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Quality of care and long-term survival after ST-elevation myocardial infarction in adults with cancer. 成人癌症患者st段抬高型心肌梗死后的护理质量和长期生存。
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-04 DOI: 10.1093/ehjqcco/qcaf004
Mohamed Dafaalla, Jan Walter Dhillon Shanmuganathan, Muhammad Rashid, Harindra C Wijeysundera, Derek J Roberts, Safi U Khan, Ayman Elbadawi, Islam Y Elgendy, Phillip Freeman, Christian Mallen, Mamas A Mamas

Background: While current evidence suggests that the clinical outcomes of ST-elevation myocardial infarction (STEMI) are worse among patients with cancer, it is unknown what role the quality of care received during admission plays. We aimed to evaluate the association between care quality and patient survival after discharge.

Methods and results: A nationally-linked cohort of STEMI patients (January 2005-March 2019) were obtained from the UK Myocardial Infarction National Audit Project and UK national Hospital Episode Statistics Admitted Patient Care registries. We used the composite opportunity-based quality indicator to measure overall care quality. Survival outcomes were assessed using Cox proportional hazard models and Kaplan-Meier and cumulative survival curves. In total, 6787 STEMI indexed admissions with cancer were identified. Of those, 4340 (63.9%) patients received optimum care, 1320 (19.5%) intermediate care, and 1127(25.2%) low care quality. Patients with low care quality were older [optimum quality median (IQR) = 72.8 (65.1, 79.6), intermediate quality 75.5 (67.9, 82.1), low quality 78.2 (69.2, 84.7)] and more frequently women (optimum quality 21.6%, intermediate quality 27.3%, low quality 35.5%). Compared to patients with optimum care, patients with low care quality had a higher risk of death at 30 days [hazard ratio (HR) 7.0, 95% confidence interval (CI) 5.7-8.7], 1 year (HR 4.0, 95% CI 3.6-4.4), and 5 years (HR 2.6, 95% CI 2.4-2.8). Relative survival analysis revealed that the number of patients who would survive nationally if they received optimal care is 84 (95% CI 67-102), 508 (95% CI 468-548), and 1096 (95% CI 1034-1158) at 30 days, 1 year, and 5 years, respectively. The association between care quality and survival was more profound in the Northwest and Northeast regions.

Conclusion: Quality of care is closely associated with short- and long-term survival among STEMI patients with cancer. Improving quality of care may save hundreds to thousands of lives in the shorter and longer term.

背景:虽然目前的证据表明,st段抬高型心肌梗死(STEMI)的临床结果在癌症患者中更差,但尚不清楚入院时接受的护理质量在其中起什么作用。我们的目的是评估护理质量与患者出院后生存之间的关系。方法:从英国心肌梗死国家审计项目(MINAP)和英国国家医院事件统计入院患者护理(HES APC)登记处获得STEMI患者的全国相关队列(2005年1月至2019年3月)。我们使用基于机会的综合质量指标(OBQI)来衡量整体护理质量。采用Cox比例风险模型、Kaplan-Meier和累积生存曲线评估生存结果。结果:共确定了6787例STEMI索引的癌症入院患者。其中,4 340例(63.9%)患者接受最佳护理,1 320例(19.5%)接受中等护理,1 127例(25.2%)接受低质量护理。护理质量低的患者以老年人(最佳质量中位数(IQR) = 72.8(65.1, 79.6)、中等质量中位数(75.5,67.9,82.1)、低质量中位数(78.2,69.2,84.7)为主,女性(最佳质量21.6%、中等质量27.3%、低质量35.5%)较多。与最佳护理的患者相比,低护理质量的患者在30天(HR 7.0, 95% CI 5.7-8.7)、1年(HR 4.0, 95% CI 3.6-4.4)和5年(HR 2.6, 95% CI 2.4-2.8)的死亡风险更高。相对生存分析显示,在30天、1年和5年期间,接受最佳护理的患者在全国范围内存活的人数分别为84人(95% CI 67-102)、508人(95% CI 468-548)和1096人(95% CI 1034-1158)。在西北和东北地区,护理质量与生存之间的关系更为深刻。结论:STEMI合并癌症患者的护理质量与短期和长期生存密切相关。提高护理质量可以在短期和长期内挽救成百上千人的生命。
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引用次数: 0
Polypharmacy on first admission to hospital for people with heart failure: baseline findings from the PULSE cohort. 心力衰竭患者首次入院时的多药治疗:PULSE队列的基线结果
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-04 DOI: 10.1093/ehjqcco/qcaf032
Janine Beezer, Andrew L Clark, Adam Todd, Andrew Kingston, John Casement, Lucy Pages, Andrew Husband

Aims: To define and characterize polypharmacy in people with heart failure.

Methods and results: The PULSE dataset is a bespoke single centre, retrospective, longitudinal, observational cohort database of patients hospitalized for heart failure, capturing data from the first heart failure admission through to death or end of data collection, including all subsequent admissions. First admission with heart failure was used to define baseline polypharmacy. There were 660 patients included in the dataset, 55.6% male, mean age 76.1 (±SD 12.3). Median number of medications on admission was 9 (25th-75th centile 7-12) and on discharge 10 (25th-75th centile 8-13). Polypharmacy prevalence was 87.3% on admission, increasing at discharge to 95.1% (P < 0.001). Mean medication complexity index score increased from 28.5 (±SD 14.9) at admission to 31.8 (±14.1) at discharge (P < 0.001). Number of medications on admission increased with increasing age (P < 0.001), higher Charlson Co-morbidity Index (P < 0.001), numerically more co-morbidities (P < 0.001), higher Clinical Frailty Scale (P < 0.001), longer length of stay (P = 0.03), worse New York Heart Association class of symptoms (P = 0.04), and a diagnosis of heart failure with preserved ejection fraction compared with heart failure with reduced ejection fraction (P = 0.002). Cardiovascular medications contributed 50% of medications. Prescribing of heart failure medications reduced with increased polypharmacy.

Conclusion: Polypharmacy is common on first admission to hospital for people with heart failure. More medications at admission are associated with increasing age, co-morbidity, and frailty. People with polypharmacy are more likely to have a heart failure with preserved ejection fraction diagnosis, have worse symptoms and a longer hospital stay.

目的:定义和描述心力衰竭患者的多药治疗。方法:PULSE数据集是一个定制的单中心、回顾性、纵向、观察性队列数据库,涵盖心力衰竭住院患者,从首次心力衰竭入院到死亡或数据收集结束,包括所有后续入院。首次入院的心力衰竭被用来定义基线多重用药。结果:纳入数据集的患者660例,男性55.6%,平均年龄76.1(±SD12.3)。入院时药物的中位数为9,出院时为10(25 -75百分位7-12)。入院时多药使用率为87.3%,出院时增加至95.1%。结论:心力衰竭患者首次入院时多药较为常见。入院时服用更多药物与年龄增加、合并症和虚弱有关。多药患者更有可能有保留射血分数诊断的心力衰竭,症状更严重,住院时间更长。
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引用次数: 0
Key priorities for the implementation of the 2023 ESC Guidelines for the management of cardiomyopathies in low-resource settings. 在低资源环境下实施2023 ESC心肌病管理指南的关键优先事项。
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-04 DOI: 10.1093/ehjqcco/qcae103
Ruxandra Jurcut, Roberto Barriales-Villa, Elena Biagini, Pablo Garcia-Pavia, Iacopo Olivotto, Alexandros Protonotarios, Eloisa Arbustini, Jens Mogensen, Perry Elliott, Elena Arbelo, Juan Pablo Kaski

ESC Guidelines provide best practice, evidence-based recommendations for diagnosing and treating patients with cardiovascular diseases. It is not always possible for best practices to be followed, however, particularly in low-resource settings. To address this issue, a set of guideline-related documents were created to identify key priorities for users in these settings. The documents highlight the related recommendations and describe key strategies for clinicians to approach implementation of these recommendations or discuss alternatives which are in line with the intention of the recommendations, if not having all of the same advantages. The suggestions cannot be used as exact substitutes for the original recommendations in the guidelines, which have not been altered and continue to reflect best practice. This document on key priorities for low-resource settings was developed by the task force chairs and other members of the task force who produced the 2023 ESC Guidelines for the management of cardiomyopathies, which are freely available on the ESC website (https://www.escardio.org/Guidelines). This document also underwent external review including international experts from within and beyond Europe and ESC partner organizations, including the Interamerican Society of Cardiology, the Pan-African Society of Cardiology, the Asian Pacific Society of Cardiology, and the ASEAN Federation of Cardiology.

ESC指南为诊断和治疗心血管疾病患者提供了最佳实践和基于证据的建议。然而,并非总是能够遵循最佳做法,特别是在资源匮乏的环境中。为了解决这个问题,创建了一组与指导方针相关的文档,以确定在这些设置中用户的关键优先级。这些文件强调了相关建议,并描述了临床医生实施这些建议的关键策略,或讨论符合建议意图的替代方案,如果不具有所有相同的优势。这些建议不能完全代替准则中的原始建议,这些建议没有改变,继续反映最佳做法。这份关于低资源环境的关键优先事项的文件是由工作组主席和工作组的其他成员制定的,该工作组制定了2023年ESC心肌病管理指南,可在ESC网站(https://www.escardio.org/Guidelines)上免费获得。该文件还经过了外部审查,包括来自欧洲内外的国际专家,包括非esc协会。非esc协会包括美洲心脏病学会(IASC)、泛非心脏病学会(PASCAR)、亚太心脏病学会(APSC)和东盟心脏病学联合会(AFC)。
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引用次数: 0
A body shape index for visceral fat and its changes predict cardiovascular outcomes of heart failure with preserved ejection fraction. 内脏脂肪的体型指数及其变化可预测保留射血分数的心力衰竭的心血管结局。
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-04 DOI: 10.1093/ehjqcco/qcaf005
Wenlong Xu, Fengling He, Haoxiang Huang, Zhiwen Yang, Zhiwen Xiao, Yilin Zhou, Wei Chen, Jiajun Zhou, Ping Lu, Yusheng Ma, Senlin Huang, Yulin Liao, Jianping Bin, Yanmei Chen

Aims: This study aimed to investigate the relationship between visceral adipose tissue (VAT), measured using a body shape index (ABSI), and outcomes in patients with heart failure with preserved ejection fraction (HFpEF).

Methods: ABSI data and cardiovascular outcomes were obtained from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial. ABSI was calculated using waist circumference, body mass index, and height. ABSI values were categorized into tertiles for analysis (≤0.078, 0.078-0.084, and >0.084).

Results: In total, 3319 patients with HFpEF were enrolled during a mean follow-up period of 3.9 years. ABSI was positively associated with a high risk of cardiovascular events in patients with HFpEF after multivariate adjustment. In the highest tertile, higher risks of all-cause mortality [hazard ratio (HR): 1.464, 95% confidence interval (CI): 1.150-1.864], cardiovascular death (HR: 1.685, 95% CI: 1.241-2.289), myocardial infarction (MI) (HR: 1.778, 95% CI: 1.088-2.904), and major adverse cardiovascular events (MACEs) (HR: 1.430, 95% CI: 1.123-1.822) were noted. Patients with previous or current high ABSI had poorer long-term prognoses, with increased risks of all-cause mortality (HR: 1.635, 95% CI: 1.116-2.396), cardiovascular death (HR: 1.724, 95% CI: 1.071-2.775), MI (HR: 2.021, 95% CI: 0.878-4.653), and MACEs (HR: 1.653, 95% CI: 1.117-2.447).

Conclusion: ABSI was independently associated with long-term prognosis in patients with HFpEF, and a history of high ABSI was associated with a poorer prognosis later in life, underscoring the importance of reducing VAT in HFpEF.

目的:本研究旨在探讨内脏脂肪组织(VAT)与保留射血分数(HFpEF)心力衰竭患者预后之间的关系,该指标采用体型指数(ABSI)测量。方法:ABSI数据和心血管结果来自醛固酮拮抗剂(TOPCAT)治疗保留心功能心力衰竭的试验。ABSI采用腰围(WC)、体重指数和身高计算。ABSI值按三分位(≤0.078、0.078 ~ 0.084、> 0.084)进行分析。结果:共有3 319例HFpEF患者入组,平均随访时间为3.9年。多因素调整后,ABSI与HFpEF患者心血管事件的高风险呈正相关。在最高的分位数中,全因死亡率(风险比[HR]: 1.464, 95%可信区间[CI]: 1.150-1.864)、心血管死亡(风险比:1.685,95% CI: 1.241-2.289)、心肌梗死(风险比:1.778,95% CI: 1.088-2.904)和主要不良心血管事件(主要心血管事件)(风险比:1.430,95% CI: 1.123-1.822)的风险较高。既往或当前ABSI较高的患者长期预后较差,全因死亡率(HR: 1.635, 95% CI: 1.116-2.396)、心血管死亡(HR: 1.724, 95% CI: 1.071-2.775)、心肌梗死(HR: 2.021, 95% CI: 0.878-4.653)和mace (HR: 1.653, 95% CI: 1.117-2.447)的风险增加。结论:ABSI与HFpEF患者的长期预后独立相关,高ABSI病史与后期预后较差相关,强调了降低HFpEF患者VAT的重要性。试验注册:该试验在ClinicalTrials.gov (NCT00094302)注册。
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引用次数: 0
Temporal trends in loss of expected lifetime associated with cardiovascular complications following newly diagnosed atrial fibrillation: a Danish nationwide cohort study from 2000 to 2022. 新诊断心房颤动后心血管并发症相关预期寿命损失的时间趋势:2000-2022年丹麦全国队列研究
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-04 DOI: 10.1093/ehjqcco/qcaf026
Nicklas Vinter, Søren Paaske Johnsen, Emelia J Benjamin, Gregory Y H Lip, Lars Frost

Aims: While advancements in care may improve the clinical course of atrial fibrillation (AF), data on trends in lost lifetime after developing cardiovascular complications are sparse.

Methods and results: In this nationwide registry-based matched cohort study (1 January 2000-31 December 2022), we followed patients with ischaemic stroke, gastrointestinal bleeding, intracranial bleeding, heart failure (HF), and myocardial infarction (MI) after AF and matched referents with AF. We estimated the average loss of life expectancy as the difference in restricted mean survival time between patients with AF with and without a complication and compared the loss between 2000-10 and 2011-22. We followed 27 809 patients with ischaemic stroke, 28 938 with gastrointestinal bleeding, 7710 with intracranial bleeding, 50 914 with HF, and 14 141 with MI and their matched referents. The loss of lifetime improved for ischaemic stroke [-2.1 vs. -1.8 years; difference 4.0 months, 95% confidence interval (CI) 2.4-5.6; P < 0.001]. We found no evidence of trends for gastrointestinal (-1.7 vs. -1.8 years; difference -0.8 months, 95% CI -2.5 to 0.8; P = 0.32) or intracranial bleeding (-3.3 vs. -3.1 years; difference 1.6 months, 95% CI -1.3 to 4.6; P = 0.28). The loss of lifetime improved for HF (-2.1 vs. -1.9 years; difference 2.4 months, 95% CI 0.9-3.8; P = 0.001) and MI (-1.6 vs. -1.1 years; difference 5.9 months, 95% CI 3.3-8.5; P < 0.001).

Conclusion: Among patients with AF, the loss of expected lifetime after incident ischaemic stroke, HF, and MI improved modestly over the past two decades but not after gastrointestinal or intracranial bleeding. These findings support the development and evaluation of interventions that prevent and reduce severity of complications after AF, particularly for bleeding.

背景和目的:虽然护理的进步可能会改善房颤(AF)的临床病程,但发生心血管并发症后损失寿命的趋势数据很少。方法:在这项基于全国登记的匹配队列研究中(2000年1月1日至2022年12月31日),我们对房颤后缺血性卒中、胃肠道出血、颅内出血、心力衰竭(HF)和心肌梗死(MI)患者以及房颤患者进行了随访。我们估计平均预期寿命损失为伴有和不伴有并发症的房颤患者限制平均生存时间的差异,并比较了2000-2010年和2011-2022年之间的损失。结果:我们随访了27,809例缺血性脑卒中患者,28,938例胃肠道出血患者,7,710例颅内出血患者,50,914例心衰患者,14,141例心肌梗死患者及其匹配参照物。缺血性卒中患者的寿命损失得到改善(-2.1 vs -1.8年;差异4.0个月,95%CI 2.4 ~ 5.6;结论:在房颤患者中,发生缺血性卒中、心衰和心肌梗死后的预期寿命损失在过去二十年中略有改善,但在胃肠道或颅内出血后没有改善。这些发现支持干预措施的发展和评估,以预防和减少房颤后并发症的严重程度,特别是出血。
{"title":"Temporal trends in loss of expected lifetime associated with cardiovascular complications following newly diagnosed atrial fibrillation: a Danish nationwide cohort study from 2000 to 2022.","authors":"Nicklas Vinter, Søren Paaske Johnsen, Emelia J Benjamin, Gregory Y H Lip, Lars Frost","doi":"10.1093/ehjqcco/qcaf026","DOIUrl":"10.1093/ehjqcco/qcaf026","url":null,"abstract":"<p><strong>Aims: </strong>While advancements in care may improve the clinical course of atrial fibrillation (AF), data on trends in lost lifetime after developing cardiovascular complications are sparse.</p><p><strong>Methods and results: </strong>In this nationwide registry-based matched cohort study (1 January 2000-31 December 2022), we followed patients with ischaemic stroke, gastrointestinal bleeding, intracranial bleeding, heart failure (HF), and myocardial infarction (MI) after AF and matched referents with AF. We estimated the average loss of life expectancy as the difference in restricted mean survival time between patients with AF with and without a complication and compared the loss between 2000-10 and 2011-22. We followed 27 809 patients with ischaemic stroke, 28 938 with gastrointestinal bleeding, 7710 with intracranial bleeding, 50 914 with HF, and 14 141 with MI and their matched referents. The loss of lifetime improved for ischaemic stroke [-2.1 vs. -1.8 years; difference 4.0 months, 95% confidence interval (CI) 2.4-5.6; P < 0.001]. We found no evidence of trends for gastrointestinal (-1.7 vs. -1.8 years; difference -0.8 months, 95% CI -2.5 to 0.8; P = 0.32) or intracranial bleeding (-3.3 vs. -3.1 years; difference 1.6 months, 95% CI -1.3 to 4.6; P = 0.28). The loss of lifetime improved for HF (-2.1 vs. -1.9 years; difference 2.4 months, 95% CI 0.9-3.8; P = 0.001) and MI (-1.6 vs. -1.1 years; difference 5.9 months, 95% CI 3.3-8.5; P < 0.001).</p><p><strong>Conclusion: </strong>Among patients with AF, the loss of expected lifetime after incident ischaemic stroke, HF, and MI improved modestly over the past two decades but not after gastrointestinal or intracranial bleeding. These findings support the development and evaluation of interventions that prevent and reduce severity of complications after AF, particularly for bleeding.</p>","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":"1023-1032"},"PeriodicalIF":4.6,"publicationDate":"2025-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143973283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Global, regional, and national burden of pulmonary arterial hypertension and related heart failure from 1990 to 2021, with predictions to 2050: insights from the global burden of disease study 2021. 1990 年至 2021 年全球、地区和国家肺动脉高压及相关心力衰竭的负担,以及对 2050 年的预测:2021 年全球疾病负担研究的见解。
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-04 DOI: 10.1093/ehjqcco/qcaf009
Ke Liu, Yi Zeng, Hualing Wang, Huiping Yang, Lida Liu, Xingyu Chen, Xiuli Yang, Yufei Liu, Yi Zhu, Chuantao Zhang

Aim: Pulmonary arterial hypertension (PAH) and PAH-related heart failure (PAH-HF) have undergone significant epidemiological changes since 1990. However, large-scale studies are scarce. This study evaluates global epidemiologic trends from 1990 to 2021 and projects them to 2050 to inform public health policies.

Methods and results: Data on the incidence, prevalence, deaths, and disability-adjusted life years (DALYs) of PAH and PAH-HF were analysed using models like joinpoint regression, Bayesian age-period-cohort and decomposition analysis. Trends were reported by sex, age group, and geographic region, with projections extending to 2050. In 2021, the global age-standardized incidence rate (ASIR), prevalence rate (ASPR), mortality rate (ASMR), and DALY rate (ASDR) for PAH were 0.52, 2.28, 0.27, and 8.24 per 100 000 population, respectively. Compared with 1990, ASIR and ASPR increased, while ASDR and ASMR declined. Females showed higher burdens in nearly all outcomes. In 2021, Zambia and Switzerland had the highest ASIR and ASPR of PAH, while Mongolia recorded the highest ASMR and ASDR. For PAH-HF, the number of prevalent cases and years lived with disability from 1990 to 2021, though most HF subtypes showed declines in ASPR. Decomposition analysis attributed increases in PAH incidence, prevalence, and DALYs primarily to population growth, while aging primarily drove increases in deaths. Future projections suggest continued growth in ASIR but declines in other burden indicators after 2021.

Conclusion: From 1990 to 2021, the global burden of PAH and PAH-HF increased, with significant gender disparities. These results provide valuable guidance for healthcare strategies and resource allocation.

背景:自1990年以来,肺动脉高压(PAH)和PAH相关性心力衰竭(PAH- hf)发生了显著的流行病学变化。然而,大规模的研究很少。本研究评估了1990年至2021年的全球流行病学趋势,并预测了到2050年的趋势,为公共卫生政策提供信息。方法:采用关节点回归、贝叶斯年龄-时期-队列和分解分析等模型对PAH和PAH- hf的发病率、患病率、死亡率和伤残调整生命年(DALYs)数据进行分析。报告了按性别、年龄组和地理区域划分的趋势,并预测了到2050年的趋势。结果:2021年,PAH的全球年龄标准化发病率(ASIR)、患病率(ASPR)、死亡率(ASMR)和DALY率(ASDR)分别为0.52、2.28、0.27和8.24 / 10万人口。与1990年相比,ASIR和ASPR上升,ASDR和ASMR下降。女性在几乎所有结果中都表现出更高的负担。2021年,赞比亚和瑞士的多环芳烃ASMR和ASDR最高,蒙古的ASMR和ASDR最高。对于PAH-HF,从1990年到2021年,虽然大多数心力衰竭亚型的ASPR下降,但流行病例数和残疾生活年限。分解分析将多环芳烃发病率、患病率和DALYs的增加主要归因于人口增长,而老龄化主要是导致死亡增加的原因。未来的预测表明,2021年后,ASIR将继续增长,但其他负担指标将下降。结论:从1990年到2021年,全球多环芳烃和多环芳烃hf负担增加,且性别差异显著。这些结果为医疗保健策略和资源分配提供了有价值的指导。
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引用次数: 0
Characteristics, use of guideline-recommended medical therapies and clinical outcomes of patients with heart failure not enrolled in a quality registry: a comparison with the Swedish Heart Failure Registry. 未在质量登记中心登记的心力衰竭患者的特征、指南推荐药物治疗的使用和临床结果:与瑞典心力衰竭登记中心的比较
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-04 DOI: 10.1093/ehjqcco/qcaf019
Ailema González-Ortiz, Paul Hjemdahl, Faizan Mazhar, Alessandro Bosi, Anne-Laure Faucon, Gianluigi Savarese, Lars H Lund, Juan Jesus Carrero

Introduction: Quality registries may involve specific inclusion criteria, detailed investigations, or selected hospitals and practitioners, which are not random. Whether the care and outcomes in quality registries are generalizable to the broader population is not well known. We here examine care indicators and outcomes in heart failure (HF) patients enrolled vs. non-enrolled in Swedish Heart Failure (SwedeHF) quality registry.

Methods and results: Observational study of 90-day survivors after a HF in Stockholm (2012-2021). We linked health records from the Stockholm Creatinine Measurements project with SwedeHF. Participants enrolled in SwedeHF were compared to those non-enrolled, focusing on settings of care, use of guideline-recommended therapies, treatment adherence, dose titration, persistence, and outcomes. Analyses considered stratification by settings of management (primary care, cardiology-outpatient, and cardiology-inpatient care). We identified 48 374 incident HF cases of which 4878 (10%) were enrolled in SwedeHF within 90 days. Enrolled participants were younger, more often men and had fewer comorbidities than non-enrolled. Enrolled participants were more likely to initiate, persist and adhere to, and achieve higher dosages of guideline-recommended HF therapies (P < 0.05 for all). Enrolled participants were less likely to experience a major cardiovascular event [CV death, nonfatal myocardial infarction or stroke; HR 0.92, 95% confidence interval (CI) 0.86-0.99] and all-cause death (HR 0.87, 95% CI 0.82-0.92), but had similar rates of HF hospitalization (HR 1.03, 95% CI 0.94-1.15) compared to non-enrolled ones. Findings were similar across settings of management.

Conclusion: Enrollment in the SwedeHF registry occurred in a minority of patients, and was associated with better adherence to guideline-recommended HF therapies and fewer major cardiovascular events and lower mortality. The generalizability of these HF registry findings to all HF patients was, however, limited.

质量登记可能涉及具体的纳入标准、详细的调查或选定的医院和从业人员,这不是随机的。质量登记的护理和结果是否可推广到更广泛的人群尚不清楚。我们在此研究了在瑞典心力衰竭(SwedeHF)质量登记处登记的与未登记的心力衰竭(HF)患者的护理指标和结果。方法:2012-2021年在斯德哥尔摩对心衰后90天存活者进行观察性研究。我们将斯德哥尔摩肌酐测量(SCREAM)项目的健康记录与SwedeHF联系起来。SwedeHF纳入的参与者与未纳入的参与者进行比较,重点关注护理环境、指南推荐疗法的使用、治疗依从性、剂量滴定、持久性和结局。分析考虑了管理设置的分层(初级保健,心脏病-门诊和心脏病-住院护理)。结果:我们确定了48374例HF事件,其中4878例(10%)在90天内纳入了SwedeHF。入组的参与者更年轻,男性居多,合并症也比未入组的少。入组的参与者更有可能开始、坚持和坚持指南推荐的心力衰竭治疗,并获得更高剂量的心力衰竭治疗(结论:少数患者入组了SwedeHF登记,并且与更好地坚持指南推荐的心力衰竭治疗、更少的主要心血管事件和更低的死亡率相关。然而,这些心衰登记结果对所有心衰患者的普遍性是有限的。
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引用次数: 0
Inclusion and reporting by age, sex, and ethnicity in clinical studies of high-risk medical devices approved in the European Union. 在欧盟批准的高风险医疗器械临床研究中按年龄、性别和种族纳入和报告。
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-04 DOI: 10.1093/ehjqcco/qcaf007
J J Coughlan, Robert A Byrne, Georgios C M Siontis, Laurna McGovern, Rory Durand, Anne Lübbeke, Arjola Bano, Alan G Fraser

Introduction: Adequate inclusion and representation of patients in clinical studies is critical for the generalizability of research findings. The aim of this analysis was to determine inclusion and reporting by age, sex, and ethnicity in clinical studies of high-risk medical devices (orthopaedic, diabetes, and cardiovascular) approved in the European Union.

Methods: This is an analysis of data from three co-ordinated systematic reviews of clinical evidence for high-risk medical devices. This analysis includes 641 studies, reporting on more than 1.9 million patients treated with high-risk orthopaedic, diabetes, and cardiovascular medical devices. The main outcomes were the proportions of studies providing data on the age, sex, and ethnicity of participants, and the performance of stratified analyses based on these factors.

Results: The majority (>90%) of studies in all three device categories (orthopaedics, diabetes, and cardiovascular) provided data on the age and sex of participants, but only a minority (<10%) provided information on ethnicity. Female patients comprised over half of the patients in the included orthopaedic and diabetes device studies, but <40% of patients in the included cardiovascular device studies (P < 0.001). A minority of studies performed analyses stratified by age (14.6%) or sex (10.4%), although those were more frequently reported in randomized studies.

Conclusions: Almost all studies in this analysis provided demographic data on age and sex, but only a small minority had analysed whether these factors had any impact on device performance. Very few studies provided information on the ethnicity of study participants. Cardiovascular device studies enrolled a lower proportion of female patients in comparison to orthopaedic and diabetes device studies.

Study registration: Cardiovascular device systematic review: PROSPERO (CRD42022308593). Diabetes device systematic review: PROSPERO (CRD42022366871). Orthopaedic device systematic review: open science framework (https://osf.io/6gmyx).

在临床研究中充分纳入和代表患者对研究结果的普遍性至关重要。本分析的目的是确定在欧洲联盟(EU)批准的高风险医疗器械(骨科、糖尿病和心血管)临床研究中按年龄、性别和种族纳入和报告情况。方法:这是对高风险医疗器械临床证据的三个协调系统评价数据的分析。该分析包括641项研究,报告了190多万接受高风险骨科、糖尿病和心血管医疗设备治疗的患者。主要结果是提供参与者年龄、性别和种族数据的研究的比例,以及基于这些因素的分层分析的表现。结果:所有三种器械类别(骨科、糖尿病和心血管)的大多数研究(>90%)提供了参与者的年龄和性别数据,但只有少数研究(结论:本分析中几乎所有研究都提供了年龄和性别的人口统计数据,但只有少数研究分析了这些因素是否对器械性能有任何影响。很少有研究提供了研究参与者的种族信息。与骨科和糖尿病器械研究相比,心血管器械研究纳入的女性患者比例较低。心血管设备系统评价:PROSPERO (CRD42022308593),糖尿病设备系统评价:PROSPERO (CRD42022366871)。骨科器械系统评价:开放科学框架(https://osf.io/6gmyx)。
{"title":"Inclusion and reporting by age, sex, and ethnicity in clinical studies of high-risk medical devices approved in the European Union.","authors":"J J Coughlan, Robert A Byrne, Georgios C M Siontis, Laurna McGovern, Rory Durand, Anne Lübbeke, Arjola Bano, Alan G Fraser","doi":"10.1093/ehjqcco/qcaf007","DOIUrl":"10.1093/ehjqcco/qcaf007","url":null,"abstract":"<p><strong>Introduction: </strong>Adequate inclusion and representation of patients in clinical studies is critical for the generalizability of research findings. The aim of this analysis was to determine inclusion and reporting by age, sex, and ethnicity in clinical studies of high-risk medical devices (orthopaedic, diabetes, and cardiovascular) approved in the European Union.</p><p><strong>Methods: </strong>This is an analysis of data from three co-ordinated systematic reviews of clinical evidence for high-risk medical devices. This analysis includes 641 studies, reporting on more than 1.9 million patients treated with high-risk orthopaedic, diabetes, and cardiovascular medical devices. The main outcomes were the proportions of studies providing data on the age, sex, and ethnicity of participants, and the performance of stratified analyses based on these factors.</p><p><strong>Results: </strong>The majority (>90%) of studies in all three device categories (orthopaedics, diabetes, and cardiovascular) provided data on the age and sex of participants, but only a minority (<10%) provided information on ethnicity. Female patients comprised over half of the patients in the included orthopaedic and diabetes device studies, but <40% of patients in the included cardiovascular device studies (P < 0.001). A minority of studies performed analyses stratified by age (14.6%) or sex (10.4%), although those were more frequently reported in randomized studies.</p><p><strong>Conclusions: </strong>Almost all studies in this analysis provided demographic data on age and sex, but only a small minority had analysed whether these factors had any impact on device performance. Very few studies provided information on the ethnicity of study participants. Cardiovascular device studies enrolled a lower proportion of female patients in comparison to orthopaedic and diabetes device studies.</p><p><strong>Study registration: </strong>Cardiovascular device systematic review: PROSPERO (CRD42022308593). Diabetes device systematic review: PROSPERO (CRD42022366871). Orthopaedic device systematic review: open science framework (https://osf.io/6gmyx).</p>","PeriodicalId":11869,"journal":{"name":"European Heart Journal - Quality of Care and Clinical Outcomes","volume":" ","pages":"962-968"},"PeriodicalIF":4.6,"publicationDate":"2025-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12587281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Standardized and hierarchically classified heart failure and complementary disease monitoring outcome measures: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart). 标准化和分级分类的心力衰竭和辅助疾病监测结果测量方法:欧洲心脏护理评估和随机试验统一登记处(EuroHeart)。
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-04 DOI: 10.1093/ehjqcco/qcae086
Asad Bhatty, Chris Wilkinson, Gorav Batra, Suleman Aktaa, Adam B Smith, Ali Wahab, Sam Chappell, Joakim Alfredsson, David Erlinge, Jorge Ferreira, Ingibjörg J Guðmundsdóttir, Þórdís Jóna Hrafnkelsdóttir, Inga Jóna Ingimarsdóttir, Alar Irs, András Jánosi, Zoltán Járai, Manuel Oliveira-Santos, Bogdan A Popescu, Peter Vasko, Dragos Vinereanu, Jonathan Yap, Raffaele Bugiardini, Edina Cenko, Ramesh Nadarajah, Matthew R Sydes, Stefan James, Aldo P Maggioni, Lars Wallentin, Barbara Casadei, Chris P Gale

Aims: The lack of standardized definitions for heart failure outcome measures limits the ability to reliably assess the effectiveness of heart failure therapies. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) aimed to produce a catalogue of internationally endorsed data definitions for heart failure outcome measures.

Methods and results: Following the EuroHeart methods for the development of cardiovascular data standards, a working group was formed of representatives from the European Society of Cardiology Heart Failure Association and other leading heart failure experts. A systematic review of observational and randomized clinical trials identified current outcome measures, which was supplemented by clinical practice guidelines and existing registries for contemporary definitions. A modified Delphi process was employed to gain consensus for variable inclusion and whether collection should be mandatory (Level 1) or optional (Level 2) within EuroHeart. In addition, a set of complementary outcome measures were identified by the working group as of scientific and clinical importance for longitudinal monitoring for people with heart failure. Five Level 1 and two Level 2 outcome measures were selected and defined, alongside five complementary monitoring outcomes for patients with heart failure.

Conclusion: We present a structured, hierarchical catalogue of internationally endorsed heart failure outcome measures. This will facilitate quality improvement, high quality observational research, registry-based trials, and post-market surveillance of medical devices.

目的:心力衰竭结果测量标准定义的缺乏限制了可靠评估心力衰竭治疗效果的能力。欧洲心脏护理评估和随机试验统一登记处(EuroHeart)的目标是为心力衰竭结果测量编制一份国际认可的数据定义目录:按照 EuroHeart 制定心血管数据标准的方法,由欧洲心脏病学会心力衰竭协会的代表和其他主要心力衰竭专家组成了一个工作组。通过对观察性临床试验和随机临床试验的系统回顾,确定了当前的结果测量方法,并通过临床实践指南和现有登记册对当代定义进行了补充。我们采用了一种改良的德尔菲流程,以便就变量的纳入以及在 EuroHeart 中应强制收集(1 级)还是选择收集(2 级)达成共识。此外,工作组还确定了一组补充性结果测量指标,认为它们对心衰患者的纵向监测具有重要的科学和临床意义:结果:选定并定义了五项一级和两项二级结果指标,以及五项针对心衰患者的补充监测结果:结论:我们提出了国际认可的心力衰竭结果测量的结构化分级目录。这将有助于质量改进、高质量的观察研究、以登记为基础的试验以及医疗设备的上市后监测。
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引用次数: 0
Performance of the ARC-HBR criteria in ST-elevation myocardial infarction. Significance of smoking as an additional bleeding risk factor. ARC-HBR标准在ST段抬高型心肌梗死中的应用。吸烟作为额外出血风险因素的意义。
IF 4.6 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-09-12 DOI: 10.1093/ehjqcco/qcae104
Henri Kesti, Kalle Mattila, Samuli Jaakkola, Joonas Lehto, Nea Söderblom, Kalle Kalliovalkama, Pekka Porela

Background and aims: The Academic Research Consortium for High Bleeding Risk criteria (ARC-HBR) are recommended by guidelines for bleeding risk assessment in ST-elevation myocardial infarction (STEMI). The aim of this study was to identify possible other risk factors and adjust the original ARC-HBR criteria for confounders.

Methods and results: All consecutive STEMI patients managed in a Finnish tertiary hospital between 2016 and 2022 were identified using a database search. Data collection was done by reviewing electronic patient records. Bleeding risk was assessed according to the ARC-HBR criteria. The primary endpoint was non-access site bleeding academic research consortium (BARC) type 3 or 5 bleeding during 1-year follow-up. A total of 1548 STEMI patients were analysed. HBR criteria was fulfilled in 661 (42.7%). Multivariable competing risk analysis identified only 4 individual ARC-HBR criteria as independent risk factors for bleeding. Smoking status was identified as a novel bleeding risk factor. Current and former smokers had increased bleeding risk compared with never smokers [hazard ratio (HR) 3.01, 95% confidence interval (CI) 1.62-5.61 and HR 1.99, CI 1.19-3.34]. In those not meeting any ARC-HBR criteria, cumulative BARC 3 or 5 incidence of current smoking was 3.40% and intracranial haemorrhage (ICH) 1.36%. Thus, exceeding ARC-HBR definition for a major criterion. In the non-HBR group the prevalence of current smoking was 40.4% (n = 358).

Conclusion: Current and former smoking predicts major bleeding complications after STEMI. Current smoking is highly prevalent among those classified as non-HBR according to the ARC-HBR criteria.

背景和目的:高出血风险标准学术研究联盟(ARC-HBR)被st段抬高型心肌梗死(STEMI)出血风险评估指南推荐。本研究的目的是确定可能的其他危险因素,并调整原有的ARC-HBR混杂因素标准。方法:通过数据库检索确定2016-2022年间在芬兰三级医院管理的所有连续STEMI患者。数据收集是通过查看电子病历完成的。根据ARC-HBR标准评估出血风险。主要终点为1年随访期间非通路部位出血学术研究联盟(BARC) 3型或5型出血。结果:共分析STEMI患者1548例。661例(42.7%)符合HBR标准。多变量竞争风险分析发现只有4个单独的ARC-HBR标准是出血的独立危险因素。吸烟状况被确定为新的出血危险因素。与从不吸烟者相比,当前吸烟者和曾经吸烟者的出血风险增加(风险比[HR] 3.01, 95%可信区间[CI] 1.62-5.61;风险比[HR] 1.99, CI 1.19-3.34)。在不符合任何ARC-HBR标准的患者中,目前吸烟的累积BARC 3或5发生率为3.40%,颅内出血(ICH)发生率为1.36%。因此,超过ARC-HBR定义为主要标准。在非hbr组中,当前吸烟率为40.4% (n = 358)。结论:当前和既往吸烟可预测STEMI后的主要出血并发症。根据ARC-HBR标准,目前吸烟在被归类为非hbr的人群中非常普遍。
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引用次数: 0
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European Heart Journal - Quality of Care and Clinical Outcomes
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