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BackgroundWe previously reported a cross-sectional analysis regarding the relationship between smoking and atrial fibrillation (AF) in a single hospital-based cohort with Japanese patients, but the effect of cessation of smoking and/or total tobacco consumption were unclear.Methods and resultsWe used data from the Shinken Database 2004–2011 (men/women, n=10,714/6803, respectively), which included all new patients attending the Cardiovascular Institute between June 2004 and March 2012. After excluding those previously diagnosed with AF (n=2296), 15,221 patients (men/women, n=9016/6205) were analyzed. During the follow-up period of 2.0±2.1 years (range 0.0–8.1), the incidence rates of new AF in smokers and non-smokers were 9.0 and 5.0 per 1000 patient-years, respectively. In adjusted models with Cox regression analysis, smokers were independently associated with new AF [hazard ratio (HR) 1.47, 95% confidence interval (CI) 1.09–2.00]. Also, current smokers (HR 1.81, 95% CI 1.17–2.79) and smokers with Brinkman index ≥800 (HR 1.69, 95% CI 1.05–2.70) were independently associated with new AF. However, in current smokers, the HRs were not different by Brinkman index (Brinkman index

Background Seasonal variations in cardiovascular disease is well recognized. However, little is known about the presentations and outcomes of Japanese heart failure (HF) patients in the winter season. Methods and results We used a single hospital-based cohort from the Shinken Database 2004–2012, comprising all new patients (n = 19,994) who visited the Cardiovascular Institute Hospital. A total of 375 patients who were admitted owing to acute decompensated HF were included in the analysis. Of these patients, 136 (36%) were admitted in winter. Winter was defined as the period between December and February. The HF patients admitted in winter were older, and had a higher prevalence of hypertension and diabetes mellitus than the patients admitted in other seasons. Patients with conditions categorized as clinical scenario 1 tended to be admitted more commonly in winter. HF with preserved left ventricular ejection fraction (LVEF) was more common in HF patients admitted in winter than in those admitted in other seasons. Beta-blocker use at hospital discharge was more common in the patients admitted in other seasons. Kaplan–Meier curves and log-rank test results indicated that the incidences of all-cause death, cardiovascular death, and HF admission were comparable between the patients admitted in winter and those admitted in other seasons. Conclusions HF admission was frequently observed in the winter season and HF patients admitted in the winter season were older, and had higher prevalence of hypertension and diabetes mellitus, and preserved LVEF suggesting that we might need to pay more attention for elderly patients with hypertension, diabetes mellitus, and HF with preserved LVEF to decrease HF admissions in the winter season.

Background Clinical data on the mortality and morbidity of unselected Japanese patients with heart failure (HF) are limited. In this study, we aimed to determine the clinical characteristics, long-term outcomes, and prognostic factors of Japanese HF patients with preserved or reduced left ventricular ejection fraction (LVEF). Methods and results We used a single hospital-based cohort from the Shinken Database 2004–2011 that comprised all new patients ( n = 17,517) visiting the Cardiovascular Institute Hospital. A total of 1,525 patients diagnosed with symptomatic HF at the initial visit were included in the analysis. Of these, 1121 patients (74%) exhibited a preserved LVEF (>50%) and 404 patients (26%) had a reduced LVEF (≤50%). HF patients with preserved LVEF (HFpEF) were older and more often female than patients with reduced LVEF (HFrEF). Kaplan–Meier curves and log-rank test results showed that HFpEF patients had a better prognosis than HFrEF patients. However, there were no significant differences in clinical outcomes between HFpEF and HFrEF patients when the analysis was limited to inpatients. Cox regression analysis showed that HFpEF patients had a significantly lower risk of all-cause death ( p = 0.027; hazard ratio, 0.547, 95% confidence interval, 0.321–0.933). Multivariate analyses performed separately showed that the independent predictors of all-cause death in HFrEF were advanced age, lower body mass index, diabetes mellitus, and the absence of statin treatment, whereas those for HFpEF were advanced age, absence of dyslipidemia, anemia, and left ventricular hypertrophy. Conclusions This prospective cohort study identified the clinical characteristics, long-term outcomes, and prognostic factors of Japanese HF patients with reduced and preserved ejection fractions in a real-world clinical setting.

SummaryBackgroundThe presence of heart failure (HF) with preserved ejection fraction (HFPEF) is increasingly recognized. However, prognostic factors for HFPEF remain unclear.Methods and resultsThe data were derived from Shinken Database 2004–2010, a prospective cohort study (n=15,227). We examined 301 consecutive HFPEF patients (New York Heart Association Class II or greater) and tracked them for an average 3.5 years. Cardiopulmonary exercise testing (CPX), blood exams, and ultrasound cardiogram (UCG) were performed at the first medical examination. Acute decompensated HF (ADHF) admission was observed in 19 patients (6.3%). CPX showed that the anaerobic threshold was lower (7.3±4.8mL/min/kg vs. 9.7±4.3mL/min/kg, p=0.02) and slope of the increase in ventilation to the increase in CO2 output (VE-VCO2 slope) was higher (40.6±8.5 vs. 34.6±7.9, p

SummaryBackgroundThe effect of early statin initiation on secondary prevention remains uncertain in unselected Japanese populations with coronary artery disease (CAD).MethodsWe investigated the mortality and morbidity in CAD patients according to presence or absence of statins within 3 months after the diagnosis of CAD in the Shinken Database cohort study. The primary endpoint was all-cause mortality.ResultsData were available on 789 Japanese patients with CAD (male 78.8%). Among those, 351 patients (44.5%) received a statin. The mean (SD) baseline low-density lipoprotein (LDL)-cholesterol levels were 113.6 (35.7) mg/dL in the statin group and 113.6 (26.4) mg/dL in the non-statin group (p=0.992). Unadjusted 2-year survival in patients with or without statins was 98.4% and 92.1%, respectively (p

Background The prognostic impact of worsening renal function (WRF) in acute coronary syndrome (ACS) patients is not fully understood in Japanese clinical practice, and clinical implication of persistent versus transient WRF in ACS patients is also unclear. Methods With a single hospital-based cohort in the Shinken database 2004–2012 ( n = 19,994), we followed 604 ACS patients who underwent percutaneous coronary intervention (PCI). WRF was defined as an increase in creatinine during hospitalization of ≥0.3 mg/dl above admission value. Persistent WRF was defined as an increase in creatinine during hospitalization of ≥0.3 mg/dl above admission value and maintained until discharge, whereas transient WRF was defined as that WRF resolved at hospital discharge. Results WRF occurred in 78 patients (13%), persistent WRF 35 patients (6%) and transient WRF 43 patients (7%). WRF patients were older and had a higher prevalence of chronic kidney disease, history of myocardial infarction (MI), and ST elevation MI. WRF was associated with elevated inflammatory markers and reduced left ventricular (LV) ejection fraction in acute, chronic phase. Incidence of all-cause death and major adverse cardiac events (MACE: all-cause death, MI, and target lesion revascularization) was significantly higher in patients with WRF. Moreover, in the WRF group, incidences of all-cause death and MACE were higher in patients with persistent WRF than those with transient WRF. A multivariate analysis showed that as well as older age, female gender, and intubation, WRF was an independent determinant of the all-cause death in ACS patients who underwent PCI. Conclusions In conclusion, WRF might have a prognostic impact among Japanese ACS patients who underwent PCI in association with enhanced inflammatory response and LV remodeling. Persistent WRF might portend increased events, while transient WRF might have association with favorable outcomes compared with persistent WRF.

BackgroundBoth the prevalence of atrial fibrillation and coronary artery disease (CAD) is increasing in aged societies. However, limited data are available regarding the prevalence of CAD and the incidence of coronary events in Japanese patients with nonvalvular atrial fibrillation (NVAF).Methods and resultsThe data in this study were derived from Shinken Database 2004–2010, which includes 15,227 new patient visitors to the Cardiovascular Institute between June 2004 and March 2011. In the database, 1835 patients were diagnosed with NVAF (mean age 63 years, mean CHADS2 score 1.1±1.1, and 75% were men). The prevalence of CAD at the initial visit was 118 patients (6.4%). They were older age and had a greater prevalence of men, more history of congestive heart failure and more history of cardiovascular risk factors rather than those without. During the follow-up period of 532±599 days, coronary events (myocardial infarction, unstable angina, and stable angina) occurred in 51 patients (1.9%/year). Multivariate analysis showed that a history of CAD (p

Summary Background In Japan, the recent status of the mortality of atrial fibrillation (AF) patients is still unclear. Methods and results We used a single-hospital based cohort database in an urban city (Tokyo) in Japan, including all the new visitors from 2004 to 2009 (n = 13,228). The non-adjusted death rates of AF patients for all-cause, stroke, and cardiovascular death were 1091, 97, and 727 per 100,000 patient-years, and the age-adjusted ones were 317 (95% CI, 316–318), 16 (95% CI, 16–16), and 238 (95% CI, 237–239), respectively. The age-adjusted relative risk of AF on all-cause mortality was 1.7 in the particular population. Conclusions The present study provides the most recent data about the characteristics and the mortality of AF patients in Tokyo, thus serving as the basic information for finding problems to solve regarding Japanese AF patients.

Women have higher mortality and frequency of complications compared with men after coronary intervention. Possible differences in coronary atherosclerosis between men and women were investigated.The left anterior descending arteries of 214 patients (164 men, mean age 62.3 +/- 9.10 years; 50 women, mean age 67.8 +/- 7.76 years) were examined. Lesion length, reference diameter, percentage diameter stenosis and minimal lumen diameter were measured by quantitative coronary angiography. Vessel area, lumen area, percentage area stenosis, and remodeling index were measured by intravascular ultrasonography, and presence of calcification in the lesion was classified. These parameters were compared between men and women.There were no significant differences in quantitative coronary angiography, but intravascular ultrasonography showed calcification was more severe in women, vessel area was significantly smaller in women (13.25 +/- 4.21 vs 15.91 +/- 4.35 mm2, p = 0.004), and remodeling index was significantly lower in women (0.95 +/- 0.13 vs 1.04 +/- 0.18, p = 0.015).Vessel area measured by intravascular ultrasonography was significantly smaller in women, and calcification was more severe in women. Such factors may be involved in the higher mortality in women.

Power spectral analysis was used to analyze fluctuations of systolic blood pressure and heart rate.Non-invasive finger plethysmography and electrocardiography were performed in 20 patients with chronic atrial fibrillation and in 10 age-matched healthy subjects with normal sinus rhythm. The impulse train was stored on a personal computer and the power spectrum of R-R interval and systolic blood pressure were obtained by Fourier analysis (0.01-0.03 Hz). The power spectrum (log power vs log frequency) characteristically revealed a linear regression as 1/f beta.The R-R interval spectrum during atrial fibrillation showed a white noise-like flat spectrum when plotted as log power against log frequency, whereas the systolic blood pressure spectrum during atrial fibrillation showed a 1/f noise-like negative slope linear pattern. The spectrum exponent of systolic blood pressure in patients with atrial fibrillation was significantly lower than that in subjects with normal sinus rhythm (2.3 +/- 0.1 vs 1.3 +/- 0.1, p0.0001).Systolic blood pressure fluctuation in patients with atrial fibrillation has a fractal component and is more complex than that of healthy subjects with normal sinus rhythm.

BackgroundSeveral reports have identified that decline in renal function and presence of proteinuria are closely associated with incidence of atrial fibrillation (AF). However, it is still unclear whether these kidney-related markers are associated with the progression of AF from paroxysmal to persistent form.Methods and resultsAmong the new patients who visited the Cardiovascular Institute Hospital between 2004 and 2010 (Shinken Database 2004–2010, n=15,227), both estimated glomerular filtration rate (eGFR) and proteinuria were measured in 1074 AF patients (paroxysmal/persistent 579/495, respectively), who were divided into tertiles of eGFR (the borderlines were 60.07 and 73.67ml[min−1]1.73[m−2], respectively), and then further divided into the two categories with/without proteinuria. The average value of eGFR was lower (63.1ml[min−1]1.73[m−2] vs. 68.8ml[min−1]1.73[m−2], p

Summary Background Several hospital-based investigations have reported that a high proportion of patients with heart failure (HF) have preserved left ventricular ejection fraction (LVEF). The purpose of this study was to determine the prevalence, prognosis, and predictors for mortality of Japanese HF patients with preserved versus reduced LVEF in a prospective cohort fashion. Methods and results Our hospital-based database including inpatients and also outpatients was used for analysis. Out of 4255 new patients, 597 patients (male/female 414/183, age 65.1 ± 12.9 years) were diagnosed as having symptomatic HF at the initial visit. Among 589 HF patients undergoing echocardiography, 398 (67.6%) showed a preserved LVEF (>50%) and 191 (32.4%) had a reduced LVEF (≤50%). Patients with preserved LVEF were older ( p = 0.004) and more likely to be female ( p = 0.002). During follow-up of an average 539 days, 34 cardiovascular deaths occurred, and patients with preserved LVEF showed a better prognosis than those with reduced LVEF (3.2% vs. 7.4% per year, p = 0.0097). Multivariate Cox hazards analysis identified LVEF as an independent predictor in all HF patients. Also, separated group analysis showed that presence of chronic kidney disease was independently associated with poor prognosis irrespective of HF types. Conclusions This prospective cohort study identified prevalence and prognosis of HF in Japanese in- and outpatients, where patients with preserved LVEF showed a better prognosis than those with reduced LVEF.

Background A blue letter (safety advisory) for dabigatran was issued by the Japanese Ministry of Health, Labour and Welfare in August 2011. Changes in physicians’ attitudes toward dabigatran use before and after the blue letter have not been previously reported. Methods and results Between March 2011 and July 2012, dabigatran was prescribed to 404 Japanese patients with nonvalvular atrial fibrillation at The Cardiovascular Institute (Tokyo, Japan). Patients were divided into three groups according to the first prescription date: phase I (before the blue letter, n = 135); phase II (after the blue letter and before permission for longer-term prescriptions, n = 112); and phase III (after permission for longer-term prescriptions, n = 157). In phase II, dabigatran use tended to be avoided for patients with older age, renal dysfunction, receiving antiplatelet medication, or p-glycoprotein inhibitors. Measurement of activated partial thromboplastin time significantly increased from phase I to III. In phase III, the tendencies seen in phase II were reversed: dabigatran use in patients with older age and renal dysfunction tended to increase, but decreased or remained the same in patients receiving antiplatelet medications or p-glycoprotein inhibitors. Conclusions We described the changes in the attitudes of attending physicians toward dabigatran prescription after the blue letter in a specialized hospital for cardiovascular care in Japan, which, we believe, involve useful information for safe use of dabigatran in a real-world clinical setting. However, a true impact or effect of the blue letter should be ascertained in a nationwide, multicenter study.

Summary Background Mortality and morbidity after acute coronary syndrome (ACS) in Japan appear to be different from those in Western countries due to different social healthcare systems, races, geographical locations, and interventional procedures, although data are limited in Japan. Methods With a hospital-based cohort study comprising all the new patients who had visited our hospital between 2004 and 2007 (n = 6562), we identified all-cause mortality, the composite endpoint of cardiac death, non-fatal myocardial infarction (MI), or target vessel revascularization and the predictors. Results Of the total, 293 patients were included with a discharge diagnosis of ACS (median follow-up of 24.5 months). Non-ST elevation-ACS (NSTE-ACS) (unstable angina and non-ST elevation MI) and ST elevation MI (STEMI) were observed in 165 (56.3%) and 128 (43.7%) patients, respectively. Percutaneous coronary intervention or coronary artery bypass graft surgery was performed in 72.7% and 14.5% of NSTE-ACS patients, respectively and in 82.8% and 10.2% of STEMI patients. The use of aspirin, ticlopidine, and beta-blockers for NSTE-ACS patients were 93.3%, 66.9%, and 38.0%, respectively, with corresponding rates of 96.0%, 75.4%, and 57.1% for STEMI patients. All-cause mortality rates in NSTE-ACS and STEMI were 1.8% and 5.5% at 30 days, respectively, and 6.3% and 12.9% at 2 years, with corresponding rates of 3.7% and 8.7% at 30 days, respectively, and 23.4% and 35.6% at 2 years for the composite endpoint. Multivariate analysis showed that predictors for mortality were older age (hazard ratio [HR] 1.13, 95% confidence interval [CI] 1.018–1.244) and estimated glomerular filtration rate value (HR 0.96, 95% CI 0.929–0.988) in NSTE-ACS, and older age (HR 1.10, 95% CI 1.011–1.119) and congestive heart failure on admission (HR 20.0, 95% CI 2.439–164.4) in STEMI. Conclusions The present study identified long-term mortality, morbidity, and predictors of adverse events for Japanese patients with ACS.

SummaryBackgroundIt has been reported that nitinol stents provide higher patency in chronic phase than stainless steel stents after intervention to superficial femoral artery (SFA). However, there are few reports about stent patency for chronic total occlusion of SFA (SFA CTO).ObjectiveTo compare clinical outcomes of self-expanding nitinol stents and stainless steel stents after percutaneous peripheral intervention (PPI) for SFA CTO.Methods and resultsBetween April 2004 and August 2007, a total of 25 SFA CTO lesions (nitinol stent group, 13; stainless steel stent group, 12) in 21 patients were treated with PPI, all patients were followed clinically, and 21 lesions (nitinol, 9; stainless steel, 12) received follow-up angiography. There was no significant difference in baseline characteristics, mean stent diameter (7.3±0.7mm vs. 6.9±1.2mm, p=0.32), pre-ankle-brachial index (ABI), and Fontaine stage between groups. Mean occlusion length and stent length were significantly longer (129.5±54.9mm vs. 39.0±20.6mm, 250.8±90.0mm vs. 145.2±64.6mm, respectively, p