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Aim: To assess the cost‐effectiveness of diabetic nephropathy treatment with sodium‐glucose cotransporter‐2 (SGLT2) inhibitors in Japanese clinical practice, considering diabetes‐related complications. Materials and Methods: A population‐based Monte Carlo simulation was used to estimate the cost‐effectiveness for people with diabetic nephropathy who initiated pharmacotherapy with an SGLT2 inhibitor plus conventional treatment or conventional treatment alone, based on quality‐adjusted life‐years (QALYs) and healthcare costs. The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation study (CREDENCE) and the Japanese Society for Dialysis Research statistical survey were the primary sources of probability and mortality, while Japanese Health Insurance Claims Data were the cost source. The state transition model included diabetic nephropathy, hospitalization due to cardiovascular disease, dialysis, and death. One‐way and probabilistic sensitivity analyses were used to explore model uncertainty. Results: Using the threshold of JPY 5 000 000 per QALY, SGLT2 inhibitor plus conventional treatment was more cost‐effective than conventional treatment alone, with an incremental cost‐effectiveness ratio of JPY 654 309 per QALY. Treating 100 000 people, SGLT2 inhibitor plus conventional treatment prevented 2234 deaths and reduced 5793 fewer heart failure cases, 3967 fewer myocardial infarctions and stroke events. Sensitivity analysis affirmed the robustness of these results for patients aged under 70 years. Conclusions: The SGLT2 inhibitor treatment appeared to be cost‐effective for the overall population of our study and particularly for younger patients (<70 years old). For older patients (≥70 years old), the cost‐effectiveness was less clear and may require further evaluation. Decision‐makers should consider this age‐based heterogeneity when making recommendations about SGLT2 inhibitor treatment. [ABSTRACT FROM AUTHOR]

Introduction: Cardiovascular diseases (CVD) that require long‐term anticoagulant and antiplatelet therapy presents a problem in people with haemophilia (PWH) who receive factor replacement therapy to reduce bleeding risk. Currently, there are no Japanese guidelines for the management of PWH with CVD. Aim: To develop expert guidance on managing CVD in PWH in Japan. Methods: A steering committee of four experts (two haemophilia specialists, one thrombosis specialist, one cardiologist) identified 44 statements related to five key themes. An online questionnaire was produced comprising a mix of 4‐point Likert scale and multiple‐choice questions that was sent to specialists in the management of PWH with CVD in Japan. Consensus was defined as high or very high if a respective ≥75% or ≥90% of respondents agreed with a statement. Results: Of 16 potential respondents, responses were received from 15 specialists. Of the Likert scale questions, 71% (29/41) achieved ≥90% agreement (very strong agreement), 17% (7/41) achieved 75%–89% agreement (strong agreement) and 15% (6/41) did not achieve consensus agreement. The three multiple‐choice questions failed to identify a strong preference. Agreement on specific target trough clotting factor levels for managing certain clinical situations, such as when in the presence of non‐valvular atrial fibrillation or myocardial infarction, was also achieved. Conclusion: The results of this consensus study provide a framework for cardiologists and haematologists to manage PWH who are at risk of, or who have, CVD. Implementation of the recommendations provided herein may improve outcomes for PWH with CVD. [ABSTRACT FROM AUTHOR]

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 < .01). QRS width significantly increased from 88 ± 4 msec to 116 ± 5 msec (p < .01) after the chemical ablation with Lugol's solution, and the activation map of the ventricles demonstrated a left bundle branch block ventricular conduction pattern. Histological examination of the LV endocardium showed lymphocyte infiltration for a depth of 1 mm. Conclusions: Chemical ablation of the LV endocardium with Lugol's solution injures endocardial conduction system and increases ventricular fibrillation threshold in the early phase of myocardial ischemia in canines. The procedure may be useful in suppressing intractable ventricular tachyarrhythmias in patients with acute myocardial ischemia. [ABSTRACT FROM AUTHOR]

Objective To comprehensively evaluate diagnostic algorithms for myocardial infarction using a high-sensitivity cardiac troponin I (hs-cTnI) assay. Patients and methods We prospectively enrolled patients with suspected myocardial infarction without ST-segment elevation from nine emergency departments in Japan. The diagnostic algorithms evaluated: (i) based on hs-cTnI alone, such as the European Society of Cardiology (ESC) 0/1-h or 0/2-h and High-STEACS pathways; or (ii) used medical history and physical findings, such as the ADAPT, EDACS, HEART, and GRACE pathways. We evaluated the negative predictive value (NPV), sensitivity as safety measures, and proportion of patients classified as low or high-risk as an efficiency measure for a primary outcome of type 1 myocardial infarction or cardiac death within 30 days. Results We included 437 patients, and the hs-cTnI was collected at 0 and 1 hours in 407 patients and at 0 and 2 hours in 394. The primary outcome occurred in 8.1% (33/407) and 6.9% (27/394) of patients, respectively. All the algorithms classified low-risk patients without missing those with the primary outcome, except for the GRACE pathway. The hs-cTnI-based algorithms classified more patients as low-risk: the ESC 0/1-h 45.7%; the ESC 0/2-h 50.5%; the High-STEACS pathway 68.5%, than those using history and physical findings (15–30%). The High-STEACS pathway ruled out more patients (20.5%) by hs-cTnI measurement at 0 hours than the ESC 0/1-h and 0/2-h algorithms (7.4%). Conclusions The hs-cTnI algorithms, especially the High-STEACS pathway, had excellent safety performance for the early diagnosis of myocardial infarction and offered the greatest improvement in efficiency. [ABSTRACT FROM AUTHOR]

Objective: Although the clinical outcomes for patients with ST-elevation myocardial infarction (STEMI) have improved significantly, some patients still experience poor clinical outcomes. The available risk classifications focus on the short-term outcomes, and it remains important to find high-risk features among patients with STEMI. In Japan, the 200 m walk electrocardiogram (ECG) test is widely performed before discharge. The purpose of this study was to investigate the association between the excessive increase in systolic blood pressure (SBP) following a 200 m walk and the long-term clinical outcomes in patients with STEMI. Methods: We included 680 patients with STEMI and divided those into an excessive increase in SBP group (n = 144) and a non-excessive increase in SBP group (n = 536) according to the SBP increase after a 200 m walk ECG test. We defined an excessive increase in SBP as SBP ≥ 20 mmHg either just after or 3 min after a 200 m walk ECG test. The primary endpoint consisted of major cardiovascular events (MACE), defined as the composite of all-cause death, non-fatal myocardial infarction, readmission for heart failure, and ischemia-driven target vessel revascularization. Results: The median follow-up duration was 831 days. MACE was more frequently observed in the excessive increase in SBP group (24.3%) than in the non-excessive increase in SBP group (15.1%). Multivariate Cox hazard analysis revealed that the excessive increase in SBP was significantly associated with MACE (HR 1.509, 95% CI: 1.005–2.267, p = 0.047) after controlling for multiple confounding factors. Conclusion: An excessive increase in SBP after the 200 m walk ECG test was significantly associated with MACE in patients with STEMI. The 200 m walk ECG test is simple and low-cost, but may help to identify high-risk patients with STEMI. [ABSTRACT FROM AUTHOR]

Peripheral artery disease (PAD) is commonly caused by atherosclerosis and has an unfavorable prognosis. Complete revascularization (CR) of the coronary artery reduces the risk of major adverse cardiovascular event (MACE) in patients with coronary artery disease (CAD). However, the impact of CR in patients with PAD has not been established to date. Therefore, we evaluated the impact of CR of CAD on the five-year clinical outcomes in patients with PAD. This study was based on a prospective, multicenter, observational registry in Japan. We enrolled 366 patients with PAD undergoing endovascular treatment. The primary endpoint was MACE, defined as a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke. After excluding ineligible patients, 96 and 68 patients received complete revascularization of the coronary artery (CR group) and incomplete revascularization of the coronary artery (ICR group), respectively. Freedom from MACE in the CR group was significantly higher than in the ICR group at 5 years (66.7% vs 46.0%, p < 0.01). Multivariate analysis revealed that CR emerged as an independent predictor of MACE (Hazard ratio: 0.56, 95% confidential interval: 0.34–0.94, p = 0.03). CR of CAD was significantly associated with improved clinical outcomes in patients with PAD undergoing endovascular treatment. [ABSTRACT FROM AUTHOR]

Purpose: Nicorandil is occasionally administered to prevent myocardial ischemia during the perioperative period in patients with ischemic heart disease (IHD); however, its effectiveness has not been clarified. In this study, we examined the effectiveness of intraoperative nicorandil administration in noncardiac surgery. Methods: We identified patients with a history of IHD who had undergone high-risk noncardiac surgery between April 2015 and March 2020 from a nationwide in-patient database in Japan. The patients were divided into those who received nicorandil (nicorandil group) and those who did not (control group). The primary outcome was the 30-day in-hospital mortality. The secondary outcome was major adverse cardiovascular events (MACE), defined as the composite outcome of the 30-day in-hospital mortality, acute myocardial infarction, percutaneous coronary intervention, and coronary artery bypass grafting. One-to-one propensity score matching was performed. The outcomes were analyzed using a Cox proportional hazards model. Results: Of 8037 patients, 2886 received nicorandil during surgery. After propensity score matching, 2554 pairs were analyzed. There was no significant difference in the 30-day in-hospital mortality (26 [1.02%] vs. 36 [1.41%]; hazard ratio [HR] 1.36; 95% confidence interval [CI] 0.82–2.26; P = 0.229) or incidence of MACE (42 [1.64%] vs. 55 [2.15%]; HR 1.24; 95% CI 0.86–1.93; P = 0.216) between the control and nicorandil groups. Conclusion: The findings of this study suggest that intraoperative nicorandil administration is not associated with the 30-day in-hospital mortality in high-risk noncardiac surgery. [ABSTRACT FROM AUTHOR]

Introduction: The efficacy of ponatinib was demonstrated in patients resistant or intolerant to prior BCR-ABL tyrosine kinase inhibitors. However, cardiac adverse events (CAEs) have become a concern as a serious side effect of ponatinib administration. No reports have described the incidence of CAEs associated with ponatinib in Japanese patients. Thus, this study aimed to determine the risk of ponatinib-induced CAEs, time to onset, and post hoc outcomes using the Japanese Adverse Drug Event Report database. Methods: We analyzed data for the period between April 2004 and March 2021. Data on CAEs were extracted, and relative risk of AEs was estimated using the reporting odds ratio. Results: We analyzed 1,772,494 reports and identified 1,152 reports of AEs caused by ponatinib. Of these, 163 CAEs were reportedly associated with ponatinib. Signals were detected for thirteen CAEs: hypertension, cardiac failure, acute cardiac failure, atrial fibrillation, increased blood pressure, coronary artery stenosis, myocardial infarction, angina pectoris, pulmonary hypertension, prolonged QT on electrocardiography, cardiomyopathy, cardiac dysfunction, and acute myocardial infarction. Among these, hypertension was the most frequently reported AE (27.6%). A histogram of times to onset showed occurrence from 4.5 to 150.5 days. Discussion/Conclusion: Hypertension, cardiac failure, coronary artery stenosis, and myocardial infarction could potentially result in serious outcomes and some cases occurred earlier or even more than 1 year after starting administration. Patients should be monitored for signs of the onset of these AEs not only at the start of ponatinib administration but also over the longer term. [ABSTRACT FROM AUTHOR]

Introduction: Acquired haemophilia A (AHA) is a rare disease. The risk factors have yet to be studied. Aim: We aimed to identify risk factors for late‐onset AHA in Japan. Methods: A population‐based cohort study was conducted using data from the Shizuoka Kokuho Database. The study population was defined as individuals aged ≥60 years. Cause‐specific Cox regression analysis was performed to calculate hazard ratios. Results: Of 1,160,934 registrants, there were 34 patients with newly diagnosed AHA. The mean follow‐up period was 5.6 years, and the incidence of AHA was 5.21 per million person‐years. Myocardial infarction, diabetes mellitus, solid tumors, antimicrobial agents, phenytoin and anti‐dementia drugs, which showed significant differences in the univariate analysis, were excluded from the multivariable analysis because of the small number of cases. Multivariable regression analysis showed that the presence of Alzheimer's disease (hazard ratio [HR]:4.28, 95% confidence interval [CI]:1.67‐10.97) and rheumatic disease (HR:4.65, 95% CI:1.79‐12.12) increased the risk of AHA development. Conclusion: We found that comorbid Alzheimer's disease is a risk factor of AHA incidence in the general population. Our findings provide insight into the etiology of AHA, and the proof of the coexistence of Alzheimer's disease may support the recent notion that Alzheimer disease is an autoimmune disease. [ABSTRACT FROM AUTHOR]

Aims: Prognosis for ST‐segment elevation myocardial infarction (STEMI) is worse when heart failure is present on admission. Understanding clinical practice in different health systems can identify areas for quality improvement initiatives to improve outcomes. In the absence of international comparison studies, we aimed to compare treatments and in‐hospital outcomes of patients admitted with ST elevation myocardial infarction (STEMI) by heart failure status in two healthcare‐wide cohorts. Methods and results: We used two nationwide databases to capture admissions with STEMI in the United Kingdom (Myocardial ischemia National Audit Project, MINAP) and Japan (Japanese Registry of All Cardiac and Vascular Diseases‐Diagnostic Procedure Combination, JROAD‐DPC) between 2012 and 2017. Participants were stratified using the HF Killip classification into three groups; Killip 1: no congestive heart failure, Killip 2–3: congestive heart failure, Killip 4: cardiogenic shock. We calculated crude rate and case mix standardized risk ratios (CSRR) for use of treatments and in‐hospital death. Patients were younger in the United Kingdom (65.4 [13.6] vs. 69.1 [13.0] years) and more likely to have co‐morbidities in the United Kingdom except for diabetes and hypertension. Japan had a higher percentage of heart failure and cardiogenic shock patients among STEMI during admission than that in the United Kingdom. Primary percutaneous coronary intervention (pPCI) rates were lower in the United Kingdom compared with Japan, especially for patients presenting with Killip 2–3 class heart failure (pPCI use in patients with Killip 1, 2–3, 4: Japan, 86.2%, 81.7%, 78.7%; United Kingdom, 79.6%, 58.2% and 79.9%). In contrast, beta‐blocker use was consistently lower in Japan than in the United Kingdom (61.4% vs. 90.2%) across Killip classifications and length of hospital stay longer (17.0 [9.7] vs. 5.0 [7.4] days). The crude rate of in‐hospital mortality increased with increasing Killip class group. Both the crude rate and CSRR was higher in the United Kingdom compared with Japan for Killip 2–3 (15.8% vs. 6.4%, CSRR 1.80 95% CI 1.73–1.87, P < 0.001), and similar for Killip 4 (36.9% vs. 36.3%, CSRR 1.11 95% CI 1.08–1.13, P < 0.001). Conclusions: Important differences in the care and outcomes for STEMI with heart failure exist between the United Kingdom and Japan. Specifically, in the United Kingdom, there was a lower rate of pPCI, and in Japan, fewer patients were prescribed beta blockers and hospital length of stay was longer. This international comparison can inform targeted quality improvement programmes to narrow the outcome gap between health systems. [ABSTRACT FROM AUTHOR]

Summary: Over the past millennia, life expectancy has drastically increased. While a mere 25 years during Bronze and Iron ages, life expectancy in many European countries and in Japan is currently above 80 years. Such an increase in life expectancy is a result of improved diet, life style, and medical care. Yet, increased life span and aging also represent the most important non‐modifiable risk factors for several pathologies including cardiovascular disease, neurodegenerative diseases, and cancer. In recent years, neutrophils have been implicated in all of these pathologies. Hence, this review provides an overview of how aging impacts neutrophil production and function and conversely how neutrophils drive aging‐associated pathologies. Finally, we provide a perspective on how processes of neutrophil‐driven pathologies in the context of aging can be targeted therapeutically. [ABSTRACT FROM AUTHOR]

Background: The relationship between diabetes control status and long-term prognosis after stroke incidence remains unclear. This study aimed to investigate the effect of diabetes status at admission on long-term survival in patients with first-ever stroke. Methods: A retrospective cohort study was conducted based on the Shiga Stroke and Heart Attack Registry in Japan. Patients were classified according to their diabetes status and glycated hemoglobin (HbA1c) value at hospital admission into the following: (1) free of diabetes (no history of diabetes and HbA1c <6.5%); (2) good control (history of diabetes and HbA1c <7%; free of history and 6.5% ≤HbA1c <7%); and (3) poor control (with or without a history of diabetes and HbA1c ≥7%). Multivariable Cox regression models were used to evaluate the association between diabetes status and long-term survival from stroke onset. Additionally, we also evaluated the association between diabetes status and conditional survival, beginning 29 days after stroke onset. Results: A total of 6,331 first-ever stroke patients were eligible for this study. Among study patients, the mean (±SD) age was 72.85 ± 13.19 years, and the mean (±SD) follow-up year was 2.76 ± 1.66 years; additionally, 42.09% of patients were women. Among patients with all strokes, considering the free-of-diabetes group as the reference group, the adjusted hazard ratio (95% confidence interval) for mortality was 1.26 (1.10, 1.44) in the good control group and 1.22 (1.05, 1.41) in the poor control group. Among patients with ischemic stroke, the adjusted hazard ratio was 1.24 (1.06, 1.46) in good control group and 1.27 (1.08, 1.50) in poor control group. After excluding patients who died within 28 days, the adjusted hazard ratio for conditional mortality in the poor control group was 1.31 (1.12, 1.54) among all stroke patients and 1.29 (1.08, 1.54) among ischemic stroke patients. No significant associations were observed between diabetic status and long-term mortality in intracerebral hemorrhage patients. Conclusions: The findings suggest that first-ever stroke patients with diabetes exhibited a higher risk of all-cause mortality than those without diabetes, particularly in the overall stroke and ischemic stroke populations. Additionally, in stroke populations after 28 days of onset, high risk of long-term mortality was stated in stroke patients with poor HbA1c control. [ABSTRACT FROM AUTHOR]

The safety profiles of COVID-19 vaccines are incompletely evaluated in Japan. To examine the risk of serious adverse effects after COVID-19 mRNA vaccination (BNT162b2 and mRNA-1273) in cohort studies and self-controlled case series (SCCS). Using an administrative claims database linked with the COVID-19 vaccination registry in a city in Japan between September 2020 and September 2021, we identified health insurance enrolees aged ≥ 18 years. We evaluated the risk of acute myocardial infarction, appendicitis, Bell's palsy, convulsions/seizures, disseminated intravascular coagulation, immune thrombocytopenia, pulmonary embolism, haemorrhagic or ischemic stroke, venous thromboembolism, and all-cause mortality, 21 days following any COVID-19 mRNA vaccination, compared with non-vaccination periods. For the cohort studies, we estimated incidence rate ratios (IRRs) by Poisson regression and rate differences (IRDs) by weighted least-squares regression, adjusting for sex, age, and Charlson comorbidity index. We applied a modified SCCS design to appropriately treat outcome-dependent exposures. For the modified SCCS, we estimated within-subject IRRs by weighted conditional Poisson regression. Subgroup analyses stratified by sex and age were also conducted. We identified 184,491 enrolees [male: 87,218; mean (standard deviation) age: 64.2 (19.5) years] with 136,667 first and 127,322 s dose vaccinations. The risks of any outcomes did not increase in any analyses, except for the fact that the modified SCCS indicated an increased risk of pulmonary embolism after the first dose in women (within-subject IRR [95%CI]: 3.97 [1.18–13.32]). The findings suggested that the COVID-19 mRNA vaccine was generally safe, whilst a signal of pulmonary embolism following the first dose of the COVID-19 mRNA vaccine was observed. [ABSTRACT FROM AUTHOR]

Body mass index (BMI) distribution and its impact on cardiovascular disease (CVD) vary between Asian and western populations. The study aimed to reveal time-related trends in the prevalence of obesity and underweight and safe ranges of BMI in Japanese patients with CVD. We analyzed 5,020,464 records from the national Japanese Registry of All Cardiac and Vascular Diseases—Diagnosis Procedure Combination dataset over time (2012–2019) and evaluated BMI trends and the impact on in-hospital mortality for six acute CVDs: acute heart failure (AHF), acute myocardial infarction (AMI), acute aortic dissection (AAD), ischemic stroke (IS), intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH). Patients were categorized into five groups using the WHO Asian-BMI criteria: underweight (< 18.5 kg/m2), normal (18.5–22.9 kg/m2), overweight at risk (23.0–24.9 kg/m2), obese I (25.0–29.9 kg/m2), and obese II (≥ 30.0 kg/m2). Age was significantly and inversely related to high BMI for all diseases (P < 0.001). The proportion of BMI categories significantly altered over time; annual BMI trends showed a significant and gradual increase, except AAD. In adjusted mixed models, underweight was significantly associated with a high risk of in-hospital mortality in all CVD patients (AHF, OR 1.41, 95% CI 1.35–1.48, P < 0.001; AMI, OR 1.27, 95% CI 1.20–1.35, P < 0.001; AAD, OR 1.23, 95% CI 1.16–1.32, P < 0.001; IS, OR 1.45, 95% CI 1.41–1.50, P < 0.001; ICH, OR 1.18, 95% CI 1.13–1.22, P < 0.001; SAH, OR 1.17, 95% CI 1.10–1.26, P < 0.001). Moreover, obese I and II groups were significantly associated with a higher incidence of in-hospital mortality, except AHF and IS. Age was associated with in-hospital mortality for all BMI categories in six CVD patients. BMI increased annually in patients with six types of CVDs. Although underweight BMI was associated with high mortality rates, the impact of obesity on in-hospital mortality differs among CVD types. [ABSTRACT FROM AUTHOR]

Purpose: Acid-suppressive drugs (ASDs) are often prescribed for patients with nonvalvular atrial fibrillation (NVAF) taking oral anticoagulants (OACs). However, the risk-benefit balance of ASDs prescription for patients with NVAF taking OACs is still unclear. This study aimed to assess the association between ASDs and clinical outcomes in patients taking OACs for NVAF. Methods: This study is a subanalysis of an historical registry study from 71 centers in Japan. We included patients taking vitamin K antagonists for NVAF and excluded those with mechanical heart valves or a history of pulmonary thrombosis or deep vein thrombosis. We registered consecutive patients in February 2013 and followed them up until February 2017. The primary outcomes were ischemic events, major bleedings, and all-cause mortality. Ischemic stroke, acute myocardial infarction, and hemorrhagic stroke comprised the secondary outcomes. Results: We included 7826 patients with a mean age of 73 years, 5274 (67%) of whom were males. The adjusted hazard ratios (95% confidence intervals) for ischemic events, major bleedings, and all-cause mortality in the ASD group compared with the no-ASD group were 0.998 (0.78–1.27), 0.98 (0.81–1.18), and 1.22 (1.02–1.47), respectively, while those for ischemic stroke, acute myocardial infarction, and hemorrhagic stroke were 0.96 (0.74–1.24), 0.82 (0.36–1.88), and 1.17 (0.69–1.99), respectively. Conclusions: ASDs were significantly associated with all-cause mortality in patients with NVAF taking OACs. [ABSTRACT FROM AUTHOR]

Although the relationship between dyslipidaemia (DL) and coronary artery disease (CAD) or between trace minerals intake and CAD is well known separately, the exact nature of this relationship remains unknown. We hypothesize that the relationship between trace mineral intake and CAD may differ depending on whether or not the individual has DL. The present study analysed the relationships among trace mineral intake, DL, and CAD in middle-aged and older adults living in Shika town, Ishikawa prefecture, Japan. This study included 895 residents following the exclusion of those with genetic risk carriers for familial hypercholesterolemia. Trace mineral intake was evaluated using the brief-type self-administered diet history questionnaire. Interactions were observed between DL and CAD with zinc ( p = 0.004), copper ( p = 0.010), and manganese intake ( p < 0.001) in a two-way analysis of covariance adjusted for covariates such as sex, age, body mass index, and current smokers and drinkers. Multiple logistic regression analysis showed that zinc (odds ratio (OR): 0.752; 95% confidence interval (CI): 0.606, 0.934; p = 0.010), copper (OR: 0.175; 95% CI: 0.042, 0.726; p = 0.016), and manganese (OR: 0.494; 95% CI: 0.291, 0.839; p = 0.009) were significant independent variables for CAD in the dyslipidaemic group. The present results suggest that DL with a low trace mineral intake is associated with CAD. Further longitudinal studies are required to confirm this relationship., Competing Interests: None., (© The Author(s) 2024.)

Bioresorbable scaffolds (BRS) emerged as an alternative to conventional stents with a fundamental idea, to avoid a permanent metallic cage with all its harmful effects on the vessel. The Absorb BVS was the first widely studied device with the promising concept of performing a percutaneous coronary intervention, giving the necessary initial support to maintain vessel integrity and avoid acute vessel thrombosis. After a period, complete resorption of the device without leaving in the vessel any metallic structure would theoretically offer several benefits as the reduction of the inflammatory response and recovering normal vasomotor function, recovering access of jailed side-branches and segments for surgical revascularization, and the reduction of very late stent thrombosis derived from late acquired malapposition. However, cumulative evidence from the different absorb randomized trials (ABSORB II, ABSORB III, ABSORB China, ABSORB Japan) raised significant concerns, due to an elevated rate of scaffold thrombosis, target lesion failure and target vessel failure, when compared to contemporary everolimus drug-eluting stents. Several mechanisms arose explaining scaffold failure; some were strictly related to the device itself, and others related to the operator and the lesion itself. Newer generation BRS are under development targeting the main limitations of the ABSORB BVS, mainly focusing on reducing strut thickness, improving the mechanical structure with faster resorption times, and a better crossing profile. The story of BRS is not over yet, with ongoing refinements in the quest for the ideal stent. • The ideal device to be used for PCI should relief the coronary obstruction with virtually no side effects. • BRS provided the possibility of restoring vessel integrity without leaving in the vessel any metallic structure. • Evidences of an higher-than expected rate of target vessel failure, mainly driven by an high rate of ScT and ScR has reduced the initial enthusiasm. [ABSTRACT FROM AUTHOR]

Background: The automated haematology analyzer XN-31 prototype (XN-31p) is a new flow cytometry-based device developed to measure the number and the ratio of malaria-infected red blood cells (MI-RBC) with a complete blood count (CBC). The XN-31p can provide results in about one minute and also can simultaneously provide information on the malaria parasite (Plasmodium) species. In this study, clinical testing of the XN-31p was performed using blood samples from patients with imported malaria in Japan. Methods: Blood samples were collected from 80 patients who visited the hospital of the National Center for Global Health and Medicine, Tokyo, Japan, for malaria diagnosis from January 2017 to January 2019. The test results by the XN-31p were compared with those by other standard methods, such as microscopic observation, rapid diagnostic tests and the nested PCR. Results: Thirty-three patients were diagnosed by the nested PCR as being malaria positive (28 Plasmodium falciparum, 2 Plasmodium vivax, 1 Plasmodium knowlesi, 1 mixed infection of P. falciparum and Plasmodium malariae, and 1 mixed infection of P. falciparum and Plasmodium ovale), and the other 47 were negative. The XN-31p detected 32 patients as "MI-RBC positive", which almost matched the results by the nested PCR and, in fact, completely matched with the microscopic observations. The ratio of RBCs infected with malaria parasites as determined by the XN-31p showed a high correlation coefficient of more than 0.99 with the parasitaemia counted under microscopic observation. The XN-31p can analyse the size and nucleic acid contents of each cell, and the results were visualized on a two-dimensional cytogram termed the "M scattergram". Information on species and developmental stages of the parasites could also be predicted from the patterns visualized in the M scattergrams. The XN-31p showed a positive coincidence rate of 0.848 with the nested PCR in discriminating P. falciparum from the other species. Conclusions: The XN-31p could rapidly provide instructive information on the ratio of MI-RBC and the infecting Plasmodium species. It was regarded to be of great help for the clinical diagnosis of malaria. [ABSTRACT FROM AUTHOR]

Background: Triple antithrombotic therapy, including dual antiplatelet therapy and oral anticoagulant (OAC), is recommended for a short-term period after percutaneous coronary intervention (PCI) in patients requiring anticoagulation therapy. The purpose of this study was to compare in-hospital clinical outcomes between low-dose prasugrel (3.75 mg/day) and clopidogrel, as part of triple antithrombotic therapy, using a large database in Japan. Methods: Patients with ischemic heart disease who underwent PCI between January 2015 and December 2019, and were prescribed triple therapy with aspirin, a P2Y12 inhibitor (clopidogrel or low-dose prasugrel), and OAC (direct oral anticoagulant: DOAC or vitamin K antagonist: VKA), were selected from the Diagnosis Procedure Combination database. The primary outcome was in-hospital mortality. The secondary outcomes were myocardial infarction, ischemic stroke, bleeding stroke, gastrointestinal bleeding, and blood transfusion. Results: Overall, 5,777 patients were eligible in this analysis. The patients were divided into 4 subgroups according to the type of P2Y12 inhibitor and OAC: clopidogrel/DOAC (n = 1,628), clopidogrel/VKA (n = 1,334), prasugrel/DOAC (n = 1,607), and prasugrel/VKA (n = 1,208). There was no significant difference in the incidence of death and gastrointestinal bleeding among the 4 subgroups. The prasugrel/DOAC group had significantly lower incidence of MI (OR 0.566, 95% CI 0.348–0.921). The incidence of ischemic stroke was significantly lower in the prasugrel/DOAC group (OR 0.701, 95% CI 0.502–0.979), and significantly higher in the clopidogrel/VKA group (OR 1.680, 95% CI 1.273–2.216). Need for blood transfusion was less frequent in the prasugrel/DOAC group (OR 0.729, 95% CI 0.598–0.890), and more frequent in both the clopidogrel/VKA group (OR 1.424, 95% CI 1.187–1.708) and the prasugrel/VKA group (OR 1.633, 95% CI 1.367–1.950). Conclusions: Combination of low-dose prasugrel and DOAC was associated with lower incidence of MI, ischemic stroke, and blood transfusion. Low-dose prasugrel may be feasible as part of triple therapy in patients undergoing PCI. [ABSTRACT FROM AUTHOR]

Objectives: To compare the outcomes of patients with acute myocardial infarction who were treated in ICUs versus high-dependency care units (HDUs).Design: A nationwide, propensity score-matched, retrospective cohort study of a national administrative inpatient database in Japan from July 2010 to March 2018.Setting: Six hundred sixty-six acute-care hospitals with ICU and/or HDU beds covering about 75% of all ICU beds and 70% of all HDU beds in Japan.Patients: Adult patients who were hospitalized for acute myocardial infarction and admitted to the ICU or HDU on the day of hospital admission. Propensity score-matching analysis was performed to compare the inhospital mortality between patients treated in the ICU and HDU on the day of hospital admission.Interventions: ICU or HDU admission on the day of hospital admission.Measurements and Main Results: Of 135,142 eligible patients, 89,382 (66%) were admitted to the ICU and 45,760 (34%) were admitted to the HDU on the day of admission. After propensity score matching, there was no statistically significant difference in inhospital mortality between the ICU and HDU groups (5.0% vs 5.5%; difference, -0.5%; 95% CI, -1.0% to 0.1%). In the subgroup analyses, inhospital mortality was significantly lower in the ICU group than that in the HDU group among patients with Killip class IV (25.6% vs 28.4%; difference, -2.9%; 95% CI, -5.4% to -0.3%), patients who underwent intubation (40.0% vs 46.6%; difference, -6.6%; 95% CI, -10.6% to -2.7%), and patients who received mechanical circulatory support (21.8% vs 24.7%; difference, -2.8%; 95% CI, -5.5% to -0.2%).Conclusions: Critical care in the ICU compared with that in the HDU was not associated with reduced inhospital mortality among the entire cohort of patients with acute myocardial infarction but was associated with reduced inhospital mortality among the subsets of patients with Killip class IV, intubation, or mechanical circulatory support. [ABSTRACT FROM AUTHOR]

Background: Dual antiplatelet therapy (DAPT) with aspirin plus P2Y12 inhibitor is used as a standard therapy for patients with acute myocardial infarction (AMI) treated with drug-eluting stents (DESs). In Japan, clopidogrel was the major P2Y12 inhibitor used for a decade until the new P2Y12 inhibitor, prasugrel, was introduced. Based on clinical studies considering Japanese features, the set dose for prasugrel was reduced to 20 mg as a loading dose (LD) and 3.75 mg as a maintenance dose (MD); these values are 60 and 10 mg, respectively, globally. Despite this dose discrepancy, little real-world clinical data regarding its efficacy and safety exist. Methods: From the K-ACTIVE registry, based on the DAPT regimen, patients were divided into a prasugrel group and a clopidogrel group. The ischemic event was a composite of cardiovascular death, non-fatal MI, and non-fatal stroke. The bleeding event was type 3 or 5 bleeding based on the Bleeding Academic Research Consortium (BARC) criteria. Results: Substantially more patients were prescribed prasugrel (n = 2786) than clopidogrel (n = 890). Clopidogrel tended to be selected over prasugrel in older patients with numerous comorbidities. Before adjustments were made, the cumulative incidence of ischemic events at 1 year was significantly greater in the clopidogrel group than in the prasugrel group (p = 0.007), while the cumulative incidence of bleeding events at 1 year was comparable between the groups (p = 0.131). After adjustments were made for the age, sex, body weight, creatine level, type of AMI, history of MI, approach site, oral anticoagulation therapy, presence of multivessel disease, Killip classification, and presence of intra-aortic balloon pumping, both ischemic and bleeding events became comparable between the groups. Conclusion: A Japanese dose of prasugrel was commonly used in AMI patients in the real-world database. Both the prasugrel and clopidogrel groups showed comparable rates of 1 year ischemic and bleeding events. [ABSTRACT FROM AUTHOR]

The relationships between intracoronary imaging modalities and outcomes among Japanese patients with coronary artery disease (CAD) based on the type of medical facility providing outpatient care remain unclear. In this multicenter prospective study (SAKURA PCI Registry), we aimed to investigate the clinical outcomes of patients with CAD who underwent percutaneous coronary intervention (PCI) between April 2015 and December 2018. In this registry, we investigated differences in patient characteristics, intracoronary imaging modalities, and clinical outcomes between two types of medical facilities. Of the 414 patients enrolled in this registry, 196 were treated at two university hospitals, and 218 were treated at five community hospitals (median follow-up 11.0 months). The primary endpoint was clinically relevant events (CREs), including a composite of all-cause death, non-fatal myocardial infarction, clinically driven target lesion revascularization, stent thrombosis, stroke, and major bleeding. Patients treated at university hospitals had higher rates of diabetes (50% vs. 38%, p = 0.015) and malignant tumors (12% vs. 6%, p = 0.015) and more frequent use of multiple intracoronary imaging modalities than patients treated at community hospitals (21% vs. 0.5%, p < 0.001). The Kaplan–Meier incidence of CREs at 1 year was comparable between university hospitals and community hospitals (8.8% vs. 7.3%, p = 0.527, log-rank test). Despite the relatively higher risk among patients in university hospitals with frequent use of multi-intracoronary imaging modalities, adverse clinical events appeared to be comparable between patients with CAD treated at university and community hospitals in Japan. [ABSTRACT FROM AUTHOR]

Aims In patients with ST-segment elevation myocardial infarction (STEMI), predicting left ventricular (LV) remodelling (LVR) and prognosis is important. We explored the clinical usefulness of three-dimensional (3D) speckle-tracking echocardiography to predict LVR and prognosis in STEMI. Methods and results The study group comprised 255 first STEMI patients (65 years; 210 men) treated with primary percutaneous coronary intervention between April 2008 and May 2012 at Yokohama City University Medical Center. Baseline global longitudinal strain (GLS) was measured with two-dimensional (2D) and 3D speckle-tracking echocardiography. Within 48 of admission, standard 2D echocardiography and 3D full-volume imaging were performed, and 2D-GLS and 3D-GLS were calculated. Infarct size was estimated by 99mTc-sestamibi single-photon emission computed tomography. Echocardiography was performed at 1 year repeatedly in 239 patients. The primary endpoint was LVR, defined as an increase of 20% of LV end-diastolic volume index and major adverse cardiac and cerebrovascular events (MACE: cardiac death, non-fatal MI, heart failure, and ischaemic stroke) at 1 year, and the secondary endpoint was cardiac death and heart failure. Patients were followed for 1 year; 64, 25, and 16 patients experienced LVR, MACE, and the secondary endpoint, respectively. Multivariate analysis revealed that 3D-GLS was the strongest predictor of LVR (odds ratio = 1.437, 95% CI: 1.047–2.257, P  = 0.02), MACE (odds ratio = 1.443, 95% CI: 1.240–1.743, P  = 0.0002), and the secondary end point (odds ratio = 1.596, 95% CI: 1.17–1.56, P  < 0.0001). Receiver-operating characteristic curve analysis showed that 3D-GLS was superior to 2D-GLS in predicting LVR and 1-year prognosis. Conclusion 3D-GLS obtained immediately after STEMI is independently associated with LVR and 1-year prognosis. [ABSTRACT FROM AUTHOR]

Short stature was suggested to be a risk factor for cardiovascular events. Because short stature increases central blood pressure, this study aimed to investigate a longitudinal association between short stature, blood pressure, and incidence of cardiovascular disease by the analysis of insurance-based real-world dataset. We analyzed data from 463,844 adults aged 40 or older with a mean age of 66.7 enrolled in National Health Insurance, excluding individuals who experienced a stroke or myocardial infarction, or required long-term care. Data from annual health checkups were used to obtain baseline clinical information. Comorbidities and incidences of stroke and myocardial infarction were obtained from the insurance data. During a 5.5-year follow-up period, we observed 11,027 cases of stroke. Adults of a short stature exhibited a higher incidence rate in both men (≤155 cm: 99.7, >175 cm: 24.4) and women (≤140 cm: 85.9, >160 cm: 13.7). Although those in the short stature group had higher blood pressure, and often took antihypertensive drugs, the inverse association between height and stroke incidence was independent of these factors (hazard ratio for 5 cm shorter in height; men: 1.06 [1.03-1.09], women: 1.11 [1.06-1.13]). Short stature and blood pressure showed additive association with stoke incidence (log-rank p < 0.001). No significant association was observed with myocardial infarction (men: 1.01 [0.95-1.06], women: 1.06 [0.98-1.14]). In a longitudinal analysis of a large general Japanese population, short stature was linked to an increased risk of stroke in both genders in any blood pressure range., (© 2024. The Author(s), under exclusive licence to The Japanese Society of Hypertension.)

Background: Acute myocardial infarction (AMI) is a major scenario for the use of an intra-aortic balloon pump (IABP), particularly when complicated by cardiogenic shock, although the utilization of mechanical circulatory support devices varies widely per hospital. We evaluated the relationship, at the hospital level, between the volume of IABP use and mortality in AMI., Methods and results: Using a Japanese nationwide administrative database, 26,490 patients with AMI undergoing primary percutaneous coronary intervention (PCI) from 154 hospitals were included in this study. The primary endpoint was the observed-to-predicted in-hospital mortality ratio. Predicted mortality per patient was calculated using baseline variables and averaged for each hospital. The associations among PCI volume for AMI, observed and predicted in-hospital mortality, and observed and predicted IABP use were assessed per hospital. Of 26,490 patients, 2,959 (11.2%) were treated with IABP and 1,283 (4.8%) died during hospitalization. The annualized number of uses of IABP per hospital in AMI was 4.5. In lower-volume primary PCI centers, IABP was more likely to be underused than expected, and the observed-to-predicted in-hospital mortality ratio was higher than in higher-volume centers., Conclusions: A lower annual number of IABP use was associated with an increased mortality risk at the hospital level, suggesting that IABP use can be an institutional quality indicator in the setting of AMI.

Background: Women with acute myocardial infarction (AMI) often present a worse risk profile and experience a higher rate of in-hospital mortality than men. However, sex differences in post-discharge prognoses remain inadequately investigated. We examined the impact of sex on 1-year post-discharge outcomes in patients with AMI undergoing percutaneous coronary intervention., Methods and results: We extracted patient-level data for the period January 2017-December 2018 from the J-PCI OUTCOME Registry, endorsed by the Japanese Association of Cardiovascular Intervention and Therapeutics. One-year all-cause and cardiovascular mortality and major adverse cardiovascular events were compared between men and women. In all, 29,856 AMI patients were studied, with 6,996 (23.4%) being women. Women were significantly older and had a higher prevalence of comorbidities than men. Crude all-cause mortality was significantly higher among women than men (7.5% vs. 5.4% [P<0.001] for ST-elevation myocardial infarction [STEMI]; 7.0% vs. 5.2% [P=0.006] for non-STEMI). These sex-related differences in post-discharge outcomes were attenuated after stratification by age. Multivariate analysis demonstrated an increase in all-cause mortality in both sexes with increasing age and advanced-stage chronic kidney disease (CKD)., Conclusions: Within this nationwide cohort, women had worse clinical outcomes following AMI than men. However, these sex-related differences in outcomes diminished after adjusting for age. In addition, CKD was significantly associated with all-cause mortality in both sexes.

Drug-eluting stents have significantly contributed to reducing mortality in patients with ST-segment elevation myocardial infarctions (STEMIs), but slow-flow/no-reflow phenomenon (SFNR) and in-stent restenosis are still clinical problems. In contrast, perfusion balloons (PBs) can compress thrombi and ruptured plaque for long inflation without ischemia and can be used as a delivery device for infusion of nitroprusside to distal risk area during ballooning. We conducted a Reduction of risk bY perfUsion balloon for ST-segment Elevated myocardial Infarction (RYUSEI) study to evaluate whether PBs before stenting are more effective than conventional stenting for STEMIs. We divided consecutive patients with STEMIs who underwent optical coherence tomography (OCT)-guided percutaneous coronary intervention into PB group who were treated with PBs (Ryusei; Kaneka Medix Corporation, Osaka, Japan) before stenting and the conventional percutaneous coronary intervention (CP) group. We compared clinical results including SFNR, OCT findings, and clinical events between the 2 groups. We finally analyzed 34 patients in PB group and 90 in CP group. After propensity score-matching, PB and CP groups consisted of 23 patients, respectively. In the propensity score-matched cohort, SFNR and maximum protrusion area detected by OCT were significantly lower (p = 0.047 and p = 0.019), and thrombolysis in myocardial infarction flow grade 3 was higher (p = 0.022) in the PB group than CP group. Kaplan-Meier analysis revealed a significantly better clinical outcome in PB group than CP group (p = 0.038). In conclusion, the RYUSEI study revealed a pre-stent lesion modification in addition to nitroprusside infusion using PB is useful to achieve better clinical courses in STEMI patients., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS2°P) is a contemporary risk scoring system for secondary prevention based on nine clinical factors. However, this scoring system has not been validated in other populations. The aim of this study was to validate the TRS2°P in patients with acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (PCI) in a nationwide registry cohort. Among 3283 consecutive patients with AMI enrolled in the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET), a total of 2611 patients who underwent primary PCI were included in this study. The performance of the TRS2°P to predict major adverse cardiovascular events (MACE) composed of all-cause death, non-fatal MI, and non-fatal stroke up to 3 years in the present cohort was evaluated. The TRS2°P had modest discriminative performance in this J-MINUET cohort with a c-statistic of 0.63, similar to that in the derived cohort (TRA2°P-TIMI50, c-statistic 0.67). A strong graded relationship between the TRS2°P and 3-year cardiovascular event rates was also observed in the J-MINUET cohort. Age ≥ 75 years, Killip ≥ 2, prior stroke, peripheral artery disease, anemia, and non-ST-elevation myocardial infarction were identified as independent factors for the incidence of MACE. The TRS2°P modestly predicted secondary cardiovascular events among patients with AMI treated by primary PCI in a nationwide cohort of Japan. Further studies are needed to develop a novel risk score better predicting secondary cardiovascular events. [ABSTRACT FROM AUTHOR]

Aims/Introduction: Increased incidence of hospitalization for heart failure (HHF) among patients with diabetes is increasingly being reported. We investigated the incidence of adverse cardiovascular events including HHF among patients with type 2 diabetes mellitus, and the potential clinical improvement with sodium–glucose cotransporter 2 inhibitors (SGLT2i) using a contemporary administrative claims database from a large governmental district of Japan. Materials and Methods: We included initiators of any oral glucose‐lowering drugs between 2013 and 2018. We estimated the 5‐year cumulative incidence of hospitalization for HF, myocardial infarction and stroke, treating death as a competing risk. We evaluated the possible impact of introducing SGLT2i to the potential recipients of the drug, using the inclusion criteria from Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA‐REG OUTCOME) and Dapagliflozin Effect on Cardiovascular Events–Thrombolysis in Myocardial Infarction 58 (DECLARE‐TIMI 58) trials, assuming the same risk reduction as theirs. Results: Among 23,340 drug initiators (54.0% men, and 6.4% aged >85 years), the 5‐year cumulative incidence was 5.4% (95% confidence interval 4.9–5.9%) for HHF, 1.9% (95% confidence interval 1.7–2.2%) for myocardial infarction admission and 6.1% (95% confidence interval 5.7–6.6%) for stroke admission. Among 6,192 patients with laboratory test data, 651 (10.5%) and 2,680 (43.3%) patients met the EMPA‐REG‐like and DECLARE‐like criteria, respectively. The 5‐year cumulative incidence among the 2,849 patients meeting either of the criteria was estimated to decrease from 97.1 to 75.6 events through 75% adoption of SGLT2i. Conclusions: The incidence of HHF was similar to that of stroke. A significant portion of our cohort met the inclusion criteria for major randomized clinical trials for SGLT2i, and estimated reduction in the HHF events was substantial. [ABSTRACT FROM AUTHOR]

Objective: To clarify the association of detailed angiographic findings with in-hospital outcome after primary percutaneous coronary intervention (p-PCI) for ST-elevation myocardial infarction (STEMI) in Japan. Background: Data regarding the association of detailed angiographic findings with in-hospital outcome after STEMI are limited in the p-PCI era. Methods: Between January-2004 and December-2018, 1735 patients with STEMI (mean age, 68.5 years; female, 24.6%) who presented to the hospital in the 24-hours after symptom onset and underwent p-PCI were evaluated using the disease registries. The registry is an ongoing, retrospective, single-center hospital-based registry. Results: The 30-day mortality rate and in-hospital mortality rate were 7.7% and 9.2%, respectively. Independent predictors of in-hospital mortality were ejection fraction (EF) < 40% [adjusted Odds Ratio (aOR), 4.446, p < 0.001], culprit lesions in the left coronary artery (LCA) (aOR, 2.940, p < 0.001) compared with those in the right coronary artery, Killip class > II (aOR, 7.438; p < 0.001), chronic kidney disease (CKD) (aOR, 4.056; p < 0.001), final thrombolysis in myocardial infarction (TIMI) grades 0/1/2 (aOR, 1.809; p = 0.03), absence of robust collaterals (aOR, 17.309; p = 0.01) and hypertension (aOR, 0.449; p = 0.01). Conclusions: Among the consecutive patients with STEMI, the in-hospital mortality rate after p-PCI significantly improved in the second half. Not only CKD, Killip class > II, and EF < 40%, but also the angiographic findings such as culprit lesions in the LCA, absence of very robust collaterals, and final TIMI grades <3 were associated with an increased risk of in-hospital mortality. [ABSTRACT FROM AUTHOR]

Anaerobic threshold (AT) from cardiopulmonary exercise tests (CPX) is the standard for measuring exercise intensity among patients with cardiovascular disease in Japan. However, it remains controversial whether AT represents the safety limit for exercise intensity in patients with cardiovascular disease. The purpose of this study was to investigate cardiac rehabilitation (CR) efficacy and safety with exercise intensities above the AT and at a traditional AT in a randomized trial. The participants included 57 patients who were admitted to the outpatient CR unit with a diagnosis of acute myocardial infarction. The participants were randomly divided as follows: 25 patients in the AT group, who performed aerobic exercises with an intensity at the AT; and 32 patients in the "Over AT" group, who performed exercises at an intensity higher than the AT. The following components were measured: maximum oxygen uptake (peak VO2), oxygen uptake at the AT (AT VO2), increase in oxygen uptake during exercise (ΔVO2/ΔWR) during the CPX, vascular endothelial function test (%FMD: the percentage of flow-mediated dilation), and isometric knee extension strength. The measurements were obtained at the start of the exercise therapy and after 2, 3, and 4 months. They were compared within and between groups, and the correlation between the rates of improvement was investigated. Peak VO2, AT VO2, ΔVO2/ΔWR, and %FMD had significantly improved after 3 months in both groups. The isometric knee extension strength had improved in the "Over AT" group after 2 months. Interactions were observed with peak VO2, ΔVO2/ΔWR, and isometric knee extension strength. However, %FMD was not significantly different between the groups. In the "Over AT" group, the rate of improvement in peak VO2 was positively correlated with the improvement in the isometric knee extension strength (r = 0.61, p < 0.001), but not with %FMD. These data suggest that exercise at an intensity above the AT improved exercise tolerance faster than that at the AT, and this improvement rate was associated with changes in isometric knee extension strength. [ABSTRACT FROM AUTHOR]

Aim: Worsening renal function (WRF) induced by acute myocardial infarction (AMI) is a strong predictor of cardiovascular events and mortality. Peak oxygen uptake may contribute to prognosis in AMI patients with WRF, however, the impact of WRF on peak oxygen uptake is unclear. Methods: Among 154 patients with AMI who underwent emergency percutaneous coronary intervention and participated in phase II cardiac rehabilitation, those who underwent cardiopulmonary exercise testing were consecutively enrolled. WRF was defined as a ≥20% decrease in estimated glomerular filtration rate (eGFR [ml/min/1.73 m2]) from admission to that at cardiopulmonary exercise testing. The association of WRF with peak oxygen uptake was evaluated by multivariate regression analysis. The non‐WRF group was divided into two subgroups according to eGFR <60/≥60 at cardiopulmonary exercise testing, and eGFR at cardiopulmonary exercise testing and peak oxygen uptake of all three groups were compared. Results: Ninety‐four patients were enrolled in the final analysis. Multiple linear regression analysis showed that WRF was associated with peak oxygen uptake (p =.003). Comparing the non‐WRF group with eGFR at cardiopulmonary exercise testing <60 and the WRF group, although eGFR at cardiopulmonary exercise testing was similar (p = 1.000), peak oxygen uptake in the WRF group was significantly lower (p =.026). Conclusion: WRF, not eGFR at cardiopulmonary exercise testing was significantly associated with peak oxygen uptake in patients with AMI. This result suggests that when considering the relationship between renal function and peak oxygen uptake, WRF must be taken into account. SUMMARY AT A GLANCE: This is a retrospective cohort study on 94 patients followed for up to 6 months in Japan showing that worsening of kidney function after acute myocardial infarction (MI) is associated with peak oxygen uptake on exercise test, and this association is independent of baseline kidney function. Thus a decline is kidney function post MI may have implications for worse outcomes than the absolute level of kidney function. [ABSTRACT FROM AUTHOR]

Takotsubo cardiomyopathy (TCM) was first initially reported in 1990 in Japan and has been increasingly recognized in clinical practice. It is characterized by transient regional left ventricular dysfunction without evidence of obstructive coronary artery disease, often precipitated by emotional and physical stressors. Although TCM does occur in young women and men, it is most commonly seen in postmenopausal women. Sepsis induced TCM is an infrequently encountered entity. We present a case of TCM in a middle age gentleman who presented with septic shock due to acute cholecystitis. Two days later, the patient developed clinical features of acute myocardial infarction. Echocardiography revealed hypokinesis of the left ventricle. Coronary angiography revealed normal arteries without any obstruction. Diagnosis of sepsis induced TCM was finally made. The patient made a dramatic recovery and discharged home in stable condition. Follow-up echocardiography showed improvement in left ventricular systolic function. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to reveal the epidemiological characteristics of thromboembolism related to combined oral contraceptives (COCs) in Japan. Methods: A survey of confirmed thromboembolism patients among Japanese COC users was conducted at randomly selected hospitals from across Japan. The survey examined six types of venous thromboembolism (VTE) and arterial thromboembolism (ATE) in all COC users: pulmonary embolism, deep vein thrombosis, other venous thrombosis, cerebral infarction, myocardial infarction, and other arterial thrombosis. The survey covered 5 years from 2009 to 2013. This study was approved in an ethical review by Hamamatsu University School of Medicine. Results: Four hundred and twenty‐five cases clearly related to COCs were analyzed. The annual estimated incidence rates per 10 000 person‐years of VTE, ATE and all thromboembolisms in all COC users were 1.17, 0.33 and 1.50, respectively. The incidence of thromboembolism was 35.2% within 30 days from the start of COCs, 53.8% within 90 days, 66.9% within 180 days and 78.2% within 360 days regardless of progestin type. Age adjusted odds ratios in the obese and underweight groups were 2.33 and 0.98 for overall thromboembolism, 2.59 and 0.77 for VTE, and 1.11 and 1.28 for ATE compared with the standard group, respectively. Odds ratios for thromboembolism in non‐O blood groups were 1.89 for overall thromboembolism, 2.16 for VTE, and 1.35 for ATE, when compared with the O blood group. Conclusion: The epidemiological characteristics of COC‐related thromboembolisms were revealed in this national survey covering the years from 2009 to 2013. [ABSTRACT FROM AUTHOR]

Background: Acute coronary syndrome and sudden cardiac death are often caused by rupture and thrombosis of lipid-rich atherosclerotic coronary plaques (known as vulnerable plaques), many of which are non-flow-limiting. The safety and effectiveness of focal preventive therapy with percutaneous coronary intervention of vulnerable plaques in reducing adverse cardiac events are unknown. We aimed to assess whether preventive percutaneous coronary intervention of non-flow-limiting vulnerable plaques improves clinical outcomes compared with optimal medical therapy alone., Methods: PREVENT was a multicentre, open-label, randomised controlled trial done at 15 research hospitals in four countries (South Korea, Japan, Taiwan, and New Zealand). Patients aged 18 years or older with non-flow-limiting (fractional flow reserve >0·80) vulnerable coronary plaques identified by intracoronary imaging were randomly assigned (1:1) to either percutaneous coronary intervention plus optimal medical therapy or optimal medical therapy alone, in block sizes of 4 or 6, stratified by diabetes status and the performance of percutaneous coronary intervention in a non-study target vessel. Follow-up continued annually in all enrolled patients until the last enrolled patient reached 2 years after randomisation. The primary outcome was a composite of death from cardiac causes, target-vessel myocardial infarction, ischaemia-driven target-vessel revascularisation, or hospitalisation for unstable or progressive angina, assessed in the intention-to-treat population at 2 years. Time-to-first-event estimates were calculated with the Kaplan-Meier method and were compared with the log-rank test. This report is the principal analysis from the trial and includes all long-term analysed data. The trial is registered at ClinicalTrials.gov, NCT02316886, and is complete., Findings: Between Sept 23, 2015, and Sept 29, 2021, 5627 patients were screened for eligibility, 1606 of whom were enrolled and randomly assigned to percutaneous coronary intervention (n=803) or optimal medical therapy alone (n=803). 1177 (73%) patients were men and 429 (27%) were women. 2-year follow-up for the primary outcome assessment was completed in 1556 (97%) patients (percutaneous coronary intervention group n=780; optimal medical therapy group n=776). At 2 years, the primary outcome occurred in three (0·4%) patients in the percutaneous coronary intervention group and in 27 (3·4%) patients in the medical therapy group (absolute difference -3·0 percentage points [95% CI -4·4 to -1·8]; p=0·0003). The effect of preventive percutaneous coronary intervention was directionally consistent for each component of the primary composite outcome. Serious clinical or adverse events did not differ between the percutaneous coronary intervention group and the medical therapy group: at 2 years, four (0·5%) versus ten (1·3%) patients died (absolute difference -0·8 percentage points [95% CI -1·7 to 0·2]) and nine (1·1%) versus 13 (1·7%) patients had myocardial infarction (absolute difference -0·5 percentage points [-1·7 to 0·6])., Interpretation: In patients with non-flow-limiting vulnerable coronary plaques, preventive percutaneous coronary intervention reduced major adverse cardiac events arising from high-risk vulnerable plaques, compared with optimal medical therapy alone. Given that PREVENT is the first large trial to show the potential effect of the focal treatment for vulnerable plaques, these findings support consideration to expand indications for percutaneous coronary intervention to include non-flow-limiting, high-risk vulnerable plaques., Funding: The CardioVascular Research Foundation, Abbott, Yuhan Corp, CAH-Cordis, Philips, and Infraredx, a Nipro company., Competing Interests: Declaration of interests S-JP reports research grants and speaker fees from Abbott Vascular, Medtronic, Daiichi-Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Edwards. D-YK reports speaker fees from Abbott Vascular, Daiichi-Sankyo, Viatris, Boryoung, and Daewoong Pharm. Y-KA reports research grants from Boston Scientific, Medtronic, Abbott, and DioMedical. C-WN reports a research grant from Abbott. J-OJ reports speaker fees from Medtronic. HS reports speaker fees from Abbott Vascular and Boston Scientific. H-LK reports grants and speaker fees from Abbott Vascular and Boston Scientific. J-YH reports research grants and speaker fees from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. K-YC reports research grant from Biotronik and Medtronik. GSM reports honoraria from Boston Scientific, Abbott, SpectraWave, and Gentuity. GWS reports speaker fees from Medtronic, Pulnovo, Infraredx, Abiomed, Abbott, Amgen, and Boehringer Ingelheim; consultant fees from Daiichi Sankyo, Ablative Solutions, CorFlow, Apollo Therapeutics, Cardiomech, Gore, Robocath, Miracor, Vectorious, Abiomed, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Elucid Bio, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, and Oxitope; equity or stock options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; and grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave outside the submitted work; and GWS's daughter is an employee at IQVIA. D-WP reports research grants and speaker fees from Abbott Vascular, Medtronic, Daiichi-Sankyo, Edwards Lifescience, ChongKunDang Pharm, and Daewoong Pharm. All other authors declare no competing interests relevant to the contents of this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Cardiovascular diseases (CVDs), such as heart disease and stroke, have a significant impact on life expectancy, healthy life expectancy, and medical costs in Japan. Each prefecture is currently promoting measures in accordance with the Japanese National Plan for Promotion of Measures Against Cerebrovascular and Cardiovascular Disease, which was established by the government. In recent years, the crude mortality rate of heart disease in Japan has been increasing year by year with the aging population. Meanwhile, the age-adjusted mortality rate has leveled off or shown a downward trend. In addition, the proportion of acute myocardial infarction has decreased, whereas the proportion of heart failure has increased. By contrast, both the crude and age-adjusted mortality rates of stroke have a declining trend. Nevertheless, considering the potential variations in death certificates issued for patients with myocardial infarction across different prefectures, it is crucial to determine the incidence of CVD in each prefecture for the accurate assessment of CVD trends. However, as for the incidence of CVD, not many prefectures have yet implemented registration programs. The age-adjusted incidence rate of acute myocardial infarction has been increasing in some areas and decreasing in others since 1990. The age-adjusted incidence rate of stroke has consistently declined since the 1960s. Nevertheless, the possible increase in the incidence rate of cerebral embolism and thrombotic cerebral infarction among patients with different stroke subtypes is a cause of concern. The impact of heart failure on the incidence of heart disease has increased. Therefore, relevant academic societies and prefectures must collaborate in registering the incidence of heart failure as well as myocardial infarction and implementing countermeasures., Competing Interests: Declaration of competing interest The authors declare that there is no conflict of interest., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

To address many uncertainties in the acute care of patients with acute myocardial infarction (AMI) in proportion to increasing age, we underwent the nationwide current survey consisted of 11,676 patients with AMI based on the database of the Japanese Acute Myocardial Infarction Registry between January 2011 and December 2013 to figure out how difference of clinical profiles and outcomes between coronary revascularization and conservative treatments for AMI. Clinical profiles in a total of 763 patients with AMI with conservative treatments (7% of all) were characterized as more elderly women (median age, 71 yeas vs. 68 years, p < 0.0001, male, 71% vs. 76%, p = 0.0008), high Killip class (Killip class I, 61% vs. 75%, p < 0.0001), and non-ST-segment elevation AMI (37% vs. 27%, p < 0.0001) as compared with 10,913 with coronary revascularization, with a consequence of more than twofold higher in-hospital mortality (12% vs. 5%, p < 0.0001). When compared with conservative treatments, highly effective of coronary revascularization to decrease in-hospital mortality was found in patients with ST-segment elevation AMI (6% vs. 16%, p < 0.0001), while these advantages were not evident in those with non-ST-segment elevation AMI (4% vs. 6%, p = 0.1107), especially with high Killip class, regardless of whether or not propensity score matching of clinical characteristics. A risk-adapted allocation of invasive management therefore may have the potential of benefiting patients with non-ST-segment elevation AMI, in particular elders. [ABSTRACT FROM AUTHOR]

Background: Sudden cardiac arrest is a serious complication of acute myocardial infarction (MI). Although in-hospital mortality from MI has decreased, the mortality of MI patients complicated with out-of-hospital cardiac arrest (OHCA) remains high. However, the features of acute MI patients with OHCA have not been well known.Objectives: We sought to characterize the clinical and angiographic features of acute MI patients with OHCA comparing with those without OHCA.Methods: We retrospectively analyzed 480 consecutive patients with acute MI undergoing percutaneous coronary intervention. Patients complicated with OHCA were compared with patients without OHCA.Results: Of the patients, 141 (29%) were complicated with OHCA. Multivariate analysis revealed that age (odds ratio [OR]: 0.8; 95% confidence interval [CI]: 0.7 to 0.9 per 5 years; p < 0.001), estimated glomerular filtration rate (OR: 0.8; 95% CI: 0.7 to 0.8 per 10 ml/min/1.73 m2; p < 0.001), peak creatine kinase-myocardial band (OR: 1.3; 95% CI: 1.2 to 1.4 per 102 U/l; p < 0.001), calcium-channel antagonists use (OR: 0.4; 95% CI: 0.2 to 0.7; p = 0.002), the culprit lesion at the left main coronary artery (OR: 5.3; 95% CI: 1.9 to 15.1; p = 0.002), and the presence of chronic total occlusion (OR: 2.9; 95% CI: 1.5 to 5.7; p = 0.001) were significantly associated with OHCA.Conclusions: Younger age, no use of calcium-channel antagonists, worse renal function, larger infarct size, culprit lesion in the left main coronary artery, and having chronic total occlusion were associated with OHCA. [ABSTRACT FROM AUTHOR]

Mechanical complications (MCs) following acute myocardial infarction (AMI), such as ventricular septal rupture (VSR), free-wall rupture (FWR), and papillary muscle rupture (PMR), are fatal. However, the risk factors of in-hospital mortality among patients with MCs have not been previously reported in Japan. The purpose of this study was to evaluate the prognostic factors of in-hospital mortality in these patients. The study cohort consisted of 233 consecutive patients with MCs from the registry of 10 facilities in the Cardiovascular Research Consortium-8 Universities (CIRC-8U) in East Japan between 1997 and 2014 (2.3% of 10,278 AMI patients). The authors conducted a retrospective observational study to analyse the correlation between the subtypes of MCs with in-hospital mortality, clinical data, and medical treatment. We observed a decreasing incidence of MC (1997–2004: 3.7%, 2005–2010: 2.1%, 2011–2014: 1.9%, p < 0.001). In-hospital mortality among patients with MCs was 46%. Thirty-three percent of patients with MCs were not able to undergo surgical repair due to advanced age or severe cardiogenic shock. In-hospital mortality among patients who had undergone surgical repair was 29% (VSR: 21%, FWR: 33%, PMR: 60%). In patients with MCs, hazard ratio for in-hospital mortality according to multivariate analysis of without surgical repair was 5.63 (95% CI 3.54–8.95). In patients with surgical repair, the hazard ratios of blow-out-type FWR (5.53, 95% confidence interval (CI) 2.22–13.76), those with renal dysfunction (3.11, 95% CI 1.37–7.05), and those receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) (3.79, 95% CI 1.81–7.96) were significantly high. Although primary percutaneous coronary intervention (PCI) is associated with decreased incidence of MCs, high in-hospital mortality persisted in patients with MCs that also presented with renal dysfunction and in those requiring VA-ECMO. Early detection and surgical repair of MCs are essential. [ABSTRACT FROM AUTHOR]

Particulate matter from natural sources such as desert dust causes harmful effects for health. Asian dust (AD) increases the risk of acute myocardial infarction (AMI). However, little is known about the risk of myocardial infarction with nonobstructive coronary arteries (MINOCA), compared to myocardial infarction with coronary artery disease (MI-CAD). Using a time-stratified case-crossover design and conditional logistic regression models, the association between short-term exposure to AD whereby decreased visibility (< 10 km) observed at each monitoring station nearest to the hospitals was used for exposure measurements and admission for AMI in the spring was investigated using a nationwide administrative database between April 2012 and March 2016. According to presence of revascularization and coronary atherosclerosis, AMI patients (n = 30,435) were divided into 2 subtypes: MI-CAD (n = 27,202) or MINOCA (n = 3233). The single lag day-2 was used in AD exposure based on the lag effect analysis. The average level of meteorological variables and co-pollutants on the 3 days prior to the case/control days were used as covariates. The occurrence of AD events 2 days before the admission was associated with admission for MINOCA after adjustment for meteorological variables [odds ratio 1.65; 95% confidence interval (CI) 1.18–2.29], while the association was not observed in MI-CAD. The absolute risk difference of MINOCA admission was 1.79 (95% CI 1.21–2.38) per 100,000 person-year. These associations between AD exposure and the admission for MINOCA remained unchanged in two-pollutant models. This study provides evidence that short-term exposure to AD is associated with a higher risk of MINOCA, but not MI-CAD. [ABSTRACT FROM AUTHOR]

Background: Observational studies using large claims databases for diabetes patients have been increasingly conducted. While validation of outcomes is important in such studies, validation studies from Japan are still scarce and small in scale with questions remaining on the representativeness of their findings. We examined the positive predictive value (PPV) of outcomes that often develop in type 2 diabetes patients: cardiovascular outcomes including congestive heart failure (CHF), myocardial infarction (MI), stroke-related diseases, and renal outcomes including end stage renal disease (ESRD), and death using a large Japanese database containing administrative claims and electronic medical record (EMR) data. Patients and Methods: We used patient-level administrative claims data from 2003 and EMR data from 1985 to the most recent data up to December 2018 provided by Real World Data Co., Ltd. The database consisted of data from over 200 hospitals including ≥ 12 million uniquely identifiable patients. Among patients who had ≥ 1 type 2 diabetes diagnosis in the EMR, those who had administrative claims for each outcome were identified, and then the PPV was calculated for each outcome using the EMR as the gold standard. Results: The numbers of patients identified for each outcome were 1,700 for MI, 2,027 for hemorrhagic stroke, 3,722 for ESRD, 4,723 for ischemic stroke, 5,404 for CHF, 6,678 for any type of stroke, and 10,815 for death. PPVs ranged from 67.4% for ESRD, 78.7% for MI, 80.3% for death, 85.7% for ischemic stroke, 88.9% for any type of stroke, 89.9% for hemorrhagic stroke, and 95.7% for CHF. A post hoc analysis showed PPV for ESRD as 83.8%. Conclusion: This large-scale validation study on diagnosis in administrative claims showed reasonable PPVs for the outcomes. We believe that the definitions of outcomes can be considered to be appropriate for future studies using Japanese administrative claims data. [ABSTRACT FROM AUTHOR]

Myocardial infarction with nonobstructive coronary arteries (MINOCA) is a common presentation of acute myocardial infarction (AMI) and has a better prognosis. However, there were few reports on large-scale, high aged population. The aim of this study was to determine the differences in the clinical characteristics and short-term prognosis between MINOCA and myocardial infarction with obstructive coronary artery disease (MI-CAD) using a nationwide administrative database in the super-aging society, Japan. This was an observational study using data of 137,678 AMI patients who underwent angiography between April 2012 through March 2016. Using the international classification of diseases 10th revision, AMI patients were divided into two groups based on the presence or absence of revascularization and coronary atherosclerosis, identifying 123,633 MI-CAD and 14,045 working diagnosis of MINOCA patients. The true MINOCA (n = 13,022) was defined as the MINOCA excluding non-ischemic causes. We assessed in-hospital mortality within 30 days. Both MINOCA groups were typically found in non-obese, non-smoker young females, with a low grade on Killip classification, and non-low ADL status. Compared to MI-CAD, chronic pulmonary diseases, peripheral vascular diseases, liver diseases, renal diseases, and cerebrovascular diseases were more common, whereas diabetes was less common in the MINOCA groups. In-hospital mortality within 30 days was higher in both MINOCA groups than in MI-CAD. Multivariate frailty model identified both MINOCA groups as an independent risk factor for in-hospital mortality. Our large-population study demonstrated that MINOCA was associated with a high risk of in-hospital mortality compared with MI-CAD in the super-aging society. • This study showed the characteristics of MINOCA in the super-aged society. • MINOCA was associated with a higher risk for in-hospital mortality. • The prognosis of MINOCA was heterogeneous due to the diversity of the causes. [ABSTRACT FROM AUTHOR]

Introduction: The safety of prasugrel in elderly and/or low body weight Japanese patients with ischemic stroke who have a relatively high bleeding risk with antiplatelet therapy remains unknown. Objective: We aimed to investigate the safety and efficacy of long-term prasugrel monotherapy for stroke prevention compared with clopidogrel in elderly and/or low body weight Japanese patients with non-cardioembolic ischemic stroke. Methods: In this randomized, double-blind, comparative, phase III study, elderly (age ≥75 years) and/or low body weight (≤50 kg) Japanese patients with a previous history of non-cardioembolic ischemic stroke were assigned to a prasugrel 3.75 mg (PRA3.75) group, a prasugrel 2.5 mg (PRA2.5) group, or a clopidogrel 50 mg (CLO50) group and followed up for 48 weeks. The primary safety endpoint was the combined incidence of primary safety events, defined as life-threatening, major, and other clinically relevant bleeding. The efficacy endpoint was a composite of ischemic stroke, myocardial infarction, and death from other vascular causes. Results: A total of 654 patients (age 76.4 ± 7.3 years, body weight 55.6 ± 9.3 kg, women 43.9%) from 74 medical institutions within Japan were enrolled. The combined incidence (95% CI) of primary safety events was 4.2% (1.9–7.8%), 1.9% (0.5–4.7%), and 3.6% (1.6–6.9%) in the PRA3.75 group (n = 216), PRA2.5 group (n = 215), and CLO50 group (n = 223), respectively (hazard ratios [HR] PRA3.75/CLO50, 1.13 [0.44–2.93]; PRA2.5/CLO50, 0.51 [0.15–1.69]). The incidences of bleeding leading to treatment discontinuation (95% CI) were 2.3% (0.8–5.3%), 0.9% (0.1–3.3%), and 2.2% (0.7–5.2%) in the PRA3.75, PRA2.5, and CLO50 groups, respectively (HRs PRA3.75/CLO50, 1.01 [0.29–3.48]; PRA2.5/CLO50, 0.41 [0.08–2.12]). There was no significant difference in all bleeding events between groups. The incidence of ischemic stroke, myocardial infarction, and death from other vascular causes was lower, but not significantly so, in patients treated with prasugrel than in patients treated with clopidogrel: PRA3.75, 0.0% (0/216); PRA2.5, 3.3% (7/215); and CLO50, 3.6% (8/223; HRs PRA3.75/CLO50, 0.00 [0.00–0.00]; PRA2.5/CLO50, 0.90 [0.32–2.47]). Conclusions: Elderly and/or low body weight -Japanese patients with previous non-cardioembolic ischemic stroke who received PRA3.75 showed similar results in terms of primary safety endpoint, and a numerically lower incidence of ischemic stroke, myocardial infarction, and death from other vascular causes, compared with those who received CLO50. [ABSTRACT FROM AUTHOR]

The SLENDER Integrated Delivery System (IDS™) is an 'all-in-one' fixed-wire coronary stenting device designed for direct stenting, precluding the need for conventional guidewires and predilatation balloons. It achieves ultra-low profiles (crossing profiles as low as 0.029″/0.737 mm), enabling the downsizing of catheters to facilitate transradial intervention in a large subsets of patients. The IDS represents the first advance in coronary stent delivery since the introduction of rapid-exchange stent delivery systems >20 years ago. SLENDER IDS has demonstrated non-inferiority compared with commercial DES, excellent long-term safety and a potentially more efficient approach to PCI where patient comfort is enhanced, procedures are streamlined, and resource consumption is reduced. This paper will summarize the novel features of this new stent delivery system and the early clinical data demonstrating safety and efficacy. [ABSTRACT FROM AUTHOR]

It is known that incidence and short-term mortality rate of acute myocardial infarction (AMI) tend to be higher in the cold season. The aim of our study was to investigate the association of onset-season with patient characteristics and long-term prognosis of AMI. This was a prospective, multicenter, Japanese investigation of 3,283 patients with AMI who were hospitalized within 48 h of symptom onset between July 2012 and March 2014. Patients were divided into 3 seasonal groups according to admission date: cold season group (December–March), hot season group (June–September), and moderate season group (April, May, October, and November). We identified 1356 patients (41.3%) admitted during the cold season, 901 (27.4%) during the hot season, and 1026 (31.3%) during the moderate season. We investigated the seasonal effect on patient characteristics and clinical outcomes. Baseline characteristics of each seasonal group were comparable, with the exception of age, Killip class, and conduction disturbances. The rates of higher Killip class and complete atrioventricular block were significantly higher in the cold season group. The 3-year cumulative survival free from major adverse cardiac events (MACE) rate was the lowest in the cold season (67.1%), showing a significant difference, followed by the moderate (70.0%) and hot seasons (72.9%) (p < 0.01). Initial severity and long-term prognoses were worse in patients admitted during the cold season. Our findings highlight the importance of optimal prevention and follow-up of AMI patients with cold season onset. [ABSTRACT FROM AUTHOR]

Aims: The Nagasaki Acute Myocardial Infarction Secondary Prevention Clinical Pathway (NASP), a guideline-based regional clinical pathway, was developed to manage low-density lipoprotein cholesterol levels for patients with acute myocardial infarction (AMI) in the Nagasaki prefecture in Japan. This study aimed to summarize the perceived best practices and barriers for the dissemination and operation of the NASP., Methods: This exploratory sequential mixed methods study was developed around the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Focus group interviews were conducted with 24 physicians with experience treating AMI in alignment with the NASP at foundation hospitals. The identified themes and insights were integrated into the development of the questionnaire. The web-based, self-administered questionnaire with a cross-sectional study design was given to 62 physicians in the Nagasaki prefecture. Mixed-method data integration of the results from both study phases was conducted through meta-inferences made from the qualitative and quantitative data., Results: The best practices included the development of multi-disciplinary operation teams at medical facilities in preparation for the implementation of the NASP, the simplification of the document preparation process, and the establishment of an additional medical fees policy for the utilization of the NASP instead of patient referral documents. Practices tailored to the type of medical institute such as instructing patients on the NASP regimen during index hospitalization for acute-care hospitals, and the development of NASP instructions and manuals for primary care hospitals/outpatient clinics were also recommended. In addition, barriers to the implementation of the NASP such as missed eligible AMI patients for the NASP and the inconsistent implementation to eligible AMI patients were identified., Conclusions: This study identified the perceived best practices and barriers for the NASP. This knowledge should be considered when expanding the NASP to other institutions across Japan.

Competing Interests: Disclosures None.

Background: Transcatheter aortic valve implantation (TAVI) is criticized by some as an expensive treatment in super-elder patients with limited life expectancy. However, there is a knowledge gap regarding the magnitude of clinical benefit provided by TAVI in comparison with conservative management in patients with severe aortic stenosis (AS) in real clinical practice, which would be important in the decision making for TAVI. Methods: We combined two independent registries, namely CURRENT AS and K-TAVI registries. CURRENT AS was a multicenter registry enrolling 3815 consecutive patients with severe AS irrespective to treatment modalities between January 2003 and December 2011. K-TAVI was a multicenter, prospective registry including 449 consecutive patients with severe AS, who underwent TAVI with SAPIEN XT balloon-expandable valves between October 2013 and June 2016. In these 2 registries, 449 patients received TAVI and 894 patients were managed with conservative strategy. We conducted propensity score matching and finally obtained a cohort of 556 patients (278 patients for each group) for the analysis. The primary outcome measures were all-cause death and heart failure (HF) hospitalization at 2-year. Results: The cumulative 2-year incidences of all-cause death and HF hospitalization were significantly lower in the TAVI group than in the conservative group (16.8% versus 36.6%, P<0.001, and 10.7% versus 37.2%, P<0.001). After adjusting the residual confounders, TAVI reduced the risks of all-cause death (HR, 0.46; 95%CI, 0.32–0.69; P = 0.0001) and HF hospitalizations (HR, 0.25; 95%CI, 0.16–0.40; P<0.0001) compared with conservative strategy. There was no difference in the cumulative incidence of non-cardiovascular death between the 2 groups. Conclusions: TAVI in the early Japanese experience was associated with striking risk reduction for all-cause death as well as HF hospitalization as compared with the historical cohort of patients with severe AS who were managed conservatively just before introduction of TAVI in Japan. [ABSTRACT FROM AUTHOR]