Details of a Researcher - SHIRAISHI Yasuyuki

Papers - SHIRAISHI Yasuyuki

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JCS/JHFS 2025 Guideline on Diagnosis and Treatment of Heart Failure

Kitai T, Kohsaka S, Kato T, Kato E, Sato K, Teramoto K, Yaku H, Akiyama E, Ando M, Izumi C, Ide T, Iwasaki YK, Ohno Y, Okumura T, Ozasa N, Kaji S, Kashimura T, Kitaoka H, Kinugasa Y, Kinugawa S, Toda K, Nagai T, Nakamura M, Hikoso S, Minamisawa M, Wakasa S, Anchi Y, Oishi S, Okada A, Obokata M, Kagiyama N, Kato NP, Kohno T, Sato T, Shiraishi Y, Tamaki Y, Tamura Y, Nagao K, Nagatomo Y, Nakamura N, Nochioka K, Nomura A, Nomura S, Horiuchi Y, Mizuno A, Murai R, Inomata T, Kuwahara K, Sakata Y, Tsutsui H, Kinugawa K, Japanese Circulation Society and the Japanese Heart Failure Society Joint Working Group

Circulation Journal : Official journal of the Japanese Circulation Society 89 ( 8 ) 1278 - 1444 2025.03

Research paper (scientific journal), ISSN 1346-9843

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Residual pulmonary hypertension and clinical outcomes in acute decompensated heart failure patients stratified by left ventricular ejection fraction

Tanaka DT, Shiraishi Y, Kang R, Kohno T, Shoji S, Okuyama T, Oi Y, Goda A, Nakamaru R, Nagatomo Y, Kitamura M, Sakamoto M, Nomoto M, Mizuno A, Nagoshi T, Kohsaka S, Yoshikawa T.

European Journal of Heart Failure 2025.07

Research paper (scientific journal), Joint Work, Accepted, ISSN 1388-9842

Aims: The precise outcomes for patients with residual pulmonary hypertension (PH) following the optimized treatment of acute decompensated heart failure (ADHF) remain poorly understood. This study aimed to investigate the prognostic association of PH, categorized according to left ventricular ejection fraction (LVEF), in hospitalized ADHF patients.

Methods and results: The WET-HF registry is a multicentre, prospective cohort ADHF registry. Patients were classified into four groups according to tricuspid regurgitation velocity (TRV) and LVEF. PH was defined as peak TRV >2.8 m/s. The primary endpoint was a composite of all-cause mortality and heart failure (HF) rehospitalization at 2 years. In total, 1702 patients had nonPH-HF with LVEF <50% (n = 689 [40.5%]), PH-HF with LVEF <50% (n = 291 [17.1%]), nonPH-HF with LVEF ≥50% (n = 453 [26.6%]), and PH-HF with LVEF ≥50% (n = 269 [15.8%]). A significant difference in the composite endpoint was observed between patients with and without PH (42.3% vs. 30.4%, p < 0.001), with no significant interaction between PH and LVEF. Notably, in the nonPH-HF group, there were significant differences in clinical outcomes between patients with more than 30% B-type natriuretic peptide (BNP) improvement and those with less (composite endpoint 27.5% vs. 41.8%, p < 0.001; all-cause mortality 9.4% vs. 24.6%, p < 0.001; HF rehospitalization 20.2% vs. 32.8%, p = 0.001). However, no such difference was evident in the PH-HF group.

Conclusions: The prognostic importance of residual PH was comparable across both HF with reduced and preserved ejection fraction patients. While the prognostic significance of BNP improvement on clinical outcomes was attenuated in the presence of residual PH, utilizing residual PH for risk stratification effectively identified patients at increased risk of mortality and rehospitalization following ADHF, irrespective of their LVEF.

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Hospital Variability in the Use of Vasoactive Agents in Patients Hospitalized for Acute Decompensated Heart Failure for Clinical Phenotypes

Shiraishi Y, Niimi N, Kohsaka S, Harada K, Kohno T, Takei M, Jimba T, Nakano H, Matsuda J, Shindo A, Kitano D, Tsukamoto S, Koba S, Yamamoto T, Takayama M

Circulation: Cardiovascular Quality and Outcomes 18 ( 3 ) e011270 2024.12

Research paper (scientific journal), Joint Work, Lead author, Accepted, ISSN 19417713

BACKGROUND: The absence of practice standards in vasoactive agent usage for acute decompensated heart failure has resulted in significant treatment variability across hospitals, potentially affecting patient outcomes. This study aimed to assess temporal trends and institutional differences in vasodilator and inotrope/vasopressor utilization among patients with acute decompensated heart failure, considering their clinical phenotypes.
METHODS: Data were extracted from a government-funded multicenter registry covering the Tokyo metropolitan area, comprising consecutive patients hospitalized in intensive/cardiovascular care units with a primary diagnosis of acute decompensated heart failure between January 2013 and December 2021. Clinical phenotypes, that is, pulmonary congestion or tissue hypoperfusion, were defined through a comprehensive assessment of clinical signs and symptoms, vital signs, and laboratory findings. We assessed the frequency and temporal trends in phenotype-based drug utilization of vasoactive agents and investigated institutional characteristics associated with adopting the phenotype-based approach using generalized linear mixed-effects models, with random intercepts to account for hospital-level variability.
RESULTS: Among 37 293 patients (median age, 80 years; 43.7% female), 88.6% and 21.2% had pulmonary congestion and tissue hypoperfusion status, respectively. Throughout the study period, both overall and phenotype-based vasodilator utilizations showed significant declines, with overall usage dropping from 61.4% in 2013 to 48.6% in 2021 (Ptrend<0.001). Conversely, no temporal changes were observed in overall inotrope/vasopressor utilization from 24.6% in 2013 to 25.8% in 2021 or the proportion of phenotype-based utilization. Notably, there was considerable variability in phenotype-based drug utilization among hospitals, with a median ranging from 48.3% to 77.8%. In multivariable-adjusted models, a higher number of board-certified cardiologists were significantly associated with lower rates of phenotype-based vasodilator utilization and reduced inappropriate inotrope/vasopressor utilization, while tertiary care hospitals were linked to more appropriate inotrope/vasopressor utilization.
CONCLUSIONS: Substantial variability existed among hospitals in phenotype-based drug utilization of vasoactive agents for patients with acute decompensated heart failure, highlighting the need for standardized treatment protocols.

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Improved prediction of sudden cardiac death in patients with heart failure through digital processing of electrocardiography.

Shiraishi Y, Goto S, Niimi N, Katsumata Y, Goda A, Takei M, Saji M, Sano M, Fukuda K, Kohno T, Yoshikawa T, Kohsaka S

EP Europace : Journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 25 ( 3 ) 922 - 930 2023.01

Research paper (scientific journal), Lead author, Corresponding author, Accepted, ISSN 1099-5129

Aims: Available predictive models for sudden cardiac death (SCD) in heart failure (HF) patients remain suboptimal. We assessed whether the electrocardiography (ECG)-based artificial intelligence (AI) could better predict SCD, and also whether the combination of the ECG-AI index and conventional predictors of SCD would improve the SCD stratification among HF patients.
Methods and results: In a prospective observational study, 4 tertiary care hospitals in Tokyo enrolled 2559 patients hospitalized for HF who were successfully discharged after acute decompensation. The ECG data during the index hospitalization were extracted from the hospitals' electronic medical record systems. The association of the ECG-AI index and SCD was evaluated with adjustment for left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, and competing risk of non-SCD. The ECG-AI index plus classical predictive guidelines (i.e. LVEF ≤35%, NYHA Class II and III) significantly improved the discriminative value of SCD [receiver operating characteristic area under the curve (ROC-AUC), 0.66 vs. 0.59; P = 0.017; Delong's test] with good calibration (P = 0.11; Hosmer-Lemeshow test) and improved net reclassification [36%; 95% confidence interval (CI), 9-64%; P = 0.009]. The Fine-Gray model considering the competing risk of non-SCD demonstrated that the ECG-AI index was independently associated with SCD (adjusted sub-distributional hazard ratio, 1.25; 95% CI, 1.04-1.49; P = 0.015). An increased proportional risk of SCD vs. non-SCD with an increasing ECG-AI index was also observed (low, 16.7%; intermediate, 18.5%; high, 28.7%; P for trend = 0.023). Similar findings were observed in patients aged ≤75 years with a non-ischaemic aetiology and an LVEF of >35%.
Conclusion: To improve risk stratification of SCD, ECG-based AI may provide additional values in the management of patients with HF.

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

Shiraishi Y, Kohsaka S, Nagai T, Goda A, Mizuno A, Nagatomo Y, Sujino Y, Fukuoka R, Sawano M, Kohno T, Fukuda K, Anzai T, Shadman R, Dardas T, Levy W, Yoshikawa T

Journal of Cardiac Failure 25 ( 7 ) 561 - 567 2019.07

Research paper (scientific journal), Joint Work, Lead author, Accepted, ISSN 10719164

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

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Patient-centered medical tools for sustained motivation in cardiac rehabilitation of patients with heart failure: protocol of a multicenter randomized controlled trial (EXERCISE-HF trial)

Yamaoka K., Katsumata Y., Kohsaka S., Shiraishi Y., Kondo M., Nagashima K., Onoue T., Kataoka M., Watanabe T., Nakashima D., Muramoto Y., Sato Y., Sato K., Nakamura M., Ieda M.

Contemporary Clinical Trials Communications 47 101522 2025.10

Introduction: Heart failure substantially affects the quality of life of patients and imposes notable social and economic burdens. Despite the beneficial effects of cardiac rehabilitation, global participation rates remain low. Recent advances in wearable biometric technologies may improve patient adherence through real-time monitoring and personalized feedback. This study aimed to develop and evaluate an exercise-support program that integrates wearable devices to enhance rehabilitation outcomes in patients with heart failure. Methods: An innovative and practical cardiac rehabilitation program combined with a wearable device was developed based on patients and physicians’ feedback. A multicenter randomized controlled clinical trial was designed to evaluate the safety and effectiveness of the application in patients with heart failure in Japan from October 2022 to January 2025. Compared with traditional exercise-monitoring applications, the developed application offers an array of features that are designed to foster patient engagement and promote long-term adherence. These features include (1) individualized goal setting, (2) direct communication with healthcare providers, (3) education on heart failure through instructional videos, (4) automated motivational feedback, and (5) a curated library of research summaries on cardiac rehabilitation and self-care. Patients who meet the inclusion criteria (including those aged ≥18 years with a clinical diagnosis of heart failure) will be randomly assigned to one of two groups as follows: the integrated exercise-support app group or the standard care group, in which only a wearable device was implemented. The change in peak VO<inf>2</inf> at 12 weeks, adjusted for baseline and allocation factors, will be analyzed as the primary endpoint. The secondary outcomes include quality-of-life measures and re-hospitalization rates. Data analysis will follow the intention-to-treat principle, with results reported as two-tailed 95 % confidence intervals and corresponding p-values. This study was approved by the relevant institutional ethics committee (approval number: DB23-001; iRCT: 2032230388). Informed consent will be obtained from all participants before study participation. The results of the study will be disseminated through peer-reviewed publications and presented at relevant scientific meetings.

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Association Between Mineralocorticoid Receptor Antagonist Use With Worsening Renal Function and Prognosis in Patients With Acute Heart Failure.

Fujimoto Y, Shiraishi Y, Nogi K, Kohsaka S, Kohno T, Kitamura M, Nagatomo Y, Ueda T, Nogi M, Ishihara S, Nakada Y, Kawakami R, Kitai T, Oishi S, Akiyama E, Suzuki S, Yamamoto M, Kida K, Okumura T, Yoshikawa T, Saito Y, Matsue Y

Journal of the American Heart Association 14 ( 14 ) e040252 2025.07

BACKGROUND: Prognostic implications of mineralocorticoid receptor antagonist (MRA) initiation in the context of worsening renal function (WRF) in patients with acute heart failure (AHF) remain unknown. METHODS: This was a post hoc analysis using data from Japanese AHF registries (NARA-HF [Nara Registry and Analyses for Heart Failure], WET-HF [West Tokyo Heart Failure], REALITY-AHF [Registry Focused on Very Early Presentation and Treatment in Emergency Department of Acute Heart Failure]). MRA-naïve patients at baseline were included, comprising 1632 patients with HF with reduced ejection fraction (HFrEF) and 2407 with heart failure with mildly reduced or preserved ejection fraction (HFmr/pEF). They were divided into 3 groups: MRA initiated without WRF (HFrEF, n=590; HFmr/pEF, n=572), MRA initiated with WRF (HFrEF, n=74; HFmr/pEF, n=100), and no MRA initiation (HFrEF, n=968; HFmr/pEF, n=1735). WRF was defined as a 0.3 mg/dL increase from admission to discharge. The composite of death or HF hospitalization after discharge was assessed. RESULTS: During the 1-year follow-up, 369 and 593 events occurred in patients with HFrEF and HFmr/pEF, respectively. Overall, MRA initiation during hospitalization of AHF was independently associated with better prognosis (hazard ratio [HR], 0.81), mainly driven by HF hospitalization. Among patients with HFrEF, the groups with MRA with and without WRF showed a lower incidence of the outcome than the no-MRA group, even after adjusting for risk factors (HR, 0.75 and 0.49, respectively). Among patients with HFmr/pEF, MRA initiation without WRF was independently associated with better prognosis (HR, 0.78), but MRA initiation with WRF was not. CONCLUSIONS: Initiating an MRA during AHF hospitalization was associated with better postdischarge outcomes in HFrEF, irrespective of creatinine elevation, whereas no such consistent association was observed in HFmr/pEF.

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Risk-Stratified Prognostic Implications of Contrast-Associated Acute Kidney Injury After Percutaneous Coronary Intervention

Suzuki T., Kohsaka S., Spertus J.A., Shoji S., Shiraishi Y., Ikemura N., Nakamaru R., Ohata T., Kodaira M., Ueda I., Noma S., Numasawa Y., Ieda M.

Jacc Advances 4 ( 7 ) 101899 2025.07

Background: The clinical importance of contrast-associated acute kidney injury (CA-AKI), the most common complication after percutaneous coronary intervention (PCI), is debated. Objectives: We aimed to assess the association between CA-AKI and long-term outcomes, overall and across the National Cardiovascular Data Registry (NCDR) AKI risk categories. Methods: We analyzed patients undergoing PCI between September 2008 and October 2021 from a Japanese registry aligned with the NCDR and categorized them by the NCDR AKI risk score tertiles (low-risk [<4.9%], intermediate-risk [4.9%-6.7%], and high-risk [≥6.7%]) groups. CA-AKI was defined as a 0.3 mg/dL increase or 50% increase in creatinine or the initiation of dialysis. Cox regression analyses assessed the association between CA-AKI and 2-year major adverse cardiovascular events (MACE; all-cause mortality, acute coronary syndrome, heart failure hospitalization, or stroke), and interactions were tested to examine whether preprocedural risk modified the association of CA-AKI with outcomes. Results: Of 7,916 patients, 723 (9.1%) developed CA-AKI; its incidence for low-risk, intermediate-risk, and high-risk groups was 2.3%, 7.3%, and 17.9%, respectively. CA-AKI was associated with an increased risk of MACE (adjusted HR [aHR]: 1.64; 95% CI: 1.37-1.97). The interaction between AKI risk profile and MACE was not significant (P interaction = 0.14), and a consistent association of CA-AKI and MACE across risk categories was observed (high-risk, aHR: 1.60; 95% CI: 1.30-1.98; intermediate, aHR: 1.64; 95% CI: 1.10-2.44; and low, aHR: 2.84; 95% CI: 1.43-5.65, respectively). Conclusions: CA-AKI was associated with long-term outcomes across all AKI risk profiles in PCI patients, underscoring the importance of interventions to reduce periprocedural CA-AKI.

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Revised Definition of Pulmonary Hypertension Subtypes Enhances Prognostic Stratification in Hospitalized Heart Failure Patients.

Fukushi K, Goda A, Kohno T, Takeuchi S, Nakamaru R, Shiraishi Y, Shoji S, Tanaka TD, Nagatomo Y, Kitamura M, Sakamoto M, Nomoto M, Mizuno A, Soejima K, Kohsaka S, Yoshikawa T, West Tokyo Heart Failure Registry Investigators

The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation 2025.06

Research paper (scientific journal), Accepted, ISSN 1053-2498

Background: Pulmonary hypertension (PH) is a common complication of heart failure (HF) that has two subtypes: isolated postcapillary PH (IpcPH) and combined postcapillary and precapillary PH (CpcPH). The definitions of these subtypes were revised in 2022, but the prognostic impacts of this change in hospitalized patients with HF remain unclear. Therefore, this study aimed to investigate how the current definitions of PH subtypes affect patient prognosis. Methods: Among 4,762 patients in the West Tokyo Heart Failure 2 registry, we analyzed 975 patients (age: 69 ± 14 years; 33% female). We analyzed patients who underwent right heart catheterization following clinical stabilization. Patients were divided into NonPH, IpcPH, or CpcPH groups according to the 2018 and 2022 definitions. We assessed the impact of PH subtypes on adverse events, defined as cardiac mortality or HF rehospitalization among those hospitalized for HF. Results: The proportion of patients with CpcPH increased to 34.8% in 2022 (from 19.8% under the 2018 definition). The 2018 definition stated that CpcPH and IpcPH were associated with an increased risk of the adverse events (CpcPH: HR 1.62, 95%CI 1.14-2.31; IpcPH: HR 1.50, 95%CI 1.07-2.10). However, according to the 2022 definition, only CpcPH was an independent risk factor for the adverse events (CpcPH: HR 1.75, 95%CI 1.30-2.36; IpcPH: HR 1.03, 95%CI 0.64-1.65). Conclusions: The prognostic impact of CpcPH was more evident with the 2022 definition among hospitalized patients with HF. This information will help create more personalized disease management strategies.

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Association of Tricuspid Regurgitation With Mortality in Heart Failure With Left-Sided Heart Disease

Kitamura M., Amami K., Yaguchi T., Okabe K., Shiraishi Y., Nakamaru R., Nagatomo Y., Goda A., Nomoto M., Mizuno A., Sakamoto M., Ichihara Y.K., Kohno T., Kohsaka S., Yoshikawa T.

Jacc Advances 4 ( 6P1 ) 101832 2025.06

Background: Left-sided heart disease is the leading etiology of tricuspid regurgitation (TR) in heart failure (HF); however, the association between different HF phenotypes and the adverse effects of TR remains unclear. Objectives: The authors aimed to elucidate the association between TR and outcomes across the subtypes of left-sided heart disease in patients hospitalized for HF. Methods: We analyzed data from the multicenter West Tokyo Heart Failure registry between January 2006 and December 2021. Moderate or severe mitral or aortic valve disease was defined as left-sided valve dysfunction (LVD). Patients with congenital heart disease, secondary cardiomyopathy, systemic conditions related to HF, or those with incomplete datasets were excluded. Using a multivariable Cox hazard model, the survival effect of TR on mortality in patients with LVD was examined. Results: Overall, 3,040 presented with LVD (median age, 80 years; 45.9% female), and 2,438 had no LVD (median age, 74 years; 27.8% female). The prevalence of moderate and severe TR was 27.6% and 6.5% in patients with LVD and 9.2% and 1.5% in those without LVD, respectively. The adjusted HRs of moderate and severe TR for mortality were 1.25 (95% CI: 1.03-1.52) and 1.72 (95% CI: 1.30-2.29) in those with LVD, respectively, and 2.15 (95% CI: 1.62-2.84) and 3.09 (95% CI: 1.87-5.09) in those without LVD, respectively. Significant interactions between the subtypes were observed (P = 0.005). Conclusions: TR severity stratified mortality after acute decompensated HF better in patients without LVD than in those with LVD.

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Exercise hemodynamic evaluation in the management of dasatinib-related pulmonary arterial hypertension: a case report.

Yamashita S, Hiraide T, Shiraishi Y, Katsumata Y, Kataoka M, Fukui S, Kawakami M, Yuasa S, Okamoto S, Fukuda K, Ieda M

Journal of medical case reports 19 ( 1 ) 209 2025.05

Background: Dasatinib-related pulmonary arterial hypertension is a rare complication of chronic therapy for hematological malignancies. Pulmonary hypertension often persists despite drug discontinuation and might require vasodilators. Normalizing pulmonary hemodynamics and avoiding the long-term use of vasodilators is challenging. Case presentation: Patient was a 55-year-old Japanese man complaining of progressive dyspnea on effort and fatigue. He had a history of hypertension and chronic myeloid leukemia treated with dasatinib. He was diagnosed with dasatinib-related pulmonary arterial hypertension by a right heart catheterization at rest, demonstrating a mean pulmonary artery pressure of 31 mmHg and a normal pulmonary arterial wedge pressure of 6 mmHg. Symptoms and hemodynamics significantly improved after the discontinuation of dasatinib and the initiation of upfront combination therapy of vasodilators. An exercise right heart catheterization, performed more than 2 years after the initiation of vasodilators, showed a mean pulmonary artery pressure of 15 mmHg at rest and 29 mmHg at peak exercise (normal reference value, < 30 mmHg), suggesting normal pulmonary microcirculation. On the basis of these findings, pulmonary vasodilators were discontinued. Notably, a repeat exercise right heart catheterization demonstrated preserved pulmonary microcirculation, and the patient has remained asymptomatic for more than 2 years after discontinuing pulmonary-arterial-hypertension-targeted therapy. Conclusions: The evaluation of pulmonary microcirculation by exercise right heart catheterization can be useful for withdrawing pulmonary vasodilators safely in the management of patients with dasatinib-related pulmonary arterial hypertension.

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Contemporary clinical characteristics and management patterns in hypertrophic cardiomyopathy: insights from baseline enrolment data in a nationwide prospective Japanese registry.

Kubo T, Sugiura K, Tokita Y, Takano H, Takamisawa I, Takayama M, Doi YL, Minami Y, Shirotani S, Ebato M, Tsujiuchi M, Nabeta T, Inomata T, Kato T, Okamoto R, Dohi K, Takei Y, Chikamori T, Watanabe E, Furugen A, Doi H, Akita K, Maekawa Y, Ogimoto A, Tada N, Yokota T, Ikeda S, Yamaguchi O, Izumiya Y, Shibata A, Takashio S, Tsujita K, Maejima Y, Fujino N, Nomura A, Akasaki Y, Higuchi K, Fujita S, Hoshiga M, Shiraishi Y, Ieda M, Miyamoto Y, Kitaoka H

Heart (British Cardiac Society) 2025.03

ISSN 1355-6037

Background The Japanese Hypertrophic Cardiomyopathy Registry Study was designed to provide comprehensive, real-world insights into the clinical characteristics and management of hypertrophic cardiomyopathy (HCM) in Japan. Methods This multicentre, prospective study enrolled consecutive patients with HCM from 24 referral hospitals across Japan starting in 2016. The baseline characteristics of 1485 patients enrolled by December 2019 are presented in this analysis. Results The median ages at registration and diagnosis were 69 and 60 years, respectively, with men accounting for 54% of the cohort. Familial HCM was confirmed in 18% of cases. Of the cohort, 36% had hypertrophic obstructive cardiomyopathy (HOCM), while 8% had mid-ventricular obstruction, 14% had apical HCM and 4% were in the end-stage phase. Atrial fibrillation was observed in 27% of patients, though the majority were asymptomatic or had mild symptoms at registration. Adverse outcomes included prior sustained ventricular tachycardia or fibrillation (6%), heart failure requiring hospitalisation (11%) and embolic events (5%). Defibrillator implantation was performed in 11% of patients. Differences in the defibrillator indications for primary prevention in the current three guidelines and status of defibrillator deployment at registration were clarified: the percentages of class IIa recommendation in the whole cohort and of patients with defibrillator implantation in class IIa were 22% and 19% in the Japanese guidelines, 4% and 39% in the European guidelines and 28% and 22% in the American guidelines, respectively. Beta blockers were prescribed to 90% of patients with HOCM, while 51% received cibenzoline. Septal reduction therapies were performed in 22% of patients with HOCM, with 6% undergoing surgical myectomy. Conclusions As the first large-scale, prospective HCM registry in Japan, this study provides valuable baseline data on the clinical characteristics and management of HCM. These findings will help address gaps between current practice and guideline recommendations, improving the care of patients with HCM.

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Cachectic biomarkers as confounders behind the obesity paradox in patients with acute decompensated heart failure.

Miura Y, Higuchi S, Kohno T, Shiraishi Y, Kitamura M, Nagatomo Y, Kawakubo Ichihara Y, Mizuno A, Nakano S, Soejima K, Goda A, Kohsaka S, Yoshikawa T, West Tokyo Heart Failure (WET-HF) Registry Investigators

International journal of obesity (2005) 49 ( 5 ) 888 - 895 2025.01

ISSN 0307-0565

Background: Obesity is a risk factor for heart failure (HF) development but is associated with a lower incidence of mortality in HF patients. This obesity paradox may be confounded by unrecognized comorbidities, including cachexia. Methods: A retrospective assessment was conducted using data from a prospectively recruiting multicenter registry, which included consecutive acute heart failure patients. A low, normal, and high body mass index (BMI) was defined as <20 kg/m2, 20–25 kg/m2, and ≥25 kg/m2, respectively. Cachexia was defined as a combination of BMI < 20 kg/m2 and any biochemical abnormalities including albumin, hemoglobin, or C-reactive protein. Patients with either of the three biochemical abnormalities were categorized as those with cachectic biomarkers. Two-year all-cause, cardiac, and noncardiac mortality were evaluated. Results: This study evaluated 3314 patients (mean BMI, 22 ± 4 kg/m2 [low BMI with cachexia, 828 (25%); low BMI without cachexia, 273 (8%); normal BMI, 1584 (48%); high BMI, 629 (19%)]). Overall, an increase of 1 point in BMI was associated with a decreased incidence of all-cause mortality (adjusted hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.90–0.94; p < 0.001). Regardless of the mode of death, the low BMI with cachexia indicated the worst prognosis, while the low BMI without cachexia showed a similar prognosis to the normal BMI. Cachectic biomarkers, which were observed more frequently in the low BMI, predicted a higher incidence of 2-year all-cause mortality across the BMI categories (adjusted HR for the low BMI, 1.90; 95% CI, 1.30–2.77; p = 0.001; adjusted HR for the normal BMI, 1.94; 95% CI, 1.34–2.79; p < 0.001; adjusted HR for the high BMI, 3.60; 95% CI, 1.61–8.08; p = 0.002). Conclusions: BMI could be only a surrogate marker. The cachectic biomarkers may reflect the underlying conditions and contribute to elucidating the obesity paradox. (Figure presented.)

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Electronic Patient-Reported Outcome System Implementation in Outpatient Cardiovascular Care: A Randomized Clinical Trial.

Yamashita S, Katsumata Y, Kohsaka S, Kitakata H, Shiraishi Y, Yamaoka K, Muramoto Y, Ono T, Shoji S, Yagyu K, Oginosawa Y, Kataoka M, Hashimoto M, Ko SBH, Kitagawa Y, Jinzaki M

JAMA network open 8 ( 1 ) e2454084 2025.01

Importance: The integration of patient-reported outcome (PRO) assessments in cardiovascular care has encountered considerable obstacles despite their established clinical relevance. Objective: To assess the impact of a physician- and patient-friendly electronic PRO (ePRO) monitoring system on the quality of cardiovascular care in clinical practice. Design, Setting, and Participants: This open-label, multicenter, pilot randomized clinical trial was phase 2 of a multiphase study that was conducted from October 2022 to October 2023 and focused on the implementation and evaluation of an ePRO monitoring system in outpatient clinics in Japan. During phase 1 (conducted from December 2021 to March 2022), this ePRO monitoring system was developed at a single outpatient center using feedback from patients and physicians. Eligible patients were older than 18 years with a clinical diagnosis of heart failure (HF), atrial fibrillation (AF), or coronary artery disease (CAD). Participants were randomly assigned 1:1 to either the ePRO or control group. Statistical analysis was based on the intention-to-treat approach. Intervention: Patients in the ePRO group were asked to complete the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT), or Seattle Angina Questionnaire (SAQ) on smart tablets before their clinical examination. Results were reviewed by physicians at each outpatient visit. The control group received usual care consisting of medication management, lifestyle modification, and invasive procedures in accordance with clinical guidelines. Both groups had 5 monthly outpatient visits. Main Outcomes and Measures: Patient satisfaction, quality of information (QOI) provided by physicians, and disease knowledge were assessed using questionnaires (eg, Patient Satisfaction Questionnaire [PSQ]; score range: 5-25, with higher scores indicating greater patient satisfaction) at baseline and the fifth visit, over approximately 4 months. Results: Of the 50 patients included, 48 (median [SD] age, 71.0 [62.3-75.0] years; 28 males [58.3%]) completed follow-up. The prevalence was 56.2% (n = 27) for HF, 75.0% (n = 36) for AF, and 10.4% (n = 5) for CAD. The distribution of PRO measures used was 21 patients (43.8%) for KCCQ-12, 24 (50.0%) for AFEQT, and 3 (6.2%) for SAQ. Compared with the control group, the ePRO group showed significant improvements in mean (SD) PSQ score (0.16 [2.06] vs 1.61 [1.75]; P = .01) and QOI score regarding treatment (-0.12 [0.53] vs 0.35 [0.71]; P = .01). The ePRO group exhibited a greater increase in the PSQ score regarding communication (-0.12 [0.53] vs 0.43 [0.90]; P = .01). Conclusions and Relevance: In this randomized clinical trial, implementation of the ePRO monitoring system significantly enhanced patient-physician communication and the clarity of physicians' explanations about treatment. These findings suggest that the ePRO monitoring system is capable of supporting patient-centered cardiovascular care. Trial Registration: University Hospital Medical Information Network Identifier: UMIN000049251.

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Bleeding risk in East Asian patients with atrial fibrillation: Validation of the DOAC score in a Japanese multicenter registry

Nishiyama T., Kohsaka S., Nakamaru R., Katsumata Y., Kimura T., Ueda I., Shiraishi Y., Ono T., Tanimoto K., Takatsuki S., Ieda M.

Heart Rhythm O2 2025

Background: Bleeding events remain relatively frequent in patients with atrial fibrillation (AF), posing significant clinical challenges in routine patient management. The recently developed direct oral anticoagulant (DOAC) score shows promise in predicting bleeding risk; however, its performance in East Asian patients is not well characterized. Objective: This study aimed to assess the performance of the DOAC score in a contemporary outpatient-based registry of Japanese patients with AF and evaluate potential modifications to enhance its predictive accuracy. Methods: The Keio Interhospital Cardiovascular Studies-Atrial Fibrillation registry is a multicenter prospective database designed according to international standards for newly diagnosed AF. Adjudicated bleeding events were prospectively collected, and we assessed each bleeding risk score's predictive capacity using the C-index and calibration analysis. Performance was evaluated at 1- and 5-year intervals. Results: Among 2101 patients (median age of 70 years; 67.9% men), the overall 1- and 5-year bleeding incidence was 2.1% and 4.7%, respectively. The DOAC score demonstrated acceptable discrimination at 1 year (C-index 0.704, 95% confidence interval [CI] 0.634–0.774), which was maintained over the extended 5-year follow-up (C-index 0.690, 95% CI 0.640–0.741). Calibration analysis showed acceptable performance across validation datasets. Notably, modifying antiplatelet scoring by distinguishing aspirin (2 points) from other antiplatelets (1 point) improved the performance (C-index 0.707, 95% CI 0.637–0.777). Conclusion: The DOAC score proved valuable for long-term bleeding risk assessment in Japanese patients with AF, with enhanced performance through antiplatelet stratification. These findings support its implementation in East Asian populations for individualized clinical decision making.

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Sweat lactate sensor for detecting anaerobic threshold in heart failure: a prospective clinical trial (LacS-001)

Katsumata Y, Muramoto Y, Ishida N, Takemura R, Nagashima K, Ikoma T, Kawamatsu N, Araki M, Goda A, Okawara H, Sawada T, Ichihara Y, Hattori O, Yamaoka K, Seki Y, Ryuzaki T, Ikura H, Nakashima D, Nagura T, Nakamura M, Sato K, Shiraishi Y

Scientific Reports 14 ( 1 ) 18985 2024.12

Research paper (scientific journal), Last author, Accepted

A simple method for determining the anaerobic threshold in patients with heart failure (HF) is needed. This prospective clinical trial (LacS-001) aimed to investigate the safety of a sweat lactate-monitoring sensor and the correlation between lactate threshold in sweat (sLT) and ventilatory threshold (VT). To this end, we recruited 50 patients with HF and New York Heart Association functional classification I–II (mean age: 63.5 years, interquartile range: 58.0–72.0). Incremental exercise tests were conducted while monitoring sweat lactate levels using our sensor. sLT was defined as the first steep increase in lactate levels from baseline. Primary outcome measures were a correlation coefficient of ≥ 0.6 between sLT and VT, similarities as assessed by the Bland–Altman analysis, and standard deviation of the difference within 15 W. A correlation coefficient of 0.651 (95% confidence interval, 0.391–0.815) was achieved in 32/50 cases. The difference between sLT and VT was −4.9 ± 15.0 W. No comparative error was noted in the Bland–Altman plot. No device-related adverse events were reported among the registered patients. Our sweat lactate sensor is safe and accurate for detecting VT in patients with HF in clinical settings, thereby offering valuable additional information for treatment.

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Rapid Reversal of Pulmonary Hypertension by High-Dose Thiamine Supplementation: A Case Report

Moriizumi T., Hiraide T., Momoi M., Shinya Y., Kishino Y., Shiraishi Y., Iai W., Matsumura K., Kohsaka S., Ieda M.

CJC Open 6 ( 12 ) 1534 - 1537 2024.12

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Pulmonary arterial hypertension therapies in patients with obesity hypoventilation syndrome: a case series.

Daigo K, Hiraide T, Momoi M, Shinya Y, Katsumata Y, Kishino Y, Shiraishi Y, Nishiyama T, Kohsaka S, Ieda M

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 21 ( 4 ) 723 - 732 2024.11

ISSN 1550-9389

Obesity hypoventilation syndrome is caused by complex interactions between multiple pathological processes, including diminished respiratory drive and sleep-related breathing alterations, leading to structural and functional respiratory impairment and ultimately, pulmonary hypertension. Because pulmonary hypertension is closely associated with obesity hypoventilation syndrome, thoroughly evaluating its etiology is essential, and individualized treatments must be considered. We describe 2 patients with obesity hypoventilation syndrome exhibiting severe pulmonary hypertension with pulmonary vascular resistance exceeding 5 Wood units; both were classified as Group 1 pulmonary hypertension, ie, pulmonary arterial hypertension. Initially admitted to our hospital complaining of dyspnea, both patients commenced pulmonary arterial hypertension therapies in addition to positive airway pressure therapy and diuretics, improving their hemodynamic status, dyspnea, and exercise capacity, and finally enabling their discharge. These findings suggest that pulmonary arterial hypertension can coexist with obesity hypoventilation syndrome, and pulmonary arterial hypertension therapies, introduced with careful consideration, may provide substantial benefits for select patients.

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Post-Discharge Self-Care Confidence and Performance Levels in Hospitalized Heart Failure Patients.

Himeno Y, Kitakata H, Kohno T, Hashimoto S, Fujisawa D, Shiraishi Y, Nakano N, Hiraide T, Kishino Y, Katsumata Y, Yuasa S, Kohsaka S, Ieda M

Journal of cardiac failure 31 ( 8 ) 1103 - 1114 2024.11

ISSN 1071-9164

Background: Multidisciplinary self-care education plays a critical role in ensuring the high-quality transitional care of patients hospitalized due to heart failure (HF). However, whether confidence concerning self-care during their index hospitalizations would influence their post-discharge self-care performances and long-term outcomes remains uncertain. Methods: We conducted an assessment of 100 consecutive patients with HF who completed self-care questionnaires both during their hospitalizations and 1 year after discharge. Among these patients hospitalized due to HF, self-care confidence was assessed immediately after they completed their pre-discharge education program. One year after the index hospitalization, we evaluated self-care performance by using the European Heart Failure Self-care Behavior Scale. Logistic regression analysis was employed to identify determinants of poor self-care behavior 1 year after the hospitalization. Additionally, the Cox proportional hazards model with adjustment for the Seattle Heart Failure Model was applied to assess their association with 2-year mortality and readmission risk. Results: The enrolled patients predominantly had HF with reduced ejection fraction (43.0%), and approximately half of the patients had experienced a previous hospitalization due to HF (47.0%). The 3 worst-performing aspects of post-discharge self-care behavior (among the 12 items) were appropriate consultation for fatigue (40.0%), weight gain (52.0%) and application of regular exercise (57.0%). After adjustment, low self-care confidence during the index hospitalization was associated with poor post-discharge self-care performance (OR: 1.11, CI: 1.00–1.21). Poor post-discharge self-care behavior was not associated with worse prognoses over a 2-year follow-up (hazard ratio [HR]: 1.82, CI: 0.85–3.86); however, the association was significant in patients with reduced ejection fraction (HR: 4.04, CI: 1.17–13.89) and previous HF hospitalization (HR: 3.66, CI: 1.46–9.13). Conclusions: Post-discharge self-care performance was associated with self-care confidence during the index HF hospitalization. Effective measures that improve pre-discharge confidence levels in self-care should be considered to enhance the quality of transitional care.

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Time to intravenous diuretic administration in patients hospitalized with heart failure: An observational study.

Shiraishi Y, Kurita Y, Mori H, Ooishi K, Matsukawa M

ESC Heart Failure 11 ( 6 ) 4061 - 4070 2024.08

Research paper (scientific journal), Lead author, Corresponding author, Accepted

Aims: To help establish optimized treatment strategies for congestion in patients with acute heart failure, this study aimed to provide a detailed summary of real-world diuretic use in hospitalized patients with heart failure requiring urgent therapy in Japan. Methods and results: This observational study used a Japanese medical records database to extract data of patients admitted to hospital with a heart failure diagnosis and an intravenous diuretic prescription from the day before admission to 2 days after. Time from hospital visit to first dose, second dose, and maximum dose of intravenous diuretics were determined. Patients were grouped according to whether they received diuretic modification, defined as an intravenous diuretic dose increase or concomitant use of other diuretics. Results: Overall, 1577 patients were included in the study (without diuretic modification, n = 1140 [72.3%]; with diuretic modification, n = 437 [27.7%]). The study population was 49.5% female (n = 780) and the mean age ± standard deviation was 80.1 ± 12.7 years. Intravenous diuretic treatment was received within 1 h of their hospital visit in 43.5% of patients (686/1577) and ≤2 h in 16.4% of patients (258/1577). Among 437 patients with an inadequate response following their first dose, 42.1% received an intravenous dose titration, 56.5% received combination diuretics, and 1.4% received both. Over half of the patients (59.0% [258/437]) with diuretic modification received it after the first 24 h of the hospital visit. The median time from hospital visit to first dose titration was similar to time to first combination diuretic use (18.6 h and 17.0 h, respectively). The mean ± standard deviation duration of intravenous diuretic use was significantly longer for patients with versus without diuretic modification (6.3 ± 5.2 vs. 3.7 ± 3.2 days), and a significantly greater proportion of patients (44.6% [195/437] vs. 35.0% [399/1140]) received repeated intravenous diuretic administration. Other characteristics/outcomes of intravenous diuretic use were similar with versus without diuretic modification, including in-hospital death (15.6% [68/437] vs. 13.9% [159/1140]) and mean ± standard deviation length of hospitalization (21.9 ± 14.7 days vs. 22.1 ± 21.2 days). Conclusions: In Japan, real-world patterns of intravenous diuretic administration for patients with heart failure remains far from the time-sensitive approach recommended in Japanese, European, and United States guidelines.

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