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Background The Clinical Frailty Scale (CFS) is a useful frailty marker for predicting clinical outcomes in patients undergoing invasive therapy. However, the clinical impact of CFS after transcatheter edge‐to‐edge repair in patients with mitral regurgitation (MR) remains unclear. This study aimed to elucidate the association between the baseline frail status defined by the CFS and clinical outcomes with or without postprocedural MR ≥2+ (post‐MR ≥2+) after transcatheter edge‐to‐edge repair. Methods and Results Based on a Japanese multicenter registry (OCEAN [Optimized Catheter Valvular Intervention]‐Mitral), data from 2078 patients with MR who underwent transcatheter edge‐to‐edge repair were analyzed. The patients were classified into 5 groups: CFS 1 to 3, 4, 5, 6, and ≥7. The procedural and clinical outcomes and post‐MR ≥2+ were compared among the groups. All‐cause mortality for up to 2 years was explored using Cox proportional hazards regression analysis. Although the rates of acute procedural success and post‐MR ≥2+ were similar, all‐cause mortality at 2 years was significantly increased across the 5 CFS categories (15.5%, 23.8%, 27.7%, 34.6%, and 48.8%, respectively, P

Abstract Objective Ventricular fibrillation remains as the major cause of death in patients with acute myocardial infarction. Effects of trans‐atrial chemical ablation of the left ventricular (LV) endocardium with Lugol's solution on ventricular fibrillation inducibility and ventricular conduction were examined in canines with acute myocardial ischemia. Materials and Methods Chemical ablation of the LV endocardium with Lugol's solution or normal saline was preformed through a left atrial appendage in 14 canines 30 min after occlusion of the left anterior coronary artery. Results Ventricular fibrillation threshold decreased after the coronary artery occlusion and increased after endocardial chemical ablation. There was a significant difference in the ventricular fibrillation threshold after chemical ablation between with Lugol's solution and with normal saline (25.9 ± 9.2 mA vs. 11.3 ± 2.7 mA, p

Abstract Principal investigators (PIs) play a key role in clinical research, and must thus understand the role of clinical research support staff to conduct successful and appropriate clinical research. This study evaluates clinical research capabilities by examining the clinical research knowledge of PIs and clinical research support staff. The participants of this cross‐sectional study were academic researchers and clinical research support staff from Japanese universities and research institutions. The participants comprised of 54 respondents, among whom 36 were PIs (physicians) and 18 were clinical research support staff. A self‐administered electronic survey was created and evaluated by experts, with 50 knowledge items. Mann–Whitney U tests were used to determine the significance of the differences in knowledge between clinical research support staff and PIs. We compared the correct answer rate of clinical research support staff and PIs for each knowledge category and observed that the clinical research support staff scored significantly higher than the PIs in all aspects of clinical research knowledge sections, including total score. Our findings showed that PIs did not have the same amount of clinical research knowledge as the clinical research support staff. Clinical research knowledge is essential for investigators, especially PIs, to protect patients and promote medical breakthroughs. Thus, more accessible clinical research education and mandatory knowledge testing will allow PIs to lead successful clinical research and further the level of medical research in Japan.

Background Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge‐to‐edge repair in the large Asian‐Pacific cohort. Methods and Results From the Optimized Catheter Valvular Intervention (OCEAN‐Mitral) registry, a total of 2150 patients (primary cause of 34.6%) undergoing transcatheter edge‐to‐edge repair were analyzed and classified into 3 groups according to the residual MR severity at discharge: MR 0+/1+, 2+, and 3+/4+. The mortality and heart failure hospitalization rates at 1 year were 12.3% and 15.0%, respectively. Both MR and symptomatic improvement were sustained at 1 year with MR ≤2+ in 94.1% of patients and New York Heart Association functional class I/II in 95.0% of patients. Compared with residual MR 0+/1+ (20.4%) at discharge, both residual MR 2+ (30.2%; P

Abstract Aims Evidence on the association between ambient temperature and the onset of acute heart failure (AHF) is scarce and mixed. We sought to investigate the incidence of AHF admissions based on ambient temperature change, with particular interest in detecting the difference between AHF with preserved (HFpEF), mildly reduced (HFmrEF), and reduced ejection fraction (HFrEF). Methods and results Individualized AHF admission data from January 2015 to December 2016 were obtained from a multicentre registry (Tokyo CCU Network Database). The primary event was the daily number of admissions. A linear regression model, using the lowest ambient temperature as the explanatory variable, was selected for the best‐estimate model. We also applied the cubic spline model using five knots according to the percentiles of the distribution of the lowest ambient temperature. We divided the entire population into HFpEF + HFmrEF and HFrEF for comparison. In addition, the in‐hospital treatment and mortality rates were obtained according to the interquartile ranges (IQRs) of the lowest ambient temperature (IQR1 19.7°C). The number of admissions for HFpEF, HFmrEF and HFrEF were 2736 (36%), 1539 (20%), and 3354 (44%), respectively. The lowest ambient temperature on the admission day was inversely correlated with the admission frequency for both HFpEF + HFmrEF and HFrEF patients, with a stronger correlation in patients with HFpEF + HFmrEF (R2 = 0.25 vs. 0.05, P 140 mmHg vs. 140–100 mmHg vs.

Abstract Aims The aim of the present study was to consider whether the ultrastructural features of cardiomyocytes in dilated cardiomyopathy can be used to guide genetic testing. Methods and results Endomyocardial biopsy and whole‐exome sequencing were performed in 32 consecutive sporadic dilated cardiomyopathy patients [51.0 (40.0–64.0) years, 75% men] in initial phases of decompensated heart failure. The predicted pathogenicity of ultrarare (minor allele frequency ≤0.0005), non‐synonymous variants was determined using the American College of Medical Genetics guidelines. Focusing on 75 cardiomyopathy‐susceptibility and 41 arrhythmia‐susceptibility genes, we identified 404 gene variants, of which 15 were considered pathogenic or likely pathogenic in 14 patients (44% of 32). There were five sarcomeric gene variants (29% of 17 variants) found in five patients (16% of 32), involving a variant of MYBPC3 and four variants of TTN. A patient with an MYBPC3 variant showed disorganized sarcomeres, three patients with TTN variants located in the region encoding the A‐band domain showed sparse sarcomeres, and a patient with a TTN variant in encoding the I‐band domain showed disrupted sarcomeres. The distribution of diffuse myofilament lysis depended on the causal genes; three patients with the same TMEM43 variant had diffuse myofilament lysis near nuclei (P = 0.011), while two patients with different DSP variants had lysis in the peripheral areas of cardiomyocytes (P = 0.033). Conclusions Derangement patterns of myofilament and subcellular distribution of myofilament lysis might implicate causal genes. Large‐scale studies are required to confirm whether these ultrastructural findings are related to the causative genes.

Abstract Aims This study investigated the prognostic value of plasma volume status (PVS) in patients who underwent transcatheter aortic valve replacement (TAVR). Methods and results Plasma volume status was calculated in 2588 patients who underwent TAVR using data from the Japanese multicentre registry. All‐cause mortality and heart failure hospitalization (HFH) within 2 years of TAVR were compared among the PVS quartiles (Q1, PVS

The purpose of this study was to conduct a factual survey to evaluate the type of clinical research support offered by service providers (supporters) in Japanese academic research organizations (AROs). From September to October 2018, we conducted an online questionnaire targeting researchers and supporters of AROs, including individuals supporting research and development (R&D) planning, as well as those involved in study management, biostatistics, coordination, data management, monitoring, and auditing. The number of responses was tabulated for each survey item. For items with written descriptions, we compiled summaries using the inductive regression method of qualitative research. Responses were obtained from 124 researchers, 258 supporters, and 40 AROs. None of the institutions responded that they had a performance index for all types of service providers, whereas 47% of institutions had an index for 1–3 types of service providers, and 40% of institutions had no index. Many institutions responded that they had a performance index for coordinators and data management, but few responded that there was a performance index for individuals engaged in R&D and study management. Furthermore, for all evaluations of AROs and researchers, the level of supporter satisfaction was low at only 20%. There was a discrepancy between the levels of researcher expectations and the actual contribution of R&D in the process of research planning. Our survey revealed that there is currently no performance index for services supporting clinical research. In future studies, we need to examine a performance index that accurately reflects the researcher attitudes revealed in this study.

Background Blood pressure (BP) variability has reportedly been a risk factor for various clinical events. To clarify the influence of BP visit‐to‐visit variability on adverse events in patients with nonvalvular atrial fibrillation, a post hoc analysis of the J‐RHYTHM Registry was performed. Methods and Results Of 7406 outpatients with nonvalvular atrial fibrillation from 158 institutions, 7226 (age, 69.7±9.9 years; men, 70.7%), in whom BP was measured 4 times or more (14.6±5.0 times) during the 2‐year follow‐up period or until occurrence of an event, constituted the study group. SD and coefficient of variation of BP values were calculated as BP variability. Thromboembolism, major hemorrhage, and all‐cause death occurred in 110 (1.5%), 121 (1.7%), and 168 (2.3%) patients, respectively. When patients were divided into quartiles of systolic BP‐SD (

Background Although transcatheter aortic valve replacement (TAVR) is the least invasive treatment for patients with symptomatic aortic stenosis, some patients hesitate to undergo the procedure. We investigated the clinical impact of treatment delay after patient refusal of TAVR. Methods and Results We used the Japanese OCEAN (Optimized Catheter valvular intervention) regsitry data of 1542 patients who underwent TAVR. Refusal was defined as at least 1 refusal of TAVR at the time of informed consent. Patients were separated into 2 groups: refusal (28/1542, 1.8%) and non‐refusal (1514/1542, 98.2%). We compared the baseline characteristics, procedural outcomes, and mortality rates between the groups. Additionally, data on reasons for refusal and those leading to eventually undergoing TAVR were collected. Age, surgical risk scores, and frailty were higher in the refusal group than in the non‐refusal group (P

Background To clarify the influence of hypertension and blood pressure (BP) control on thromboembolism and major hemorrhage in patients with nonvalvular atrial fibrillation, a post hoc analysis of the J‐RHYTHM Registry was performed. Methods and Results A consecutive series of outpatients with atrial fibrillation was enrolled from 158 institutions. Of 7937 patients, 7406 with nonvalvular atrial fibrillation (70.8% men, 69.8±10.0 years) were followed for 2 years or until an event occurred. Hypertension was defined as a systolic BP ≥140 mm Hg, a diastolic BP ≥90 mm Hg, a history of hypertension, and/or antihypertensive drug use. Hypertension was an independent risk factor for major hemorrhage (hazard ratio 1.52, 95% CI 1.05–2.21, P=0.027) but not for thromboembolism (hazard ratio 1.05, 95% CI 0.73–1.52, P=0.787). When patients were divided into quartiles according to their systolic BP at the time closest to the event or at the end of follow‐up (Q1,

BackgroundHypertension is one of the main comorbidities associated with dyslipidemia. This study aimed to examine the extent to which dyslipidemia increases the risk of developing hypertension in a Japanese working‐age male population. Methods and ResultsWe analyzed data from 14 215 nonhypertensive male workers (age 38±9 years) who underwent annual medical checkups. Subjects were followed up for a median of 4 years to determine new‐onset hypertension, defined as blood pressure (BP) ≥140/90 mm Hg or use of antihypertensive medication. The associations between serum lipid levels and development of hypertension were examined. During the follow‐up period, 1483 subjects developed hypertension. After adjusting for age, body mass index, impaired fasting glucose/diabetes, baseline BP category, alcohol intake, smoking, exercise, and parental history of hypertension, subjects with a total cholesterol (TC) level ≥222 mg/dL were at a significantly increased risk of developing hypertension (hazard ratio: 1.28; 95% CI: 1.06–1.56) compared to subjects with a TC level ≤167 mg/dL. Similar results were observed for subjects with high low‐density lipoprotein cholesterol (LDLC) and non‐high‐density lipoprotein cholesterol (HDLC) levels. A U‐shaped relationship was found between HDLC level and risk of hypertension; compared to the third quintile, the multiadjusted hazard ratio was 1.22 (95% CI: 1.03–1.43) in the lowest quintile and 1.34 (95% CI: 1.12–1.60) in the highest quintile. ConclusionsElevated serum levels of TC, LDLC, and non‐HDLC were associated with an increased risk of hypertension in working‐age Japanese men. For HDLC, risk of hypertension was increased at both low and high levels.