Pub Date : 2026-02-23DOI: 10.1136/heartjnl-2025-327116
Ying Li, Dongqing Ren, Dandan Sun
{"title":"Abnormal echocardiographic finding: what is the cystic mass in a young woman with secundum atrial septal defect.","authors":"Ying Li, Dongqing Ren, Dandan Sun","doi":"10.1136/heartjnl-2025-327116","DOIUrl":"https://doi.org/10.1136/heartjnl-2025-327116","url":null,"abstract":"","PeriodicalId":12835,"journal":{"name":"Heart","volume":"112 6","pages":"350-352"},"PeriodicalIF":4.4,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147276179","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}
Pub Date : 2026-02-23DOI: 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.
{"title":"Cardiopulmonary exercise test criteria for heart transplantation referral of patients with ambulatory heart failure in the current era.","authors":"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","doi":"10.1136/heartjnl-2025-327208","DOIUrl":"10.1136/heartjnl-2025-327208","url":null,"abstract":"<p><strong>Background: </strong>Current guidelines recommend evaluating patients with ambulatory heart failure (HF) for heart transplantation if their peak oxygen consumption (peak VO<sub>2</sub>) is <12 mL/kg/min. However, these recommendations are based on decades-old data.</p><p><strong>Methods: </strong>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 VO<sub>2</sub> <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 CO<sub>2</sub> production slope (VE/VCO<sub>2</sub>) >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.</p><p><strong>Results: </strong>Patients with peak VO<sub>2</sub> <12 mL/kg/min demonstrated better survival than heart transplantation recipients, with survival curves intersecting at approximately 2.7 years. Among those with VE/VCO<sub>2</sub> ≤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/VCO<sub>2</sub> and exercise oscillatory ventilation identified four distinct risk groups with significantly different 10-year outcomes (p<0.01). Patients with peak VO<sub>2</sub> <12 mL/kg/min, VE/VCO<sub>2</sub> ≤34 and no exercise oscillatory ventilation exhibited survival comparable to heart transplantation recipients at year 5.</p><p><strong>Conclusions: </strong>In contemporary practice, a peak VO<sub>2</sub> <12 mL/kg/min alone may not reliably identify patients with HF with sufficiently high short-term mortality to warrant heart transplantation referral. VE/VCO<sub>2</sub> and exercise oscillatory ventilation provide important additional risk stratification, supporting re-evaluation of transplant referral criteria to reflect improved HF management and outcomes.</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":"146165145","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}
Pub Date : 2026-02-23DOI: 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.
{"title":"Electrocardiographic imaging: technical developments and future applications for non-invasive electroanatomical study of the human heart.","authors":"Nikhil Kadambadi, Matthew Webber, Gabriella Captur","doi":"10.1136/heartjnl-2024-324963","DOIUrl":"10.1136/heartjnl-2024-324963","url":null,"abstract":"<p><p>Electrocardiographic imaging (ECGI) is a non-invasive technique that combines patient-specific cardiac anatomy with numerous body-surface potentials to gain insight into the <i>in vivo</i> 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.</p>","PeriodicalId":12835,"journal":{"name":"Heart","volume":" ","pages":"307-317"},"PeriodicalIF":4.4,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144511804","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}
Pub Date : 2026-02-23DOI: 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。
{"title":"Impact of air pollution and multimorbidity on the risk of incident atrial fibrillation.","authors":"Junguo Zhang, Ge Chen, Shengtao Wei, Wanquan Li, Gregory Y H Lip, Hualiang Lin","doi":"10.1136/heartjnl-2024-325451","DOIUrl":"10.1136/heartjnl-2024-325451","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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 (PM<sub>2.5</sub>), particulate matter with a diameter ≤10 μm (PM<sub>10</sub>), nitrogen oxides (NO<sub>x</sub>) and nitrogen dioxide (NO<sub>2</sub>)) 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.</p><p><strong>Results: </strong>During a median follow-up of 12.5 years (IQI 11.8 to 13.2), 28 977 incident AF cases occurred. Exposure to PM<sub>2.5</sub> was associated with a 37% higher AF risk per 1 µg/m³ higher PM<sub>2.5</sub> (HR 1.37, 95% CI 1.36 to 1.38), with similar patterns for PM<sub>10</sub> (HR 1.18, 95% CI 1.17 to 1.18), NOₓ (HR 1.06, 95% CI 1.06 to 1.06) and NO<sub>2</sub> (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 PM<sub>2.5</sub> 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 PM<sub>2.5</sub> to the 10th percentile could prevent 26-52% of AF cases in multimorbidity subgroups, with the largest reductions in cardiometabolic (52%) clusters.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12835,"journal":{"name":"Heart","volume":" ","pages":"318-325"},"PeriodicalIF":4.4,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144333007","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}
Pub Date : 2026-02-23DOI: 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.
{"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}
Pub Date : 2026-02-23DOI: 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.
{"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}
Pub Date : 2026-02-23DOI: 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。
{"title":"Benefit-risk of colchicine and spironolactone in acute myocardial infarction: a prespecified generalised pairwise comparisons analysis of the CLEAR trial.","authors":"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","doi":"10.1136/heartjnl-2025-326218","DOIUrl":"10.1136/heartjnl-2025-326218","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":12835,"journal":{"name":"Heart","volume":" ","pages":"326-332"},"PeriodicalIF":4.4,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145000476","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}
Pub Date : 2026-02-23DOI: 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}