American heart journal最新文献

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Artificial intelligence-enabled electrocardiogram guidance for pulmonary valve replacement timing in repaired tetralogy of Fallot 人工智能心电图指导修复后法洛四联症肺动脉瓣置换术时机。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-08-29 DOI: 10.1016/j.ahj.2025.08.019
Joshua Mayourian MD, PhD , Lynn A. Sleeper ScD , Vedang Diwanji , Alon Geva MD, MPH , John K. Triedman MD , Rachel M. Wald MD , Anne Marie Valente MD , Tal Geva MD
{"title":"Artificial intelligence-enabled electrocardiogram guidance for pulmonary valve replacement timing in repaired tetralogy of Fallot","authors":"Joshua Mayourian MD, PhD ,&nbsp;Lynn A. Sleeper ScD ,&nbsp;Vedang Diwanji ,&nbsp;Alon Geva MD, MPH ,&nbsp;John K. Triedman MD ,&nbsp;Rachel M. Wald MD ,&nbsp;Anne Marie Valente MD ,&nbsp;Tal Geva MD","doi":"10.1016/j.ahj.2025.08.019","DOIUrl":"10.1016/j.ahj.2025.08.019","url":null,"abstract":"<div><h3>Background</h3><div>Optimal timing of pulmonary valve replacement (PVR) in repaired tetralogy of Fallot (rTOF) remains challenging. We hypothesized that pre-PVR artificial intelligence-enabled electrocardiogram (AI-ECG) may inform optimal PVR timing in rTOF.</div></div><div><h3>Methods</h3><div>rTOF PVR patients at Boston Children’s Hospital (BCH) and Toronto General Hospital (TGH) with analyzable ECGs ≤3 months pre-PVR were included. Patients undergoing PVR were propensity score-matched 1:1 to non-PVR patients. Patients were partitioned into risk tertiles based on pre-PVR AI-ECG probabilities of 5-year mortality: low-, intermediate-, and high-risk.</div></div><div><h3>Results</h3><div>The PVR cohort included 605 patients (504 at Boston Children’s Hospital (BCH), 101 at Toronto General Hospital (TGH); median age 20.3 [IQR, 13.6-32.0] years; median follow-up 7.5 [IQR, 4.7-10.6] years; 3.6% mortality). Pre-PVR AI-ECG risk probability was predictive of post-PVR mortality (c-index 0.77), outperforming an established imaging-based model benchmark (c-index 0.70). AI-ECG remained an independent predictor when added to the benchmark model (<em>P</em> &lt; .001) with a higher c-index of 0.84. Survival was similar between low- and intermediate-risk groups (97-98% 15-year survival; <em>P</em> = .6), with increased mortality for the high-risk group (83% 15-year survival; <em>P</em> = .009). The matched cohort demonstrated that PVR was associated with increased survival overall (HR 0.28 [95% CI, 0.13-0.60], <em>P</em> = .001). Exploratory analyses stratified by risk group tertiles showed survival benefit associated with PVR in the intermediate-risk (HR 0.10 [95% CI, 0.01-0.86]; <em>P</em> = .04) and high-risk (HR 0.3 [0.1-0.7]; <em>P</em> = .005) groups, but not in the low-risk group (<em>P</em> = .8).</div></div><div><h3>Conclusions</h3><div>AI-ECG predicts post-PVR survival in rTOF patients with a PVR survival benefit in intermediate- and high-risk, but not low-risk, groups. AI-ECG may complement imaging biomarkers to determine rTOF PVR timing.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 153-161"},"PeriodicalIF":3.5,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939464","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 3.5 2区 医学
American heart journal Pub Date : 2025-08-27 DOI: 10.1016/S0002-8703(25)00312-6
{"title":"Information for Readers","authors":"","doi":"10.1016/S0002-8703(25)00312-6","DOIUrl":"10.1016/S0002-8703(25)00312-6","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"290 ","pages":"Page v"},"PeriodicalIF":3.5,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144903842","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
Rationale and design of European microcirculatory resistance and absolute flow team: The Euro-CRAFT registry 欧洲微循环阻力和绝对流量团队的基本原理和设计:欧洲工艺注册。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-08-27 DOI: 10.1016/j.ahj.2025.08.018
Masahiro Hada MD, PhD , Carlos Collet MD, PhD , Tatyana Storozhenko MD, PhD , Daniel Munhoz MD, PhD , Adriaan Wilgenhof MD , Alejandro Gutiérrez-Barrios MD, PhD , Annemiek de Vos MD , Branko Beleslin MD, PhD , Colin Berry MD, PhD , Divaka Perera MD , Fernando Rivero MD , Frederic Bouisset MD, PhD , Giovanni Luigi De Maria MD, PhD , Grigoris Karamasis MD, PhD , Jacob Lønborg MD, PhD , Javier Escaned MD, PhD , Kazumasa Ikeda MD , Kevin Carson MD , Klio Konstantinou MBBS , Mark Mariathas BM , Bernard De Bruyne MD, PhD
{"title":"Rationale and design of European microcirculatory resistance and absolute flow team: The Euro-CRAFT registry","authors":"Masahiro Hada MD, PhD ,&nbsp;Carlos Collet MD, PhD ,&nbsp;Tatyana Storozhenko MD, PhD ,&nbsp;Daniel Munhoz MD, PhD ,&nbsp;Adriaan Wilgenhof MD ,&nbsp;Alejandro Gutiérrez-Barrios MD, PhD ,&nbsp;Annemiek de Vos MD ,&nbsp;Branko Beleslin MD, PhD ,&nbsp;Colin Berry MD, PhD ,&nbsp;Divaka Perera MD ,&nbsp;Fernando Rivero MD ,&nbsp;Frederic Bouisset MD, PhD ,&nbsp;Giovanni Luigi De Maria MD, PhD ,&nbsp;Grigoris Karamasis MD, PhD ,&nbsp;Jacob Lønborg MD, PhD ,&nbsp;Javier Escaned MD, PhD ,&nbsp;Kazumasa Ikeda MD ,&nbsp;Kevin Carson MD ,&nbsp;Klio Konstantinou MBBS ,&nbsp;Mark Mariathas BM ,&nbsp;Bernard De Bruyne MD, PhD","doi":"10.1016/j.ahj.2025.08.018","DOIUrl":"10.1016/j.ahj.2025.08.018","url":null,"abstract":"<div><h3>Introduction</h3><div>Coronary microvascular dysfunction (CMD) is increasingly recognized as an important cause of anginal symptoms and poor outcomes. Angina with nonobstructive coronary arteries (ANOCA) is often related to CMD. While physiological assessment of microcirculatory function by coronary bolus thermodilution is widely practiced, more precise and reproducible methodology as well as systematic assessment are necessary. Recently, absolute flow measurements by coronary continuous thermodilution and the concept of Microvascular Resistance Reserve (MRR) have been introduced.</div></div><div><h3>Aim</h3><div>The European microCirculatory Resistance and Absolute Flow Team (EuroCRAFT) registry aims to compare major adverse cardiac and cerebrovascular events (MACCE)-rates in patients with and without CMD based on MRR at 1-year follow-up.</div></div><div><h3>Methods</h3><div>This prospective international, investigator-initiated, multicenter study is enrolling patients with stable chest pain suggestive of angina and nonobstructive epicardial coronary arteries on invasive coronary angiography, defined as fractional flow reserve &gt;0.80. Patients will undergo coronary angiography and microvascular assessment using bolus and continuous thermodilution methods. The primary endpoint is to compare the rate of MACCE in patients with and without CMD assessed with MRR at 1 year. Based on the sample size estimation, 671 patients are initially planned for enrollment.</div><div>We hypothesize that coronary continuous thermodilution-derived MRR has superior prognostic value for MACCE at 1 year compared to bolus thermodilution-derived microvascular metrics.</div></div><div><h3>Results</h3><div>Study recruitment started in September 2022 and has been completed in May 2025, resulting in a total of 678 patients enrolled.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 136-143"},"PeriodicalIF":3.5,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939541","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
Reviving readiness: Youth training, CPR decay, and the intergenerational imperative of emergency action plans 恢复准备:青年培训,CPR衰退,以及紧急行动计划的代际必要性
IF 3.5 2区 医学
American heart journal Pub Date : 2025-08-27 DOI: 10.1016/j.ahj.2025.07.002
Alina Yang
{"title":"Reviving readiness: Youth training, CPR decay, and the intergenerational imperative of emergency action plans","authors":"Alina Yang","doi":"10.1016/j.ahj.2025.07.002","DOIUrl":"10.1016/j.ahj.2025.07.002","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"290 ","pages":"Page 371"},"PeriodicalIF":3.5,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144903843","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
Response to letter by Yang regarding article, “The 2024 think tank on prevention of sudden cardiac death in the young: Pathway to survival: A report from the Cardiac Safety Research Consortium” 对杨先生关于《2024年预防青少年心源性猝死智库:生存之路:心脏安全研究联盟报告》一篇文章的回复
IF 3.5 2区 医学
American heart journal Pub Date : 2025-08-27 DOI: 10.1016/j.ahj.2025.07.003
Jordan E. Ezekian MD, MPH , Salim F. Idriss MD, PhD
{"title":"Response to letter by Yang regarding article, “The 2024 think tank on prevention of sudden cardiac death in the young: Pathway to survival: A report from the Cardiac Safety Research Consortium”","authors":"Jordan E. Ezekian MD, MPH ,&nbsp;Salim F. Idriss MD, PhD","doi":"10.1016/j.ahj.2025.07.003","DOIUrl":"10.1016/j.ahj.2025.07.003","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"290 ","pages":"Pages 372-373"},"PeriodicalIF":3.5,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144903844","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
REview and improvement of Cardiac implanTable device InFection management qualitY initiative (RECTIFY): Rationale and Design for a Cardiac Implantable Electronic Device Infection Quality Initiative Demonstration Project. 心脏植入式电子设备感染管理质量倡议(整改)的回顾与改进:心脏植入式电子设备感染质量倡议示范项目的理论基础与设计。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-08-26 DOI: 10.1016/j.ahj.2025.08.017
Nkiru Osude, Christopher B Granger, Rebecca Young, Hussein Al-Khalidil, Kimberly Ward, Monica Leyva, Cameron Lambert, Michael Tillery, Albert Lin, Rohit Mehta, Misra Satish, Graham Peigh, Austin Wright, Laurence M Epstein, Carina Blomstrom Lundqvist, Jonathn P Piccini, Rizwan Sohail, Sean D Pokorney
{"title":"REview and improvement of Cardiac implanTable device InFection management qualitY initiative (RECTIFY): Rationale and Design for a Cardiac Implantable Electronic Device Infection Quality Initiative Demonstration Project.","authors":"Nkiru Osude, Christopher B Granger, Rebecca Young, Hussein Al-Khalidil, Kimberly Ward, Monica Leyva, Cameron Lambert, Michael Tillery, Albert Lin, Rohit Mehta, Misra Satish, Graham Peigh, Austin Wright, Laurence M Epstein, Carina Blomstrom Lundqvist, Jonathn P Piccini, Rizwan Sohail, Sean D Pokorney","doi":"10.1016/j.ahj.2025.08.017","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.08.017","url":null,"abstract":"<p><p>Cardiac implantable electronic device (CIED) infections are a growing concern due to their associated high morbidity, mortality, and healthcare costs. Current guidelines given complete device and lead removal for CIED infection a class I recommendation, yet adherence to these gudelines are low with delays in extraction associated with poor adverse clinical events. The REview and improvement of Cardiac implanTable device InFection qualitY initiative (RECTIFY) is a multi-center demonstration project aimed to identify and address health system-wide barriers to timely diagnosis and guideline-driven management of CIED infections. This prospective interventional study conducted across three U.S health systems employs quality improvement (QI) interventions aimed at increasing early identification of CIED infections, minimizing delays to device extraction, and enhancing referral efficiency.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.5,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939530","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
Democracy, healthcare, and the public good 民主、医疗保健和公益事业。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-08-22 DOI: 10.1016/j.ahj.2025.08.008
Richard C. Becker MD
{"title":"Democracy, healthcare, and the public good","authors":"Richard C. Becker MD","doi":"10.1016/j.ahj.2025.08.008","DOIUrl":"10.1016/j.ahj.2025.08.008","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 121-127"},"PeriodicalIF":3.5,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939532","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
Association between conversion from an initial shockable rhythm to pulseless electrical activity before extracorporeal cardiopulmonary resuscitation and outcome: A secondary analysis of the SAVE-J II study 体外心肺复苏前从最初的休克节律到无脉电活动的转换与结果的关系——SAVE-JⅡ研究的二次分析
IF 3.5 2区 医学
American heart journal Pub Date : 2025-08-22 DOI: 10.1016/j.ahj.2025.08.012
Shinichi Ijuin MD , Akihiko Inoue MD, PhD , Toru Hifumi MD, PhD , Takuya Taira MD , Taiki Moriyama MD , Masafumi Suga MD , Takeshi Nishimura MD, PhD , Tetsuya Sakamoto MD, PhD , Yasuhiro Kuroda MD, PhD , Satoshi Ishihara MD, PhD , SAVE-J II Study Group
{"title":"Association between conversion from an initial shockable rhythm to pulseless electrical activity before extracorporeal cardiopulmonary resuscitation and outcome: A secondary analysis of the SAVE-J II study","authors":"Shinichi Ijuin MD ,&nbsp;Akihiko Inoue MD, PhD ,&nbsp;Toru Hifumi MD, PhD ,&nbsp;Takuya Taira MD ,&nbsp;Taiki Moriyama MD ,&nbsp;Masafumi Suga MD ,&nbsp;Takeshi Nishimura MD, PhD ,&nbsp;Tetsuya Sakamoto MD, PhD ,&nbsp;Yasuhiro Kuroda MD, PhD ,&nbsp;Satoshi Ishihara MD, PhD ,&nbsp;SAVE-J II Study Group","doi":"10.1016/j.ahj.2025.08.012","DOIUrl":"10.1016/j.ahj.2025.08.012","url":null,"abstract":"<div><h3>Aim</h3><div>Shockable rhythm on initial electrocardiogram is a predictor of favorable neurological outcomes of out-of-hospital cardiac arrest in patients undergoing extracorporeal cardiopulmonary resuscitation (ECPR). The present study evaluated the impact of conversion from shockable rhythm to pulseless electrical activity (PEA) before ECPR on patient outcomes.</div></div><div><h3>Methods</h3><div>In this secondary analysis of the data from SAVE-J II, a retrospective multicenter registry including 36 participating institutions in Japan, patients with initial shockable rhythm were categorized into those with conversion to PEA and sustained shockable rhythm. The primary outcome was favorable neurological outcome, defined as a cerebral performance category of 1-2 at hospital discharge.</div></div><div><h3>Results</h3><div>The final cohort included 718 patients. The rate of favorable neurological outcomes was lower in patients who were converted to PEA than in those with sustained shockable rhythm (12.9 % vs 26.4 %, <em>P</em> &lt; .01). By multivariable analysis, conversion to PEA was significantly associated with a lower rate of favorable neurological outcomes (odds ratio 0.42, 95% confidence interval 0.27-0.66; <em>P</em> &lt; .01). The rates of favorable neurologic outcomes were 9.8%, 18.0%, and 21.4% (<em>P</em> = .06) in patients who converted to PEA, during emergency medical services transport, at hospital arrival, and before ECMO initiation, respectively. However, outcomes did not significantly differ between the patients who converted to PEA after hospital arrival and those with sustained shockable rhythm (19.6% vs 26.4%, <em>P</em> = .19).</div></div><div><h3>Conclusions</h3><div>Patients with conversion to PEA before ECPR were associated with a lower rate of favorable neurological outcomes in those with an initial shockable rhythm. Especially, early conversion to PEA, ie, during EMS transport, may be a factor for lower favorable neurological outcomes compared to those with sustained shockable rhythm.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 144-152"},"PeriodicalIF":3.5,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939436","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 left atrial stiffness, pulmonary congestion, and impaired aerobic capacity in adults with repaired coarctation of aorta 主动脉缩窄修复后成人左心房僵硬、肺充血和有氧能力受损的关系
IF 3.5 2区 医学
American heart journal Pub Date : 2025-08-21 DOI: 10.1016/j.ahj.2025.08.013
Alexander C. Egbe MD, MPH, MS, Omar Abozied MBBCh, Ahmed T. Abdelhalim MBBCh, C. Charles Jain MD, William R. Miranda MD, Zeyad Kholeif MBBCh, Heidi M. Connolly MD, Barry A. Borlaug MD
{"title":"Relationship between left atrial stiffness, pulmonary congestion, and impaired aerobic capacity in adults with repaired coarctation of aorta","authors":"Alexander C. Egbe MD, MPH, MS,&nbsp;Omar Abozied MBBCh,&nbsp;Ahmed T. Abdelhalim MBBCh,&nbsp;C. Charles Jain MD,&nbsp;William R. Miranda MD,&nbsp;Zeyad Kholeif MBBCh,&nbsp;Heidi M. Connolly MD,&nbsp;Barry A. Borlaug MD","doi":"10.1016/j.ahj.2025.08.013","DOIUrl":"10.1016/j.ahj.2025.08.013","url":null,"abstract":"<div><h3>Background</h3><div>Left atrial (LA) stiffness is linked to pulmonary congestion and exercise intolerance in patients with acquired form of heart failure but has not been studied in adults with coarctation of aorta (COA). We hypothesized that adults with COA had increased LA stiffness, and in turn, worse cardiac reserve, pulmonary congestion, and impaired aerobic capacity compared to controls, and that LA stiffness index was associated with the presence of these abnormalities in the COA group.</div></div><div><h3>Method</h3><div>In this prospective study, 46 adults with repaired COA and 46 controls underwent exercise echocardiogram with expired gas analysis. LA stiffness was assessed at rest as the quotient for lateral E/e’ and LA reservoir strain (E/e’/LARS). Cardiac reserve was assessed by exercise-induced change in LA reservoir strain, right ventricular free wall strain/right ventricular systolic pressure (RV-PA coupling), and cardiac output (CO). Pulmonary congestion was assessed by lung ultrasound.</div></div><div><h3>Results</h3><div>The COA group had higher LA stiffness index (0.47 ± 0.12 vs 0.14 ± 0.09, <em>P</em> &lt; .001), and in turn, worse cardiac reserve, pulmonary congestion, and aerobic capacity compared to controls. Within the COA group, those with high LA stiffness index (&gt;0.42) had worse cardiac reserve, pulmonary congestion, and aerobic capacity. The correlates of LA stiffness index were high pulsatile left ventricular (LV) afterload, LV hypertrophy, and atrial fibrillation.</div></div><div><h3>Conclusions</h3><div>These data suggest a mechanistic link between LA stiffness, pulmonary congestion, and exercise intolerance among patients with COA, and the correlates of LA stiffness index may provide viable targets for therapeutic interventions to improve outcomes in this population.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 89-100"},"PeriodicalIF":3.5,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939525","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
IMpact of therapY using coleSevelam treatment reducing bile acids in patients with fonTan cIrCulation (MYSTIC): Rationale and study design 使用coleSevelam治疗降低fonTan循环(MYSTIC)患者胆汁酸的影响:理论基础和研究设计。
IF 3.5 2区 医学
American heart journal Pub Date : 2025-08-19 DOI: 10.1016/j.ahj.2025.08.011
Ashish H. Shah MD , Heather K. Armstrong MSc, PhD , Ishika Mittal BSc , Aleisha Reimer , Setor K. Kunutsor BSc, MD, MPhil, PhD , Robin A. Ducas MD , Keivan Alizadeh MD , James W. Tam MD , Amir Ravandi MD, PhD , Sanjiv Dhingra PhD
{"title":"IMpact of therapY using coleSevelam treatment reducing bile acids in patients with fonTan cIrCulation (MYSTIC): Rationale and study design","authors":"Ashish H. Shah MD ,&nbsp;Heather K. Armstrong MSc, PhD ,&nbsp;Ishika Mittal BSc ,&nbsp;Aleisha Reimer ,&nbsp;Setor K. Kunutsor BSc, MD, MPhil, PhD ,&nbsp;Robin A. Ducas MD ,&nbsp;Keivan Alizadeh MD ,&nbsp;James W. Tam MD ,&nbsp;Amir Ravandi MD, PhD ,&nbsp;Sanjiv Dhingra PhD","doi":"10.1016/j.ahj.2025.08.011","DOIUrl":"10.1016/j.ahj.2025.08.011","url":null,"abstract":"<div><h3>Rationale</h3><div>Patients with a Fontan circulation suffer from progressive multiorgan dysfunction, yet central biochemical drivers remain poorly defined. Our recent work exploring metabolomic analyses have identified - elevated circulating bile acids (BAs) in adult Fontan patients compared with healthy controls. Elevated BAs, especially secondary and hydrophobic ones produced by the gut microbiome were found to correlate with worse exercise capacity, greater frailty, and impaired hemodynamics.</div></div><div><h3>Primary hypothesis</h3><div>Bile acid accumulation may contribute to Fontan pathophysiology. Colesevelam, a nonabsorbed bile acid sequestrant, offers a potential targeted therapy to reduce BA levels and interrupt this disease pathway.</div></div><div><h3>Design</h3><div>The MYSTIC trial is a prospective, randomized, double-blind, placebo-controlled cross-over pilot study in 25 adult Fontan patients (with 25 age- and sex-matched healthy controls for baseline comparisons) to evaluate the safety, tolerability, and efficacy of colesevelam in lowering plasma BA levels. Primary outcomes include safety/tolerability and change in total plasma BA levels. Secondary outcomes include changes in noninvasive hemodynamics, gut microbiome composition, fecal bile acid excretion, and biochemical profiles.</div></div><div><h3>Sites</h3><div>Single center.</div></div><div><h3>Estimated enrollment</h3><div>25 patients and 25 healthy subjects.</div></div><div><h3>Enrollment dates</h3><div>September 2025 to August 2027.</div></div><div><h3>Trial Registration</h3><div>NCT06197763 This manuscript describes the rationale and design of the MYSTIC study, which to our knowledge is the first interventional trial targeting a Fontan-specific metabolic derangement. The results will inform the feasibility of BA sequestration therapy in Fontan patients and guide future larger studies aimed at improving outcomes in this growing high-risk population.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"291 ","pages":"Pages 81-88"},"PeriodicalIF":3.5,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939511","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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