Pub Date : 2025-04-30eCollection Date: 2025-07-01DOI: 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。
{"title":"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).","authors":"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","doi":"10.1093/ehjdh/ztaf038","DOIUrl":"10.1093/ehjdh/ztaf038","url":null,"abstract":"<p><strong>Aims: </strong>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 (CAF<sub>ICU</sub>) that substantially adds to current risk stratification strategies.</p><p><strong>Methods and results: </strong>CAF<sub>ICU</sub> is based on periodic repolarization dynamics, a marker of sympathetic overactivity and deceleration capacity of heart rate, a parameter of vagal imbalance. We developed CAF<sub>ICU</sub> 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. CAF<sub>ICU</sub> was significantly higher in non-survivors than survivors (2.58 ± 1.34 vs. 1.76 ± 0.97 units; <i>P</i> = 0.003 in the training cohort and 2.20 ± 1.05 vs. 1.70 ± 0.83 units; <i>P</i> < 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; <i>P</i> = 0.001] and validation cohorts (HR 4.70; 95% CI 2.79-7.92; <i>P</i> < 0.001). In the pooled cohort, CAF<sub>ICU</sub> significantly improved risk stratification based on SAPS3 (IDI-increase 0.033; 95% CI 0.010-0.061; <i>P</i> < 0.001).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":72965,"journal":{"name":"European heart journal. Digital health","volume":"6 4","pages":"822-832"},"PeriodicalIF":3.9,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700534","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}
Pub Date : 2025-04-30eCollection Date: 2025-07-01DOI: 10.1093/ehjdh/ztaf045
Ioannis Skalidis, Philippe Garot, Thomas Hovasse
{"title":"Decoding coronary physiology: towards standardized interpretation through machine learning.","authors":"Ioannis Skalidis, Philippe Garot, Thomas Hovasse","doi":"10.1093/ehjdh/ztaf045","DOIUrl":"10.1093/ehjdh/ztaf045","url":null,"abstract":"","PeriodicalId":72965,"journal":{"name":"European heart journal. Digital health","volume":"6 4","pages":"524-525"},"PeriodicalIF":3.9,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700538","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}
Pub Date : 2025-04-29eCollection Date: 2025-07-01DOI: 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.
{"title":"Effects of a digitally enabled cardiac rehabilitation intervention on risk factors, recurrent hospitalization and mortality.","authors":"Justin Braver, Thomas H Marwick, Agus Salim, Dulari Hakamuwalekamlage, Catherine Keating, Stephanie R Yiallourou, Brian Oldenburg, Melinda J Carrington","doi":"10.1093/ehjdh/ztaf043","DOIUrl":"10.1093/ehjdh/ztaf043","url":null,"abstract":"<p><strong>Aims: </strong>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.</p><p><strong>Methods and results: </strong>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 (<i>n</i> = 266) or (ii) face-to-face CR (F2F-CR, <i>n</i> = 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 <i>P</i> > 0.05). Patients in the DeCR group spent significantly fewer days in hospital compared with usual care within 30-days (<i>P</i> = 0.026), 90-days (<i>P</i> = 0.003), and 12-months (<i>P</i> = 0.04) post-discharge. Cardiac-related rehospitalization bed days were reduced at 30-days (<i>P</i> = 0.005) and 90-days (<i>P</i> = 0.017) but not 12-months (<i>P</i> = 0.20). There were no group differences between DeCR and F2F-CR across any outcomes (all <i>P</i> > 0.05).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Lay summary: </strong>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.</p>","PeriodicalId":72965,"journal":{"name":"European heart journal. Digital health","volume":"6 4","pages":"688-703"},"PeriodicalIF":3.9,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700487","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}
Pub Date : 2025-04-29eCollection Date: 2025-07-01DOI: 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}
Pub Date : 2025-04-24eCollection Date: 2025-07-01DOI: 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.
{"title":"Study design and rationale of the AZIMUTH trial: a smartphone, app-based, E-health-integrated model of care for heart failure patients.","authors":"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","doi":"10.1093/ehjdh/ztaf040","DOIUrl":"10.1093/ehjdh/ztaf040","url":null,"abstract":"<p><strong>Aims: </strong>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.</p><p><strong>Methods and results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":72965,"journal":{"name":"European heart journal. Digital health","volume":"6 4","pages":"840-848"},"PeriodicalIF":3.9,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282352/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700509","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}
Pub Date : 2025-04-24eCollection Date: 2025-07-01DOI: 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.
{"title":"Synthetic electrocardiograms for Brugada syndrome: from data generation to expert cardiologists evaluation.","authors":"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","doi":"10.1093/ehjdh/ztaf039","DOIUrl":"10.1093/ehjdh/ztaf039","url":null,"abstract":"<p><strong>Aims: </strong>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.</p><p><strong>Methods and results: </strong>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).</p><p><strong>Conclusion: </strong>Synthetic Brugada ECGs cannot be adequately distinguished from real patients' ECGs by BrS specialists.</p>","PeriodicalId":72965,"journal":{"name":"European heart journal. Digital health","volume":"6 4","pages":"683-687"},"PeriodicalIF":3.9,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282356/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700510","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}
Pub Date : 2025-04-23eCollection Date: 2025-07-01DOI: 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.
{"title":"Medicine, healthcare and the AI act: gaps, challenges and future implications.","authors":"Emmanouil P Vardas, Maria Marketou, Panos E Vardas","doi":"10.1093/ehjdh/ztaf041","DOIUrl":"10.1093/ehjdh/ztaf041","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":72965,"journal":{"name":"European heart journal. Digital health","volume":"6 4","pages":"833-839"},"PeriodicalIF":3.9,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12282355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700503","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}
Pub Date : 2025-04-21eCollection Date: 2025-07-01DOI: 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.
{"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}
Pub Date : 2025-04-16eCollection Date: 2025-07-01DOI: 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}