Details of a Researcher - SHIRAISHI Yasuyuki

Papers - SHIRAISHI Yasuyuki

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Evidence-to-practice gap for preventing procedure-related acute kidney injury in patients undergoing percutaneous coronary intervention

Shoji S., Sawano M., Sandhu A.T., Heidenreich P.A., Shiraishi Y., Noma S., Suzuki M., Numasawa Y., Fukuda K., Kohsaka S.

Journal of the American Heart Association (Journal of the American Heart Association) 10 ( 15 ) e020047 2021

BACKGROUND: Acute kidney injury (AKI) is a common complication of percutaneous coronary intervention. This risk can be minimized with reduction of contrast volume via preprocedural risk assessment. We aimed to identify quality gaps for implementing the available risk scores introduced to facilitate more judicious use of contrast volume. METHODS AND RESULTS: We grouped 14 702 patients who underwent percutaneous coronary intervention according to the calculated NCDR (National Cardiovascular Data Registry) AKI risk score quartiles (Q1 [lowest]–Q4 [highest]). We compared the used contrast volume by the baseline renal function and NCDR AKI risk score quartiles. Factors associated with increased contrast volume usage were determined using multivariable linear regression analysis. The overall incidence of AKI was 8.9%. The used contrast volume decreased in relation to the stages of chronic kidney disease (168 mL [SD, 73.8 mL], 161 mL [SD, 75.0 mL], 140 mL [SD, 70.0 mL], and 120 mL [SD, 73.7 mL] for no, mild, moderate, and severe chronic kidney disease, respectively; P<0.001), albeit no significant correlation was observed with the calculated NCDR AKI risk quartiles. Of the variables included in the NCDR AKI risk score, anemia (7.31 mL [1.76–12.9 mL], P=0.01), heart failure on admission (10.2 mL [6.05–14.3 mL], P<0.001), acute coronary syndrome presentation (10.3 mL [7.87–12.7 mL], P<0.001), and use of an intra-aortic balloon pump (17.7 mL [3.9–31.5 mL], P=0.012) were associated with increased contrast volume. CONCLUSIONS: The contrast volume was largely determined according to the baseline renal function, not the patients’ overall AKI risk. These findings highlight the importance of comprehensive risk assessment to minimize the contrast volume used in susceptible patients.

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

Horie H, Kohno T, Kohsaka S, Kitakata H, Shiraishi Y, Katsumata Y, Hayashida K, Yuasa S, Takatsuki S, Fukuda K

European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology (European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology) 20 ( 5 ) 421 - 427 2020.12

ISSN 1474-5151

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

Kitakata H, Kohno T, Kohsaka S, Fujisawa D, Nakano N, Shiraishi Y, Katsumata Y, Yuasa S, Fukuda K

Journal of cardiac failure (Journal of Cardiac Failure) 27 ( 3 ) 318 - 326 2020.11

ISSN 1071-9164

© 2020 Elsevier Inc. 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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Successful Percutaneous Abscess Drainage and Irrigation for the Treatment of Infected Aortic Aneurysm Post–Thoracic Endovascular Aortic Repair

Tsuzuki I., Kishino Y., Shiraishi Y., Katsumata Y., Yuasa S., Ito N., Inoue M., Ito T., Shimizu H., Fukuda K.

CJC Open (CJC Open) 2 ( 6 ) 735 - 738 2020.11

© 2020 Canadian Cardiovascular Society Infected aortic aneurysm (IAA) is a rare, life-threatening disease with rapid progression and a high mortality rate. An 84-year-old man developed IAA caused by urosepsis owing to extended-spectrum β-lactamase–producing Escherichia coli infection. Considering surgical risk and perioperative mortality, the patient underwent computed tomography–guided percutaneous abscess drainage and continuous irrigation with optimal antibiotic therapy. We controlled his systemic inflammation without surgery; thus, he was discharged. Six months later, we confirmed that the abscess had almost disappeared in the follow-up computed tomography scan. Percutaneous abscess drainage and irrigation may be an effective therapeutic option for surgical high-risk patients with IAA.

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Feasibility of the deep learning method for estimating the ventilatory threshold with electrocardiography data

Miura K, Goto S, Katsumata Y, Ikura H, Shiraishi Y, Sato K, Fukuda K

NPJ digital medicine 3 ( 1 ) 141 2020.10

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Derivation and Validation of Clinical Prediction Models for Rapid Risk Stratification for Time-Sensitive Management for Acute Heart Failure

Shiraishi Y, Kohsaka S, Abe T, Nagai T, Goda A, Nishihata Y, Nagatomo Y, Saji M, Toyosaki Y, Takei M, Kitai T, Kohno T, Fukuda K, Matsue Y, Anzai T, Yoshikawa T

Journal of Clinical Medicine (Journal of Clinical Medicine) 9 ( 11 ) 1 - 13 2020.10

Research paper (scientific journal), Lead author, Accepted, ISSN 2077-0383

Early and rapid risk stratification of patients with acute heart failure (AHF) is crucial for appropriate patient triage and outcome improvements. We aimed to develop an easy-to-use, in-hospital mortality risk prediction tool based on data collected from AHF patients at their initial presentation. Consecutive patients’ data pertaining to 2006-2017 were extracted from the West Tokyo Heart Failure (WET-HF) and National Cerebral and Cardiovascular Center Acute Decompensated Heart Failure (NaDEF) registries (n = 4351). Risk model development involved stepwise logistic regression analysis and prospective validation using data pertaining to 2014-2015 in the Registry Focused on Very Early Presentation and Treatment in Emergency Department of Acute Heart Failure Syndrome (REALITY-AHF) (n = 1682). The final model included data describing six in-hospital mortality risk predictors, namely, age, systolic blood pressure, blood urea nitrogen, serum sodium, albumin, and natriuretic peptide (SOB-ASAP score), available at the time of initial triage. The model showed excellent discrimination (c-statistic = 0.82) and good agreement between predicted and observed mortality rates. The model enabled the stratification of the mortality rates across sixths (from 14.5% to <1%). When assigned a point for each associated factor, the integer score’s discrimination was similar (c-statistic = 0.82) with good calibration across the patients with various risk profiles. The models’ performance was retained in the independent validation dataset. Promptly determining in-hospital mortality risks is achievable in the first few hours of presentation; they correlate strongly with mortality among AHF patients, potentially facilitating clinical decision-making.

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Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention.

Niimi N, Sawano M, Ikemura N, Nagai T, Nakano S, Shoji S, Shiraishi Y, Ueda I, Numasawa Y, Suzuki M, Noma S, Fukuda K, Kohsaka S

Journal of clinical medicine (Journal of Clinical Medicine) 9 ( 9 ) 1 - 14 2020.09

ISSN 2077-0383

In the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial, an early invasive strategy did not decrease mortality compared to a conservative strategy for stable ischemic heart disease (SIHD) patients with moderate-to-severe ischemia, and the role of revascularization would be revised. However, the applicability and potential influence of this trial in daily practice remains unclear. Our objective was to assess the eligibility and representativeness of the ISCHEMIA trial on the patients with percutaneous coronary intervention (PCI). From a multicenter registry, we extracted a consecutive 13,223 SIHD patients with PCI (baseline cohort). We applied ISCHEMIA eligibility criteria and compared the baseline characteristics between the eligible patients and the actual study participants (randomized controlled trial (RCT) patients). In 3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry. In the baseline cohort, 77.3% of SIHD patients with moderate-to-severe ischemia were eligible for the ISCHEMIA. They were comparable with RCT patients for baseline characteristics and outcomes unlike the non-eligible patients. In conclusion, the trial results seem applicable for the majority of PCI patients with moderate-to-severe ischemia except for the non-eligible patients.

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Natriuretic Peptide Measurement is Key to a Solution in the Clinical Trial and Clinical Practice

Momoi M, Shiraishi Y, Kohsaka S, Fukuda K, Yoshikawa T

JACC Heart Failure 8 ( 9 ) 782 - 783 2020.09

ISSN 2213-1779

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Delay in seeking treatment before emergent heart failure readmission and its association with clinical phenotype

Takei M., Harada K., Shiraishi Y., Matsuda J., Iwasaki Y., Yamamoto Y., Matsushita K., Miyazaki T., Miyamoto T., Iida K., Tanimoto S., Nagatomo Y., Hosoda T., Kohsaka S., Yamamoto T., Nagao K., Takayama M.

Journal of Intensive Care (Journal of Intensive Care) 8 ( 1 ) 65 2020.08

ISSN 2052-0492

© 2020 The Author(s). Background: Many patients with emergent heart failure (HF) readmission have a delay between symptom onset and hospitalization. The present study aimed to characterize the interval between symptom onset and hospitalization in patients being readmitted for HF and to compare the clinical phenotypes of patients with delay before emergent readmission with those who presented to the hospital earlier. Methods: Data for a total of 2073 consecutive patients was collected from the Tokyo CCU Network database; the patients were divided into delayed (those who sought medical help > 2 days after symptom onset; n = 271) and early groups (remaining patients; n = 1802), and their clinical characteristics and mode of presentation were compared. Results: Age, sex, and laboratory findings including brain natriuretic peptide and serum creatinine levels were not significantly different between the two groups. Patients in the delayed group had greater chronic fluid retention and symptoms not associated with respiratory failure, whereas those in the early group were more likely to have acute respiratory distress, faster heart and respiration rates, and higher systolic blood pressure. Conclusions: More than one in ten patients with HF readmission delay seeking treatment > 2 days after symptom onset. Patients who delayed seeking treatment showed the phenotype of chronic fluid retention, whereas those who presented to the hospital earlier had the phenotype of acute respiratory failure.

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Successful Surgical Treatment Combined With Infliximab in a Patient With Acute Aortic Regurgitation Caused by Behçet Disease

Kawakubo Y., Katsumata Y., Komuro J., Shiraishi Y., Yuasa S., Itabashi Y., Kohno T., Fukuda K.

Canadian Journal of Cardiology (Canadian Journal of Cardiology) 36 ( 7 ) 1161.e3 - 1161.e5 2020.07

ISSN 0828282X

© 2020 Canadian Cardiovascular Society Standard aortic valve replacement for aortic regurgitation caused by Behçet disease (BD) is frequently complicated by postoperative recurrent prosthetic valve detachment. Tumour necrosis factor (TNF) α is known to be associated with higher inflammation activities. Therefore, the concomitant use of immunomodulatory agents with TNFα inhibitors may be the key to a better outcome. This is a case report of a 46-year-old woman with severe acute aortic regurgitation due to BD. Immunosuppressive therapy including the TNFα inhibitor infliximab, which has not been reported for perioperative use to date, resulted in the prompt remission of inflammation, leading to the success of Bentall surgery.

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Impact of tacrolimus versus cyclosporin A on renal function during the first year after heart transplant

Shiraishi Y, Amiya E, Hatano M, Katsuki T, Bujo C, Tsuji M, Nitta D, Maki H, Ishida J, Kagami Y, Endo M, Kimura M, Ando M, Shimada S, Kinoshita O, Ono M, Komuro I

ESC Heart Failure 7 ( 4 ) 1842 - 1849 2020.05

Research paper (scientific journal), Lead author, Accepted

Aims: Nephrotoxicity of calcineurin inhibitors (CNIs) is associated with adverse events in patients undergoing heart transplant (HTx), although studies directly comparing tacrolimus (TAC) versus cyclosporin A (CsA), especially in combination with everolimus and low-dose CNIs approach, are limited. Thus, we sought to investigate the associations of TAC and CsA with clinical outcomes in HTx recipients, with specific focus on renal function. Methods and results: From August 2007 to February 2017, 72 consecutive patients (39 treated with TAC vs. 33 with CsA) receiving de novo HTx in a single transplant centre were retrospectively evaluated. We used the instrumental variable method to account for unmeasured confounding. The study outcomes were percentage change in estimated glomerular filtration rates (eGFR) (safety endpoint) and biopsy-proven acute rejection (efficacy endpoint) within the first year after HTx. The enrolled patients (median age 40 years) were predominantly men (68%). There were no significant differences in baseline characteristics, including eGFR (64.8 [45.7–96.4] mL/min/1.73 m2 in TAC vs. 65.6 [57.9–83.0] mL/min/1.73 m2 for CsA; P = 0.48), other than sex (male, 49% for TAC vs. 91% for CsA; P < 0.001) between the two groups. Within the first year after HTx, 23 (59%) in the TAC group switched mycophenolate mofetil to everolimus, whereas 16 (48%) in the CsA group (P = 0.52). At 12 months, the rates of mortality and end-stage renal disease requiring renal replacement therapies were both 0%. In the instrumental variable analysis, no differences in renal function as well as graft rejection for 1 year after HTx existed between the TAC and CsA groups. These results were similar when taking into account of everolimus use. Conclusions: Irrespective of everolimus use with low-dose CNIs, our analysis using the instrumental variable method showed no differences in renal function as well as graft rejection during the first year after HTx between HTx recipients who received TAC or CsA.

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Prognostic Implications of Early and Midrange Readmissions After Acute Heart Failure Hospitalizations: A Report From a Japanese Multicenter Registry

Kitakata H, Kohno T, Kohsaka S, Shiraishi Y, Parizo JT, Niimi N, Goda A, Nishihata Y, Heidenreich PA, Yoshikawa T

Journal of the American Heart Association (Journal of the American Heart Association) 9 ( 10 ) e014949 2020.05

Background Although 30-day readmission is thought to be an important quality indicator in patients with hospitalized heart failure, its prognostic impact and comparison of patients who were readmitted beyond 30 days has not been investigated. We assessed early (0-30 days) versus midrange (31-90 days) readmission in terms of incidence and distribution, and elucidated whether the timing of readmission could have a different prognostic significance. Methods and Results We examined patients with hospitalized heart failure registered in the WET-HF (West Tokyo Heart Failure) registry. The primary outcomes analyzed were all-cause death and HF readmission. Data of 3592 consecutive patients with hospitalized heart failure (median follow-up, 2.0 years [interquartile range, 0.8-3.1 years]; 39.6% women, mean age 73.9±13.3 years) were analyzed. Within 90 days after discharge, HF readmissions occurred in 11.1% patients. Of them, patients readmitted within 30 and 31 to 90 days after discharge accounted for 43.1% and 56.9%, respectively. Independent predictors of 30- and 90-day readmission were almost identical, and after adjustment, readmission for HF within 90 days (including both early and midrange readmission) was an independent predictor of subsequent all-cause death (hazard ratio, 2.36; P<0.001). Among 90-day readmitted patients, the time interval from discharge to readmission was not significantly associated with subsequent all-cause death. Conclusions Among patients readmitted within 90 days after index hospitalization discharge, ≈60% of readmission events occurred beyond 30 days. Patients readmitted within 90 days had a higher risk of long-term mortality, regardless of the temporal proximity of readmission to the index hospitalization.

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Optimal sampling in derivation studies was associated with improved discrimination in external validation for heart failure prognostic models

Iwakami N., Nagai T., Furukawa T.A., Tajika A., Onishi A., Nishimura K., Ogata S., Nakai M., Takegami M., Nakano H., Kawasaki Y., Alba A.C., Guyatt G.H., Shiraishi Y., Kohsaka S., Kohno T., Goda A., Mizuno A., Yoshikawa T., Anzai T.

Journal of Clinical Epidemiology (Journal of Clinical Epidemiology) 121 71 - 80 2020.05

ISSN 08954356

© 2020 Elsevier Inc. Objectives: The objective of the study was to identify determinants of external validity of prognostic models. Study Design and Setting: We systematically searched for studies reporting prognostic models of heart failure (HF) and examined their performance for predicting 30-day death in a cohort of consecutive 3,452 acute HF patients. We applied published critical appraisal tools and examined whether bias or other characteristics of original derivation studies determined model performance. Results: We identified 224 models from 6,354 eligible studies. The mean c-statistic in the cohort was 0.64 (standard deviation, 0.07). In univariable analyses, only optimal sampling assessed by an adequate and valid description of the sampling frame and recruitment details to collect the population of interest (total score range: 0–2, higher scores indicating lower risk of bias) was associated with high performance (standardized β = 0.25, 95% CI: 0.12 to 0.38, P < 0.001). It was still significant after adjustment for relevant study characteristics, such as data source, scale of study, stage of illness, and study year (standardized β = 0.24, 95% CI: 0.07 to 0.40, P = 0.01). Conclusion: Optimal sampling representing the gap between the population of interest and the studied population in derivation studies was a key determinant of external validity of HF prognostic models.

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Hospital meal intake in acute heart failure patients and its association with long-term outcomes.

Yoshida T, Shoji S, Shiraishi Y, Kawana M, Kohno T, Inoue K, Fukuda K, Heidenreich PA, Kohsaka S

Open heart (Open Heart) 7 ( 1 ) 2020.05

ISSN 2398595X

© 2020 Author(s). Background: Risk prediction for hospitalised heart failure (HF, HHF) patients remains suboptimal. We aimed to determine the prognostic value of hospital food intake (FI) immediately before discharge among HHF patients. Method: We analysed the data of 255 HHF patients extracted from the records of a single university hospital. The FI percentage of the three meals the day before hospital discharge was averaged. Patients were stratified into adequate FI (100% consumption) and inadequate FI (less than 100% consumption) groups. The primary outcome was the composite of all-cause mortality and/or HF readmission within 1 year. Results: Only 49.3% of HHF patients consumed 100% of their meals. Patients with inadequate FI were older; predominantly women; and had a lower body mass index, higher brain natriuretic peptide levels and Clinical Frailty Scale scores at discharge than those with adequate FI. Inadequate FI was significantly associated with adverse outcomes after adjustments (HR 2.00; 95% CI 1.09 to 3.67; p=0.026). The effect of interaction by ejection fraction (EF) was highly significant: HF with preserved EF (≥40%) was significantly associated with inadequate FI with adverse outcomes (HR 4.95; 95% CI 1.71 to 14.36; p=0.003) but HF with reduced EF (<40%) was not (HR 0.77; 95% CI 0.31 to 1.95; p=0.590). Conclusions: The hospital FI assessment might be a simple, useful tool for predicting and stratifying risk for HHF patients.

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Exploring Triaging and Short-Term Outcomes of Early Invasive Strategy in Non-ST Segment Elevation Acute Coronary Syndrome: A Report from Japanese Multicenter Registry.

Ikemura N, Shiraishi Y, Sawano M, Ueda I, Numasawa Y, Noma S, Suzuki M, Momiyama Y, Hayashida K, Yuasa S, Miyata H, Fukuda K, Kohsaka S

Journal of Clinical Medicine (Journal of Clinical Medicine) 9 ( 4 ) 2020.04

Research paper (scientific journal), Accepted, ISSN 2077-0383

This observational study aimed to examine the extent of early invasive strategy (EIS) utilization in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) according to the National Cardiovascular Data Registry (NCDR) CathPCI risk score, and its association with clinical outcomes. Using a prospective multicenter Japanese registry, 2968 patients with NSTE-ACS undergoing percutaneous coronary intervention within 72 hours of hospital arrival were analyzed. Multivariable logistic regression analyses were performed to determine predictors of EIS utilization. Additionally, adverse outcomes were compared between patients treated with and without EIS. Overall, 82.1% of the cohort (n = 2436) were treated with EIS, and the median NCDR CathPCI risk score was 22 (interquartile range: 14-32) with an expected 0.3-0.6% in-hospital mortality. Advanced age, peripheral artery disease, chronic kidney disease or patients without elevation of cardiac biomarkers were less likely to be treated with EIS. EIS utilization was not associated with a risk of in-hospital mortality; yet, it was associated with an increased risk of acute kidney injury (AKI) (adjusted odds ratio: 1.42; 95% confidence interval: 1.02-2.01) regardless of patients’ in-hospital mortality risk. Broader use of EIS utilization comes at the cost of increased AKI development risk; thus, the pre-procedural risk-benefit profile of EIS should be reassessed appropriately in patients with lower mortality risk.

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

Fukuoka R, Kohno T, Kohsaka S, Shiraishi Y, Sawano M, Abe T, Nagatomo Y, Goda A, Mizuno A, Fukuda K, Shadman R, Dardas TF, Levy WC, Yoshikawa T

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology (Europace) 22 ( 4 ) 588 - 597 2020.04

ISSN 1099-5129

© 2020 Published on behalf of the European Society of Cardiology. All rights reserved. Aims: Heart failure (HF) is associated with an increased risk of sudden cardiac death (SCD). This study sought to demonstrate the incidence of SCD within a multicentre Japanese registry of HF patients hospitalized for acute decompensation, and externally validate the Seattle Proportional Risk Model (SPRM). Methods and results: We consecutively registered 2240 acute HF patients from academic institutions in Tokyo, Japan. The discrimination and calibration of the SPRM were assessed by the c-statistic, Hosmer-Lemeshow statistic, and visual plotting among non-survivors. Patient-level SPRM predictions and implantable cardioverter-defibrillator (ICD) benefit [ICD estimated hazard ratio (HR), derived from the Cox proportional hazards model in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)] was calculated. During the 2-year follow-up, 356 deaths (15.9%) occurred, which included 76 adjudicated SCDs (3.4%) and 280 non-SCDs (12.5%). The SPRM showed acceptable discrimination [c-index = 0.63; 95% confidence interval (CI) 0.56-0.70], similar to that of original SPRM-derivation cohort. The calibration plot showed reasonable conformance. Among HF patients with reduced ejection fraction (EF; < 40%), SPRM showed improved discrimination compared with the ICD eligibility criteria (e.g. New York Heart Association functional Class II-III with EF ≤ 35%): c-index = 0.53 (95% CI 0.42-0.63) vs. 0.65 (95% CI 0.55-0.75) for SPRM. Finally, in the subgroup of 246 patients with both EF ≤ 35% and SPRM-predicted risk of ≥ 42.0% (SCD-HeFT defined ICD benefit threshold), mean ICD estimated HR was 0.70 (30% reduction of all-cause mortality by ICD). Conclusion: The cumulative incidence of SCD was 3.4% in Japanese HF registry. The SPRM performed reasonably well in Japanese patients and may aid in improving SCD prediction.

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Ischemic and Bleeding Events Among Patients With Acute Coronary Syndrome Associated With Low-Dose Prasugrel vs Standard-Dose Clopidogrel Treatment

Shoji S., Sawano M., Sandhu A.T., Heidenreich P.A., Shiraishi Y., Ikemura N., Ueno K., Suzuki M., Numasawa Y., Fukuda K., Kohsaka S.

JAMA network open (JAMA network open) 3 ( 4 ) e202004 2020.04

Importance: Prasugrel was approved at a lower dose in 2014 in Japan than in the West because East Asian patients are considered more susceptible to bleeding than Western patients. However, real-world outcomes with low-dose prasugrel treatment remain unclear. Objective: To investigate the association of low-dose prasugrel vs standard-dose clopidogrel administration with short-term outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). Design, Setting, and Participants: This study used data from the Japan Cardiovascular Database-Keio Interhospital Cardiovascular Studies registry, a large, ongoing, multicenter, retrospective cohort of consecutive patients who underwent PCI. The present cohort study evaluated 2770 patients with acute coronary syndrome who underwent PCI and received either low-dose prasugrel (loading dose, 20 mg; maintenance dose, 3.75 mg) or clopidogrel (loading dose, 300 mg; maintenance dose, 75 mg) in combination with aspirin between 2014 and 2018. Propensity score-matching analysis was conducted to balance the baseline characteristics of patients receiving low-dose prasugrel and those receiving clopidogrel. Data analysis was conducted in June 2019. Exposures: Prescription of either low-dose prasugrel or standard-dose clopidogrel prior to PCI. Main Outcomes and Measures: Primary ischemic events (in-hospital death, recurrent myocardial infarction, and ischemic stroke) and primary bleeding events, defined as bleeding complications within 72 hours after PCI consistent with the National Cardiovascular Data Registry CathPCI Registry definition. Results: Of 2559 patients included in the study, the mean (SD) age was 67.8 (12.7) years, and 78.2% were male. In total, 1297 patients (50.7%) received low-dose prasugrel, and 1262 patients (49.3%) received clopidogrel. After propensity score matching, primary ischemic events among patients receiving low-dose prasugrel and those receiving clopidogrel were comparable (odds ratio [OR], 1.42; 95% CI, 0.90-2.23), but primary bleeding events were significantly higher among patients receiving prasugrel (OR, 2.91; 95% CI, 1.63-5.18). This increase in bleeding events was associated with the presence of a profile of high-bleeding risk (≥75 years of age, body weight <60 kg, or history of stroke or transient ischemic attack) (OR, 4.08; 95% CI, 1.86-8.97), being female (OR, 3.84; 95% CI, 1.05-14.0), or the presence of ST-segment elevation myocardial infarction (OR, 2.07; 95% CI, 1.05-4.09) or chronic kidney disease (OR, 4.78; 95% CI, 1.95-11.7). Conclusions and Relevance: Since its approval, low-dose prasugrel has been used by nearly 80% of patients who undergo PCI. Despite the modified dose, bleeding events were higher among patients receiving low-dose prasugrel than among patients receiving clopidogrel, with no difference in ischemic events between the 2 groups. These results suggest the importance of a risk assessment of bleeding prior to selecting a P2Y12 inhibitor, even for the use of a lower approved dose, when treating patients of East Asian descent.

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Benefit and harm of intravenous vasodilators across the clinical profile spectrum in acute cardiogenic pulmonary oedema patients

Shiraishi Y, Kohsaka S, Katsuki T, Harada K, Miyazaki T, Miyamoto T, Matsushita K, Iida K, Takei M, Yamamoto Y, Shindo A, Kitano D, Nagatomo Y, Jimba T, Yamamoto T, Nagao K, Takayama M, for Tokyo CCU Network Scientific Committee.

European Heart Journal: Acute Cardiovascular Care 9 ( 5 ) 2048872619891075 - 458 2020.01

Research paper (scientific journal), Lead author, Accepted, ISSN 2048-8726

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Long-Term Outcomes According to Etiology May Alter Under Different Circumstances

Shoji S, Shiraishi Y, Kohsaka S, Fukuda K, Yoshikawa T

JACC: Heart Failure 8 ( 1 ) 83 - 84 2020.01

Research paper (scientific journal), Accepted, ISSN 2213-1779

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Peripheral pulmonary stenosis with Noonan syndrome treated by balloon pulmonary angioplasty

Ko S., Komuro J., Katsumata Y., Shiraishi Y., Kawakami T., Yamada Y., Yuasa S., Kohno T., Kosaki K., Fukuda K.

Pulmonary Circulation (Pulmonary Circulation) 10 ( 4 ) 2045894020954310 2020

ISSN 20458932

© The Author(s) 2020. Noonan syndrome is known to have various cardiovascular defects, which include pulmonary artery stenosis. Pulmonary artery stenosis is characterized by obstruction of pulmonary artery blood flow that can cause elevated pulmonary artery pressure and ventilation-perfusion inequality, which can cause dyspnea on exertion and eventually, heart failure. Although the etiology of pulmonary artery stenosis related to congenital diseases is still unknown, balloon pulmonary angioplasty has being reported to be effective to selected patients with Alagille and Williams syndromes, but not from Noonan syndrome despite of modest prevalence of pulmonary artery stenosis. Here, we report the first Noonan syndrome patient with pulmonary artery stenosis who underwent successful balloon pulmonary angioplasty. The strategy used in balloon pulmonary angioplasty was planned with careful morphologic evaluation by computed tomographic angiography, and performed with scoring balloons in a graded approach with multiple sessions. After balloon pulmonary angioplasty, we confirmed maintained dilation of lesions and symptom alleviation, suggesting that balloon pulmonary angioplasty can be performed safely on pulmonary artery stenosis in a Noonan syndrome patient.

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