Impact of Sex Differences on Clinical Outcomes in Patients Following Primary Revascularization for Acute Myocardial Infarction　- Insights From the Japanese Nationwide Registry.

BACKGROUND: Women with acute myocardial infarction (AMI) often present a worse risk profile and experience a higher rate of in-hospital mortality than men. However, sex differences in post-discharge prognoses remain inadequately investigated. We examined the impact of sex on 1-year post-discharge outcomes in patients with AMI undergoing percutaneous coronary intervention. METHODS AND RESULTS: We extracted patient-level data for the period January 2017-December 2018 from the J-PCI OUTCOME Registry, endorsed by the Japanese Association of Cardiovascular Intervention and Therapeutics. One-year all-cause and cardiovascular mortality and major adverse cardiovascular events were compared between men and women. In all, 29,856 AMI patients were studied, with 6,996 (23.4%) being women. Women were significantly older and had a higher prevalence of comorbidities than men. Crude all-cause mortality was significantly higher among women than men (7.5% vs. 5.4% [P<0.001] for ST-elevation myocardial infarction [STEMI]; 7.0% vs. 5.2% [P=0.006] for non-STEMI). These sex-related differences in post-discharge outcomes were attenuated after stratification by age. Multivariate analysis demonstrated an increase in all-cause mortality in both sexes with increasing age and advanced-stage chronic kidney disease (CKD). CONCLUSIONS: Within this nationwide cohort, women had worse clinical outcomes following AMI than men. However, these sex-related differences in outcomes diminished after adjusting for age. In addition, CKD was significantly associated with all-cause mortality in both sexes.

Study Profile of the Tsuruoka Metabolomics Cohort Study (TMCS).

The Tsuruoka Metabolomics Cohort Study (TMCS) is an ongoing population-based cohort study being conducted in the rural area of Yamagata Prefecture, Japan. This study aimed to enhance the precision prevention of multi-factorial, complex diseases, including non-communicable and aging-associated diseases, by improving risk stratification and prediction measures. At baseline, 11,002 participants aged 35-74 years were recruited in Tsuruoka City, Yamagata Prefecture, Japan, between 2012 and 2015, with an ongoing follow-up survey. Participants underwent various measurements, examinations, tests, and questionnaires on their health, lifestyle, and social factors. This study uses an integrative approach with deep molecular profiling to identify potential biomarkers linked to phenotypes that underpin disease pathophysiology and provide better mechanistic insights into social health determinants. The TMCS incorporates multi-omics data, including genetic and metabolomic analyses of 10,933 participants, and comprehensive data collection ranging from physical, psychological, behavioral, and social to biological data. The metabolome is used as a phenotypic probe because it is sensitive to changes in physiological and external conditions. The TMCS focuses on collecting outcomes for cardiovascular disease, cancer incidence and mortality, disability and functional decline due to aging and disease sequelae, and the variation in health status within the body represented by omics analysis that lies between exposure and disease. It contains several sub-studies on aging, heated tobacco products, and women's health. This study is notable for its robust design, high participation rate (89%), and long-term repeated surveys. Moreover, it contributes to precision prevention in Japan and East Asia as a well-established multi-omics platform.

One-year outcomes of patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy catheter: Insights from the J-PCI OUTCOME registry.

OBJECTIVES: We sought to investigate the 1-year outcomes, including all-cause and cardiovascular mortality, major adverse cardiovascular events (MACEs), and major bleeding, of patients undergoing percutaneous coronary intervention (PCI) with or without the revived directional coronary atherectomy (DCA) catheter in a Japanese nationwide registry. BACKGROUND: Clinical data regarding the midterm outcomes of patients undergoing PCI with DCA are scarce in contemporary real-world practice. METHODS: We analyzed the data of 74,764 patients who underwent PCI at 179 hospitals from January 2017 to December 2018. The baseline characteristics and 1-year outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without DCA were assessed. RESULTS: Overall, 431 patients (0.6%) underwent PCI with DCA. Patients in the DCA group were younger and predominantly male, with fewer comorbidities than patients in the non-DCA group. Stentless PCI with DCA following additional drug-coated balloon (DCB) angioplasty was the dominant strategy in the DCA group (43.6%). One-year outcomes, including all-cause mortality (1.2% in the DCA group vs. 2.5% in the non-DCA group, respectively, p = 0.075), cardiovascular death (0.9% vs. 1.0%, p = 0.69), MACEs (1.9% vs. 1.8%, p = 0.96), and nonfatal major bleeding requiring readmission (1.2% vs. 1.4%, p = 0.62), were comparable between the two groups. In the DCA group, 1-year outcomes were comparable, regardless of whether the stent or DCB was used. CONCLUSIONS: One-year clinical outcomes after PCI with DCA in patients with stable coronary artery disease or unstable angina are acceptable, regardless of stent use.

One-year outcome after percutaneous coronary intervention in nonagenarians: Insights from the J-PCI OUTCOME registry.

BACKGROUND: Nonagenarian patients who undergo percutaneous coronary intervention (PCI) are increasing, and a few previous studies have reported their long-term outcomes. However, differences in their long-term outcomes between generations remain unclear. This study aimed to investigate 1-year all-cause and cardiovascular (CV) mortality, and major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, and stroke) of nonagenarian patients who underwent PCI compared with the other elder patients, using a nationwide registration system. METHODS: The patient-level data registered between January 2017 and December 2017 was extracted from the J-PCI OUTCOME Registry endorsed by the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT). The one-year all-cause and cardiovascular (CV) mortality, MACE, and major bleeding events were identified. RESULTS: Out of 40,722 patients over 60 years of age, 880 (2.1%) were nonagenarians. For nonagenarians, the 1-year mortality rate was substantial (13.5%). The MACE and CV death rates were also high (8.1%, and 6.8%, respectively) for nonagenarians, and these event rates were approximately 1.5 times higher in nonagenarians than octogenarians. Multivariate regression analysis showed that presentation with cardiogenic shock [hazard ratio (HR) 2.32; 95 confidence intervals (CI): 1.22-4.41], or cardiac arrest (HR 2.91; 90% CI: 1.28-6.62), and use of oral anticoagulants (HR 2.10; 90% CI: 1.07-4.12) were the predictors of 1-year MACE. CONCLUSIONS: Even in the contemporary era, nonagenarians who have undergone PCI still face a considerably increased risk for adverse cardiovascular events that reduces long-term survival. In addition to having poorer lesion characteristics, adverse events, including death, MACEs, and major bleeding, occurred 1.5 times more frequently in nonagenarians than in octogenarians.

Overview of in-hospital outcomes in patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy.

OBJECTIVES: We sought to provide clinical insights on the usage rate, indications, and in-hospital outcomes of the revived directional coronary atherectomy (DCA) catheter (Atherocut™) in a Japanese nationwide percutaneous coronary intervention (PCI) registry. BACKGROUND: Debulking devices such as the revived DCA catheter have become increasingly important in the era of complex PCI. However, little is known about PCI outcomes using a novel DCA catheter in contemporary real-world practice. METHODS: We analyzed 188,324 patients who underwent PCI in 1112 hospitals from January to December 2018. Baseline characteristics and in-hospital outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without the DCA were analyzed. RESULTS: Overall, 1696 patients (0.9%) underwent PCI with the DCA during the study period, predominantly for left main trunk or proximal left anterior descending artery lesions under a transfemoral approach. Patients in the DCA group were younger and had fewer comorbidities such as hypertension, diabetes mellitus, and chronic kidney disease than patients in the non-DCA group. Stentless PCI using the DCA with drug-coated balloon angioplasty was a preferred treatment strategy in the DCA group (50.0%). Predefined in-hospital adverse outcomes, including mortality (0.2% vs. 0.3%, p = 0.446) and periprocedural complications (1.8% vs. 1.7%, p = 0.697), were comparable between the two groups, whereas the fluoroscopy time was longer and the total contrast volume was higher in the DCA group. CONCLUSIONS: In Japan, PCI using the revived DCA catheter is safely performed with low complication rates in patients with stable coronary artery disease or unstable angina.

Bleeding avoidance strategies and percutaneous coronary intervention outcomes: A 10-year observation from a Japanese Multicenter Registry.

BACKGROUND: Bleeding avoidance strategies (BASs) are increasingly adopted for patients undergoing percutaneous coronary intervention (PCI) due to bleeding complications. However, their association with bleeding events outside of Western countries remains unclear. In collaboration with the National Cardiovascular Data Registry (NCDR) CathPCI registry, we aimed to assess the time trend and impact of BAS utilization among Japanese patients. METHODS: Our study included 19,656 consecutive PCI patients registered over 10 years. These patients were divided into 4-time frame groups (T1: 2008-2011, T2: 2012-2013, T3: 2014-2015, and T4: 2016-2018). BAS was defined as the use of transradial approach or vascular closure device (VCD) use after transfemoral approach (TFA). Model performance of the NCDR CathPCI bleeding model was evaluated. The degree of bleeding reduction associated with BAS adoption was estimated via multilevel mixed-effects multivariable logistic regression analysis. RESULTS: The NCDR CathPCI bleeding risk score demonstrated good discrimination in the Japanese population (C-statistics 0.79-0.81). The BAS adoption rate increased from 43% (T1) to 91% (T4), whereas the crude CathPCI-defined bleeding rate decreased from 10% (T1) to 7% (T4). Adjusted odds ratios for bleeding events were 0.25 (95% confidence interval, 0.14-0.45, P< .001) for those undergoing TFA with VCD in T4 and 0.26 (95% confidence interval 0.20-0.35, P< .001) for transradial approach in T4 compared to patients that received TFA without VCD in T1. CONCLUSIONS: BAS use over the studied time frames was associated with lower risk of bleeding complications among Japanese. Nonetheless, observed bleeding rates remained higher compared to the US population.

Contemporary Management of Stable Coronary Artery Disease　- Implications of the ISCHEMIA Trial.

Coronary artery disease (CAD) remains a leading cause of mortality and morbidity in developed countries. Although urgent revascularization is the cornerstone of management of acute coronary syndrome (ACS), for patients with stable CAD recent large-scale clinical trials indicate that a mechanical 'fix' of a narrowed artery is not obviously beneficial; ACS and stable CAD are increasingly recognized as different clinical entities. We review the perspectives on (1) modifying the diagnostic pathway of stable CAD with the incorporation of modern estimates of pretest probability, (2) non-imaging evaluations based on their availability, (3) the optimal timing of invasive coronary angiography and revascularization, and (4) the implementation of medical therapy during the work-up.

One-Year Outcome After Percutaneous Coronary Intervention for Acute Coronary Syndrome　- An Analysis of 20,042 Patients From a Japanese Nationwide Registry.

BACKGROUND: Acute coronary syndrome (ACS) hospital survivors experience a wide array of late adverse cardiac events, despite considerable advances in the quality of care. We investigated 30-day and 1-year outcomes of ACS hospital survivors using a Japanese nationwide cohort.Methods and Results:We studied 20,042 ACS patients who underwent percutaneous coronary intervention (PCI) in 2017: 10,242 (51%) with ST-elevation myocardial infarction (STEMI), 3,027 (15%) with non-ST-elevation myocardial infarction (NSTEMI), and 6,773 (34%) with unstable angina (UA). The mean (±SD) age was 69.6±12.4 years, 77% of the patients were men, and 20% had a previous history of PCI. The overall 30-day all-cause, cardiac, and non-cardiac mortality rates were 3.0%, 2.4%, and 0.6%, respectively. The overall 1-year incidence of all-cause, cardiac, and non-cardiac death was 7.1%, 4.2%, and 2.8%, respectively. Compared with UA patients, STEMI patients had a higher risk of all fatal events, non-fatal ischemic stroke, and acute heart failure, and NSTEMI patients had a higher risk of heart failure. CONCLUSIONS: The results from our ACS hospital survivor PCI database suggest the need to improve care for the acute myocardial infarction population to lessen the burden of 30-day mortality due to ACS, heart failure, and sudden cardiac death, as well as 1-year ischemic stroke and heart failure events.

A Novel Risk Stratification System for Ischemic Stroke in Japanese Patients With Non-Valvular Atrial Fibrillation.

BACKGROUND: Recently, identification of independent risk factors for ischemic stroke in Japanese non-valvular atrial fibrillation (NVAF) patients was made by analyzing the 5 major Japanese registries: J-RHYTHM Registry, Fushimi AF Registry, Shinken Database, Keio interhospital Cardiovascular Studies, and the Hokuriku-Plus AF Registry.Methods and Results:The predictive value of the risk scheme in Japanese NVAF patients was assessed. Of 16,918 patients, 12,289 NVAF patients were analyzed (mean follow up, 649±181 days). Hazard ratios (HRs) of each significant, independent risk factor were determined by using adjusted Cox-hazard proportional analysis. Scoring system for ischemic stroke was created by transforming HR logarithmically and was estimated by c-statistic. During the 21,820 person-years follow up, 241 ischemic stroke events occurred. Significant risk factors were: being elderly (aged 75-84 years [E], HR=1.74), extreme elderly (≥85 years [EE], HR=2.41), having hypertension (H, HR=1.60), previous stroke (S, HR=2.75), type of AF (persistent/permanent) (T, HR=1.59), and low body mass index <18.5 kg/m2(L, HR=1.55) after adjusting for oral anticoagulant treatment. The score was assigned as follows: 1 point to H, E, L, and T, and 2 points to EE and S (HELT-E2S2score). The C-statistic, using this score, was 0.681 (95% confidence interval [CI]=0.647-0.714), which was significantly higher than those using CHADS2(0.647; 95% CI=0.614-0.681, P=0.027 for comparison) and CHA2DS2-VASc scores (0.641; 95% CI=0.608-0.673, P=0.008). CONCLUSIONS: The HELT-E2S2score may be useful for identifying Japanese NVAF patients at risk of ischemic stroke.

Association of decreasing hemoglobin levels with the incidence of acute kidney injury after percutaneous coronary intervention: a prospective multi-center study.

Acute kidney injury (AKI) is common in patients undergoing percutaneous coronary intervention (PCI). One risk factor for AKI is periprocedural hemoglobin drop level (> 3 g/dL); however, whether the relationship between hemoglobin drop and AKI is linear or nonlinear remains unknown. We aimed to investigate the relationship between periprocedural hemoglobin drop and AKI after PCI. We evaluated 14,273 consecutive patients undergoing PCI between September 2008 and March 2019. AKI was defined as an absolute or a relative increase in serum creatinine level of 0.3 mg/dL or 50%, respectively. Restricted cubic spline was constructed to assess the association between hemoglobin drop and AKI by logistic regression and machine learning (ML) models, which were used to predict the risk of AKI. The patients' mean age was 68.4 ± 11.6 years; the AKI incidence was 10.5% (N = 1499). An absolute > 3 g/dL or 20% relative decrease in hemoglobin level was an independent predictor of AKI incidence (odds ratio, OR [95% confidence interval, CI]: 2.24 [1.92-2.61], P < 0.001; 2.35 [2.04-2.71], P < 0.001, respectively). An adjusted restricted cubic spline demonstrated that absolute/relative decrease in hemoglobin was linearly associated with AKI. Logistic and ML models with absolute/relative hemoglobin changes were comparable while estimating the risk of AKI (absolute area under the curve [AUC] (logistic):0.826, AUC (ML): 0.820; relative AUC (logistic): 0.818, AUC (ML): 0.816). An absolute/relative decrease in periprocedural hemoglobin after PCI was linearly associated with AKI. Detection of a relative/absolute decrease in hemoglobin may help clinicians identify individuals as high risk for AKI after PCI.

Electrocardiographic ST-T Abnormities Are Associated With Stroke Risk in the REGARDS Study.

Background and Purpose- In previous studies, isolated nonspecific ST-segment and T-wave abnormalities (NSSTTAs), a common finding on ECGs, were associated with greater risk for incident coronary artery disease. Their association with incident stroke remains unclear. Methods- The REGARDS (Reasons for Geographic and Racial Differences in Stroke) study is a population-based, longitudinal study of 30 239 white and black adults enrolled from 2003 to 2007 in the United States. NSSTTAs were defined from baseline ECG using the standards of Minnesota ECG Classification (Minnesota codes 4-3, 4-4, 5-3, or 5-4). Participants with prior stroke, coronary heart disease, and major and minor ECG abnormalities other than NSSTTAs were excluded from analysis. Multivariable Cox proportional hazards regression was used to examine calculate hazard ratios of incident ischemic stroke by presence of baseline NSSTTAs. Results- Among 14 077 participants, 3111 (22.1%) had NSSTTAs at baseline. With a median of 9.6 years follow-up, 106 (3.4%) with NSSTTAs had ischemic stroke compared with 258 (2.4%) without NSSTTAs. The age-adjusted incidence rates (per 1000 person-years) of stroke were 2.93 in those with NSSTTAs and 2.19 in those without them. Adjusting for baseline age, sex, race, geographic location, and education level, isolated NSSTTAs were associated with a 32% higher risk of ischemic stroke (hazard ratio, 1.32 [95% CI, 1.05-1.67]). With additional adjustment for stroke risk factors, the risk of stroke was increased 27% (hazard ratio, 1.27 [95% CI, 1.00-1.62]) and did not differ by age, race, or sex. Conclusions- Presence of NSSTTAs in persons with an otherwise normal ECG was associated with a 27% increased risk of future ischemic stroke.

Prediction of sudden cardiac death in Japanese heart failure patients: international validation of the Seattle Proportional Risk Model.

AIMS: Heart failure (HF) is associated with an increased risk of sudden cardiac death (SCD). This study sought to demonstrate the incidence of SCD within a multicentre Japanese registry of HF patients hospitalized for acute decompensation, and externally validate the Seattle Proportional Risk Model (SPRM). METHODS AND RESULTS: We consecutively registered 2240 acute HF patients from academic institutions in Tokyo, Japan. The discrimination and calibration of the SPRM were assessed by the c-statistic, Hosmer-Lemeshow statistic, and visual plotting among non-survivors. Patient-level SPRM predictions and implantable cardioverter-defibrillator (ICD) benefit [ICD estimated hazard ratio (HR), derived from the Cox proportional hazards model in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)] was calculated. During the 2-year follow-up, 356 deaths (15.9%) occurred, which included 76 adjudicated SCDs (3.4%) and 280 non-SCDs (12.5%). The SPRM showed acceptable discrimination [c-index = 0.63; 95% confidence interval (CI) 0.56-0.70], similar to that of original SPRM-derivation cohort. The calibration plot showed reasonable conformance. Among HF patients with reduced ejection fraction (EF; < 40%), SPRM showed improved discrimination compared with the ICD eligibility criteria (e.g. New York Heart Association functional Class II-III with EF ≤ 35%): c-index = 0.53 (95% CI 0.42-0.63) vs. 0.65 (95% CI 0.55-0.75) for SPRM. Finally, in the subgroup of 246 patients with both EF ≤ 35% and SPRM-predicted risk of ≥ 42.0% (SCD-HeFT defined ICD benefit threshold), mean ICD estimated HR was 0.70 (30% reduction of all-cause mortality by ICD). CONCLUSION: The cumulative incidence of SCD was 3.4% in Japanese HF registry. The SPRM performed reasonably well in Japanese patients and may aid in improving SCD prediction.

Guideline-Based Medications for Older Adults Discharged after Percutaneous Coronary Intervention in a Suburban City of Japan: A Cohort Study Using Claims Data.

Secondary prevention with medications is essential for the better prognosis of patients who have experienced cardiovascular events. We aimed to evaluate the use of guideline-based medications for secondary prevention in older adults in the community settings after discharge following percutaneous coronary intervention (PCI). A retrospective cohort study was conducted using anonymized claims data of older beneficiaries in a suburban city of Japan between April 2012 and March 2015. The prescriptions of antiplatelets, statins, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin II receptor blockers (ARB), and ß-blockers were evaluated for 3 months before and after the month in which the participants underwent PCI. Multivariable logistic regression analysis was conducted to evaluate the associations of age ("pre-old" group [63-72 years] vs. "old" group [≥ 73 years]) and sex with the prescriptions, adjusting for whether a participant was followed-up by the PCI-performing hospital. Of 815 participants, 59.6% constituted the old group and 70.9% were men. The prescription rates for antiplatelets, statins, ACEi/ARB, and ß-blockers after discharge were 94.6%, 65.0%, 59.3%, and 32.9%, respectively. The adjusted analysis indicated that statins were less likely to be prescribed for the old group (adjusted odds ratio [aOR], 0.70; 95% confidence interval [CI], 0.51-0.95; p = 0.023) and for men (aOR, 0.64; 95% CI, 0.45-0.89; p = 0.008). ß-blockers were more likely to be prescribed for men (aOR, 1.66; 95% CI, 1.17-2.33; p = 0.004). Our results suggest the potential for improvements in secondary prevention by increasing the prescription rates of guideline-based medications in this population.

Validation and Recalibration of Seattle Heart Failure Model in Japanese Acute Heart Failure Patients.

BACKGROUND: Precise risk stratification in heart failure (HF) patients enables clinicians to tailor the intensity of their management. The Seattle Heart Failure Model (SHFM), which uses conventional clinical variables for its prediction, is widely used. We aimed to externally validate SHFM in Japanese HF patients with a recent episode of acute decompensation requiring hospital admission. METHODS AND RESULTS: SHFM was applied to 2470 HF patients registered in the West Tokyo Heart Failure and National Cerebral And Cardiovascular Center Acute Decompensated Heart Failure databases from 2006 to 2016. Discrimination and calibration were assessed with the use of the c-statistic and calibration plots, respectively, in HF patients with reduced ejection fraction (HFrEF; <40%) and preserved ejection fraction (HFpEF; ≥40%). In a perfectly calibrated model, the slope and intercept would be 1.0 and 0.0, respectively. The method of intercept recalibration was used to update the model. The registered patients (mean age 74 ± 13 y) were predominantly men (62%). Overall, 572 patients (23.2%) died during a mean follow-up of 2.1 years. Among HFrEF patients, SHFM showed good discrimination (c-statistic = 0.75) but miscalibration, tending to overestimate 1-year survival (slope = 0.78; intercept = -0.22). Among HFpEF patients, SHFM showed modest discrimination (c-statistic = 0.69) and calibration, tending to underestimate 1-year survival (slope = 1.18; intercept = 0.16). Intercept recalibration (replacing the baseline survival function) successfully updated the model for HFrEF (slope = 1.03; intercept = -0.04) but not for HFpEF patients. CONCLUSIONS: In Japanese acute HF patients, SHFM showed adequate performance after recalibration among HFrEF patients. Using prediction models to tailor the care for HF patients may improve the allocation of medical resources.

An overview of percutaneous coronary intervention in dialysis patients: Insights from a Japanese nationwide registry.

OBJECTIVES: This study sought to provide an overview of percutaneous coronary intervention (PCI) in dialysis patients from a Japanese nationwide registry. BACKGROUND: Little is known about dialysis patients undergoing PCI because few are enrolled in clinical trials. METHODS: We analyzed 624,900 PCI cases including 41,384 dialysis patients (6.6%) from 1,017 Japanese hospitals between 2014 and 2016. We investigated differences in characteristics and in-hospital outcomes between dialysis and nondialysis patients, and assessed factors associated with an increased risk of adverse outcomes. RESULTS: Dialysis patients had more comorbidities than nondialysis patients and higher rates of complications including in-hospital mortality (3.3% vs. 1.5%, respectively, in the acute coronary syndrome [ACS] cohort, 0.2% vs. 0.1% in the non-ACS cohort) and bleeding complications requiring blood transfusion (1.1% vs. 0.4% in ACS, 0.5% vs. 0.2% in non-ACS). Dialysis was significantly associated with an increased risk of in-hospital mortality (odds ratio [OR]: 1.42, 95% confidence interval [CI]: 1.24-1.62 in ACS, OR: 2.25, 95% CI: 1.66-3.05 in non-ACS) and bleeding (OR: 1.60, 95% CI: 1.30-1.96 in ACS, OR: 1.55, 95% CI: 1.27-1.88 in non-ACS). For dialysis patients, age, acute heart failure, and cardiogenic shock were associated with an increased risk of in-hospital mortality in the ACS cohort, whereas age, female gender, and history of heart failure were associated with higher in-hospital mortality in the non-ACS cohort. CONCLUSIONS: PCI was widely performed for dialysis patients with either ACS or non-ACS in Japan. Dialysis patients had a greater risk of adverse outcomes than nondialysis patients after PCI.

Discrepancy between patient-reported quality of life and the prognostic assessment of Japanese patients hospitalized with acute heart failure.

Patient-reported quality of life (PRQL) is a primary therapeutic target for patients with chronic heart failure (HF) and is associated with long-term prognosis. However, its utility in hospitalized HF (HHF) patients in the acute setting remains unclear. We aimed to assess the utility of PRQL (the Kansas City Cardiomyopathy Questionnaire [KCCQ]) in HHF patients and its association with long-term prognosis as well as with the clinical risk score (Get With The Guidelines-Heart Failure [GWTG-HF] risk score). PRQL was evaluated using the KCCQ in consecutive 114 HHF patients. Its association with the composite outcome of all-cause mortality or HF readmission within the first year after discharge was analyzed. Furthermore, its distribution by the clinical risk score (GWTG-HF) was evaluated using Pearson's correlation coefficient. The median KCCQ was 34.9, but was widely distributed (interquartile range 23.7-56.8). After adjustment for known prognostic indicators, the KCCQ was not an independent predictor of the composite outcome within the first year (group with high vs. low KCCQ scores: hazard ratio, 0.67; 95% confidence interval 0.26-1.71). There was no significant correlation between the KCCQ and the GWTG-HF risk score. In conclusion, PRQL during the acute phase of HF was significantly impaired and also varied widely, irrespective of patient characteristics or severity. PRQL assessment and risk prediction for HHF patients in the acute setting seemed to provide two distinct types of information for health care providers.

Real-world use of intravascular ultrasound in Japan: a report from contemporary multicenter PCI registry.

Clinical trial data suggest that intravascular ultrasound (IVUS) may improve clinical outcomes after PCI. The aim of this study was to investigate the safety of IVUS in its broader use for percutaneous coronary intervention (PCI). A total of 11,570 consecutive patients undergoing PCI between 2008 and 2014 in Japan were analyzed. Associations between IVUS use, PCI-related complications were assessed with logistic regression and propensity score matching analyses. Subgroup analysis was performed in elective PCI patients. IVUS was used in 84.8% of patients (N = 9814; IVUS group); its use was almost universal in elective PCIs (90.8 vs. 81.7% in urgent/emergent PCIs, P < 0.001). The non-IVUS group were older (68.7 ± 11.4 vs. 67.9 ± 10.8 years, P = 0.004), with more comorbid conditions. The non-IVUS group had smaller stent lumens (2.97 ± 0.42 mm vs. 3.09 ± 0.45 mm, P < 0.001) and a higher proportion of plain old balloon angioplasty. After matching, a lower rate of flow-impairing coronary dissections was observed in the IVUS group, although this was limited only to elective PCIs, not among urgent/emergent PCIs (non-IVUS vs. IVUS; 2.7% vs. 1.0%, P = 0.018, 0.7% vs. 1.2%, P = 0.32, respectively). With a multivariate logistic regression analysis, IVUS use remained an independent predictor to reduce risk of flow impairing severe coronary dissection among elective PCIs (odds ratio 0.38, 95% confidence interval 0.22-0.66: P = 0.001). In this Japanese PCI registry, IVUS was used extensively during the study period, particularly in elective cases. Using IVUS was associated with a lower event rate of flow-impairing coronary dissections that was limited to elective PCIs, not among urgent/emergent PCIs, without increasing PCI-related complications.

Increasing mixed venous oxygen saturation is a predictor of improved renal function after balloon pulmonary angioplasty in patients with chronic thromboembolic pulmonary hypertension.

Balloon pulmonary angioplasty (BPA) has emerged as an effective treatment for patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). Renal function has been identified as a prognostic marker in patients with pulmonary hypertension in previous studies. We, therefore, aimed to investigate the clinical parameters associated with improvements in renal function in patients with CTEPH. A total of 45 consecutive patients with inoperable CTEPH undergoing BPA (mean age 62.2 ± 15.1 years) were included in the study. We evaluated the patients' clinical characteristics at baseline and at 1-year post-BPA, and investigated the association between renal function and hemodynamic parameters, including right heart function. Hemodynamics and renal function showed sustained improvements at 1 year after BPA in 64.4% of patients. Improved estimated glomerular filtration rate (eGFR) was significantly correlated with increased cardiac index (r = 0.433, p = 0.003) and mixed venous oxygen saturation (SvO2; r = 0.459, p = 0.002), and with decreased mean pulmonary arterial pressure (r = - 0.420, p = 0.004) and pulmonary vascular resistance (r = -- 0.465, p = 0.001). Multivariate analysis revealed that an increase in SvO2 immediately after the final BPA was associated with improved eGFR after the 1st year (odds ratio 1.041; 95% confidence interval 1.004-1.078; P = 0.027). The cut-off value for predicting improved eGFR was an increase in SvO2 after the final BPA of >125.4% over the baseline value (specificity 100%, sensitivity 24.1%). In conclusion, BPA improved symptoms, right heart function, hemodynamics, and renal function up to the chronic phase. Increasing SvO2 by >125.4% above baseline in the acute phase is important for improving renal function at 1 year after BPA in CTEPH patients.

Barriers Associated With Door-to-Balloon Delay in Contemporary Japanese Practice.

BACKGROUND: Door-to-balloon (DTB) time ≤90 min is an important quality indicator in the management of ST-elevation myocardial infarction (STEMI), but a considerable number of patients still do not meet this goal, particularly in countries outside the USA and Europe.Methods and Results:We analyzed 2,428 STEMI patients who underwent primary PCI ≤12 h of symptom onset who were registered in an ongoing prospective multicenter database (JCD-KiCS registry), between 2008 and 2013. We analyzed both the time trend in DTB time within this cohort in the registry, and independent predictors of delayed DTB time >90 min. Median DTB time was 90 min (IQR, 68-115 min) during the study period and there were no significant changes with year. Predictors for delay in DTB time included peripheral artery disease, prior revascularization, off-hour arrival, age >75 years, heart failure at arrival, and use of IABP or VA-ECMO. Notably, high-volume PCI-capable institutions (PCI ≥200/year) were more adept at achieving shorter DTB time compared with low-volume institutions (PCI <200/year). CONCLUSIONS: Half of the present STEMI patients did not achieve DTB time ≤90 min. Targeting the elderly and patients with multiple comorbidities, and PCI performed in off-hours may aid in its improvement.