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Cardiac autonomic function score: a novel risk stratification tool in the cardiac intensive care unit based on periodic repolarization dynamics and deceleration capacity of heart rate (LMU-eICU study). 心脏自主功能评分:一种基于周期性复极化动力学和心率减速能力的新型心脏重症监护病房风险分层工具(LMU-eICU研究)。
IF 3.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-30 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf038
Mathias Klemm, Lukas von Stülpnagel, Valentin Ostermaier, Carsten Theurer, Laura E Villegas Sierra, Felix Wenner, Elodie Eiffener, Aresa Krasniqi, Konstantinos Mourouzis, Lauren E Sams, Luisa Freyer, Steffen Massberg, Axel Bauer, Konstantinos D Rizas

Aims: Treatment capacities on intensive care units (ICUs) are a limited resource reserved for high-risk patients. To facilitate risk stratification of ICU patients, several scoring systems have been developed over time. Among them, the Simplified Acute Physiology Score 3 (SAPS3) is the gold standard, but lacks specificity for cardiac ICU patients. Here, we propose a novel, fully automated, electrocardiogram-based cardiac autonomic risk stratification score (CAFICU) that substantially adds to current risk stratification strategies.

Methods and results: CAFICU is based on periodic repolarization dynamics, a marker of sympathetic overactivity and deceleration capacity of heart rate, a parameter of vagal imbalance. We developed CAFICU in a retrospective cohort of 355 ICU patients and subsequently validated the score in a cohort of 702 ICU patients, enrolled between February-November 2018 and December 2018-April 2020 at a large cardiac ICU in a tertiary hospital. The primary endpoint of the study was 30-day intrahospital mortality. Thirty (8.5%) and 100 (14.2%) patients reached the primary endpoint in the training and validation cohorts, respectively. CAFICU was significantly higher in non-survivors than survivors (2.58 ± 1.34 vs. 1.76 ± 0.97 units; P = 0.003 in the training cohort and 2.20 ± 1.05 vs. 1.70 ± 0.83 units; P < 0.001 in the validation cohort) and was a strong predictor of mortality in both the training [hazard ratio (HR) 25.67; 95% confidence interval (CI) 3.50-188.40; P = 0.001] and validation cohorts (HR 4.70; 95% CI 2.79-7.92; P < 0.001). In the pooled cohort, CAFICU significantly improved risk stratification based on SAPS3 (IDI-increase 0.033; 95% CI 0.010-0.061; P < 0.001).

Conclusion: ECG-based automatic autonomic risk stratification by means of PRD and DC is highly predictive of short-term mortality in the ICU and can be combined with the SAPS3-Score to identify patients with increased risk for intrahospital mortality. This method can be integrated in conventional monitors and may improve risk stratification strategies in cardiac ICUs.

目的:重症监护病房(icu)的治疗能力是为高危患者保留的有限资源。随着时间的推移,为了促进ICU患者的风险分层,已经开发了几种评分系统。其中,简化急性生理评分3 (SAPS3)是金标准,但对心脏ICU患者缺乏特异性。在这里,我们提出了一种新颖的、全自动的、基于心电图的心脏自主风险分层评分(CAFICU),它大大增加了当前的风险分层策略。方法和结果:CAFICU基于周期性复极化动力学,是交感神经过度活跃和心率减速能力的标志,是迷走神经失衡的参数。我们在355名ICU患者的回顾性队列中开发了CAFICU,随后在702名ICU患者的队列中验证了评分,这些患者于2018年2月至11月和2018年12月至2020年4月在一家三级医院的大型心脏ICU登记。该研究的主要终点是30天院内死亡率。在训练组和验证组中,分别有30例(8.5%)和100例(14.2%)患者达到了主要终点。非幸存者的CAFICU显著高于幸存者(2.58±1.34比1.76±0.97单位;训练组P = 0.003, 2.20±1.05 vs 1.70±0.83单位;在验证队列中P < 0.001),并且在训练[危险比(HR) 25.67;95%置信区间(CI) 3.50-188.40;P = 0.001]和验证队列(HR 4.70;95% ci 2.79-7.92;P < 0.001)。在合并队列中,CAFICU显著改善了基于SAPS3的风险分层(idi增加0.033;95% ci 0.010-0.061;P < 0.001)。结论:基于心电图的PRD和DC自动自主风险分层对ICU短期死亡率具有较高的预测价值,可与SAPS3-Score联合识别院内死亡风险增高的患者。这种方法可以集成到传统的监护仪中,并可能改善心脏重症监护病房的风险分层策略。
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引用次数: 0
Decoding coronary physiology: towards standardized interpretation through machine learning. 解码冠状动脉生理学:通过机器学习实现标准化解释。
IF 3.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-30 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf045
Ioannis Skalidis, Philippe Garot, Thomas Hovasse
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引用次数: 0
Enhanced spatial understanding through virtual reality in valve-in-valve TAVI planning. 通过虚拟现实在阀中阀TAVI规划中增强空间理解。
IF 3.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-29 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf046
Ioannis Skalidis, Antoinette Neylon, Mariama Akodad
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引用次数: 0
Effects of a digitally enabled cardiac rehabilitation intervention on risk factors, recurrent hospitalization and mortality. 数字化心脏康复干预对危险因素、复发住院和死亡率的影响
IF 3.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-29 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf043
Justin Braver, Thomas H Marwick, Agus Salim, Dulari Hakamuwalekamlage, Catherine Keating, Stephanie R Yiallourou, Brian Oldenburg, Melinda J Carrington

Aims: Cardiac rehabilitation (CR) programmes are effective, but they are underutilized. Digitally enabled CR programmes (DeCR) offer alternative means of healthcare delivery. We aimed to assess the effects of a DeCR programme on cardiovascular risk factors and healthcare utilization.

Methods and results: In this observational cohort study that used propensity score matching, privately insured Australian patients, recruited nationally following a cardiac hospitalization, were given a digital app and received weekly telehealth consultations. Risk factors were assessed before and after the intervention. Propensity scoring methods were used to compare differences in 30-day, 90-day, and 12-month rehospitalizations, hospital-days, and mortality rates in the DeCR group with patients who undertook: (i) usual care (n = 266) or (ii) face-to-face CR (F2F-CR, n = 115). Overall, 172 intervention patients (70% men, age 68 ± 10 years, 36% living in regional/remote areas) were enrolled (59% agreed to participate and 91% completed final follow-up). The DeCR group had significant improvements in most risk factors. Rehospitalization and mortality rates were similar between the DeCR group and both comparison groups at all time points (all P > 0.05). Patients in the DeCR group spent significantly fewer days in hospital compared with usual care within 30-days (P = 0.026), 90-days (P = 0.003), and 12-months (P = 0.04) post-discharge. Cardiac-related rehospitalization bed days were reduced at 30-days (P = 0.005) and 90-days (P = 0.017) but not 12-months (P = 0.20). There were no group differences between DeCR and F2F-CR across any outcomes (all P > 0.05).

Conclusion: DeCR was associated with lower healthcare utilization than usual care, yet comparable compared with F2F-CR. DeCR represents a suitable option for cardiac patients post-discharge.

Lay summary: We investigated whether a digitally enabled cardiac rehabilitation (DeCR) programme, delivered to patients following a heart disease hospitalization, improved patients' cardiovascular disease risk factors and whether they had a reduction in rehospitalizations, spent fewer days in hospital and improved survival compared with matched controls who undertook either face-to-face cardiac rehabilitation (F2F-CR) or usual care.• DeCR was associated with similar healthcare utilization outcomes compared with F2F-CR. This suggests that the potential benefits of DeCR may be comparable. Additionally, DeCR programmes create an opportunity for patients to choose the style of CR to undertake and have an advantage of broader access.• The DeCR group spent significantly fewer readmission days in hospital compared with the usual care group, which may reflect differences in the nature of rehospitalizations when they occur.

目的:心脏康复(CR)方案是有效的,但它们没有得到充分利用。数字化的社会责任项目(DeCR)提供了另一种医疗保健服务方式。我们的目的是评估DeCR项目对心血管危险因素和医疗保健利用的影响。方法和结果:在这项使用倾向评分匹配的观察性队列研究中,在心脏病住院治疗后,在全国范围内招募私人保险的澳大利亚患者,给他们一个数字应用程序,并接受每周的远程医疗咨询。在干预前后评估危险因素。采用倾向评分方法比较DeCR组患者30天、90天和12个月再住院、住院天数和死亡率的差异:(i)常规护理(n = 266)或(ii)面对面CR (F2F-CR, n = 115)。总共纳入172例干预患者(70%为男性,年龄68±10岁,36%生活在地区/偏远地区)(59%同意参加,91%完成最终随访)。DeCR组在大多数危险因素上有显著改善。在所有时间点,DeCR组与对照组的再住院率和死亡率相似(P < 0.05)。DeCR组患者出院后30天(P = 0.026)、90天(P = 0.003)和12个月(P = 0.04)住院天数明显少于常规护理组。心脏相关的再住院天数在30天(P = 0.005)和90天(P = 0.017)时减少,但在12个月时没有减少(P = 0.20)。DeCR和F2F-CR在任何结果上均无组间差异(均P < 0.05)。结论:与常规护理相比,DeCR与较低的医疗保健利用率相关,但与F2F-CR相当。DeCR是心脏病患者出院后的合适选择。摘要:我们调查了与接受面对面心脏康复(F2F-CR)或常规护理的对照组相比,向心脏病住院患者提供数字化心脏康复(DeCR)计划是否改善了患者的心血管疾病危险因素,以及他们是否减少了再住院、住院天数减少和生存率提高。•与F2F-CR相比,DeCR与类似的医疗保健利用结果相关。这表明DeCR的潜在益处可能是可比的。此外,DeCR项目为患者选择进行CR的方式创造了机会,并具有更广泛的优势。•与常规护理组相比,DeCR组的再入院天数明显减少,这可能反映了再住院发生时性质的差异。
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引用次数: 0
Validation of a popular consumer-grade cuffless blood pressure device for continuous 24 h monitoring. 验证一种流行的消费级无袖血压装置,用于24小时连续监测。
IF 4.4 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-29 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf044
Bhavini J Bhatt, Haashim Mohammad Amir, Siana Jones, Alexandra Jamieson, Nishi Chaturvedi, Alun Hughes, Michele Orini

Aims: Hypertension is a leading cause of death worldwide, yet many hypertensive cases remain undiagnosed. Wearable, cuffless blood pressure (BP) monitors could be deployed at scale, but their accuracy remains undetermined.

Methods and results: This study validated a popular consumer-grade wearable BP monitor (W-BPM, Aktiia), using a medical-grade ambulatory device (A-BPM, Mobil-O-Graph), for reference. Thirty-one participants (aged 19-62 years, 17 (55%) females, in office BP 121 ± 15 over 77 ± 12 mmHg) simultaneously wore both devices for 24 h. Systolic BP (SBP), diastolic BP (DBP), and heart rate (HR) were measured in pre-set intervals by the A-BPM and at rest by the W-BPM. Agreement was assessed using standard methods. Accuracy in identifying high BP (mean 24 h SBP/DBP > 130/80 mmHg) was assessed. Compared to A-BMP, mean SBP and DBP tended to be slightly lower during the day and not significantly different at night. Nocturnal BP dipping and BP variability were significantly underestimated by the W-BPM. Agreement between the two devices was poor to moderate (limits of agreement of about -30/+30 mmHg for SBP and -20/+15 mmHg for DBP, correlation coefficients between 0.20 and 0.42). Sensitivity and specificity for high BP detection were around 50% and 80%, respectively. Limiting the analysis to measures taken in similar conditions (within 10 min and with HR within ±10 b.p.m.) did not improve agreement.

Conclusion: Low agreement suggests that the cuffless device may not be a suitable replacement for standard 24 h cuff-based ambulatory monitoring. Further data are required to assess the clinical role of cuffless BP monitors.

目的:高血压是世界范围内死亡的主要原因,但许多高血压病例仍未得到诊断。可穿戴式、无袖带式血压监测仪可以大规模部署,但其准确性仍有待确定。方法和结果:本研究验证了流行的消费级可穿戴式血压监测仪(W-BPM, Aktiia),并使用医疗级动态设备(a - bpm, mobile - o - graph)作为参考。31名参与者(年龄19-62岁,17名(55%)女性,办公室血压121±15高于77±12 mmHg)同时佩戴两种装置24小时。收缩压(SBP)、舒张压(DBP)和心率(HR)在预先设定的时间间隔内由A-BPM测量,静止时由W-BPM测量。采用标准方法评估一致性。评估了识别高血压(平均24小时收缩压/舒张压> 130/80 mmHg)的准确性。与A-BMP相比,平均收缩压和舒张压在白天略低,夜间差异不显著。夜间血压下降和血压变异性被W-BPM显著低估。两种装置之间的一致性较差至中等(舒张压的一致性极限约为-30/+30 mmHg,舒张压的一致性极限为-20/+15 mmHg,相关系数在0.20和0.42之间)。高血压检测的敏感性和特异性分别约为50%和80%。将分析限制在类似条件下(10分钟内,HR在±10 b.p.m.内)采取的措施并没有提高一致性。结论:低一致性表明无袖带装置可能不是标准24小时基于袖带的动态监测的合适替代品。需要进一步的数据来评估无袖血压监测仪的临床作用。
{"title":"Validation of a popular consumer-grade cuffless blood pressure device for continuous 24 h monitoring.","authors":"Bhavini J Bhatt, Haashim Mohammad Amir, Siana Jones, Alexandra Jamieson, Nishi Chaturvedi, Alun Hughes, Michele Orini","doi":"10.1093/ehjdh/ztaf044","DOIUrl":"10.1093/ehjdh/ztaf044","url":null,"abstract":"<p><strong>Aims: </strong>Hypertension is a leading cause of death worldwide, yet many hypertensive cases remain undiagnosed. Wearable, cuffless blood pressure (BP) monitors could be deployed at scale, but their accuracy remains undetermined.</p><p><strong>Methods and results: </strong>This study validated a popular consumer-grade wearable BP monitor (W-BPM, Aktiia), using a medical-grade ambulatory device (A-BPM, Mobil-O-Graph), for reference. Thirty-one participants (aged 19-62 years, 17 (55%) females, in office BP 121 ± 15 over 77 ± 12 mmHg) simultaneously wore both devices for 24 h. Systolic BP (SBP), diastolic BP (DBP), and heart rate (HR) were measured in pre-set intervals by the A-BPM and at rest by the W-BPM. Agreement was assessed using standard methods. Accuracy in identifying high BP (mean 24 h SBP/DBP > 130/80 mmHg) was assessed. Compared to A-BMP, mean SBP and DBP tended to be slightly lower during the day and not significantly different at night. Nocturnal BP dipping and BP variability were significantly underestimated by the W-BPM. Agreement between the two devices was poor to moderate (limits of agreement of about -30/+30 mmHg for SBP and -20/+15 mmHg for DBP, correlation coefficients between 0.20 and 0.42). Sensitivity and specificity for high BP detection were around 50% and 80%, respectively. Limiting the analysis to measures taken in similar conditions (within 10 min and with HR within ±10 b.p.m.) did not improve agreement.</p><p><strong>Conclusion: </strong>Low agreement suggests that the cuffless device may not be a suitable replacement for standard 24 h cuff-based ambulatory monitoring. Further data are required to assess the clinical role of cuffless BP monitors.</p>","PeriodicalId":72965,"journal":{"name":"European heart journal. Digital health","volume":"6 4","pages":"704-712"},"PeriodicalIF":4.4,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282388/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Study design and rationale of the AZIMUTH trial: a smartphone, app-based, E-health-integrated model of care for heart failure patients. AZIMUTH试验的研究设计和基本原理:一种基于智能手机、应用程序、电子健康一体化的心力衰竭患者护理模式。
IF 3.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-24 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf040
Domenico D'Amario, Attilio Restivo, Renzo Laborante, Donato Antonio Paglianiti, Alfredo Cesario, Stefano Patarnello, Sofoklis Kyriazakos, Alice Luraschi, Konstantina Kostopoulou, Antonio Iaconelli, Enrico Incaminato, Gaetano Rizzo, Marco Gorini, Stefania Marcoli, Vincenzo Bartoli, Thomas Griffiths, Peter Fenici, Simona Giubilato, Maurizio Volterrani, Giuseppe Patti, Vincenzo Valentini, Giovanni Scambia, Filippo Crea

Aims: Despite advancements in disease-modifying therapies, the rate of hospitalizations in patients with heart failure (HF) remains high, with an increased risk of future adverse events and healthcare costs. In this context, the AZIMUTH study aims to evaluate the large-scale applicability of a smartphone app-based model of care to improve the quality of care and clinical outcomes of HF patients.

Methods and results: The AZIMUTH trial is a multicentre, prospective, pragmatic, interventional, single-cohort study enrolling HF patients. Three hundred patients will be recruited from four different sites. For comparative analyses, historical data from participating hospitals for the 6 months before enrolment and propensity-matching score analyses from GENERATOR HF DataMart, will be used. The estimated duration of the study is 6 months. During the whole observational period, the patients are asked to provide information regarding their clinical status, transmit remote clinical parameters, and periodically answer validated questionnaires, the Kansas City Cardiomyopathy Questionnaire Health and Morisky Medication Adherence Scale 8-item, on a mobile application, through which healthcare providers implement therapeutic adjustments and remote clinical assessments. The primary objective of this study is to evaluate the feasibility, usability, and perceived benefits for key stakeholders (patients and clinical staff) of the AZIMUTH digital platform in the enrolled patients when compared to standard of care. Secondary endpoints will be the description of the rate of hospital readmissions, ambulatory visits and prescribed therapy in the 6 months following enrolment in the experimental group compared to both the historical and propensity-matched cohorts.

Conclusion: The AZIMUTH aims to enhance HF management by leveraging digital technologies to support the care process and enhance monitoring, engagement, and personalized treatment for HF patients.

目的:尽管疾病改善疗法取得了进展,但心力衰竭(HF)患者的住院率仍然很高,未来不良事件和医疗费用的风险增加。在此背景下,AZIMUTH研究旨在评估基于智能手机应用程序的护理模式的大规模适用性,以提高心衰患者的护理质量和临床结果。方法和结果:AZIMUTH试验是一项多中心、前瞻性、实用性、介入性、单队列研究,纳入了心衰患者。将从四个不同的地点招募300名患者。为了进行比较分析,将使用参与医院入组前6个月的历史数据和GENERATOR HF DataMart的倾向匹配评分分析。预计研究时间为6个月。在整个观察期间,要求患者在移动应用程序上提供有关其临床状态的信息,传输远程临床参数,并定期回答有效问卷,堪萨斯城心肌病问卷健康和莫里斯基药物依从性量表8项,医疗服务提供者通过该应用程序实施治疗调整和远程临床评估。本研究的主要目的是评估与标准护理相比,入组患者中AZIMUTH数字平台的可行性、可用性和对关键利益相关者(患者和临床工作人员)的感知益处。次要终点将是与历史组和倾向匹配组相比,实验组在入组后6个月内再入院率、门诊就诊率和处方治疗率的描述。结论:AZIMUTH旨在通过利用数字技术支持护理过程,加强对心衰患者的监测、参与和个性化治疗,从而加强心衰管理。
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引用次数: 0
Synthetic electrocardiograms for Brugada syndrome: from data generation to expert cardiologists evaluation. Brugada综合征的合成心电图:从数据生成到心脏病专家评估。
IF 3.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-24 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf039
Beatrice Zanchi, Giuliana Monachino, Francesca Dalia Faraci, Matteo Metaldi, Pedro Brugada, Georgia Sarquella-Brugada, Elijah R Behr, Josep Brugada, Lia Crotti, Bernard Belhassen, Giulio Conte

Aims: Synthetic electrocardiograms (ECGs) for inherited cardiac diseases may overcome the issue related to data scarcity for artificial intelligence (AI)-based algorithms. This study aimed to evaluate experienced cardiologists' ability to differentiate synthetic and real Brugada ECGs.

Methods and results: A total of 2244 ECG instances (50% synthetic generated by a generative adversarial network, 50% real Brugada patients' ECGs) were evaluated by 7 cardiologists, each with >15 years of experience. All ECGs were standard 12-lead recordings acquired with identical settings (paper speed 25 mm/s, amplitude 10 mm/mV) and randomly assigned without identifying markers. The examination was blinded and conducted in 2 rounds with at least 2 h gap between rounds to assess potential learning effects and intra-rater reliability. Each physician classified the recordings as 'real' or 'synthetic' without having any additional information. Performance metrics, including accuracy, sensitivity, specificity, and intra-rater reliability (Cohen's Kappa), were analyzed. Brugada syndrome (BrS) specialists' repeated evaluations were characterized by low accuracy (first round 40%, second round 42%), specificity (first round 22%, second round 26%) and sensitivity (first round 58%, second round 58%). Intra-rater reliability varied widely (Cohen's Kappa: -0.12 to 0.80).

Conclusion: Synthetic Brugada ECGs cannot be adequately distinguished from real patients' ECGs by BrS specialists.

目的:遗传性心脏病的合成心电图(ECGs)可以克服基于人工智能(AI)算法的数据稀缺问题。这项研究旨在评估有经验的心脏病专家区分合成和真实Brugada心电图的能力。方法和结果:共有2244例心电图(50%是由生成对抗网络合成的,50%是真实的Brugada患者的心电图)由7名心脏病专家评估,每个专家都有50 - 15年的经验。所有心电图都是标准的12导联记录,设置相同(纸张速度25 mm/s,振幅10 mm/mV),随机分配,没有识别标记。该研究采用盲法,分两轮进行,两轮之间至少间隔2小时,以评估潜在的学习效果和评分者内信度。每位医生在没有任何附加信息的情况下,将录音分为“真实”和“合成”。性能指标,包括准确性、敏感性、特异性和内部可靠性(Cohen’s Kappa)进行分析。Brugada综合征(BrS)专家重复评估的特点是准确性低(第一轮40%,第二轮42%),特异性低(第一轮22%,第二轮26%),敏感性低(第一轮58%,第二轮58%)。内部信度差异很大(科恩Kappa: -0.12至0.80)。结论:BrS专家无法将合成的Brugada心电图与真实患者的心电图充分区分开来。
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引用次数: 0
Medicine, healthcare and the AI act: gaps, challenges and future implications. 医学、医疗保健和人工智能法案:差距、挑战和未来影响。
IF 3.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-23 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf041
Emmanouil P Vardas, Maria Marketou, Panos E Vardas

The European Union's Artificial Intelligence Act (AI Act), published in July 2024, is a pioneering horizontal regulatory framework aimed at ensuring the ethical and safe integration of AI technologies across sectors, including healthcare. While it offers the potential to improve patient care and drive innovation, it also presents challenges for healthcare providers, such as identifying high-risk applications, ensuring transparency in algorithms, and mitigating data bias. However, there are several challenges in its implementation. These include unclear guidance for certain technologies, the need to ensure fairness for diverse patient populations, effective monitoring of AI performance after deployment, and clarifying responsibility in cases of errors. Additionally, varying levels of resources among EU countries may lead to inconsistent implementation of the regulations. This article explores the core elements of the AI Act and its relevance to cardiology and identifies key gaps and unanswered questions that need to be addressed to effectively advance AI-driven medical practices.

欧盟于2024年7月发布的《人工智能法案》(AI Act)是一个开创性的横向监管框架,旨在确保人工智能技术在包括医疗保健在内的各个部门的道德和安全整合。虽然它提供了改善患者护理和推动创新的潜力,但它也给医疗保健提供商带来了挑战,例如识别高风险应用程序、确保算法的透明度以及减轻数据偏差。然而,在实施过程中存在一些挑战。这些问题包括对某些技术的指导不明确,需要确保对不同患者群体的公平性,部署后对人工智能性能的有效监测,以及在出现错误时明确责任。此外,欧盟国家之间资源水平的差异可能导致法规的执行不一致。本文探讨了人工智能法案的核心要素及其与心脏病学的相关性,并确定了需要解决的关键差距和未解决的问题,以有效推进人工智能驱动的医疗实践。
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引用次数: 0
Detection of subclinical atherosclerosis by image-based deep learning on chest X-ray. 基于图像的胸部x线深度学习检测亚临床动脉粥样硬化。
IF 3.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-21 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf033
Guglielmo Gallone, Francesco Iodice, Alberto Presta, Davide Tore, Ovidio De Filippo, Michele Visciano, Carlo Alberto Barbano, Alessandro Serafini, Paola Gorrini, Alessandro Bruno, Walter Grosso Marra, James Hughes, Mario Iannaccone, Paolo Fonio, Attilio Fiandrotti, Alessandro Depaoli, Marco Grangetto, Gaetano Maria De Ferrari, Fabrizio D'Ascenzo

Aims: To develop a deep-learning-based system for recognition of subclinical atherosclerosis on a plain frontal chest X-ray.

Methods and results: A deep-learning algorithm to predict coronary artery calcium (CAC) score (the AI-CAC model) was developed on 460 chest X-ray (80% training cohort, 20% internal validation cohort) of primary prevention patients [58.4% male, median age 63 (51-74) years] with available paired chest X-ray and chest computed tomography (CT) indicated for any clinical reason and performed within 3 months. The CAC score calculated on chest CT was used as ground truth. The model was validated on a temporally independent validation cohort of 90 patients from the same institution (external validation). The diagnostic accuracy of the AI-CAC model assessed by the area under the curve (AUC) was the primary outcome. Overall, median AI-CAC score was 35 (0-388) and 28.9% patients had no AI-CAC. AUC of the AI-CAC model to identify a CAC >0 was 0.90 (95%CI 0.84-0.97) in the internal validation cohort and 0.77 (95%CI 0.67-0.86) in the external validation cohort. Sensitivity was consistently above 92% in both cohorts. In the overall cohort (n = 540), among patients with AI-CAC = 0, a single ASCVD event occurred, after 4.3 years. Patients with AI-CAC > 0 had significantly higher Kaplan Meier estimates for ASCVD events (13.5% vs. 3.4%, log-rank = 0.013).

Conclusion: The AI-CAC model seems to accurately detect subclinical atherosclerosis on chest X-ray with high sensitivity, and to predict ASCVD events with high negative predictive value. Adoption of the AI-CAC model to refine CV risk stratification or as an opportunistic screening tool requires prospective evaluation.

目的:开发一种基于深度学习的识别亚临床动脉粥样硬化的胸部x线平片系统。方法和结果:对460例初级预防患者(58.4%为男性,中位年龄63(51-74)岁)进行了深度学习算法,用于预测冠状动脉钙(CAC)评分(AI-CAC模型),其中80%为训练队列,20%为内部验证队列),并在3个月内进行了任何临床原因的胸部x线和胸部计算机断层扫描(CT)。以胸部CT计算的CAC评分为基础真值。该模型在来自同一机构的90名患者的临时独立验证队列中进行验证(外部验证)。以曲线下面积(AUC)评估AI-CAC模型的诊断准确性是主要预后指标。总体而言,AI-CAC中位评分为35分(0-388分),28.9%的患者没有AI-CAC。AI-CAC模型识别CAC bb0 0的AUC在内部验证队列中为0.90 (95%CI 0.84-0.97),在外部验证队列中为0.77 (95%CI 0.67-0.86)。在两个队列中,敏感性均在92%以上。在整个队列中(n = 540),在AI-CAC = 0的患者中,在4.3年后发生了一次ASCVD事件。AI-CAC患者的ASCVD事件Kaplan Meier估计值明显较高(13.5% vs. 3.4%, log-rank = 0.013)。结论:AI-CAC模型在胸片上能准确检测亚临床动脉粥样硬化,灵敏度高,预测ASCVD事件阴性预测值高。采用AI-CAC模型来完善心血管风险分层或作为机会性筛查工具需要进行前瞻性评估。
{"title":"Detection of subclinical atherosclerosis by image-based deep learning on chest X-ray.","authors":"Guglielmo Gallone, Francesco Iodice, Alberto Presta, Davide Tore, Ovidio De Filippo, Michele Visciano, Carlo Alberto Barbano, Alessandro Serafini, Paola Gorrini, Alessandro Bruno, Walter Grosso Marra, James Hughes, Mario Iannaccone, Paolo Fonio, Attilio Fiandrotti, Alessandro Depaoli, Marco Grangetto, Gaetano Maria De Ferrari, Fabrizio D'Ascenzo","doi":"10.1093/ehjdh/ztaf033","DOIUrl":"10.1093/ehjdh/ztaf033","url":null,"abstract":"<p><strong>Aims: </strong>To develop a deep-learning-based system for recognition of subclinical atherosclerosis on a plain frontal chest X-ray.</p><p><strong>Methods and results: </strong>A deep-learning algorithm to predict coronary artery calcium (CAC) score (the AI-CAC model) was developed on 460 chest X-ray (80% training cohort, 20% internal validation cohort) of primary prevention patients [58.4% male, median age 63 (51-74) years] with available paired chest X-ray and chest computed tomography (CT) indicated for any clinical reason and performed within 3 months. The CAC score calculated on chest CT was used as ground truth. The model was validated on a temporally independent validation cohort of 90 patients from the same institution (external validation). The diagnostic accuracy of the AI-CAC model assessed by the area under the curve (AUC) was the primary outcome. Overall, median AI-CAC score was 35 (0-388) and 28.9% patients had no AI-CAC. AUC of the AI-CAC model to identify a CAC >0 was 0.90 (95%CI 0.84-0.97) in the internal validation cohort and 0.77 (95%CI 0.67-0.86) in the external validation cohort. Sensitivity was consistently above 92% in both cohorts. In the overall cohort (<i>n</i> = 540), among patients with AI-CAC = 0, a single ASCVD event occurred, after 4.3 years. Patients with AI-CAC > 0 had significantly higher Kaplan Meier estimates for ASCVD events (13.5% vs. 3.4%, log-rank = 0.013).</p><p><strong>Conclusion: </strong>The AI-CAC model seems to accurately detect subclinical atherosclerosis on chest X-ray with high sensitivity, and to predict ASCVD events with high negative predictive value. Adoption of the AI-CAC model to refine CV risk stratification or as an opportunistic screening tool requires prospective evaluation.</p>","PeriodicalId":72965,"journal":{"name":"European heart journal. Digital health","volume":"6 4","pages":"567-576"},"PeriodicalIF":3.9,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of seismocardiography in detecting pre-load changes and cardiovascular disease: a comparative study with transthoracic echocardiography. 评价地震心动图在检测负荷变化和心血管疾病中的作用:与经胸超声心动图的比较研究。
IF 3.9 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-04-16 eCollection Date: 2025-07-01 DOI: 10.1093/ehjdh/ztaf037
Ahmad Agam, Ali Agam, Emil Korsgaard, Troels Yding, Charlotte Burup Kristensen, Rasmus Mogelvang, Kristian Kragholm, Kasper Janus Grønn Emerk, Peter Søgaard, Samuel Emil Schmidt

Aims: This study aimed to test whether seismocardiography (SCG) can detect changes in loading conditions and detect significant differences in SCG signals between healthy individuals and those with cardiovascular disease (CVD).

Methods and results: Twenty-six subjects (age 45 ± 16 years and 77% male) were included, 11 healthy subjects and 15 subjects with CVD. SCG was compared with transthoracic echocardiography (TTE) before and after infusion of 2 L of isotonic saline. Nine subjects (34%) with CVD did not tolerate the full infusion (2 L infusion intolerant), while the remaining 17 subjects (2 L infusion tolerant) successfully completed the infusion. Significant changes in SCG measurements were observed after infusion, including amplitudes Ls (19%, P = 0.015), Dd (23%, P = 0.016), and Ed (48%, P < 0.001) as well as most time intervals. TTE measurements also showed post-infusion changes in stroke volume (15%, P = 0.038), mitral annular velocity (7%, P = 0.013), left ventricular ejection time (1%, P = 0.035), and global longitudinal strain (6%, P = 0.003). Although SCG did not detect differences between the healthy and CVD groups, the diastolic amplitude Cd-Dd significantly differed between the infusion tolerant and intolerant groups (pre-infusion: 7.7 vs. 3.7 mg, P = 0.046; post-infusion: 8.3 vs. 4.1 mg, P = 0.034).

Conclusion: SCG can detect changes in pre-load in both healthy subjects and subjects with CVD. SCG were also able to detect differences in SCG diastolic amplitudes between infusion-tolerant and -intolerant subjects, which may indicate ability to detect diastolic dysfunction and differences in left ventricular filling pressures.

目的:本研究旨在测试地震心动图(SCG)是否可以检测负荷条件的变化,并检测健康个体和心血管疾病(CVD)患者之间SCG信号的显着差异。方法与结果:纳入26例(年龄45±16岁,男性77%),11例健康,15例心血管疾病。比较输注2l等渗盐水前后SCG与经胸超声心动图(TTE)的差异。9名CVD患者(34%)不能耐受全量输注(2 L输注不耐受),而其余17名患者(2 L输注耐受)成功完成输注。输注后SCG测量值发生显著变化,包括振幅Ls (19%, P = 0.015)、Dd (23%, P = 0.016)和Ed (48%, P < 0.001)以及大多数时间间隔。TTE测量还显示了输注后卒中容量(15%,P = 0.038)、二尖瓣环速度(7%,P = 0.013)、左心室射血时间(1%,P = 0.035)和整体纵向应变(6%,P = 0.003)的变化。尽管SCG在健康组和心血管疾病组之间没有发现差异,但输注耐受组和不耐受组的舒张幅度Cd-Dd有显著差异(输注前:7.7 vs 3.7 mg, P = 0.046;注射后:8.3 vs 4.1 mg, P = 0.034)。结论:SCG可以检测健康者和心血管病患者的负荷变化。SCG还能够检测输注耐受和不耐受受试者之间SCG舒张幅度的差异,这可能表明能够检测舒张功能障碍和左心室充盈压力的差异。
{"title":"Evaluation of seismocardiography in detecting pre-load changes and cardiovascular disease: a comparative study with transthoracic echocardiography.","authors":"Ahmad Agam, Ali Agam, Emil Korsgaard, Troels Yding, Charlotte Burup Kristensen, Rasmus Mogelvang, Kristian Kragholm, Kasper Janus Grønn Emerk, Peter Søgaard, Samuel Emil Schmidt","doi":"10.1093/ehjdh/ztaf037","DOIUrl":"10.1093/ehjdh/ztaf037","url":null,"abstract":"<p><strong>Aims: </strong>This study aimed to test whether seismocardiography (SCG) can detect changes in loading conditions and detect significant differences in SCG signals between healthy individuals and those with cardiovascular disease (CVD).</p><p><strong>Methods and results: </strong>Twenty-six subjects (age 45 ± 16 years and 77% male) were included, 11 healthy subjects and 15 subjects with CVD. SCG was compared with transthoracic echocardiography (TTE) before and after infusion of 2 L of isotonic saline. Nine subjects (34%) with CVD did not tolerate the full infusion (2 L infusion intolerant), while the remaining 17 subjects (2 L infusion tolerant) successfully completed the infusion. Significant changes in SCG measurements were observed after infusion, including amplitudes Ls (19%, <i>P</i> = 0.015), Dd (23%, <i>P</i> = 0.016), and Ed (48%, <i>P</i> < 0.001) as well as most time intervals. TTE measurements also showed post-infusion changes in stroke volume (15%, <i>P</i> = 0.038), mitral annular velocity (7%, <i>P</i> = 0.013), left ventricular ejection time (1%, <i>P</i> = 0.035), and global longitudinal strain (6%, <i>P</i> = 0.003). Although SCG did not detect differences between the healthy and CVD groups, the diastolic amplitude Cd-Dd significantly differed between the infusion tolerant and intolerant groups (pre-infusion: 7.7 vs. 3.7 mg, <i>P</i> = 0.046; post-infusion: 8.3 vs. 4.1 mg, <i>P</i> = 0.034).</p><p><strong>Conclusion: </strong>SCG can detect changes in pre-load in both healthy subjects and subjects with CVD. SCG were also able to detect differences in SCG diastolic amplitudes between infusion-tolerant and -intolerant subjects, which may indicate ability to detect diastolic dysfunction and differences in left ventricular filling pressures.</p>","PeriodicalId":72965,"journal":{"name":"European heart journal. Digital health","volume":"6 4","pages":"811-821"},"PeriodicalIF":3.9,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700489","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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European heart journal. Digital health
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