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Recently, one observational study showed that patients with ST-segment elevation myocardial infarction (STEMI) without standard cardiovascular risk factors were associated with increased mortality compared with patients with risk factors. This unexpected result should be evaluated in other populations including those with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and chronic coronary syndrome (CCS). Among 30,098 consecutive patients undergoing first coronary revascularization in the CREDO-Kyoto PCI/CABG (Coronary Revascularization Demonstrating Outcome Study in Kyoto Percutaneous Coronary Intervention/Coronary Artery Bypass Grafting) registry cohort-2 and 3, we compared clinical characteristics and outcomes between patients with and without risk factors stratified by their presentation (STEMI n = 8,312, NSTE-ACS n = 3,386, and CCS n = 18,400). Patients with risk factors were defined as having at least one of the following risk factors: hypertension, dyslipidemia, diabetes, and current smoking. The proportion of patients without risk factors was low (STEMI: 369 patients [4.4%], NSTE-ACS: 110 patients [3.2%], and CCS: 462 patients [2.5%]). Patients without risk factors compared with those with risk factors more often had advanced age, low body weight, and malignancy and less often had history of atherosclerotic disease and prescription of optimal medical therapy. In patients with STEMI, patients without risk factors compared with those with risk factors were more often women and more often had atrial fibrillation, long door-to-balloon time, and severe hemodynamic compromise. During a median of 5.6 years follow-up, patients without risk factors compared with those with risk factors had higher crude incidence of all-cause death. After adjusting confounders, the mortality risk was significant in patients with CCS (hazard ratio [HR] 1.22, 95% confidence interval [CI] 1.01 to 1.49, p = 0.04) but not in patients with STEMI (HR 1.06, 95% CI 0.89 to 1.27, p = 0.52) and NSTE-ACS (HR 1.07, 95% CI, 0.74 to 1.54, p = 0.73). In conclusion, among patients undergoing coronary revascularization, patients without standard cardiovascular risk factors had higher crude incidence of all-cause death compared with those with at least one risk factor. After adjusting confounders, the mortality risk was significant in patients with CCS but not in patients with STEMI and NSTE-ACS.

Aims Little is known about the characteristics and outcomes of patients who undergo coronary angiography during heart failure (HF) hospitalization, as well as those with coronary stenosis, and those who underwent coronary revascularization. Methods and results We analysed 2163 patients who were hospitalized for HF without acute coronary syndrome or prior HF hospitalization. We compared patient characteristics and 1 year clinical outcomes according to (i) patients with versus without coronary angiography, (ii) patients with versus without coronary stenosis, and (iii) patients with versus without coronary revascularization. The primary outcome measure was the composite of all‐cause death or HF hospitalization. Coronary angiography was performed in 37.0% of patients. In the multivariable logistic regression analysis, factors independently associated with coronary angiography were age

The treatment of coronary artery disease has substantially changed over the past two decades. However, it is unknown whether and how much these changes have contributed to the improvement of long-term outcomes after coronary revascularization. We assessed trends in the demographics, practice patterns and long-term outcomes in 24,951 patients who underwent their first percutaneous coronary intervention (PCI) (n = 20,106), or isolated coronary artery bypass grafting (CABG) (n = 4,845) using the data in a series of the CREDO-Kyoto PCI/CABG Registries (Cohort-1 [2000 to 2002]: n = 7,435, Cohort-2 [2005 to 2007]: n = 8,435, and Cohort-3 [2011 to 2013]: n = 9,081). From Cohort-1 to Cohort-3, the patients got progressively older across subsequent cohorts (67.0 ± 10.0, 68.4 ± 9.9, and 69.8 ± 10.2 years, ptrend

BACKGROUND Traumatic brain injury (TBI) initiates immune responses involving infiltration of monocyte-derived macrophages (MDMs) in the injured brain tissue. These MDMs play a key role in perioperative neurocognitive disorders (PNDs). We tested the hypothesis that preanesthetic treatment with dexmedetomidine (DEX) could suppress infiltration of MDMs into the hippocampus of TBI model mice, ameliorating PND. METHODS We first performed bone marrow transplantation from green fluorescent protein-transgenic mice to C57BL/6 mice to identify MDMs. We used only male mice for homogeneity. Four weeks after transplantation, a controlled cortical impact model of TBI was created using recipient mice. Four weeks after TBI, mice received pretreatment with DEX before general anesthesia (GA). Mice performed the Barnes maze test (8-12 mice/group) 2 weeks after GA and were euthanized for immunohistochemistry (4-5 mice/group) or immunoblotting (7 mice/group) 4 weeks after GA. RESULTS In Barnes maze tests, TBI model mice showed longer primary latency (mean difference, 76.5 [95% confidence interval, 41.4-111.6], P < .0001 versus Naive), primary path length (431.2 [98.5-763.9], P = .001 versus Naive), and more primary errors (5.7 [0.62-10.7], P = .017 versus Naive) than Naive mice on experimental day 3. Expression of MDMs in the hippocampus was significantly increased in TBI mice compared to Naive mice (2.1 [0.6-3.7], P = .003 versus Naive). Expression of monocyte chemotactic protein-1 (MCP1)-positive areas in the hippocampus was significantly increased in TBI mice compared to Naive mice (0.38 [0.09-0.68], P = .007 versus Naive). Immunoblotting indicated significantly increased expression of interleukin-1β in the hippocampus in TBI mice compared to Naive mice (1.59 [0.08-3.1], P = .035 versus Naive). In contrast, TBI mice pretreated with DEX were rescued from these changes and showed no significant difference from Naive mice. Yohimbine, an α2 receptor antagonist, mitigated the effects of DEX (primary latency: 68.3 [36.5-100.1], P < .0001 versus TBI-DEX; primary path length: 414.9 [120.0-709.9], P = .0002 versus DEX; primary errors: 6.6 [2.1-11.2], P = .0005 versus TBI-DEX; expression of MDMs: 2.9 [1.4-4.4], P = .0001 versus TBI-DEX; expression of MCP1: 0.4 [0.05-0.67], P = .017 versus TBI-DEX; expression of interleukin-1β: 1.8 [0.34-3.35], P = .01 versus TBI-DEX). CONCLUSIONS Preanesthetic treatment with DEX suppressed infiltration of MDMs in the hippocampus and ameliorated PND in TBI model mice. Preanesthetic treatment with DEX appears to suppress infiltration of MDMs in the hippocampus and may lead to new treatments for PND in patients with a history of TBI.

BACKGROUND: Although diabetes mellitus (DM) is a common comorbidity of aortic stenosis (AS), clinical evidence about the long-term effect of DM on patients with AS is insufficient.Methods and Results:Data were acquired from CURRENT AS, a large Japanese multicenter registry that enrolled 3, 815 patients with severe AS. Patients without initial valve replacement were defined as the conservative group; among them, 621 (23.4%) had DM, whereas 1997 did not. The DM group was further divided into 2 groups according to insulin treatment (insulin-treated DM, n=130; non-insulin treated DM, n=491). The primary outcome was a composite of aortic valve (AV)-related death and heart failure (HF) hospitalization. Secondary outcomes were AV-related death, HF hospitalization, all-cause death, cardiovascular death, sudden death, and surgical or transcatheter AV replacement during follow up. As a result, DM was associated with higher risk for the primary outcome (52.8% vs. 42.9%, P

There is a scarcity of data comparing long-term clinical outcomes between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel coronary artery disease (3VD) in the new-generation drug-eluting stents era. CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients who had undergone first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013. We identified 2525 patients with 3VD (PCI: n = 1747 [69%], and CABG: n = 778 [31%]). The primary outcome measure was all-cause death. Median follow-up duration was 5.7 (interquartile range: 4.4 to 6.6) years. The cumulative 5-year incidence of all-cause death was significantly higher in the PCI group than in the CABG group (19.8% vs 13.2%, log-rank p = 0.001). After adjusting confounders, the excess risk of PCI relative to CABG for all-cause death remained significant (HR, 1.45; 95% CI, 1.14 to 1.86; p = 0.003), which was mainly driven by the excess risk for non-cardiovascular death (HR, 1.88; 95% CI, 1.30 to 2.79; p = 0.001), while there was no excess risk for cardiovascular death between PCI and CABG (HR, 1.19; 95% CI, 0.87 to 1.64; p = 0.29). There was significant excess risk of PCI relative to CABG for myocardial infarction (HR, 1.77; 95% CI, 1.19 to 2.69; p = 0.006), whereas there was no excess risk of PCI relative to CABG for stroke (HR, 1.24; 95% CI, 0.83 to 1.88; p = 0.30). In conclusion, in the present study population reflecting real-world clinical practice in Japan, PCI compared with CABG was associated with significantly higher risk for all-cause death, while there was no excess risk for cardiovascular death between PCI and CABG.

Aims The association between serum cholinesterase and prognosis in acute heart failure (AHF) remains to be elucidated. We investigated the serum cholinesterase level at discharge from hospitalization for AHF and its association with clinical outcomes in patients with AHF. Methods and results Among 4056 patients enrolled in the Kyoto Congestive Heart Failure multicentre registry, we analysed 2228 patients with available serum cholinesterase data. The study population was classified into three groups according to serum cholinesterase level at discharge: low tertile ( Conclusions Low serum cholinesterase levels are associated with congestive findings on echocardiography, higher BNP, and higher risks for a composite of all-cause death and HF hospitalization in patients with AHF.

Objectives The association of preoperative RV function with hemodynamics during OPCAB or emergency conversion is not clear. The aim of this study was to investigate the association of vasoactive-inotropic score with tricuspid annular plane systolic excursion and tricuspid regurgitation in off-pump coronary artery bypass grafting, and to calculate the optimal cut-off value of tricuspid annular plane systolic excursion to predict emergency conversion to cardiopulmonary bypass. Methods Patients over 20 years of age who had undergone off-pump coronary artery bypass grafting between April 2015 and March 2020 were enrolled in this study. We retrospectively assessed the association of intraoperative maximum “vasoactive-inotropic score”, a weighted sum of various inotropes and vasoconstrictors, with tricuspid annular plane systolic excursion and tricuspid regurgitation. A receiver operating characteristic curve of conversion on tricuspid annular plane systolic excursion was also constructed. Results 135 patients were included in final analysis. Conversion was performed in 10 cases. Multiple regression analysis showed that tricuspid annular plane systolic excursion, mild or more tricuspid regurgitation and experienced surgeon were significantly related to vasoactive-inotropic score. The receiver operating characteristic curve to predict conversion by tricuspid annular plane systolic excursion showed an optimal cut-off value of 15.0 mm and area under the curve of 0.808. Conclusions Tricuspid annular plane systolic excursion and tricuspid regurgitation were associated with vasoactive-inotropic score in off-pump coronary artery bypass grafting. The optimal cut-off value of tricuspid annular plane systolic excursion to predict emergency conversion was 15 mm.

The effect of body weight (BW) on bleeding and ischemic events has not been adequately evaluated in real-world percutaneous coronary intervention (PCI) practice.Methods and Results:12,690 consecutive patients undergoing first PCI in the CREDO-Kyoto registry cohort-2 were divided into 3 groups according to tertiles of BW stratified by sex (male; Tertile 1 [60.0 kg], 2 [60.0-68.0 kg], and 3 [68.0 kg], and female; Tertile 1 [47.9 kg], 2 [47.9-55.8 kg], and 3 [55.8 kg]). Cumulative 5-year incidences of the primary bleeding (GUSTO moderate/severe) and ischemic (myocardial infarction/ischemic stroke) endpoints increased incrementally with decrease in BW in both strata (male Tertiles 1, 2, and 3: 13.7%, 10.3%, and 8.0%, P0.001, and 13.9%, 11.3%, and 10.2%, P0.001; female Tertiles 1, 2, and 3: 17.9%, 12.9%, and 10.1%, P0.001, and 17.9%, 12.9%, and 10.1%, P0.001). Compared with Tertile 3, the adjusted risks of Tertile 1 for the primary bleeding and ischemic endpoints remained significant in the female stratum (hazard ratio (HR): 1.45, 95% confidence interval (CI): 1.14-1.87, P=0.003, and HR:1.49, 95% CI:1.13-1.95, P=0.004), but not in the male stratum (HR:1.10, 95% CI:0.92-1.32, P=0.31, and HR:1.06, 95% CI:0.90-1.27, P=0.47).Cumulative incidences of bleeding and ischemic events increased incrementally as BW decreased in both men and women. The adjusted risks of underweight relative to overweight for bleeding and ischemic events were significant only in women.

There are uncertainties on the influence of the days of diagnosis in a week (weekends versus weekdays) on clinical outcomes in patients with acute venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT). The COMMAND VTE registry is a multicenter cohort study enrolling 3027 consecutive patients with acute symptomatic VTE. The current study population consisted of 337 patients diagnosed on weekends and 2690 patients diagnosed on weekdays. We compared the clinical characteristics, management strategies and 30-day outcomes between the 2 groups. The patients diagnosed on weekends more often presented with PE (72% vs. 55%, P

Introduction Although partial cystectomy has been performed by laparoscopy in patients with benign disease, there have only been a few reports regarding the laparoscopic partial resection of urinary bladder–adherent colorectal cancer. This study was conducted to evaluate the short-term surgical outcomes of laparoscopic partial resection of urinary bladder–adherent colorectal cancer. Case presentation Between April 2014 and February 2017, 6 patients with colorectal cancers that were adherent to the urinary bladder underwent laparoscopic colorectal cancer resection combined with partial cystectomy. Their surgical outcomes were reviewed retrospectively. The primary colorectal cancer was located in the sigmoid colon in 5 patients and the upper rectum in 1 patient. None of the patients required conversion to open surgery. The median duration of surgery was 411 minutes, and the median amount of intraoperative blood loss was 284 mL. In the patients with sigmoid colon cancer, the bladder was primarily closed under direct visualization via the small lower abdominal incision used to remove the tumor. In the patient with upper rectal cancer, the bladder was primarily closed laparoscopically. None of the patients demonstrated urinary leakage on retrograde cystography or anastomotic leakage, and there were no cases of perioperative mortality or morbidity. None of the patients developed recurrence of cancer at the median follow-up of 21 months. Conclusion Laparoscopic partial resection of urinary bladder–adherent colorectal cancer produces good short-term outcomes without increasing morbidity. Performing bladder closure under direct visualization via a small lower abdominal incision might be useful in selected patients.

Background There are no data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) outcomes in real clinical practice in Japan. Methods and results We combined 2 independent registries, the K-TAVI Registry (a 6-center prospective registry of consecutive patients who underwent TAVI) and the CURRENT AS Registry (a large, 27-center registry of 3,815 consecutive patients with severe aortic stenosis [AS]). In the K-TAVI Registry, 338 patients underwent TAVI with SAPIEN XT balloon-expandable valves from October 2013 to January 2016, whereas in the CURRENT AS Registry 237 patients with severe AS underwent SAVR from January 2003 to December 2011. Propensity score matching was conducted, with final cohort comprising 306 patients. The cumulative 2-year incidence of all-cause death and heart failure (HF) hospitalization did not differ significantly between the TAVI and SAVR groups (13.7% vs. 12.4% [P=0.81] and 7.9% vs 3.9% [P=0.13], respectively). After adjusting for residual confounders, there were no significant differences between the TAVI and SAVR groups in the risk for all-cause death (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.35-1.58; P=0.43) or HF hospitalization (HR 1.27; 95% CI 0.40-4.59; P=0.69). Conclusions These findings from 2 independent Japanese registries suggest that the 2-year risk of all-cause mortality and HF does not differ significantly between TAVI and SAVR groups in real-world practice in Japan.

Background The simplified Pulmonary Embolism Severity Index (sPESI) score is a practical score for identification of patients with low-risk pulmonary embolism (PE), although it has not been applied in patients with active cancer. The current study aimed to evaluate the usefulness of the sPESI score in patients with PE and active cancer. Methods The COMMAND VTE Registry is a multicenter registry enrolling consecutive patients with acute symptomatic VTE. The current study population consisted of 368 patients with PE and active cancer. The 30-day clinical outcomes were compared between patients with sPESI score = 1 and patients with sPESI scores ≥ 2. Results Overall, 37 patients (10%) died during the 30 days after diagnosis. The cumulative 30-day incidences of mortality, and PE-related death, were lower in patients with sPESI score = 1 than in patients with sPESI scores ≥ 2 (6.3% vs 13.1%; log-rank P = .03; and 0.7% vs 3.9%; log-rank P = .046). Among patients with sPESI score = 1, the predominant cause of death was cancer. There were no significant differences in the cumulative 30-day incidence of recurrent VTE and major bleeding between the two groups (3.9% vs 5.6%; log-rank P = .46; and 6.4% vs 4.5%; log-rank P = .45). Conclusions Among patients with PE and active cancer, patients with sPESI score = 1 had a lower 30-day mortality rate compared with patients with sPESI scores ≥ 2, and they showed very low PE-related mortality risk, although the overall mortality rate remained high because of cancer-related mortality. They also showed relatively high risks for recurrence and major bleeding, suggesting the need for careful follow-up. Trial Registry UMIN Clinical Trials Registry; No.: UMIN000021132; URL: http://www.umin.ac.jp/ctr/index.htm

There is a paucity of studies exploring whether the ischemia-bleeding trade-off could be different according to the stages of renal dysfunction in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI). Among 19,598 patients in a pooled database from 3 Japanese PCI studies (CREDO-Kyoto Cohort-2, RESET, and NEXT), 1,547 patients had concomitant AF. Patients were divided into 4 groups according to their renal function (Creatinine clearance [CCr]60 ml/min: n = 703, 60≥ CCr30 ml/min: n = 627, CCr ≤30 ml/min: n = 126, Dialysis: n = 91). The cumulative 3-year incidences of both the primary ischemic (ischemic stroke/myocardial infarction) and bleeding (GUSTO moderate/severe) outcome increased incrementally with worsening renal function (11.4%, 12.6%, 16.8%, and 31.7%, p0.001, and 7.5%, 14.9%, 26.3%, and 29.5%, p0.001, respectively). Compared with CCr60 ml/min group, the excess adjusted risk for the primary ischemic outcome was significant only in dialysis group (hazards ratio [HR] 2.15, 95% confidence interval [CI] 1.22 to 3.69, p = 0.009), but not in 60≥ CCr30 ml/min and CCr ≤30 ml/min groups (HR 0.89, 95% CI 0.62 to 1.29, p = 0.54, and HR 0.94, 95% CI 0.49 to 1.69, p = 0.83, respectively), whereas the excess adjusted risk for the primary bleeding outcome was significant in all 3 groups of renal dysfunction (HR 1.66, 95% CI 1.13 to 2.45, p = 0.01, HR 2.70, 95% CI 1.58 to 4.61, p0.001, and HR 3.26, 95% CI 1.85 to 5.75, p0.001, respectively). In conclusion, in AF patients receiving PCI, the worsening renal function was strongly associated with the increasingly higher risk for bleeding events, whereas the excess risk for ischemic events was significant only in patients on dialysis.

Background No studies have explored the association between newly diagnosed infections after admission and clinical outcomes in patients with acute heart failure. We aimed to explore the factors associated with newly diagnosed infection after admission for acute heart failure, and its association with in‐hospital and post‐discharge clinical outcomes. Methods and Results Among 4056 patients enrolled in the Kyoto Congestive Heart Failure registry, 2399 patients without any obvious infectious disease upon admission were analyzed. The major in‐hospital and post‐discharge outcome measures were all‐cause deaths. There were 215 patients (9.0%) with newly diagnosed infections during hospitalization, and 2184 patients (91.0%) without infection during hospitalization. The factors independently associated with a newly diagnosed infection were age ≥80 years, acute coronary syndrome, non‐ambulatory status, hyponatremia, anemia, intubation, and patients who were not on loop diuretics as outpatients. The newly diagnosed infection group was associated with a higher incidence of in‐hospital mortality (16.3% and 3.2%, P P P P =0.02) compared with the non‐infection group. Conclusions Elderly patients with multiple comorbidities were associated with the development of newly diagnosed infections after admission for acute heart failure. Newly diagnosed infections after admission were associated with higher in‐hospital and post‐discharge mortality in patients with acute heart failure. Registration URL: https://clinicaltrials.gov ; Unique identifier: NCT02334891.

Background Heart failure (HF) is a known risk factor for ischemic stroke, but data regarding ischemic stroke during hospitalization for acute decompensated HF (ADHF) are limited. Methods and Results We analyzed the data from a multicenter registry (Kyoto Congestive Heart Failure [KCHF] Registry) that enrolled 4056 consecutive patients with ADHF in Japan (mean age, 78 years; men, 2238 patients [55%]; acute coronary syndrome [ACS], 239 patients [5.9%]). We investigated the incidence and predictors of ischemic stroke during hospitalization for ADHF. During the hospitalization, 63 patients (1.6%) developed ischemic stroke. The median interval from admission to the onset of ischemic stroke was 7 [interquartile range: 2–14] days, and the most common underlying cause was cardioembolism (64%). Men (OR, 1.87; 95%CI, 1.11–3.24), ACS (OR, 2.31; 95%CI, 1.01–4.93), absence of prior HF hospitalization (OR, 2.21; 95%CI, 1.24–4.21), and high B‐type natriuretic peptide (BNP)/N‐terminal proBNP (NT‐proBNP) levels (above the median) at admission (OR, 3.15; 95%CI, 1.84–5.60) were independently associated with ischemic stroke. In patients without ACS, the independent risk factors for ischemic stroke were fully consistent with those in the main analysis. Higher quartiles of BNP/NT‐proBNP levels were significantly associated with higher incidence of ischemic stroke ( P for trend, Conclusions During hospitalization for ADHF, 1.6% of the patients developed ischemic stroke. Men, ACS, absence of prior HF hospitalization, and high BNP/NT‐proBNP levels at admission were independently associated with ischemic stroke.

People with diabetes mellitus are susceptible to both cardiovascular disease and severe influenza A virus infection. We hypothesized that diabetes also increases risks of influenza-associated cardiac complications. A murine type 1 (streptozotocin-induced) diabetes model was employed to investigate influenza-induced cardiac distress. Lung histopathology and viral titres revealed no difference in respiratory severity between infected control and diabetic mice. However, compared with infected control mice, infected diabetic mice had increased serum cardiac troponin I and creatine-kinase MB, left ventricular structural changes and right ventricular functional alterations, providing the first experimental evidence of type I diabetes increasing risks of influenza-induced cardiovascular complications.

Background Heart failure might be an important determinant in choosing coronary revascularization modalities. There was no previous study evaluating the effect of heart failure on long‐term clinical outcomes after percutaneous coronary intervention (PCI) relative to coronary artery bypass grafting (CABG). Methods and Results Among 14 867 consecutive patients undergoing first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013 in the CREDO‐Kyoto PCI/CABG registry Cohort‐3, we identified the current study population of 3380 patients with three‐vessel or left main coronary artery disease, and compared clinical outcomes between PCI and CABG stratified by the subgroup based on the status of heart failure. There were 827 patients with heart failure (PCI: N=511, and CABG: N=316), and 2553 patients without heart failure (PCI: N=1619, and CABG: N=934). In patients with heart failure, the PCI group compared with the CABG group more often had advanced age, severe frailty, acute and severe heart failure, and elevated inflammatory markers. During a median 5.9 years of follow‐up, there was a significant interaction between heart failure and the mortality risk of PCI relative to CABG (interaction P =0.009), with excess mortality risk of PCI relative to CABG in patients with heart failure (HR, 1.75; 95% CI, 1.28–2.42; P P =0.77). Conclusions There was a significant interaction between heart failure and the mortality risk of PCI relative to CABG with excess risk in patients with heart failure and neutral risk in patients without heart failure.

There is a scarcity of data on ischemic and bleeding events in patients who experienced major bleeding after percutaneous coronary intervention (PCI). Moreover, there also is a shortage of data on comparative outcomes between patients with and without interruption of an antithrombotic drug after major bleeding. We evaluated the incidence and prognostic impacts of ischemic (myocardial infarction or ischemic stroke) and bleeding (Bleeding Academic Research Consortium type 3 or 5) events after major bleeding in 12,691 consecutive patients who underwent first PCI in the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI registry cohort-3. In the entire cohort, incidence of the first ischemic event and bleeding event was 2.3 per 100 person-years and 3.8 per 100 person-years, respectively. Major bleeding (Bleeding Academic Research Consortium type 3) occurred in 2,142 patients during a median follow-up of 5.7 years. In patients with major bleeding, cumulative 30-day, 1-year, and 5-year incidence of an ischemic event was 2.6%, 4.8%, and 13.2% (3.2 per 100 person-years), respectively, whereas that of a bleeding event was 6.3%, 16.1%, and 29.2% (8.5 per 100 person-years), respectively. Ischemic and bleeding events were independently associated with mortality (hazard ratio 2.36, 95% confidence interval 1.87 to 2.96, p

Background It remains unclear whether beta‐blocker use at hospital admission is associated with better in‐hospital outcomes in patients with acute decompensated heart failure. Methods and Results We evaluated the factors independently associated with beta‐blocker use at admission, and the effect of beta‐blocker use at admission on in‐hospital mortality in 3817 patients with acute decompensated heart failure enrolled in the Kyoto Congestive Heart Failure registry. There were 1512 patients (39.7%) receiving, and 2305 patients (60.3%) not receiving beta‐blockers at admission for the index acute decompensated heart failure hospitalization. Factors independently associated with beta‐blocker use at admission were previous heart failure hospitalization, history of myocardial infarction, atrial fibrillation, cardiomyopathy, and estimated glomerular filtration rate 2 . Factors independently associated with no beta‐blocker use were asthma, chronic obstructive pulmonary disease, lower body mass index, dementia, older age, and left ventricular ejection fraction P P P for interaction 0.04). Conclusions Beta‐blocker use at admission was associated with lower in‐hospital mortality in patients with acute decompensated heart failure. Registration URL: https://www.upload.umin.ac.jp/ ; Unique identifier: UMIN000015238.

Background: We sought to explore the effects of previous heart failure (HF) hospitalization on mortality in patients hospitalized for acute decompensated HF (ADHF) in a large Japanese contemporary observational database. Methods and Results: We prospectively enrolled consecutive patients with ADHF in 19 participating hospitals between October 2014 and March 2016. Of 4, 056 patients, 1, 442 patients (35.4%) had at least 1 previous HF hospitalization (previous hospitalization group), while 2, 614 patients (64.5%) did not have a history of HF hospitalization (de novo hospitalization group). Patients with previous hospitalization were older and more often had comorbidities such as anemia, and renal failure than those without. The cumulative 1-year incidence of all-cause death was significantly higher in the previous hospitalization group than in the de novo hospitalization group (28% vs. 19%, P

The duration of anticoagulation therapy after venous thromboembolism (VTE) should be based on the balance between risks of recurrent VTE and bleeding. However, there is uncertainty about the impact of these events on subsequent mortality.We evaluated the association of recurrent VTE and major bleeding events with mortality among 3026 patients in the COMMAND VTE Registry. We estimated the risks of the recurrent VTE events and the major bleeding events for subsequent mortality by the time-updated multivariable Cox proportional hazard model.During the median follow-up period of 1218 days, 225 patients developed recurrent VTE events, 274 patients developed major bleeding events, and 763 patients died. The multivariable Cox proportional hazard model revealed that both the recurrent VTE and major bleeding events were strongly associated with subsequent mortality risk (recurrent VTE: HR 3.24, 95%CI 2.57-4.08, P 0.001; major bleeding: HR 3.53, 95%CI 2.88-4.31, P 0.001). Both the recurrent pulmonary embolism (PE) and recurrent deep vein thrombosis (DVT) events were associated with subsequent mortality risk (recurrent PE events: HR 4.42, 95%CI 3.28-5.95, P 0.001; recurrent DVT events: HR 2.42, 95%CI 1.75-3.36, P 0.001).In the real-world patients with VTE, both the recurrent VTE events and the major bleeding events were strongly associated with subsequent mortality risk with the comparable effect size. The recurrent PE and recurrent DVT events were also associated with increased risks for mortality, although the magnitude of the effect on mortality was numerically greater with the recurrent PE events than with the recurrent DVT events.

Purpose Prolonged propofol infusion induces skeletal muscle damage. However, it is well known that the lipid emulsion that is the solvent of propofol causes various types of tissue damage via lipid peroxidation, and that propofol, conversely, has an anti-lipid peroxidative effect. The purpose of this study was to determine whether propofol or the lipid emulsion is the cause of muscle damage following prolonged administration. Methods Rats were divided into four groups: NI group (no intervention), Cath group (venous catheter insertion only), Prop group (1% propofol (Maruishi) intravenous infusion at 10 mg/kg/h), and Lipid group (10% Lipofundin® intravenous infusion at 100 mg/kg/h) (n = 10, each group). 1% Propofol (Maruishi) or Lipofundin was infused at 1 mL/kg/h for 72 h. The solvent of 1% propofol (Maruishi) is a 10% lipid emulsion. Lipofundin consists of 50% long-chain triacylglycerols and 50% medium-chain triacylglycerols, similar to the propofol solvent. Plasma concentrations of creatine kinase and myoglobin, superoxide production level, and 4-hydroxynonenal and malondialdehyde expression in the gastrocnemius muscle were evaluated 72 h after the interventions. Results Plasma concentrations of creatine kinase and myoglobin in the Lipid group were significantly higher than those in the other three groups. The superoxide production level, and 4-hydroxynonenal and malondialdehyde expression in the Lipid group were also significantly higher than in the other three groups. Conclusion Lipofundin induces skeletal muscle damage via lipid peroxidation, and 1% propofol (Maruishi) conversely suppresses the muscle damage via antioxidant effects.

[Background] There are limited data on the long-term stent-related adverse events as related to the duration of dual antiplatelet therapy (DAPT) in second-generation (G2) drug-eluting stents (DES) compared with first-generation (G1) DES. [Objectives] This study sought to compare the long-term stent-related outcomes of G2-DES with those of G1-DES. [Methods] The study group consisted of 15, 009 patients who underwent their first coronary revascularization with DES from the CREDO-Kyoto PCI/CABG (Coronary Revascularization Demonstrating Outcome Study in Kyoto Percutaneous Coronary Intervention/Coronary Artery Bypass Grafting) Registry Cohort-2 (first-generation drug-eluting stent [G1-DES] period; n = 5, 382) and Cohort-3 (second-generation drug eluting stent [G2-DES] period; n = 9, 627). The primary outcome measures were definite stent thrombosis (ST) and target vessel revascularization (TVR). [Results] The cumulative 5-year incidences of definite ST and TVR were significantly lower in the G2-DES group than in the G1-DES group (0.7% vs 1.4%; P < 0.001; and 16.2% vs 22.1%; P < 0.001, respectively). The lower adjusted risk of G2-DES relative to G1-DES for definite ST and TVR remained significant (HR: 0.53; 95% CI: 0.37-0.76; P < 0.001; and HR: 0.74; 95% CI: 0.68-0.81; P < 0.001, respectively). In the landmark analysis that was based on the DAPT status at 1 year, the lower adjusted risk of on-DAPT status relative to off-DAPT was significant for definite ST beyond 1 year in the G1-DES stratum (HR: 0.42; 95% CI: 0.24-0.76; P = 0.004) but not in the G2-DES stratum (HR: 0.66; 95% CI: 0.26-1.68; P = 0.38) (Pinteraction = 0.14). [Conclusions] G2-DES compared with G1-DES were associated with a significantly lower risk for stent-related adverse events, including definite ST and TVR. DAPT beyond 1 year was associated with a significantly lower risk for very late ST of G1-DES but not for that of G2-DES.

BACKGROUND Data evaluating the effects of acute coronary syndrome (ACS) relative to stable coronary artery disease (CAD) on bleeding risk after percutaneous coronary intervention (PCI) are scarce.Methods and Results:From the CREDO-Kyoto Registry Cohort-3, 13,258 patients undergoing first PCI (5,521 ACS; 7,737 stable CAD) were identified. Patients were further stratified according to ACS presentation and Academic Research Consortium High Bleeding Risk (HBR): ACS/HBR: n=2,502; ACS/no-HBR: n=3,019; stable CAD/HBR: n=3,905; and stable CAD/no-HBR: n=3,832. The primary bleeding endpoint was Bleeding Academic Research Consortium 3/5 bleeding, whereas the primary ischemic endpoint was myocardial infarction (MI)/ischemic stroke. Compared with stable CAD, ACS was associated with a significantly higher adjusted risk for bleeding (hazard ratio [HR] 1.85; 95% confidence interval [CI] 1.68-2.03; P

ObjectiveThe association between sequential changes in left atrial diameter (LAD) and prognosis in heart failure (HF) remains to be elucidated. The present study aimed to investigate the link between reduction in LAD and clinical outcomes in patients with HF.DesignA multicentre prospective cohort study.SettingThis study was nested from the Kyoto Congestive Heart Failure registry including consecutive patients admitted for acute decompensated heart failure (ADHF) in 19 hospitals throughout Japan.ParticipantsThe current study population included 673 patients with HF who underwent both baseline and 6-month follow-up echocardiography with available paired LAD data. We divided them into two groups: the reduction in the LAD group (change Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or hospitalisation for HF during 180 days after 6-month follow-up echocardiography. The secondary outcome measures were defined as the individual components of the primary composite outcome measure and a composite of cardiovascular death or hospitalisation for HF.ResultsThe cumulative 180-day incidence of the primary outcome measure was significantly lower in the reduction in the LAD group than in the no-reduction in the LAD group (13.3% vs 22.2%, p=0.002). Even after adjusting 15 confounders, the lower risk of reduction in LAD relative to no-reduction in LAD for the primary outcome measure remained significant (HR 0.59, 95% CI 0.36 to 0.97 p=0.04).ConclusionPatients with reduction in LAD during follow-up after ADHF hospitalisation had a lower risk for a composite endpoint of all-cause death or HF hospitalisation, suggesting that the change of LAD might be a simple and useful echocardiographic marker during follow-up.

ObjectivesTo evaluate patient characteristics and long-term outcomes in patients with non–ST-segment elevation acute coronary syndrome (NSTEACS) in the past two decades.DesignMulticenter retrospective study.SettingThe Coronary REvascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG) Registry Cohort-2 (2005–2007) and Cohort-3 (2011–2013).Participants3254 patients with NSTEACS who underwent first coronary revascularisation.Primary and secondary outcome measuresThe primary outcome was all-cause death. The secondary outcomes were cardiovascular death, cardiac death, sudden cardiac death, non-cardiovascular death, non-cardiac death, myocardial infarction, definite stent thrombosis, stroke, hospitalisation for heart failure, major bleeding, any coronary revascularisation and target vessel revascularisation.ResultsPatients in Cohort-3 were older and more often had heart failure at admission than those in Cohort-2. The prevalence of PCI, emergency procedure and guideline-directed medical therapy was higher in Cohort-3 than in Cohort-2. In patients who received PCI, the prevalence of transradial approach, drug-eluting stent use and intravascular ultrasound use was higher in Cohort-3 than in Cohort-2. There was no change in 3-year adjusted mortality risk from Cohort-2 to Cohort-3 (HR 1.00, 95% CI 0.83 to 1.22, p=0.97). Patients in Cohort-3 compared with those in Cohort-2 were associated with lower adjusted risks for stroke (HR 0.65, 95% CI 0.46 to 0.92, p=0.02) and any coronary revascularisation (HR 0.76, 95%CI 0.66 to 0.87, pConclusionsIn the past two decades, we did not find improvement for mortality in patients with NSTEACS. We observed a reduction in the risks for definite stent thrombosis, stroke and any coronary revascularisation, but an increase in the risk for major bleeding.

Background The detailed causes of death in non–ST-segment–elevation myocardial infarction (NSTEMI) have not been adequately evaluated compared to those in ST-segment elevation myocardial infarction (STEMI). Methods The study population was 6,228 AMI patients who underwent percutaneous coronary intervention (STEMI: 4,625 patients and NSTEMI: 1,603 patients). The primary outcome was all-cause death. Results Within 6 months after AMI, the adjusted mortality risk was not significantly different between NSTEMI patients and STEMI patients (HR: 0.83, 95%CI: 0.67–1.03, P = 0.09). Regarding the causes of death within 6 months after AMI, mechanical complications more frequently occurred in STEMI patients than in NSTEMI patients, while proportions of post resuscitation status on arrival and heart failure were higher in in NSTEMI patients than in STEMI patients. Beyond 6 months after AMI, the adjusted mortality risk of NSTEMI relative to STEMI was not significantly different. (HR: 1.04, 95%CI: 0.90–1.20, P = 0.59). Regarding causes of death beyond 6 months after AMI, almost half of deaths were cardiovascular causes in both groups, and breakdown of causes of death was similar between NSTEMI and STEMI. Conclusion The mortality risk within and beyond 6 months after AMI were not significantly different between STEMI patients and NSTEMI patients after adjusting confounders. Deaths due to post resuscitation status and heart failure were more frequent in NSTEMI within 6 months after AMI.

Background. Chronic and/or intermittent exposure to hypobaric hypoxia reportedly exerts cardioprotective effects against ischemia-reperfusion injury. However, few studies have focused on the cardioprotective effects of acute and/or short-term hypobaric and hypoxic exposures. This study investigated the effects of acute hypobaric hypoxia on myocardial ischemia-reperfusion injury. Materials and Methods. Rats were assigned to groups receiving normobaric normoxia (NN group), hypobaric hypoxia (HH group), or normobaric hypoxia (NH group). HH group rats were exposed to 60.8 kPa and 12.6% fraction of inspired oxygen in a hypobaric chamber for 6 h. NH group rats were exposed to hypoxic conditions under normal pressure. After each exposure, 30 min of myocardial ischemia was followed by 60 min of reperfusion. Cardiac function and infarct size were determined after reperfusion. Expression of hypoxia-inducible factor 1 alpha (HIF1α) was also measured. Results. Cardiac function was better preserved in the HH and NH groups than in the NN group ( p p p p p

ObjectivesTo examine the association of a high C-reactive protein (CRP) level at discharge from an acute decompensated heart failure (ADHF) hospitalisation with the 1-year clinical outcomes.DesignA post-hoc subanalysis of a prospective cohort study of patients hospitalised for ADHF (using the Kyoto Congestive Heart Failure (KCHF) registry) between October 2014 and March 2016 with a 1-year follow-up.SettingA physician-initiated multicentre registry enrolled consecutive hospitalised patients with ADHF for the first time at 19 secondary and tertiary hospitals in Japan.ParticipantsAmong the 4056 patients enrolled in the KCHF registry, the present study population consisted of 2618 patients with an available CRP value both on admission and at discharge and post-discharge clinical follow-up data. We divided the patients into two groups, those with a high CRP level (>10 mg/L) and those with a low CRP level (≤10 mg/L) at discharge from the index hospitalisation.Primary and secondary outcome measuresThe primary outcome measure was all-cause death after discharge from the index hospitalisation. The secondary outcome measures were heart failure hospitalisations, cardiovascular death and non-cardiovascular death.ResultsThe high CRP group and low CRP group included 622 patients (24%) and 1996 patients (76%), respectively. During a median follow-up period of 468 days, the cumulative 1-year incidence of the primary outcome was significantly higher in the high CRP group than low CRP group (24.1% vs 13.9%, log-rank pConclusionsA high CRP level (>10 mg/L) at discharge from an ADHF hospitalisation was associated with an excess mortality risk at 1 year.Trial registration detailshttps://clinicaltrials.gov/ct2/show/NCT02334891 (NCT02334891) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017241 (UMIN000015238).

Background Despite the prognostic importance of hypoalbuminemia, the prognostic implication of a change in albumin levels has not been fully investigated during hospitalization in patients with acute decompensated heart failure (ADHF). Methods Using the data from the Kyoto Congestive Heart Failure registry on 3160 patients who were discharged alive for acute heart failure hospitalization and in whom the change in albumin levels was calculated at discharge, we evaluated the association with an increase in serum albumin levels from admission to discharge and clinical outcomes by a multivariable Cox hazard model. The primary outcome measure was a composite of all-cause death or hospitalization for heart failure. Findings Patients with increased albumin levels (N = 1083, 34.3%) were younger and less often had smaller body mass index and renal dysfunction than those with no increase in albumin levels (N = 2077, 65.7%). Median follow-up was 475 days with a 96% 1-year follow-up rate. Relative to the group with no increase in albumin levels, the lower risk of the increased albumin group remained significant for the primary outcome measure (hazard ratio: 0.78, 95% confidence interval: 0.69–0.90: P = 0.0004) after adjusting for confounders including baseline albumin levels. When stratified by the quartiles of baseline albumin levels, the favorable effect of increased albumin was more pronounced in the lower quartiles of albumin levels, but without a significant interaction effect (interaction P = 0.49). Conclusions Independent of baseline albumin levels, an increase in albumin during index hospitalization was associated with a lower 1-year risk for a composite of all-cause death and hospitalization in patients with acute heart failure.

Background: The prognostic implications of very low body mass index (BMI) values remain unclear in patients with acute decompensated heart failure (ADHF). This study aimed to investigate the prognostic impact of BMI classification based on the World Health Organization criteria in patients with ADHF. Methods and Results: Using data from 4056 consecutive patients with ADHF hospitalized in 19 participating hospitals in Japan between October 2014 and March 2016, we analyzed 3509 patients with available BMI data at discharge. The patients were divided into five groups; (1) Severely underweight: BMI2 , (2) Underweight: BMI≥16 kg/m 2 and 2 , (3) Normal weight: BMI≥18.5 kg/m 2 and 2 , (4) Overweight: BMI≥25 kg/m 2 and 2 (5) Obese: BMI≥30 kg/m 2 . The primary outcome measure was all-cause death. The median follow-up duration was 471 days, with 96.4% follow up at 1-year. The cumulative 1-year incidence of all-cause death was higher in underweight groups, and lower in overweight groups (Severely underweight: 36.3%, Underweight: 23.9%, Normal weight: 14.4%, Overweight: 7.9%, and Obese: 9.0%, P Conclusions: Lower BMI, not obesity, was associated with a higher risk for all-cause death after discharge in patients with ADHF.

Background Two-dimensional speckle tracking echocardiography (2D-STE) has been reported to be useful for the diagnosis of myocardial ischemia by detecting delayed relaxation (diastolic stunning) after an episode of angina. 2D-longitudinal strain is not specific besides ischemia such as diastolic dysfunction, and diabetes have been associated with abnormal longitudinal fibers. The aim is to evaluate the diagnostic accuracy of Left ventricular (LV) diastolic transverse strain imaging by STE to detect the presence of acute coronary syndrome (ACS) in diabetic patients with acute chest pain. Methods 385 consecutive patients with acute chest pain and without wall motion abnormality, who were admitted to an emergency department (ED) at 1 of 12 clinical sites in Japan, were enrolled and underwent 2D-STE at ED. Left ventricular (LV) transverse strain values at aortic valve closure (A) and one-third of diastole duration (B) were measured. The strain imaging diastolic index (SI-DI) was value was determined as: (A − B)/A × 100% to assess the LV diastolic strain imaging and was used to identify the regional LV delayed relaxation. All patients underwent coronary CT or coronary angiography to establish the diagnosis of ACS. Clinicians were blinded to the 2D-STE results. Results Out of 385 patients, 2D-STE analysis was possible in 365 patients (94%). 76 patients were diabetic (DM+), and 289 patients were non-diabetic (DM-). With assessment of coronary CT or coronary angiography, ACS was diagnosed in 125 patients (34%). 2D-STE was obtained at a mean of 5.3 hours after chest pain episode. Transverse SI-DI of ischemic segments were significantly lower than those of non-ischemic segments (p value Conclusion LV diastolic transverse strain imaging by 2D-STE at ED increase the sensitivity, specificity and accuracy to predict the presence of ACS in diabetic patients with chest pain, as well as non-diabetic patients. (UMIN000013859). Figure 1. Transverse Strain (SI-DI): AUC (95% CI) Funding Acknowledgement Type of funding source: None

Objective This study aimed to investigate the prognostic impact of the decrease in tricuspid regurgitation pressure gradient (TRPG) at 6-month follow-up in patients after discharge with heart failure (HF). Background No previous study has reported the association between TRPG decrease during follow-up and clinical outcomes in HF. Methods Among 748 patients with 6-months follow-up echocardiography after discharge from the acute decompensated heart failure in 19 centers in Japan, we analyzed 721 patients with available TRPG data and divided into two groups: the decrease in TRPG group (N=179) and no decrease in TRPG group (N=542). We defined the decrease in TRPG as >10mmHg decrease compared in the initial hospitalization. The primary outcome measure was a composite of all cause deaths and hospitalization due to HF. Results The patients in the decrease in TRPG group had a lower prevalence of hypertension, dyslipidemia, atrial fibrillation, and a reduced EF, higher levels of blood albumin and lower levels of sodium than those in no decrease in TRPG group. The median follow-up duration after the follow up echocardiography was 302 (inter quartile range: 206–490), with a 90.9% follow up rate at 6-month. The cumulative 6-month incidence of the primary outcome measure was significantly lower in the decrease in TRPG group than in no decrease in TRPG group (12.2% vs. 18.9%, P=0.0011). After adjusting confounders, the excess risk of the decrease in TRPG relative to no decrease in TRPG for the primary outcome measure remained significant (HR: 0.60, 95% CI 0.34–0.99). There were no significant interactions between the subgroup factors and the effect of the decrease in TRPG for primary outcomes. Conclusions HF patients with the decrease in TRPG at 6-month after discharge had a lower risk of clinical outcome than those without decrease in TRPG. Funding Acknowledgement Type of funding source: None

OBJECTIVES To evaluate utility of the complex percutaneous coronary intervention (PCI) criteria in real-world practice. BACKGROUND Applicability of procedural complexity criteria for risk stratification has not been adequately evaluated in real-world practice. METHODS Among 13,087 patients undergoing first PCI in the CREDO-Kyoto registry cohort-2, the study population consisted of 7,871 patients after excluding patients with acute myocardial infarction and those without stent implantation. Complex PCI was defined as PCI, which fulfills at least one of the followings: three vessels treated, > = 3 stents implanted, > = 3 lesions treated, bifurcation with two stents, >60 mm total stent lengths, and target of chronic total occlusion. RESULTS The cumulative incidences of and adjusted risks for the primary ischemic (myocardial infarction/ischemic stroke), and bleeding (GUSTO moderate/severe) endpoints were significantly higher in patients with complex PCI (N = 2,777 [35%]) than in those with noncomplex PCI (N = 5,094 [65%]) (15.4% vs. 10.9%, log-rank p

Long-term safety of percutaneous coronary intervention (PCI) as compared with coronary artery bypass grafting (CABG) is still controversial in patients with unprotected left main coronary artery disease (ULMCAD), and there is a scarcity of real-world data on the comparative long-term clinical outcomes between PCI and CABG for ULMCAD in new-generation drug-eluting stents era. The CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients undergoing first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013, and we identified 855 patients with ULMCAD (PCI: N = 383 [45%], and CABG: N = 472 [55%]). The primary outcome measure was all-cause death. Median follow-up duration was 5.5 (interquartile range: 3.9 to 6.6) years. The cumulative 5-year incidence of all-cause death was not significantly different between the PCI and CABG groups (21.9% vs 17.6%, Log-rank p = 0.13). After adjusting confounders, the excess risk of PCI relative to CABG remained insignificant for all-cause death (HR, 1.00; 95% CI, 0.68 to 1.47; p = 0.99). There were significant excess risks of PCI relative to CABG for myocardial infarction and any coronary revascularization (HR, 2.07; 95% CI, 1.30 to 3.37; p = 0.002, and HR, 2.96; 95% CI, 1.96 to 4.46; p0.001), whereas there was no significant excess risk of PCI relative to CABG for stroke (HR, 0.85; 95% CI, 0.50 to 1.41; p = 0.52). In conclusion, there was no excess long-term mortality risk of PCI relative to CABG, while the excess risks of PCI relative to CABG were significant for myocardial infarction and any coronary revascularization in the present study population reflecting real-world clinical practice in Japan.

The prognostic implications of very low body mass index (BMI) values remain unclear in patients with acute decompensated heart failure (ADHF). This study aimed to investigate the prognostic impact of BMI classification based on the World Health Organization criteria in patients with ADHF. Among 3509 patients with ADHF and available BMI data at discharge in 19 participating hospitals in Japan between October 2014 and March 2016, the study population was divided into five groups; (1) Severely underweight: BMI 2, (2) Underweight: BMI ≥ 16 kg/m2 and 2, (3) Normal weight: BMI ≥ 18.5 kg/m2 and 2, (4) Overweight: BMI ≥ 25 kg/m2 and 2 (5) Obese: BMI ≥ 30 kg/m2. The primary outcome measure was all-cause death. The median follow-up duration was 471 days, with 96.4% follow up at 1-year. The cumulative 1-year incidence of all-cause death was higher in underweight groups, and lower in overweight groups (Severely underweight: 36.3%, Underweight: 23.9%, Normal weight: 14.4%, Overweight: 7.9%, and Obese: 9.0%, P P P = 0.005) relative to the normal weight group, while the lower mortality risk was no longer significant in the overweight group (HR, 0.82; 95%CI, 0.62–1.10; P = 0.18) and in the obese group (HR, 1.09; 95%CI, 0.65–1.85; P = 0.74). Very low BMI was associated with a higher risk for one-year mortality after discharge in patients with ADHF.

BACKGROUND Patients with cancer-associated venous thromboembolism (VTE) are at high risk for recurrent VTE and are recommended to receive prolonged anticoagulation therapy if they are at a low risk for bleeding. However, there are no established risk factors for bleeding during anticoagulation therapy.Methods and Results:The COMMAND VTE Registry is a multicenter retrospective registry enrolling 3,027 consecutive patients with acute symptomatic VTE among 29 Japanese centers. The present study population consisted of 592 cancer-associated VTE patients with anticoagulation therapy. We constructed a multivariable Cox proportional hazard model to estimate the hazard ratio (HR) and 95% confidence interval (CI) of the potential risk factors for major bleeding. During a median follow-up period of 199 days, major bleeding occurred in 72 patients. The cumulative incidence of major bleeding was 5.8% at 3 months, 13.8% at 1 year, 17.5% at 2 years, and 28.1% at 5 years. The most frequent major bleeding site was gastrointestinal tract (47%). Terminal cancer (adjusted HR, 4.17; 95% CI, 2.22-7.85, P

Cerebrospinal fluid drainage (CSFD) is recommended as a spinal cord protective strategy in open and endovascular thoracic aortic repair. Although small studies support the use of CSFD, systematic reviews have not suggested definite conclusion and a large-scale study is needed. Therefore, we reviewed medical records of patients who had undergone descending and thoracoabdominal aortic repair (both open and endovascular repair) at multiple institutions to assess the association between CSFD and postoperative motor deficits. Patients included in this study underwent descending or thoracoabdominal aortic repair between 2000 and 2013 at 12 hospitals belonging to the Japanese Association of Spinal Cord Protection in Aortic Surgery. We conducted a retrospective study to investigate whether motor-evoked potential monitoring is effective in reducing motor deficits in thoracic aortic aneurysm repair. We use the same dataset to examine whether CSFD reduces motor deficits after propensity score matching. We reviewed data from 1214 patients [open surgery, 601 (49.5%); endovascular repair, 613 (50.5%)]. CSFD was performed in 417 patients and not performed in the remaining 797 patients. Postoperative motor deficits were observed in 75 (6.2%) patients at discharge. After propensity score matching (n = 700), mixed-effects logistic regression performed revealed that CSFD is associated with postoperative motor deficits at discharge [adjusted odds ratio (OR), 3.87; 95% confidence interval (CI), 2.30–6.51]. CSFD may not be effective for postoperative motor deficits at discharge.

It remains unclear the clinical characteristics and prognosis of implantable cardioverter defibrillator (ICD) on prevention for sudden cardiac death (SCD) in Japanese patients with acute decompensated heart failure (ADHF) and reduced left ventricular ejection fraction (LVEF). We investigated the prevalence, clinical characteristics, and clinical outcomes in a contemporary large-scale Japanese ADHF registry.Among the consecutive 3785 patients hospitalized for ADHF and discharged alive in the Kyoto Congestive Heart Failure registry, we identified 1409 patients with reduced LVEF (ICD: N = 115, non-ICD: N = 1294).Patients in the ICD group were younger (69.3 ± 12.9/74.2 ± 13.6 years; p0.001), more likely to be men (84%/65%), and more often had a history of heart failure hospitalization (70%/36%; p = 0.001), cardiomyopathy as the underlying heart disease (51%/27%; p0.001), and previous serious ventricular arrhythmia (57%/3.8%; p0.001), and had lower LVEF (25.4±7.4%/29.5±6.9%; p0.001), and estimated glomerular filtration rate (43.0±19.7/47.8±23.4 mL/min/1.73m2; p = 0.04) than those in the non-ICD group. The cumulative 1-year incidence of the primary arrhythmic composite endpoint of SCD, arrhythmic death, or resuscitated cardiac arrest trended to be lower in the ICD group than in the non-ICD group (0.0% versus 3.4%, p = 0.053), and the lower adjusted risk of the ICD group relative to the non-ICD group was significant for the primary arrhythmic endpoint (HR 0.10, 95% CI, 0.01-0.53; p = 0.003). However, there were no differences in the cumulative incidences of all-cause death between the ICD and non-ICD groups (17.3% versus 17.5%, p = 0.68), and the adjusted risk of the ICD group relative to the non-ICD group remained insignificant for all-cause death (HR, 0.85; 95%CI, 0.52-1.36, p = 0.51).This study elucidated the real-world features of ADHF patients between those with ICD and those without. ICD use in patients with ADHF and reduced LVEF as compared with non-ICD use was associated with significant risk reduction for arrhythmic events, but not for mortality.

ObjectiveThis observational study aimed to examine the prognostic association of angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin receptor blockers (ARB) in different left ventricular ejection fraction (LVEF) categories.MethodsIn 3717 patients enrolled in the KCHF Registry, a multicentre registry including consecutive patients hospitalized for acute heart failure (HF), we assessed patient characteristics and association between ACE-I/ARB and clinical outcomes according to LVEF. In the three LVEF categories (reduced LVEF [HFrEF], mid-range LVEF [HFmrEF] and preserved LVEF [HFpEF]), we compared the patients with ACE-I/ARB as discharge medication and those without, and assessed their 1-year clinical outcomes. We defined the primary outcome measure as a composite of all-cause death and HF hospitalization.ResultsThe 1-year cumulative incidences of the primary outcome measure were 36.3% in HFrEF, 30.1% in HFmrEF and 33.8% in HFpEF (log-rank P = 0.07). The adjusted risks of the ACE-I/ARB group relative to the no ACE-I/ARB group for the primary outcome measure were significantly lower in HFrEF and HFmrEF (HR 0.66 [95%CI 0.54-0.79], PConclusionsACE-I/ARB for patients who were hospitalized for acute HF was associated with significantly lower risk for a composite of all-cause death and HF hospitalization in HFrEF and HFmrEF, but not in HFpEF. ACE-I/ARB might be a potential treatment option in HFmrEF as in HFrEF.

Introduction The external validation of the modified Ottawa score to predict the risk of recurrence in patients with cancer-associated venous thromboembolism (VTE) has not yet been firmly established. The present study aimed to evaluate the utility and limitations of the modified Ottawa score in the risk stratification of recurrent VTE in patients with cancer-associated VTE. Materials and methods The COMMAND VTE Registry is a multicenter retrospective registry enrolling 3027 consecutive patients with acute symptomatic VTE among 29 Japanese centers. The present study population consisted of 614 cancer-associated VTE patients, who were divided into 3 groups; High-risk group: 202 patients (33%) with a modified Ottawa score ≥ 1, Intermediate-risk group: 269 patients (44%) with a score = 0, and Low-risk group: 143 patients (23%) with a score ≤ −1. Results Recurrent VTE occurred in 39 patients on anticoagulation therapy within 6 months. The cumulative incidence of recurrent VTE substantially increased in the higher risk categories by the modified Ottawa score (high-risk group: 13.6% [95%CI, 8.9%–20.2%], intermediate-risk group: 5.9% [95%CI, 3.5%–9.8%], and low-risk group: 3.0% [95%CI, 1.1%–7.8%], P = .02). The discriminating power of the score was modest with a C-statistic of 0.63. Each score component of the score had a different impact on recurrent events with a variable effect size. Conclusions The risks of recurrence in patients with cancer-associated VTE substantially increased in the higher risk categories by using the modified Ottawa score, but the discriminating power of the score for recurrence was modest with a variable impact of each score component on recurrent events.

The high controlling nutritional status (CONUT) score that represents poor nutritional status has been acknowledged to have prognostic implications in chronic heart failure. We aimed to investigate its role in acute decompensated heart failure (ADHF). Using the data from an multicenter registry that enrolled 4056 consecutive patients hospitalized for ADHF in Japan between 2014 and 2016, we analyzed 2466 patients in whom data on the components of the CONUT score at hospital presentation were available. The decrease of lymphocyte count and total cholesterol was assigned with 0, 1, 2, and 3 points and the decrease of albumin was assigned with 0, 2, 4, and 6 points according to the severity. We defined low CONUT score as 0–4 (N = 1568) and high CONUT score as 5–9 (N = 898). The patients in the high CONUT score group were older and more likely to have a smaller body mass index than those in the low CONUT score group. The high CONUT score group was associated with higher rate of death and infection during the index hospitalization compared to the low CONUT score group (9.0% versus 4.4%, and 21.9% versus 12.7%, respectively). After adjusting for confounders, the excess risk of high relative to low CONUT score for mortality and infection was significant (OR: 1.61, 95%CI: 1.05–2.44, and OR: 1.66, 95%CI: 1.30–2.12, respectively). The effect was incremental according to the score. High CONUT score was associated with higher risk for in-hospital mortality and infection in an incremental manner in patients hospitalized for ADHF.

ObjectiveTo investigate the prevalence and risk factors of functional decline during hospitalisation and its relationship with postdischarge outcomes in very old patients with acute decompensated heart failure (ADHF) hospitalisation.DesignProspective cohort study between 1 October 2014 and 31 March 2016.SettingA physician-initiated, multicentre study of consecutive patients admitted for ADHF in 19 hospitals throughout Japan.ParticipantsAmong 3555 patients hospitalised for ADHF (median age (IQR), 80 (71–86) years; 1572 (44%) women), functional decline during the index hospitalisation occurred in 528 patients (15%).Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or heart failure (HF) hospitalisation after discharge. The secondary outcome measures were all-cause death, HF hospitalisation, and a composite of all-cause death or all-cause hospitalisation.ResultsThe independent risk factors for functional decline included age ≥80 years (OR 2.71; 95% CI 2.09 to 3.51), female (OR 1.32; 95% CI 1.05 to 1.67), prior stroke (OR 1.67; 95% CI 1.28 to 2.19), dementia (OR 2.26; 95% CI 1.74 to 2.95), ambulatory before admission (OR 1.74; 95% CI 1.29 to 2.35), elevated body temperature (OR 1.91; 95% CI 1.31 to 2.79), New York Heart Association class III or IV on admission (OR 1.54; 95% CI 1.07 to 2.22), decreased albumin levels (OR 1.76; 95% CI 1.32 to 2.34), hyponatraemia (OR 1.49; 95% CI 1.10 to 2.03) and renal dysfunction (OR 1.55; 95% CI 1.22 to 1.98), after multivariable adjustment. The cumulative 1-year incidence of the primary outcome in the functional decline group was significantly higher than that in the no functional decline group (50% vs 31%, log-rank pConclusionsIndependent risk factors of functional decline in very old patients with ADHF were related to both frailty and severity of HF. Functional decline during ADHF hospitalisation was associated with unfavourable postdischarge outcomes.Trial registration numberNCT02334891UMIN000015238.

BACKGROUND The effect of diabetes mellitus (DM) status on the long-term risk for heart failure (HF) in patients undergoing coronary revascularization has not been adequately evaluated.Methods and Results:In this study, 15,231 patients who underwent coronary revascularization in the CREDO-Kyoto Registry Cohort-2 were divided into 2 groups according to DM status (DM group: n=5,999; Non-DM group: n=9,232). The DM group was further divided into 2 groups according to insulin treatment (insulin-treated DM [ITDM]: n=1,353; non-insulin-treated DM [NITDM]: n=4,646). The primary outcome measure was HF hospitalization. The cumulative 5-year incidence of HF hospitalization was significantly higher in the DM than non-DM group (11.0% vs. 6.6%, respectively; log-rank P

Background Recently, direct oral anticoagulants have been introduced for venous thromboembolism ( VTE ), which might change the management strategies of VTE . However, there have been limited data on the current real‐world practice pattern for VTE in Asian countries. Methods and Results The JROAD‐DPC (Japanese Registry of All Cardiac and Vascular Diseases\xF6Diagnosis Procedure Combination) is a nationwide claim database from 1022 hospitals in Japan between April 2012 and March 2017. We identified 54 369 patients who were hospitalized with a diagnosis of VTE at admission based on the International Classification of Diseases, Tenth Revision ( ICD‐10 ) code. The mean age was 69.1±15.6 years, 59% were women, and mean body mass index was 23.5±5.0 kg/m 2 . The proportion of patients with deep vein thrombosis decreased over time from 72% in 2012 to 38% in 2017. After the release of direct oral anticoagulants, the proportion of patients receiving direct oral anticoagulants increased dramatically among patients with anticoagulation therapy at discharge with the use of edoxaban, rivaroxaban, and apixaban in 35%, 22%, and 27% of patients, respectively, in 2017. On the other hand, the proportion of patients receiving warfarin decreased from 94% in 2012 to 15% in 2017. The median length of a hospital stay decreased over time from 20 days in 2012 to 13 days in 2017 in patients with pulmonary embolism, and from 14 days in 2012 to 12 days in 2017 in patients with deep vein thrombosis. The median cost of hospitalization for pulmonary embolism moderately decreased over time, whereas that for deep vein thrombosis slightly decreased over time. Conclusions A nationwide claim‐based database provided the current practice pattern for VTE in Japan, which revealed dynamic changes after the release of direct oral anticoagulants. Clinical Trial Registration URL : www.umin.ac.jp . Unique identifier: UMIN 000037868.