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Hypertension is a significant risk factor for heart failure (HF). Since hypertension definition varies across guidelines, identifying blood pressure (BP) categories that should be targeted to prevent HF is required. We, therefore, investigated the association between hypertension per the 2017 American College of Cardiology/American Heart Association (ACC/AHA) and 2018 European Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines and HF risk. This prospective cohort study included randomly selected 2809 urban Japanese people from the Suita Study. Cox regression was used to assess HF risk, in the form of hazard ratios (HRs) and 95% confidence intervals (95% CIs), for different BP categories in both guidelines, compared to a reference category defined as systolic BP (SBP) 120 mmHg and diastolic BP (DBP) 80 mmHg. Within 8 years of median follow-up, 339 HF cases were detected. Per the 2017 ACC/AHA guidelines, hypertension I and II and isolated systolic hypertension were associated with increased HF risk: HRs (95% CIs) = 1.81 (1.33-2.47), 1.68 (1.24-2.27), and 1.64 (1.13-2.39), respectively. Per the 2018 ESC/ESH guidelines, high-normal BP, hypertension I, II, and III, and isolated systolic hypertension were associated with increased HF risk: HRs (95% CIs) = 1.88 (1.35-2.62), 1.57 (1.13-2.16), 2.10 (1.34-3.29), 2.57 (1.15-5.77), and 1.51 (1.04-2.19), respectively. In conclusion, hypertension and isolated systolic hypertension per the 2017 ACC/AHA and 2018 ESC/ESH guidelines and high-normal BP per the 2018 ESC/ESH guidelines are risk factors for HF.

Aims The benefits of nationwide screening and tailored health guidance on improving obesity and cardiovascular risk factors is uncertain. The aim of the present study was to investigate the association of the national health screening and tailored health guidance with population health outcomes. Methods and results A fuzzy regression discontinuity design analysed data of men and women aged 40–74 years who participated in a nationwide health screening programme in Japan from 1 April 2008 to 31 March 2019 and were recorded in the Japanese National Database. Exposure was assignment to the national health guidance of counselling on healthy lifestyle and clinical follow-up for individuals found to have waist circumference ≥85 cm for men ≥90 cm for women with one or more cardiovascular risk factors during annual national health screening. The primary outcomes were changes in obesity status and cardiovascular risk factors 1 year after screening. Of 3 490 112 men and 2 328 929 women, the assignment to the health guidance resulted in small reductions in obesity parameters: waist circumference; men, −0.27 cm [95% confidence interval (CI) −0.29 to −0.26]; women −0.34 (−0.41 to −0.27); body mass index, −0.07 kg/m2 (−0.075 to −0.066); −0.11 kg/m2 (−0.13 to −0.10); weight, −0.21 kg (−0.22 to −0.19); −0.28 kg (−0.32 to −0.24) that attenuated over time. Short-term improvements were also observed in blood pressure, haemoglobin A1c, fasting glucose and triglycerides across both sexes. Conclusion A nationwide health screening programme was associated with only small, and transient improvements in obesity and cardiovascular risk factors.

This study aimed to investigate the association of mild hypertensive retinopathy with cardiovascular disease (CVD) risk.A total of 7,027 residents aged 30-79 years without a history of CVD participated in the annual health checkups and retinal photography assessments. Retinal microvascular abnormalities were graded using the standard protocols and classified according to the Keith-Wagener-Barker classification. Mild hypertensive retinopathy was defined as grades 1 and 2. Cox proportional hazard model was used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for total CVD and its subtypes according to the presence and absence of mild hypertensive retinopathy.During a median follow-up of 17 years, 351 incident stroke and 247 coronary heart disease (CHD) cases were diagnosed. After adjustment for traditional cardiovascular risk factors, mild hypertensive retinopathy was positively associated with risk of CVD (multivariable HR=1.24; 95% CI, 1.04-1.49) and stroke (1.28; 1.01-1.62) but not with risk of CHD (1.19; 0.89-1.58). Generalized arteriolar narrowing and enhanced arteriolar wall reflex were positively associated with CVD risk, the multivariable HR (95% CI) was 1.24 (1.00-1.54) and 1.33 (1.02-1.74), respectively. Moreover, mild hypertensive retinopathy was positively associated with stroke risk in normotensive participants.Mild hypertensive retinopathy was positively associated with CVD and stroke risk in the urban Japanese population. Especially, generalized arteriolar narrowing and enhanced arteriolar wall reflex were positively associated with CVD risk. These findings suggested that retinal photography could be helpful for cardiovascular risk stratification in the primary cardiovascular prevention.

The association between serum uric acid levels and the risk of diabetes mellitus in women stratified by menopausal status is not well-established. Therefore, we investigated this association among a cohort of Japanese urban women.We conducted a prospective cohort study on 3,304 women (1,252 premenopausal and 2,052 postmenopausal), aged 30 to 79 years, with no prior cardiovascular disease or diabetes mellitus, and enrolled from a general urban population. Cox proportional hazard model was used to calculate hazard ratios and 95% confidence intervals (CIs) for incident diabetes mellitus according to serum uric acid quartiles.During 13.8 years of median follow-up, 219 incident diabetes mellitus cases were diagnosed. The incidence rate per 1,000 person-years was 3.42 in premenopausal women and 6.19 in postmenopausal women. After adjustment for potential risk factors, the multivariable hazard ratios (95% CIs) of the highest versus lowest serum uric acid quartiles were 1.56 (0.77-3.16) in premenopausal women, 2.00 (1.19-3.34) in postmenopausal women, and 1.81 (1.21-2.73) in all women. The interaction based on menopausal status was not significant ( P = 0.872). The corresponding population attributable fractions (95% CIs) were 13.3% (-8.9% to 31.1%), 19.1% (5.3%-30.9%), and 17.0% (5.6%-27.0%), respectively.Serum uric acid levels were positively associated with the risk of diabetes mellitus in postmenopausal women, but not in premenopausal women. However, the lack of an association in premenopausal women may have been due to limited power, so further research is required to confirm this menopausal status-specific association.

Introduction: Stroke remains a major cause of death and disability in Japan and worldwide. Detecting individuals at high risk for stroke to apply preventive approaches is recommended. This study aimed to develop a stroke risk prediction model among urban Japanese using cardiovascular risk factors. Methods: We followed 6,641 participants aged 30–79 years with neither a history of stroke nor coronary heart disease. The Cox proportional hazard model estimated the risk of stroke incidence adjusted for potential confounders at the baseline survey. The model’s performance was assessed using the receiver operating characteristic curve and the Hosmer-Lemeshow statistics. The internal validity of the risk model was tested using derivation and validation samples. Regression coefficients were used for score calculation. Results: During a median follow-up duration of 17.1 years, 372 participants developed stroke. A risk model including older age, current smoking, increased blood pressure, impaired fasting blood glucose and diabetes, chronic kidney disease, and atrial fibrillation predicted stroke incidence with an area under the curve = 0.76 and p value of the goodness of fit = 0.21. This risk model was shown to be internally valid (p value of the goodness of fit in the validation sample = 0.64). On a risk score from 0 to 26, the incidence of stroke for the categories 0–5, 6–7, 8–9, 10–11, 12–13, 14–15, and 16–26 was 1.1%, 2.1%, 5.4%, 8.2%, 9.0%, 13.5%, and 18.6%, respectively. Conclusion: We developed a new stroke risk model for the urban general population in Japan. Further research to determine the clinical practicality of this model is required.

Background Higher baseline uric acid (UA) was significantly associated with higher atrial fibrillation (AF) incidence in Japanese women. However, no prospective study is evident in the association between UA and incident AF in Japanese urban residents. Methods A total of 6863 participants (aged 30‐79 years; 47% men) without prior AF were followed for 13.9 years on average in the Suita Study. According to the UA categories, cox proportional hazards regression models were used to estimating the Hazard Ratios (HRs) and 95% confidence intervals (CIs) for incident AF. Results During 95178 person‐years of follow‐up, we observed 311 cases of incident AF (204 cases in men and 107 cases in women). Compared to the subjects with UA of 4.0‐4.9 mg/dL, multivariable‐adjusted HR (95% CIs) of incident AF was 1.50 (1.01‐2.25) (P = .047) for the subjects with UA ≥7.0 mg/dL. Conclusion High UA was associated with an increased risk for incident AF in the Japanese population., High UA was associated with an increased risk for incident AF in the Japanese population. During 95 178 person‐years of follow‐up, we observed 311 cases of incident AF (204 cases in men and 107 cases in women). Compared to the subjects with UA of 4.0‐4.9 mg/dL, multivariable‐adjusted HR (95% CIs) of incident AF was 1.50 (1.01‐2.25) for the subjects with UA ≥7.0 mg/dL.

We aimed to investigate the combined impact of liver enzymes and alcohol consumption on the diabetes risk.Data on 5972 non-diabetic participants aged 30-79 years from the Suita study were analyzed. Diabetes incidence was surveyed every 2 years. Current daily alcohol consumption was defined as light drinking ( 23.0 g ethanol/day in men and 11.5 g in women), moderate drinking (23.0-45.9 g and 11.5-22.9 g), and heavy drinking (≥ 46.0 g and ≥ 23.0 g). The nondrinkers category included both never-drinkers and former drinkers.During the median follow-up of 13 years, 597 incident diabetes cases were diagnosed. Higher levels of γ-glutamyltransferase (GGT), alanine aminotransferase (GPT), and aspartate aminotransferase (GOT) were associated with an increased diabetes risk, and current light drinkers had a lower risk of diabetes than nondrinkers. No sex differences were observed in these associations. Compared to nondrinkers having the lowest quartiles of liver enzymes, nondrinkers and current moderate/heavy drinkers having the highest quartiles had an increased risk of diabetes. However, no association was observed for current light drinkers having the highest quartiles of liver enzymes; the multivariable hazard ratios (95% CIs) in current light drinkers with the highest quartile of liver enzymes were 1.27 (0.68-2.37) for GGT, 1.05 (0.59-1.89) for GPT, and 0.76 (0.40-1.47) for GOT, respectively.High liver enzymes were associated with an increased diabetes risk. No increased diabetes risk was observed in current light drinkers, even in these who had high levels of liver enzymes.

Background: Population-based studies of atrial fibrillation (AF) incidence are needed to inform health-service planning, but evidence is conflicting. We assessed trends of AF incidence in a large general population cohort from England. Methods: We used linked primary and secondary electronic health records of 3.4 million individuals. Eligible patients aged 16 years and older contributed data between Jan 2 1998 and Dec 31 2017. For patients with incident AF, we extracted baseline characteristics, comorbidities, socioeconomic status and geographic region. We calculated standardised rates by applying direct age and sex standardisation to the 2013 European Standard Population. We applied year-specific, age-specific and sex-specific incidence to UK census mid-year population estimates for yearly total incident AF. Findings: Comparing 2017 to 1998 standardised AF incidence increased by 30% (322 vs. 247 per 100 000 person-years; adjusted incidence ratio [IRR] 1·30, 95% CI 1·27-1·33). Absolute number of incident AF increased by 72% (202 333 vs. 117 880), due to an increasing number of older persons. Comorbidity burden at diagnosis of AF increased (3·74 [SD 2·29] vs 2·58 [1·83]; adjusted difference 1·26, 95% CI 1·14-1·39). The age of AF diagnosis declined in the most deprived individuals compared to the most affluent (adjusted difference 0·74 years, 0·62-0·88). Across the study period, age-standardised incidence was higher in men than women (IRR 1·49; 95% CI 1·46-1·52), and men were younger at diagnosis (adjusted difference 5·53 years; 95% CI 5·36 to 5·69). Socioeconomically deprived individuals had more comorbidities and a higher incidence of AF than the most affluent individuals (IRR 1·20; 95% CI 1·15-1·24). Interpretation: In England AF incidence has increased, and the socioeconomic gradient in age at diagnosis and comorbidity burden widened. This changing burden requires policy-based interventions to achieve health equity. Funding: British Heart Foundation and National Institute for Health Research.

Background To analyze the type of ablation procedure, acute outcomes, and complications related to catheter ablation in Japan during the year of 2018. Method The Japanese Catheter Ablation (J‐AB) registry is a voluntary, nationwide, multicenter, prospective, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center using a Research Electronic Data Capture system. The procedural outcome and complications during hospitalizations were collected. Result A total of 55 525 procedures (mean age of 64.5 years and 66.5% male) from 369 hospitals were collected. The total number of target arrhythmias was 61 610 including atrial fibrillation (AF, 65.6%), atrial flutter (AFL) or atrial tachycardia (16.7%), atrioventricular nodal reentrant tachycardia (7.4%), atrioventricular reentrant tachycardia (3.5%), premature ventricular contractions (4.1%), and ventricular tachycardia (VT, 2.0%). Over a 90% acute success rate was observed among all arrhythmias except for VT due to structural heart disease, and notably, an over 99% success rate was achieved for pulmonary vein isolation of AF and inferior vena cava‐tricuspid valve isthmus block for isthmus‐dependent AFL. Acute complications during hospitalization were observed in 1558 patients (2.8%), including major bleeding (Bleeding Academic Research Consortium: BARC criteria ≥2) in 1.1%, cerebral or systemic embolisms in 0.2%, and death in 0.1%. Acute complications were more often observed with AF ablation (P, J‐AB is a prospective nationwide multicenter registry designed to collect clinical variables and sort‐term outcome data, aiming to register all catheter ablation cases performed in Japan. We successfully collected 55 525 procedures including 61 610 target arrhythmias during the year of 2018 and analyzed the acute success and complications during the hospitalization.

Aim: To construct a risk prediction model for cardiovascular disease (CVD) based on the Suita study, an urban Japanese cohort study, and compare its accuracy against the Framingham CVD risk score (FRS) model. Methods: After excluding participants with missing data or those who lost to follow-up, this study consisted of 3,080 men and 3,470 women participants aged 30–79 years without CVD at baseline in 1989–1999. The main outcome of this study was incidence of CVD, defined as the incidence of stroke or coronary heart disease. Multivariable Cox proportional hazards models with stepwise selection were used to develop the prediction model. To assess model performance, concordance statistics (C-statistics) and their 95% confidence intervals (CIs) were calculated using a bootstrap procedure. A calibration test was also conducted. Results: During a median follow-up period of 16.9 years, 351 men and 241 women developed CVD. We formulated risk models with and without electrocardiogram (ECG) data that included age, sex, systolic blood pressure, diastolic blood pressure, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, lowdensity lipoprotein cholesterol, diabetes mellitus, smoking, and urinary protein as risk factors. The C-statistics of the Suita CVD risk models with ECG data (0.782; 95% CI, 0.766–0.799) and without ECG data (0.781; 95% CI, 0.765–0.797) were significantly higher than that of the FRS model (0.768; 95% CI, 0.750–0.785). Conclusions: The Suita CVD risk model is feasible to use and improves predictability of the incidence of CVD relative to the FRS model in Japan.

Direct oral anticoagulants (DOACs) are effective and safe alternatives to warfarin for stroke prophylaxis for atrial fibrillation (AF). Whether this extends to patients at the extremes of body mass index (BMI) is unclear.Using linked primary and secondary data, Jan 1, 2010 to Nov 30, 2018, we included CHAWe included 29,135 (22,818 warfarin, 6317 DOAC); 585 (2.0%) underweight, 8427 (28.9%) normal weight, 10,705 (36.7%) overweight, 5910 (20.3%) class I obesity and 3508 (12.0%) class II/III obesity. Patients treated with DOACs were older and more comorbid. After 3.7 (SD 2.5) years follow up, there was no difference in risk of ischaemic stroke and major bleeding by BMI category between DOACs and warfarin. Normal weight, overweight and obese class I patients had higher risk of all-cause mortality when treated with DOACs compared with warfarin (HR: 1.45 [95% CI 1.24-1.69],In patients with AF in each BMI classification we found no difference in ischaemic stroke and bleeding risk for DOACs compared with warfarin. Underweight patients experienced divergent risk-benefit patterns from oral anticoagulation compared with other BMI categories.None.

ObjectiveAtrial fibrillation (AF) screening by age achieves a low yield and misses younger individuals. We aimed to develop an algorithm in nationwide routinely collected primary care data to predict the risk of incident AF within 6 months (Future Innovations in Novel Detection of Atrial Fibrillation (FIND-AF)).MethodsWe used primary care electronic health record data from individuals aged ≥30 years without known AF in the UK Clinical Practice Research Datalink-GOLD dataset between 2 January 1998 and 30 November 2018, randomly divided into training (80%) and testing (20%) datasets. We trained a random forest classifier using age, sex, ethnicity and comorbidities. Prediction performance was evaluated in the testing dataset with internal bootstrap validation with 200 samples, and compared against the CHA2DS2-VASc (Congestive heart failure, Hypertension, Age >75 (2 points), Stroke/transient ischaemic attack/thromboembolism (2 points), Vascular disease, Age 65–74, Sex category) and C2HEST (Coronary artery disease/Chronic obstructive pulmonary disease (1 point each), Hypertension, Elderly (age ≥75, 2 points), Systolic heart failure, Thyroid disease (hyperthyroidism)) scores. Cox proportional hazard models with competing risk of death were fit for incident longer-term AF between higher and lower FIND-AF-predicted risk.ResultsOf 2 081 139 individuals in the cohort, 7386 developed AF within 6 months. FIND-AF could be applied to all records. In the testing dataset (n=416 228), discrimination performance was strongest for FIND-AF (area under the receiver operating characteristic curve 0.824, 95% CI 0.814 to 0.834) compared with CHA2DS2-VASc (0.784, 0.773 to 0.794) and C2HEST (0.757, 0.744 to 0.770), and robust by sex and ethnic group. The higher predicted risk cohort, compared with lower predicted risk, had a 20-fold higher 6-month incidence rate for AF and higher long-term hazard for AF (HR 8.75, 95% CI 8.44 to 9.06).ConclusionsFIND-AF, a machine learning algorithm applicable at scale in routinely collected primary care data, identifies people at higher risk of short-term AF.

Introduction: According to the world health organization, an estimated 1.13 billion individuals worldwide have hypertension (HT). However, limited studies discussed the risk prediction for incident HT. We aim to evaluate the incidence of HT and identify its risk factors in urban Japanese residents. Methods: We followed up 4,314 normotensive participants at the baseline survey. Blood pressure (BP) was measured twice in the sitting position under rest. The participants have continued to visit the center every two years for regular health check-ups and all of them gave informed consent. The BP categories were defined by the ESC/ESH Guidelines. Cox regression model was used to detect HT's risks by cardiovascular risk factors. Results: During the mean follow-up period of 17.6 years, 25.8 per 1000 person-years of participants developed HT (optimal 16.7, normal 30.7, and elevated BPs 43.5 per 1000 person-years, respectively). The adjusted hazards ratio (HRs, 95% CIs) for developing HT for age groups in the 40s (HR=1.34, 95% CI=1.14 - 1.58), 50s (1.73, 1.47 - 2.04), 60s (2.26, 1.91 - 2.68), and 70s (2.95, 2.41 - 3.61), normal BP (2.23, 1.98 - 2.50), elevated BP (4.25, 3.78 - 4.76), smoking > 10 cig/d (1.21, 1.05 - 1.40), never drinking alcohol 1.22 (1.07 - 1.40), drinking alcohol ≥ 4 units/day 1.36 (1.15 - 1.60), parental history of HT (1.18, 1.03 - 1.34), fasting plasma glucose levels ≥ 126 mg/dL (1.39, 1.10 - 1.76), and chronic kidney disease (1.15, 1.02 -1.29) in the normotensive population. Conclusion: The incident and risk factors for developing HT were firstly shown in Japan. The study emphasizes the importance of controlling the risk factors for incident HT as primary prevention.

Background: Acute coronary syndrome (ACS) due to an unprotected left main coronary artery (LMCA) lesion is a critical condition, but there are limited data available on in-hospital outcomes of percutaneous coronary intervention (PCI). Methods and Results: The Japan Acute Myocardial Infarction Registry is a nationwide, real-world database. The clinical data on 13,548 ACS patients hospitalized between January 2011 and December 2013 were retrospectively collected from 10 representative regional ACS registry groups. We compared the 404 patients (3.0%) with LMCA ACS with the remaining 13,144 patients with non-LMCA ACS. The LMCA group was characterized by older age, lower rate of ST-segment elevation myocardial infarction, and higher rate of advanced Killip class. In-hospital mortality was significantly higher in patients with LMCA ACS than in those with non-LMCA ACS (23.3% vs. 5.5%, respectively; P

Measuring quality of care is central to quality improvement. Improving outcomes for heart failure (HF) may relate to hospital care delivery. However, there is limited nationwide data on the relationship between hospital-level HF performance measures and clinical outcomes.From the Japanese Registry of All cardiac and vascular Diseases (JROAD-DPC) database, 83,567 HF patients hospitalised in 731 certificated hospitals in 2014 by the Japanese Circulation Society were analysed. Five performance measures were prescription rate of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, beta-blocker, and mineralocorticoid receptor antagonist and measurement rate of echocardiography and B-type natriuretic peptide during hospitalisation. Relationships between these measures and 1-year readmission due to HF were analysed. Composite performance score (CPS) obtained from the five performance measures and outcomes were also analysed. We also investigated the relationships between CPS and hospital structural factors.From the cohort (mean age; 78.2 years, woman 48.4%), HF readmission rate at 1 year was 19.6% (n = 16,368). Readmission rate decreased with higher quartiles of prescription rate in each medication and diagnostic performance rates. The highest CPS group was associated with a 15% risk reduction in HF readmission compared with the lowest CPS group (hazard ratio, 0.85, 95% confidence interval [0.80-0.89], p 0.001) after covariate adjustment. Several structural factors such as number of cardiology specialists, hospital case volume for HF, and presence of cardiac surgery division were associated with high CPS.Higher hospital performance measures for HF were inversely associated with HF readmissions.

Introduction: The fibrosis index based on four factors (FIB-4 index) is a score that predicts liver fibrosis easily, quickly, and inexpensively, but there is little evidence of its relationship with the onset of cardiovascular disease in general population in Japan. Therefore, we examined the relationship between incident cardiovascular disease (CVD) by the FIB-4 index level in urban area residents. Methods: We studied 5,333 follow-up Japanese individuals (2,478 men, 2,855 women) with no history of CVD in the Suita Study. The platelet count was measured at the time of medical examination. The FIB-4 index was calculated using age (yrs), alanine aminotransferase (ALT, IU/L), aspartate aminotransferase (AST, IU/L), and platelet count (PLT, 10^9/L) as follow: FIB-4 index = (AST x Age) / (PLT x (square root of ALT)). The primary endpoint was CVD events, including stroke or ischemic heart disease. The risk of CVD was analyzed by the FIB-4 index level using the Cox proportional hazards model adjusted by the components of the ischemic heart disease risk score in the Suita Study. Results: The percentage of the FIB-4 index ≥2.67 in the 30s to 80s at the baseline survey was 0%, 1%, 2%, 7,%, 21%, 43% for men, and 0%, 0%, 1%, 5%, 16%, 39% for women, respectively. During the mean follow-up period of 9.3 years, 195 strokes and 137 ischemic heart diseases were observed. Based on men with FIB-4 index Conclusion: The FIB-4 index was considered to be useful as a predictor of ischemic heart disease in urban men in Japan.

Purpose: We have first reported that the new progression of carotid artery plaque (Prog-PQ) is a risk factor for incident cardiovascular disease (CVD), but the Prog-PQ risk score has not been established. Methods: We studied 4,724 Japanese (mean age 59.7 years) without CVD, whose intima-media thickness (IMT) was measured with carotid ultrasonography on both sides of the entire carotid artery areas as a baseline survey (April 1994 to August 2001). We defined carotid plaque as a maximum IMT of the common carotid artery >1.1mm. We excluded subjects with carotid plaque at baseline (n=1,044), lost to follow-up (n=167), and missing data (n=2). For 3,511 subjects, carotid ultrasonographic follow-ups were performed every two years until March 2016. Blood pressures (BPs) were used the average of two measurements recorded more than 1 min apart. Cox proportional hazard ratios were analyzed after adjusting for cardiovascular risk factors. We used the area under the receiver operating characteristic curve to evaluate the model's discrimination. Results: During 38,454 person-years of follow-up, 1,771 instances of the Prog-PQ occurred. Compared to subjects with systolic BP (SBP) Conclusion: High SBP was a significant risk factor for the Prog-PQ. We have developed a 10-year risk score for the Prog-PQ, which can efficiently predict atherosclerosis in routine clinic/health examinations without carotid ultrasonography.

Background Transvenous lead extractions (TLEs) in Japan have grown to become the standard therapy since the approval of the laser extraction system in 2008. However, little is known about the current indications, methods, success rate, and acute complications in the real‐world setting. Methods The Japanese Lead EXtraction (J‐LEX) registry is a nationwide, multicenter, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center. This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system. The acute success rate at discharge and complications associated with TLEs will be collected in all cases. Based on the provided information, the annual incidence and predictive factors for the outcomes will be investigated by the Event Assessment Committee (EAC). This registry started in July 2018 and the number of participating medical institutions will be more than 50 hospitals and the target number of procedures will be 500‐1000 per year. We will also compare the results with other registries in foreign countries. Result The results of this study are currently under investigation. Conclusion The J‐LEX registry will provide real‐world data regarding the results and complications of TLEs for the various types of indications, methods, and performing hospitals in Japan., The Japanese Lead EXtraction (J‐LEX) registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society (JHRS), collaborated with National Cerebral and Cardiovascular Center (NCVC). This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system.

ObjectiveTo assess sex-specific differences regarding use of conventional risks and coronary artery calcification (CAC) to detect coronary artery disease (CAD) using coronary CT angiography (CCTA).MethodsThe Nationwide Gender-specific Atherosclerosis Determinants Estimation and Ischemic Cardiovascular Disease Prospective Cohort study is a prospective, multicentre, nationwide cohort study. Candidates with suspected CAD aged 50–74 years enrolled from 2008 to 2012. The outcome was obstructive CAD defined as any stenosis ≥50% by CCTA. We constructed logistic regression models for obstructive CAD adjusted for conventional risks (clinical model) and CAC score. Improvement in discrimination beyond risks was assessed by C-statistic; net reclassification index (NRI) for CAD probability of low (ResultsAmong 991 patients (456 women, 535 men; 65.2 vs 64.4 years old), women had lower CAC scores (median, 4 vs 60) and lower CAD prevalence (21.7% vs 37.0%) than men. CAC significantly improved model discrimination compared with clinical model in both sexes (0.66–0.79 in women vs 0.61–0.83 in men). The NRI for women was 0.33, which was much lower than that for men (0.71). Adding CAC to clinical model had a larger benefit in terms of moving an additional 43.3% of men to the most determinant categories (high or low risk) compared with −1.4% of women.ConclusionsThe addition of CAC to a prediction model based on conventional variables significantly improved the classification of risk in suspected patients with CAD, with sex differences influencing the predictive ability.Trial registration numberUMIN-CTR Clinical Trial: UMIN000001577.

To investigate the influence of comorbidities on undergoing a diabetic eye examination in patients with newly diagnosed type 2 diabetes mellitus (T2DM).Retrospective cohort study METHODS: This was a retrospective cohort study using data from health insurance claims made between January 2005 and March 2013 in Japan. The primary outcome was implementation of the fundus examination that includes fundus photography, ophthalmoscopy and optical coherence tomography by a doctor within one year of initial drug therapy for Type2 Diabetes Mellitus (T2DM). We used multivariable logistic regression models with adjustment for demographic parameters to investigate the influence of comorbidities (hypertension and/or hyperlipidemia) on patients with T2DM receiving fundus examinations. We conducted an additional analysis to investigate whether the site of treatment might influence the performance of fundus examinations in patients with T2DM.A total of 6,492 patients were eligible for this analysis, of which 1,044 (16.1%) had comorbidities and 2,212 (34.1%) received the fundus examination. In the multivariable analysis, there was a significant association between comorbidities and a lower proportion of examination implementation (odds ratio [OR], 0.57; 95% confidence interval [CI], 0.48-0.68; P0.001). The implementation proportion for patients treated for comorbidities and T2DM in the same facility was also low (OR, 0.52; 95% CI, 0.43-0.63; P0.001).These results suggest that the proportion of taking fundus examination is low among patients with comorbidities, especially in patients treated at the same facility for comorbidities and T2DM. This may help to increase the proportion of T2DM patients receiving fundus examinations.

Introduction Epidemiological estimate lifetime risk (LTR) is a measure that expresses the probability of disease in the remaining lifetime for individuals of a specific index age. These estimates can be useful for general audience targeted knowledge translation activities against diabetes. There are only a few reports on lifetime of impact of diabetes on coronary heart disease (CHD) events. Methods The Suita Study, a cohort study of cardiovascular diseases (CVD), was established in 1989. We included all participants who were CVD free at baseline. Age (in years) was used as the time scale. Age-specific incidence rates were calculated with person-year method within ten-year bands. We estimated the sex and index-age specific LTR of first-ever CHD with taking the competing risk of death into account. Results We followed 5559 participants without CHD history during 1989–2007 for 71,745.4 person-years. At age 40 years the competing risk of death adjusted LTR for all CHD were 16.61% for men without diabetes and 21.06% for men with diabetes. Therefore the LTD for CHD was higher by 4.45% for men with diabetes compared to men without. The competing risk adjusted LTR of CHD at 40 years of aged women was 9.18% for without diabetes and 14.21% for with diabetes. This increased LTR of CHD for diabetic patients were observed among both men and women across all index ages. Conclusion In this urban community based population we observed that diabetes has significant effect on the residual LTR of CHD among both men and women of middle age. This easy understandable knowledge can be used as important indexes to assist public health education and planning.

We previously reported the secretion of C-type natriuretic peptide (CNP) from vascular endothelial cells and proposed the existence of a vascular natriuretic peptide system composed of endothelial CNP and smooth muscle guanylyl cyclase-B (GC-B), the CNP receptor, and involved in the regulation of vascular tone, remodeling, and regeneration. In this study, we assessed the functional significance of this system in the regulation of blood pressure in vivo using vascular endothelial cell–specific CNP knockout and vascular smooth muscle cell–specific GC-B knockout mice. These mice showed neither the skeletal abnormality nor the early mortality observed in systemic CNP or GC-B knockout mice. Endothelial cell–specific CNP knockout mice exhibited significantly increased blood pressures and an enhanced acute hypertensive response to nitric oxide synthetase inhibition. Acetylcholine-induced, endothelium-dependent vasorelaxation was impaired in rings of mesenteric artery isolated from endothelial cell–specific CNP knockout mice. In addition, endothelin-1 gene expression was enhanced in pulmonary vascular endothelial cells from endothelial cell–specific CNP knockout mice, which also showed significantly higher plasma endothelin-1 concentrations and a greater reduction in blood pressure in response to an endothelin receptor antagonist than their control littermates. By contrast, vascular smooth muscle cell–specific GC-B knockout mice exhibited blood pressures similar to control mice, and acetylcholine-induced vasorelaxation was preserved in their isolated mesenteric arteries. Nonetheless, CNP-induced acute vasorelaxation was nearly completely abolished in mesenteric arteries from vascular smooth muscle cell–specific GC-B knockout mice. These results demonstrate that endothelium-derived CNP contributes to the chronic regulation of vascular tone and systemic blood pressure by maintaining endothelial function independently of vascular smooth muscle GC-B.

Background Measuring the process of care has become a widely used practice to improve a quality of care. Recently, some studies have demonstrated poor to no correlation between 30-day readmission rates and quality of care for heart failure (HF) among hospitalized HF patients. However the investigation about relationships of care quality for HF and 1 year outcome is limited. Purpose To investigate the relationship between quality of care in each hospitals and readmission among HF patients in Japan. Methods From Japanese Registry of All cardiac and vascular diseases (JROAD-DPC) database in 2014, 84,325 HF patients hospitalized to 741 certificated hospitals by Japanese Circulation Society were analyzed. A primary endpoint was readmission for HF in one year. Five performance measures were defined as prescription rate of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB), prescription rate of beta blocker and prescription rate of spironolactone, measurement rate of echocardiography and measurement rate of B-type natriuretic peptide (BNP) during hospitalization. For each of the five measures, a composite score was created by giving points ranging from 1 to 4 from the lower quartile of rates, with the score ranging from 5 to 20 points. Hazard ratios (HR) indicating the effects of the performance measures were estimated using Cox proportional hazard models. Covariates included age, gender, Charson score, and NYHA class. Results In Japanese HF patients (age; 78.1 years old, man 52%), the HF readmission rate in one year was 14,520 (17.2%). The readmission rate decreased with higher quartiles of prescription rate in each medications and performance rates. The highest quartile of each measurements was significantly lower risk for readmission compared to the lowest quartile (ACE/ARB, adjusted HR 0.87 [95% CI, 0.83–0.91], p Figure 1 Conclusion The hospital performance measures were associated with a significant risk reduction of readmission in Japanese patients with HF.

Background We aimed to quantify contributions of changes in risks and uptake of evidence-based treatment to coronary heart disease (CHD) mortality trends in Japan between 1980 and 2012. Methods We conducted a modelling study for the general population of Japan aged 35 to 84 years using the validated IMPACT model incorporating data sources like Vital Statistics. The main outcome was difference in the number of observed and expected CHD deaths in 2012. Results From 1980 to 2012, age-adjusted CHD mortality rates in Japan fell by 61%, resulting in 75,700 fewer CHD deaths in 2012 than if the age and sex-specific mortality rates had remained unchanged. Approximately 56% (95% uncertainty interval [UI]: 54–59%) of the CHD mortality decrease, corresponding to 42,300 (40,900–44,700) fewer CHD deaths, was attributable to medical and surgical treatments. Approximately 35% (28–41%) of the mortality fall corresponding to 26,300 (21,200–31,000) fewer CHD deaths, was attributable to risk factor changes in the population, 24% (20–29%) corresponding to 18,400 (15,100–21,900) fewer and 11% (8–14%) corresponding to 8400 (60,500–10,600) fewer from decreased systolic blood pressure (8.87 mm Hg) and smoking prevalence (14.0%). However, increased levels of cholesterol (0.28 mmol/L), body mass index (BMI) (0.68 kg/m2), and diabetes prevalence (1.6%) attenuated the decrease in mortality by 2% (1–3%), 3% (2–3%), and 4% (1–6%), respectively. Conclusions Japan should continue their control policies for blood pressure and tobacco, and build a strategy to control BMI, diabetes, and cholesterol levels to prevent further CHD deaths.

Background Few previous studies used information on changes in fasting plasma glucose ( FPG ) assessed at multiple points in time in relationship to cardiovascular disease ( CVD ) incidence. The present study aimed to identify subgroups of FPG trajectories with assessing CVD incidence. Methods and Results The present study was based on the Suita study, a population‐based cohort study in Japan. The primary outcome was incidence of the first CVD events consisting of stroke and coronary heart diseases between 1989 and 2013. The main exposure was FPG assessed every 2 years. We used joint latent class mixed models to derive FPG trajectories over time while evaluating cumulative incidence of CVD , and categorized participants into several subgroups based on those trajectories and cumulative incidence. We observed 356 and 243 CVD events during the median follow‐up of 17.2 and 20.2 years among 3120 men and 3482 women, respectively. The joint latent mixed models found 3 subgroups in men and 2 subgroups in women. Of the 3 subgroups in men, 1 subgroup had FPG levels that increased sharply (96.5–205.0 mg/dL from aged 40 to 80 years) and higher CVD cumulative incidence. Of the 2 subgroups in women, 1 subgroup had FPG levels that increased sharply (97.7–190.5 mg/dL from aged 40 to 80 years) and tended to have slightly higher CVD incidence compared with the other subgroup. Conclusion It can be important to manage CVD risk factors especially for people whose FPG trajectories sharply increased to prevent CVD .

The lifetime risk estimate conveys the probability of disease in the remaining lifetime for an index age. These estimates may be useful for general audience-targeted knowledge translation activities against hypertension. There are only a few reports on the impact of hypertension on the lifetime risk of cardiovascular events. The Suita Study, a cohort study of urban residents, was established in 1989. We included all participants who were coronary heart disease (CHD) free at baseline. Age (in years) was used as the timescale. Age-specific incidence rates were calculated with the person-year method within 5-year bands. We estimated the sex- and index-age-specific lifetime risk of first-ever CHD, taking the competing risk of death into account. We followed 5834 participants from 1989 to 2007 for a total of 75 387.5 person-years. At age 45 years, the competing risk of death-adjusted lifetime risk for all CHD for men was 14.12% for normotensive men and 26.95% for hypertensive men. The competing risk of death-adjusted lifetime risk for all CHD at 45 years of age for women was 6.21% for normotensive women and 14.85% for hypertensive women. This increased lifetime risk of CHD for hypertensive patients was observed among both men and women across all index ages. Although the overall lifetime risk of CHD was lower than in the Western population, hypertension showed a significant effect on the residual lifetime risk of CHD among Japanese middle-aged men and women. This easy-to-understand knowledge may be used as an important index to assist public health education and planning.

The lifetime risk (LTR) articulates the probability of disease in the residual lifetime for an index age. These estimates can be useful for general audience-targeted knowledge translation activities against hypertension. There are only a few reports on lifetime of impact of hypertension on stroke events in Asians in whom stroke incidence is higher than Westerners.The Suita Study, a cohort study of cardiovascular diseases in Japan, was established in 1989. We included all participants who were stroke free at baseline. Age (in years) was used as the time scale. Age-specific incidence rates were calculated with person-year method within 10-year bands. We estimated the sex and index-age specific LTR of first-ever stroke with taking the competing risk of death into account.We followed 5783 men and women during 1989-2007 for 74 933 person-years. During the follow-up period, 276 (149 men and 127 women) participants had incident stroke. Of them, majority were cerebral infarction; 166 (102 men and 64 women). The LTR of stroke, accounted for competing risk of death, at 45 years of age for men without hypertension was 17.21% and it was 32.79% for hypertensive men. Among the hypertensive patients, participants with stage 2 or greater hypertension had higher LTR of stroke than the participants with stage 1 hypertension. This increased LTR of stroke for hypertensive patients were also observed among women and across all index ages for stroke.In this urban community-based population, we observed that hypertension has significant effect on the residual LTR of stroke among both men and women of middle age, specifically for ischemic stroke.

Background Catheter ablation has become a popular interventional treatment for cardiac tachyarrhythmias and the number has been on the rise year by year. However, little is known about its efficacy and safety in the real‐world settings. Method Japanese Catheter Ablation (J‐AB) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society (JHRS), collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system. Detailed data collection including antiarrhythmic medication is also performed every September. The acute success rate at discharge and the complications associated with ablation procedure will be collected in all cases. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the Event Assessment Committee. This registry started in August 2017 and the number of participating medical instructions will be more than 250 hospitals and the target procedure number will be 70 000 per year. We will also compare the results with other registries in foreign countries. Result The results of this study are currently under investigation. Conclusion The J‐AB registry will provide a real‐world data regarding the acute success and complications in Japan, focusing on various types of catheter ablation for cardiac arrhythmias.

Introduction: Many studies investigated associations of stroke risk factors assessed at one point in time with stroke onset. However, few studies investigated growth curves (trajectories) of the stroke risk factors assessed at multiple points in time before stroke onset. Hypothesis: We assessed the hypothesis that people with stroke, compared with their controls, would have higher values of the stroke risk factors at multiple points in time and higher change rates by year (slopes) of those factors before stroke onset. Methods: The present study used a nested case-control design based on the Suita study that is a cohort study launched in 1989 with 15,746 community-dwelling participants in an urban city, Suita, Japan. During a 24-year follow-up, 201 cases (43.8% in women) were identified. Corresponding to the cases, 2010 controls (51.5% in women) matched by age (± 4 years) were identified by incidence density sampling. As the stroke risk factors, we included systolic blood pressure (SBP), diastolic BP (DBP), blood glucose level, body mass index, waist circumference, non-HDL cholesterol, and triglyceride assessed every two years on health check-ups. Linear mixed models were performed to investigate adjusted mean differences in the stroke risk factors between the stroke cases and the controls at 20, 15, 10, 5 years and the last assessment before stroke onset. Mean differences in slopes of the stroke risk factors before stroke onset were also investigated. Results: The linear mixed models showed that SBP and DBP were significantly higher in the cases than the controls at any points in time before stroke onset (the adjusted mean differences [95% CI] at the last assessment before stroke onset: 4.52 [1.4, 7.64] mmHg for SBP and 2.93 [1.23, 4.63] mmHg for DBP). However, slopes of SBP and DBP were not significantly different between the cases and the controls. We observed no significant difference between the cases and the controls in blood glucose level at 20 years before stroke onset (the adjusted mean difference: 2.24 [-0.26, 4.74] mg/dl). However, compared with the controls, the cases significantly had a steeper slop of blood glucose increase (the adjusted mean difference in the slope per year: 0.21 [0.02, 0.40] mg/dl; and the adjusted mean differences at 15, 10, and 5 years and the last assessment before stroke onset: 3.29 [1.31, 5.26], 4.34 [2.51, 6.16], 5.39 [3.25, 7.52], 6.44 [3.69, 9.19] mg/dl, respectively). We observed no significant differences of means and slopes in BMI, waist circumference, non-HDL cholesterol, and triglyceride between the cases and the controls. Conclusions: In conclusions, multiple assessments of the stroke risk factors on health check-ups can be useful to early identify people who will be likely to develop stroke by observing SBP and DBP at any points in time, and the trajectory of blood glucose level.

Background: Cardiovascular diseases, including acute myocardial infarction (AMI), are leading causes of death among the Japanese, who have the longest life expectancy in the world. Over the past 50 years in Japan, the percentage of elderly individuals has increased 4-fold, from 5.7% in 1960 to 23.1% in 2010. To explore medical practices and emergency care for AMI in this aging society, the Japan Acute Myocardial Infarction Registry (JAMIR) was established as a nationwide real-world database. Methods: JAMIR conducted retrospective analysis of 20,462 AMI patients (mean age, 68.8 ± 13.3 years; 15,281 men [74.7%]) hospitalized between January 2011 and December 2013. Results: The rates of ambulance use and emergency PCI were 78.9% and 87.9%, respectively. The median door-to-balloon time was 80 min (interquartile range, 53–143 min). Overall in-hospital mortality was 8.3%, including 6.6% due to cardiac death. JAMIR included 4837 patients aged ≥80 years (23.6%). In this age group, patients who underwent PCI (79.9%) had significantly lower in-hospital mortality than those who did not (11.1% vs. 36.9%, P

Background Lifestyle interventions can substantially improve obesity and cardiometabolic risks. However, evidence of long-term benefits of national intervention is sparse. We aimed to evaluate the long-term effectiveness of a nationwide program for abdominal obesity. Methods A retrospective cohort study was performed using a longitudinal nationwide individual data in subjects aged 40–74 years who underwent checkups in fiscal year (FY) 2008. Lifestyle interventions were provided via interview in subjects with abdominal obesity and at least one cardiometabolic risk factor. Subjects who attended the lifestyle intervention (participants) were compared to those who did not attend (non-participants). Outcomes were waist circumferences (WC) and body mass index (BMI) reduction, reversal of metabolic syndrome (MetS), and changes in cardiometabolic risks. We used a three-step process with robust analytic approaches to account for selection bias that included traditional multivariate analysis, propensity-score matching and instrumental variable (IV) analyses. Results Of 19,969,722 subjects, 4,370,042 were eligible for analyses; 111,779 participants and 907,909 non-participants. A higher percentage of participants had ≥5% reductions in obesity profiles at year 3, compared to non-participants (WC, 21.4% vs 16.1%; BMI, 17.6% vs 13.6%; p

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.

Backgrounds The association between weight gain and the incidence of type 2 diabetes is well known. The aim of our study was to investigate the relationship between change in waist circumference (WC) and type 2 diabetes incidence. Methods The participants in the Suita Study, a population-based cohort study in an urban area of Japan, underwent a baseline survey between 1989 and 1994 (Exam 1) and were examined at follow-up every 2 years. We performed a 9.3-year cohort study of 946 men and 1327 women with no history of diabetes who underwent Exam 1 and Exam 2 (between 1997 and 1999). Participants were stratified by sex and median WC at Exam 1, and, in each stratum, participants were further classified into three categories by tertile of WC change per year between Exam 1 and Exam 2. Hazard ratios (HRs) and 95% confidence intervals (CIs) for type 2 diabetes incidence were calculated by Cox proportional hazard models. The endpoints were first diagnosis of type 2 diabetes or March 2011. Results During follow-up, 287 participants developed type 2 diabetes. In both sexes with median WC or higher, participants in the highest tertile of WC change had a significantly higher risk of developing type 2 diabetes. Multivariable adjusted HRs were 1.84 (95% CI, 1.10-3.08) in men and 2.30 (95% CI, 1.31-4.04) in women. No significant association was observed among participants with WC below median. Conclusions Preventing WC gain is important in preventing type 2 diabetes in the Japanese population, especially among individuals with a relatively high WC.

BACKGROUND The European Society of Cardiology recommends a risk-based antithrombotic strategy for patients with atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) based on CHA2DS2-VASc and HAS-BLED scores. However, because it is unclear if that strategy can be generalized to Asians, we aimed to describe antithrombotic therapies among Japanese patients.Methods and Results:Using a nationwide claims database in Japan, this retrospective cohort study identified AF patients who underwent PCI from April 1, 2014 to March 31, 2015. The primary outcome was utilization of anticoagulant and antiplatelet agents before PCI, at discharge, and 6, 9, and 12 months after PCI. The secondary outcome was incidence of stroke after PCI. We identified 10,862 patients and 87.5% of them had high CHA2DS2-VASc and HAS-BLED scores. There were no significant differences in antithrombotic therapies across the risk strata. More than 30% of patients at high risk of thrombosis did not receive oral anticoagulant prescriptions at discharge. The hazard ratio of incidence of stroke in patients with prior stroke compared with patients without prior stroke was 9.09 (95% confidence interval 7.86-10.50, P