Publications by authors named "Shun Kohsaka"

363 Publications

Use of Thrombus Aspiration for Patients With Acute Coronary Syndrome: Insights From the Nationwide J-PCI Registry.

J Am Heart Assoc 2022 Aug 10:e025728. Epub 2022 Aug 10.

Japanese Association of Cardiovascular Intervention and Therapeutics Tokyo Japan.

Background There is significant regional or institutional variation in the use of thrombus aspiration (TA) in patients undergoing percutaneous coronary intervention (PCI). We investigated the temporal trend in TA use and its association with clinical outcomes in acute coronary syndrome using the nationwide J-PCI (Japanese PCI) registry. Methods and Results Between 2016 and 2018, patients with acute coronary syndrome undergoing PCI (n=282 606; median age, 71.0 years; interquartile range, 62.0-79.0 years; women, 24.7%) at 1124 hospitals were stratified on the basis of whether TA was performed (TA and non-TA). The patients were subdivided according to clinical presentation (ST-segment-elevation myocardial infarction, non-ST-segment-elevation myocardial infarction, and unstable angina). Successful PCI, defined as the achievement of TIMI (Thrombolysis in Myocardial Infarction) 3 flow, and in-hospital mortality were assessed. During the study period, 83 422 patients (29.5%) underwent TA (52.9%, 23.5%, and 5.2% for ST-segment-elevation myocardial infarction, non-ST-segment-elevation myocardial infarction, and unstable angina, respectively), and the TA implementation rate remained relatively stable throughout. Patients treated with TA had higher rate of successful PCI than non-TA (98.7% versus 97.8%; <0.001). TA was not associated with in-hospital death among patients with ST-segment-elevation myocardial infarction (adjusted odds ratio [aOR], 1.02 [95% CI, 0.94-1.12]). However, TA use was associated with higher rates of in-hospital death in patients with non-ST-segment-elevation myocardial infarction ( aOR, 1.51 [95% CI, 1.23-1.86]) or unstable angina ( aOR, 1.95 [95% CI, 1.37-2.79]). Conclusions In our retrospective analysis of the nationwide PCI registry, TA use was associated with a higher achievement of successful PCI without impairing in-hospital mortality among patients with ST-segment-elevation myocardial infarction. Nevertheless, its use should be cautioned in less-established indications (eg, non-ST-segment-elevation myocardial infarction and unstable angina).
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http://dx.doi.org/10.1161/JAHA.122.025728DOI Listing
August 2022

Balloon pulmonary angioplasty versus riociguat in inoperable chronic thromboembolic pulmonary hypertension (MR BPA): an open-label, randomised controlled trial.

Lancet Respir Med 2022 Aug 1. Epub 2022 Aug 1.

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

Background: Treatment options for patients with chronic thromboembolic pulmonary hypertension ineligible for pulmonary endarterectomy (inoperable CTEPH) include balloon pulmonary angioplasty (BPA) and riociguat. However, these two treatment options have not been compared prospectively. We aimed to compare the safety and efficacy of BPA and riociguat in patients with inoperable CTEPH.

Methods: This open-label, randomised controlled trial was conducted at four high-volume CTEPH centres in Japan. Patients aged 20-80 years with inoperable CTEPH (mean pulmonary arterial pressure ≥25 to <60 mm Hg and pulmonary artery wedge pressure ≤15 mm Hg) and WHO functional class II or III were randomly assigned (1:1) to BPA or riociguat via a computer program located at the registration centre using a minimisation method with biased-coin assignment. In the BPA group, the aim was for BPA to be completed within 4 months of the initial date of the first procedure. BPA was repeated until mean pulmonary arterial pressure decreased to less than 25 mm Hg. The frequency of BPA procedures depended on the difficulty and number of the lesions. In the riociguat group, 1·0 mg riociguat was administered orally thrice daily. When the systolic blood pressure was maintained at 95 mm Hg or higher, the dose was increased by 0·5 mg every 2 weeks up to a maximum of 2·5 mg thrice daily; dose adjustment was completed within 4 months of the date of the first dose. The primary endpoint was change in mean pulmonary arterial pressure from baseline to 12 months, measured in the full analysis set (patients who were enrolled and randomly assigned to one of the study treatments, and had at least one assessment after randomisation). BPA-related complications and indices related to clinical worsening were recorded throughout the study period. Adverse events were recorded throughout the study period and evaluated in the safety analysis set (patients who were enrolled and randomely assigned to one of the study treatments, and had received part of or all the study treatments). This trial is registered in the Japan Registry of Clinical Trials (jRCT; jRCTs031180239) and is completed.

Findings: Between Jan 8, 2016, and Oct 31, 2019, 61 patients with inoperable CTEPH were enrolled and randomly assigned to BPA (n=32) or riociguat (n=29). Patients in the BPA group underwent an average of 4·7 (SD 1·6) BPA procedures. In the riociguat group, the mean maintenance dose was 7·0 (SD 1·0) mg/day at 12 months. At 12 months, mean pulmonary arterial pressure had improved by -16·3 (SE 1·6) mm Hg in the BPA group and -7·0 (1·5) mm Hg in the riociguat group (group difference -9·3 mm Hg [95% CI -12·7 to -5·9]; p<0·0001). A case of clinical worsening of pulmonary hypertension occurred in the riociguat group, whereas none occurred in the BPA group. The most common adverse event was haemosputum, haemoptysis, or pulmonary haemorrhage, affecting 14 patients (44%) in the BPA group and one (4%) in the riociguat group. In 147 BPA procedures done in 31 patients, BPA-related complications were observed in 17 procedures (12%) in eight patients (26%).

Interpretation: Compared with riociguat, BPA was associated with a greater improvement in mean pulmonary arterial pressure in patients with inoperable CTEPH at 12 months, although procedure-related complications were reported. These findings support BPA as a reasonable option for inoperable CTEPH in centres with experienced BPA operators, with attention to procedure-related complications.

Funding: Bayer Yakuhin.

Translation: For the Japanese translation of the abstract see Supplementary Materials section.
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http://dx.doi.org/10.1016/S2213-2600(22)00171-0DOI Listing
August 2022

Mechanical circulatory support devices for elective percutaneous coronary interventions: novel insights from the Japanese nationwide J-PCI registry.

Eur Heart J Open 2022 Jul 27;2(4):oeac041. Epub 2022 Jun 27.

Department of Cardiology, Tokai University School of Medicine, Isehara, Japan.

Aims: We examined in-hospital outcomes of patients that required mechanical circulatory support (MCS), such as intra-aortic balloon pumping (IABP), Impella®, or veno-arterial extracorporeal membrane oxygenation (VA-ECMO), for elective percutaneous coronary interventions (PCIs).

Methods And Results: The J-PCI is a prospective Japanese nationwide multicentre registry sponsored by the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) and designed to collect clinical variables and in-hospital outcome data on consecutive patients undergoing PCI. Of the 253 228 patients registered between January 2018 and December 2018, 1627 patients (0.6%) undergoing elective PCI under MCS at 551 sites were analyzed. The mean age of the patients was 74 years, and 25.2% of the patients were females. Multivessel disease and left main disease were observed in 59.0% and 19.7% of the patients, respectively. Majority of patients were treated with IABP alone (86.2%), followed by IABP plus VA-ECMO (6.0%) and Impella alone (3.9%). In-hospital mortality was reported in 134 patients (8.2%). Cardiac death was more common than non-cardiac death (6.8% vs. 1.5%). About 34.6% of the patients receiving VA-ECMO died during hospitalization, whereas 7.2% and 5.3% of patients receiving Impella and IABP died, respectively ( < 0.01). The proportion of patients with VA-ECMO or Impella who had major bleeding requiring blood transfusion was higher than that of patients with IABP (14.1% vs. 13.0% vs. 2.8%).

Conclusion: In the setting of elective PCI, in-hospital mortality of patients requiring MCS was considerably high. VA-ECMO or Impella was associated with a higher risk of major bleeding than IABP.
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http://dx.doi.org/10.1093/ehjopen/oeac041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9308127PMC
July 2022

Divergent effect of blood glucose dysregulation on long-term clinical outcome in acute decompensated heart failure: A reappraisal in contemporary practice.

Int J Cardiol 2022 Jul 25. Epub 2022 Jul 25.

Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.

Background: The prognostic implication of elevated or decreased blood glucose (BG) level in acute decompensated heart failure (ADHF) has been still controversial. Indices of stress hyperglycemia, expressed by the ratio of BG and chronic BG control, has been reported to be associated with poor outcome in different disease population. We sought to assess BG at admission and %ΔBG, an index of BG deviation from estimated average BG calculated from glycated hemoglobin (HbA1c), on the long-term outcome in ADHF patients.

Methods And Results: The West Tokyo Heart Failure (WET-HF) Registry is a prospective multicenter registry enrolling consecutive hospitalized ADHF patients. Among the patients (N = 3078, 77 [67-84] years, male 59%), BG at admission discriminated the long-term (1000 days) incidence of ADHF rehospitalization, but not cardiac death. BG at admission showed a U-shape relationship with the long-term incidence of ADHF rehospitalization after adjustment for covariates. Especially, in patients with HbA1c ≥ 6.5%, the lowest quartile showed the highest risk of ADHF rehospitalization. On the contrary, %ΔBG showed U-shape relationship with the long-term incidence of cardiac death after discharge, rather than ADHF rehospitalization after adjustment for covariates. In addition, elevated %ΔBG was associated with the long-term risk of sudden cardiac death (SCD) even after adjustment for covariates.

Conclusions: For ADHF patients, BG at admission and %ΔBG might be a simple, useful tool for predicting and stratifying long-term risk of cardiac events. Especially, elevated %ΔBG might be an important in predicting hard events such as cardiac death or SCD.
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http://dx.doi.org/10.1016/j.ijcard.2022.07.041DOI Listing
July 2022

Comparison of Unguided De-Escalation Versus Guided Selection of Dual Antiplatelet Therapy After Acute Coronary Syndrome: A Systematic Review and Network Meta-Analysis.

Circ Cardiovasc Interv 2022 Jul 28:101161CIRCINTERVENTIONS122011990. Epub 2022 Jul 28.

Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).

Background: The benefit of dual antiplatelet therapy (DAPT) for reducing ischemic events is greatest in the early period of acute coronary syndrome, and recent randomized controlled trials have investigated the unguided de-escalation strategy of changing potent P2Y inhibitors to less potent or reduced-dose P2Y inhibitors 1 month after acute coronary syndrome. However, it remains unclear which strategy is more effective and safer: the uniform unguided de-escalation strategy versus the personalized guided selection of DAPT with genotype or platelet function tests.

Methods: PubMed, EMBASE, and Cochrane Central were searched for articles published from database inception to September 10, 2021. Randomized controlled trials investigating DAPT using clopidogrel, low-dose prasugrel, standard-dose prasugrel, ticagrelor, unguided de-escalation strategy, and guided selection strategy for patients with acute coronary syndrome were included. Hazard ratios and relative risk estimates were extracted from each study. The estimates were pooled using a random-effects network meta-analysis. The primary efficacy outcome was major adverse cardiovascular events, defined as a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major or minor bleeding. Secondary outcomes were all-cause death, cardiovascular death, myocardial infarction, stroke, stent thrombosis, and major bleeding.

Results: This study included 19 randomized controlled trials with 69 746 patients. Compared with guided selection of DAPT, unguided de-escalation of DAPT was associated with a decreased risk of the primary safety outcome (hazard ratio, 0.48 [95% CI, 0.33-0.72]) without increased risks of major adverse cardiovascular events (hazard ratio, 0.82 [95% CI, 0.53-1.28]) or any secondary outcomes. The results were similar when the guided selection strategy was divided into platelet function-guided and genotype-guided strategies.

Conclusions: Compared with guided selection of DAPT, unguided de-escalation of DAPT decreased bleeding without increasing ischemic events in patients after acute coronary syndrome. If a strategy of de-escalation is chosen, these findings do not support the routine use of personalized guiding tests.

Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42021273082.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.122.011990DOI Listing
July 2022

Sex Differences in Clinical Outcomes Among Patients With COVID-19 and Cardiovascular Disease - Insights From the CLAVIS-COVID Registry.

Circ Rep 2022 Jul 28;4(7):315-321. Epub 2022 May 28.

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

Male sex is associated with a worse clinical course and outcomes of COVID-19, particularly in older patients. However, studies on COVID-19 patients with cardiovascular disease and/or risk factors (CVDRF), which are representative risk factors of COVID-19, are limited. In this study, we investigated the effect of sex on the outcomes of hospitalized COVID-19 patients with CVDRF. We analyzed 693 COVID-19 patients with CVDRF. Patients were divided into 2 groups based on sex, and baseline characteristics and in-hospital outcomes were compared between the 2 groups. The mean age of the 693 patients was 68 years; 64.8% were men and 96.1% were Japanese. In a univariate analysis model, sex was not significantly associated with in-hospital mortality (odds ratio [OR] 1.22; 95% confidence interval [CI] 0.74-2.02; P=0.43). However, men had higher in-hospital mortality than women, especially among older (age ≥80 years) patients (OR 2.21; 95% CI 1.11-4.41; P=0.024). After adjusting for age and pivotal risk factors (hypertension, diabetes, heart failure, coronary artery disease, chronic lung disease, and chronic kidney disease), multivariate analysis suggested that male sex was an independent predictor of in-hospital mortality (OR 2.20; 95% CI 1.23-3.92; P=0.008). In this post hoc analysis of a nationwide registry focusing on patients with COVID-19 and CVDRF, men had higher in-hospital mortality than women, especially among older patients.
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http://dx.doi.org/10.1253/circrep.CR-22-0047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9257456PMC
July 2022

Catheter ablation for patients with atrial fibrillation and heart failure with reduced and preserved ejection fraction: insights from the KiCS-AF multicentre cohort study.

Europace 2022 Jul 19. Epub 2022 Jul 19.

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

Aims: The usefulness of catheter ablation (CA) for atrial fibrillation (AF) across a broad spectrum of heart failure (HF) patients remains to be established. We assessed the association of CA with both health-related quality of life (QoL) and cardiovascular events among HF patients with reduced and preserved left ventricular ejection fraction (LVEF) in an 'all-comer' outpatient-based AF registry.

Methods And Results: Of 3303 patients with AF consecutively enrolled in a retrospective multicentre registry that mandated the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire at registration and 1-year follow-up, we extracted data from 530 patients complicating clinical HF. The association between CA and both 1-year change in AFEQT Overall Summary (AFEQT-OS) scores and 2-year composite clinical outcomes (including all-cause death, stroke, and HF hospitalization) was assessed by multivariable analyses. The median duration of AF was 108 days (52-218 days), and 83.4% had LVEF >35%. Overall, 75 patients (14.2%) underwent CA for AF within 1-year after registration. At 1-year follow-up, 67.2% in the ablation group showed clinically meaningful improvements of ≥ 5 points in AFEQT-OS score than 47.8% in the non-ablation group {adjusted odds ratio, 2.03 [95% confidence interval (CI): 1.13-3.64], P = 0.017}. Furthermore, the composite endpoint of all-cause death, stroke, and HF hospitalization occurred less frequently in the ablation group than the non-ablation group [adjusted hazard ratio, 0.27 (95% CI: 0.09-0.86), P = 0.027].

Conclusion: Among AF-HF patients, CA was associated with improved QoL and lower risk of cardiovascular events against drug therapy alone, even for patients with mildly reduced and preserved LVEF.
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http://dx.doi.org/10.1093/europace/euac108DOI Listing
July 2022

National survey on the secondary preventive measures for coronary artery disease among interventional cardiologists: a report from the Japanese Association of Cardiovascular Intervention and Therapeutics.

Cardiovasc Interv Ther 2022 Jul 14. Epub 2022 Jul 14.

Department of Cardiology, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, 480-1195, Japan.

Insights from recent clinical trial testing revascularization strategies have interested interventional cardiologists in optimal medical therapy and secondary prevention modalities. As no large-scale survey has been recently conducted, this report presents the results of a nationwide survey on interventionists' concerns regarding secondary prevention after percutaneous coronary intervention (PCI) and discusses medical support system needs in Japan. A questionnaire to assess the status and challenges of secondary prevention interventions by interventional cardiologists during outpatient visits was supplied to Cardiovascular Interventional Technology (CVIT)-certificated hospitals. This was answered by representative cardiologists of each hospital and comprised three queries: (1) the necessity of outpatient cardiac rehabilitation to promote post-PCI lifestyle guidance; (2) the feasibility of providing lifestyle guidance; and (3) the barriers to lifestyle guidance, during outpatient visits. Questions 1 and 2 were answered using a 5-point Likert scale. Survey responses were received from 391 hospitals (54.9% of 712 CVIT-certificated facilities). For Question 1, 327 hospitals (84.1%) answered "agree", and 386 hospitals (98.7%) answered "agree" or "somewhat agree". For Question 2, 10% of hospitals answered "agree", and "agree" and "somewhat agree" amounted to less than 50%. For Question 3, 83.5% of the facilities answered lack of time as the major reason). The next reasons included an early reverse referral to family doctors after PCI, and a lack of managerial advantage (60% and 40% of the hospitals, respectively). In conclusion, interventionists are concerned about secondary prevention for their patients. The issues clarified in the survey will be important for developing next-generation secondary prevention systems.
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http://dx.doi.org/10.1007/s12928-022-00874-yDOI Listing
July 2022

Implications of QRS Prolongation in Patients With Atrial Fibrillation (from a Multicenter Outpatient Registry).

Am J Cardiol 2022 Jul 7. Epub 2022 Jul 7.

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

Patients with atrial fibrillation (AF) at the highest risk of progression to heart failure (HF) need to be identified. We investigated whether QRS duration can stratify patients with AF at risk for poor clinical outcomes, including health-related quality of life (HR-QoL). We analyzed data from a multicenter registry-based cohort study of patients with AF. Patients were grouped according to the QRS duration (narrow: <120 ms; wide: ≥120 ms) at registration (baseline). The primary outcome was a composite of all-cause death and HF hospitalizations during a 2-year follow-up. In addition, the AF effect on the quality-of-life overall summary score was compared between the groups. In 3,269 patients, 302 (9.2%) had a wide QRS; these patients were more likely to be older, male, and have higher CHADS-VASc scores than those with a narrow QRS. The incidence of the composite outcome was higher in patients with a wide QRS than those with a narrow QRS (13.1% vs 4.9%, p <0.001). After adjustment, a wide QRS was an independent predictor of the primary outcome (adjusted hazard ratio 1.58, 95% confidence interval 1.09 to 2.29, p = 0.016), and the results persisted after the exclusion of patients with bundle branch block or cardiac implantable electronic devices. Regarding HR-QoL outcomes, patients with a wide QRS were less likely to improve AF effect on quality-of-life overall summary scores at 1 year than those with a narrow QRS (adjusted difference -2.31, 95% confidence interval -4.06 to -0.57, p = 0.009). QRS prolongation, even for a nonspecific conduction disturbance, was an independent predictor of adverse outcomes and worse HR-QoL in patients with AF.
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http://dx.doi.org/10.1016/j.amjcard.2022.05.011DOI Listing
July 2022

Effectiveness and Safety of Apixaban in over 3.9 Million People with Atrial Fibrillation: A Systematic Review and Meta-Analysis.

J Clin Med 2022 Jun 30;11(13). Epub 2022 Jun 30.

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool L14 3PE, UK.

Background: There is a plethora of real-world data on the safety and effectiveness of direct-acting oral anticoagulants (DOACs); however, study heterogeneity has contributed to inconsistent findings. We compared the effectiveness and safety of apixaban with those of other direct-acting oral anticoagulants (DOACs) and vitamin K antagonists (VKA e.g., warfarin).

Methods: A systematic review and meta-analysis was conducted retrieving data from PubMed, SCOPUS and Web of Science from January 2009 to December 2021. Studies that evaluated apixaban (intervention) prescribed for adults (aged 18 years or older) with AF for stroke prevention compared to other DOACs or VKAs were identified. Primary outcomes included stroke/systemic embolism (SE), all-cause mortality, and major bleeding. Secondary outcomes were intracranial haemorrhage (ICH) and ischaemic stroke. Randomised controlled trials and non-randomised trials were considered for inclusion.

Results: In total, 67 studies were included, and 38 studies were meta-analysed. Participants taking apixaban had significantly lower stroke/SE compared to patients taking VKAs (relative risk (RR) 0.77, 95% confidence interval (CI) 0.64-0.93, I = 94%) and dabigatran (RR 0.84, 95% CI 0.74-0.95, I = 66%), but not to patients administered rivaroxaban. There was no statistical difference in mortality between apixaban and VKAs or apixaban and dabigatran. Compared to patients administered rivaroxaban, participants taking apixaban had lower mortality rates (RR 0.83, 95% CI 0.71-0.96, I = 96%). Apixaban was associated with a significantly lower risk of major bleeding compared to VKAs (RR 0.58, 95% CI 0.52-0.65, I = 90%), dabigatran (RR 0.79, 95% CI 0.70-0.88, I = 78%) and rivaroxaban (RR 0.61, 95% CI 0.53-0.70, I = 87%).

Conclusions: Apixaban was associated with a better overall safety and effectiveness profile compared to VKAs and other DOACs.
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http://dx.doi.org/10.3390/jcm11133788DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267894PMC
June 2022

Assessment of thromboembolism risk in COVID-19 patients with cardiovascular disease risk factors: Analysis of a Japanese Nationwide Registry.

Thromb Res 2022 Aug 24;216:90-96. Epub 2022 Jun 24.

Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan. Electronic address:

Introduction: Patients with COVID-19 and cardiovascular disease risk factors (CVDRF) have been reported to develop coagulation abnormalities frequently. However, there are limitations in conventional predictive models for the occurrence of thromboembolism in patients with COVID-19 and CVDRF.

Methods: Among data on 1518 hospitalized patients with COVID-19 registered with CLAVIS-COVID, a Japanese nationwide cohort study, 693 patients with CVDRF were subjected to least absolute shrinkage and selection operator (LASSO) analysis; a method of shrinking coefficients for reducing variance and minimizing bias to increase predictive accuracy. LASSO analysis was performed to identify risk factors for systemic thromboembolic events; occurrence of arterial and venous thromboembolism during the index hospitalization as the primary endpoint.

Results: LASSO analysis identified a prior systemic thromboembolism, male sex, hypoxygenemia requiring invasive mechanical ventilation support, C-reactive protein levels and D-dimer levels at admission, and congestion on chest X-ray at admission as potential risk factors for the primary endpoint. The developed risk model consisting of these risk factors showed good discriminative performance (AUC-ROC: 0.83, 95 % confidence interval [CI]: 0.77-0.90), which was significantly better than that shown by D-dimer (AUC-ROC: 0.70, 95 % CI: 0.60-0.80) (p < 0.001). Furthermore, systemic embolic events were independently associated with in-hospital mortality (adjusted odds ratio: 3.29; 95 % CI: 1.31-8.00).

Conclusions: Six parameters readily available at the time of admission were identified as risk factors for thromboembolic events, and these may be capable of stratifying the risk of in-hospital thromboembolic events, which are associated with in-hospital mortality, in patients with COVID-19 and CVDRF.
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http://dx.doi.org/10.1016/j.thromres.2022.06.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9232261PMC
August 2022

Use of short-acting vs. long-acting loop diuretics after heart failure hospitalization.

ESC Heart Fail 2022 Jun 21. Epub 2022 Jun 21.

Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.

Aims: Furosemide, a short-acting loop diuretic (SD), is the dominant agent prescribed for heart failure (HF) in clinical practice. However, accumulating data suggests that long-acting loop diuretics (LD), such as torsemide or azosemide, might have more favourable pharmacological profiles. This study aimed to investigate the relationship between the type of loop diuretics and long-term outcomes among patients hospitalized for acute HF enrolled in a contemporary multicentre registry.

Methods And Results: Within the West Tokyo Heart Failure Registry from 2006 to 2017, a total of 2680 patients (60.1% men with a median age of 77 years) were analysed. The patients were characterized by the type of diuretics used at the time of discharge; 2073 (77.4%) used SD, and 607 (22.6%) used LD. The primary endpoint was composite of all-cause death or HF re-admission after discharge, and the secondary endpoints were all-cause death and HF re-admission, respectively. During the median follow-up period of 2.1 years, 639 patients died [n = 519 (25.0%) in the SD group; n = 120 (19.8%) in the LD group], and 868 patients were readmitted for HF [n = 697 (33.6%) in the SD group; n = 171 (28.2%) in the LD group]. After multivariable adjustment, the LD group had lower risk for the composite outcome [hazard ratio (HR), 0.80; 95% confidence interval (CI), 0.66-0.96; P = 0.017], including all-cause death (HR; 0.73; 95% CI; 0.54-0.99; P = 0.044) and HF re-admission (HR, 0.81; 95% CI, 0.66-0.99; P = 0.038), than the SD group. Propensity score matching yielded estimates that were consistent with those of the multivariable analyses, with sub-group analyses demonstrating that use of LD was associated with favourable outcomes predominantly in younger patients with reduced ejection fraction.

Conclusions: LD was associated with lower risk of long-term outcomes in patients with HF and a recent episode of acute decompensation.
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http://dx.doi.org/10.1002/ehf2.14030DOI Listing
June 2022

Association of ambient temperature and acute heart failure with preserved and reduced ejection fraction.

ESC Heart Fail 2022 Jun 19. Epub 2022 Jun 19.

Tokyo CCU Network Scientific Committee, Tokyo, Japan.

Aims: Evidence on the association between ambient temperature and the onset of acute heart failure (AHF) is scarce and mixed. We sought to investigate the incidence of AHF admissions based on ambient temperature change, with particular interest in detecting the difference between AHF with preserved (HFpEF), mildly reduced (HFmrEF), and reduced ejection fraction (HFrEF).

Methods And Results: Individualized AHF admission data from January 2015 to December 2016 were obtained from a multicentre registry (Tokyo CCU Network Database). The primary event was the daily number of admissions. A linear regression model, using the lowest ambient temperature as the explanatory variable, was selected for the best-estimate model. We also applied the cubic spline model using five knots according to the percentiles of the distribution of the lowest ambient temperature. We divided the entire population into HFpEF + HFmrEF and HFrEF for comparison. In addition, the in-hospital treatment and mortality rates were obtained according to the interquartile ranges (IQRs) of the lowest ambient temperature (IQR1 <5.5°C; IQR25.5-13.3°C; IQR3 13.3-19.7°C; and IQR4 >19.7°C). The number of admissions for HFpEF, HFmrEF and HFrEF were 2736 (36%), 1539 (20%), and 3354 (44%), respectively. The lowest ambient temperature on the admission day was inversely correlated with the admission frequency for both HFpEF + HFmrEF and HFrEF patients, with a stronger correlation in patients with HFpEF + HFmrEF (R  = 0.25 vs. 0.05, P < 0.001). In the sensitivity analysis, the decrease in the ambient temperature was associated with the greatest incremental increases in HFpEF, followed by HFmrEF and HFrEF patients (3.5% vs. 2.8% vs. 1.5% per -1°C, P < 0.001), with marked increase in admissions of hypertensive patients (systolic blood pressure >140 mmHg vs. 140-100 mmHg vs. <100 mmHg, 3.0% vs. 2.0% vs. 0.8% per -1°C, P for interaction <0.001). A mediator analysis indicated the presence of the mediator effect of systolic blood pressure. The in-hospital mortality rate (7.5%) did not significantly change according to ambient temperature (P = 0.62).

Conclusions: Lower ambient temperature was associated with higher frequency of AHF admissions, and the effect was more pronounced in HFpEF and HFmrEF patients than in those with HFrEF.
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http://dx.doi.org/10.1002/ehf2.14010DOI Listing
June 2022

Cost-Effectiveness Analysis of Initiating Type 2 Diabetes Therapy with a Sodium-Glucose Cotransporter 2 Inhibitor Versus Conventional Therapy in Japan.

Diabetes Ther 2022 Jul 16;13(7):1367-1381. Epub 2022 Jun 16.

Department of Health Policy and Management, Keio University School of Medicine, Tokyo, Japan.

Introduction: Many patients with type 2 diabetes mellitus (T2DM) suffer from complications that impose substantial burdens on prognosis and medical costs. Accumulating evidence has demonstrated the clinical benefit of sodium-glucose cotransporter 2 inhibitors (SGLT2i) on cardiovascular and renal complications. However, the health economic impact of SGLT2i remains unclear. The aim of this study was to evaluate the cost-effectiveness of initiating antidiabetic therapy with an SGLT2i using Japanese real-world data.

Methods: We constructed a natural history model incorporating heart failure (HF), myocardial infarction, stroke, chronic kidney disease, and end-stage renal disease (ESRD) as complications. The target population comprised patients with T2DM who newly initiated their first oral glucose-lowering drugs. By using a population-based microsimulation, we estimated the 10-year medical costs in Japanese yen (JPY) and outcomes (hospitalization for/development of complications and quality-adjusted life years [QALY]) for patients who initiated antidiabetic therapy with an SGLT2i or conventional therapy. Sensitivity analyses included a probabilistic sensitivity analysis (PSA) with 1,000,000 iterations.

Results: In the base-case analysis, the total medical cost per person was JPY 1,638,806 versus JPY 1,825,033 and the QALYs were 8.732 versus 8.513 for the SGLT2i strategy versus the conventional strategy, respectively. Thus, initiating treatment with an SGLT2i was dominant, more effective (QALY gain), and lower cost. When treating 10,000 patients, the SGLT2i strategy would reduce all-cause deaths by 410 (552 vs 962), HF events by 201 (897 vs 1098), and ESRD events by 16 (16 vs 32) versus the conventional strategy. The PSA revealed that the probability of dominance for initiating SGLT2i therapy was 90.5%, demonstrating the robustness of the results.

Conclusion: Our results suggest that initiating T2DM treatment with SGLT2i, aimed at managing cardiovascular and renal complications from the early stages of diabetes, can improve the clinical outcome and reduce cost burden of T2DM.
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http://dx.doi.org/10.1007/s13300-022-01270-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9240120PMC
July 2022

Elderly aortic stenosis patients' perspectives on treatment goals in transcatheter aortic valvular replacement.

ESC Heart Fail 2022 Aug 8;9(4):2695-2702. Epub 2022 Jun 8.

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

Aims: Transcatheter aortic valvular replacement (TAVR) is increasingly being performed for elderly patients with aortic stenosis (AS), and current guidelines acknowledge the importance of shared decision-making in their management. This study aimed to evaluate elderly symptomatic severe AS patients' perspectives on their treatment goals and identify factors that influence their treatment choice.

Methods And Results: We performed a pre-procedural cross-sectional survey using a questionnaire at a single university hospital. The questionnaire included three primary domains: (i) symptom burden, (ii) goals and important factors related to treatment, and (iii) preferred place of residence after treatment. We investigated 98 symptomatic severe AS patients who underwent TAVR (median age 86 years, 26% men). None of the patients died during hospitalization, and most of them (94%) were discharged home. Prior to TAVR, the three most common symptom burdens were poor mobility (52%), shortness of breath (52%), and weakness (44%). The reported preferred treatment goals were symptom burden reduction (78%), independence maintenance (68%), ability to perform a specific activity/hobby (62%), and improvement in prognosis (58%). In total, 54% of the patients rated 'in alignment with my values' as the factor that affected their decision to undergo TAVR. Nearly all patients (95%) stated that they preferred to live at home after TAVR.

Conclusions: Among elderly AS patients with varying symptoms who underwent TAVR, symptom burden reduction was the most cited patient-reported goal. Nearly all the patients preferred to live at home after the procedure. Encouraging patients to define their specific goals may improve the quality of shared decision-making in such settings.
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http://dx.doi.org/10.1002/ehf2.14008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9288810PMC
August 2022

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

Catheter Cardiovasc Interv 2022 07 20;100(1):51-58. Epub 2022 May 20.

Division of Cardiology, Tokai University School of Medicine, Isehara, Japan.

Objectives: We sought to provide clinical insights on the usage rate, indications, and in-hospital outcomes of the revived directional coronary atherectomy (DCA) catheter (Atherocut™) in a Japanese nationwide percutaneous coronary intervention (PCI) registry.

Background: Debulking devices such as the revived DCA catheter have become increasingly important in the era of complex PCI. However, little is known about PCI outcomes using a novel DCA catheter in contemporary real-world practice.

Methods: We analyzed 188,324 patients who underwent PCI in 1112 hospitals from January to December 2018. Baseline characteristics and in-hospital outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without the DCA were analyzed.

Results: Overall, 1696 patients (0.9%) underwent PCI with the DCA during the study period, predominantly for left main trunk or proximal left anterior descending artery lesions under a transfemoral approach. Patients in the DCA group were younger and had fewer comorbidities such as hypertension, diabetes mellitus, and chronic kidney disease than patients in the non-DCA group. Stentless PCI using the DCA with drug-coated balloon angioplasty was a preferred treatment strategy in the DCA group (50.0%). Predefined in-hospital adverse outcomes, including mortality (0.2% vs. 0.3%, p = 0.446) and periprocedural complications (1.8% vs. 1.7%, p = 0.697), were comparable between the two groups, whereas the fluoroscopy time was longer and the total contrast volume was higher in the DCA group.

Conclusions: In Japan, PCI using the revived DCA catheter is safely performed with low complication rates in patients with stable coronary artery disease or unstable angina.
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http://dx.doi.org/10.1002/ccd.30233DOI Listing
July 2022

Potential association with malnutrition and allocation of combination medical therapies in hospitalized heart failure patients with reduced ejection fraction.

Sci Rep 2022 05 18;12(1):8318. Epub 2022 May 18.

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

Malnutrition is common in patients with heart failure with reduced ejection fraction (HFrEF) and may influence the long-term prognosis and allocation of combination medical therapy. We reviewed 1231 consecutive patient-level records from a multicenter Japanese registry of hospitalized HFrEF patients. Nutritional status was assessed using geriatric nutritional risk index (GNRI). Combination medical therapy were categorized based on the use of beta-blockers, renin-angiotensin system inhibitors, and mineralocorticoid receptor antagonists. The composite outcome of all-cause death and HF rehospitalization was assessed. The mean age was 72.0 ± 14.2 years and 42.6% patients were malnourished (GNRI < 92). At discharge, 43.6% and 33.4% of patients were receiving two and three agents, respectively. Malnourished patients had lower rates of combination medical therapy use. The standardized GNRI score was independently associated with the occurrence of adverse events (hazard ratio [HR]: 0.88, 95% confidence interval [CI] 0.79-0.98). Regardless of the GNRI score, referenced to patients receiving single agent, risk of adverse events were lower with those receiving three (HR: 0.70, 95% CI 0.55-0.91) or two agents (HR: 0.70, 95% CI 0.56-0.89). Malnutrition assessed by GNRI score predicts long-term adverse outcomes among hospitalized HFrEF patients. However, its prognosis may be modified with combination medical therapy.
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http://dx.doi.org/10.1038/s41598-022-12357-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9117205PMC
May 2022

Multimorbidity, guideline-directed medical therapies, and associated outcomes among hospitalized heart failure patients.

ESC Heart Fail 2022 Aug 13;9(4):2500-2510. Epub 2022 May 13.

Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.

Aims: Multimorbidity is common among heart failure (HF) patients and may attenuate guideline-directed medical therapy (GDMT). Multimorbid patients are under-represented in clinical trials; therefore, the effect of multimorbidity clustering on the prognosis of HF patients remains unknown. We evaluated the prevalence of multimorbidity clusters among consecutively registered hospitalized HF patients and assessed whether GDMT attenuated outcomes.

Methods And Results: We examined 1924 hospitalized HF patients with reduced left ventricular ejection fraction (<50%) in a multicentre registry (West Tokyo HF Registry: WET-HF). Ten comorbid conditions in the WET-HF were abstracted: coronary artery disease, atrial fibrillation, stroke, anaemia, chronic obstructive pulmonary disease, renal dysfunction, obesity, hypertension, dyslipidaemia, and diabetes. Patients were divided into three groups (0-2: n = 451; 3-4: n = 787; and ≥5: n = 686) based on the number of comorbid conditions. The primary composite endpoint was all-cause mortality and HF rehospitalization. The most prevalent comorbidities were renal dysfunction (67.9%), hypertension (66.0%), and anaemia (53.8%). Increased comorbidity was associated with increased adverse outcomes [3-4: hazard ratio (HR) 1.42, 95% confidence interval (CI) 1.13-1.77, P = 0.003; ≥5: HR 2.12, 95%CI 1.69-2.65, P < 0.001; and reference: 0-2] and lower GDMT prescription rate (0-2: 69.2%; 3-4: 57.7%; and ≥5: 57.6%). GDMT was associated with decreased adverse outcomes; this association was maintained even as the comorbidity burden increased but tended to weaken (0-2: HR 0.53, 95%CI 0.35-0.78; P = 0.001; 3-4: HR 0.82, 95%CI 0.65-1.04, P = 0.095; and ≥5: HR 0.81, 95%CI 0.65-1.00, P = 0.053; P for interaction = 0.156).

Conclusions: Comorbidity clusters were prevalent and associated with poorer outcomes. GDMT remained beneficial regardless of the comorbidity burden but tended to weaken with increasing comorbidity burden. Further research is required to optimize medical care in these patients.
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http://dx.doi.org/10.1002/ehf2.13954DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9288806PMC
August 2022

Machine learning models for prediction of adverse events after percutaneous coronary intervention.

Sci Rep 2022 04 15;12(1):6262. Epub 2022 Apr 15.

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

An accurate prediction of major adverse events after percutaneous coronary intervention (PCI) improves clinical decisions and specific interventions. To determine whether machine learning (ML) techniques predict peri-PCI adverse events [acute kidney injury (AKI), bleeding, and in-hospital mortality] with better discrimination or calibration than the National Cardiovascular Data Registry (NCDR-CathPCI) risk scores, we developed logistic regression and gradient descent boosting (XGBoost) models for each outcome using data from a prospective, all-comer, multicenter registry that enrolled consecutive coronary artery disease patients undergoing PCI in Japan between 2008 and 2020. The NCDR-CathPCI risk scores demonstrated good discrimination for each outcome (C-statistics of 0.82, 0.76, and 0.95 for AKI, bleeding, and in-hospital mortality) with considerable calibration. Compared with the NCDR-CathPCI risk scores, the XGBoost models modestly improved discrimination for AKI and bleeding (C-statistics of 0.84 in AKI, and 0.79 in bleeding) but not for in-hospital mortality (C-statistics of 0.96). The calibration plot demonstrated that the XGBoost model overestimated the risk for in-hospital mortality in low-risk patients. All of the original NCDR-CathPCI risk scores for adverse periprocedural events showed adequate discrimination and calibration within our cohort. When using the ML-based technique, however, the improvement in the overall risk prediction was minimal.
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http://dx.doi.org/10.1038/s41598-022-10346-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9012739PMC
April 2022

Non-cardiovascular readmissions after transcatheter aortic valve replacement: Insights from a Japanese nationwide registry of transcatheter valve therapies.

J Cardiol 2022 Sep 12;80(3):197-203. Epub 2022 Apr 12.

Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.

Background: Despite advances in technology and technique, a certain proportion of patients experience non-cardiovascular (CV) readmissions after transcatheter aortic valve replacement (TAVR). However, the actual burden and details of non-CV readmission remain uncertain.

Methods: The Japan-Transcatheter Valve Therapies (J-TVT) registry is a representative nationwide registry, and mandates complete data entry, including 1-year outcomes, for patients undergoing TAVR in Japan. We analyzed the non-CV adverse events (AEs) requiring readmission after the index TAVR procedure between 2013 and 2018.

Results: A total of 14,472 patients were analyzed (68.8% of women with median age of 85 years). Overall, 367 patients (2.5%) and 1050 patients (7.2%) had non-CV readmission at 30 days and 1 year, respectively. The most frequent non-CV AEs were related to respiratory (24.0%) and gastrointestinal disease (19.3%). Specifically, 79.0% of all respiratory AEs were pneumonia (infectious, interstitial, or aspiration). Of the gastrointestinal AEs, 22.1% were malignancies, and 18.5% were non-procedural-related bleeding. Age ≥90 years, male sex, body mass index <20 kg/m, New York Heart Association functional class III/IV, atrial fibrillation/flutter, malignancy, chronic obstructive pulmonary disease, dialysis, hemoglobin level, albumin level, creatinine level, and non-transfemoral approach were independent predictors of non-CV readmission.

Conclusions: In this analysis of the nationwide registry of patients undergoing TAVR, rate of non-CV readmission at 30 days and 1 year, particularly those related to respiratory and gastrointestinal conditions, were lower than those previously reported. However, caution is still needed when performing TAVR on patients susceptible to these conditions.
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http://dx.doi.org/10.1016/j.jjcc.2022.03.010DOI Listing
September 2022

Conventional medical therapy in heart failure patients eligible for the PARADIGM-HF, DAPA-HF, and SHIFT trials.

Int J Cardiol 2022 Jul 11;359:76-83. Epub 2022 Apr 11.

Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.

Background: Recent trials on novel heart failure (HF) treatments (angiotensin receptor-neprilysin inhibitor, sodium-glucose cotransporter 2 inhibitor, and ivabradine) emphasize the use of conventional medical therapy (angiotensin-converting enzyme inhibitors, beta-blockers [BB], and mineral corticosteroid receptor antagonists). We aimed to evaluate the prescription rate of conventional medical therapy and its association with long-term outcomes in patients eligible for recent trials.

Methods: We examined 1295 consecutive patients with HF with reduced ejection fraction (HFrEF) from a multicenter registry (WET-HF registry). We assessed conventional medical therapy implementation among patients meeting the PARADIGM-HF/DAPA-HF and SHIFT enrollment criteria. We also examined the association between conventional medical therapy use and long-term outcomes within each enrollment criterion.

Results: Overall, 62.2% and 35.3% of HFrEF patients met the enrollment criteria of the PARADIGM-HF/DAPA-HF and SHIFT trials. Only 33.9% and 31.9% received full conventional medical therapy within each patient subset. Notably, 84.2% of patients who met the SHIFT enrollment criteria were on BB, and only 23.0% and 4.4% were on ≥50% or the full recommended dose, respectively. Implementation of full conventional medical therapy use was associated with lower 2-year mortality and HF readmission rates in the PARADIGM-HF/ DAPA-HF eligible group (HR 0.68, 95% CI 0.50-0.92). The use of BB at ≥50% of the recommended dose was associated with lower 2-year mortality and HF readmission rates in the SHIFT-eligible group (HR 0.50, 95% CI 0.30-0.84).

Conclusions: Conventional medical therapy was underutilized among patients eligible for novel trials within a Japanese HF registry. Further efforts to optimize conventional medical therapy are needed.
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http://dx.doi.org/10.1016/j.ijcard.2022.04.020DOI Listing
July 2022

Effect of Tricuspid Regurgitation on the Reported Quality of Life and Subsequent Outcomes in Patients With Atrial Fibrillation.

J Am Heart Assoc 2022 04 6;11(8):e022713. Epub 2022 Apr 6.

Department of Cardiology Keio University School of Medicine Tokyo Japan.

Background Atrial fibrillation and heart failure (HF) possess mutual risk factors and share a common pathophysiological pathway. Tricuspid regurgitation (TR) is a known predictor of adverse events in patients with HF. However, its implications on patients with atrial fibrillation in its early stage remain unknown. Methods and Results Data of 2211 patients without previous HF diagnosis were extracted from a prospective, multicenter registry of newly diagnosed patients with atrial fibrillation. TR was categorized as absent, mild, moderate, and severe based on the American Society of Echocardiography recommendations. The primary outcome was time to first hospitalization for HF after enrollment. The Atrial Fibrillation Effects on Quality-of-Life scores were compared. Overall, 1107 patients (50.1%) had TR (42.3%, 7.2%, and 0.6% for mild, moderate, and severe, respectively). During follow-up (median 730 [interquartile range, 366-731] days), 44 patients (2.0%) experienced HF hospitalization, and the incidence increased with severity of TR (<0.001). TR was an associated predictor of the primary outcome (hazard ratio [HR]: 2.51, =0.050; HR: 6.19, =0.008; for moderate and severe TR versus no TR). Changes in AFEQT overall score were negatively related to TR severity (8.7±17.5 versus 8.5±17.0 versus 3.1±17.5 versus 1.4±11.8, absent versus mild versus moderate versus severe TR, respectively), although it was not an independent predictor after adjustments. Conclusions TR severity at atrial fibrillation diagnosis was an associated predictor of subsequent hospitalization for HF, which may warrant the need for a more intensive follow-up and HF-related management.
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http://dx.doi.org/10.1161/JAHA.121.022713DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9238472PMC
April 2022

Percutaneous coronary intervention during the COVID-19 pandemic in Japan: Insights from the nationwide registration data.

Lancet Reg Health West Pac 2022 May 22;22:100434. Epub 2022 Mar 22.

Department of Cardiology, Tokai University School of Medicine, Kanagawa, Japan.

Background: Coronavirus disease 2019 (COVID-19) has negatively affected access to healthcare systems and treatment timelines. This study was designed to explore the impact of the COVID-19 pandemic on patients who underwent percutaneous coronary intervention (PCI).

Methods: From January 2019 to December 2020, 489,001 patients from 1068 institutions were registered in the Japanese nationwide PCI (J-PCI) registry. We constructed generalized linear models to assess the difference in the daily number of patients and in-hospital outcomes between 2019 and 2020.

Findings: In total, 207 institutions (19·3%) had closed or restricted access during the first COVID-19 outbreak in May 2020; the number of closed or restricted institutions had plateaued at a median of 121 institutions (11·3%). The daily case volume of PCI significantly decreased in 2020 (by 6·7% compared with that in 2019; 95% confidence interval [CI], 6·2-7·2%;  < 0·001). Marked differences in the presentation of PCI patients were observed; more patients presented with ST-segment elevation myocardial infarction (18·3% vs. 17·5%;  < 0·001), acute heart failure (4·49% vs. 4·30%;  = 0·001), cardiogenic shock (3·79% vs. 3·45%;  < 0·001), and cardiopulmonary arrest (2·12% vs. 2·00%;  = 0·002) in 2020. The excess adjusted in-hospital mortality rate in patients treated in 2020 relative to those treated in 2019 was significant (adjusted odds ratio, 1·054; 95% CI, 1·004-1·107;  = 0·03).

Interpretation: While the number of patients who underwent PCI substantially decreased during the COVID-19 pandemic, more patients presented with high-risk characteristics and were associated with significantly higher adjusted in-hospital mortality.

Funding: The J-PCI registry is a registry led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics. The present study was supported by the Grant-in-Aid from the Ministry of Health and Labour (No. 20IA2002 and 21FA1015), the Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (KAKENHI; No. 21K08064), and the Japan Agency for Medical Research and Development (No. 17ek0210097h000).
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http://dx.doi.org/10.1016/j.lanwpc.2022.100434DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8939342PMC
May 2022

Regional variations in the process of care for patients undergoing percutaneous coronary intervention in Japan.

Lancet Reg Health West Pac 2022 May 15;22:100425. Epub 2022 Mar 15.

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

Background: Measuring the quality of care has been central for improving the outcomes of patients undergoing percutaneous coronary intervention (PCI). This study described the performance rates and regional variations in quality metrics for PCI using a representative national Japanese registry.

Methods: Overall, 760,854 patients across 714 institutions (2016-2018) were analysed. Quality metrics included preprocedural antiplatelet therapy use, door-to-balloon time ≤90 min for ST-elevation myocardial infarction, transradial approach, and preprocedural noninvasive stress testing for elective cases in 47 Japanese prefectures. Coronary computed tomography angiography (CCTA) and fractional flow reserve (FFR) were also evaluated. Factors associated with preprocedural testing rates were evaluated using multivariable linear regression.

Findings: Rates of preprocedural antiplatelet therapy use were high with low variations (96·4% [94·7-97·2%]), but there was still substantial room for improvement in the rates of door-to-balloon time (74·7% [71·2-78·9%]) and transradial approach use (70·9% [65·1-73·4%]). Rates of preprocedural noninvasive stress testing were low with substantial variation (36·6% [27·1-49·7%]). Additionally, we found substantial variations in CCTA (50·0% [39·5-55·1%]) and FFR measurement (15·7% [113·-18·3%]) rates. The number of scintigraphy scanners/ prefecture was associated with the performance of noninvasive stress testing (13·4% [95% CI, 2·45-24·4%] increase for every 1/100,000 population increase in scanners).

Interpretations: We observed substantial regional variation in the use of preprocedural testing, and its performance was directly related to nuclear-scanner availability. These findings suggest the need for targeted efforts in improving testing rates, whether by optimising resource allocation or additional education or feedback mechanisms.

Funding: This study was funded by the Japan Society for the Promotion of Science (Grant Nos. 20H03915, 16H05215, 16KK0186, and 20K22883) and by the Ministry of Health, Labor and Welfare Grants-in-Aid for Scientific Research Program (Grant No. 21FA1015). The J-PCI registry is led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics.
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http://dx.doi.org/10.1016/j.lanwpc.2022.100425DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8928076PMC
May 2022

Quality Indicators in Patient Referral Documents for Heart Failure in Japan.

Int Heart J 2022 Mar 15;63(2):278-285. Epub 2022 Mar 15.

Sakakibara Heart Institute.

This study examined quality indicators (QIs) for heart failure (HF) in patients' referral documents (PRDs).We conducted a nationwide questionnaire survey to identify information that general practitioners (GPs) would like hospital cardiologists (HCs) to include in PRDs and that HCs actually include in PRDs. The percentage of GPs that desired each item included in PRDs was converted into a deviation score, and items with a deviation score of ≥ 50 were defined as QIs. We rated the quality of PRDs provided by HCs based on QI assessment.We received 281 responses from HCs and 145 responses from GPs. The following were identified as QIs: 1) HF cause; 2) B-type natriuretic peptide (BNP) or N-terminal pro-BNP concentration; 3) left ventricular ejection fraction or echocardiography; 4) body weight; 5) education of patients and their families on HF; 6) physical function, and 7) functions of daily living. Based on QI assessment, only 21.7% of HCs included all seven items in their PRDs. HCs specializing in HF and institutions with many full-time HCs were independently associated with including the seven items in PRDs.The quality of PRDs for HF varies among physicians and hospitals, and standardization is needed based on QI assessment.
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http://dx.doi.org/10.1536/ihj.21-617DOI Listing
March 2022

Practice Patterns and Outcomes of Transcatheter Aortic Valve Replacement in the United States and Japan: A Report From Joint Data Harmonization Initiative of STS/ACC TVT and J-TVT.

J Am Heart Assoc 2022 03 4;11(6):e023848. Epub 2022 Mar 4.

Department of Cardiovascular Surgery Osaka University Hospital Osaka Japan.

Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; <0.001), were more frequently women (45.9% versus 68.1%; <0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; <0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; <0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; <0.001) but had higher conversion to open surgery (0.94% versus 0.56%; <0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.
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http://dx.doi.org/10.1161/JAHA.121.023848DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9075277PMC
March 2022

Variability in Coronary Artery Disease Testing for Patients With New-Onset Heart Failure.

J Am Coll Cardiol 2022 03;79(9):849-860

Division of Cardiovascular Medicine, Department of Medicine, Stanford University, Stanford, California, USA. Electronic address: https://twitter.com/ATSandhu.

Background: Coronary artery disease (CAD) is the most common cause of new-onset heart failure (HF). Although guidelines recommend ischemic evaluation in this population, testing has historically been underutilized.

Objectives: This study aimed to identify contemporary trends in CAD testing for patients with new-onset HF, particularly after publication of the STICHES (Surgical Treatment for Ischemic Heart Failure Extension Study), and to characterize geographic and clinician-level variability in testing patterns.

Methods: We determined the proportion of patients with incident HF who received CAD testing from 2004 to 2019 using an administrative claims database covering commercial insurance and Medicare. We identified demographic and clinical predictors of CAD testing during the 90 days before and after initial diagnosis. Patients were grouped by their county of residence to assess national variation. Patients were then linked to their primary care physician and/or cardiologist to evaluate variation across clinicians.

Results: Among 558,322 patients with new-onset HF, 34.8% underwent CAD testing and 9.3% underwent revascularization. After multivariable adjustment, patients who underwent CAD testing were more likely to be younger, male, diagnosed in an acute care setting, and have systolic dysfunction or recent cardiogenic shock. Incidence of CAD testing remained flat without significant change post-STICHES. Covariate-adjusted testing rates varied from 20% to 45% across counties. The likelihood of testing was higher among patients co-managed by a cardiologist (adjusted OR: 5.12; 95% CI: 4.98-5.27) but varied substantially across cardiologists (IQR: 50.9%-62.4%).

Conclusions: Most patients with new-onset HF across inpatient and outpatient settings did not receive timely testing for CAD. Substantial variability in testing persists across regions and clinicians.
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http://dx.doi.org/10.1016/j.jacc.2021.11.061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9031351PMC
March 2022

Assessment of coding-based frailty algorithms for long-term outcome prediction among older people in community settings: a cohort study from the Shizuoka Kokuho Database.

Age Ageing 2022 03;51(3)

Department of Healthcare Quality Assessment, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.

Objectives: To assess the applicability of Electronic Frailty Index (eFI) and Hospital Frailty Risk Score (HFRS) algorithms to Japanese administrative claims data and to evaluate their association with long-term outcomes.

Study Design And Setting: A cohort study using a regional government administrative healthcare and long-term care (LTC) claims database in Japan 2014-18.

Participants: Plan enrollees aged ≥50 years.

Methods: We applied the two algorithms to the cohort and assessed the scores' distributions alongside enrollees' 4-year mortality and initiation of government-supported LTC. Using Cox regression and Fine-Gray models, we evaluated the association between frailty scores and outcomes as well as the models' discriminatory ability.

Results: Among 827,744 enrollees, 42.8% were categorised by eFI as fit, 31.2% mild, 17.5% moderate and 8.5% severe. For HFRS, 73.0% were low, 24.3% intermediate and 2.7% high risk; 35 of 36 predictors for eFI, and 92 of 109 codes originally used for HFRS were available in the Japanese system. Relative to the lowest frailty group, the highest frailty group had hazard ratios [95% confidence interval (CI)] of 2.09 (1.98-2.21) for mortality and 2.45 (2.28-2.63) for LTC for eFI; those for HFRS were 3.79 (3.56-4.03) and 3.31 (2.87-3.82), respectively. The area under the receiver operating characteristics curves for the unadjusted model at 48 months was 0.68 for death and 0.68 for LTC for eFI, and 0.73 and 0.70, respectively, for HFRS.

Conclusions: The frailty algorithms were applicable to the Japanese system and could contribute to the identifications of enrollees at risk of long-term mortality or LTC use.
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http://dx.doi.org/10.1093/ageing/afac009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9077119PMC
March 2022
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