American heart journal最新文献

英文中文

Design and rationale of CATO, a Phase IIA, randomized, double-blind, placebo-controlled study of single or repeated intravenous administration of umbilical cord-derived mesenchymal stromal cells in ischemic cardiomyopathy CATO的设计和基本原理，这是一项IIA期、随机、双盲、安慰剂对照的研究，研究对象是缺血性心肌病患者单次或多次静脉注射脐带源性间充质间质细胞。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-13 DOI: 10.1016/j.ahj.2025.107328

Roberto Bolli MD, DSc , Xian-Liang Tang MD , Joshua M. Hare MD , Raul D. Mitrani MD , Emerson C. Perin MD, PhD , João AC Lima MD , Barry E. Hurwitz PhD , Dinesh Kalra MD , Gurnoor Singh MD , Russell G. Saltzman MPH , Lina V. Caceres MHS , Adriana Nettina MS , Yee-Shuan Lee PhD , Ketty Bacallao PhD , Edward Grant MPH , Aisha Khan PhD

Rationale

To date, almost all studies of cell therapy in chronic heart failure (HF) have delivered cells transendocardially or intracoronarily and all have used a single cell dose, which limits therapeutic efficacy because transplanted cells disappear rapidly. Repeated administrations are necessary to replace the cells that disappear, but this is difficult or impossible when cells are delivered invasively. Further, transendocardial delivery is not feasible in many patients, carries risks, and requires specialized training and equipment, thereby limiting its widespread applicability. Intravenous infusion of cells is cheaper, simpler, safer, and less invasive; most importantly, it enables administration of multiple cell doses.

Primary goal

The CATO trial tests a new strategy–repeated intravenous infusions of cells in chronic HF. The goal is to determine whether intravenous cell therapy is beneficial and whether multiple cell doses are superior to a single dose. This trial is the culmination of a translational journey that began more than a decade ago in animal models of HF.

Design

CATO is a Phase IIA randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy of intravenous infusion of umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in patients with ischemic HF. Sixty subjects will be randomized to 3 groups: control (placebo), 1 dose of UC-MSCs, or 4 repeated doses of UC-MSCs, with a comprehensive evaluation of cardiac function and structure, functional capacity, quality of life, and biomarkers over 12 months.

Enrollment dates and current status

CATO began enrollment on March 4, 2024. As of November 30, 2025, a total of 47 patients have been enrolled. Enrollment is expected to be completed by March 2026, and follow-up by March 2027.

Significance

CATO is the first trial of UC-MSCs for HF in the US, the first study of intravenous cell therapy for ischemic HF in the US, and the first randomized, double-blind, placebo-controlled trial of repeated cell doses for chronic HF. The 2 strategies tested in CATO (intravenous cell delivery and repeated doses) have the potential to be important advances in the management of HF

Clinical Trial Registration

Clinicaltrials.gov, NCT06145035

https://clinicaltrials.gov/study/ NCT06145035.

理由：迄今为止，几乎所有慢性心力衰竭（HF）的细胞治疗研究都是经心内膜或冠状动脉内递送细胞，并且都使用单个细胞剂量，这限制了治疗效果，因为移植细胞很快消失。为了替换消失的细胞，反复给药是必要的，但当细胞是侵入性的时候，这是困难的或不可能的。此外，经心内膜分娩在许多患者中不可行，存在风险，需要专门的培训和设备，从而限制了其广泛的适用性。静脉输注细胞更便宜、更简单、更安全、侵入性更小；最重要的是，它允许给药多个细胞剂量。主要目标：CATO试验测试了一种新的策略——反复静脉输注细胞治疗慢性心衰。目的是确定静脉注射细胞治疗是否有益，以及多剂量细胞治疗是否优于单剂量细胞治疗。这项试验是十多年前在HF动物模型中开始的转化之旅的高潮。设计：CATO是一项IIA期随机、双盲、安慰剂对照、多中心研究，旨在评估静脉输注脐带源性间充质细胞（UC-MSCs）治疗缺血性心衰患者的疗效。60名受试者将被随机分为3组：对照组（安慰剂）、1剂UC-MSCs或4剂重复剂量的UC-MSCs，在12个月内对心功能和结构、功能容量、生活质量和生物标志物进行综合评估。入学日期和现状：CATO于2024年3月4日开始招生。截至2025年11月30日，共有47名患者入组。预计入学将于2026年3月完成，后续工作将于2027年3月完成。意义：CATO是美国首个用UC-MSCs治疗HF的试验，也是美国首个静脉注射细胞治疗缺血性HF的研究，也是首个重复细胞剂量治疗慢性HF的随机、双盲、安慰剂对照试验。在CATO试验的两种策略（静脉注射细胞和重复给药）有可能成为心衰治疗的重要进展。

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引用次数: 0

Coronary computed tomography angiography versus invasive coronary angiography for interventional triage in acute coronary syndrome: Design of the randomized TRACTION trial 冠状动脉计算机断层血管造影与侵入性冠状动脉造影在急性冠状动脉综合征介入分诊中的对比——随机牵引试验的设计。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-06 DOI: 10.1016/j.ahj.2025.107325

Mathias Holm Sørgaard MD, PhD , Andreas Torp Kristensen MD , Kristian Eskesen MD, PhD , Klaus Fuglsang Kofoed MD, PhD, DMSc , Jesper James Linde MD, PhD , Henning Kelbæk , Michael Ottesen MD, PhD , Keld Neland MD, PhD , Charlotte Kragelund MD, PhD , Mette Lykke Norgaard Bertelsen MD, PhD , Jens Dahlgaard Hove MD, PhD , Gorm Mørk MD, PhD , Ole Peter Kristiansen MD, PhD , Thomas Engstrøm MD, PhD, DMSc , Jacob Thomsen Lønborg MD, PhD, DMSc , Jørgen Tobias Kühl MD, PhD, DMSc , Signe Stelling Risom RN, PhD , Paul Blanche MSc, PhD , Niels Thue Olsen MD, PhD

Purpose

In patients admitted with acute coronary syndrome, invasive coronary angiography (ICA) is performed to determine which patients need revascularization. Coronary computed tomography angiography (CCTA) offers a widely available, non-invasive alternative that could reduce patient discomfort, procedural risks, and healthcare costs. The current trial aims to determine whether CCTA is noninferior to ICA in determining the interventional strategy for patients admitted with non-ST elevation acute coronary syndrome (NSTE-ACS)(Central Illustration).

Methods

TRACTION (Team-based Interventional Triage in Acute Coronary Syndrome Based on Noninvasive Coronary Computed Tomography Angiography Versus Invasive Coronary Angiography) is a multicenter, randomized, open-label, noninferiority trial enrolling 2,300 patients. Patients hospitalized with non-ST elevation myocardial infarction or unstable angina with ischemic changes on ECG will be randomized 1:1 to CCTA vs ICA (standard of care). In the CCTA group, a Coronary Team reviews the CCTA and clinical information to determine the interventional strategy. The primary composite endpoint is major adverse cardiac events at 1 year, comprised of all-cause mortality, nonfatal myocardial infarction, hospitalization due to refractory angina, or hospitalization due to heart failure. Secondary outcomes include cardiovascular death, revascularization, symptom status, procedure-related adverse events, and resource utilization. The trial is designed to demonstrate noninferiority if the 95% confidence interval excludes an absolute risk difference of the primary endpoint larger than 5%.

Perspectives

If CCTA is shown to be noninferior to ICA in patients admitted with NSTE-ACS, CCTA could become the preferred management in a large group of patients. This could result in fewer patients exposed to invasive procedures and improved resource utilization.

ClinicalTrials.gov identifier: NCT06101862

目的：对入院的急性冠脉综合征患者进行有创冠状动脉造影（ICA）以确定哪些患者需要血运重建术。冠状动脉计算机断层血管造影（CCTA）提供了一种广泛可用的、无创的替代方法，可以减少患者的不适、手术风险和医疗保健费用。目前的试验旨在确定CCTA在确定非st段抬高急性冠脉综合征（NSTE-ACS）患者的介入策略方面是否优于ICA。方法：TRACTION（基于无创冠状动脉计算机断层造影与有创冠状动脉造影的急性冠状动脉综合征团队介入分诊）是一项多中心、随机、开放标签、非效性试验，纳入了2300例患者。住院的非st段抬高型心肌梗死或伴有心电图缺血性改变的不稳定型心绞痛患者将按1:1随机分为CCTA组和ICA组（标准治疗组）。在CCTA组，冠状动脉小组回顾CCTA和临床信息来确定介入策略。主要复合终点是一年内的主要心脏不良事件，包括全因死亡率、非致死性心肌梗死、因难治性心绞痛住院或因心力衰竭住院。次要结局包括心血管死亡、血运重建、症状状态、手术相关不良事件和资源利用。如果95%置信区间排除了主要终点的绝对风险差异大于5%，则该试验旨在证明非劣效性。展望：如果CCTA在NSTE-ACS患者中不劣于ICA， CCTA可能成为一大批患者的首选治疗方法。这可以减少接受侵入性手术的患者，提高资源利用率。

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引用次数: 0

Response to letter by Golestanieraghi regarding article, “Association between vasopressin administration and mortality in patients with cardiogenic shock” 对Golestanieraghi关于《心源性休克患者抗利尿激素使用与死亡率的关系》一文的回复

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-03 DOI: 10.1016/j.ahj.2025.09.002

Dhruv Sarma BMBCh , Aniket S Rali MD , Jacob C Jentzer MD

引用次数: 0

Corrigendum to “Medical treatment of hypercortisolism with relacorilant: Final results of the phase 3 GRACE study” [American Heart Journal 278S (2024) Pages 10-11] “用抗凝剂治疗高皮质醇血症：GRACE 3期研究的最终结果”的勘误表[American Heart Journal 278S (2024) page 10-11]

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-03 DOI: 10.1016/j.ahj.2025.107286

Rosario Pivonello , Giorgio Arnaldi , Richard J. Auchus , Corin Badiu , Robert S. Busch , Salvatore Cannavo , Ulrich Dischinger , Georgiana A. Dobri , Diane Donegan , Atanaska Elenkova , Pouneh K. Fazeli , Richard A. Feelders , Rogelio Garcia-Centeno , Aleksandra Gilis-Januszewska , Oksana Hamidi , Zeina C. Hannoush , Harold J. Miller , Aurelian-Emil Ranetti , Monica Recasens , Martin Reincke , Andreas G. Moraitis

引用次数: 0

Letter to the Editor regarding “Association between vasopressin administration and mortality in patients with cardiogenic shock” 致编辑关于“抗利尿激素给药与心源性休克患者死亡率的关系”的信

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-03 DOI: 10.1016/j.ahj.2025.09.001

Niloufar Dadashpour MD, Majid Golestanieraghi MD

引用次数: 0

Cerebral embolic protection in TAVR: Moving beyond all-comers to a targeted high-risk approach TAVR中的脑栓塞保护：从所有患者到有针对性的高风险方法

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-03 DOI: 10.1016/j.ahj.2025.09.007

Artur Dziewierz MD, PhD , Paweł Kleczyński MD, PhD

引用次数: 0

Information for Readers 读者资讯

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-03 DOI: 10.1016/S0002-8703(25)00380-1

引用次数: 0

Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics. REMBRANDT试验的基本原理和设计：一项评估obicetrapib/ezetimibe对冠状动脉斑块特征影响的3期研究。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-01 Epub Date: 2025-07-17 DOI: 10.1016/j.ahj.2025.07.012

Cian P McCarthy, Christie M Ballantyne, Ron Blankstein, Matthew J Budoff, Marc Ditmarsch, C Michael Gibson, John J P Kastelein, Ann Marie Navar, Stephen J Nicholls, Kausik K Ray, Cheerag Shirodaria, Michelle C Williams, James L Januzzi

Background: Obicetrapib is a potent, selective cholesteryl ester transfer protein (CETP) inhibitor that significantly lowers low-density lipoprotein cholesterol (LDL-C). Additive reductions in LDL-C occur when obicetrapib is combined with ezetimibe. The impact of obicetrapib and ezetimibe fixed-dose combination (FDC) on coronary plaque burden is unknown. Favorable changes in noncalcified coronary atherosclerotic plaque volume (NCPV) may indicate a potential beneficial effect on atherosclerotic cardiovascular disease (ASCVD) events.

Methods: REMBRANDT is a placebo-controlled, double-blind, randomized trial designed to assess the efficacy of obicetrapib and ezetimibe FDC on coronary plaque burden. Individuals aged 45 years or older with ASCVD (imaging evidence of vascular disease or clinically manifested ASCVD) and an LDL-C of ≥70 mg/dL despite maximally tolerated lipid-modifying therapy are eligible to participate. Eligible participants (N = 300) will be randomized in a 1:1 ratio to obicetrapib 10 mg and ezetimibe 10 mg FDC once daily or placebo tablet once daily. The primary efficacy outcome of REMBRANDT is percent change in total NCPV from baseline to 18 months as assessed by coronary computed tomographic angiography (CCTA). Secondary endpoints include absolute change in total NCPV, percent and absolute change in NCPV in the most diseased coronary segment, percent change in LDL-C, and change in perivascular fat attenuation index from baseline to 18 months.

Conclusion: The REMBRANDT trial will determine whether the favorable effects of obicetrapib and ezetimibe FDC on LDL-C translate to a reduction in coronary plaque burden as a potential mechanism for ASCVD risk reduction.

Clinical trial registration: NCT06305559.

Obicetrapib是一种有效的选择性胆固醇酯转移蛋白（CETP）抑制剂，可显著降低低密度脂蛋白胆固醇（LDL-C）。当obictrapib与ezetimibe联合使用时，LDL-C会发生累加性降低。obicetrapib和ezetimibe固定剂量组合（FDC）对冠状动脉斑块负荷的影响尚不清楚。非钙化冠状动脉粥样硬化斑块体积（NCPV）的有利变化可能表明对动脉粥样硬化性心血管疾病（ASCVD）事件的潜在有益影响。方法：REMBRANDT是一项安慰剂对照、双盲、随机试验，旨在评估obicetrapib和ezetimibe FDC对冠状动脉斑块负荷的疗效。年龄在45岁或以上的动脉粥样硬化性心血管疾病（血管疾病的影像学证据或临床表现的ASCVD）患者，尽管接受了最大耐受的脂质调节治疗，但LDL-C≥70 mg/dL的患者有资格参加。符合条件的参与者（N=300）将按1:1的比例随机分配至obictrapib 10mg和ezetimibe 10mg FDC，每日一次或安慰剂片，每日一次。REMBRANDT的主要疗效指标是通过冠状动脉计算机断层血管造影（CCTA）评估的从基线到18个月的总NCPV变化百分比。次要终点包括总NCPV的绝对变化，最病变冠状动脉段NCPV的百分比和绝对变化，LDL-C的百分比变化，以及从基线到18个月血管周围脂肪衰减指数的变化。结论：REMBRANDT试验将确定obictrapib和ezetimibe FDC对LDL-C的有利作用是否转化为降低冠状动脉斑块负担，作为降低ASCVD风险的潜在机制。临床试验注册：NCT06305559。

{"title":"Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics.","authors":"Cian P McCarthy, Christie M Ballantyne, Ron Blankstein, Matthew J Budoff, Marc Ditmarsch, C Michael Gibson, John J P Kastelein, Ann Marie Navar, Stephen J Nicholls, Kausik K Ray, Cheerag Shirodaria, Michelle C Williams, James L Januzzi","doi":"10.1016/j.ahj.2025.07.012","DOIUrl":"10.1016/j.ahj.2025.07.012","url":null,"abstract":"<p><strong>Background: </strong>Obicetrapib is a potent, selective cholesteryl ester transfer protein (CETP) inhibitor that significantly lowers low-density lipoprotein cholesterol (LDL-C). Additive reductions in LDL-C occur when obicetrapib is combined with ezetimibe. The impact of obicetrapib and ezetimibe fixed-dose combination (FDC) on coronary plaque burden is unknown. Favorable changes in noncalcified coronary atherosclerotic plaque volume (NCPV) may indicate a potential beneficial effect on atherosclerotic cardiovascular disease (ASCVD) events.</p><p><strong>Methods: </strong>REMBRANDT is a placebo-controlled, double-blind, randomized trial designed to assess the efficacy of obicetrapib and ezetimibe FDC on coronary plaque burden. Individuals aged 45 years or older with ASCVD (imaging evidence of vascular disease or clinically manifested ASCVD) and an LDL-C of ≥70 mg/dL despite maximally tolerated lipid-modifying therapy are eligible to participate. Eligible participants (N = 300) will be randomized in a 1:1 ratio to obicetrapib 10 mg and ezetimibe 10 mg FDC once daily or placebo tablet once daily. The primary efficacy outcome of REMBRANDT is percent change in total NCPV from baseline to 18 months as assessed by coronary computed tomographic angiography (CCTA). Secondary endpoints include absolute change in total NCPV, percent and absolute change in NCPV in the most diseased coronary segment, percent change in LDL-C, and change in perivascular fat attenuation index from baseline to 18 months.</p><p><strong>Conclusion: </strong>The REMBRANDT trial will determine whether the favorable effects of obicetrapib and ezetimibe FDC on LDL-C translate to a reduction in coronary plaque burden as a potential mechanism for ASCVD risk reduction.</p><p><strong>Clinical trial registration: </strong>NCT06305559.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"325-338"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144666899","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

Incremental cost of complications after TAVR and SAVR in contemporary clinical practice. 当代临床TAVR和SAVR术后并发症的增量成本。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-01 Epub Date: 2025-07-12 DOI: 10.1016/j.ahj.2025.07.001

James E Harvey, Michael Ryan, Candace Gunnarsson, Soumya Chikermane, Suzanne J Baron

Background: Prior studies have demonstrated that peri-procedural complications are associated with increased healthcare costs after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). Given the technological and procedural advances that have occurred in the management of aortic valve disease over the last decade, this study aims to understand the incremental cost of specific complications after SAVR and TAVR in contemporary practice.

Methods: Using the Medicare 100% standard analytic file, we identified all beneficiaries receiving SAVR or TAVR in the United States during fiscal year 2021. Specific complications were identified via ICD-10 codes. Multivariable analyses were performed to estimate the incremental cost and length of stay (LOS) for each complication. Attributable costs were calculated by adjusting the incremental cost of each complication for its incidence.

Results: The cost of an uncomplicated TAVR index hospitalization was $46,257 with LOS 2.2 days, while an uncomplicated SAVR cost $58,488 with LOS 8.1 days. The presence of any complication increased costs and LOS for TAVR ($66,601; 5.9 days) and SAVR ($88,900; 13.4 days). Prolonged ventilation was associated with the highest incremental cost for TAVR ($55,742), while pacemaker implantation had the highest attributable cost ($1,270). Prolonged ventilation accounted for the highest incremental ($69,728) and attributable ($2,580) cost associated with SAVR.

Conclusion: This study provides contemporary data on the incremental costs of specific peri-procedural complications associated with TAVR and SAVR. These findings can be used to develop targeted interventions to optimize healthcare resource utilization in patients undergoing aortic valve replacement.

先前的研究表明，手术主动脉瓣置换术（SAVR）和经导管主动脉瓣置换术（TAVR）后术中并发症与医疗费用增加有关。鉴于过去十年来主动脉瓣疾病治疗技术和程序的进步，本研究旨在了解当代实践中SAVR和TAVR后特定并发症的增量成本。方法：使用医疗保险100%标准分析文件，我们确定了2021财年美国所有接受SAVR或TAVR的受益人。通过ICD-10代码确定特定并发症。进行多变量分析以估计每种并发症的增量成本和住院时间（LOS）。归因成本是通过调整每个并发症的发生率的增量成本来计算的。结果：单纯TAVR指数住院费用为46,257美元，住院时间为2.2天；单纯SAVR住院费用为58,488美元，住院时间为8.1天。任何并发症的存在增加了TAVR的费用和LOS ($66,601；5.9天)和SAVR ($88,900；13.4天)。延长通气与TAVR的最高增量成本相关（55,742美元），而起搏器植入的可归因成本最高（1,270美元）。延长通气与SAVR相关的增量成本（69,728美元）和可归因成本（2,580美元）最高。结论：本研究提供了与TAVR和SAVR相关的特定围手术期并发症的增量成本的当代数据。这些发现可用于制定有针对性的干预措施，以优化主动脉瓣置换术患者的医疗资源利用。

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引用次数: 0

Defining diastolic dysfunction post-Fontan: Threshold, risk factors, and associations with outcomes. 定义fontan后舒张功能障碍：阈值、危险因素和与结果的关联。

IF 3.5 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal

Pub Date : 2025-12-01 Epub Date: 2025-07-10 DOI: 10.1016/j.ahj.2025.07.007

Tarek Alsaied, Runjia Li, Haley Grant, Mary D Schiff, Yu Li, Adam B Christopher, Jacqueline Kreutzer, Bryan H Goldstein, Jonathan H Soslow, Yue-Hin Loke, Mark A Fogel, Timothy C Slesnick, Rajesh Krishnamurthy, Vivek Muthurangu, Adam L Dorfman, Christopher Lam, Justin D Weigand, Joshua D Robinson, Laura J Olivieri, Rahul H Rathod

Background: Following the Fontan procedure, patients with single ventricle physiology are at high risk of diastolic dysfunction (DD) and elevated end-diastolic pressure (EDP).

Objective: This study aims to determine (1) the optimal EDP threshold correlated with adverse outcomes post-Fontan and (2) the clinical and imaging predictors of DD.

Methods: The study included patients from the Fontan Outcome Registry using CMR Examinations (FORCE) who underwent cardiac catheterization and cardiac magnetic resonance (CMR) within a 2-year window. The composite outcome was defined as all-cause mortality, sustained atrial or ventricular arrhythmia, plastic bronchitis, protein-losing enteropathy, or listing for transplantation. The EDP cutoff was determined using the lowest Brier score from Cox proportional hazard models.

Results: The study included 861 patients (mean age 16.4 ± 9.3 years). Mean EDP was 9.0 ± 3.5 mm Hg, with DD defined at an optimal EDP threshold >13 mm Hg. Patients were followed for a median of 3.6 years after catheterization. By univariable analysis patients with DD were more likely to have Fontan associated liver disease (40% vs 29%, P = .03) and kidney disease (19% vs 6%, P < .001). In multivariable analyses, DD was associated with the composite outcome (HR 3.37, 95% CI: 2.03-5.59, P < .001). Ninety-seven patients (11.3%) had DD. Multivariable analysis demonstrated that older age at catheterization, greater body mass index (BMI), nonleft ventricular morphology, and higher ventricular end-diastolic volume (EDV) were associated with DD.

Conclusion: DD, defined as an EDP >13 mm Hg, is linked to over 3-fold higher risk of adverse outcomes. Risk factors for DD include older age, higher BMI, nonleft ventricular morphology, and larger EDV. The presence of risk factors may warrant screening catheterization to identify DD and modify care accordingly.

背景：在Fontan手术后，单心室生理的患者发生舒张功能障碍（DD）和舒张末期压（EDP）升高的风险很高。目的：本研究旨在确定(1)与Fontan术后不良结果相关的最佳EDP阈值和(2)dd的临床和影像学预测因素。方法：研究纳入了使用CMR检查（FORCE）的Fontan预后登记的患者，这些患者在两年的窗口内接受了心导管插管和心脏磁共振（CMR）。综合结局定义为全因死亡率、持续性房性或室性心律失常、可塑性支气管炎、蛋白质丧失性肠病或移植清单。EDP临界值采用Cox比例风险模型的最低Brier评分确定。结果：纳入861例患者，平均年龄16.4±9.3岁。平均EDP为9.0±3.5 mm Hg， DD定义为最佳EDP阈值bbb13 mm Hg。置管后患者的中位随访时间为3.6年。通过单变量分析，DD患者更有可能患有丰坦相关的肝脏疾病（40% vs 29%, p=0.03）和肾脏疾病（19% vs 6%, p）。结论：DD，定义为EDP bb0 13 mm Hg，与不良结局风险增加三倍以上相关。DD的危险因素包括年龄较大、BMI较高、非左心室形态和较大的EDV。危险因素的存在可能需要进行导管筛查，以确定DD并相应地修改护理。

{"title":"Defining diastolic dysfunction post-Fontan: Threshold, risk factors, and associations with outcomes.","authors":"Tarek Alsaied, Runjia Li, Haley Grant, Mary D Schiff, Yu Li, Adam B Christopher, Jacqueline Kreutzer, Bryan H Goldstein, Jonathan H Soslow, Yue-Hin Loke, Mark A Fogel, Timothy C Slesnick, Rajesh Krishnamurthy, Vivek Muthurangu, Adam L Dorfman, Christopher Lam, Justin D Weigand, Joshua D Robinson, Laura J Olivieri, Rahul H Rathod","doi":"10.1016/j.ahj.2025.07.007","DOIUrl":"10.1016/j.ahj.2025.07.007","url":null,"abstract":"<p><strong>Background: </strong>Following the Fontan procedure, patients with single ventricle physiology are at high risk of diastolic dysfunction (DD) and elevated end-diastolic pressure (EDP).</p><p><strong>Objective: </strong>This study aims to determine (1) the optimal EDP threshold correlated with adverse outcomes post-Fontan and (2) the clinical and imaging predictors of DD.</p><p><strong>Methods: </strong>The study included patients from the Fontan Outcome Registry using CMR Examinations (FORCE) who underwent cardiac catheterization and cardiac magnetic resonance (CMR) within a 2-year window. The composite outcome was defined as all-cause mortality, sustained atrial or ventricular arrhythmia, plastic bronchitis, protein-losing enteropathy, or listing for transplantation. The EDP cutoff was determined using the lowest Brier score from Cox proportional hazard models.</p><p><strong>Results: </strong>The study included 861 patients (mean age 16.4 ± 9.3 years). Mean EDP was 9.0 ± 3.5 mm Hg, with DD defined at an optimal EDP threshold >13 mm Hg. Patients were followed for a median of 3.6 years after catheterization. By univariable analysis patients with DD were more likely to have Fontan associated liver disease (40% vs 29%, P = .03) and kidney disease (19% vs 6%, P < .001). In multivariable analyses, DD was associated with the composite outcome (HR 3.37, 95% CI: 2.03-5.59, P < .001). Ninety-seven patients (11.3%) had DD. Multivariable analysis demonstrated that older age at catheterization, greater body mass index (BMI), nonleft ventricular morphology, and higher ventricular end-diastolic volume (EDV) were associated with DD.</p><p><strong>Conclusion: </strong>DD, defined as an EDP >13 mm Hg, is linked to over 3-fold higher risk of adverse outcomes. Risk factors for DD include older age, higher BMI, nonleft ventricular morphology, and larger EDV. The presence of risk factors may warrant screening catheterization to identify DD and modify care accordingly.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":"288-296"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144615794","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}

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