Clinical Outcomes of Mitral Valve Surgery in Atrial Functional Mitral Regurgitation in the REVEAL-AFMR Registry.

Importance: The characteristics and treatment strategies of atrial functional mitral regurgitation (AFMR) are poorly understood. Objective: To investigate the prevalence, clinical characteristics, and outcomes of mitral valve (MV) surgery in AFMR. Design, Setting, and Participants: This retrospective cohort study, called the Real-World Observational Study for Investigating the Prevalence and Therapeutic Options for Atrial Functional Mitral Regurgitation (REVEAL-AFMR), was conducted across 26 Japanese centers (17 university hospitals, 1 national center, 3 public hospitals, and 5 private hospitals). All transthoracic echocardiography procedures performed from January 1 to December 31, 2019, were reviewed to enroll adult patients (aged ≥20 years) with moderate or severe AFMR, defined by preserved left ventricular function, a dilated left atrium, and an absence of degenerative valvular changes. Data were analyzed from May 8, 2023, to May 16, 2024. Exposures: Mitral valve surgery, with or without tricuspid valve intervention. Main Outcomes and Measures: The primary composite outcome included heart failure hospitalization and all-cause mortality. Results: In 177 235 patients who underwent echocardiography, 8867 had moderate or severe MR. Within this group, 1007 (11.4%) were diagnosed with AFMR (mean [SD] age, 77.8 [9.5] years; 55.7% female), of whom 807 (80.1%) had atrial fibrillation. Of these patients, 113 underwent MV surgery, with 92 (81.4%) receiving concurrent tricuspid valve surgery. Patients who underwent surgery were younger but had more severe MR (57.5% [n = 65] vs 9.4% [n = 84]; P < .001), a larger mean (SD) left atrial volume index (152.5 [97.8] mL/m2 vs 87.7 [53.1] mL/m2; P < .001), and a higher prevalence of heart failure (according to the New York Heart Association class III [marked limitation of physical activity] or class IV [symptoms of heart failure at rest], 26.5% [n = 30] vs 9.3% [n = 83]; P < .001) than those who remained under medical therapy. During a median follow-up of 1050 days (IQR, 741-1188 days), 286 patients (28.4%) experienced the primary outcome. Despite a more severe disease status, only the surgical group showed a decrease in natriuretic peptide levels at follow-up and had a significantly lower rate of the primary outcome (3-year event rates were 18.3% vs 33.3%; log-rank, P = .03). Statistical adjustments did not alter these findings. Conclusions and Relevance: The findings of this cohort study suggest that in patients with AFMR, who were typically older and predominantly had atrial fibrillation, MV surgery was associated with lower rates of adverse clinical outcomes. Future studies are warranted to investigate a possible causal relationship to better regulate cardiovascular medicine.

Complications after peripherally inserted central catheter versus central venous catheter implantation in intensive care unit: propensity score analysis using a nationwide database.

BACKGROUND: It remains unclear whether peripherally inserted central catheters (PICCs) are superior to central venous catheters (CVCs); therefore, we compared post-implantation complications between CVC and PICC groups. RESEARCH DESIGN AND METHODS: Patients who received CVCs or PICCs between April 2010 and March 2018 were identified from the Diagnosis Procedure Combination database, a national inpatient database in Japan. The outcomes of interest included catheter infection, pulmonary embolism, deep vein thrombosis, and phlebitis. Propensity score overlap weighting was used to balance patient backgrounds. Outcomes were compared using logistic regression analyses. RESULTS: We identified 164,185 eligible patients, including 161,605 (98.4%) and 2,580 (1.6%) in the CVC and PICC groups, respectively. The PICC group was more likely to have overall complications (odds ratio [OR], 1.70; 95% confidence interval [CI], 1.32-2.19), pulmonary embolism (OR, 2.32; 95% CI, 1.38-3.89), deep vein thrombosis (OR, 1.86; 95% CI, 1.16-2.99), and phlebitis (OR, 1.72; 95% CI, 1.27-2.32) than the CVC group. There was no significant intergroup difference in catheter infection (OR, 1.09; 95% CI, 0.39-3.04). CONCLUSIONS: Patients with PICCs had a significantly greater incidence of complications than did those with CVCs. Further research is necessary to explore the factors contributing to these complications.

Use of Japanese Herbal Kampo Medicine in Patients With Acute Cardiovascular Disease　- A 12-Year Nationwide Cohort Analysis.

BACKGROUND: Kampo, a Japanese herbal medicine, is approved for the treatment of various symptoms/conditions under national medical insurance coverage in Japan. However, the contemporary nationwide status of Kampo use among patients with acute cardiovascular diseases remains unknown. METHODS AND RESULTS: Using the Japanese Diagnosis Procedure Combination database, we retrospectively identified 2,547,559 patients hospitalized for acute cardiovascular disease (acute myocardial infarction, heart failure, pulmonary embolism, or aortic dissection) at 1,798 hospitals during the fiscal years 2010-2021. Kampo medicines were used in 227,008 (8.9%) patients, with a 3-fold increase from 2010 (4.3%) to 2021 (12.4%), regardless of age, sex, disease severity, and primary diagnosis. The top 5 medicines used were Daikenchuto (29.4%), Yokukansan (26.1%), Shakuyakukanzoto (15.8%), Rikkunshito (7.3%), and Goreisan (5.5%). From 2010 to 2021, Kampo medicines were initiated earlier during hospitalization (from a median of Day 7 to Day 3), and were used on a greater proportion of hospital days (median 16.7% vs. 21.4%). However, the percentage of patients continuing Kampo medicines after discharge declined from 57.9% in 2010 to 39.4% in 2021, indicating their temporary use. The frequency of Kampo use varied across hospitals, with the median percentage of patients prescribed Kampo medications increasing from 7.7% in 2010 to 11.5% in 2021. CONCLUSIONS: This nationwide study demonstrates increasing Kampo use in the management of acute cardiovascular diseases, warranting further pharmacoepidemiological studies on its effectiveness.

Body Mass Index and Outcomes in Patients with Takotsubo Syndrome: A Nationwide Retrospective Cohort Study.

BACKGROUND: Takotsubo syndrome (TTS) is a cardiac disorder that mimics acute coronary syndrome at presentation. While previous studies have demonstrated a relationship between body mass index (BMI) and outcomes in acute coronary syndrome, few have examined its relationship with TTS. METHODS: Using the Japanese Diagnosis Procedure Combination database, we retrospectively identified 14,551 patients admitted for TTS between 2010 and 2021. By applying multivariable regressions with restricted cubic splines, we examined the association between BMI and in-hospital mortality after adjusting for potential confounders. RESULTS: Mean BMI was 21.1 kg/m2, classifying patients into severe underweight (<16.0 kg/m2, 7.1%), mild/moderate underweight (16.0-18.4 kg/m2, 18.3%), normal weight (18.5-22.9 kg/m2, 46.8%), overweight (23.0-27.4 kg/m2, 22.2%), and obese (≥27.5 kg/m2, 5.6%) groups. Patients with severe or mild/moderate underweight were older and had a higher prevalence of impaired physical activity, malignancy, chronic pulmonary disease, and pneumonia. In-hospital mortality was the highest (9.4%) in the severe underweight group, followed by the mild/moderate underweight group (5.4%), with the lowest being in the obese group (2.1%). Severe underweight (adjusted odds ratio = 2.05; 95% confidence interval [CI] = 1.54-2.73) and mild/moderate underweight (1.26; 95% CI = 1.01-1.57) were significantly associated with higher mortality compared with normal weight, while no significant association was noted with obesity. A nonlinear association between continuous BMI and mortality was observed, with mortality increasing when BMI decreased <20.0 kg/m2 but nearly plateauing in BMI >20.0 kg/m2. CONCLUSIONS: The present nationwide analysis demonstrated a nonlinear association between BMI and in-hospital mortality of TTS. BMI is an easily available and clinically relevant marker for the risk stratification of TTS.

Predictive Factors for Infusion Site Induration After Outpatient Chemotherapy in Japan: A Secondary Analysis.

PURPOSE: Even in the absence of extravasation, some patients develop induration at the peripheral intravenous catheterization site prior to the next day's treatment. Infusion site induration commonly affects patients who undergo repeated chemotherapy administrations. Vessel health is crucial for the continuation of chemotherapy. However, there is no effective method to prevent induration. Hence, this study aimed to investigate the factors that could cause induration for preventing its occurrence. METHODS: This study was a secondary analysis of a prospective observational study. All participants were undergoing outpatient chemotherapy. Participant characteristics and related catheterization data were collected on the treatment day as baseline, and induration incidence was recorded on the subsequent treatment day. Receiver operating characteristic (ROC) analysis was performed to determine the sensitivity and specificity of cutoff points of the vein and catheter diameter ratios for distinguishing between developed induration and not developed induration. Additionally, cox regression analysis with multiple imputation was used to investigate the factors that predicted induration. RESULTS: Seventy-one patients participated in the study. The cutoff point of the vein/catheter diameter ratio calculated using ROC analysis was ≥3.7. The ratio of larger-diameter veins to catheter diameter of ≥3.7 times was negatively associated with induration in both complete case analysis (HR: 0.11; p = 0.034) and multiple imputation analysis (HR: 0.12; p = .049). CONCLUSIONS: Selecting the vein with 3.7 times higher diameter than the catheter diameter for the catheterization site may help prevent induration on the next treatment day.

Efficacy of initial high- versus low-dose intravenous corticosteroid therapy in patients with acute exacerbation of idiopathic interstitial pneumonia: A nationwide observational study.

BACKGROUND: Acute exacerbation of idiopathic interstitial pneumonias (AE-IIPs) has a high mortality. However, there is no established treatment for AE-IIPs. Therefore, we aimed to compare the efficacy of high- and low-dose corticosteroid therapies in AE-IIPs patients. METHODS: Data were retrospectively collected from the Japanese Diagnosis Procedure Combination database from July 2010 to March 2018. Adult patients with AE-IIPs who received high-dose (methylprednisolone at a dose of 500-1000 mg/day for 3 days starting within 4 days after admission) or low-dose (methylprednisolone at a dose of 100-200 mg/day for at least 5 days starting within 4 days after admission) corticosteroid therapy were identified. Eligible patients (n = 17,317) were divided into the high-dose (n = 16,998) and low-dose (n = 319) groups. A stabilized inverse probability of treatment weighting using propensity scores was performed to compare outcomes between the groups. RESULTS: The primary outcome was in-hospital mortality, and the secondary outcomes were 28-day mortality, infections during hospitalization, length of hospitalization, duration of steroid use, and discharge to home. The in-hospital mortality rates of the high- and low-dose corticosteroid groups were 50.6% and 47.0%, respectively. In-hospital mortality did not significantly differ between the two groups after stabilized inverse probability of treatment weighting, and the odds ratio in the low-dose corticosteroid group was 0.86 (95% confidence interval: 0.64-1.16; p = 0.33). The secondary outcomes also did not significantly differ between the groups. CONCLUSIONS: There was no significant difference in outcomes between patients with AE-IIPs who received high- and low-dose corticosteroid therapies.

Introduction to Survival Analysis in the Presence of Competing Risks.

Survival analysis is often used in studies of clinical epidemiology, but the existence of competing risks has not been adequately considered. Competing risks may hinder observation of the outcome of interest or modify the occurrence of the outcome. In the presence of competing risks, conventional survival analysis leads to biased results. To conduct a survival analysis in the presence of competing risks, researchers should select an appropriate method from the following two options: cause-specific hazard model and subdistribution hazard model. This article explains the issues raised by the presence of competing risks and describes methods to account for competing risks in survival analysis.