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Purpose A four-parameter risk model that included cardiac iodine-123 metaiodobenzylguanidine (MIBG) imaging and readily available clinical parameters was recently developed for prediction of 2-year cardiac mortality risk in patients with chronic heart failure. We sought to validate the ability of this risk model to predict post-discharge clinical outcomes in patients with acute decompensated heart failure (ADHF) and to compare its prognostic value with that of the Acute Decompensated Heart Failure National Registry (ADHERE) and Get With The Guidelines-Heart Failure (GWTG-HF) risk scores. Methods We studied 407 consecutive patients who were admitted for ADHF and survived to discharge, with definitive 2-year outcomes (death or survival). Cardiac MIBG imaging was performed just before discharge. The 2-year cardiac mortality risk was calculated using four parameters, namely age, left ventricular ejection fraction, New York Heart Association functional class, and cardiac MIBG heart-to-mediastinum ratio on delayed images. Patients were stratified into three groups based on the 2-year cardiac mortality risk: low- (< 4%), intermediate- (4–12%), and high-risk (> 12%) groups. The ADHERE and GWTG-HF risk scores were also calculated. Results There was a significant difference in the incidence of cardiac death among the three groups stratified using the 2-year cardiac mortality risk model ( p  < 0.0001). The 2-year cardiac mortality risk model had a higher C-statistic (0.732) for the prediction of cardiac mortality than the ADHERE and GWTG-HF risk scores. Conclusion The 2-year MIBG-based cardiac mortality risk model is useful for predicting post-discharge clinical outcomes in patients with ADHF. Trial registration number UMIN000015246, 25 September 2014.

Aims Anaemia has been reported as poor predictor in heart failure with preserved ejection fraction (HFpEF). The aim of this study was to evaluate the impact of changes in haemoglobin (Hb) from discharge to 1 year after discharge on the prognosis using a lower cut‐off value of Hb than the World Health Organization (WHO) criteria. Methods and results First, 547 HFpEF cases were divided into two groups, Hb < 11.0 g/dL (n = 218) and Hb ≥ 11.0 g/dL (n = 329), according to Hb at discharge, and further were divided according to Hb 1 year after discharge into Hb < 11.0 g/dL (G1, n = 113), Hb ≥ 11.0 g/dL (G2, n = 105), Hb < 11.0 g/dL (G3, n = 66), and Hb ≥ 11.0 g/dL (G4, n = 263), respectively. Major adverse cardiovascular events (MACE) was defined as composite of all‐cause death and heart failure readmission after a visit 1 year after discharge. The cut‐off value of Hb was analysed by the receiver operating characteristics curve that predicts MACE. We examined the incidence rate of MACE between G4 and other subgroups and verified predictors of improving or worsening anaemia and covarying factors with change in Hb. In multivariate Cox proportional hazard model, MACE was significantly higher in G3 with worsening anaemia from Hb ≥ 11.0 g/dL to <11.0 g/dL than G4 with persistently Hb ≥ 11 g/dL (adjusted hazard ratio (HR): 3.14 [95% confidence interval (CI), 1.76–5.60], P < 0.001). MACE was not significantly different between G2 with improving anaemia from Hb < 11.0 g/dL to ≥ 11.0 g/dL and G4 (adjusted HR: 1.37 [95% CI, 0.68–2.75], P = 0.38). In multivariate logistic regression analysis, independent predictors of improving anaemia were male [odds ratio (OR): 0.45], chronic obstructive pulmonary disease (OR: 10.3), prior heart failure hospitalization (OR: 0.38), and estimated glomerular filtration rate (OR: 1.04). Independent predictors of worsening anaemia were age (OR: 1.07), body mass index (BMI) (OR: 0.86), clinical frailty scale score (OR: 1.29), Hb at discharge (OR: 0.63), and use of angiotensin‐converting‐enzyme inhibitor or angiotensin II receptor blocker (OR: 2.76). In multivariate linear regression analysis, covarying factors with change in Hb were BMI (β = −0.098), serum albumin (β = 0.411), and total cholesterol (β = 0.179). Conclusions Change in haemoglobin after discharge using a lower cut‐off value than WHO criteria has prognostic impact in patients with HFpEF.

Aims The prognostic value of serum chloride level has been reported primarily in patients with heart failure with reduced ejection fraction, and hence, there is limited evidence in patients of heart failure with preserved ejection fraction (HFpEF). This study was conducted to clarify the relationship between serum chloride level and clinical outcomes in patients with HFpEF with acute decompensated heart failure (ADHF). Methods and results Patient data were extracted from The Prospective mUlticenteR obServational stUdy of patIenTs with Heart Failure with Preserved Ejection Fraction (PURSUIT HFpEF) study, a prospective multicentre observational registry for ADHF‐HFpEF in Osaka. The data of 870 patients were analysed after excluding patients with in‐hospital death, missing follow‐up data, missing data of serum chloride level, or on chronic dialysis therapy. The primary endpoint of this study was all‐cause mortality. At discharge, right ventricular systolic dysfunction was significantly associated with the lowest tertile of serum chloride level after multivariable adjustment (P = 0.0257). During a mean follow‐up period of 1.8 ± 1.0 years, 186 patients died. Cox multivariable analysis showed that serum chloride level at discharge (P = 0.0017) was independently associated with all‐cause mortality after multivariable adjustment of major confounders, whereas serum sodium level was no longer significant (P = 0.6761). Kaplan–Meier survival curve analysis revealed a significantly increased risk of mortality stratified by the tertile of serum chloride level [29% vs. 19% vs. 16%, P = 0.0002; hazard ratio (HR): 2.09 (95% confidence interval, CI: 1.31 to 3.34), HR: 1.03 (95% CI: 0.65 to 1.64)]. Conclusions Serum chloride level was useful for the prediction of poor outcome in ADHF patients with preserved ejection fraction.

Aims Malnutrition and inflammation are associated with poor outcomes with heart failure (HF). As a marker integrating inflammation and nutritional status, the advanced lung cancer inflammation index (ALI), calculated by body mass index × serum albumin level / neutrophil‐to‐lymphocyte ratio, has been developed for the prognosis of several diseases including HF. The aim of this study is to investigate the prognostic value of ALI in elderly multimorbid HF patients with HF with preserved ejection fraction (HFpEF). Methods The study utilized data from the Prospective mUlticenteR obServational stUdy of patIenTs with Heart Failure with preserved Ejection Fraction (PURSUIT‐HFpEF). Patients with acute decompensated HF and left ventricular ejection fraction ≥50% were included. ALI levels were calculated from discharge data. The primary endpoint was all‐cause death. Results A total of 1238 patients [83 (77, 87) years, 555 (45%) male] were enrolled, with 1121 analysed for prognostic value of ALI. In the multivariable Cox model, ALI was significantly associated with the primary endpoint [adjusted hazard ratio (HR) for log‐transformed ALI: 0.50, 95% confidence interval (CI): 0.34–0.75, P = 0.001]. ALI appears to enhance the prognostic value of the MAGGIC risk score [net reclassification improvement (NRI) = 46% (95% CI: 28%–65%), P < 0.001; integrated discrimination improvement (IDI) = 4.6% (95% CI: 2.8%–6.5%), P < 0.001], the geriatric nutritional risk index [NRI = 16% (95% CI: −3% to 35%), P = 0.103; IDI = 2.0% (95% CI: 0.8%–3.1%), P < 0.001] and C‐reactive protein [NRI = 39% (95% CI: 20%–58%), P < 0.001; IDI = 4.8% (95% CI: 2.9%–6.6%), P < 0.001]. Conclusions Low ALI levels were significantly associated with poor prognosis in elderly multimorbid HFpEF patients. ALI might complement existing risk indices for prognostic assessment. The advanced lung cancer inflammation index (ALI) is an integrated marker of inflammation and nutritional status, calculated by body mass index × serum albumin / neutrophil‐to‐lymphocyte ratio. Low ALI levels were significantly associated with poor prognosis in elderly multimorbid HFpEF patients.

Aims Electron microscopy reveals microstructural alterations in cardiomyocyte nuclei and myofilaments in non‐ischaemic cardiomyopathy (NICM), particularly in dilated cardiomyopathy (DCM). Nevertheless, the correlation between such observations and clinical outcomes, including prognosis and left ventricular reverse remodelling (LVRR), remains unclear. This study aimed to examine the association between electron microscopic findings and outcomes in patients with NICM. Methods In this multicentre, prospective, observational study, 170 patients with NICM with reduced ejection fraction (EF) < 40%, scheduled for diagnostic endomyocardial biopsy and optimization of medical therapies, were enrolled. Electron microscopic findings of cardiomyocytes such as discontinuous or continuous nuclear envelopes and injured or preserved myofilaments were evaluated. Data on cardiac events (cardiac death or left ventricular assist device implantation) and LVRR, defined as achieving an EF > 35% with a 10% unit absolute increase, were collected 1 year post‐biopsy. Results A total of 148 patients were finally analysed. Discontinuous nuclear envelopes and myofilament injuries were observed in 17 (11%) and 46 (31%) patients with NICM, respectively. The incidence of cardiac events at 1 year did not differ between groups with discontinuous and continuous nuclear envelopes [12% vs. 6%, odds ratio (OR): 2.05, 95% confidential interval (CI): 0.40–10.6, P = 0.391], whereas the LVRR rate was significantly lower in the discontinuous group than in the continuous group (24% vs. 52%, OR: 0.29, 95% CI: 0.08–0.92, P = 0.036). The incidences of cardiac events and LVRR at 1 year differed between the injured and preserved myofilament groups (15% vs. 3%, OR: 6.64, 95% CI: 1.32–33.5, P = 0.022; 15% vs. 64%, OR: 0.10, 95% CI: 0.04–0.25, P < 0.001, respectively). These associations between electron microscopic findings and clinical outcomes persisted, even in patients who were finally diagnosed with DCM. Conclusions Discontinuous nuclear envelopes were associated with a reduced LVRR rate, whereas injured myofilaments were correlated with higher 1 year cardiac events and a decreased LVRR. Evaluation of electron microscopic images in diagnostic endomyocardial biopsy can facilitate risk stratification of NICM or DCM with reduced EF.

Aims Patient reported outcomes (PROs) are gradually being incorporated into daily practice to assess individual health‐related quality of life (QOL). However, despite accumulating evidence of the prognostic utility of heart failure (HF)‐specific QOL indices, evidence on the generic QOL score is scarce, especially in patients with HF with preserved ejection fraction (HFpEF). Methods and results Patient data were extracted from the Prospective mUlticenteR obServational stUdy of patIenTs with Heart Failure with Preserved Ejection Fraction (PURSUIT HFpEF) study. EuroQol 5 dimensions 5‐level (EQ‐5D‐5L) data were obtained at discharge to evaluate patients' health‐related QOL. The study population (n = 864) was divided into tertiles based on their EQ‐5D‐5L index as follows: low EQ‐5D‐5L 0.038–0.664 (n = 287), middle EQ‐5D‐5L 0.665–0.867 (n = 293), and high EQ‐5D‐5L 0.871–1.000 (n = 284). A total of 206 patients died over a mean follow‐up period of 2.0 ± 1.2 years. Kaplan–Meier analysis revealed that the risk of mortality increased with the tertile of the EQ‐5D‐5L index (34% vs. 23% vs. 14%, P < 0.001). Cox multivariable analysis revealed that patients with EQ‐5D‐5L index in the low and middle tertiles had a significantly greater risk of mortality than those with EQ‐5D‐5L index in the high tertile [low EQ‐5D‐5L: adjusted hazard ratio (HR): 1.81 (1.12–2.92), P = 0.002, middle EQ‐5D‐5L: adjusted HR 1.91 (1.21–3.03), P = 0.006]. Among the dimensions of EQ‐5D‐5L, mobility (P = 0.014), self‐care (P = 0.023) and usual activities (P = 0.008) were significant factors associated with all‐cause mortality after multivariable adjustment. Conclusions EQ‐5D‐5L is useful tool for risk stratification in patients with HFpEF.

Aims Interleukin‐16 (IL‐16) has been reported to mediate left ventricular myocardial fibrosis and stiffening in patients with heart failure with preserved ejection fraction (HFpEF). We sought to elucidate whether IL‐16 has a distinct impact on pathophysiology and prognosis across different subphenotypes of acute HFpEF. Methods and results We analysed 211 patients enrolled in a prospective multicentre registry of acute decompensated HFpEF for whom serum IL‐16 levels after stabilization were available (53% female, median age 81 [interquartile range 75–85] years). We divided this sub‐cohort into four phenogroups using our established clustering algorithm. The study endpoint was all‐cause death. Patients were subclassified into phenogroup 1 (‘rhythm trouble’ [n = 69]), phenogroup 2 (‘ventricular‐arterial uncoupling’ [n = 49]), phenogroup 3 (‘low output and systemic congestion’ [n = 41]), and phenogroup 4 (‘systemic failure’ [n = 52]). After a median follow‐up of 640 days, 38 patients had died. Among the four phenogroups, phenogroup 2 had the highest IL‐16 level. The IL‐16 level showed significant associations with indices of cardiac hypertrophy, diastolic dysfunction, and congestion only in phenogroup 2. Furthermore, the IL‐16 level had a significant predictive value for all‐cause death only in phenogroup 2 (C‐statistic 0.750, 95% confidence interval 0.606–0.863, P = 0.017), while there was no association between the IL‐16 level and the endpoint in the other phenogroups. Conclusions Our results indicated that the serum IL‐16 level had a significant association with indices that reflect the pathophysiology and prognosis of HFpEF in a specific phenogroup in acute HFpEF.

Aims Cardiohepatic interactions have been a focus of attention in heart failure (HF). The model for end‐stage liver disease excluding international normalized ratio (MELD‐XI) score has been shown to be useful for predicting poor outcomes in patients with acute decompensated HF (ADHF). Furthermore, the fibrosis‐4 (FIB‐4) index, a simple marker to assess liver fibrosis, predicts adverse prognoses in patients with HF as well. However, there is little information available on the prognostic significance of the combination of the MELD‐XI score and FIB‐4 index in patients with ADHF and its association with left ventricular ejection fraction (LVEF) subgroup. Methods and results We prospectively studied 466 consecutive patients who were admitted for ADHF [HF with reduced LVEF (LVEF < 40%): n = 164, HF with mid‐range LVEF (40% ≤ LVEF < 50%): n = 104, and HF with preserved LVEF (LVEF ≥ 50%): n = 198]. We calculated the MELD‐XI score and FIB‐4 indices at discharge. The primary endpoint was all‐cause death (ACD). During the mean follow‐up period of 2.8 years, 143 patients had ACD. In the multivariate Cox analysis, the MELD‐XI score and FIB‐4 index were independently associated with ACD. Patients were stratified into the following three groups according to the median value of MELD‐XI score (=11) and FIB‐4 index (=2.13): Group 1 had both a low MELD‐XI score and a low FIB‐4 index; Group 2 had either a high MELD‐XI score (MELD‐XI score ≥11) or a high FIB‐4 index (FIB‐4 index ≥2.13); and Group 3 had both a high MELD‐XI score and a high FIB‐4 index. Kaplan–Meier analysis revealed that Group 2 and Group 3 had a significantly greater risk of ACD than Group 1 [Group 2 vs. Group 1: adjusted hazard ratio, 2.48 (95% confidence interval: 1.75–3.53), P < 0.0001; Group 3 vs. Group 1: adjusted hazard ratio, 7.03 (95% confidence interval: 3.95–13.7), P < 0.0001]. In addition, the patients with both a higher MELD‐XI score and FIB‐4 index showed a significantly higher risk of ACD also in the patients with HF with reduced LVEF, HF with mid‐range LVEF, and HF with preserved LVEF (all P < 0.0001). Conclusions The combination of MELD‐XI score and FIB‐4 index may be useful for stratifying patients at risk for ACD in patients with ADHF, irrespective of LVEF.

Aims Low‐density lipoprotein cholesterol (LDL‐C), anaemia and low platelets have been associated with worse clinical outcomes in heart failure patients. We investigated the relationship between the combination of these three components and clinical outcome in patients with heart failure with preserved ejection fraction (HFpEF). Methods and results We examined the data of 1021 patients with HFpEF hospitalized with acute decompensated heart failure (HF) from the PURSUIT‐HFpEF registry, a prospective, multicenter observational study. The enrolled patients were classified into four groups by an LEP (LDL‐C, Erythrocyte, and Platelet) score of 0 to 3 points, with 1 point each for LDL‐C, erythrocyte and platelet values less than the cut‐off values as calculated by receiver operating characteristic curve analysis. The endpoint, a composite of all‐cause death and HF readmission, was evaluated among the four groups. Median follow‐up duration was 579 [300, 978] days. Risk of the composite endpoint significantly differed among the four groups (P < 0.001). Kaplan–Meier analysis showed that the groups with an LEP score of 2 had higher risk of the composite endpoint than those with an LEP score of 0 or 1 (P < 0.001, and P = 0.013, respectively), while those with an LEP score of 3 had higher risk than those with an LEP score of 0, 1 or 2 (P < 0.001, P < 0.001 and P = 0.020, respectively). Cox proportional hazards analysis showed that an LEP score of 3 was significantly associated with the composite endpoint (P = 0.030). Kaplan–Meier analysis showed that risk of the composite of all‐cause death and HF readmission was significantly higher in low LDL values (less than the cut‐off values as calculated by receiver operating characteristic curve analysis) patients with statin use than in those without statin use (log rank P = 0.002). Conclusions LEP score, which comprehensively reflects extra‐cardiac co‐morbidities, is significantly associated with clinical outcomes in HFpEF patients.

The CHADS 2 score is useful in stratifying the risk of ischemic stroke or transient ischemic attack (TIA) in patients with non-valvular atrial fibrillation (AF). However, it remains unclear whether the CHADS 2 score could predict stroke or TIA in chronic heart failure (CHF) patients without AF. Recently, the new stroke risk score was proposed from 2 contemporary heart failure trials. We evaluated the prognostic power of the CHADS 2 score for stroke or TIA in CHF patients without AF in comparison to the “stroke risk score”. We retrospectively studied 127 CHF patients [left ventricular ejection fraction (LVEF) <40 %] without AF, who had been enrolled in our previous prospective cohort study. The primary endpoint was the incidence of stroke or TIA. The mean baseline CHADS 2 score was 2.1 ± 1.0. During the follow-up period of 8.4 ± 5.1 years, stroke or TIA occurred in 21 of 127 patients. At multivariate Cox analysis, CHADS 2 score (C-index 0.794), but not “stroke risk score” (C-index 0.625), was significantly and independently associated with stroke or TIA. The incidence of stroke or TIA appeared to increase in relation to the CHADS 2 score [low (=1), 0 per 100 person-years; intermediate (=2), 1.6 per 100 person-years; high (≥3), 4.7 per 100 person-years; p  = 0.04]. CHADS 2 score could stratify the risk of ischemic stroke in CHF patients with the absence of AF, with greater prognostic power than the “stroke risk score”.