Osaka, Japan: A Retrospective Observational Study.

The epidemiological and clinical characteristics, treatments, and outcomes of patients with coronavirus disease 2019 (COVID-19) who are admitted to the intensive care unit (ICU) have not been adequately evaluated in Japan. We analyzed the registry data of 205 patients with COVID-19 admitted to the ICU between February and November 2020, in Osaka Prefecture, Japan. A Cox proportional hazards model was used to assess the association between epidemiological factors and mortality among ICU patients. Of the 205 ICU patients, 161 (78.5%) were men and 149 (72.7%) were older than 60 years. A total of 117 patients (57.1%) had comorbidities. The most common symptoms at diagnosis were mild (n = 131, 63.9%). A total of 187 patients (91.2%) received mechanical ventilation, and 32 patients (15.6%) required extracorporeal membrane oxygenation. Patients were followed up for a median of 25 days after ICU admission. A total of 147 patients (71.7%) were alive at discharge, and 58 patients (28.3%) died. The hazard ratio for mortality among patients aged >80 years was 6.02 (95% confidence interval: 2.10-17.25) in the multivariable model, which was higher than that among those aged ≤59 years. These results are useful for recognizing the clinical course of this infection in ICU patients.

Characteristics and Outcomes of Pediatric COVID-19 Patients in Osaka, Japan.

The epidemiological information on characteristics, in-hospital treatments, and outcomes of the coronavirus disease 2019 (COVID-19) among pediatric patients has not been fully evaluated in Japan. This was a retrospective observational study conducted in the Osaka Prefecture, Japan, and we enrolled laboratory-confirmed COVID-19 patients aged ≤ 19 years old from January to November in 2020. Of 14,846 COVID-19 eligible patients, 1240 pediatric patients (8.4%) were registered during the study period; 329 were children aged 0-9 years (26.5%) and 911 were adolescents aged 10-19 years (73.5%). The majority of the patients exhibited mild symptoms at diagnosis (872, 70.3%), some were asymptomatic (296, 23.9%). Cluster infections occurred in child-care facilities (26, 7.9%) among children and in universities (27, 3.0%) and schools (18, 2.0%) among adolescents. The number of close-contact cases was 260 (69.0%) in children and 459 (50.4%) in adolescents. Sixty of the children (18.2%) and 90 of the adolescents (9.9%) were hospitalized. One patient received mechanical ventilation, and none underwent extracorporeal membrane oxygenation. One patient was admitted to the intensive care unit; there were no deaths. These results are useful for recognizing the clinical course from transmission route to outcomes of this infection in pediatric patients.

Characteristics of patients with novel coronavirus disease (COVID-19) during the first surge versus the second surge of infections in Osaka Prefecture, Japan.

In Japan, the differences in characteristics, severity, and mortality of novel coronavirus disease (COVID-19) patients between the first and second surges of infections have not been fully understood. This study is a retrospective cohort study of COVID-19 patients confirmed between February 1 and August 31, 2020 in Osaka Prefecture, Japan. Publicly available information on patients was collected from the website of Osaka Prefecture. Patients were divided into two groups according to the date of the positive laboratory test result: the first surge (February 1 to May 22) and the second surge (May 23 to August 31). Patients' characteristics were compared between the two groups. A multivariable Cox proportional-hazards model was applied to compare severity and mortality between the two groups, where sex, age group at the onset date, city of residence, and days to test positive were adjusted. Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated. A total of 8,541 patients included 1,780 and 6,761 patients in the first and second surges, respectively. Age at the onset date was younger in the second surge (p < 0.001), and median of days from the onset date to the positive test date shortened from 7 to 6 days (p < 0.001). The multivariable Cox proportional-hazards model revealed that both severity and mortality were lower in the second surge than in the first surge (severity: HR: 0.51 [0.39-0.67]; mortality: HR: 0.37 [0.25-0.56]). In conclusion, severity and mortality were lower in the second surge than in the first surge among COVID-19 patients in Osaka Prefecture, Japan.

Profile of Patients with Novel Coronavirus Disease 2019 (COVID-19) in Osaka Prefecture, Japan: A Population-Based Descriptive Study.

Little is known about the epidemiological characteristics of patients with coronavirus disease 2019 (COVID-19) in Japan. This is a retrospective observational study of COVID-19 patients; study was conducted from February 1 to May 31, 2020. We used publicly collected data on cases of COVID-19 confirmed by polymerase chain reaction (PCR) testing in Osaka Prefecture, Japan. We described the patient characteristics. The Cox proportional-hazards model was applied to evaluate the association between factors (sex, onset month, age group, city of residence) and mortality, and hazard ratios (HRs) with 95% confidence intervals were estimated. During the study period, 5.7% (1782/31,152) of individuals who underwent PCR testing for COVID-19 showed positive results. Among 244 patients with information on symptoms, the most common symptom was fever (76.6%), followed by cough (44.3%). Of the 1782 patients, 86 patients died. Compared with those aged 0-59 years, higher mortality was observed among those aged 60-69 years (HR: 12.02 [3.37-42.93]), 70-79 years (HR: 44.62 [15.16-131.30]), 80-89 years (HR: 68.38 [22.93-203.89]), and ≥90 years (HR: 144.71 [42.55-492.15]). In conclusion, in Osaka Prefecture, Japan, the most common symptom was fever, and older adults had higher mortality among COVID-19 patients.