Novel subgroups of obesity and their association with outcomes: a data-driven cluster analysis.

BACKGROUND: Obesity is associated with various complications and decreased life expectancy, and substantial heterogeneity in complications and outcomes has been observed. However, the subgroups of obesity have not yet been clearly defined. This study aimed to identify the subgroups of obesity especially those for target of interventions by cluster analysis. METHODS: In this study, an unsupervised, data-driven cluster analysis of 9,494 individuals with obesity (body mass index ≥ 35 kg/m2) was performed using the data of ICD-10, drug, and medical procedure from the healthcare claims database. The prevalence and clinical characteristics of the complications such as diabetes in each cluster were evaluated using the prescription records. Additionally, renal and life prognoses were compared among the clusters. RESULTS: We identified seven clusters characterised by different combinations of complications and several complications were observed exclusively in each cluster. Notably, the poorest prognosis was observed in individuals who rarely visited a hospital after being diagnosed with obesity, followed by those with cardiovascular complications and diabetes. CONCLUSIONS: In this study, we identified seven subgroups of individuals with obesity using population-based data-driven cluster analysis. We clearly demonstrated important target subgroups for intervention as well as a metabolically healthy obesity group.

Oral anticoagulation after atrial fibrillation catheter ablation: benefits and risks.

BACKGROUND AND AIMS: Few recent large-scale studies have evaluated the risks and benefits of continuing oral anticoagulant (OAC) therapy after catheter ablation (CA) for atrial fibrillation (AF). This study evaluated the status of continuation of OAC therapy and the association between continuation of OAC therapy and thromboembolic and bleeding events according to the CHADS2 score. METHODS: This retrospective study included data from the Japanese nationwide administrative claims database of patients who underwent CA for AF between April 2014 and March 2021. Patients without AF recurrence assessed by administrative data of the treatment modalities were divided into two groups according to continuation of OAC therapy 6 months after the index CA. The primary outcomes were thromboembolism and major bleeding after a landmark period of 6 months. After inverse probability of treatment weighting analysis, the association between OAC continuation and outcomes was determined according to the CHADS2 score. RESULTS: Among 231 374 patients included, 69.7%, 21.6%, and 8.7% had CHADS2 scores of ≤1, 2, and ≥3, respectively. Of these, 71% continued OAC therapy at 6 months. The OAC continuation rate was higher in the high CHADS2 score group than that in the low CHADS2 score group. Among all patients, 2451 patients (0.55 per 100 person-years) had thromboembolism and 2367 (0.53 per 100 person-years) had major bleeding. In the CHADS2 score ≤1 group, the hazard ratio of the continued OAC group was 0.86 [95% confidence interval (CI): 0.74-1.01, P = .06] for thromboembolism and was 1.51 (95% CI: 1.27-1.80, P < .001) for major bleeding. In the CHADS2 score ≥3 group, the hazard ratio of the continued OAC group was 0.61 (95% CI: 0.46-0.82, P = .001) for thromboembolism and was 1.05 (95% CI: 0.71-1.56, P = 0.81) for major bleeding. CONCLUSIONS: This observational study suggests that the benefits and risks of continuing OAC therapy after CA for AF differ based on the patient's CHADS2 score. The risk of major bleeding due to OAC continuation seems to outweigh the risk reduction of thromboembolism in patients with lower thromboembolic risk.

Insights from the trends of omalizumab and mepolizumab utilization in patients with asthma: A population-based cohort study using the National Database in Japan.

BACKGROUND: Biologics are increasingly being used in patients with severe uncontrolled asthma. However, the trends in their use for treating severe asthma in Japan remain unclear. METHODS: The number of patients with asthma prescribed omalizumab or mepolizumab between April 2017 and March 2018 was estimated according to sex, age, and geographical region using data from the National Database of Health Insurance Claims and Specific Health Checkups of Japan. RESULTS: Overall, 5,014, 3,449 and 7,977 patients were prescribed omalizumab, mepolizumab, or either combination, respectively. The total number of patients prescribed biologics displayed a bimodal distribution with peaks in their early teens and seventies. Biologics were most commonly used by male and female patients in their seventies. Prescription was 1.24 times higher in males than in females up to the teenage years, whereas it was 1.95 times higher in females than in males from their twenties onwards. Omalizumab was prescribed 1.45 times more frequently than mepolizumab, especially in pediatric patients, and was prescribed 1.96 times more often to female patients than to male patients. Regional differences were observed in the proportion of patients prescribed biologics. Correlation analysis suggested a weak relationship (r = 0.3226, p = 0.0270) between the proportion of patients prescribed biologics and board-certified allergists according to the geographic region. CONCLUSIONS: In Japan, biologics are prescribed more often to older patients with severe asthma compared to those in other countries. Thus, eliminating the regional disparities in asthma treatment by specialists is necessary to provide appropriate medical care to patients with severe asthma.

Antithyroid drug-induced leukopenia and G-CSF administration: a long-term cohort study.

Although antithyroid drug (ATD)-induced agranulocytosis is a significant concern, its risks associated with long-term use and re-administration are not fully elucidated. Therefore, we performed this study to determine the incidence of ATD-induced leukopenia and G-CSF administration using administrative claims database. Retrospective cohort study. This study was performed using the DeSC Japanese administrative claims database. A total of 12,491 patients with newly diagnosed Graves' disease (GD) who received methimazole or propylthiouracil between April 2014, and February 2021 among 3.44 million patients in the database were included in the study. We measured the six-year incidence of leukopenia and granulocyte colony-stimulating factor (G-CSF) administration. The incidence of leukopenia and G-CSF administration was 1.34% (168 patients) and 0.30% (38 patients), respectively. Leukopenia had a dose-dependent and biphasic incidence. The incidence of leukopenia and G-CSF administration was 37.2 (0.7%) and 8.0 (0.2%) per 1000 person-years during the first 72 days of ATD initiation, whereas it was 3.1 and 0.7 per 1000 person-years during the subsequent 6 years, respectively. The incidence of both outcomes was comparable between first administration and re-administration of ATD. The incidence of ATD-induced leukopenia and G-CSF administration was high in the first 72 days, with a reduced risk for at least 6 years thereafter. The incidence was similar between first administration and re-administration. ATD, a standard therapy, is often administered for a long period; therefore, our findings can guide the treatment of GD.

Risk factors for mortality after hip fracture surgery in Japan using the National Database of Health Insurance Claims and Specific Health Checkups of Japan.

We investigated the risk factors for mortality of hip fracture in the elderly using the National Database of Health Insurance Claims in Japan, and survival was significantly related to sex, age, fracture type, surgical procedure, delayed operative date, comorbidities, blood transfusions, and pulmonary embolism. PURPOSE: Hip fracture is the most common fracture in the elderly and is known to have a high mortality rate. In Japan, to the best of our knowledge, no studies have reported on mortality risk factors for hip fracture using nationwide registry databases. This study aimed to determine the number of occurrences of hip fracture and factors that increase mortality using the National Database of Health Insurance Claims and Specific Health Checkups of Japan. METHODS: This study included extracted data from patients who were hospitalized and underwent surgical treatment for hip fracture between 2013 and 2021, using a nationwide health insurance claims database in Japan. Patient characteristics, such as sex, age, fracture type, surgical procedure, delayed operative date, comorbidities, blood transfusions, and pulmonary embolism, were tabulated to obtain 1-year and in-hospital mortality rates. RESULTS: Both 1-year and in-patient survival were significantly lower in men, older patients, patients who underwent surgery after 3 days of admission, and patients with trochanteric and subtrochanteric fractures, internal fixation, more preoperative comorbidities, blood transfusions, and pulmonary embolism. CONCLUSIONS: Survival was significantly related to sex, age, fracture type, surgical procedure, delayed operative date, comorbidities, blood transfusions, and pulmonary embolism. As the number of male patients with hip fracture will increase with the aging of society, medical staff must provide sufficient information before surgery to avoid postoperative mortality.

Sodium-glucose cotransporter 2 inhibitor use in early-phase acute coronary syndrome with severe heart failure.

AIMS: Sodium-glucose cotransporter 2 inhibitor (SGLT2i) improves clinical outcomes in patients with heart failure (HF), but has limited evidence of SGLT2i use in early-phase acute coronary syndrome (ACS). We determined association of early SGLT2i use compared with either non-SGLT2i or dipeptidyl peptidase 4 inhibitor (DPP4i) use in hospitalized patients with ACS. METHODS AND RESULTS: This retrospective cohort study that used the Japanese nationwide administrative claims database included patients hospitalized with ACS aged ≥20 years between April 2014 and March 2021. The primary outcome was a composite of all-cause mortality or HF/ACS rehospitalization. Using 1:1 propensity score matching, the association with outcomes of the early SGLT2i use (≤14 days after admission) compared with non-SGLT2i or DPP4i use was determined according to the HF treatment. Among 388 185 patients included 115 612 and 272 573 with and without severe HF, respectively. Compared to non-SGLT2i users, the SGLT2i users had a lower hazard ratio (HR) with the primary outcome [HR: 0.83, 95% confidence interval (CI): 0.76-0.91; P < 0.001] in the severe HF group; however, there was no significant difference in the non-severe HF group (HR: 0.92, 95% CI: 0.82-1.03; P = 0.16). SGLT2i use showed a lower risk of the outcome in patients with severe HF and diabetes compared with DPP4i use (HR: 0.83, 95% CI: 0.69-1.00; P = 0.049). CONCLUSION: SGLT2i use in patients with early-phase ACS showed a lower risk of primary outcome in patients with severe HF, but the effect was not apparent in patients without severe HF.

Research note changes in the number of outpatient visits in Japan during the COVID-19 pandemic.

OBJECTIVE: This study aimed to determine the change in the number of outpatient visits in Japan since the beginning of the COVID-19 pandemic, using data on the outpatient claims submitted by medical institutions to insurers in 2019 and 2020, from the National Database of Health Insurance Claims and Specific Health Check-ups. We calculated the total number of outpatient visits, and number of visits for individual diseases according to the International Classification of Diseases-10 codes on the claim form. RESULTS: The number of outpatient visits per million people decreased by 9.98% in 2020 compared to 2019. Of the diseases included in the analysis, 71 showed a decrease in the number of visits by ≥ 1%. There were significant decreases in the number of visits related to infectious diseases (influenza, acute bronchitis, and acute laryngitis, etc.), and chronic diseases (hemorrhoids, cystic kidney disease, dyspepsia, and chronic sinusitis, etc.). The observed decreased rate of outpatient visit might have been due to, a decrease in the incidence of disease, a decreased frequency of visit by patients with the disease, or both. Our analysis method using actual health insurance claim data can be applied worldwide, where researchers have access to national information on health insurance claims.

Risk of Lactic Acidosis in Hospitalized Diabetic Patients Prescribed Biguanides in Japan: A Retrospective Total-Population Cohort Study.

Patient data from the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) are used to assess the effect of biguanide administration on rates of lactic acidosis (LA) in hospitalized diabetes mellitus (DM) patients. In this retrospective cohort study (from April 2013 to March 2016), we compare DM inpatients prescribed biguanides to DM inpatients who were not prescribed biguanides to quantify the association between biguanides and incidence of LA. In total, 8,111,848 DM patient records are retrieved from the NDB. Of the 528,768 inpatients prescribed biguanides, 782 develop LA. Of the 1,967,982 inpatients not prescribed biguanides, 1310 develop LA. The rate ratio of inpatients who develop LA and are administered biguanides to those who developed LA without receiving biguanides is 1.44 (95% CI, 1.32-1.58). Incidence rates and rate ratios for both sexes are elevated in the group prescribed biguanides for patients aged 70 years and older, markedly in those 80 years and older: 40.12 and 6.31 (95% CI, 4.75-8.39), respectively, for men and 34.96 and 5.40 (95% CI, 3.91-7.46), respectively, for women. Biguanides should be used conservatively in patients older than 70 years, particularly for those with comorbidities, and with caution in patients 80 years and older.

Validity of Diagnostic Algorithms for Cardiovascular Diseases in Japanese Health Insurance Claims.

BACKGROUND: We aimed to validate a claims-based diagnostic algorithm to identify hospitalized patients with acute major cardiovascular diseases (CVDs) from health insurance claims in Japan.Methods and Results: This retrospective multicenter validation study was conducted at 4 institutes, including Japanese Circulation Society-certified and uncertified hospitals in Japan. Data on patients with CVDs in departmental lists or with International Classification of Diseases, 10th Revision (ICD-10) codes for CVDs hospitalized between April 2018 and March 2019 were extracted. We examined the sensitivity and positive predictive value of a diagnostic algorithm using ICD-10 codes, medical examinations, and treatments for acute coronary syndrome (ACS), acute heart failure (HF), and acute aortic disease (AAD). We identified 409 patients with ACS (mean age 70.6 years; 24.7% female), 615 patients with acute HF (mean age 77.3 years; 46.2% female), and 122 patients with AAD (mean age 73.4 years; 36.1% female). The respective sensitivity and positive predictive value for the algorithm were 0.86 (95% confidence interval [CI] 0.82-0.89) and 0.95 (95% CI 0.92-0.97) for ACS; 0.74 (95% CI 0.70-0.77) and 0.79 (95% CI 0.76-0.83) for acute HF; and 0.86 (95% CI 0.79-0.92) and 0.83 (95% CI 0.76-0.89) for AAD. CONCLUSIONS: The validity of the diagnostic algorithm for Japanese claims data was acceptable. Our results serve as a foundation for future studies on CVDs using nationwide administrative data.

Hospital- and Patient-Level Analysis of Quality Indicators in Acute Coronary Syndrome Care: A Nationwide Database Study.

BACKGROUND: This study aimed to clarify the variations in the quality of care provided to patients with acute coronary syndrome (ACS) and to investigate the association between quality of care and mortality at both hospital and patient levels with the use of a nationwide database. METHODS: Patients with ACS who underwent percutaneous coronary intervention (PCI) from April 2014 to March 2018 were included from the National Database of Health Insurance Claims and Specific Health Checkups of Japan. Twelve quality indicators (QIs) available from administrative data and the association of the QIs with all-cause mortality were investigated. RESULTS: From the analysis of 216,436 patients from 1215 hospitals, adherence to PCI on admission day, aspirin use on arrival, P2Y12 inhibitor use, and left ventricular function assessment were high (median proportion > 90%), and adherence to outpatient cardiac rehabilitation was low (median proportion < 10%). At the hospital level, acute-phase composite QI score was associated with reduced risk-adjusted 30-day mortality (ß = -0.92 [95% confidence interval -1.19 to -0.65]; P < 0.001). At the patient level, all acute-phase and subacute-phase QIs were inversely associated with 30-day and 2-year mortalities, respectively (all P < 0.001). CONCLUSIONS: Substantial variations in ACS care were observed in the current nationwide database. High adherence to the QI sets was associated with significant survival gains at both hospital and patient levels. Multilevel approach in QI assessment may be effective for improvement of survival in this population.

Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events.

OBJECTIVE: To identify the risks of myocarditis or pericarditis after vaccination with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines in Japan. METHODS: We conducted an observed-to-expected analysis (OE analysis) of spontaneous reports of suspected adverse events from pharmaceutical companies, calculating rate ratios with myocarditis and pericarditis after the vaccination of the mRNA vaccines Comirnaty (BNT162b2) and Spikevax (mRNA-1273) and expected rate of myocarditis and pericarditis in the population before the COVID-19 pandemic. These reports dated from 17/2/2021 to 14/11/2021 and from 22/5/2021 to 14/11/2021 for Comirnaty and Spikevax, respectively. The observed-to-expected ratios (OE ratios) for each vaccine were estimated by age groups and sex. RESULTS: We identified 281 and 195 cases of myocarditis or pericarditis for Comirnaty and Spikevax, respectively, which were administrated 163,059,502 and 31,768,352 doses for Comirnaty and Spikevax until the 14th of November 2021, respectively. The OE ratios were statistically significantly higher in adolescent and young adult males in their age of teens and twenties after the second dose in a two-dose series [Comirnaty in teens male: 6.15 (95% CI, 2.26-21.98), Comirnaty in twenties male: 2.86 (95% CI, 1.13-8.38), Spikevax in teens male: 41.59 (95% CI, 5.64-43,281.94), Spikevax in twenties male: 16.84 (95%CI, 6.77-57.49)]. CONCLUSIONS: Risks of myocarditis and pericarditis following SARS-CoV-2 mRNA vaccines in Japan seems to be significantly elevated for adolescent and young adult males.

Multifactorial Effects of Outpatient Cardiac Rehabilitation in Patients with Heart Failure: A Nationwide Retrospective Cohort Study.

AIM: Although cardiac rehabilitation (CR) is a strongly recommended therapy, no large study has assessed the effects of outpatient CR in patients with heart failure (HF) in real-world settings. Therefore, this study aimed to investigate the multifactorial effects of outpatient CR in patients with HF using a nationwide database. METHODS AND RESULTS: This nationwide retrospective cohort study was performed using the National Database of Health Insurance Claims and Specific Health Checkups of Japan. Patients with acute HF who underwent inpatient CR between April 2014 and March 2020 were included. The association between outpatient CR participation and all-cause mortality, rehospitalisation for HF, use of medical resources, and medical costs was analysed using propensity score matching analysis. Of 250,528 patients, 17,884 (7.1%) underwent outpatient CR. After propensity score matching, the CR (+) group was associated with a reduction in the risk of all-cause mortality (hazard ratio [HR]: 0.64, 95% confidence interval [CI]: 0.60-0.68, p < 0.001) and rehospitalisation for HF compared to the CR (-) group (HR: 0.87, 95% CI: 0.82-0.92, p < 0.001). The proportion of guideline-based medication use for HF at 1 year was higher in the CR (+) group than in the CR (-) group. The total medical costs from the index hospitalisation to 1.5 years after admission were similar between the groups. CONCLUSION: Outpatient CR participation after discharge from HF was associated with reduced mortality and rehospitalisation for HF without increasing medical costs.

Rehabilitation services and related health databases, Japan.

The demographic transition towards an ageing population and the epidemiological transition from communicable to noncommunicable diseases have increased the demand for rehabilitation services globally. The aims of this paper were to describe the integration of rehabilitation into the Japanese health system and to illustrate how health information systems containing real-world data can be used to improve rehabilitation services, especially for the ageing population of Japan. In addition, there is an overview of how evidence-informed rehabilitation policy is guided by the analysis of large Japanese health databases, such as: (i) the National Database of Health Insurance Claims and Specific Health Checkups; (ii) the long-term care insurance comprehensive database; and (iii) the Long-Term Care Information System for Evidence database. Especially since the 1990s, the integration of rehabilitation into the Japanese health system has been driven by the country's ageing population and rehabilitation is today provided widely to an increasing number of older adults. General medical insurance in Japan covers acute and post-acute (or recovery) intensive rehabilitation. Long-term care insurance covers rehabilitation at long-term care institutions and community facilities for older adults with the goal of helping to maintain independence in an ageing population. The analysis of large health databases can be used to improve the management of rehabilitation care services and increase scientific knowledge as well as guide rehabilitation policy and practice. In particular, such analyses could help solve the current challenges of overtreatment and undertreatment by identifying strict criteria for determining who should receive long-term rehabilitation services.

Tant la transition démographique vers un vieillissement de la population que la transition épidémiologique des maladies transmissibles vers les maladies non transmissibles ont entraîné une augmentation de la demande en services de réadaptation dans le monde. Le présent document poursuit plusieurs objectifs: décrire l'intégration de la réadaptation dans le système de santé au Japon, et illustrer comment les systèmes de santé contenant des données réelles peuvent être utilisés en vue d'améliorer de tels services, en particulier pour une population nipponne vieillissante. En outre, il offre un aperçu de la manière dont la politique de réadaptation étayée par des faits s'inspire de l'analyse de vastes bases de données sanitaires japonaises, parmi lesquelles: (i) la base de données nationale des demandes de remboursement au titre de l'assurance-maladie et des bilans de santé spécifiques; (ii) la base de données complète de l'assurance pour les soins longue durée; et enfin, (iii) la base de données du système d'information relatif aux attestations de soins longue durée. Le vieillissement de la population a poussé le Japon à inclure la réadaptation dans son système de santé, surtout depuis les années 1990; aujourd'hui, un nombre croissant de personnes âgées ont aisément accès à des services de réadaptation. Au Japon, l'assurance-maladie globale prend en charge la réadaptation intensive aiguë et post-aiguë (ou de rétablissement). De son côté, l'assurance pour les soins longue durée couvre la réadaptation dans les établissements dédiés et les infrastructures collectives accueillant des personnes âgées, avec pour but de contribuer à préserver l'autonomie au sein d'une population vieillissante. L'analyse de vastes bases de données sanitaires peut favoriser une meilleure gestion des services de réadaptation et accroître les connaissances scientifiques, mais aussi orienter les politiques et pratiques en la matière. Ce type d'analyse peut surtout aider à s'attaquer aux enjeux actuels que représentent les traitements excessifs ou insuffisants, en identifiant des critères stricts permettant de déterminer qui doit faire l'objet d'une réadaptation sur le long terme.

La transición demográfica hacia el envejecimiento de la población y la transición epidemiológica de las enfermedades transmisibles a las no transmisibles han aumentado la demanda de servicios de rehabilitación en todo el mundo. Los objetivos de este artículo son describir la integración de la rehabilitación en el sistema sanitario japonés e ilustrar cómo los sistemas de información sanitaria que contienen datos del mundo real se pueden utilizar para mejorar los servicios de rehabilitación, en especial para la población que envejece en Japón. Además, se ofrece una visión general de cómo la política de rehabilitación fundamentada en la evidencia se guía por el análisis de las grandes bases de datos sanitarias japonesas, como: (i) la Base de Datos Nacional de Reclamaciones al Seguro de Enfermedad y Chequeos Médicos Específicos; (ii) la base de datos integral del seguro de cuidados de larga duración; y (iii) la base de datos del Sistema de Información de Cuidados de Larga Duración para la Evidencia. En particular, desde la década de 1990, la integración de la rehabilitación en el sistema sanitario japonés se ha visto impulsada por el envejecimiento de la población del país y, en la actualidad, la rehabilitación se ofrece de forma generalizada a una cantidad cada vez mayor de adultos mayores. El seguro médico general de Japón cubre la rehabilitación intensiva aguda y posaguda (o de recuperación). El seguro de cuidados de larga duración cubre la rehabilitación en instituciones de larga estancia y centros comunitarios para adultos mayores con el objetivo de ayudar a mantener la independencia en una población que envejece. El análisis de las grandes bases de datos sanitarias puede servir para mejorar la gestión de los servicios de atención a la rehabilitación y aumentar los conocimientos científicos, así como para orientar la política y la práctica de la rehabilitación. En concreto, estos análisis podrían ayudar a resolver los problemas actuales de sobretratamiento y subtratamiento, al identificar criterios estrictos para determinar quién debe recibir servicios de rehabilitación de larga duración.

Age-dependent association of discharge heart-failure medications with clinical outcomes in a super-aged society.

AIMS: Real-world evidence about heart failure (HF) medical care for elderly patients is limited. The aim of this study was to clarify the age-dependent associations of HF medications at discharge with clinical outcomes in a super-aged society using a real-world big database. METHODS AND RESULTS: Patients hospitalized with a first episode of acute HF in 2013-2019 were identified in a nationwide claims database in Japan and were analyzed based on the HF medications at discharge. Hazard ratios (HRs) and 95 % confidence intervals (95 % CIs) for clinical outcomes were calculated after adjustment. Among 325,468 patients from 4351 hospitals, 130,230 (40.0 %) were aged ≥ 85 years. All-cause mortality and HF readmission rate within 1 year were 14 % and 23 %, respectively. ß-Blockers and angiotensin-converting-enzyme inhibitors or angiotensin II receptor blockers (ACEI/ARB) uses were associated with lower mortality (HR [95 %CI]: 0.84 [0.83,0.86] and 0.73 [0.71,0.74], respectively) and HF readmission (0.98 [0.97,0.99] and 0.89 [0.88,0.90], respectively). The associations were attenuated as the age increased and, in ß-blockers use, the favorable associations with mortality and HF readmission were not observed in patients with ≥ 95 years and ≥ 80 years, respectively. In contrast, mineralocorticoid receptor antagonists (MRA) use was associated only with lower HF readmission (0.83 [0.82,0.84]), which was not attenuated with increased age. CONCLUSIONS: The favorable associations of ß-blockers and ACEI/ARB uses with mortality and HF readmission were age-dependently attenuated in patients across a broad spectrum of HF in a super-aged society. In contrast, positive impact of MRA use on HF readmission was not attenuated with aging.

Severe Complications after General Anesthesia versus Sedation during Pediatric Diagnostic Cardiac Catheterization for Ventricular Septal Defect.

Pediatric cardiac catheterization requires unconsciousness and immobilization through general anesthesia or sedation. This study aimed to compare the occurrence of severe complications in pediatric diagnostic cardiac catheterization for ventricular septal defect between general anesthesia and sedation performed under similar institutional environments. Using the Japanese Diagnosis Procedure Combination database, we retrospectively identified pediatric patients (aged <2 years) who underwent diagnostic cardiac catheterization for ventricular septal defect between July 2010 and March 2019. The composite outcome was the occurrence of severe complications, including catecholamine use and intensive care unit admission, within seven days after catheterization. Overlap weighting based on propensity scores was used to adjust for patient- and hospital-level confounding factors. We identified 3159 patients from 87 hospitals, including 930 under general anesthesia and 2229 under sedation. The patient- and hospital-level baseline characteristics differed between the groups. After adjustment, the proportion of patients with severe complications was significantly higher in the general anesthesia group than in the sedation group (2.4% vs. 0.6%; risk difference, 1.8% [95% confidence interval, 0.93−2.6%]). Severe complications occurred more frequently in the general anesthesia group than in the sedation group. Further research on anesthetic methods is necessary to assess the safety and accuracy of pediatric diagnostic cardiac catheterization.

Contemporary use of SGLT2 inhibitors in heart failure patients with diabetes mellitus: a comparison of DPP4 inhibitors in a nationwide electric health database of the superaged society.

BACKGROUND: There is a lack of recent data reflecting the actual use of sodium-glucose cotransporter-2 (SGLT2) inhibitors for heart failure (HF) and type 2 diabetes (DM) in the superaged society. The present study investigated the association between the use of SGLT2 inhibitors and one-year prognosis in patients hospitalized across a broad spectrum of HF patients with DM in the superaged society using the Nationwide Electric Health Database in Japan. METHODS: The patients hospitalized with the first episode of acute HF were identified from the National Database of Health Insurance Claims and Specific Health Checkups of Japan between April 2014 and March 2019. A cohort of 2,277 users of SGLT2 inhibitors and 41,410 users of the active comparator, dipeptidyl peptidase-4 (DPP4) inhibitors were compared. A propensity score-matched cohort study of 2,101 users of each inhibitor was also conducted. A multivariable multilevel mixed-effects survival model was conducted with adjustments, and hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated. RESULTS: Among 300,398 patients discharged with HF in 4,176 hospitals, 216,016 (71.9%) were 75 years or older, and 60,999 (20.3%) took antidiabetic medications. Among them, the patients treated with SGLT2 inhibitors were younger and had a more severe status than those treated with DPP4 inhibitors. Kaplan-Meier analysis showed that patients treated with SGLT2 inhibitors had a lower mortality risk and HF readmission. In propensity-matched cohorts, SGLT2 inhibitor use was associated with a lower risk of mortality and HF readmission than DPP-4 inhibitor use (HR [95% CI]; 0.70 [0.56, 0.89] and 0.52 [0.45, 0.61], respectively). Very elderly (≥ 75 years) patients showed similar results. Favorable effects were also observed across all age groups, including ≥ 75 years, in patients with coronary artery disease or atrial fibrillation and with concomitant ß-blocker, diuretics, or insulin. CONCLUSION: The use of SGLT2 inhibitors at discharge was associated with a lower risk of one-year mortality and HF readmission in patients across a broad spectrum of HF with DM in the superaged society. The findings further support the benefits of using SGLT2 inhibitors in very elderly HF care and complement the current evidence.

Trends and Factors Associated With Cardiac Rehabilitation Participation　- Data From Japanese Nationwide Databases.

BACKGROUND: Few studies have comprehensively evaluated the trends and factors associated with CR participation across major cardiovascular diseases in Japan.Methods and Results: This study performed a nationwide cross-sectional study using the National Database of Health Insurance Claims and Specific Health Checkups of Japan and the Japanese Registry of All Cardiac and Vascular Diseases and the Diagnosis Procedure Combination database. This study described the nationwide trends and evaluated patient- and hospital-level associated factors of CR participation for patients with acute heart failure (AHF), acute coronary syndrome (ACS), acute aortic dissection (AAD), peripheral artery disease (PAD), and after cardiovascular surgery using mixed-effect logistic regression analysis. Although the annual number of patients who underwent CR has increased during the study period, the total number of patients participating in outpatient CR was lower than that of inpatient CR. The outpatient CR participation rate was lower for patients with AHF (3.5%), AAD (3.2%), and PAD (1.7%), compared with ACS (7.9%) and after surgery (9.4%). Age, sex, body mass index, Barthel index, Charlson comorbidity index, and institutional capacity were identified as significant associated factors of CR participation in inpatient and outpatient settings. CONCLUSIONS: Participation in outpatient CR was still low, and higher age, multi-comorbidity, and low institutional capacity contributed to the lower outpatient CR participation rate. Identification of the associated factors may help cardiologists to increase CR participation.

Safety monitoring of COVID-19 vaccines in Japan.

The assessment of the efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines in actual practice is extremely important, and monitoring efforts are being implemented worldwide. In Japan, a joint council in the Ministry of Health, Labour and Welfare is held every two to three weeks to summarise information on the adverse events following COVID-19 vaccination, with careful assessment of individual case safety reports and comparison with background incidence rates. In 2021, the joint council mainly reviewed anaphylaxis, death, myocarditis/pericarditis, and thrombosis with thrombocytopenia syndrome. These activities resulted in several safety-related regulatory actions, including the revision of vaccine package inserts with warnings about myocarditis/pericarditis. International sharing of vaccine safety information, as well as details of the evaluation systems, is important for international discussion and decision-making on better safety monitoring of COVID-19 vaccines.