External Validation of the Japanese Clinical Score for Mortality Prediction in Patients With Acute Heart Failure.

BACKGROUND: To predict mortality in patients with acute heart failure (AHF), we created and validated an internal clinical risk score, the KICKOFF score, which takes physical and social aspects, in addition to clinical aspects, into account. In this study, we validated the prediction model externally in a different geographic area.Methods and Results: There were 2 prospective multicenter cohorts (1,117 patients in Osaka Prefecture [KICKOFF registry]; 737 patients in Kochi Prefecture [Kochi YOSACOI study]) that had complete datasets for calculation of the KICKOFF score, which was developed by machine learning incorporating physical and social factors. The outcome measure was all-cause death over a 2-year period. Patients were separated into 3 groups: low risk (scores 0-6), moderate risk (scores 7-11), and high risk (scores 12-19). Kaplan-Meier curves clearly showed the score's propensity to predict all-cause death, which rose independently in higher-risk groups (P<0.001) in both cohorts. After 2 years, the cumulative incidence of all-cause death was similar in the KICKOFF registry and Kochi YOSACOI study for the low-risk (4.4% vs. 5.3%, respectively), moderate-risk (25.3% vs. 22.3%, respectively), and high-risk (68.1% vs. 58.5%, respectively) groups. CONCLUSIONS: The unique prediction score may be used in different geographic areas in Japan. The score may help doctors estimate the risk of AHF mortality, and provide information for decisions regarding heart failure treatment.

Gap in the prognostic impact of short physical performance battery among phenotypes of heart failure.

BACKGROUND: The Short Physical Performance Battery (SPPB) has been reported to predict clinical outcomes in patients with heart failure (HF). However, whether the discriminative capacity of SPPB score for adverse outcomes varies according to the phenotypes of HF, such as HF with reduced, mid-range, and preserved left-ventricular ejection fraction (HFrEF, HFmrEF, and HFpEF) remains unclear. The aim of this study was to investigate the difference in discriminative capacity of SPPB score for predicting 2-year mortality among phenotypes of HF. METHODS: We consecutively enrolled 542 adult patients admitted for HF (HFrEF, n = 187; HFmrEF, n = 94; HFpEF, n = 261). The patients underwent SPPB score when discharged from hospital. The primary endpoint was all-cause mortality during the 2 years after hospital discharge. We assessed the discriminative capacity of SPPB score for predicting mortality by using receiver operating characteristic (ROC) curve analysis. RESULTS: A total of 95 events (17.5%) occurred during the follow-up period. The area under the curve of ROC (95% confidence interval) was 0.80 (0.71-0.88) in HFrEF, 0.61 (0.46-0.76) in HFmrEF, and 0.70 (0.61-0.79) in HFpEF group. After adjustment for potential confounders, the hazard ratios (95% confidence interval) of the lower SPPB score were 5.38 (2.34-14.6) in HFrEF group, 1.12 (0.36-3.29) in HFmrEF group, and 3.19 (1.68-6.22) in HFpEF group. CONCLUSIONS: Prognostic value of SPPB score varies according to the HF phenotype. SPPB score predicts mortality in patients with HFrEF and HFpEF, but not in patients with HFmrEF. These findings lead to more precise risk prediction by SPPB score in patients with HF.

A clinical score to predict mortality in patients after acute heart failure from Japanese registry.

AIMS: Clinical scores that consider physical and social factors to predict long-term observations in patients after acute heart failure are limited. This study aimed to develop and validate a prediction model for patients with acute heart failure at the time of discharge. METHODS AND RESULTS: This study was retrospective analysis of the Kitakawachi Clinical Background and Outcome of Heart Failure Registry database. The registry is a prospective, multicentre cohort of patients with acute heart failure between April 2015 and August 2017. The primary outcome to be predicted was the incidence of all-cause mortality during the 3 years of follow-up period. The development cohort derived from April 2015 to July 2016 was used to build the prediction model, and the test cohort from August 2016 to August 2017 was used to evaluate the prediction model. The following potential predictors were selected by the least absolute shrinkage and selection operator method: age, sex, body mass index, activities of daily living at discharge, social background, comorbidities, biomarkers, and echocardiographic findings; a risk scoring system was developed using a logistic model to predict the outcome using a simple integer based on each variable's ß coefficient. Out of 1253 patients registered, 1117 were included in the analysis and divided into the development (n = 679) and test (n = 438) cohorts. The outcomes were 246 (36.2%) in the development cohort and 143 (32.6%) in the test cohort. Eleven variables including physical and social factors were set into the logistic regression model, and the risk scoring system was created. The patients were divided into three groups: low risk (score 0-5), moderate risk (score 6-11), and high risk (score ≥12). The observed and predicted mortality rates were described by the Kaplan-Meier curve divided by risk group and independently increased (P < 0.001). In the test cohort, the C statistic of the prediction model was 0.778 (95% confidence interval: 0.732-0.824), and the mean predicted probabilities in the groups were low, 6.9% (95% confidence interval: 3.8-10%); moderate, 30.1% (95% confidence interval: 25.4%-34.8%); and high, 79.2% (95% confidence interval: 72.6%-85.8%). The predicted probability was well calibrated to the observed outcomes in both cohorts. CONCLUSIONS: The Kitakawachi Clinical Background and Outcome of Heart Failure score was helpful in predicting adverse events in patients with acute heart failure over a long-term period. We should evaluate the physical and social functions of such patients before discharge to prevent adverse outcomes.

Mode of death in elderly and super-elderly patients with acute heart failure: Insights from Japanese heart failure registry.

BACKGROUND: In Japan, both the prevalence of the elderly and super-elderly and those of acute heart failure (AHF) have been increasing rapidly. METHODS: This registry was a prospective multicenter cohort, which enrolled a total of 1253 patients with AHF. In this study, 1117 patients' follow-up data were available and were categorized into three groups according to age: <75 years old (nonelderly), 75-84 years old (elderly), and ≥ 85 years old (super-elderly). The endpoint was defined as all-cause death and each mode of death after discharge during the 3-years follow-up period. RESULTS: Based on the Kaplan-Meier analysis, a gradually increased risk of all-cause death according to age was found. Among the three groups, the proportion of HF death was of similar trend; however, the proportion of infection death was higher in elderly and super-elderly patients. After adjusting for potentially confounding effects using the Cox and Fine-Gray model, the hazard ratio (HR) of all-cause death increased significantly in elderly and super-elderly patients (HR, 2.60; 95% confidence interval [CI], 1.93-3.54 and HR, 5.04; 95% CI, 3.72-6.92, respectively), when compared with nonelderly patients. The highest sub-distribution HR in detailed mode of death was infection death in elderly and super-elderly patients (HR, 4.25; 95% CI, 1.75-10.33 and HR, 10.10; 95% CI, 3.78-27.03, respectively). CONCLUSIONS: In this population, the risk of all-cause death was found to increase in elderly and super-elderly. Elderly patients and especially super-elderly patients with AHF were at a higher risk for noncardiovascular death, especially infection death.

Association Between Physical Status and the Effects of Combination Therapy With Renin-Angiotensin System Inhibitors and ß-Blockers in Patients With Acute Heart Failure.

Background: This study investigated whether combination therapy (CT) with renin-angiotensin system inhibitors and ß-blockers improved endpoints in acute heart failure (AHF). Methods and Results: AHF patients were recruited to this prospective multicenter cohort study between April 2015 and August 2017. Patients were divided into 3 categories based on ejection fraction (EF), namely heart failure (HF) with reduced EF (HFrEF), HF with midrange EF (HFmrEF), and HF with preserved EF (HFpEF), and a further into 2 groups according to physical status (those who could walk independently outdoors and those who could not). The composite endpoint included all-cause mortality and hospitalization for HF. Data at the 1-year follow-up were available for 1,018 patients. The incidence of the composite endpoint was significantly lower in the CT than non-CT group for HFrEF patients, but not among HFmrEF and HFpEF patients. For patients who could walk independently outdoors, a significantly lower rate of the composite endpoint was recorded only in the HFrEF group. The differences were maintained even after adjustment for comorbidities and prescriptions, with hazard ratios (95% confidence intervals) of 0.39 (0.20-0.76) and 0.48 (0.22-0.99), respectively. Conclusions: In this study, CT was associated with the prevention of adverse outcomes in patients with HFrEF. Moreover, CT prevented adverse events only among patients without a physical disorder, not among those with a physical disorder.

The clinical characteristics and outcomes of heart failure patient with chronic obstructive pulmonary disease from the Japanese community-based registry.

Both heart failure (HF) and chronic obstructive pulmonary disease (COPD) are common diseases, but few studies have assessed the relationship between COPD and outcomes in patients with acute HF, especially in relation to age or ejection fraction (EF). The Kitakawachi Clinical Background and Outcome of Heart Failure Registry was a prospective, multicenter, community-based cohort and enrolled a total of 1,102 patients with acute HF between 2015 and 2017 in this study. The primary endpoint was defined as a composite endpoint that included all-cause mortality and hospitalization for HF. We stratified patients into two groups: those aged ≥ 80 years (elderly) and < 80 years (nonelderly). HF with preserved EF (HFpEF) was defined as EF ≥ 50%, whereas HF with reduced ejection fraction (HFrEF) was defined as EF < 50%. A total of 159 patients (14.4%) with COPD and 943 patients (83.6%) without COPD were included. COPD was found to be independently associated with a higher risk of the composite endpoint (adjusted hazard ratio: 1.42, 95% confidence interval: 1.14-1.77; p = 0.003). During a subgroup analysis, COPD was exposed as an independent risk factor of the composite endpoint in nonelderly patients; however, there was not such a finding observed among elderly patients. Separately, there was a significant association with COPD and the composite endpoint in patients with HFpEF. COPD showed a significantly higher risk of the composite endpoint after discharge in acute HF. However, this heightened risk was observable only in the subgroup of nonelderly patients and those of HFpEF.

Living Alone and Gender Differences in Rehospitalization for Heart Failure After Discharge Among Acute Heart Failure Patients.

Home treatment for heart failure (HF) is one of the most important problems in patients after discharge as a secondary preventive measure for rehospitalization for HF. However, there are no detailed studies on gender differences in sociopsychological factors such as living alone for HF rehospitalization among patients with acute HF (AHF).This prospective multicenter cohort study enrolled patients with AHF between April 2015 and August 2017. Patients of each gender with first AHF were divided into those living alone and those not living alone. The primary endpoint was defined as rehospitalization for HF after discharge. Cox proportional hazard analysis was performed to determine the association between living alone and the endpoint.Overall, 581 patients were included in this study during the 3-year follow-up. The proportion of rehospitalization for HF was significantly higher in patients living alone than in those not living alone among male patients. However, female patients showed no difference in endpoints between the two groups. The difference was independently maintained even after adjusting for differences in social backgrounds in male patients (adjusted hazard ratio (HR) 2.02; 95% confidence interval (CI), 1.07-3.70). In female patients, the HR for rehospitalization for HF showed no difference between the two groups (adjusted HR, 0.99; 95% CI, 0.56-1.69).In this study population, male patients living alone after first AHF discharge had a higher risk of rehospitalization for HF than those not living alone, but these differences were not observed in female patients.

Impact of home- and community-based services in the long-term care insurance system on outcomes of patients with acute heart failure: Insights from the Kitakawachi Clinical Background and Outcome of Heart Failure Registry.

AIM: In Japan, the long-term care insurance (LTCI) system is important for elderly people living at home; however, no clinical studies have revealed a relationship between home- or community-based services and outcomes in patients with acute heart failure (AHF). METHODS: This was a prospective multicenter cohort study of patients with AHF enrolled between April 2015 and August 2017. Patients aged ≥65 years with LTCI were divided into those receiving home- and community-based services (service users) and without home and community-based services (service non-users). The endpoint was defined as a composite endpoint, which included all-cause mortality and hospitalization for heart failure after discharge. Subgroup analyses were performed for elderly patients (<85 years) or super-elderly patients (≥85 years). RESULTS: The study participants were eligible for LTCI two times more than community-dwelling people were. At the 1-year follow-up period, the rate of the composite endpoint showed no significant difference between service users and service non-users among all patients or super-elderly patients. However, in elderly patients, the rate of the composite endpoint was significantly lower among service users than service non-users. The difference was independently maintained even after adjustments for differences in comorbidities or in social backgrounds (adjusted hazard ratio 0.62; 95% confidence interval 0.38-0.99, and adjusted hazard ratio 0.57; 95% confidence interval 0.35-0.90, respectively). CONCLUSIONS: In this study, adverse events following discharge of patients with AHF who used home- and community-based services were prevented only in elderly patients, not in super-elderly patients. Geriatr Gerontol Int 2020; 20: 967-973.

Clinical Characteristics and Outcomes of Heart Failure Patients With Long-Term Care Insurance　- Insights From the Kitakawachi Clinical Background and Outcome of Heart Failure Registry.

BACKGROUND: In Japan, the long-term care insurance (LTCI) system has an important role in helping elderly people, but there have been no clinical studies that have examined the relationship between the LTCI and prognosis for patients with acute heart failure (HF).Methods and Results:This registry was a prospective multicenter cohort, 1,253 patients were enrolled and 965 patients with acute HF aged ≥65 years were comprised the study group. The composite endpoint included all-cause death and hospitalization for HF after discharge. We divided the patients into 4 groups: (i) patients without LTCI, (ii) patients requiring support level 1 or 2, (iii) patients with care level 1 or 2, and (iv) patients with care levels 3-5. The Kaplan-Meier analysis identified a lower rate of the composite endpoint in group (i) than in the other groups. After adjusting for potentially confounding effects using a Cox proportional regression model, the hazard ratio (HR) of the composite endpoint increased significantly in groups (iii) and (iv) (adjusted HR, 1.62; 95% confidence interval [CI], 1.22-1.98 and adjusted HR, 1.62; 95% CI, 1.23-2.14, respectively) when compared with group (i). However, there was no significant difference between groups (i) and (ii). CONCLUSIONS: The level of LTCI was associated with a higher risk of the composite endpoint after discharge in acute HF patients.

Active Participation in Outpatient Cardiac Rehabilitation Is Associated With Better Prognosis After Coronary Artery Bypass Graft Surgery　- J-REHAB CABG Study.

BACKGROUND: There is little evidence regarding the effect of outpatient cardiac rehabilitation (CR) on exercise capacity or the long-term prognosis in patients after coronary artery bypass graft surgery (CABG). This study aimed to determine whether participation in outpatient CR improves exercise capacity and long-term prognosis in post-CABG Japanese patients in a multicenter cohort.Methods and Results:We enrolled 346 post-CABG patients who underwent cardiopulmonary exercise testing during early (2-3 weeks) and late (3-6 months) time points after surgery. They formed the Active (n=240) and Non-Active (n=106) CR participation groups and were followed for 3.5 years. Primary endpoint was a major adverse cardiac event (MACE): all-cause death or rehospitalization for acute myocardial infarction/unstable angina/worsening heart failure. Peak oxygen uptake at 3-5 months from baseline was significantly more increased in Active than in Non-Active patients (+26±24% vs. +19±20%, respectively; P<0.05), and the MACE rate was significantly lower in Active than Non-Active patients (3.4% vs. 10.5%, respectively; P=0.02). Multivariate Cox proportional hazard analysis showed that participation in outpatient CR was a significant prognostic determinant of MACE (P=0.03). CONCLUSIONS: This unique study showed that a multicenter cohort of patients who underwent CABG and actively participated in outpatient CR exhibited greater improvement in exercise capacity and better survival without cardiovascular events than their counterparts who did not participate.

Omental herniation through the esophageal hiatus: A rare cause of gastric outlet obstruction and its CT findings.

A man in his 60s visited the emergency department because of epigastric pain and vomiting. Noncontrast helical abdominal CT revealed a lipomatous mass on the right side of the lower esophagus. Caudal slices showed that the mass appeared to displace the gastric antrum causing gastric outlet obstruction. Further observation revealed a linear structure from the greater curvature of the stomach into the omental vessels. Based on these findings, a diagnosis of intrathoracic omental hernia through the esophageal hiatus was made. Intraoperatively, a defect in the lesser omentum was seen, and the greater omentum herniated through the defect into the esophageal hiatus. Omental herniation through the lesser omentum into the esophageal hiatus can present as gastric outlet obstruction.

A decline in activities of daily living due to acute heart failure is an independent risk factor of hospitalization for heart failure and mortality.

BACKGROUND: Although activities of daily living (ADL) are recognized as being pertinent in averting relevant readmission of heart failure (HF) and mortality, little research has been conducted to assess a correlation between a decline in ADL and outcomes in HF patients. METHODS: The Kitakawachi Clinical Background and Outcome of Heart Failure Registry is a prospective, multicenter, community-based cohort of HF patients. We categorized the patients into four types of ADL: independent outdoor walking, independent indoor walking, indoor walking with assistance, and abasia. We defined a decline in ADL (decline ADL) as downgrade of ADL and others (non-decline ADL) as preservation of ADL before discharge compared with admission. RESULTS: Among 1253 registered patients, 923 were eligible, comprising 98 (10.6%) with decline ADL and 825 (89.4%) with non-decline ADL. Decline ADL exhibited a higher risk of hospitalization for HF and mortality compared with non-decline ADL. A multivariate analysis revealed that decline ADL emerged as an independent risk factor of hospitalization for HF [hazard ratio (HR), 1.42; 95% confidence interval (CI): 1.01-1.96; p=0.046] and mortality (HR, 1.95; 95% CI: 1.23-2.99; p<0.01). Although 66.3% of patients with decline ADL were registered for long-term care insurance, few received daycare services (32.7%) or home-visit medical services (8.2%). CONCLUSIONS: Decline in ADL is a predictor of hospitalization for HF and mortality in HF patients.

Evaluation by various methods of the physiological mechanism of a high-flow nasal cannula (HFNC) in healthy volunteers.

INTRODUCTION: Several reports have described the usefulness of a high-flow nasal cannula (HFNC). However, the physiological mechanisms of this system are unclear. In the current study, various methods were used to investigate the physiological mechanisms of an HFNC in healthy volunteers. METHODS: The physiological mechanisms of the constant-flow and constant-pressure models of HFNC were studied in 10 healthy volunteers by the oesophageal balloon method, the electrical impedance method and the forced oscillation technique (FOT). RESULTS: The tidal volume (TV) increased markedly during HFNC (off, 30 L/min, 50 L/min: 685.6±236.5 mL, 929.8±434.7 mL, 968.8±451.1 mL). The end-inspiratory oesophageal pressure (EIOP) was not significantly different, but there was a tendency for it to decrease. HFNC 30 L/min and 50 L/min, the increment in TV and the difference in EIOP showed strong negative correlations (p=0.0025, 0.003). The end-expiratory oesophageal pressure (EEOP) increased. The respiratory system reactance at 5 Hz (X5) by FOT decreased significantly. There was a flow rate-dependent EEOP increase, and the positive end-expiratory pressure (PEEP) effect of HFNC was confirmed. There was a correlation between the difference in X5 and the difference in EEOP during HFNC 30 L/min and 50 L/min, with correlation coefficients of 0.534 and 0.404 (p=0.112, 0.281). The amount of change in EEOP and the fluctuation in X5 were positively correlated. CONCLUSIONS: The PEEP effect of HFNC was confirmed by the electrical impedance method and FOT. The increment in TV and the difference in EIOP of HFNC showed strong negative correlations.

Sclerosing thymoma-like thymic amyloidoma with nephrotic syndrome: a case report.

BACKGROUND: Primary localized amyloidosis presenting as an isolated mediastinal mass is extremely rare, especially in the thymus. Sclerosing thymoma is also an extremely rare anterior mediastinal tumor, pathologically characterized by extensive sclerotic lesions with hyalinization and calcification. Only 14 cases of sclerosing thymoma and five cases of thymic amyloidosis have been reported to date. CASE PRESENTATION: A 78-year-old Japanese woman was diagnosed as having sclerosing thymoma (Masaoka stage IVa pericardial dissemination)-like thymic amyloidoma. She was diagnosed as having either lung cancer or mediastinal tumor with pericardial dissemination, and received palliative treatment. Three years later, she was readmitted with a complaint of general malaise. Since minimal change nephrotic syndrome was suspected based on the disease onset and selectivity index of urinary protein, steroid pulse therapy was started. Subsequently, because a marked reduction in tumor size was observed during maintenance treatment with prednisolone, a thoracoscopic needle biopsy was performed for a definitive diagnosis. According to the pathological findings and clinical investigations, a final diagnosis of sclerosing thymoma (Masaoka stage IVa pericardial dissemination)-like thymic amyloidoma was made. CONCLUSIONS: This is a case report of sclerosing thymoma-like thymic amyloidoma. Both sclerosing thymoma and thymic amyloidoma are extremely rare diseases: only 14 cases of sclerosing thymoma and five cases of thymic amyloidosis have been reported to date. In either diagnosis, our case is the first case in which marked reduction in tumor size was observed with steroid therapy. All reported cases of sclerosing thymomas underwent surgical resection, but steroid therapy to sclerosing thymoma has not been reported. It is still unknown whether steroid therapy is effective or not. The hyalinized components of sclerosing thymoma possibly contain amyloid deposits. The marked reduction in tumor size with steroid therapy may result in amyloid deposits. The association between sclerosing thymoma and thymic amyloidoma remains uncertain. Sclerosing thymoma should be stained with Congo red.

Clinical Characteristics and Social Frailty of Super-Elderly Patients With Heart Failure　- The Kitakawachi Clinical Background and Outcome of Heart Failure Registry.

BACKGROUND: Social background is important in preventing admission/readmission of heart failure (HF) patients. However, few clinical studies have been conducted to assess the social background of these patients, especially elderly patients.Methods and Results:The Kitakawachi Clinical Background and Outcome of Heart Failure (KICKOFF) Registry is a prospective multicenter community-based cohort of HF patients, established in April 2015. We compared the clinical characteristics and social background of the super-elderly group (≥85 years old) and the non-super-elderly group (<85 years old). This study included 647 patients; 11.8% of the super-elderly patients were living alone, 15.6% were living with only a partner, and of these, only 66.7% had the support of other family members. The super-elderly group had less control over their diet and drug therapies than the non-super-elderly group. Most patients in the super-elderly group were registered for long-term care insurance (77.4%); 73.5% of the super-elderly patients could walk independently before admission, but only 55.5% could walk independently at discharge, whereas 94% of the non-super-elderly patients could walk independently before admission and 89.4% could walk independently at discharge. CONCLUSIONS: The KICKOFF Registry provides unique detailed social background information of Japanese patients with HF. Super-elderly patients are at serious risk of social frailty; they need the support of other people and their ability to perform activities of daily living decline when hospitalized.

Adaptive servoventilation versus oxygen therapy for sleep disordered breathing in patients with heart failure: a randomised trial.

BACKGROUND: Both adaptive servoventilation (ASV) and nocturnal oxygen therapy improve sleep disordered breathing (SDB), but their effects on cardiac parameters have not been compared systematically. METHODS AND RESULTS: 43 patients with chronic heart failure (CHF; left ventricular ejection fraction (LVEF) ≤50%) with SDB were randomly assigned to undergo ASV (n=19, apnoea hypopnoea index (AHI)=34.2±12.1/h) or oxygen therapy (n=24, 36.9±9.9/h) for 3 months. More than 70% of SDB events in both groups were central apnoeas or hypopnoeas. Although nightly adherence was less for the ASV group than for the oxygen group (4.4±2.0 vs 6.2±1.8 h/day, p<0.01), the improvement in AHI was larger in the ASV group than in the oxygen group (-27.0±11.5 vs -16.5±10.2/h, p<0.01). The N-terminal pro-brain natriuretic peptide (NT-proBNP) level in the ASV group improved significantly after titration (1535±2224 to 1251±2003 pg/mL, p=0.01), but increased slightly at follow-up and this improvement was not sustained (1311±1592 pg/mL, p=0.08). Meanwhile, the level of plasma NT-proBNP in the oxygen group did not show a significant change throughout the study (baseline 1071±1887, titration 980±1913, follow-up 1101±1888 pg/mL, p=0.19). The significant difference in the changes in the NT-proBNP level throughout the study between the 2 groups was not found (p=0.30). Neither group showed significant changes in echocardiographic parameters. CONCLUSIONS: Although ASV produced better resolution of SDB in patients with CHF as compared with oxygen therapy, neither treatment produced a significant improvement in cardiac function in the short term. Although we could not draw a definite conclusion because of the small number of participants, our data do not seem to support the routine use of ASV or oxygen therapy to improve cardiac function in patients with CHF with SDB. TRIAL REGISTRATION NUMBER: NCT01187823 (http://www.clinicaltrials.gov).

Cardiovascular efficacy of sitagliptin in patients with diabetes at high risk of cardiovascular disease: a 12-month follow-up.

BACKGROUND: Gliptins should have beneficial effects beyond glycemic control, potentially on the pathophysiology of cardiovascular (CV) diseases, with some basic studies demonstrating this possibility. However, we are yet to answer whether there are any direct CV effects in the clinical setting. We aimed to examine the beneficial effects of sitagliptin in Japanese patients with diabetes and high CV risk for 12 months. METHODS: This was a prospective, multicenter, observational study of 205 patients with type 2 diabetes. All participants had more than one major CV risk factor and were treated with sitagliptin for 12 months. At 3 or 12 months, we examined the effects of treatment on glycemic control, CV function (by electrocardiography, echocardiography, and reactive hyperemia-peripheral arterial tonometry), and CV biomarkers. RESULTS: Patients were predominantly elderly (68.8 ± 9.9 years) and male (71.5 %) and typically had more than three CV risk factors (79.2 %). Treatment with sitagliptin significantly reduced the hemoglobin A1c (HbA1c) level from 7.09 % ± 0.81 % at baseline to 6.67 % ± 0.69 % at 3 months and 6.68 % ± 0.73 % at 12 months (both P < 0.001). The reduction in HbA1c was also in tandem with the decrease in the level of high-sensitive C-reactive protein throughout the study. Independent of the change in HbA1c, sitagliptin reduced systolic (-7.0 ± 18.9 mmHg) and diastolic blood pressure (-5.1 ± 11.7 mmHg) at 12 months, and this was associated with a decrease in urinary albumin. In contrast, there were no beneficial effects on cardiac and endothelial function or on the levels of serum B-type natriuretic peptide, high-sensitive troponin T, and urinary 8-hydroxy-2'-deoxyguanosine. CONCLUSIONS: In Japanese patients with diabetes and multiple CV risk factors, sitagliptin showed a decrease in blood pressure associated with an improvement in albuminuria in addition to glycemic control. TRIAL REGISTRATION: UMIN000005663.

Holter monitoring for the screening of cardiac disease in diabetes mellitus: The non-invasive Holter monitoring observation of new cardiac events in diabetics study.

We investigated the usefulness of Holter monitoring to detect cardiac disease and predict future cardiovascular risk in asymptomatic diabetic patients. This is a multi-centre, prospective study in 406 asymptomatic diabetic patients. They were categorized into three groups based on findings of Holter monitoring. A total of 377 met inclusion criteria and were classified as low (n = 172), moderate (n = 136) and high risk (n = 69). In total, 86 in moderate and 53 in high risk receive further evaluation. In total, 29 in moderate and 25 in high risk were diagnosed as cardiac disease and 12 required additional treatment, including coronary intervention. Over 1.8 years of mean follow-up, 11 (16.5 per 1000 person-years) experienced cardiovascular events. The cumulative incidence in moderate and high risk was higher than that in low risk (p = 0.029 and p = 0.014, respectively). Our study suggests that Holter monitoring may be a useful screening tool to detect cardiac disease and predict future cardiovascular risk in asymptomatic diabetic patients.

Clinical efficacy of thrombus aspiration on 5-year clinical outcomes in patients with ST-segment elevation acute myocardial infarction undergoing percutaneous coronary intervention.

BACKGROUND: Adjunctive thrombus aspiration (TA) during primary percutaneous coronary intervention (PCI) was reported to promote better coronary and myocardial reperfusion. However, long-term mortality benefit of TA remains controversial. The objective of this study is to investigate the clinical impact of TA on long-term clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. METHODS AND RESULTS: The CREDO-Kyoto AMI Registry is a large-scale cohort study of acute myocardial infarction patients undergoing coronary revascularization in 2005-2007 at 26 hospitals in Japan. Among 5429 patients enrolled in the registry, the current study population consisted of 3536 patients who arrived at the hospital within 12 hours after the symptom onset and underwent primary PCI. Clinical outcomes were compared between the 2 patient groups with or without TA. During primary PCI procedures, 2239 out of 3536 (63%) patients underwent TA (TA group). The cumulative 5-year incidence of all-cause death was significantly lower in the TA group than in the non-TA group (18.5% versus 23.9%, log-rank P<0.001). After adjusting for confounders, however, the risk for all-cause death in the TA group was not significantly lower than that in the non-TA group (hazard ratio: 0.90, 95% CI: 0.76 to 1.06, P=0.21). The adjusted risks for cardiac death, myocardial infarction, stroke, and target-lesion revascularization were also not significantly different between the 2 groups. CONCLUSIONS: Adjunctive TA during primary PCI was not associated with better 5-year mortality in STEMI patients.

A propensity score-matching analysis of transthoracic echocardiography and abdominal ultrasonography for the detection of abdominal aortic aneurysms.

INTRODUCTION: We previously reported that the prevalence of abdominal aortic aneurysms (AAAs) was higher in patients undergoing scheduled transthoracic echocardiography (TTE) than in patients undergoing abdominal ultrasonography (AUS); however, intergroup patient backgrounds differed significantly in that report. PURPOSE: We tested the hypothesis that TTE could detect AAA as effectively as AUS. DESIGN: A propensity score-matching analysis of a cross-sectional study was adopted as the design for this study. METHODS: We enrolled 7,619 and 15,433 patients scheduled to undergo TTE with additional evaluation of abdominal aorta at the end of the routine study and AUS, respectively, from 2009 to 2010 in our hospital, as reported. A propensity score for profiles of patients who underwent TTE or AUS was developed to adjust for potential confounding bias. Consequently, 4,388 patients in each group were matched for analyses. RESULTS: In propensity-matched patients, AAA was detected in 59 patients of the TTE group and in 48 patients of the AUS group; the prevalence of AAA detection did not differ significantly between TTE and AUS groups (P = 0.331). Positive associations were observed between AAA detection and male sex (adjusted odds ratio [OR]: 3.25; 95% confidence interval [CI], 2.05-5.15; P < 0.001), older age (adjusted OR: 1.029; 95% CI: 1.01-1.04; P < 0.001), and the presence of ischemic heart disease (adjusted OR: 1.78; 95% CI: 1.04-3.03; P = 0.033) and hypertension (adjusted OR: 2.16; 95% CI: 1.38-3.37; P = 001). CONCLUSION: TTE detected AAA with comparable efficacy as AUS in propensity-matched groups who underwent scheduled TTE and AUS.