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Recently, one observational study showed that patients with ST-segment elevation myocardial infarction (STEMI) without standard cardiovascular risk factors were associated with increased mortality compared with patients with risk factors. This unexpected result should be evaluated in other populations including those with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and chronic coronary syndrome (CCS). Among 30,098 consecutive patients undergoing first coronary revascularization in the CREDO-Kyoto PCI/CABG (Coronary Revascularization Demonstrating Outcome Study in Kyoto Percutaneous Coronary Intervention/Coronary Artery Bypass Grafting) registry cohort-2 and 3, we compared clinical characteristics and outcomes between patients with and without risk factors stratified by their presentation (STEMI n = 8,312, NSTE-ACS n = 3,386, and CCS n = 18,400). Patients with risk factors were defined as having at least one of the following risk factors: hypertension, dyslipidemia, diabetes, and current smoking. The proportion of patients without risk factors was low (STEMI: 369 patients [4.4%], NSTE-ACS: 110 patients [3.2%], and CCS: 462 patients [2.5%]). Patients without risk factors compared with those with risk factors more often had advanced age, low body weight, and malignancy and less often had history of atherosclerotic disease and prescription of optimal medical therapy. In patients with STEMI, patients without risk factors compared with those with risk factors were more often women and more often had atrial fibrillation, long door-to-balloon time, and severe hemodynamic compromise. During a median of 5.6 years follow-up, patients without risk factors compared with those with risk factors had higher crude incidence of all-cause death. After adjusting confounders, the mortality risk was significant in patients with CCS (hazard ratio [HR] 1.22, 95% confidence interval [CI] 1.01 to 1.49, p = 0.04) but not in patients with STEMI (HR 1.06, 95% CI 0.89 to 1.27, p = 0.52) and NSTE-ACS (HR 1.07, 95% CI, 0.74 to 1.54, p = 0.73). In conclusion, among patients undergoing coronary revascularization, patients without standard cardiovascular risk factors had higher crude incidence of all-cause death compared with those with at least one risk factor. After adjusting confounders, the mortality risk was significant in patients with CCS but not in patients with STEMI and NSTE-ACS.

Aims Little is known about the characteristics and outcomes of patients who undergo coronary angiography during heart failure (HF) hospitalization, as well as those with coronary stenosis, and those who underwent coronary revascularization. Methods and results We analysed 2163 patients who were hospitalized for HF without acute coronary syndrome or prior HF hospitalization. We compared patient characteristics and 1 year clinical outcomes according to (i) patients with versus without coronary angiography, (ii) patients with versus without coronary stenosis, and (iii) patients with versus without coronary revascularization. The primary outcome measure was the composite of all‐cause death or HF hospitalization. Coronary angiography was performed in 37.0% of patients. In the multivariable logistic regression analysis, factors independently associated with coronary angiography were age

There is a scarcity of data on incidence, risk factors, especially clinical severity, and long-term prognostic impact of periprocedural stroke after coronary revascularization in contemporary real-world practice. Among 14,867 consecutive patients undergoing first coronary revascularization between January 2011 and December 2013 (percutaneous coronary intervention [PCI]: N = 13258, and coronary artery bypass grafting [CABG]: N = 1609) in the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG registry Cohort-3, we evaluated the details on periprocedural stroke. Periprocedural stroke was defined as stroke within 30 days after the index procedure. Incidence of periprocedural stroke was 0.96% after PCI and 2.13% after CABG (log-rank p0.001). Proportions of major stroke defined by modified Rankin Scale ≥2 at hospital discharge were 68% after PCI, and 77% after CABG. Independent risk factors of periprocedural stroke were acute coronary syndrome (ACS), carotid artery disease, advanced age, heart failure, and end-stage renal disease after PCI, whereas they were ACS, carotid artery disease, atrial fibrillation, chronic obstructive pulmonary disease, malignancy, and frailty after CABG. There was excess long-term mortality risk of patients with periprocedural stroke relative to those without after both PCI and CABG (hazard ratio 1.71 [1.25 to 2.33], and hazard ratio 4.55 [2.79 to 7.43]). In conclusion, incidence of periprocedural stroke was not negligible not only after CABG, but also after PCI in contemporary real-world practice. Majority of patients with periprocedural stroke had at least mild disability at hospital discharge. ACS and carotid artery disease were independent strong risk factors of periprocedural stroke after both PCI and CABG. Periprocedural stroke was associated with significant long-term mortality risk after both PCI and CABG.

Aims The association between serum cholinesterase and prognosis in acute heart failure (AHF) remains to be elucidated. We investigated the serum cholinesterase level at discharge from hospitalization for AHF and its association with clinical outcomes in patients with AHF. Methods and results Among 4056 patients enrolled in the Kyoto Congestive Heart Failure multicentre registry, we analysed 2228 patients with available serum cholinesterase data. The study population was classified into three groups according to serum cholinesterase level at discharge: low tertile ( Conclusions Low serum cholinesterase levels are associated with congestive findings on echocardiography, higher BNP, and higher risks for a composite of all-cause death and HF hospitalization in patients with AHF.

Antiplatelet agents and statin therapies are widely used in patients with known cardiovascular disease. Plaque rupture (PR) and plaque erosion (PE) are the most frequent underlying mechanisms of acute coronary syndromes (ACS). The conditions and medications that are associated with ST-segment elevation myocardial infarction (STEMI) following PR or PE have not been systematically studied. A total of 838 ACS patients (494 with STEMI, 344 with NSTE-ACS) who were diagnosed with PR or PE by optical coherence tomography were included. The patients were categorized into two groups based on underlying pathology, and the baseline characteristics and culprit plaque morphology associated with STEMI were investigated within each group. Among 838 patients, 467 (55.7%) had PR, and 371 (44.3%) were diagnosed with PE. Among patients with PR, older age, hyperlipidemia, no antiplatelet therapy, higher level of low-density lipoprotein cholesterol, and greater lipid burden and macrophage infiltration were associated with increased probability of STEMI. Among patients with PE, no dual antiplatelet therapy and no statin therapy were associated with increased probability of STEMI. The incidence of STEMI caused by PR was significantly lower on antiplatelet therapy (P

Ethnic differences in the pathobiology of acute coronary syndromes (ACS) have not been systematically studied. We compared the underlying mechanisms of ACS between Asians and Whites. ACS patients with the culprit lesion imaged by optical coherence tomography were included. Patients were stratified into ST-elevation myocardial infarction (STEMI) and non-ST-elevation-ACS (NSTE-ACS), and baseline characteristics, underlying mechanisms of ACS, and culprit plaque characteristics were compared between Asians and Whites. Of 1,225 patients, 1,019 were Asian (567 STEMI and 452 NSTE-ACS) and 206 were White (71 STEMI and 135 NSTE-ACS). Asians had more diabetes and hypertension among STEMI patients; among NSTE-ACS patients, Asians had higher prevalence of diabetes and renal insufficiency, and lower prevalence of hyperlipidemia. There were no differences in the incidence of plaque rupture, plaque erosion and calcified plaque between Asians and Whites with STEMI (61.2%, 28.6%, 10.2% vs 46.5%, 38.0%, 15.5%, respectively, p = 0.055). Among NSTE-ACS patients, there was a significant difference between Asians and Whites (40.5%, 47.6%, 11.9% vs 27.4%, 48.9%, 23.7%, respectively, p = 0.001). After adjustment for clinical confounders, the risk of plaque rupture (p = 0.713), plaque erosion (p = 0.636), and calcified plaque (p = 0.986) was similar between the groups with STEMI. In NSTE-ACS patients, the only difference was an increased risk of calcified plaque in Whites (odds ratio: 2.125, 95% confidence interval: 1.213 to 3.723, p = 0.008). In conclusion, after adjustment for clinical confounders, Asian and White patients presenting with STEMI and NSTE-ACS showed similar underlying mechanisms of ACS, except for a higher risk of calcified plaque in Whites with NSTE-ACS.

Background No studies have explored the association between newly diagnosed infections after admission and clinical outcomes in patients with acute heart failure. We aimed to explore the factors associated with newly diagnosed infection after admission for acute heart failure, and its association with in‐hospital and post‐discharge clinical outcomes. Methods and Results Among 4056 patients enrolled in the Kyoto Congestive Heart Failure registry, 2399 patients without any obvious infectious disease upon admission were analyzed. The major in‐hospital and post‐discharge outcome measures were all‐cause deaths. There were 215 patients (9.0%) with newly diagnosed infections during hospitalization, and 2184 patients (91.0%) without infection during hospitalization. The factors independently associated with a newly diagnosed infection were age ≥80 years, acute coronary syndrome, non‐ambulatory status, hyponatremia, anemia, intubation, and patients who were not on loop diuretics as outpatients. The newly diagnosed infection group was associated with a higher incidence of in‐hospital mortality (16.3% and 3.2%, P P P P =0.02) compared with the non‐infection group. Conclusions Elderly patients with multiple comorbidities were associated with the development of newly diagnosed infections after admission for acute heart failure. Newly diagnosed infections after admission were associated with higher in‐hospital and post‐discharge mortality in patients with acute heart failure. Registration URL: https://clinicaltrials.gov ; Unique identifier: NCT02334891.

Background Heart failure (HF) is a known risk factor for ischemic stroke, but data regarding ischemic stroke during hospitalization for acute decompensated HF (ADHF) are limited. Methods and Results We analyzed the data from a multicenter registry (Kyoto Congestive Heart Failure [KCHF] Registry) that enrolled 4056 consecutive patients with ADHF in Japan (mean age, 78 years; men, 2238 patients [55%]; acute coronary syndrome [ACS], 239 patients [5.9%]). We investigated the incidence and predictors of ischemic stroke during hospitalization for ADHF. During the hospitalization, 63 patients (1.6%) developed ischemic stroke. The median interval from admission to the onset of ischemic stroke was 7 [interquartile range: 2–14] days, and the most common underlying cause was cardioembolism (64%). Men (OR, 1.87; 95%CI, 1.11–3.24), ACS (OR, 2.31; 95%CI, 1.01–4.93), absence of prior HF hospitalization (OR, 2.21; 95%CI, 1.24–4.21), and high B‐type natriuretic peptide (BNP)/N‐terminal proBNP (NT‐proBNP) levels (above the median) at admission (OR, 3.15; 95%CI, 1.84–5.60) were independently associated with ischemic stroke. In patients without ACS, the independent risk factors for ischemic stroke were fully consistent with those in the main analysis. Higher quartiles of BNP/NT‐proBNP levels were significantly associated with higher incidence of ischemic stroke ( P for trend, Conclusions During hospitalization for ADHF, 1.6% of the patients developed ischemic stroke. Men, ACS, absence of prior HF hospitalization, and high BNP/NT‐proBNP levels at admission were independently associated with ischemic stroke.

Background Lymphocyte, total cholesterol, and albumin levels consist of Controlling Nutritional Status (CONUT) score, which has been reported to prognosticate patients with acute heart failure (AHF). However, the influence of each component of CONUT score on outcomes in patients with AHF was not fully elucidated. Purpose We aimed to evaluate the prognostic implication of the decrease in lymphocyte, total cholesterol, and albumin levels in patients with AHF. Methods We analyzed 1812 AHF patients in whom data at discharge were available from a multicenter registry. The decrease of lymphocyte (Ly) count was assigned with Ly≥1600/mL (31.0%), 1200≤ Ly Results Cumulative one-year incidence of the all-cause death was higher with decreasing Ly, TC, and Alb levels (P Conclusions The prognostic implications after discharge were different in albumin, lymphocyte count, and total cholesterol in patients with AHF. Funding Acknowledgement Type of funding sources: None. Figure 1

Background: We sought to explore the effects of previous heart failure (HF) hospitalization on mortality in patients hospitalized for acute decompensated HF (ADHF) in a large Japanese contemporary observational database. Methods and Results: We prospectively enrolled consecutive patients with ADHF in 19 participating hospitals between October 2014 and March 2016. Of 4, 056 patients, 1, 442 patients (35.4%) had at least 1 previous HF hospitalization (previous hospitalization group), while 2, 614 patients (64.5%) did not have a history of HF hospitalization (de novo hospitalization group). Patients with previous hospitalization were older and more often had comorbidities such as anemia, and renal failure than those without. The cumulative 1-year incidence of all-cause death was significantly higher in the previous hospitalization group than in the de novo hospitalization group (28% vs. 19%, P

Postmortem studies reported plaque erosion is frequent in young women. Recent in vivo studies failed to show age and sex differences in the plaque erosion prevalence. The aim of this study was to investigate the prevalence of plaque erosion by age and sex among acute coronary syndromes (ACS) patients. From 1699 ACS patients, 1083 with plaque erosion or rupture were analyzed. Patients were categorized as 5 age groups (≤ 50, 51-60, 61-70, 71-80, ≥ 81 years). Overall prevalence of plaque erosion was similar between males and females (p = 0.831). Males age ≤ 50 had higher (p = 0.018) and age 71-80 had lower (p = 0.006) prevalence of plaque erosion. Females age 61-70 had higher (p = 0.021) and age 71-80 had lower (p = 0.045) prevalence of plaque erosion. In advanced age groups (≥ 71 years), rupture was the dominant etiology in both sexes. In multivariate analysis of males, age ≤ 50 demonstrated a trend to increase (OR 1.418, 95% CI 0.961-2.093, p = 0.078) the erosion risk. Females age ≤ 70 independently increased (OR 2.138, 95% CI 1.249-3.661, p = 0.006) the risk for erosion. The prevalence of plaque erosion was similar between males and females. Plaque erosion risk was increased in the males age ≤ 50 and in the females age ≤ 70 among ACS patients.

Although an in vivo diagnosis of coronary plaque erosion has become possible by optical coherence tomography (OCT), angiographic characteristics of erosion have not been studied. The aim of this study was to investigate the angiographic features of plaque erosion in patients with non-ST elevation acute coronary syndromes (NSTE-ACS).Patients with NSTE-ACS who underwent OCT of the culprit lesion were collected at 11 institutions from 6 countries. Patients were classified as erosion or non-erosion based on OCT images. Angiographic features of both groups were compared.Among 494 cases with NSTE-ACS, 242 had plaque erosion and 252 had non-erosion. Compared to non-erosion group, erosion patients had less multivessel disease (28.5% vs. 49.6%, p 0.001), lower Jeopardy score (4.2 vs. 5.0, p 0.001), lower Gensini score (21.3 vs. 25.6, p = 0.014), and lower Syntax score (8.9 vs. 11.5, p 0.001). With regard to the culprit lesion morphology, plaque erosion group had smaller reference diameter (2.8 mm vs. 3.0 mm, p = 0.032), less frequent type B2/C lesions (51.2% vs. 71.8%, p 0.001), and lower prevalence of calcification (4.1% vs. 13.9%, p 0.001) and thrombus (16.5% vs. 28.2%, p = 0.002). In the mid left anterior descending artery (LAD), erosion was significantly more frequent than non-erosion (30.2% vs. 21.8%, p = 0.034).Patients with NSTE-ACS caused by plaque erosion have less complex angiographic features both at the 3-vessel level and at the culprit lesion level. Plaque erosion was frequently found in the mid LAD.

Diabetes mellitus (DM) increases cardiovascular morbidity and mortality. A statin is routinely prescribed to patients with DM. However, whether a statin therapy is equally effective in plaque stabilization in DM patients compared with non-DM patients is unknown. A total of 117 lipid-rich plaques were imaged in 90 patients (54 plaques in 41 DM patients and 63 plaques in 49 non-DM patients) with coronary artery disease, those who were treated with a statin and underwent serial optical coherence tomography imaging were included in this study (mean follow-up period, 362 ± 38 days). The changes in minimum fibrous cap thickness (FCT) and lipid index between baseline and 1-year follow-up were compared between the 2 groups. Minimum FCT increased and lipid index decreased with statin therapy in both groups. No significant differences were observed in percent changes of minimum FCT (p = 0.796) and lipid index (p = 0.336) between DM and non-DM patients. Statin therapy induced a significant increase in FCT and a significant decrease in lipid index in both groups. Vascular response to statin therapy was similar between the 2 groups irrespective of DM status.

Background It remains unclear whether beta‐blocker use at hospital admission is associated with better in‐hospital outcomes in patients with acute decompensated heart failure. Methods and Results We evaluated the factors independently associated with beta‐blocker use at admission, and the effect of beta‐blocker use at admission on in‐hospital mortality in 3817 patients with acute decompensated heart failure enrolled in the Kyoto Congestive Heart Failure registry. There were 1512 patients (39.7%) receiving, and 2305 patients (60.3%) not receiving beta‐blockers at admission for the index acute decompensated heart failure hospitalization. Factors independently associated with beta‐blocker use at admission were previous heart failure hospitalization, history of myocardial infarction, atrial fibrillation, cardiomyopathy, and estimated glomerular filtration rate 2 . Factors independently associated with no beta‐blocker use were asthma, chronic obstructive pulmonary disease, lower body mass index, dementia, older age, and left ventricular ejection fraction P P P for interaction 0.04). Conclusions Beta‐blocker use at admission was associated with lower in‐hospital mortality in patients with acute decompensated heart failure. Registration URL: https://www.upload.umin.ac.jp/ ; Unique identifier: UMIN000015238.

[Background] There are limited data on the long-term stent-related adverse events as related to the duration of dual antiplatelet therapy (DAPT) in second-generation (G2) drug-eluting stents (DES) compared with first-generation (G1) DES. [Objectives] This study sought to compare the long-term stent-related outcomes of G2-DES with those of G1-DES. [Methods] The study group consisted of 15, 009 patients who underwent their first coronary revascularization with DES from the CREDO-Kyoto PCI/CABG (Coronary Revascularization Demonstrating Outcome Study in Kyoto Percutaneous Coronary Intervention/Coronary Artery Bypass Grafting) Registry Cohort-2 (first-generation drug-eluting stent [G1-DES] period; n = 5, 382) and Cohort-3 (second-generation drug eluting stent [G2-DES] period; n = 9, 627). The primary outcome measures were definite stent thrombosis (ST) and target vessel revascularization (TVR). [Results] The cumulative 5-year incidences of definite ST and TVR were significantly lower in the G2-DES group than in the G1-DES group (0.7% vs 1.4%; P < 0.001; and 16.2% vs 22.1%; P < 0.001, respectively). The lower adjusted risk of G2-DES relative to G1-DES for definite ST and TVR remained significant (HR: 0.53; 95% CI: 0.37-0.76; P < 0.001; and HR: 0.74; 95% CI: 0.68-0.81; P < 0.001, respectively). In the landmark analysis that was based on the DAPT status at 1 year, the lower adjusted risk of on-DAPT status relative to off-DAPT was significant for definite ST beyond 1 year in the G1-DES stratum (HR: 0.42; 95% CI: 0.24-0.76; P = 0.004) but not in the G2-DES stratum (HR: 0.66; 95% CI: 0.26-1.68; P = 0.38) (Pinteraction = 0.14). [Conclusions] G2-DES compared with G1-DES were associated with a significantly lower risk for stent-related adverse events, including definite ST and TVR. DAPT beyond 1 year was associated with a significantly lower risk for very late ST of G1-DES but not for that of G2-DES.

ObjectiveThe association between sequential changes in left atrial diameter (LAD) and prognosis in heart failure (HF) remains to be elucidated. The present study aimed to investigate the link between reduction in LAD and clinical outcomes in patients with HF.DesignA multicentre prospective cohort study.SettingThis study was nested from the Kyoto Congestive Heart Failure registry including consecutive patients admitted for acute decompensated heart failure (ADHF) in 19 hospitals throughout Japan.ParticipantsThe current study population included 673 patients with HF who underwent both baseline and 6-month follow-up echocardiography with available paired LAD data. We divided them into two groups: the reduction in the LAD group (change Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or hospitalisation for HF during 180 days after 6-month follow-up echocardiography. The secondary outcome measures were defined as the individual components of the primary composite outcome measure and a composite of cardiovascular death or hospitalisation for HF.ResultsThe cumulative 180-day incidence of the primary outcome measure was significantly lower in the reduction in the LAD group than in the no-reduction in the LAD group (13.3% vs 22.2%, p=0.002). Even after adjusting 15 confounders, the lower risk of reduction in LAD relative to no-reduction in LAD for the primary outcome measure remained significant (HR 0.59, 95% CI 0.36 to 0.97 p=0.04).ConclusionPatients with reduction in LAD during follow-up after ADHF hospitalisation had a lower risk for a composite endpoint of all-cause death or HF hospitalisation, suggesting that the change of LAD might be a simple and useful echocardiographic marker during follow-up.

BACKGROUND The prevalence of and expected bleeding event rate in patients with the Japanese version of high bleeding risk (J-HBR) criteria are currently unknown in real-world percutaneous coronary intervention (PCI) practice.Methods and Results:We applied the J-HBR criteria in the multicenter CREDO-Kyoto registry cohort-3 that enrolled 13,258 consecutive patients who underwent first PCI. The J-HBR criteria included Japanese-specific major criteria such as heart failure, low body weight, peripheral artery disease and frailty in addition to the Academic Research Consortium (ARC)-HBR criteria. There were 8,496 patients with J-HBR, and 4,762 patients without J-HBR. The J-HBR criteria identified a greater proportion of patients with HBR than did ARC-HBR (64% and 48%, respectively). Cumulative incidence of the Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding was significantly higher in the J-HBR group than in the no-HBR group (14.0% vs. 4.1% at 1 year; 23.1% vs. 8.4% at 5 years, P

ObjectivesTo examine the association of a high C-reactive protein (CRP) level at discharge from an acute decompensated heart failure (ADHF) hospitalisation with the 1-year clinical outcomes.DesignA post-hoc subanalysis of a prospective cohort study of patients hospitalised for ADHF (using the Kyoto Congestive Heart Failure (KCHF) registry) between October 2014 and March 2016 with a 1-year follow-up.SettingA physician-initiated multicentre registry enrolled consecutive hospitalised patients with ADHF for the first time at 19 secondary and tertiary hospitals in Japan.ParticipantsAmong the 4056 patients enrolled in the KCHF registry, the present study population consisted of 2618 patients with an available CRP value both on admission and at discharge and post-discharge clinical follow-up data. We divided the patients into two groups, those with a high CRP level (>10 mg/L) and those with a low CRP level (≤10 mg/L) at discharge from the index hospitalisation.Primary and secondary outcome measuresThe primary outcome measure was all-cause death after discharge from the index hospitalisation. The secondary outcome measures were heart failure hospitalisations, cardiovascular death and non-cardiovascular death.ResultsThe high CRP group and low CRP group included 622 patients (24%) and 1996 patients (76%), respectively. During a median follow-up period of 468 days, the cumulative 1-year incidence of the primary outcome was significantly higher in the high CRP group than low CRP group (24.1% vs 13.9%, log-rank pConclusionsA high CRP level (>10 mg/L) at discharge from an ADHF hospitalisation was associated with an excess mortality risk at 1 year.Trial registration detailshttps://clinicaltrials.gov/ct2/show/NCT02334891 (NCT02334891) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017241 (UMIN000015238).

Background Despite the prognostic importance of hypoalbuminemia, the prognostic implication of a change in albumin levels has not been fully investigated during hospitalization in patients with acute decompensated heart failure (ADHF). Methods Using the data from the Kyoto Congestive Heart Failure registry on 3160 patients who were discharged alive for acute heart failure hospitalization and in whom the change in albumin levels was calculated at discharge, we evaluated the association with an increase in serum albumin levels from admission to discharge and clinical outcomes by a multivariable Cox hazard model. The primary outcome measure was a composite of all-cause death or hospitalization for heart failure. Findings Patients with increased albumin levels (N = 1083, 34.3%) were younger and less often had smaller body mass index and renal dysfunction than those with no increase in albumin levels (N = 2077, 65.7%). Median follow-up was 475 days with a 96% 1-year follow-up rate. Relative to the group with no increase in albumin levels, the lower risk of the increased albumin group remained significant for the primary outcome measure (hazard ratio: 0.78, 95% confidence interval: 0.69–0.90: P = 0.0004) after adjusting for confounders including baseline albumin levels. When stratified by the quartiles of baseline albumin levels, the favorable effect of increased albumin was more pronounced in the lower quartiles of albumin levels, but without a significant interaction effect (interaction P = 0.49). Conclusions Independent of baseline albumin levels, an increase in albumin during index hospitalization was associated with a lower 1-year risk for a composite of all-cause death and hospitalization in patients with acute heart failure.

Background: The prognostic implications of very low body mass index (BMI) values remain unclear in patients with acute decompensated heart failure (ADHF). This study aimed to investigate the prognostic impact of BMI classification based on the World Health Organization criteria in patients with ADHF. Methods and Results: Using data from 4056 consecutive patients with ADHF hospitalized in 19 participating hospitals in Japan between October 2014 and March 2016, we analyzed 3509 patients with available BMI data at discharge. The patients were divided into five groups; (1) Severely underweight: BMI2 , (2) Underweight: BMI≥16 kg/m 2 and 2 , (3) Normal weight: BMI≥18.5 kg/m 2 and 2 , (4) Overweight: BMI≥25 kg/m 2 and 2 (5) Obese: BMI≥30 kg/m 2 . The primary outcome measure was all-cause death. The median follow-up duration was 471 days, with 96.4% follow up at 1-year. The cumulative 1-year incidence of all-cause death was higher in underweight groups, and lower in overweight groups (Severely underweight: 36.3%, Underweight: 23.9%, Normal weight: 14.4%, Overweight: 7.9%, and Obese: 9.0%, P Conclusions: Lower BMI, not obesity, was associated with a higher risk for all-cause death after discharge in patients with ADHF.

Objective This study aimed to investigate the prognostic impact of the decrease in tricuspid regurgitation pressure gradient (TRPG) at 6-month follow-up in patients after discharge with heart failure (HF). Background No previous study has reported the association between TRPG decrease during follow-up and clinical outcomes in HF. Methods Among 748 patients with 6-months follow-up echocardiography after discharge from the acute decompensated heart failure in 19 centers in Japan, we analyzed 721 patients with available TRPG data and divided into two groups: the decrease in TRPG group (N=179) and no decrease in TRPG group (N=542). We defined the decrease in TRPG as >10mmHg decrease compared in the initial hospitalization. The primary outcome measure was a composite of all cause deaths and hospitalization due to HF. Results The patients in the decrease in TRPG group had a lower prevalence of hypertension, dyslipidemia, atrial fibrillation, and a reduced EF, higher levels of blood albumin and lower levels of sodium than those in no decrease in TRPG group. The median follow-up duration after the follow up echocardiography was 302 (inter quartile range: 206–490), with a 90.9% follow up rate at 6-month. The cumulative 6-month incidence of the primary outcome measure was significantly lower in the decrease in TRPG group than in no decrease in TRPG group (12.2% vs. 18.9%, P=0.0011). After adjusting confounders, the excess risk of the decrease in TRPG relative to no decrease in TRPG for the primary outcome measure remained significant (HR: 0.60, 95% CI 0.34–0.99). There were no significant interactions between the subgroup factors and the effect of the decrease in TRPG for primary outcomes. Conclusions HF patients with the decrease in TRPG at 6-month after discharge had a lower risk of clinical outcome than those without decrease in TRPG. Funding Acknowledgement Type of funding source: None

The prognostic implications of very low body mass index (BMI) values remain unclear in patients with acute decompensated heart failure (ADHF). This study aimed to investigate the prognostic impact of BMI classification based on the World Health Organization criteria in patients with ADHF. Among 3509 patients with ADHF and available BMI data at discharge in 19 participating hospitals in Japan between October 2014 and March 2016, the study population was divided into five groups; (1) Severely underweight: BMI 2, (2) Underweight: BMI ≥ 16 kg/m2 and 2, (3) Normal weight: BMI ≥ 18.5 kg/m2 and 2, (4) Overweight: BMI ≥ 25 kg/m2 and 2 (5) Obese: BMI ≥ 30 kg/m2. The primary outcome measure was all-cause death. The median follow-up duration was 471 days, with 96.4% follow up at 1-year. The cumulative 1-year incidence of all-cause death was higher in underweight groups, and lower in overweight groups (Severely underweight: 36.3%, Underweight: 23.9%, Normal weight: 14.4%, Overweight: 7.9%, and Obese: 9.0%, P P P = 0.005) relative to the normal weight group, while the lower mortality risk was no longer significant in the overweight group (HR, 0.82; 95%CI, 0.62–1.10; P = 0.18) and in the obese group (HR, 1.09; 95%CI, 0.65–1.85; P = 0.74). Very low BMI was associated with a higher risk for one-year mortality after discharge in patients with ADHF.

It remains unclear the clinical characteristics and prognosis of implantable cardioverter defibrillator (ICD) on prevention for sudden cardiac death (SCD) in Japanese patients with acute decompensated heart failure (ADHF) and reduced left ventricular ejection fraction (LVEF). We investigated the prevalence, clinical characteristics, and clinical outcomes in a contemporary large-scale Japanese ADHF registry.Among the consecutive 3785 patients hospitalized for ADHF and discharged alive in the Kyoto Congestive Heart Failure registry, we identified 1409 patients with reduced LVEF (ICD: N = 115, non-ICD: N = 1294).Patients in the ICD group were younger (69.3 ± 12.9/74.2 ± 13.6 years; p0.001), more likely to be men (84%/65%), and more often had a history of heart failure hospitalization (70%/36%; p = 0.001), cardiomyopathy as the underlying heart disease (51%/27%; p0.001), and previous serious ventricular arrhythmia (57%/3.8%; p0.001), and had lower LVEF (25.4±7.4%/29.5±6.9%; p0.001), and estimated glomerular filtration rate (43.0±19.7/47.8±23.4 mL/min/1.73m2; p = 0.04) than those in the non-ICD group. The cumulative 1-year incidence of the primary arrhythmic composite endpoint of SCD, arrhythmic death, or resuscitated cardiac arrest trended to be lower in the ICD group than in the non-ICD group (0.0% versus 3.4%, p = 0.053), and the lower adjusted risk of the ICD group relative to the non-ICD group was significant for the primary arrhythmic endpoint (HR 0.10, 95% CI, 0.01-0.53; p = 0.003). However, there were no differences in the cumulative incidences of all-cause death between the ICD and non-ICD groups (17.3% versus 17.5%, p = 0.68), and the adjusted risk of the ICD group relative to the non-ICD group remained insignificant for all-cause death (HR, 0.85; 95%CI, 0.52-1.36, p = 0.51).This study elucidated the real-world features of ADHF patients between those with ICD and those without. ICD use in patients with ADHF and reduced LVEF as compared with non-ICD use was associated with significant risk reduction for arrhythmic events, but not for mortality.

Background Seasonal variations in acute coronary syndromes ( ACS ) have been reported, with incidence and mortality peaking in the winter. However, the underlying pathophysiology for these variations remain speculative. Methods and Results Patients with ACS who underwent optical coherence tomography were recruited from 6 countries. The prevalence of the 3 most common pathologies (plaque rupture, plaque erosion, and calcified plaque) were compared between the 4 seasons. In 1113 patients with ACS (885 male; mean age, 65.8±11.6 years), the rates of plaque rupture, plaque erosion, and calcified plaque were 50%, 39%, and 11% in spring; 44%, 43%, and 13% in summer; 49%, 39%, and 12% in autumn; and 57%, 30%, and 13% in winter ( P =0.039). After adjusting for age, sex, and other coronary risk factors, winter was significantly associated with increased risk of plaque rupture (odds ratio [OR], 1.652; 95% CI, 1.157–2.359; P =0.006) and decreased risk of plaque erosion (OR, 0.623; 95% CI, 0.429–0.905; P =0.013), compared with summer as a reference. Among patients with rupture, the prevalence of hypertension was significantly higher in winter ( P =0.010), whereas no significant difference was observed in the other 2 groups. Conclusions Seasonal variations in the incidence of ACS reflect differences in the underlying pathobiology. The proportion of plaque rupture is highest in winter, whereas that of plaque erosion is highest in summer. A different approach may be needed for the prevention and treatment of ACS depending on the season of its occurrence. Registration URL : https://www.clini​caltr​ials.gov . Unique identifier: NCT 03479723.

ObjectiveThis observational study aimed to examine the prognostic association of angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin receptor blockers (ARB) in different left ventricular ejection fraction (LVEF) categories.MethodsIn 3717 patients enrolled in the KCHF Registry, a multicentre registry including consecutive patients hospitalized for acute heart failure (HF), we assessed patient characteristics and association between ACE-I/ARB and clinical outcomes according to LVEF. In the three LVEF categories (reduced LVEF [HFrEF], mid-range LVEF [HFmrEF] and preserved LVEF [HFpEF]), we compared the patients with ACE-I/ARB as discharge medication and those without, and assessed their 1-year clinical outcomes. We defined the primary outcome measure as a composite of all-cause death and HF hospitalization.ResultsThe 1-year cumulative incidences of the primary outcome measure were 36.3% in HFrEF, 30.1% in HFmrEF and 33.8% in HFpEF (log-rank P = 0.07). The adjusted risks of the ACE-I/ARB group relative to the no ACE-I/ARB group for the primary outcome measure were significantly lower in HFrEF and HFmrEF (HR 0.66 [95%CI 0.54-0.79], PConclusionsACE-I/ARB for patients who were hospitalized for acute HF was associated with significantly lower risk for a composite of all-cause death and HF hospitalization in HFrEF and HFmrEF, but not in HFpEF. ACE-I/ARB might be a potential treatment option in HFmrEF as in HFrEF.

This cohort study of Japanese patients with acute decompensated heart failure examines the incidence and mode of postdischarge mortality among patients with reduced, midrange, and preserved ejection fraction., Key Points Question Are there differences in the mode of death after hospital discharge in patients with reduced, midrange, and preserved left ventricular ejection fraction? Findings In this cohort study of 3717 hospitalized patients with acute decompensated heart failure with a median follow-up of 470 days, 848 patients died (523 cardiovascular deaths and 98 sudden cardiac deaths). The risks of each cause of death were comparable among the patients with heart failure with reduced, midrange, and preserved ejection fraction. Meaning This study found nonnegligible incidence of sudden cardiac death in patients with heart failure with preserved ejection fraction; further study appears to be warranted to identify a high-risk subset in this population., Importance Despite intensive treatment, hospitalized patients with acute decompensated heart failure (ADHF) have a substantial risk of postdischarge mortality. Limited data are available on the possible differences in the incidence and mechanisms of death among patients with heart failure with reduced ejection fraction (HFrEF), heart failure with midrange ejection fraction (HFmrEF), and heart failure with preserved ejection fraction (HFpEF). Objectives To examine the incidences and mode of postdischarge mortality among patients with ADHF and to compare the risk profile among patients with HFrEF, HFmrEF, and HFpEF. Design, Setting, and Participants This prospective cohort study of 4056 patients hospitalized for ADHF analyzed data from 3717 patients who were discharged from October 1, 2014, to March 31, 2016. Data analysis was performed from April 1 to August 31, 2019. Exposures Death among patients with ADHF after hospital discharge. Main Outcomes and Measures All-cause death and cause of postdischarge mortality after the index hospitalization by left ventricular ejection fraction (LVEF) subgroup. Results A total of 3717 patients (mean [SD] age, 77.7 [12.0] years; 2049 [55.1%] male) were included in the study. The mean (SD) LVEF at baseline was 46.4% (16.2%). Among 3717 enrolled patients, 1383 (37.2%) were categorized as having HFrEF (LVEF

Objective: Healed plaques, signs of previous plaque destabilization, are frequently found in the coronary arteries. Healed plaques can now be diagnosed in living patients. We investigated the prevalence, angiographic, and optical coherence tomography features of healed plaques in patients with stable angina pectoris. Approach and Results: Patients with stable angina pectoris who had undergone optical coherence tomography imaging were included. Healed plaques were defined as plaques with one or more signal-rich layers of different optical density. Patients were divided into 2 groups based on layered or nonlayered phenotype at the culprit lesion. Among 163 patients, 87 (53.4%) had layered culprit plaque. Patients with layered culprit plaque had more multivessel disease (62.1% versus 44.7%, P =0.027) and more angiographically complex culprit lesions (64.4% versus 35.5%, P P =0.004), macrophage infiltration (58.6% versus 35.5%, P =0.003), calcifications (78.2% versus 63.2%, P =0.035), and thrombus (28.7% versus 14.5%, P =0.029). Lipid index ( P =0.001) and percent area stenosis ( P =0.015) were greater in the layered group. The number of nonculprit plaques, evaluated using coronary angiograms, tended to be greater in patients with layered culprit plaque (4.2±2.5 versus 3.5±2.1, P =0.053). Nonculprit plaques in patients with layered culprit lesion had higher prevalence of layered pattern ( P =0.002) and lipid phenotype ( P =0.005). Lipid index ( P =0.013) and percent area stenosis ( P =0.002) were also greater in this group. Conclusions: In patients with stable angina pectoris, healed culprit plaques are common and have more features of vulnerability and advanced atherosclerosis both at culprit and nonculprit lesions.

[Background]: There is a scarcity of reports on the clinical characteristics and management practice in contemporary all-comer patients with acute decompensated heart failure (ADHF). [Methods and Results]: The Kyoto Congestive Heart Failure (KCHF) registry is a prospective observational cohort study enrolling 4, 056 consecutive patients who had hospital admission due to ADHF without any exclusion criteria between October 2014 and March 2016 in the 19 participating hospitals in Japan. Baseline characteristics, clinical presentations, management, and in-hospital outcomes were compared between heart failure (HF) with reduced left ventricular ejection fraction (LVEF; HFrEF, LVEF

OBJECTIVES The present study aimed to develop a swine coronary bifurcation model. BACKGROUND In human coronary bifurcation lesion, atherosclerotic plaques are usually observed in the lateral wall, whereas the flow divider regions are spared. There is currently no suitable coronary bifurcation animal model, on which a new stent can be tested. METHODS We developed a novel directional heat injury catheter, which comprised of a non-compliant balloon catheter (diameter: 3.0mm, length: 15mm), and two electrode cables, that were attached to either side of the balloon catheter. The technique was performed on 4 healthy pigs, and assessed in 7 lesions. We inflated the balloon at the main bifurcation branch, following which a high frequency generator was used to transmit heat to the opposite side of the electrode, towards the bifurcation carina (duration: 5min, frequency: 2 times). We performed a post-angiography 28days after the pre-angiography, to observe the distribution of neointima. The neointimal area was divided into the carina side and the opposite side of carina, and the 2 sides were compared. RESULTS The neointimal area at the opposite side of the carina was significantly larger than the carina side (1.51±0.40mm2 vs. 0.95±0.27mm2, p

INTRODUCTION Cardiovascular mortality of patients with combined peripheral arterial disease (PAD) and coronary artery disease (CAD) is twice as high as that in those with either disease alone. It is known that patients with PAD undergoing percutaneous coronary intervention have a higher incidence of adverse cardiac events such as myocardial infarction or target vessel revascularization. OBJECTIVE In this study, we compared the detailed characteristics of culprit and nonculprit plaques between patients with and those without PAD using optical coherence tomography. PATIENTS AND METHODS We performed propensity score matching using the following variables: (i) age; (ii) sex; (iii) clinical presentation; (iv) diabetes mellitus; (v) hyperlipidemia; (vi) smoking; (vii) hypertension; (viii) BMI; and (ix) coronary lesion location. Finally, we matched 34 culprit lesions and 30 nonculprit lesions in patients with PAD to 68 culprit lesions and 60 nonculprit lesions in patients without PAD (1 : 2 ratio). RESULTS In culprit lesions, PAD patients when compared with those without PAD had a higher prevalence of lipid-rich plaque (73.5 vs. 51.5%; P=0.033), higher lipid index (1744±1110 vs. 1246±656; P=0.043), calcification (79.4 vs. 58.8%; P=0.039), macrophage accumulation (70.6 vs. 48.5%; P=0.034), and cholesterol crystals (32.4 vs. 10.3%; P=0.006). In nonculprit lesions, PAD patients had a higher prevalence of calcification (76.7 vs. 55.0%; P=0.046), macrophage accumulation (63.3 vs. 38.3%; P=0.025), and cholesterol crystals (36.7 vs. 16.7%; P=0.034). CONCLUSION Our study suggests greater coronary plaque vulnerability in both culprit and nonculprit lesions in patients with PAD. This observation underscores the need for more aggressive risk management in patients with combined PAD and coronary artery disease.

Background Lipid-rich plaque (LRP) is thought to be a precursor to cardiac events. However, its clinical significance in coronary arteries has never been systematically investigated. Objectives This study investigated the prevalence and clinical significance of LRP in the nonculprit region of the target vessel in patients undergoing percutaneous coronary intervention (PCI). Methods The study included 1,474 patients from 20 sites across 6 countries undergoing PCI, who had optical coherence tomography (OCT) imaging of the target vessel. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, acute myocardial infarction, and ischemia-driven revascularization. Patients were followed for up to 4 years (median of 2 years). Results Lipid-rich plaque was detected in nonculprit regions of the target vessel in 33.6% of patients. The cumulative rate of nonculprit lesion-related MACE (NC-MACE) over 48 months in patients with LRP was higher than in those without LRP (7.2% vs. 2.6%, respectively; p = 0.033). Acute coronary syndrome at index presentation (risk ratio: 2.538; 95% confidence interval [CI]: 1.246 to 5.173; p = 0.010), interruption of statin use ≥1 year (risk ratio: 4.517; 95% CI: 1.923 to 10.610; p = 0.001), and LRP in nonculprit regions (risk ratio: 2.061; 95% CI: 1.050 to 4.044; p = 0.036) were independently associated with increased NC-MACE. Optical coherence tomography findings revealed that LRP in patients with NC-MACE had longer lipid lengths (p Conclusions Presence of LRP in the nonculprit regions of the target vessel by OCT predicts increased risk for future NC-MACE, which is primarily driven by revascularization for recurrent ischemia. Lipid-rich plaque with longer lipid length, wider lipid arc, and higher degree of stenosis identified patients at higher risk of future cardiac events. (The Massachusetts General Hospital Optical Coherence Tomography Registry; NCT01110538 )

AIMS Irregular protrusion identified by optical coherence tomography (OCT) immediately following stent implantation has been reported as an independent predictor for adverse cardiac events at one year. However, baseline characteristics for the development of irregular protrusion are unknown. The aim of the study was to identify predictors for irregular protrusion following stent implantation. METHODS AND RESULTS A total of 900 lesions in 786 patients who had post-stent OCT imaging were analysed. The patients were divided into two groups: those with (484 lesions, 456 patients) and those without (416 lesions, 330 patients) irregular protrusion. Baseline characteristics (n=786) as well as pre-stent angiogram (n=786), intravascular ultrasound (IVUS; n=31) and OCT (n=159) findings were compared between the two groups. Multivariate analysis showed that patients with irregular protrusion had higher low-density lipoprotein (LDL) cholesterol levels and lesions with greater stent length, greater percent atheroma volume on IVUS, greater lipid content and a higher prevalence of thrombus on OCT before stent implantation. CONCLUSIONS Irregular protrusion was found more frequently in patients with higher LDL cholesterol levels. In addition, lesions treated with longer stents, with greater plaque burden, larger lipid content and a higher prevalence of thrombus were identified as predictors for irregular protrusion following stent implantation.

The high controlling nutritional status (CONUT) score that represents poor nutritional status has been acknowledged to have prognostic implications in chronic heart failure. We aimed to investigate its role in acute decompensated heart failure (ADHF). Using the data from an multicenter registry that enrolled 4056 consecutive patients hospitalized for ADHF in Japan between 2014 and 2016, we analyzed 2466 patients in whom data on the components of the CONUT score at hospital presentation were available. The decrease of lymphocyte count and total cholesterol was assigned with 0, 1, 2, and 3 points and the decrease of albumin was assigned with 0, 2, 4, and 6 points according to the severity. We defined low CONUT score as 0–4 (N = 1568) and high CONUT score as 5–9 (N = 898). The patients in the high CONUT score group were older and more likely to have a smaller body mass index than those in the low CONUT score group. The high CONUT score group was associated with higher rate of death and infection during the index hospitalization compared to the low CONUT score group (9.0% versus 4.4%, and 21.9% versus 12.7%, respectively). After adjusting for confounders, the excess risk of high relative to low CONUT score for mortality and infection was significant (OR: 1.61, 95%CI: 1.05–2.44, and OR: 1.66, 95%CI: 1.30–2.12, respectively). The effect was incremental according to the score. High CONUT score was associated with higher risk for in-hospital mortality and infection in an incremental manner in patients hospitalized for ADHF.

ObjectiveTo investigate the prevalence and risk factors of functional decline during hospitalisation and its relationship with postdischarge outcomes in very old patients with acute decompensated heart failure (ADHF) hospitalisation.DesignProspective cohort study between 1 October 2014 and 31 March 2016.SettingA physician-initiated, multicentre study of consecutive patients admitted for ADHF in 19 hospitals throughout Japan.ParticipantsAmong 3555 patients hospitalised for ADHF (median age (IQR), 80 (71–86) years; 1572 (44%) women), functional decline during the index hospitalisation occurred in 528 patients (15%).Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or heart failure (HF) hospitalisation after discharge. The secondary outcome measures were all-cause death, HF hospitalisation, and a composite of all-cause death or all-cause hospitalisation.ResultsThe independent risk factors for functional decline included age ≥80 years (OR 2.71; 95% CI 2.09 to 3.51), female (OR 1.32; 95% CI 1.05 to 1.67), prior stroke (OR 1.67; 95% CI 1.28 to 2.19), dementia (OR 2.26; 95% CI 1.74 to 2.95), ambulatory before admission (OR 1.74; 95% CI 1.29 to 2.35), elevated body temperature (OR 1.91; 95% CI 1.31 to 2.79), New York Heart Association class III or IV on admission (OR 1.54; 95% CI 1.07 to 2.22), decreased albumin levels (OR 1.76; 95% CI 1.32 to 2.34), hyponatraemia (OR 1.49; 95% CI 1.10 to 2.03) and renal dysfunction (OR 1.55; 95% CI 1.22 to 1.98), after multivariable adjustment. The cumulative 1-year incidence of the primary outcome in the functional decline group was significantly higher than that in the no functional decline group (50% vs 31%, log-rank pConclusionsIndependent risk factors of functional decline in very old patients with ADHF were related to both frailty and severity of HF. Functional decline during ADHF hospitalisation was associated with unfavourable postdischarge outcomes.Trial registration numberNCT02334891UMIN000015238.

There has been no previous prospective study evaluating 3-month dual antiplatelet therapy (DAPT) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation in patients with acute coronary syndrome (ACS). The STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration in all-comer population after CoCr-EES implantation. Among 1525 study patients enrolled from 58 Japanese centers, the present study compared the 1-year clinical outcomes between ACS patients (N = 487) and stable coronary artery disease (CAD) patients (N = 1038). In the ACS group, 228 patients (47%) had unstable angina and 259 patients (53%) had myocardial infarction. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding. Thienopyridine was discontinued within 4-month in 455 patients (94.0%) in the ACS group and 977 patients (94.3%) in the stable CAD group. Cumulative 1-year incidence of and the adjusted risk for the primary endpoint were not significantly different between the ACS and stable CAD groups (2.3% vs. 3.0%, P = 0.42, and HR 0.94, 95%CI 0.44–1.87, P = 0.87). In the 3-month landmark analysis, cumulative incidence of the primary endpoint was also not significantly different between the ACS and stable CAD groups (1.3% vs. 2.4%, P = 0.16). There was no definite/probable ST through 1-year in both groups. In the propensity matched analysis, the cumulative 1-year incidence of the primary endpoint were similar between the ACS and stable CAD groups (2.3% versus 2.1%, P = 0.82). In conclusion, stopping DAPT at 3 months after CoCr-EES implantation in patients with ACS including 47% of unstable angina was as safe as that in patients with stable CAD.

Background Healed plaques, the signature of prior subclinical plaque destabilization, are frequently found in autopsy studies and have recently been described in patients with acute coronary syndromes (ACS). Objectives To compare the prevalence and features of plaque vulnerability of healed culprit lesions in stable angina pectoris (SAP) versus ACS patients by using Optical Coherence Tomography (OCT). Methods A total of 752 patients were included: 376 patients with SAP were selected using propensity score matching, comparable to 376 patients with ACS. Healed plaques were identified using established criteria, defined as layers of different optical density on OCT. Healed plaque prevalence along with angiographic and OCT findings were compared between the two groups. Results Healed plaques were more frequent in SAP than in ACS patients (42.0% vs 28.7%, p Conclusions Healed plaques, detected more frequently in SAP than in ACS patients, portend different atherosclerotic backgrounds. In SAP patients, plaque destabilization frequently does not lead to occlusive thrombosis, possibly due to low level of local vulnerability and systemic inflammation. In ACS patients, the presence of high level of local vulnerability and systemic inflammation may play an important role in occlusive thrombus formation, resulting in terminating the cycles of subclinical thrombosis and healing.

Background The favourable effect of mineralocorticoid receptor antagonists (MRAs) on mortality was established in patients with stable heart failure (HF) with reduced ejection fraction (EF). However, its prognostic effect of MRAs in acute decompensated heart failure (ADHF) including HF with preserved EF (HFpEF) was unclear. Purpose This study sought to investigate the long-term impact of MRA on the post-discharge outcomes in patients with ADHF. Methods From the consecutive 3717 patients hospitalized for ADHF and discharged alive in the KCHF registry, we developed the propensity score (PS) for MRA use and constructed the PS-matched cohort. We compared the effect of MRA use on the primary outcome measure of all-cause death or HF hospitalization. Results A total of 1678 patients (45%) received MRA at discharge from the index hospitalization. Median follow-up was 470 days with 96% 1-year follow-up rate. In the PS-matched cohort (N=1034 in each group), the cumulative 1-year incidence of the primary outcome measure was significantly lower in the MRA group than in the no MRA group (28.4% vs. 33.9%, P=0.003) (Figure 1). The cumulative 1-year incidence of HF hospitalization was significantly lower in the MRA group than in the no MRA group (18.7% vs. 24.8%, P Figure 1 Conclusion The use of MRA was associated with lower risk for the primary composite outcome of all-cause death or HF hospitalization in patients hospitalized for ADHF including HFpEF, which was mainly driven by the lower risk for HF hospitalization.

Background The current guidelines recommend different medical treatment strategies for heart failure (HF) patients according to category of left ventricular ejection fraction (LVEF). Angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACE-I/ARB) is an established medical treatment for heart failure with reduced ejection fraction (HFrEF), whereas its usefulness remains to be elucidated for non-HFrEF, especially for heart failure with mid-range ejection fraction (HFmrEF). Purpose This study aimed to assess the difference in association between ACE-I/ARB and clinical outcomes depending on LVEF category. Methods The Kyoto Congestive Heart Failure (KCHF) Registry is a multicentre registry without any exclusion criteria which included consecutive patients hospitalized for congestive HF in Japan. In each LVEF group (HFrEF, HFmrEF and heart failure with preserved ejection fraction [HFpEF]), we compared those who were prescribed ACE-I/ARB as discharge medication and those not, and assessed their 1-year clinical outcomes. We defined the primary outcome measure as a composite of all-cause death and HF hospitalization. We constructed a multivariable Cox regression model incorporating 24 clinically relevant factors. We assessed adjusted hazard ratios (HRs) of those with ACE-I/ARB relative to those not, and also interaction between ACE-I/ARB prescription at discharge and LVEF category. Results A total of 3717 patients were included in this study, where the number of patients in each LVEF group were as follows; 1383 patients with HFrEF, 703 with HFmrEF and 1631 with HFpEF, respectively (Figure). As shown in the table, the HRs for the primary outcome measure were significant in the HFrEF and HFmrEF groups, whereas the HR in the HFpEF group was insignificant. The interaction between ACE-I/ARB prescription and LVEF category for the primary outcome measure was statistically significant. Hazard ratios by LVEF category Outcome measures HFrEF HFmrEF HFpEF P interaction HR (95% CI) P value HR (95% CI) P value HR (95% CI) P value All-cause death + HF hospitalization 0.66 (0.54–0.79) Study flowchart Conclusions The risk ratios of those who were prescribed ACE-I/ARB relative to those not were significantly low in HFmrEF as well as HFrEF, whereas the risk ratios were insignificant in HFpEF. ACE-I/ARB could be a potential choice of treatment for HFmrEF patients.

Background Impact of hyponatremia improvement on prognosis in patients with acute decompensated heart failure (ADHF) remains unclear. Methods Patients hospitalized for ADHF at 19 hospitals in Japan were enrolled between October 2014 and March 2016. Hyponatremia was defined as serum sodium concentration less than 135 mmol/l. Primary endpoint was composite of all-cause death and heart failure rehospitalization one year after discharge. Results Among 3805 patients enrolled, 486 patients with hyponatremia at admission showed higher in-hospital mortality (13.3% vs. 5.4%, p Patient characteristics Group P (n=143) Group I (n=253) p value Age (years) 81 (72–86) 81 (72–87) 0.73 Female 71 (49.7) 110 (43.5) 0.24 Ischemic etiology 42 (29.4) 81 (32.0) 0.58 Prior hospitalization 62 (43.7) 98 (39.5) 0.42 SBP at admission (mmHg) 140±36 144±38 0.40 HR at admission (bpm) 92±23 95±29 0.27 Atrial Fibrillation 47 (32.9) 103 (40.7) 0.12 NYHA class IV 60 (42.2) 138 (54.8) 0.02 Intravenous inotropic use 35 (24.5) 59 (23.3) 0.80 LVEF Conclusion Improvement of hyponatremia at discharge was not associated with better prognosis in patients hospitalized for ADHF.

Key Points Question Is use of mineralocorticoid receptor antagonist at discharge associated with better outcomes in patients hospitalized for acute decompensated heart failure? Findings In this cohort study of 2068 propensity score–matched Japanese patients hospitalized for acute decompensated heart failure, mineralocorticoid receptor antagonist administered at discharge was statistically significantly associated with a lower risk for the primary composite outcome of mortality or heart failure readmission, although no difference in all-cause death was observed. Meaning Use of mineralocorticoid receptor antagonist at discharge from acute decompensated heart failure hospitalization may be associated with heart failure hospitalization but not with lower mortality., Importance Scarce data are available on the association of mineralocorticoid receptor antagonist (MRA) use with outcomes in acute decompensated heart failure (ADHF). Objective To investigate the association of MRA use with all-cause mortality and hospital readmission in patients with ADHF. Design, Setting, and Participants This cohort study examines participants enrolled in the Kyoto Congestive Heart Failure (KCHF) registry, a physician-initiated, prospective, multicenter cohort study of consecutive patients admitted for ADHF, between October 1, 2014, and March 31, 2016, into 1 of 19 secondary and tertiary hospitals throughout Japan. To balance the baseline characteristics associated with the selection of MRA use, a propensity score–matched cohort design was used, yielding 2068 patients. Data analysis was conducted from April to August 2018. Exposures Prescription of MRA at discharge from the index hospitalization. Main Outcomes and Measures Composite of all-cause death or heart failure hospitalization after discharge. Results Among 3717 patients hospitalized for ADHF, 1678 patients (45.1%) had received MRA at discharge and 2039 (54.9%) did not. After propensity score matching, 2068 patients (with a median [interquartile range] age of 80 [72-86] years, and of whom 937 [45.3%] were women) were included. In the matched cohort (n = 1034 in each group), the cumulative 1-year incidence of the primary outcome was statistically significantly lower in the MRA use group than in the no MRA use group (28.4% vs 33.9%; hazard ratio [HR], 0.81; 95% CI, 0.70-0.93; P = .003). Of the components of the primary outcome, the cumulative 1-year incidence of heart failure hospitalization was significantly lower in the MRA use group than in the no MRA use group (18.7% vs 24.8%; HR, 0.70; 95% CI, 0.60-0.86; P, This cohort study of Japanese participants with acute decompensated heart failure in the Kyoto Congestive Heart Failure study evaluates the association of mineralocorticoid receptor antagonist use with all-cause mortality and hospital readmission.

BACKGROUND Fibrous cap thickness (FCT) is one of the key features of coronary vulnerable plaque. FCT is measured at an arbitrary point, determined on visual assessment of 2-D cross-sectional imaging. This method has poor reproducibility. The aim of this study was to compare the 3-D structure of FC in non-culprit lipid plaques between patients with ST-elevation myocardial infarction (STEMI) and with stable angina (SA) on optical coherence tomography. Methods and Results: A total of 54 non-culprit plaques from 23 STEMI and 23 SA patients were evaluated. Thin cap fibroatheroma (TCFA), defined as lipid plaque with FCT

There was no previous report on the prognostic impact of new-onset or improved anemia after discharge from acute decompensated heart failure (ADHF).We analyzed 771 patients with ADHF and who were followed in multicenters in Japan was divided into 4 groups based on the hemoglobin values at discharge and 6-month index visit: 373 patients (48.4%) with persistent anemia, 87 patients (11.3%) with new-onset anemia, 91 patients (11.8%) with improved anemia, and 220 patients (28.5%) without anemia.The primary outcome measure was a composite of all-cause death or HF hospitalization after index visit. The cumulative 6-month incidences of the primary outcome measure were 25.2% for persistent anemia, 18.5% for new onset anemia, 9.0% for improved anemia, and 9.2% for no anemia (log-rank P

Aims Over the last decade, major developments in medicine have led to significant changes in the clinical management of heart failure patients. This study was designed to evaluate the recent trends in clinical characteristics, management, and short-term and long-term prognosis of patients with acute decompensated heart failure (ADHF) in Japan. Methods and results The Kyoto Congestive Heart Failure study is a prospective, observational, multicentre cohort study, enrolling consecutive ADHF patients from 19 participating hospitals in Japan from November 2014 to March 2016. A total of 4000 patients will be enrolled into the study and patients' anthropometric, socio-economic, and clinical data from hospital admission to discharge will be collected. In addition, in a pre-determined subgroup of patients (n=1500), a longitudinal follow-up for 2 years is scheduled. Conclusions The Kyoto Congestive Heart Failure study will provide valuable information regarding patients with ADHF in the real-world clinical practice of Japan and will be indispensable for future clinical and policy decision-making with respect to heart failure.

Background Transcatheter aortic valve implantation (TAVI) is an established therapy for patients who are inoperable or at high risk for open heart surgery. The retrograde transfemoral approach is the most widely used and is the first choice in TAVI. However, existence of peripheral vascular disease or a small iliofemoral artery often limits the application of the transfemoral approach. Transvenous antegrade transseptal TAVI is an attractive option, but has already been abandoned due to its technical complexities. Methods and results We have previously described a novel technique to simplify antegrade transseptal balloon aortic valvuloplasty, which utilizes a custom-made Inoue balloon catheter with two stylets. The technique is named as the looped Inoue balloon technique, and its feasibility and efficacy were proven in an animal model and a clinical case. We applied this technique to TAVI. The present study aimed to assess the feasibility of the looped Inoue balloon technique for TAVI in two healthy pigs. The valve implantation was successful in both pigs, although the pigs died soon after the implantation (2 and 24 h). The causes of death were access site bleeding (Case 1) and migration of the prosthetic valve (Case 2). Conclusions Although several improvements and further studies are required, the study results indicate that antegrade TAVI using the looped Inoue balloon technique is feasible.

BACKGROUND In ST-segment elevation myocardial infarction (STEMI), QRS score at presentation ECG may reflect the progression of infarction and facilitate prediction of the degree of myocardial salvage achieved by reperfusion therapy.Methods and Results:Admission electrocardiogram (ECG) was studied in 2,607 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) within 24 h of symptom onset. Patients were classified into 3 groups according to QRS score: low (0-3, n=1,227), intermediate (4-7, n=810), and high (≥8, n=570). An increase of infarct size estimated by median peak creatine phosphokinase was observed as QRS score increased (low score, 1,836 IU/L; inter-quartile range (IQR), 979-3,190 IU/L; intermediate score, 2,488 IU/L; IQR, 1,126-4,640 IU/L; high score, 3,454 IU/L; IQR, 1,759-5,639 IU/L; P

Objectives The aim of this study was to evaluate if residual thrombus burden after aspiration thrombectomy affects the outcomes of primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI). Background Recent studies failed to show clinical benefit of aspiration thrombectomy in STEMI patients. This might be due to insufficient removal of thrombus at the culprit lesion. Methods A total of 109 STEMI patients who underwent aspiration thrombectomy followed by stenting within 24 h from symptom onset were included. Optical coherence tomography was performed after thrombectomy to measure residual thrombus burden. Patients were divided into tertiles based on the amount of residual thrombus and the outcomes were compared. Results Myocardial no reflow, defined as TIMI (Thrombolysis In Myocardial Infarction) flow grade of ≤2 and/or myocardial blush grade of ≤1 after stenting, was more observed frequently in patients in the highest tertile compared with those in the lowest tertile (44.4% vs. 16.7%; p = 0.001). Patients in the highest tertile also had greater myocardial damage measured by creatine kinase MB compared with those in the lowest tertile (p = 0.002). Conclusions STEMI patients with greater residual thrombus burden after aspiration thrombectomy had worse microvascular dysfunction and greater myocardial damage compared with those with smaller residual thrombus burden.

Background-—Plaque erosion is responsible for 25% to 40% of patients with acute coronary syndromes (ACS). Recent studies suggest that anti-thrombotic therapy without stenting may be an option for this subset of patients. Currently, however, an invasive procedure is required to make a diagnosis of plaque erosion. The aim of this study was to identify clinical or laboratory predictors of plaque erosion in patients with ACS to enable a diagnosis of erosion without additional invasive procedures. Methods and Results-—Patients with ACS who underwent optical coherence tomography imaging were selected from 11 institutions in 6 countries. The patients were classified into plaque rupture, plaque erosion, or calcified plaque, and predictors were identified using multivariable logistic modeling. Among 1241 patients with ACS, 477 (38.4%) patients were found to have plaque erosion. Plaque erosion was more frequent in non–ST-segment elevation-ACS than in ST-segment–elevation myocardial infarction (47.9% versus 29.8%, P=0.0002). Multivariable logistic regression models showed 5 independent parameters associated with plaque erosion: age 15.0 g/dL, and normal renal function. When all 5 parameters are present in a patient with non–ST-segment elevation-ACS, the probability of plaque erosion increased to 73.1%. Conclusions-—Clinical and laboratory parameters associatedwith plaque erosion are explored in this retrospective registry study. These parametersmay be useful to identify the subset ofACS patients with plaque erosion and guide themto conservativemanagement without invasive procedures. The results of this exploratory analysis need to be confirmed in large scale prospective clinical studies, Dr. Jang has received an educational grant from Abbott Vascular and Medicure. Dr. Adriaenssens has received grants and consulting fees from Abbott Vascular

Background Healed plaques, morphologically characterized by a layered phenotype, are frequently found in subjects with sudden cardiac death. However, in vivo data are lacking. Objectives The purpose of this study was to determine the prevalence, morphological characteristics, and clinical significance of healed culprit plaques in patients with acute coronary syndromes (ACS) using optical coherence tomography (OCT). Methods A total of 376 ACS patients (252 ST-segment elevation myocardial infarction [MI] and 124 non–ST-segment elevation acute coronary syndrome) who had undergone pre-intervention OCT imaging of the culprit lesion were enrolled. Patients were stratified according to the presence of layered phenotype, defined as layers of different optical density at OCT. Clinical and laboratory data, OCT characteristics, and 1-year outcome were compared between the 2 groups. Results Among 376 patients, 108 (28.7%) healed plaques were identified. Hyperlipidemia, diabetes, and history of MI were more frequent in patients with healed plaques (44.4% vs. 33.2%; p = 0.041; 35.2% vs. 23.5%; p = 0.021; and 15.7% vs. 6.3%; p = 0.009, respectively). High-sensitivity C-reactive protein was significantly higher in patients with healed plaques (median 4.98 mg/l [interquartile range: 1.00 to 11.32 mg/l] vs. 3.00 mg/l [interquartile range: 0.30 to 10.15 mg/l]; p = 0.029). Plaque rupture (64.8% vs. 53.0%; p = 0.039), thin cap fibroatheroma (56.5% vs. 42.5%; p = 0.016), and macrophage accumulation (81.1% vs. 63.4%; p = 0.001) were common in the layered group. OCT also revealed greater area stenosis in plaques with layered phenotype (79.2 ± 9.5% vs. 74.3 ± 14.3%; p = 0.001). The incidence of major adverse cardiovascular events was similar between the 2 groups, except that the all-cause rehospitalization rate was higher among healed plaques (32.7% vs. 16.5%; p = 0.013). Conclusions Healed plaques, a signature of prior plaque destabilization, were found at the culprit site in more than one-quarter of ACS patients. Such patients more frequently were diabetic, were hyperlipidemic, or had a history of MI. Healed plaques frequently showed OCT features of vulnerability with evidence of local and systemic inflammation. The combination of plaque vulnerability, local inflammation, and greater plaque burden in addition to systemic inflammation may outweigh the protective mechanism of plaque healing and predispose those plaques to develop occlusive thrombus.