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Pulsed field ablation-related hemoglobinuria and acute kidney injury: Insights and strategies for effective management 脉冲场消融相关的血红蛋白尿和急性肾损伤:有效管理的见解和策略。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-07-28 DOI: 10.1016/j.ahj.2025.07.013
Kamala P. Tamirisa MD , Javier E. Sanchez MD , Vincenzo Mirco La Fazia MD , Carola Gianni MD , Frans Serpa MD , Sanghamitra Mohanty MD , Amin Al-Ahmad MD , Andrea Natale MD
{"title":"Pulsed field ablation-related hemoglobinuria and acute kidney injury: Insights and strategies for effective management","authors":"Kamala P. Tamirisa MD ,&nbsp;Javier E. Sanchez MD ,&nbsp;Vincenzo Mirco La Fazia MD ,&nbsp;Carola Gianni MD ,&nbsp;Frans Serpa MD ,&nbsp;Sanghamitra Mohanty MD ,&nbsp;Amin Al-Ahmad MD ,&nbsp;Andrea Natale MD","doi":"10.1016/j.ahj.2025.07.013","DOIUrl":"10.1016/j.ahj.2025.07.013","url":null,"abstract":"<div><h3>Background</h3><div>Pulsed field ablation has emerged as a novel technique for atrial fibrillation ablation, offering myocardial preferential ablation and safety advantages over traditional thermal energy methods. Complications such as hemolysis, hemoglobinuria, and acute kidney injury have been reported, particularly with high-energy delivery and excessive applications.</div></div><div><h3>Objective</h3><div>To understand the underlying mechanisms and potential preventative strategies, and identifying at-risk populations, to optimize procedural safety and ensure consistent outcomes.</div></div><div><h3>Methods</h3><div>This narrative review explores current data on mechanisms, incidence, clinical biomarkers, and risk factors that contribute to these issues.</div></div><div><h3>Results</h3><div>While transient and subclinical hemolysis is common, large scale registry data demonstrate that clinically significant hemolysis-induced renal complications remain rare, with fewer than 0.05% of patients requiring intervention. As catheter design and technology continue to evolve, further research with long-term data is crucial to continue to better understand and standardize mitigation strategies.</div></div><div><h3>Conclusion</h3><div>This paper provides an evidence-based framework and practical strategies, individual patient assessment, and postprocedural management to address and support safer integration of pulsed field ablation into clinical practice.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"290 ","pages":"Pages 339-346"},"PeriodicalIF":3.5,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Selective C-reactive protein apheresis in ST-elevation myocardial infarction: Design and rationale of the randomized CRP-STEMI trial 选择性c反应蛋白分离治疗st段抬高型心肌梗死:随机CRP-STEMI试验的设计和基本原理
IF 3.5 2区 医学
American heart journal Pub Date : 2025-07-28 DOI: 10.1016/j.ahj.2025.07.067
Sebastian J. Reinstadler MD, PhD , Andreas Kronbichler MD, PhD , Martin Reindl MD, PhD , Christina Tiller MD, PhD , Magdalena Holzknecht MD, PhD , Fritz Oberhollenzer MD , Alex Kaser MD , Philipp Gauckler MD , Thomas Stiermaier MD , Hans-Josef Feistritzer MD, PhD , Agnes Mayr MD , Elke R. Gizewski MD, MHBA , Richard Rezar MD, PhD , Heiko Bugger MD , Kathrin Eller MD , Ingo Eitel MD , Steffen Schneider PhD , Gert Mayer MD , Holger Thiele MD , Axel Bauer MD , Ivan Lechner MD, PhD
{"title":"Selective C-reactive protein apheresis in ST-elevation myocardial infarction: Design and rationale of the randomized CRP-STEMI trial","authors":"Sebastian J. Reinstadler MD, PhD ,&nbsp;Andreas Kronbichler MD, PhD ,&nbsp;Martin Reindl MD, PhD ,&nbsp;Christina Tiller MD, PhD ,&nbsp;Magdalena Holzknecht MD, PhD ,&nbsp;Fritz Oberhollenzer MD ,&nbsp;Alex Kaser MD ,&nbsp;Philipp Gauckler MD ,&nbsp;Thomas Stiermaier MD ,&nbsp;Hans-Josef Feistritzer MD, PhD ,&nbsp;Agnes Mayr MD ,&nbsp;Elke R. Gizewski MD, MHBA ,&nbsp;Richard Rezar MD, PhD ,&nbsp;Heiko Bugger MD ,&nbsp;Kathrin Eller MD ,&nbsp;Ingo Eitel MD ,&nbsp;Steffen Schneider PhD ,&nbsp;Gert Mayer MD ,&nbsp;Holger Thiele MD ,&nbsp;Axel Bauer MD ,&nbsp;Ivan Lechner MD, PhD","doi":"10.1016/j.ahj.2025.07.067","DOIUrl":"10.1016/j.ahj.2025.07.067","url":null,"abstract":"<div><h3>Background</h3><div>Despite the effectiveness of primary percutaneous coronary intervention (PCI) in treating ST-elevation myocardial infarction (STEMI), myocardial salvage is often incomplete, resulting in large infarct size and an increased risk of heart failure and mortality. Inflammation is involved in this process, with C-reactive protein (CRP) potentially contributing to infarct expansion. Whether selective CRP apheresis in addition to standard care can reduce infarct size in STEMI remains to be determined.</div></div><div><h3>Trial Design</h3><div>Selective C-reactive protein apheresis in ST-elevation myocardial infarction (<em>CRP-STEMI)</em> is an investigator-initiated, randomized, open-label (<em>outcome assessor blinded</em>), multicenter trial investigating whether selective CRP apheresis using the PentraSorb-CRP system, in addition to standard care, can reduce infarct size in STEMI patients undergoing PCI within 12 hours of symptom onset. The trial will enroll 202 patients at 5 tertiary care centers in Austria and Germany, randomized 1:1 to either the intervention group (standard care + CRP apheresis) or the control group (standard care). In the intervention group, CRP apheresis will be performed on days 1, 2, and 3 post-PCI. The primary endpoint is infarct size as assessed by late gadolinium enhanced cardiac magnetic resonance at 5 ± 2 days after PCI.</div></div><div><h3>Outlook</h3><div>CRP-STEMI is the first randomized trial to investigate whether selective CRP apheresis, as an adjunct to standard care, can effectively reduce infarct size in acute STEMI patients.</div></div><div><h3>Trial Registration</h3><div>CRP-STEMI, NCT04939805, is registered at <span><span>https://clinicaltrials.gov/study/</span><svg><path></path></svg></span>NCT04939805.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 1-9"},"PeriodicalIF":3.5,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A pragmatic individually randomized trial to evaluate bivalent RSV prefusion F protein–based vaccine effectiveness for preventing RSV hospitalizations in adults aged 60 years or above (DAN-RSV): Rationale and trial design 一项评估基于二价RSV预融合F蛋白疫苗预防60岁及以上成人RSV住院(DAN-RSV)有效性的实用个体随机试验:理论基础和试验设计
IF 3.5 2区 医学
American heart journal Pub Date : 2025-07-28 DOI: 10.1016/j.ahj.2025.07.068
Mats C. Højbjerg Lassen MD , Sine H. Christensen MSc , Niklas D. Johansen MD , Negar Aliabadi MD, MS , Kristoffer G. Skaarup MD , Daniel Modin MD , Brian L. Claggett PhD , Carsten S. Larsen MD, DMSc , Lykke Larsen MD, PhD , Lothar Wiese MD, PhD , Michael Dalager-Pedersen MD, PhD , Matias G. Lindholm MD, PhD , Lars Køber MD, DMSc , Scott D. Solomon MD , Jens Ulrik Stæhr Jensen MD, PhD , Cyril Jean-Marie Martel PhD , Claudia Schwarz PhD , Elisa Gonzalez MS , Mette Skovdal MSc , Lawrence H. Moulton PhD, MS , Tor Biering-Sørensen MD, MSc, MPH, PhD
{"title":"A pragmatic individually randomized trial to evaluate bivalent RSV prefusion F protein–based vaccine effectiveness for preventing RSV hospitalizations in adults aged 60 years or above (DAN-RSV): Rationale and trial design","authors":"Mats C. Højbjerg Lassen MD ,&nbsp;Sine H. Christensen MSc ,&nbsp;Niklas D. Johansen MD ,&nbsp;Negar Aliabadi MD, MS ,&nbsp;Kristoffer G. Skaarup MD ,&nbsp;Daniel Modin MD ,&nbsp;Brian L. Claggett PhD ,&nbsp;Carsten S. Larsen MD, DMSc ,&nbsp;Lykke Larsen MD, PhD ,&nbsp;Lothar Wiese MD, PhD ,&nbsp;Michael Dalager-Pedersen MD, PhD ,&nbsp;Matias G. Lindholm MD, PhD ,&nbsp;Lars Køber MD, DMSc ,&nbsp;Scott D. Solomon MD ,&nbsp;Jens Ulrik Stæhr Jensen MD, PhD ,&nbsp;Cyril Jean-Marie Martel PhD ,&nbsp;Claudia Schwarz PhD ,&nbsp;Elisa Gonzalez MS ,&nbsp;Mette Skovdal MSc ,&nbsp;Lawrence H. Moulton PhD, MS ,&nbsp;Tor Biering-Sørensen MD, MSc, MPH, PhD","doi":"10.1016/j.ahj.2025.07.068","DOIUrl":"10.1016/j.ahj.2025.07.068","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory syncytial virus (RSV) can cause serious illness in older adults and those with chronic conditions. While the bivalent RSVpreF vaccine has been shown to protect against RSV-related respiratory tract disease, its impact on severe RSV-related and broader cardiorespiratory hospitalizations remains untested in a fully powered randomized trial. This pragmatic, individually randomized, open-label, parallel-group trial aims to evaluate RSVpreF vaccine effectiveness (VE) in reducing the risk of RSV-related and all-cause cardiorespiratory hospitalizations in adults aged 60 and older.</div></div><div><h3>Methods</h3><div>DAN-RSV is randomizing Danish adults 1:1 to receive either RSVpreF or no RSV vaccine. The trial uses nationwide registries for recruitment, where eligible citizens are identified and invited via the national electronic messaging system and can provide electronic informed consent remotely. Baseline, safety, and outcome data are collected through the national health registries using the civil registration number provided at consent. Up to 130,000 participants will be enrolled during the 2024/2025 winter season. The primary objective is to assess vaccine effectiveness (VE) against RSV-related respiratory tract disease hospitalization. Secondary endpoints include RSV-related and all-cause lower respiratory tract disease hospitalizations, RSV-related and all-cause cardiorespiratory hospitalizations, and all-cause death.</div></div><div><h3>Conclusion</h3><div>DAN-RSV is an innovative trial combining the gold standard of individual randomization with pragmatic data collection via centralized health records and national health registries. This design offers a feasible approach to assess the impact of RSVpreF on clinically meaningful cardio-respiratory outcomes in adults ≥60 years in a real-world setting – while minimizing bias through use of randomization. The results will support cost-effectiveness analyses and inform future vaccination policies.</div></div><div><h3>Trial registration</h3><div>NCT06684743, registered November 9, 2024 (<span><span>https://clinicaltrials.gov/study/NCT06684743</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 14-25"},"PeriodicalIF":3.5,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Information for Readers 读者资讯
IF 3.7 2区 医学
American heart journal Pub Date : 2025-07-26 DOI: 10.1016/S0002-8703(25)00280-7
{"title":"Information for Readers","authors":"","doi":"10.1016/S0002-8703(25)00280-7","DOIUrl":"10.1016/S0002-8703(25)00280-7","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"289 ","pages":"Page iv"},"PeriodicalIF":3.7,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144704755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Relationship between industry payments to physicians and prescription patterns for PCSK9is, ARNis and DOACs: A report from the NCDR PINNACLE registry 行业对医生的支付与pcsk9、ARNis和DOACs处方模式的关系:一份来自NCDR PINNACLE注册中心的报告。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-07-24 DOI: 10.1016/j.ahj.2025.07.015
Amarnath R. Annapureddy MD MSc , Karthik Murugiah MD , Luke Zheng BS , Karl E. Minges PhD, MPH , Gowtham R. Grandhi MD, MPH , Joseph S. Ross MD, MHS , Tariq Ahmad MD, MPH , Benjamin A. Rodwin MD , Sanket S. Dhruva MD, MHS , Saket Girotra MD, SM , Elias J. Dayoub MD , Jeptha P. Curtis MD , Nihar R. Desai MD
{"title":"Relationship between industry payments to physicians and prescription patterns for PCSK9is, ARNis and DOACs: A report from the NCDR PINNACLE registry","authors":"Amarnath R. Annapureddy MD MSc ,&nbsp;Karthik Murugiah MD ,&nbsp;Luke Zheng BS ,&nbsp;Karl E. Minges PhD, MPH ,&nbsp;Gowtham R. Grandhi MD, MPH ,&nbsp;Joseph S. Ross MD, MHS ,&nbsp;Tariq Ahmad MD, MPH ,&nbsp;Benjamin A. Rodwin MD ,&nbsp;Sanket S. Dhruva MD, MHS ,&nbsp;Saket Girotra MD, SM ,&nbsp;Elias J. Dayoub MD ,&nbsp;Jeptha P. Curtis MD ,&nbsp;Nihar R. Desai MD","doi":"10.1016/j.ahj.2025.07.015","DOIUrl":"10.1016/j.ahj.2025.07.015","url":null,"abstract":"<div><h3>Background</h3><div>We examined the association of industry payments to physicians and prescriptions for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, angiotensin receptor-neprilysin inhibitor (ARNi), and direct oral anticoagulants (DOAC).</div></div><div><h3>Methods</h3><div>Using 2017 data from the NCDR PINNACLE Registry, we idenitifed 3 patient cohorts: those with atherosclerotic cardiovascular disease (ASCVD) and/or dyslipidemia, heart failure with reduced ejection fraction (HFrEF), and nonvalvular atrial fibrillation (NVAF). We linked physicians to the 2017 Open Payments data using National Provider Identifiers to determine whether they had received industry payments related to PCSK9 inhibitors, ARNi, or DOACs. The primary outcome of the study was the proportion of patients within each cohort who were prescribed the corresponding medication. Within each cohort, we evaluated the association between the receipt of industry payments by the treating physician (&lt;$100, $100-$1,000, &gt;$1,000) and likelihood of prescribing the corresponding medication using regression analyses.</div></div><div><h3>Results</h3><div>Overall, 0.2% of ASCVD patients were prescribed PCSK9 inhibitors, 9.0% of HFrEF patients were prescribed ARNi, and 38.7% of NVAF patients were prescribed DOACs. Patients whose physicians receiveds payments related to PCSK inhibitors were more likely to be prescribed them (ASCVD cohort: odds ratio [OR] 1.35; 95% confidence interval [CI],1.15-1.57), as were patients in the HFrEF cohort prescribed ARNi (OR 1.43; 95% CI, 1.19-1.71). No significant association was observed for DOAC prescribing (OR 0.99; 95% CI, 0.95-1.03). Across all 3 cohorts, physicians who received higher-value payments were more likely to prescribe the corresponding medications than those who received lower-value payments.</div></div><div><h3>Conclusions</h3><div>Patients with ASCVD or HFrEF whose physicians received industry payments were more likely to be prescribed PCSK9 inhibitors or ARNi, regardless of the payment amount. For DOACs, an association with prescribing was observed only among physicians who received higher-value payments.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 26-36"},"PeriodicalIF":3.5,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Referral patterns and clinical outcomes in patients with severe aortic stenosis: A multicenter cohort study 重度主动脉瓣狭窄患者的转诊模式和临床结果:一项多中心队列研究
IF 3.5 2区 医学
American heart journal Pub Date : 2025-07-22 DOI: 10.1016/j.ahj.2025.07.014
Azin Vakilpour MD , Michael G Levin MD, MSc , Emeka C Anyanwu MD, MSc , Srinivas Denduluri PhD , Krishna Ravindra MD , Ellen Boakye MD , Estherland Duqueney MD , Jamey A Cutts MD , Liam C Giffin MD , Ian K Weber MD , Jennifer N. Lee MD , Srinath Adusumalli MD, MSc , Juan Lopez-Mattei MD , Jesse Chittams MS , David B. Jones DNP, CRNP, BC , Kathleen Weiss BA, BS , Carlton Hartwell ACS , Michael Bolooki MD , Jamieson M Bourque MD, MSc , Marielle Scherrer-Crosbie MD, PhD
{"title":"Referral patterns and clinical outcomes in patients with severe aortic stenosis: A multicenter cohort study","authors":"Azin Vakilpour MD ,&nbsp;Michael G Levin MD, MSc ,&nbsp;Emeka C Anyanwu MD, MSc ,&nbsp;Srinivas Denduluri PhD ,&nbsp;Krishna Ravindra MD ,&nbsp;Ellen Boakye MD ,&nbsp;Estherland Duqueney MD ,&nbsp;Jamey A Cutts MD ,&nbsp;Liam C Giffin MD ,&nbsp;Ian K Weber MD ,&nbsp;Jennifer N. Lee MD ,&nbsp;Srinath Adusumalli MD, MSc ,&nbsp;Juan Lopez-Mattei MD ,&nbsp;Jesse Chittams MS ,&nbsp;David B. Jones DNP, CRNP, BC ,&nbsp;Kathleen Weiss BA, BS ,&nbsp;Carlton Hartwell ACS ,&nbsp;Michael Bolooki MD ,&nbsp;Jamieson M Bourque MD, MSc ,&nbsp;Marielle Scherrer-Crosbie MD, PhD","doi":"10.1016/j.ahj.2025.07.014","DOIUrl":"10.1016/j.ahj.2025.07.014","url":null,"abstract":"<div><h3>Background</h3><div>Patients with severe aortic stenosis (AS) require timely follow-up by cardiac specialists and aortic valve replacement (AVR). This multicenter study evaluates how the specialty of the provider who ordered the initial echocardiogram influences these endpoints.</div></div><div><h3>Methods</h3><div>Patients from 3 health systems with a first echocardiogram (index echo) diagnosing severe AS from Jan 1, 2019 to Dec 31, 2022, were categorized based on the specialty of the provider ordering the echo. Endpoints included a composite outcome of early cardiac follow-up or AVR (within 90 days), AVR during follow-up, and mortality. Logistic regression and Cox proportional hazard models were used to identify factors associated with the endpoints.</div></div><div><h3>Results</h3><div>4,249 patients (77 years; 58% male; 88% white; 72% symptomatic AS) were followed for a median of 552 days. Eighty-nine percent of patients achieved the composite outcome, yet 1,801 patients (42%) did not receive an AVR during the follow-up period, including 32% of symptomatic patients. Patients referred for the index echo by noncardiac specialty providers had lower rates of early cardiac follow-up or AVR (adjusted OR: 0.33, 95% CI, 0.25-0.43), lower AVR rates (adjusted HR: 0.59, 95% CI, 0.53-0.66), and higher mortality (adjusted HR: 1.65; 95% CI, 1.44-1.90) compared to the patients referred by a cardiology provider; the discrepancy was more pronounced in patients with low-flow, low-gradient AS.</div></div><div><h3>Conclusion</h3><div>In this large multicenter study of patients with severe AS, patients with a noncardiac specialty provider were less likely to receive timely cardiac follow-up and AVR, and had higher mortality. Initiatives to address disparities in care and improve outcomes for this high-risk population are needed.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"290 ","pages":"Pages 347-358"},"PeriodicalIF":3.5,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Design and rationale of the HARTc 2.0 trial: A multicenter randomized controlled study on the impact of point-of-care high-sensitivity cardiac troponin-I testing in prehospital acute coronary syndrome triage on diagnosis and cost-effectiveness HARTc 2.0试验的设计和基本原理:一项多中心随机对照研究,研究院前ACS分诊中即时hs-cTnI检测对诊断和成本效益的影响。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-07-16 DOI: 10.1016/j.ahj.2025.07.009
Anne Catherine M.H. van der Lande MSc , Nina M. Diederiks MSc , Enrico R. de Koning MD , Jan Bosch RN , Fred P.H.T.M. Romijn , Wouter P. M van der Loo MD , M. Elske van den Akker-van Marle PhD , Reza Alizadeh Dehnavi MD , Wouter J. Tietge MD , Bart J.A. Mertens PhD , J. Wouter Jukema MD, PhD , Christa M. Cobbaert EuSpLM, PhD , Martin J. Schalij MD, PhD , Mark J. Boogers MD, PhD
{"title":"Design and rationale of the HARTc 2.0 trial: A multicenter randomized controlled study on the impact of point-of-care high-sensitivity cardiac troponin-I testing in prehospital acute coronary syndrome triage on diagnosis and cost-effectiveness","authors":"Anne Catherine M.H. van der Lande MSc ,&nbsp;Nina M. Diederiks MSc ,&nbsp;Enrico R. de Koning MD ,&nbsp;Jan Bosch RN ,&nbsp;Fred P.H.T.M. Romijn ,&nbsp;Wouter P. M van der Loo MD ,&nbsp;M. Elske van den Akker-van Marle PhD ,&nbsp;Reza Alizadeh Dehnavi MD ,&nbsp;Wouter J. Tietge MD ,&nbsp;Bart J.A. Mertens PhD ,&nbsp;J. Wouter Jukema MD, PhD ,&nbsp;Christa M. Cobbaert EuSpLM, PhD ,&nbsp;Martin J. Schalij MD, PhD ,&nbsp;Mark J. Boogers MD, PhD","doi":"10.1016/j.ahj.2025.07.009","DOIUrl":"10.1016/j.ahj.2025.07.009","url":null,"abstract":"<div><h3>Introduction</h3><div>Chest pain accounts for ∼10% of emergency department visits, though most cases are not acute coronary syndrome (ACS), underscoring the need for effective prehospital triage. The HARTc 2.0 study evaluates the modified History, Electrocardiogram, Age, Risk Factors, and Troponin (HEART) score incorporating point-of-care (POC) high-sensitivity cardiac troponin-I (hs-cTnI) capillary fingerprick testing with sex-specific cut-offs to improve ACS risk stratification. The randomized controlled trial compares a prehospital triage strategy using this modified HEART score and a 0/2-hour POC hs-cTnI algorithm to standard care using HEAR score and in-hospital 0/1-hour hs-cTnT testing. Cost-effectiveness and diagnostic timing are also assessed.</div></div><div><h3>Methods and Analysis</h3><div>The HARTc 2.0 study consists of 4 prospective phases to improve prehospital risk stratification for patients with suspected ACS. Phase 0 investigates technical operability of the Siemens Atellica VTLi POC hs-cTnI device. Phase 1 verifies preanalytical and analytical performance. Phase 2 evaluates clinical comparability between modified HEART score (with POC hs-cTnI) and standard HEART score. Phase 3 is a multicenter randomized controlled trial assessing the impact of prehospital risk stratification—into low, intermediate, or high-risk for ACS—on clinical decision-making, time-to-diagnosis, and cost-effectiveness.</div></div><div><h3>Conclusion</h3><div>This trial evaluates modified HEART score with POC hs-cTnI testing, incorporating sex-specific cut-offs, to improve prehospital ACS risk stratification. Phases 0 and 1 confirm the reliability of capillary whole blood POC hs-cTnI. Furthermore, the trial is a randomized trial which evaluates prehospital risk stratification for ACS using a 0/2-hour POC hs-cTnI algorithm on clinical decision-making, time-to-diagnosis, as well as its cost-effectiveness. Improved prehospital risk stratification for ACS aims to enhance triage accuracy, time-to-diagnosis and time-to-treatment, thereby reducing unnecessary hospital admissions and improve resource allocation in prehospital and emergency care.</div></div><div><h3>Trial Registration</h3><div>NL80873.000.22, NL9475 (registered in the Dutch Trial Register, the Netherlands).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"290 ","pages":"Pages 359-370"},"PeriodicalIF":3.5,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of low-dose rivaroxaban in elderly patients with atrial fibrillation for oral anticoagulation therapy: Rationale, design, and study protocol for a multicenter randomized controlled trial (SAFE-AF) 低剂量利伐沙班口服抗凝治疗老年房颤患者的疗效和安全性:多中心随机对照试验(SAFE-AF)的基本原理、设计和研究方案
IF 3.5 2区 医学
American heart journal Pub Date : 2025-07-15 DOI: 10.1016/j.ahj.2025.07.011
Jiawei Han MD , Wenwei Qi MD , Shuo Yuan MD , Hanning Liu MD, PhD , Yang Wang PhD , Heng Zhang MD, PhD , Jiamin Liu MD , Yan Zhao MD , Yue Zhang MD , Lihui Zheng MD, PhD , Yan Yao MD, PhD , Zhe Zheng MD, PhD
{"title":"Efficacy and safety of low-dose rivaroxaban in elderly patients with atrial fibrillation for oral anticoagulation therapy: Rationale, design, and study protocol for a multicenter randomized controlled trial (SAFE-AF)","authors":"Jiawei Han MD ,&nbsp;Wenwei Qi MD ,&nbsp;Shuo Yuan MD ,&nbsp;Hanning Liu MD, PhD ,&nbsp;Yang Wang PhD ,&nbsp;Heng Zhang MD, PhD ,&nbsp;Jiamin Liu MD ,&nbsp;Yan Zhao MD ,&nbsp;Yue Zhang MD ,&nbsp;Lihui Zheng MD, PhD ,&nbsp;Yan Yao MD, PhD ,&nbsp;Zhe Zheng MD, PhD","doi":"10.1016/j.ahj.2025.07.011","DOIUrl":"10.1016/j.ahj.2025.07.011","url":null,"abstract":"<div><h3>Background</h3><div>Non–vitamin K antagonist anticoagulant (NOAC) is considered the first-line treatment for atrial fibrillation (AF) patients to reduce the risk of stroke, especially in the elderly. However, robust clinical evidence is lacking regarding the appropriateness of low-dose NOAC.</div></div><div><h3>Design</h3><div>The SAFE-AF trial is an investigator-initiated, multicenter, open-label, randomized controlled, blind endpoint evaluation, non-inferiority designed trial comparing the efficacy and safety of low-dose rivaroxaban with standard-dose rivaroxaban in patients aged ≥70 years with AF. Participants (<em>N</em> = 4,374) will be randomized 1:1 to receive either standard-dose rivaroxaban (20 mg once daily) or low-dose rivaroxaban (15 mg once daily). The primary efficacy endpoint is the composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolic events (SEE). The primary safety endpoint is the composite endpoint of major bleeding events and clinically relevant non-major bleeding events.</div></div><div><h3>Conclusions</h3><div>The SAFE-AF trial is intended to provide valid evidence concerning low-dose rivaroxaban for anticoagulant therapy in older patients with AF.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov, identifier NCT06108414.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"290 ","pages":"Pages 268-277"},"PeriodicalIF":3.5,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trends in urine drug screening and positivity among patients with heart failure: Insights from a large health system 心力衰竭患者尿液药物筛选和阳性趋势:来自大型卫生系统的见解。
IF 3.7 2区 医学
American heart journal Pub Date : 2025-07-10 DOI: 10.1016/j.ahj.2025.07.008
Onyedika J. Ilonze MD, MPH , Laura J. Helmkamp MS , Colleen K. McIlvennan PhD, DNP, ANP , Larry A. Allen MD, MHS , Khadijah Breathett MD, MS , Chioma O. Enyi MD, MPH , Robert L. Page PharmD, MSPH
{"title":"Trends in urine drug screening and positivity among patients with heart failure: Insights from a large health system","authors":"Onyedika J. Ilonze MD, MPH ,&nbsp;Laura J. Helmkamp MS ,&nbsp;Colleen K. McIlvennan PhD, DNP, ANP ,&nbsp;Larry A. Allen MD, MHS ,&nbsp;Khadijah Breathett MD, MS ,&nbsp;Chioma O. Enyi MD, MPH ,&nbsp;Robert L. Page PharmD, MSPH","doi":"10.1016/j.ahj.2025.07.008","DOIUrl":"10.1016/j.ahj.2025.07.008","url":null,"abstract":"<div><h3>Background</h3><div>Substance use is common in patients with HF and affects candidacy for advanced HF therapies. Rates and results of urine drug screening (UDS) are understudied particularly in the setting of increasing decriminalization of some substances. Substance use, particularly cannabis, has been increasing in older age groups who are most at risk of HF. However, while UDS assesses substance use, no guidelines recommend routine screening for patients with HF, outside of evaluation for advanced therapies.</div></div><div><h3>Methods</h3><div>We performed a retrospective study including data from the Epic electronic health record of a large academic health system in Colorado. We identified 75,166 adult patients who had a UDS, of which 6,725 (8.9%) had HF or cardiomyopathy.</div></div><div><h3>Results</h3><div>Among patients with a UDS, any positive result was found in 64.6% for patients with HF and 56.0% for patients without HF. For patients with HF who had a UDS, the highest positivity rates were for opiates (42.4%), cannabinoids (29.0%), benzodiazepines (28.0%), and cocaine (11.0%). Patients who were tested with UDS were more likely to have HF if they were older, male, Black and were Medicare beneficiaries. Our analysis demonstrated a high rate of UDS positivity among patients presenting with HF who were tested for UDS in a tertiary care center.</div></div><div><h3>Conclusion</h3><div>Conclusion: Findings suggest that substance use, particularly opioids and cannabinoids, may be common in patients with HF.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"290 ","pages":"Pages 226-229"},"PeriodicalIF":3.7,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Accurate Fick cardiac output estimation: direct and simultaneous oxygen consumption measurement is imperative in heart failure 准确的菲克心输出量估计:直接和同时的耗氧量测量是必要的心力衰竭。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-07-09 DOI: 10.1016/j.ahj.2025.06.020
Marlus Karsten PhD , Carlo Vignati MD , Beatrice Pezzuto MD, PhD , Anna Apostolo MD , Giovanni Teruzzi MD , Giulia Santagostino Baldi MD , Sebastiano Gili MD , Jeness Campodonico MD, PhD , Giulia Grilli MD , Arianna Galotta MSc , Irene Mattavelli MSc , Elisabetta Salvioni PhD , Daniela Trabattoni MD , Piergiuseppe Agostoni MD, PhD
{"title":"Accurate Fick cardiac output estimation: direct and simultaneous oxygen consumption measurement is imperative in heart failure","authors":"Marlus Karsten PhD ,&nbsp;Carlo Vignati MD ,&nbsp;Beatrice Pezzuto MD, PhD ,&nbsp;Anna Apostolo MD ,&nbsp;Giovanni Teruzzi MD ,&nbsp;Giulia Santagostino Baldi MD ,&nbsp;Sebastiano Gili MD ,&nbsp;Jeness Campodonico MD, PhD ,&nbsp;Giulia Grilli MD ,&nbsp;Arianna Galotta MSc ,&nbsp;Irene Mattavelli MSc ,&nbsp;Elisabetta Salvioni PhD ,&nbsp;Daniela Trabattoni MD ,&nbsp;Piergiuseppe Agostoni MD, PhD","doi":"10.1016/j.ahj.2025.06.020","DOIUrl":"10.1016/j.ahj.2025.06.020","url":null,"abstract":"<div><h3>Background</h3><div>Estimated oxygen consumption (VO<sub>2</sub>) values may compromise the accuracy of the Fick method for predicting cardiac output (CO) during a right heart catheterization (RHC). We aimed to compare VO<sub>2</sub> measured in the hemodynamic laboratory (HL) with those measured on the ward or estimated, and to compare derived CO values with that obtained by thermodilution (TD) in people with severe heart failure (HF).</div></div><div><h3>Methods and Results</h3><div>In this prospective observational study, VO<sub>2</sub> was measured breath-by-breath in the HL and in the ward (within 24h of RHC), or estimated using formulas. CO was calculated from both estimated and measured VO<sub>2</sub> and assessed by TD. Eighty individuals with HF (69.6 ± 8.3 years; 74% male) were included. Significant differences were found between HL-measured VO<sub>2</sub> (247 ± 55 mL/min), ward-measured VO<sub>2</sub> (267 ± 74 mL/min), and the estimated values (Bergstra: 287 ± 33; Dehmer: 234 ± 24; LaFarge: 163 ± 11 mL/min). CO calculated from HL-measured VO<sub>2</sub> (5.03 ± 1.51 L/min) differed from CO based on ward-measured VO<sub>2</sub> (5.46 ± 1.93 L/min), estimated VO<sub>2</sub> (Bergstra: 5.85 ± 1.38; Dehmer: 4.77 ± 1.12; LaFarge: 3.34 ± 0.80 L/min), and by TD (3.65 ± 1.22 L/min). Measured and estimated VO<sub>2</sub> values showed moderate association (r values range: 0.479-0.526). CO calculated from HL-measured VO<sub>2</sub> showed higher association (r values range: 0.708-0.765) with CO calculated from ward-measured VO<sub>2</sub> and estimated VO<sub>2</sub>. The agreement between HL and ward-measured VO<sub>2</sub> was moderate, with a concordance correlation coefficient of 0.48 (0.31;0.62).</div></div><div><h3>Conclusions</h3><div>In people with severe HF undergoing RHC, VO<sub>2</sub> must be directly measured in the HL, rather than on the ward or estimated.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"290 ","pages":"Pages 249-257"},"PeriodicalIF":3.5,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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