Publications by authors named "Shun Kohsaka"

286 Publications

Patient Perspectives in the Era of Remote Medical Visits During the Coronavirus Disease (COVID-19) Pandemic - Insights From Outpatient Care of Cardiovascular Disease.

Circ Rep 2021 Apr 28;3(5):300-303. Epub 2021 Apr 28.

Department of Cardiology, Keio University School of Medicine Tokyo Japan.

Patient perspectives in cardiovascular diseases (CVD) are significantly associated with clinical outcomes. Among 100 patients who responded to a telephone survey in a university hospital setting in Tokyo during the coronavirus disease (COVID-19) pandemic, 20% reported depressive symptoms and 33% were hesitant to contact medical staff in the event of CVD exacerbation. Interestingly, the frequency of depressive symptoms was maintained even after a decline in the number of newly COVID-19-infected patients. Our telemedicine practices revealed the magnitude of our patients' mental health conditions and their hesitation to contact medical facilities in the event of CVD exacerbation.
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http://dx.doi.org/10.1253/circrep.CR-21-0039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099663PMC
April 2021

Cardiovascular and Renal Outcomes Associated With Hyperkalemia in Chronic Kidney Disease: A Hospital-Based Cohort Study.

Mayo Clin Proc Innov Qual Outcomes 2021 Apr 19;5(2):274-285. Epub 2021 Jan 19.

Cardiovascular, Renal, and Metabolism, Medical Affairs, AstraZeneca KK, Osaka, Japan.

Objective: To examine the association between hyperkalemia and long-term cardiovascular and renal outcomes in patients with chronic kidney disease.

Patients And Methods: An observational retrospective cohort study was performed using a Japanese hospital claims registry, Medical Data Vision (April 1, 2008, to September 30, 2018). Of 1,208,894 patients with at least 1 potassium measurement, 167,465 patients with chronic kidney disease were selected based on codes or estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m. Hyperkalemia was defined as at least 2 potassium measurements of 5.1 mmol/L or greater within 12 months. Normokalemic controls were patients without a record of potassium levels of 5.1 mmol/L or greater and 3.5 mmol/L or less. Changes in eGFRs and hazard ratios of death, hospitalization for cardiac events, heart failure, and renal replacement therapy introduction were assessed between propensity score-matched hyperkalemic patients and normokalemic controls.

Results: Of 16,133 hyperkalemic patients and 11,898 normokalemic controls eligible for analyses, 5859 (36.3%) patients and 5859 (49.2%) controls were selected after propensity score matching. The mean follow-up period was 3.5 years. The 3-year eGFR change in patients and controls was -5.75 and -1.79 mL/min/1.73 m, respectively. Overall, hyperkalemic patients had higher risks for death, hospitalization for cardiac events, heart failure, and renal replacement therapy introduction than controls, with hazard ratios of 4.40 (95% CI, 3.74 to 5.18), 1.95 (95% CI, 1.59 to 2.39), 5.09 (95% CI, 4.17 to 6.21), and 7.54 (95% CI, 5.73 to 9.91), respectively.

Conclusion: Hyperkalemia was associated with significant risks for mortality and adverse clinical outcomes, with more rapid decline of renal function. These findings underscore the significance of hyperkalemia as a predisposition to future adverse events in patients with chronic kidney disease.
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http://dx.doi.org/10.1016/j.mayocpiqo.2020.10.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8105529PMC
April 2021

Clinical and Biomarker Profiles and Prognosis of Elderly Patients With Coronavirus Disease 2019 (COVID-19) With Cardiovascular Diseases and/or Risk Factors.

Circ J 2021 05 29;85(6):921-928. Epub 2021 Apr 29.

Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine.

Background: This study investigated the effects of age on the outcomes of coronavirus disease 2019 (COVID-19) and on cardiac biomarker profiles, especially in patients with cardiovascular diseases and/or risk factors (CVDRF).Methods and Results:A nationwide multicenter retrospective study included 1,518 patients with COVID-19. Of these patients, 693 with underlying CVDRF were analyzed; patients were divided into age groups (<55, 55-64, 65-79, and ≥80 years) and in-hospital mortality and age-specific clinical and cardiac biomarker profiles on admission evaluated. Overall, the mean age of patients was 68 years, 449 (64.8%) were male, and 693 (45.7%) had underlying CVDRF. Elderly (≥80 years) patients had a significantly higher risk of in-hospital mortality regardless of concomitant CVDRF than younger patients (P<0.001). Typical characteristics related to COVID-19, including symptoms and abnormal findings on baseline chest X-ray and computed tomography scans, were significantly less prevalent in the elderly group than in the younger groups. However, a significantly (P<0.001) higher proportion of elderly patients were positive for cardiac troponin (cTn), and B-type natriuretic peptide (BNP) and N-terminal pro BNP (NT-proBNP) levels on admission were significantly higher among elderly than younger patients (P<0.001 and P=0.001, respectively).

Conclusions: Elderly patients with COVID-19 had a higher risk of mortality during the hospital course, regardless of their history of CVDRF, were more likely to be cTn positive, and had significantly higher BNP/NT-proBNP levels than younger patients.
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http://dx.doi.org/10.1253/circj.CJ-21-0160DOI Listing
May 2021

Association Between Statin Use Prior to Admission and Lower Coronavirus Disease 2019 (COVID-19) Severity in Patients With Cardiovascular Disease or Risk Factors.

Circ J 2021 05 29;85(6):939-943. Epub 2021 Apr 29.

Department of Cardiovascular Medicine, Toho University Graduate School of Medicine.

Background: Cardiovascular diseases and/or risk factors (CVDRF) have been reported as risk factors for severe coronavirus disease 2019 (COVID-19).Methods and Results:In total, we selected 693 patients with CVDRF from the CLAVIS-COVID database of 1,518 cases in Japan. The mean age was 68 years (35% females). Statin use was reported by 31% patients at admission. Statin users exhibited lower incidence of extracorporeal membrane oxygenation (ECMO) insertion (1.4% vs. 4.6%, odds ratio [OR]: 0.295, P=0.037) and septic shock (1.4% vs. 6.5%, OR: 0.205, P=0.004) despite having more comorbidities such as diabetes mellitus.

Conclusions: This study suggests the potential benefits of statins use against COVID-19.
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http://dx.doi.org/10.1253/circj.CJ-21-0087DOI Listing
May 2021

Abnormal Liver Function Tests and Long-Term Outcomes in Patients Discharged after Acute Heart Failure.

J Clin Med 2021 Apr 16;10(8). Epub 2021 Apr 16.

Department of Cardiology, Sakakibara Heart Institute, Tokyo 183-0003, Japan.

Abnormal liver function tests (LFTs) are known to be associated with impaired clinical outcomes in heart failure (HF) patients. However, this implication varies with each single LFT panel. We aim to evaluate the long-term outcomes of acute HF (AHF) patients by assessing multiple LFT panels in combination. From a prospective multicenter registry in Japan, 1158 AHF patients who were successfully discharged were analyzed (mean age, 73.9 ± 13.5 years; men, 58%). LFTs (i.e., total bilirubin, aspartate aminotransferase or alanine aminotransferase, and alkaline phosphatase) at discharge were assessed; borderline and abnormal LFTs were defined as 1 and ≥2 parameter values above the normal range, respectively. The primary endpoint was composite of all-cause death or HF readmission. At the time of discharge, 28.7% and 8.6% of patients showed borderline and abnormal LFTs, respectively. There were 196 (16.9%) deaths and 298 (25.7%) HF readmissions during a median 12.4-month follow-up period. The abnormal LFTs group had a significantly higher risk of experiencing the composite outcome (adjusted hazard ratio: 1.51, 95% confidence interval: 1.08-2.12, = 0.017), whereas the borderline LFTs group was not associated with higher risk of adverse events when referenced to the normal LFTs group. Among AHF patients, the combined elevation of ≥2 LFT panels at discharge was associated with long-term adverse outcomes.
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http://dx.doi.org/10.3390/jcm10081730DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8072793PMC
April 2021

Revisiting the Role of Guideline-Directed Medical Therapy for Patients with Heart Failure and Severe Functional Mitral Regurgitation.

Cardiol Clin 2021 May;39(2):255-265

Department of Cardiovascular Medicine, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo 192-8508, Japan.

Patients with heart failure often have mitral regurgitation, which can generate a vicious cycle. Medical therapy remains the cornerstone of their treatment in this setting. This review revisits the role of medical therapy and its optimization for severe functional mitral regurgitation in the contemporary era.
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http://dx.doi.org/10.1016/j.ccl.2021.01.008DOI Listing
May 2021

National survey of percutaneous coronary intervention during the COVID-19 pandemic in Japan: second report of the Japanese Association of Cardiovascular Intervention and Therapeutics.

Cardiovasc Interv Ther 2021 Apr 17. Epub 2021 Apr 17.

Department of Cardiology, Tokai University, Isehara, Japan.

Healthcare systems worldwide have been overburdened by the coronavirus disease 2019 (COVID-19) outbreak. Accordingly, hospitals have had to implement strategies to profoundly reorganize activities, which have affected procedures such as primary percutaneous coronary interventions (PCIs). This study aimed to describe changes in PCI practices during the health emergency at the national level. The Japanese Association of Cardiovascular Intervention and Therapeutics performed provided serial surveys of institutions throughout Japan during the pandemic. The data obtained on December, 2020 and February 2021 (during the 2nd wave of pandemic) were compared with the data obtained on August 2020 (1st wave). Primary PCI for STEMI was performed as usual in 99.1%, 98.7%, and 97.5% of institutions in mid-August, mid-December, 2020 and mid-February, 2021, respectively. The COVID-19 screening tests rates in patients were significantly higher during the third wave than during the second wave (54.0% in mid-August, 2020 and 64.6% in mid-February, 2021, P = 0.002). In addition, hospitals reported that personal protective equipment was more available over time (66.4% in mid-August, 2020 and 83.8% in mid-February, 2021, P < 0.001). In conclusion, most institutions surveyed in Japan continued to perform primary PCI as usual for STEMI patients during the second and third waves of the COVID-19 pandemic. In addition, the COVID-19 screening tests were more frequently performed over time.
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http://dx.doi.org/10.1007/s12928-021-00776-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8052934PMC
April 2021

In-hospital outcomes and usage of embolic protection devices in percutaneous coronary intervention for coronary artery bypass grafts: Insights from a Japanese nationwide registry.

Catheter Cardiovasc Interv 2021 Apr 16. Epub 2021 Apr 16.

Division of Cardiovascular Medicine, Department of Internal Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.

Objectives: We evaluated the in-hospital outcomes of percutaneous coronary intervention (PCI) for bypass graft vessels (GV-PCI) compared with those of PCI for native vessels (NV-PCI) using data from the Japanese nationwide coronary intervention registry.

Methods: We included PCI patients (N = 748,229) registered between January 2016 and December 2018 from 1,123 centers. We divided patients into three groups: GV-PCI (n = 2,745); NV-PCI with a prior coronary artery bypass graft (pCABG) (n = 23,932); and NV-PCI without pCABG (n = 721,552).

Results: GV-PCI implementation was low, and most cases of PCI in pCABG patients were performed in native vessels (89.7%) in contemporary Japanese practice. The risk profile of patients with pCABG was higher than that of those without pCABG. Consequently, GV-PCI patients had a significantly higher in-hospital mortality than NV-PCI patients without pCABG after adjusting for covariates (odds ratio [OR] 2.36, 95% confidence interval [CI] 1.66-3.36, p < .001). Of note, embolic protection devices (EPDs) were used in 18% (n = 383) of PCIs for saphenous vein grafts (SVG-PCI) with a significant variation in its use among institutions (number of PCI: hospitals that had never used an EPD vs. EPD used one or more times = 240 vs. 345, p < .001). The EPDs used in the SVG-PCI group had a significantly lower prevalence of the slow-flow phenomenon after adjusting for covariates (OR 0.45, 95% CI 0.21-0.91, p = .04).

Conclusion: GV-PCI is associated with an increased risk of in-hospital mortality. EDP use in SVG-PCI was associated with a low rate of the slow-flow phenomenon. The usage of EPDs during SVG-PCI is low, with a significant variation among institutions.
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http://dx.doi.org/10.1002/ccd.29695DOI Listing
April 2021

Healthcare resource utilization after initiation of sodium-glucose co-transporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors or other glucose-lowering drugs in Japanese patients with type 2 diabetes.

Diabetes Obes Metab 2021 Apr;23 Suppl 2:28-39

Cardiovascular, Renal, and Metabolism, Medical Affairs, AstraZeneca K.K., Osaka, Japan.

Aim: To examine healthcare resource utilization in type 2 diabetes (T2D) patients after initiation of sodium-glucose co-transporter-2 inhibitors (SGLT-2is) versus dipeptidyl peptidase-4 inhibitors (DPP-4is) or other glucose-lowering drugs (oGLDs).

Materials And Methods: A cost-utilization analysis was performed using a nationwide hospital-based administrative claims database (Medical Data Vision) during 2014-2018 in Japan, where universal healthcare coverage is maintained under a single-payer system. Data on T2D patients initiated on either SGLT-2is or oGLDs during the study period (228 514 patients) were extracted and subjected to a 1:1 propensity score-matching analysis (7626 patient pairs for DPP-4is and 28 484 for oGLDs). Direct healthcare resource utilizations and inpatient and outpatient costs were compared.

Results: After matching, baseline characteristics were well balanced, including healthcare costs within 3 and 12 months before the index date (standardized difference <5% for all variables), with a mean age of 61.6-64.1 years. While diabetes medication costs were higher in patients initiated with SGLT-2is than in those initiated with DPP-4is or oGLDs, further breakdown of individual cost components showed that SGLT-2is were associated with a lower hospitalization frequency and a shorter total hospital stay (by 213.0 or 204.6 days/100 patient-years compared with DPP-4is or oGLDs, respectively; P < .001). Accordingly, overall mean cumulative cost per patient at the 2.5-year postindex date was lower in patients with SGLT-2is than in those with DPP-4is or oGLDs by $2545 (1384.6-3759.7) and $2330 (1793.1-2882.9), respectively (P < .001).

Conclusions: Our results show the benefits in healthcare resource utilization associated with SGLT-2i use in Japanese T2D patients.
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http://dx.doi.org/10.1111/dom.14289DOI Listing
April 2021

Current trends in diabetes mellitus database research in Japan.

Diabetes Obes Metab 2021 Apr;23 Suppl 2:3-18

Cardiovascular, Renal, and Metabolism, Medical Affairs, AstraZeneca K.K., Osaka, Japan.

With the widespread use of electronic medical records and administrative claims databases, analytic results from so-called real-world data have become increasingly important in healthcare decision-making. Diabetes mellitus is a heterogeneous condition that involves a broad spectrum of patients. Real-world database studies have been recognised as a powerful tool to understand the impact of current practices on clinical courses and outcomes, such as long-term glucose control, development of microvascular or macro-vascular diseases, and mortality. Diabetes is also a major global health issue and poses a significant social and economic burden worldwide. Therefore, it is critical to understand the epidemiology, clinical course, treatment reality, and long-term outcomes of diabetes to determine realistic solutions to a variety of disease-related issues that we are facing. In the present review, we summarise the healthcare system and large-scale databases currently available in Japan, introduce the results from recent database studies involving Japanese patients with diabetes, and discuss future opportunities and challenges for the use of databases in the management of diabetes.
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http://dx.doi.org/10.1111/dom.14325DOI Listing
April 2021

Prediction of sudden arrhythmic death in patients with heart failure: towards validation in a worldwide broader range of patients.

Eur Heart J 2021 Mar 18. Epub 2021 Mar 18.

Department of Cardiology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan.

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http://dx.doi.org/10.1093/eurheartj/ehab159DOI Listing
March 2021

Design of the Japanese Comprehensive Health-Economic Assessment for Appropriate Cardiac Imaging Strategy Including Outcome and Cost-Effectiveness in Stable Coronary Artery Disease Study (J-CONCIOUS).

Circ Rep 2020 Nov 17;2(12):759-763. Epub 2020 Nov 17.

Division of Cardiovascular Medicine, Toho University Ohashi Medical Center Tokyo Japan.

The evaluation of stable coronary artery disease (SCAD) has evolved, and contemporary clinical practice guidelines emphasize the importance of in-depth consideration of procedure indications, risk stratification, and results of non-invasive imaging tests. However, little is known about the appropriate selection of imaging modalities for ischemia evaluation and the comparative cost-effectiveness in real-world clinical practice. The Japanese Comprehensive Health-Economic Assessment for Appropriate Cardiac Imaging Strategy including Outcome and cost-effectiveness in Stable Coronary Artery Disease Study (J-CONCIOUS), a multicenter observational study, was designed to prospectively enroll 2,500 patients with suspected or known SCAD, register clinical information and administrative records, and follow patients for 3 years. Any diagnostic or cardiac imaging modality (including stress tests using electrocardiography, echocardiography, or myocardial perfusion imaging; coronary computed tomographic angiography; and/or invasive coronary angiography with or without fractional flow reserve assessment) is acceptable. Clinical endpoints, such as all-cause mortality, cardiac death, and non-fatal myocardial infarction, will be obtained, along with quality of life assessment using the Seattle Angina Questionnaire. The cost-effectiveness of individual assessment patterns will be quantified by analysis of Diagnosis Procedure Combination (DPC) data, and quality-adjusted life years and the incremental cost-effectiveness ratio will be calculated. J-CONCIOUS is expected to establish a risk-based and cost-effective imaging strategy for the detection and evaluation of functional myocardial ischemia and/or anatomical coronary imaging in Japan.
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http://dx.doi.org/10.1253/circrep.CR-20-0109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937523PMC
November 2020

Transcatheter Aortic Valve Replacement in Patients With a Small Annulus - From the Japanese Nationwide Registry (J-TVT).

Circ J 2021 Feb 27. Epub 2021 Feb 27.

Department of Cardiovascular Medicine, Kitasato University.

Background: The details and consequences of a small aortic annulus among transcatheter aortic valve replacement (TAVR) patients remain uncertain. This study investigated the short-term outcomes in patients with small annular size and compared the 30-day outcome between intra- and supra-annular devices, with similar outer casing diameter in this subgroup.Methods and Results:Cases registered in the Japanese national TAVR registry between August 2013 and December 2017 were analyzed. Among a total of 5,870 registered patients, 647 (11.0%) had small annulus (area ≤314 mm) measured by multi-detector computed tomography. Patients with a small annulus had a significantly smaller indexed effective orifice area (iEOA, 1.10 cm/m[0.92-1.35] vs. 1.16 cm/m[0.96-1.39], P<0.001) and higher mean pressure gradient (mPG, 10.0 mmHg [6.9-14.2] vs. 8.5 mmHg [6.0-11.5], P<0.001) compared with a normal-sized annulus. Among patients with a small annulus, those receiving a 20 mm intra-annular device had a smaller iEOA (0.94 cm/m[0.78-1.06] vs. 1.07 cm/m[0.8-1.24], P=0.001) and higher mPG (14.0 mmHg [10.0-18.5] vs. 11.0 [7.0-14.0], P<0.001) compared with those receiving a 23-mm supra-annular device, although the incidence of paravalvular leakage (≥moderate) was similar (14.4% vs. 16.5%, P=0.69).

Conclusions: Patients with a small annulus were associated with less hemodynamic improvement. A supra-annular device is associated with better echocardiographic improvement in patients with a small annulus, without increasing paravalvular leakage.
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http://dx.doi.org/10.1253/circj.CJ-20-1084DOI Listing
February 2021

Frequent nightmares and its associations with psychological and sleep disturbances in hospitalized patients with cardiovascular diseases.

Eur J Cardiovasc Nurs 2020 Dec 17. Epub 2020 Dec 17.

Division of Cardiology, Department of Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.

Aims: Frequent nightmares can pose a serious clinical problem, especially in association with sleep and psychological disturbances, in the general population. However, this association has not been investigated in inpatients with cardiovascular (CV) diseases. Furthermore, whether CV medications could induce iatrogenic nightmares remains unknown. In a cross-sectional designed study, we evaluated the prevalence and determinants of frequent nightmares and its association with sleep and psychological disturbances among hospitalized CV patients.

Methods And Results: A total of 1233 patients (mean age, 64 ± 15 years; 25.1% female) hospitalized for various CV diseases in a single university hospital were enrolled. We assessed nightmares and sleep characteristics using the Pittsburgh Sleep Quality Index (PSQI), sleep-disordered breathing (SDB) using nocturnal pulse oximetry, and psychological disturbances using Hospital Anxiety and Depression Scale (HADS). Overall, 14.8% and 3.6% of the patients had at least one nightmare per month and per week (frequent nightmares), respectively. In this cohort, 45.9% had insomnia (modified PSQI > 5), 28.0% had SDB (3% oxygen desaturation index > 15), 18.5% had depression (HADS-depression ≥ 8), and 16.9% had anxiety (HADS-anxiety ≥ 8). Frequent nightmares were not associated with CV medications and SDB but were associated with depression [odds ratio (OR) = 4.61, 95% confidence interval (CI) = 2.03-10.48], anxiety (OR = 5.32, 95% CI = 2.36-12.01), and insomnia (OR = 7.15, 95% CI = 2.41-21.22).

Conclusions: Frequent nightmares were not uncommon in patients hospitalized for CV diseases. Although the cause-effect relationship is unclear, frequent nightmares were associated with psychological disturbances and insomnia, but not iatrogenic factors, among hospitalized CV patients. Cardiologists should be more conscientious to nightmare complaints with respect to screening for psychological disturbances and insomnia.
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http://dx.doi.org/10.1093/eurjcn/zvaa016DOI Listing
December 2020

Association of sodium-glucose cotransporter-2 inhibitors with outcomes in type 2 diabetes with reduced and preserved left ventricular ejection fraction: Analysis from the CVD-REAL 2 study.

Diabetes Obes Metab 2021 Jun 23;23(6):1431-1435. Epub 2021 Mar 23.

Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, Missouri, USA.

This study of real-world data from the Maccabi database in Israel compared the risk of heart failure hospitalization (HHF) or death in patients with type 2 diabetes (T2D) initiating sodium-glucose cotransporter-2 (SGLT2) inhibitors versus other glucose-lowering drugs (OGLDs) according to baseline left ventricular (LV) ejection fraction (EF). After propensity-matching patients by baseline EF there were 10 614 episodes of treatment initiation; 57% had diabetes for >10 years, the mean glycated haemoglobin level was 66 mmol/mol (8.2%), ∼43% had cardiovascular disease, ∼7% had heart failure and ∼ 20% had chronic kidney disease. A total of 2876 patients (∼9%) had reduced EF (<50%). Over a mean follow-up of 1.5 years there were 371 HHFs or deaths, 88 (23.7%) in patients with reduced EF. Initiation of SGLT2 inhibitors versus OGLDs was associated with lower risk of HHF or death overall (hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.46-0.70]; P < 0.001) and in patients with both reduced EF (HR 0.61, 95% CI 0.40-0.93) and preserved EF (HR 0.55, 95% CI 0.43-0.70), with no significant heterogeneity (P = 0.72). Our findings from real-world clinical practice show that the lower risk of HHF and death associated with use of SGLT2 inhibitors versus OGLDs is consistent in T2D patients with both reduced and preserved EF.
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http://dx.doi.org/10.1111/dom.14356DOI Listing
June 2021

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

Am Heart J 2021 May 17;235:113-124. Epub 2021 Jan 17.

Department of Cardiology, Keio University School of Medicine, Tokyo, Japan. Electronic address:

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.
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http://dx.doi.org/10.1016/j.ahj.2021.01.010DOI Listing
May 2021

To the Future and Beyond: Recent Advances in the Application of Percutaneous Coronary Intervention.

Authors:
Shun Kohsaka

J Clin Med 2021 Jan 6;10(2). Epub 2021 Jan 6.

Department of Cardiology, Keio University School of Medicine, Shinanomachi 35, Shinjuku-ku, Tokyo 160-8582, Japan.

We are very fortunate to be practicing interventional cardiology during an era of rapid clinical and technological evolution, which allows us to offer potentially life-saving options for challenging cardiac conditions [...].
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http://dx.doi.org/10.3390/jcm10020177DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7825296PMC
January 2021

Psychological disturbances and their association with sleep disturbances in patients admitted for cardiovascular diseases.

PLoS One 2021 4;16(1):e0244484. Epub 2021 Jan 4.

Division of Cardiology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan.

Background: Depression and anxiety are common mental health problems that are strongly associated with sleep disturbances, according to community-based researches. However, this association has not been investigated among patients admitted for cardiovascular diseases (CVDs). We examined the prevalence of depression and anxiety in inpatients with various CVDs and their association with sleep disturbances.

Materials And Methods: This cross-sectional study included 1294 patients hospitalized for CVDs in a Japanese university hospital were evaluated for their mental status using the Hospital Anxiety and Depression Scale (HADS), for sleep-disordered breathing (SDB) using pulse oximetry, and for sleep quality using the Pittsburgh Sleep Quality Index (PSQI).

Results: Patient characteristics were as below: mean age, 63.9±14.7 years; 25.7% female. Overall, 18.9% had depression (HADS-depression≥8) and 17.1% had anxiety (HADS-anxiety≥8). The presence of depression was associated with female sex, older age, higher plasma brain natriuretic peptide level, lower estimated glomerular filtration rate, and the prevalence of heart failure. Overall, 46.5% patients were categorized as having a poor sleep quality (PSQI>5), and 28.5% patients had SDB (3% oxygen desaturation index>15). Although depression and anxiety were not associated with SDB, they were independently associated with poor sleep quality (OR = 3.09, 95% CI 2.19-4.36; OR = 3.93, 95% CI 2.71-5.69, respectively).

Conclusions: Depression and anxiety were not uncommon in patients with CVDs. Poor sleep quality could be an important risk factor linked to psychological disturbances.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0244484PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7781384PMC
April 2021

Symptom Under-Recognition of Atrial Fibrillation Patients in Consideration for Catheter Ablation: A Report From the KiCS-AF Registry.

JACC Clin Electrophysiol 2021 05 24;7(5):565-574. Epub 2020 Dec 24.

Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.

Objectives: This study sought to investigate whether symptom under-recognition is associated with the application of catheter ablation.

Background: Atrial fibrillation (AF) symptom burden is frequently under-recognized and may affect the choice of treatment strategies.

Methods: A total of 3,276 patients with AF consecutively registered in a Japanese multicenter database from 2012 to 2017 were analyzed. All patients underwent AF symptom burden assessment via the symptom and daily activities domain within the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. For the present analysis, 1,173 symptomatic patients (AFEQT score ≤80) with a clinical indication for catheter ablation were included. Under-recognition of symptom burden was defined as no subjective complaints checked by physicians despite self-reported AFEQT scores ≤80. Logistic regression analysis identified the predictors associated with receiving catheter ablation.

Results: Of the 1,173 patients (age: 68 ± 12 years, men: 61%) analyzed, 459 underwent catheter ablation (ablation group); they had lower overall AFEQT scores (p < 0.01 for all domains) compared with the nonablation group. At the 1-year follow-up, greater improvement in the AFEQT scores was noted in the ablation group, even after adjusting for clinically relevant factors (+20.0 ± 1.2, +14.2 ± 0.9, respectively; p < 0.001). Notably, 306 (28%) patients met the criteria for symptom under-recognition, which was associated with the nonuse of catheter ablation during follow-up (odds ratio: 0.41; 95% confidence interval: 0.28 to 0.60; p < 0.001).

Conclusions: Under-recognition of AF symptom burden was frequently noted and was associated with less use of catheter ablation. Standardized recognition of symptoms using the application of validated questionnaires may facilitate outcome improvement.
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http://dx.doi.org/10.1016/j.jacep.2020.10.016DOI Listing
May 2021

Incidence of adverse cardiovascular events in type 2 diabetes mellitus patients after initiation of glucose-lowering agents: A population-based community study from the Shizuoka Kokuho database.

J Diabetes Investig 2020 Dec 21. Epub 2020 Dec 21.

Research Support Center, Shizuoka General Hospital, Shizuoka, Japan.

Aims/introduction: Increased incidence of hospitalization for heart failure (HHF) among patients with diabetes is increasingly being reported. We investigated the incidence of adverse cardiovascular events including HHF among patients with type 2 diabetes mellitus, and the potential clinical improvement with sodium-glucose cotransporter 2 inhibitors (SGLT2i) using a contemporary administrative claims database from a large governmental district of Japan.

Materials And Methods: We included initiators of any oral glucose-lowering drugs between 2013 and 2018. We estimated the 5-year cumulative incidence of hospitalization for HF, myocardial infarction and stroke, treating death as a competing risk. We evaluated the possible impact of introducing SGLT2i to the potential recipients of the drug, using the inclusion criteria from Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58) trials, assuming the same risk reduction as theirs.

Results: Among 23,340 drug initiators (54.0% men, and 6.4% aged >85 years), the 5-year cumulative incidence was 5.4% (95% confidence interval 4.9-5.9%) for HHF, 1.9% (95% confidence interval 1.7-2.2%) for myocardial infarction admission and 6.1% (95% confidence interval 5.7-6.6%) for stroke admission. Among 6,192 patients with laboratory test data, 651 (10.5%) and 2,680 (43.3%) patients met the EMPA-REG-like and DECLARE-like criteria, respectively. The 5-year cumulative incidence among the 2,849 patients meeting either of the criteria was estimated to decrease from 97.1 to 75.6 events through 75% adoption of SGLT2i.

Conclusions: The incidence of HHF was similar to that of stroke. A significant portion of our cohort met the inclusion criteria for major randomized clinical trials for SGLT2i, and estimated reduction in the HHF events was substantial.
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http://dx.doi.org/10.1111/jdi.13485DOI Listing
December 2020

Clinical and Economic Burden of Hyperkalemia: A Nationwide Hospital-Based Cohort Study in Japan.

Kidney Med 2020 Nov-Dec;2(6):742-752.e1. Epub 2020 Oct 17.

Cardiovascular, Renal, and Metabolism, Medical Affairs, AstraZeneca K.K., Osaka, Japan.

Rationale & Objective: Hyperkalemia is a common electrolyte abnormality of chronic kidney disease and heart failure associated with increased mortality and morbidity. We aimed to assess the long-term economic burden of hyperkalemia.

Design: Observational cohort study using a Japanese nationwide hospital claims database (April 1, 2008, to September 30, 2018).

Setting & Population: : Patients 18 years or older with at least 1 serum potassium value (N = 1,208,894).

Exposures: Hyperkalemia defined with the presence of at least 2 serum potassium values ≥ 5.1 mmol/L.

Outcome Measures: Direct health care costs and resource use in patients with hyperkalemia within and after 12 months from first hyperkalemia episodes.

Analytical Approach: Health care costs and resource use were compared with propensity score-matched or nonmatched normokalemic controls. Multivariable regression analysis was performed to examine factors associated with health care costs.

Results: 27,534 patients with hyperkalemia and 233,098 normokalemic controls were studied. Mean ± SD age was 73±13 years in patients with hyperkalemia; among them, 59% and 35% had chronic kidney disease and heart failure, respectively. In the propensity score-matched cohort (n = 5,859 in each group), average numbers of hospitalizations per patient per year in patients with hyperkalemia within and after 12 months were 1.2 and 1.6 times higher, respectively, compared with those in patients with normokalemia. The total cost per patient in patients with hyperkalemia was higher than for controls, with mean differences of $8,611 (95% CI, $8,046-$9,175) within 12 months and $5,150 (95% CI, $4,733-$5,566) after 12 months. The number of repeat hyperkalemic episodes was the factor with the strongest association with long-term health care costs, whereas severity of hyperkalemia was not associated.

Limitations: This study used secondary data; therefore, residual confounders may not be fully excluded.

Conclusions: Hyperkalemia was associated with significant long-term economic burden with frequent hospitalizations due to recurrent episodes, indicating the importance of hyperkalemia treatment for the sake of reducing health economic burdens and clinical complications.
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http://dx.doi.org/10.1016/j.xkme.2020.09.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7729225PMC
October 2020

Time-sensitive approach in the management of acute heart failure.

ESC Heart Fail 2021 Feb 9;8(1):204-221. Epub 2020 Dec 9.

Department of Cardiology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.

Acute heart failure (AHF) has become a global public health burden largely because of the associated high morbidity, mortality, and cost. The treatment options for AHF have remained relatively unchanged over the past decades. Historically, clinical congestion alone has been considered the main target for treatment of acute decompensation in patients with AHF; however, this is an oversimplification of the complex pathophysiology. Within the similar clinical presentation of congestion, significant differences in pathophysiological mechanisms exist between the fluid accumulation and redistribution. Tissue hypoperfusion is another vital characteristic of AHF and should be promptly treated with appropriate interventions. In addition, recent clinical trials of novel therapeutic strategies have shown that heart failure management is 'time sensitive' and suggested that treatment selection based on individual aetiologies, triggers, and risk factor profiles could lead to better outcomes. In this review, we aim to describe the specifics of the 'time-sensitive' approach by the clinical phenotypes, for example, pulmonary/systemic congestion and tissue hypoperfusion, wherein patients are classified based on pathophysiological conditions. This mechanistic classification, in parallel with the comprehensive risk assessment, has become a cornerstone in the management of patients with AHF and thus supports effective decision making by clinicians. We will also highlight how therapeutic modalities should be individualized according to each clinical phenotype.
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http://dx.doi.org/10.1002/ehf2.13139DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835610PMC
February 2021

Association of Diagnostic Coding-Based Frailty and Outcomes in Patients With Heart Failure: A Report From the Veterans Affairs Health System.

J Am Heart Assoc 2020 12 7;9(24):e016502. Epub 2020 Dec 7.

Division of Cardiovascular Medicine Stanford University School of Medicine Stanford CA.

Background The aim of this study was to determine whether frailty is associated with increased admission and mortality risk in the setting of heart failure. Methods and Results This retrospective cohort analysis included patients treated within the Veterans Affairs Health System who had () codes for heart failure on 2 or more dates over a 2-year period. The clinical variables identifiable in claims data, such as demographic variables and markers of physical and cognitive dysfunction, were used to identify patients meeting the frailty phenotype. Of 388 785 extracted patients with coding of heart failure between 2015 and 2018, 163 085 patients (41.9%) with ejection fraction (EF) measurement were included in the present analysis (38.3% with reduced EF and 61.7% with preserved EF). There were 16 660 patients (10.2%) who were identified as frail (9.1% in heart failure with reduced EF and 10.9% in heart failure with preserved EF). Frail patients were older, more often depressed, and were likely to have been admitted in the previous year. One-year all-cause mortality rate was 9.7% and 28.1%, and admission rate was 58.1% and 79.5% for nonfrail and frail patients, respectively. Frailty was associated with mortality and admission risk compared with the nonfrail group (adjusted odds ratio [OR], 1.71; 95% CI, 1.65-1.77 for mortality; adjusted OR, 1.29; 95% CI, 1.24-1.34 for admission) independent of EF. Conclusions Frailty based on diagnostic coding was associated with particularly higher risk of mortality despite adjustment for known clinical variables. Our findings underscore the importance of nontraditional parameters in the prognostic assessment.
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http://dx.doi.org/10.1161/JAHA.120.016502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955364PMC
December 2020

In-Hospital Outcomes after Endovascular Therapy for Acute Limb Ischemia: A Report from a Japanese Nationwide Registry [J-EVT Registry].

J Atheroscler Thromb 2020 Nov 20. Epub 2020 Nov 20.

Division of Cardiovascular Medicine, Tokai University Hospital.

Aim: The aim of the current study was to describe the clinical profile, frequency of in-hospital complications, and predictors of adverse events in patients undergoing endovascular therapy (EVT) for acute limb ischemia (ALI), and to compare them with those of patients undergoing EVT for chronic symptomatic peripheral artery disease (PAD).

Methods: The current study compared 2,398 cases of EVT for ALI with 74,171 cases of EVT for chronic symptomatic PAD performed between January 2015 and December 2018 in Japan. We first compared the clinical profiles of ALI patients with those of PAD patients. We then evaluated the proportion of in-hospital complications and investigated their risk factors in the ALI patients. The association of clinical characteristics with the risk of in-hospital complications was analyzed via logistic regression modeling.

Results: Patients with ALI were older and had a higher prevalence of female sex, impaired mobility, and history of cerebrovascular disease, but a lower prevalence of cardiovascular risk factors and history of coronary artery disease. The proportion of in-hospital EVT-related complications in ALI was 6.1% and was significantly higher compared with those in chronic symptomatic PAD patients (2.0%, P<0.001). Bedridden status (adjusted odds ratio [aOR], 1.74 [1.14 to 2.66]; P=0.010), history of coronary artery disease (aOR, 1.80 [1.21 to 2.68]; P=0.004), and a suprapopliteal lesion (aOR, 1.70 [1.05 to 2.74]; P=0.030) were identified as independent risk factors for in-hospital complications.

Conclusion: The current study demonstrated that ALI patients with significant comorbidities show a higher proportion of in-hospital complications after EVT.
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http://dx.doi.org/10.5551/jat.60053DOI Listing
November 2020

Appropriateness rating for the application of optimal medical therapy and multidisciplinary care among heart failure patients.

ESC Heart Fail 2021 Feb 17;8(1):300-308. Epub 2020 Nov 17.

Sakakibara Heart Institute, Tokyo, Japan.

Aims: Clinical guidelines for improving the patients' quality of care vary in clinical practice, particularly in super-aging societies, like in Japan. We aimed to develop a set of appropriate-use criteria (AUC) for contemporary heart failure (HF) management to assist physicians in decision making.

Methods And Results: With the use of the RAND methodology, a multidisciplinary writing group developed patient-based clinical scenarios in 10 selected key topics, stratified mainly by HF stage, age, and renal function. Nine nationally recognized expert panellists independently rated the clinical scenario appropriateness twice on a scale of 1-9, as 'appropriate' (7-9), 'may be appropriate' (4-6), or 'rarely appropriate' (1-3). Decisions were based on clinical evidence and professional opinions in the context of available resource use and costs. An interactive round-table discussion was held between the first and second ratings; the median score of the nine experts was then assigned to an appropriate-use category. Most clinical scenarios without strong evidence were evaluated as 'may be appropriate'. Frailty assessments in elderly patients (age ≥ 75 years), regardless of the HF stage, and advanced care planning in patients with stage C/D HF, regardless of age, were considered 'appropriate'. For HF with reduced ejection fraction, beta-blocker administration in elderly patients (age ≥ 75 years) with heart rate < 50 b.p.m. and mineral corticosteroid receptor antagonist use in elderly patients (age ≥ 75 years) with an estimated glomerular filtration rate < 30 mL/min/1.73 m were considered 'rarely appropriate'.

Conclusions: The HF management AUC provide a practical guide for physicians regarding scenarios commonly encountered in daily practice.
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http://dx.doi.org/10.1002/ehf2.13062DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835502PMC
February 2021

Association of the Hemoglobin to Serum Creatinine Ratio with In-Hospital Adverse Outcomes after Percutaneous Coronary Intervention among Non-Dialysis Patients: Insights from a Japanese Nationwide Registry (J-PCI Registry).

J Clin Med 2020 Nov 10;9(11). Epub 2020 Nov 10.

Division of Cardiology, Tokai University School of Medicine, Isehara 259-1193, Japan.

Although baseline hemoglobin and renal function are both important predictors of adverse outcomes after percutaneous coronary intervention (PCI), scarce data exist regarding the combined impact of these factors on outcomes. We sought to investigate the impact and threshold value of the hemoglobin to creatinine (Hgb/Cr) ratio, on in-hospital adverse outcomes among non-dialysis patients in a Japanese nationwide registry. We analyzed 157,978 non-dialysis patients who underwent PCI in 884 Japanese medical institutions in 2017. We studied differences in baseline characteristics and in-hospital clinical outcomes among four groups according to their quartiles of the Hgb/Cr ratios. Compared with patients with higher Hgb/Cr ratios, patients with lower ratios were older and had more comorbidities and complex coronary artery disease. Patients with lower hemoglobin and higher creatinine levels had a higher rate of in-hospital adverse outcomes including in-hospital mortality and procedural complications (defined as occurrence of cardiac tamponade, cardiogenic shock after PCI, emergency operation, or bleeding complications that required blood transfusion). On multivariate analyses, Hgb/Cr ratio was inversely associated with in-hospital mortality (odds ratio: 0.91, 95% confidence interval: 0.89-0.92; < 0.001) and bleeding complications (odds ratio: 0.92, 95% confidence interval: 0.90-0.94; < 0.001). Spline curve analysis demonstrated that these risks started to increase when the Hgb/Cr ratio was <15, and elevated exponentially when the ratio was <10. Hgb/Cr ratio is a simple index among non-dialysis patients and is inversely associated with in-hospital mortality and bleeding complications after PCI.
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http://dx.doi.org/10.3390/jcm9113612DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7696709PMC
November 2020

Prognostic Understanding and Preference for the Communication Process with Physicians in Hospitalized Heart Failure Patients.

J Card Fail 2021 Mar 7;27(3):318-326. Epub 2020 Nov 7.

Department of Cardiology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan.

Background: Heart failure (HF) is a highly prevalent, heterogeneous, and life-threatening condition. Precise prognostic understanding is essential for effective decision making, but little is known about patients' attitudes toward prognostic communication with their physicians.

Methods And Results: We conducted a questionnaire survey, consisting of patients' prognostic understanding, preferences for information disclosure, and depressive symptoms, among hospitalized patients with HF (92 items in total). Individual 2-year survival rates were calculated using the Seattle Heart Failure Model, and its agreement level with patient self-expectations of 2-year survival were assessed. A total of 113 patients completed the survey (male 65.5%, median age 75.0 years, interquartile range 66.0-81.0 years). Compared with the Seattle Heart Failure Model prediction, patient expectation of 2-year survival was matched only in 27.8% of patients; their agreement level was low (weighted kappa = 0.11). Notably, 50.9% wished to know "more," although 27.7% felt that they did not have an adequate prognostic discussion. Compared with the known prognostic variables (eg, age and HF severity), logistic regression analysis demonstrated that female and less depressive patients were associated with patients' preference for "more" prognostic discussion.

Conclusions: Patients' overall prognostic understanding was suboptimal. The communication process requires further improvement for patients to accurately understand their HF prognosis and be involved in making a better informed decision.
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http://dx.doi.org/10.1016/j.cardfail.2020.10.009DOI Listing
March 2021

Outcomes With IVUS-Guided PCI.

JACC Cardiovasc Interv 2020 11;13(21):2579-2580

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http://dx.doi.org/10.1016/j.jcin.2020.09.012DOI Listing
November 2020