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From risk factor to therapeutic target: obesity therapy and cardiovascular outcomes. 从危险因素到治疗目标:肥胖治疗和心血管预后。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2026-327845
Ronen Arbel, Dror Dicker
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引用次数: 0
Abnormal echocardiographic finding: what is the cystic mass in a young woman with secundum atrial septal defect. 异常超声心动图发现:什么是囊性肿块的年轻女性与第二房间隔缺损。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2025-327116
Ying Li, Dongqing Ren, Dandan Sun
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引用次数: 0
Cardiopulmonary exercise test criteria for heart transplantation referral of patients with ambulatory heart failure in the current era. 心肺运动试验标准在当代动态心衰患者心脏移植转诊中的应用。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2025-327208
Maryam Azar, Anna Apostolo, Elisabetta Salvioni, Arianna Galotta, Michele Emdin, Massimo Piepoli, Alberto Palazzuoli, Gianfranco Sinagra, Damiano Magrì, Stefania Paolillo, Massimo Mapelli, Jeness Campodonico, Ugo Corrà, Rosa Raimondo, Antonio Cittadini, Annamaria Iorio, Andrea Salzano, Roberto Badagliacca, Michele Senni, Pasquale Perrone-Filardi, Michele Correale, Enrico Perna, Marco Metra, Carlo Vignati, Mauro C Contini, Nikita Baracchini, Gaia Cattadori, Marco Guazzi, Giuseppe Limongelli, Gianfranco Parati, Beatrice Pezzuto, Robin Willixhofer, Pietro Palermo, Maria Vittoria Matassini, Francesco Bandera, Maurizio Bussotti, Ermes Carulli, Federica Re, Angela Beatrice Scardovi, Susanna Sciomer, Andrea Passantino, Davide Girola, Claudio Passino, Luigi Adamo, Piergiuseppe Agostoni

Background: Current guidelines recommend evaluating patients with ambulatory heart failure (HF) for heart transplantation if their peak oxygen consumption (peak VO2) is <12 mL/kg/min. However, these recommendations are based on decades-old data.

Methods: We retrospectively analysed 8060 patients with ambulatory HF with cardiopulmonary exercise testing (CPET) data. The primary analysis focused on 1218 patients with left ventricular ejection fraction <40% and peak VO2 <12 mL/kg/min, enrolled between 2010 and 2022. Survival outcomes (composite of death/left ventricular assist device/heart transplantation) were compared with those of heart transplantation recipients from the International Society for Heart and Lung Transplantation registry. Patients were stratified by ventilatory efficiency (ventilation versus CO2 production slope (VE/VCO2) >34 vs ≤34) and presence of exercise oscillatory ventilation. Survival analyses were performed using Kaplan-Meier curves compared with log-rank tests and Cox proportional hazards models, with heart transplantation survival curves reconstructed from aggregate data.

Results: Patients with peak VO2 <12 mL/kg/min demonstrated better survival than heart transplantation recipients, with survival curves intersecting at approximately 2.7 years. Among those with VE/VCO2 ≤34, 10-year mortality risk was halved (p<0.01), with survival curves crossing those of heart transplantation recipients around year 4. Absence of exercise oscillatory ventilation was similarly associated with a 50% lower long-term mortality. Combining VE/VCO2 and exercise oscillatory ventilation identified four distinct risk groups with significantly different 10-year outcomes (p<0.01). Patients with peak VO2 <12 mL/kg/min, VE/VCO2 ≤34 and no exercise oscillatory ventilation exhibited survival comparable to heart transplantation recipients at year 5.

Conclusions: In contemporary practice, a peak VO2 <12 mL/kg/min alone may not reliably identify patients with HF with sufficiently high short-term mortality to warrant heart transplantation referral. VE/VCO2 and exercise oscillatory ventilation provide important additional risk stratification, supporting re-evaluation of transplant referral criteria to reflect improved HF management and outcomes.

背景:目前的指南建议评估动态心力衰竭(HF)患者的心脏移植,如果他们的峰值耗氧量(峰值VO2)是。方法:我们回顾性分析了8060例动态心力衰竭患者的心肺运动试验(CPET)数据。初步分析集中于1218例左心室射血分数22产生斜率(VE/VCO2) >34 vs≤34)和存在运动振荡通气的患者。生存分析采用Kaplan-Meier曲线与log-rank检验和Cox比例风险模型进行比较,心脏移植生存曲线由汇总数据重建。结果:峰值VO2≤34的患者,10年死亡风险减半(p2),运动振荡通气确定了四个不同的风险组,其10年结局显著不同(p2≤34,无运动振荡通气的患者在第5年的生存率与心脏移植受体相当。结论:在当代实践中,VO2峰值和运动振荡通气提供了重要的额外风险分层,支持重新评估移植转诊标准,以反映改善的心衰管理和结果。
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引用次数: 0
Electrocardiographic imaging: technical developments and future applications for non-invasive electroanatomical study of the human heart. 心电图成像:人类心脏无创电解剖研究的技术发展和未来应用。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2024-324963
Nikhil Kadambadi, Matthew Webber, Gabriella Captur

Electrocardiographic imaging (ECGI) is a non-invasive technique that combines patient-specific cardiac anatomy with numerous body-surface potentials to gain insight into the in vivo electrical epicardial activity across the whole heart. This review summarises some of the latest hardware developments for ECGI data acquisition as well as innovative software solutions to address the inverse problem of electrocardiography. It delves into some of the successful clinical applications of ECGI while highlighting the hurdles that still stand in the way of its more widespread roll-out to healthcare. As well as serving as a powerful tool for electrophysiological research, ECGI promises to play an increasingly valuable role in the personalised diagnosis and management of cardiac arrhythmias.

心电图成像(ECGI)是一种非侵入性技术,它结合了患者特定的心脏解剖和许多体表电位,以深入了解整个心脏的体内心外膜电活动。这篇综述总结了ECGI数据采集的一些最新硬件发展,以及解决心电图逆问题的创新软件解决方案。它深入研究了ECGI的一些成功的临床应用,同时强调了在其更广泛地推广到医疗保健领域的道路上仍然存在的障碍。作为电生理学研究的有力工具,ECGI有望在心律失常的个性化诊断和管理中发挥越来越有价值的作用。
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引用次数: 0
Impact of air pollution and multimorbidity on the risk of incident atrial fibrillation. 空气污染和多种疾病对房颤发生风险的影响。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2024-325451
Junguo Zhang, Ge Chen, Shengtao Wei, Wanquan Li, Gregory Y H Lip, Hualiang Lin

Background: Emerging evidence suggests associations between air pollution, multimorbidity, and atrial fibrillation (AF), but their interplay remains unclear. We evaluated these relationships in a prospective cohort.

Methods: We retrieved a total of 480 344 individuals from the UK Biobank. The quantification of air pollutants (particulate matter with a diameter ≤2.5 μm (PM2.5), particulate matter with a diameter ≤10 μm (PM10), nitrogen oxides (NOx) and nitrogen dioxide (NO2)) was conducted at the geocoded residential locations of each participant. Multimorbidity clusters were determined using latent class analysis using 35 long-term conditions (LTCsc. Three latent classes were identified: non-cardiovascular disease (non-CVD) multimorbidity, mental health multimorbidity and cardiometabolic multimorbidity. These were compared with no LTCs and singular LTCs. Cox models examined the effects of air pollution and multimorbidity status on AF incidence. Counterfactual analyses were performed to calculate the proportion of preventable AF.

Results: During a median follow-up of 12.5 years (IQI 11.8 to 13.2), 28 977 incident AF cases occurred. Exposure to PM2.5 was associated with a 37% higher AF risk per 1 µg/m³ higher PM2.5 (HR 1.37, 95% CI 1.36 to 1.38), with similar patterns for PM10 (HR 1.18, 95% CI 1.17 to 1.18), NOₓ (HR 1.06, 95% CI 1.06 to 1.06) and NO2 (HR 1.03, 95% CI 1.03 to 1.03). Compared with no multimorbidity, cardiometabolic multimorbidity showed a 1.84-fold higher AF risk (95% CI 1.76 to 1.93), while non-CVD multimorbidity showed a 2.13-fold higher risk (95% CI 1.97 to 2.30). Additive interactions were observed between air pollution and multimorbidity. For example, participants with high PM2.5 exposure and non-CVD multimorbidity had a sixfold higher AF risk (95% CI 5.25 to 6.82; relative excess risk due to interaction (RERI) 2.31, 95% CI 1.55 to 3.07), exceeding the sum of individual risks. Counterfactual analysis suggested that reducing PM2.5 to the 10th percentile could prevent 26-52% of AF cases in multimorbidity subgroups, with the largest reductions in cardiometabolic (52%) clusters.

Conclusion: Air pollution and multimorbidity were independently and synergistically associated with higher AF risk. Mitigation strategies targeting pollution may reduce AF burden, particularly in high-risk populations.

背景:新出现的证据表明空气污染、多病和房颤(AF)之间存在关联,但它们之间的相互作用尚不清楚。我们在一个前瞻性队列中评估了这些关系。方法:我们从UK Biobank中检索了480344个个体。在每个参与者的地理编码居住地进行空气污染物(直径≤2.5 μm的颗粒物(PM2.5)、直径≤10 μm的颗粒物(PM10)、氮氧化物(NOx)和二氧化氮(NO2))的量化。使用35个长期条件(LTCsc)的潜在类分析确定多发病群。确定了三个潜在类别:非心血管疾病(non-CVD)多病、精神健康多病和心脏代谢多病。与无LTCs和单一LTCs进行比较。Cox模型检验了空气污染和多病状态对房颤发病率的影响。结果:在12.5年(IQI为11.8 ~ 13.2)的中位随访期间,共发生28977例AF。暴露于PM2.5中,每增加1 μ g/m³,AF风险增加37% (HR 1.37, 95% CI 1.36至1.38),PM10 (HR 1.18, 95% CI 1.17至1.18),NOₓ(HR 1.06, 95% CI 1.06至1.06)和NO2 (HR 1.03, 95% CI 1.03至1.03)也有类似的模式。与无多重发病相比,心脏代谢多重发病的AF风险高出1.84倍(95% CI 1.76 - 1.93),而非心血管疾病多重发病的风险高出2.13倍(95% CI 1.97 - 2.30)。观察到空气污染与多发病之间存在叠加性相互作用。例如,高PM2.5暴露和非心血管疾病多重发病率的参与者患房颤的风险高出6倍(95% CI 5.25至6.82;相互作用导致的相对超额风险(rei) 2.31, 95% CI 1.55 ~ 3.07),超过了个体风险的总和。反事实分析表明,在多疾病亚组中,将PM2.5降低到第10个百分位数可以预防26-52%的房颤病例,其中心脏代谢群的减少幅度最大(52%)。结论:空气污染和多种疾病与房颤的发生有独立和协同的关系。针对污染的缓解战略可减轻房颤负担,特别是在高危人群中。
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引用次数: 0
Accelerometry-defined physical activity and quality of life in hypertrophic cardiomyopathy. 加速计定义的肥厚性心肌病患者的身体活动和生活质量。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2025-326217
Stephan A C Schoonvelde, Peter-Paul Zwetsloot, Alexander Hirsch, Arend F L Schinkel, Christian Knackstedt, Tjeerd Germans, Marjon A van Slegtenhorst, Judith M A Verhagen, Rudolf A de Boer, Michelle Michels

Background: Patients with hypertrophic cardiomyopathy (HCM) often reduce their physical activity due to concerns about sudden cardiac death. However, objective data on activity patterns in HCM, particularly in relation to clinical phenotype and quality of life (QoL), remain limited.

Methods: We assessed physical activity using 7-day accelerometry in 203 patients with HCM and 37 genotype-positive, phenotype-negative (G+/P-) individuals. Outcomes included daily step counts, time spent in moderate-to-vigorous physical activity (MVPA) and sedentariness. QoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQoL 5-domain 5-level (EQ-5D-5L).

Results: HCM patients took fewer steps/day (5254 vs 6573), engaged in less MVPA (3.4% vs 4.5% of the day) and were more often sedentary (61% vs 35% spending >80% of the day sedentary) compared with G+/P- controls (all p<0.01). Symptomatic and obstructive HCM patients showed the lowest activity levels. Notably, asymptomatic obstructive HCM patients demonstrated reduced activity comparable to symptomatic individuals. Obesity and use of cardiac medications were also associated with lower activity. Step counts were positively associated with QoL scores: a 250 steps/day increment corresponded to a 2.15-point higher KCCQ score and a 1000 steps/day increment to a 0.05-point higher EQ-5D-5L score (both p<0.001), remaining significant after adjustment for age and sex. Most HCM patients (62%) recalled receiving exercise guidance, and many (59%) reported reducing their activity as a result.

Conclusions: Objectively measured physical activity was significantly lower in HCM patients compared with G+/P- individuals, particularly among those with symptoms, obstruction or obesity. Even modestly higher daily step counts were associated with better QoL, highlighting the relevance of individualised, phenotype-informed exercise counselling in HCM.

背景:肥厚性心肌病(HCM)患者往往由于担心心源性猝死而减少体力活动。然而,关于HCM活动模式的客观数据,特别是与临床表型和生活质量(QoL)相关的数据仍然有限。方法:我们使用7天加速度计评估203例HCM患者和37例基因型阳性、表型阴性(G+/P-)个体的身体活动。结果包括每日步数、中等到剧烈体育活动(MVPA)的时间和久坐时间。生活质量采用堪萨斯城心肌病问卷(KCCQ)和EuroQoL 5-domain 5-level (EQ-5D-5L)进行测量。结果:与G+/P-对照组相比,HCM患者每天走的步数更少(5254对6573),MVPA更少(3.4%对4.5%),并且更经常久坐(61%对35%,每天有80%的时间久坐)(所有结论:与G+/P-对照组相比,HCM患者客观测量的身体活动显著降低,特别是那些有症状、梗阻或肥胖的患者。即使是稍微高的每日步数也与更好的生活质量相关,这突出了HCM个体化、表型知情的运动咨询的相关性。
{"title":"Accelerometry-defined physical activity and quality of life in hypertrophic cardiomyopathy.","authors":"Stephan A C Schoonvelde, Peter-Paul Zwetsloot, Alexander Hirsch, Arend F L Schinkel, Christian Knackstedt, Tjeerd Germans, Marjon A van Slegtenhorst, Judith M A Verhagen, Rudolf A de Boer, Michelle Michels","doi":"10.1136/heartjnl-2025-326217","DOIUrl":"10.1136/heartjnl-2025-326217","url":null,"abstract":"<p><strong>Background: </strong>Patients with hypertrophic cardiomyopathy (HCM) often reduce their physical activity due to concerns about sudden cardiac death. However, objective data on activity patterns in HCM, particularly in relation to clinical phenotype and quality of life (QoL), remain limited.</p><p><strong>Methods: </strong>We assessed physical activity using 7-day accelerometry in 203 patients with HCM and 37 genotype-positive, phenotype-negative (G+/P-) individuals. Outcomes included daily step counts, time spent in moderate-to-vigorous physical activity (MVPA) and sedentariness. QoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQoL 5-domain 5-level (EQ-5D-5L).</p><p><strong>Results: </strong>HCM patients took fewer steps/day (5254 vs 6573), engaged in less MVPA (3.4% vs 4.5% of the day) and were more often sedentary (61% vs 35% spending >80% of the day sedentary) compared with G+/P- controls (all p<0.01). Symptomatic and obstructive HCM patients showed the lowest activity levels. Notably, asymptomatic obstructive HCM patients demonstrated reduced activity comparable to symptomatic individuals. Obesity and use of cardiac medications were also associated with lower activity. Step counts were positively associated with QoL scores: a 250 steps/day increment corresponded to a 2.15-point higher KCCQ score and a 1000 steps/day increment to a 0.05-point higher EQ-5D-5L score (both p<0.001), remaining significant after adjustment for age and sex. Most HCM patients (62%) recalled receiving exercise guidance, and many (59%) reported reducing their activity as a result.</p><p><strong>Conclusions: </strong>Objectively measured physical activity was significantly lower in HCM patients compared with G+/P- individuals, particularly among those with symptoms, obstruction or obesity. Even modestly higher daily step counts were associated with better QoL, highlighting the relevance of individualised, phenotype-informed exercise counselling in HCM.</p>","PeriodicalId":12835,"journal":{"name":"Heart","volume":" ","pages":"333-340"},"PeriodicalIF":4.4,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144951431","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
Towards patient-centred benefit-risk assessment with generalised pairwise comparisons. 以患者为中心的获益-风险评估与广义两两比较。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2025-327051
Johan Verbeeck
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引用次数: 0
Is the FDA regulation of cardiology AI devices supporting cardiovascular innovation: a scoping review. FDA对支持心血管创新的心脏病学人工智能设备的监管:范围审查。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2025-326307
Ahmed Hussain, Ahmad Guni, Rishikesh Gandhewar, John Warner-Levy, Alexander Davidson, Kamal Shah, Ara Darzi, Hutan Ashrafian

Background: Artificial intelligence (AI) and machine learning (ML) have shown immense potential in cardiology, leveraging data-driven insights to enhance diagnosis, treatment planning and patient care. This study presents a comprehensive evaluation of US Food and Drug Administration (FDA)-approved AI/ML devices in cardiology, analysing trends in clinical applications, regulatory pathways and evidence transparency.

Methods: FDA clearance summaries from the AI/ML medical device database were reviewed to identify cardiology-specific applications. Devices were categorised using the descriptive, diagnostic, predictive and prescriptive framework. Regulatory pathways, AI technologies and validation data were critically assessed.

Results: Of 1016 FDA-approved AI/ML devices, 277 (27.3%) had cardiology applications, predominantly for imaging (65.3%) and diagnostics (64.3%). Predictive and prescriptive tools constituted only 5.4% and 0.7%, respectively. Most devices (97.1%) were cleared via the 510(k) pathway, with 58.0% at risk of predicate creep. Quality of clinical evidence was limited, with only 3.2% of devices supported by high-quality trials. The type of AI technology was often underreported (58.8%).

Conclusion: While AI/ML technologies are reshaping cardiology, regulatory challenges and reporting transparency impede their optimal use. Strengthened regulatory frameworks, improved trial design and robust post-market surveillance are essential to ensure safety, efficacy and equity in the deployment of AI tools in cardiology.

背景:人工智能(AI)和机器学习(ML)在心脏病学中显示出巨大的潜力,利用数据驱动的见解来增强诊断、治疗计划和患者护理。本研究对美国食品和药物管理局(FDA)批准的心脏病学AI/ML设备进行了全面评估,分析了临床应用趋势、监管途径和证据透明度。方法:审查AI/ML医疗器械数据库中的FDA许可摘要,以确定心脏病学特异性应用。使用描述性、诊断性、预测性和规范性框架对设备进行分类。对监管途径、人工智能技术和验证数据进行了严格评估。结果:在1016个fda批准的AI/ML设备中,277个(27.3%)具有心脏病学应用,主要用于成像(65.3%)和诊断(64.3%)。预测性和规范性工具分别仅占5.4%和0.7%。大多数器械(97.1%)通过510(k)途径清除,58.0%存在谓词蠕变风险。临床证据的质量有限,只有3.2%的器械得到高质量试验的支持。人工智能技术的类型往往被低估(58.8%)。结论:虽然AI/ML技术正在重塑心脏病学,但监管挑战和报告透明度阻碍了它们的最佳使用。加强监管框架、改进试验设计和强有力的上市后监测对于确保在心脏病学中部署人工智能工具的安全性、有效性和公平性至关重要。
{"title":"Is the FDA regulation of cardiology AI devices supporting cardiovascular innovation: a scoping review.","authors":"Ahmed Hussain, Ahmad Guni, Rishikesh Gandhewar, John Warner-Levy, Alexander Davidson, Kamal Shah, Ara Darzi, Hutan Ashrafian","doi":"10.1136/heartjnl-2025-326307","DOIUrl":"10.1136/heartjnl-2025-326307","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence (AI) and machine learning (ML) have shown immense potential in cardiology, leveraging data-driven insights to enhance diagnosis, treatment planning and patient care. This study presents a comprehensive evaluation of US Food and Drug Administration (FDA)-approved AI/ML devices in cardiology, analysing trends in clinical applications, regulatory pathways and evidence transparency.</p><p><strong>Methods: </strong>FDA clearance summaries from the AI/ML medical device database were reviewed to identify cardiology-specific applications. Devices were categorised using the descriptive, diagnostic, predictive and prescriptive framework. Regulatory pathways, AI technologies and validation data were critically assessed.</p><p><strong>Results: </strong>Of 1016 FDA-approved AI/ML devices, 277 (27.3%) had cardiology applications, predominantly for imaging (65.3%) and diagnostics (64.3%). Predictive and prescriptive tools constituted only 5.4% and 0.7%, respectively. Most devices (97.1%) were cleared via the 510(k) pathway, with 58.0% at risk of predicate creep. Quality of clinical evidence was limited, with only 3.2% of devices supported by high-quality trials. The type of AI technology was often underreported (58.8%).</p><p><strong>Conclusion: </strong>While AI/ML technologies are reshaping cardiology, regulatory challenges and reporting transparency impede their optimal use. Strengthened regulatory frameworks, improved trial design and robust post-market surveillance are essential to ensure safety, efficacy and equity in the deployment of AI tools in cardiology.</p>","PeriodicalId":12835,"journal":{"name":"Heart","volume":" ","pages":"300-306"},"PeriodicalIF":4.4,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144951538","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
Benefit-risk of colchicine and spironolactone in acute myocardial infarction: a prespecified generalised pairwise comparisons analysis of the CLEAR trial. 秋水仙碱和螺内酯在急性心肌梗死中的获益-风险:CLEAR试验的预先指定的一般两两比较分析。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2025-326218
Marc-André d'Entremont, Sanjit S Jolly, Faisal Alharthi, Binita Shah, David Austin, Quilong Yi, Robert F Storey, Matthias Bossard, Jan Cornel, Jeroen Jaspers Focks, Sasko Kedev, Valon Asani, Goran Stankovic, Michael Tsang, Nicholas Valettas, Jessica Tyrwhitt, Jackie Betz, Shun Fu Lee, Rajibul Mian, Johanne Silvain, Farzin Beygui, Andrew Czarnecki, Payam Dehghani, Warren Cantor, Shahar Lavi, James C Spratt, Emilie P Belley-Côté, John W Eikelboom

Background: Composite outcomes in cardiovascular trials often group events of unequal clinical importance, and conventional analyses may obscure treatment trade-offs. Generalised pairwise comparisons (GPC), expressed as a win ratio (WR), allow for hierarchical ranking of events and incorporation of recurrent outcomes, providing a potentially more intuitive assessment of benefit-risk.

Methods: In a prespecified exploratory analysis of the 2×2 factorial, randomised CLEAR (Colchicine and Spironolactone in Patients with Myocardial Infarction) trial (7062 patients within 72 hours of acute myocardial infarction (MI) and percutaneous coronary intervention), we applied both time-to-first and recurrent-event GPC to reassess low-dose colchicine (0.5 mg daily) and spironolactone (25 mg daily) versus placebo. For the colchicine comparison, the hierarchical benefit-risk outcome included all-cause death, stroke, recurrent MI, unplanned ischaemia-driven revascularisation, serious infection or diarrhoea. For the spironolactone comparison, the outcome included all-cause death, stroke, MI, new or worsening heart failure, significant ventricular arrhythmia, hyperkalaemia or gynaecomastia/gynaecodynia. GPC results were compared with Cox, logistic and Andersen-Gill models.

Results: For colchicine, the time-to-first event GPC showed a 12% lower proportional win rate compared with placebo (WR 0.88, 95% CI 0.79 to 0.98; win difference -2.10%, 95% CI -3.84 to -0.37), driven largely by excess diarrhoea. For spironolactone, patients experienced a 14% lower win rate (WR 0.86, 95% CI 0.75 to 0.99; win difference -1.46%, 95% CI -2.84% to -0.08%), largely attributable to gynaecomastia and hyperkalaemia. Conventional statistical approaches yielded concordant results. Across both interventions, higher-order efficacy outcomes (death, MI, stroke, heart failure) showed no benefit.

Conclusions: In patients with post-MI, both low-dose colchicine and spironolactone demonstrated disadvantageous benefit-risk profiles, reinforcing that neither agent should be used routinely. This prespecified application of GPC provided results consistent with traditional methods but offered a clinically intuitive framework for interpreting composite outcomes.

背景:心血管试验中的综合结果通常将临床重要性不相等的事件分组,传统分析可能会模糊治疗权衡。以胜率(WR)表示的广义两两比较(GPC)允许对事件进行分层排序,并纳入经常性结果,从而提供潜在的更直观的收益-风险评估。方法:在2×2因子的预先指定的探索分析中,随机CLEAR(秋水仙碱和螺内酯在心肌梗死患者中的应用)试验(7062例急性心肌梗死(MI)和经皮冠状动脉介入治疗72小时内的患者),我们应用时间到头和复发事件GPC重新评估低剂量秋水仙碱(0.5 mg /天)和螺内酯(25 mg /天)与安慰剂。对于秋水仙碱的比较,分级获益-风险结果包括全因死亡、中风、复发性心肌梗死、计划外缺血驱动的血运重建、严重感染或腹泻。对于安内酯组的比较,结果包括全因死亡、中风、心肌梗死、新发或恶化的心力衰竭、显著性室性心律失常、高钾血症或妇科乳房发育/妇科痛。GPC结果与Cox、logistic和Andersen-Gill模型进行比较。结果:对于秋水仙碱,与安慰剂相比,首次事件发生时间GPC的比例胜率低12% (WR 0.88, 95% CI 0.79至0.98;胜率差-2.10%,95% CI -3.84至-0.37),主要是由过量腹泻引起的。对于安内酯,患者的胜率降低14% (WR 0.86, 95% CI 0.75至0.99;胜率差-1.46%,95% CI -2.84%至-0.08%),主要归因于妇科乳房发育和高钾血症。传统的统计方法得出了一致的结果。在两种干预措施中,高阶疗效结果(死亡、心肌梗死、中风、心力衰竭)均未显示出获益。结论:在心肌梗死后患者中,低剂量秋水仙碱和螺内酯均显示出不利的获益-风险概况,这强化了这两种药物都不应常规使用。这种预先指定的GPC应用提供了与传统方法一致的结果,但为解释综合结果提供了临床直观的框架。
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引用次数: 0
Impact of name-based implicit bias on time to diagnosis and outcomes in ST-elevation myocardial infarction. 基于名字的内隐偏倚对st段抬高型心肌梗死诊断时间和预后的影响。
IF 4.4 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-02-23 DOI: 10.1136/heartjnl-2025-327383
Dorian Garin, Sonja Lehmann, Wesley Bennar, Diego Mondragon, Selma T Cook, Serban G Puricel, Pascal Meier, Mario Togni, Stéphane Cook

Background: Patients with marginalised characteristics experience delayed ST-elevation myocardial infarction (STEMI) diagnosis despite fast-track protocols. We aimed to determine whether patients with phonetically uncommon surnames in our community experience delays from first medical contact (FMC) to STEMI diagnosis compared with patients with common surnames within an established fast-track network.

Methods: The Fast-Track Protocol for ST-Elevation Myocardial Infarction prospective registry enrolled consecutive STEMI patients from June 2008 to November 2024. Patient surnames were classified as phonetically common or uncommon using standardised phonetic matching against Canton Fribourg population data. Generalised linear models examined FMC-to-diagnosis time, FMC-to-balloon time and infarct size markers. Cox regression assessed major adverse cardiac and cerebrovascular events (MACE) at 30 days, 1 year and 5 years.

Results: Among 1208 patients, 284 (23.5%) had phonetically uncommon surnames. Patients with uncommon names experienced prolonged FMC-to-diagnosis time (59.4±87.6 vs 40.6±37.6 min; mean difference +16.8 min; p=0.009) and FMC-to-balloon time (116.8±90.5 vs 97.5±45.7 min; mean difference +17.5 min; p=0.016). Patients with uncommon names were significantly more likely to exceed the 90 min FMC-to-balloon threshold (39.2% vs 48.4%; p=0.010) and the 120 min threshold (16.4% vs 23.5%; p=0.018). Diagnosis-to-balloon time remained unaffected (p>0.80). Peak creatine kinase muscle-brain showed non-significant elevation (mean difference +52.0 U/L; p=0.077). No differences were observed in MACE at 30 days and 5 years between patients with common and uncommon names.

Conclusions: Patients with phonetically uncommon surnames experienced significant STEMI diagnostic delays within an efficient fast-track network. Protocol-driven care following diagnosis operated equitably, leading to no difference in long-term MACE.

背景:尽管采用了快速通道方案,但具有边缘特征的患者仍会经历延迟st段抬高型心肌梗死(STEMI)的诊断。我们的目的是确定在我们的社区中,与已建立的快速通道网络中姓氏常见的患者相比,姓氏发音不常见的患者从首次医疗接触(FMC)到STEMI诊断是否会延迟。方法:st段抬高型心肌梗死快速通道方案前瞻性登记纳入2008年6月至2024年11月连续STEMI患者。根据弗里堡州人口数据进行标准化的语音匹配,将患者姓氏按语音常见或不常见进行分类。广义线性模型检查了fmc到诊断时间、fmc到球囊时间和梗死面积标记物。Cox回归评估了30天、1年和5年的主要心脑血管不良事件(MACE)。结果:1208例患者中,姓氏语音不常见者284例(23.5%)。不常见名称患者fmc到诊断时间(59.4±87.6 vs 40.6±37.6 min,平均差值+16.8 min, p=0.009)和fmc到球囊时间(116.8±90.5 vs 97.5±45.7 min,平均差值+17.5 min, p=0.016)延长。名字不常见的患者更有可能超过90分钟fmc到球囊阈值(39.2%比48.4%,p=0.010)和120分钟阈值(16.4%比23.5%,p=0.018)。诊断到球囊的时间未受影响(p < 0.80)。肌脑肌酸激酶峰值无显著性升高(平均差值+52.0 U/L; p=0.077)。常见名字和不常见名字患者30天和5年的MACE无差异。结论:姓氏发音不常见的患者在高效的快速通道网络中经历了显著的STEMI诊断延迟。诊断后的方案驱动护理操作公平,导致长期MACE无差异。
{"title":"Impact of name-based implicit bias on time to diagnosis and outcomes in ST-elevation myocardial infarction.","authors":"Dorian Garin, Sonja Lehmann, Wesley Bennar, Diego Mondragon, Selma T Cook, Serban G Puricel, Pascal Meier, Mario Togni, Stéphane Cook","doi":"10.1136/heartjnl-2025-327383","DOIUrl":"https://doi.org/10.1136/heartjnl-2025-327383","url":null,"abstract":"<p><strong>Background: </strong>Patients with marginalised characteristics experience delayed ST-elevation myocardial infarction (STEMI) diagnosis despite fast-track protocols. We aimed to determine whether patients with phonetically uncommon surnames in our community experience delays from first medical contact (FMC) to STEMI diagnosis compared with patients with common surnames within an established fast-track network.</p><p><strong>Methods: </strong>The Fast-Track Protocol for ST-Elevation Myocardial Infarction prospective registry enrolled consecutive STEMI patients from June 2008 to November 2024. Patient surnames were classified as phonetically common or uncommon using standardised phonetic matching against Canton Fribourg population data. Generalised linear models examined FMC-to-diagnosis time, FMC-to-balloon time and infarct size markers. Cox regression assessed major adverse cardiac and cerebrovascular events (MACE) at 30 days, 1 year and 5 years.</p><p><strong>Results: </strong>Among 1208 patients, 284 (23.5%) had phonetically uncommon surnames. Patients with uncommon names experienced prolonged FMC-to-diagnosis time (59.4±87.6 vs 40.6±37.6 min; mean difference +16.8 min; p=0.009) and FMC-to-balloon time (116.8±90.5 vs 97.5±45.7 min; mean difference +17.5 min; p=0.016). Patients with uncommon names were significantly more likely to exceed the 90 min FMC-to-balloon threshold (39.2% vs 48.4%; p=0.010) and the 120 min threshold (16.4% vs 23.5%; p=0.018). Diagnosis-to-balloon time remained unaffected (p>0.80). Peak creatine kinase muscle-brain showed non-significant elevation (mean difference +52.0 U/L; p=0.077). No differences were observed in MACE at 30 days and 5 years between patients with common and uncommon names.</p><p><strong>Conclusions: </strong>Patients with phonetically uncommon surnames experienced significant STEMI diagnostic delays within an efficient fast-track network. Protocol-driven care following diagnosis operated equitably, leading to no difference in long-term MACE.</p>","PeriodicalId":12835,"journal":{"name":"Heart","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147276145","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}
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