Journal of Cardiac Failure最新文献

英文中文

Comparing Analytical Methods for Composite End Points in Clinical Trials: Insights from the Vericiguat Global Study in Subjects with Heart Failure With Reduced Ejection Fraction Trial 比较临床试验中复合终点的分析方法：射血分数降低的心力衰竭受试者韦立克全球研究（VICTORIA）试验的启示。

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2024.08.038

CYNTHIA M. WESTERHOUT PhD , SARAH RATHWELL MSc , KEVIN J. ANSTROM PhD , ADRIAN F. HERNANDEZ MD, MHS , PIOTR PONIKOWSKI MD , JUSTIN A. EZEKOWITZ MBBCh, MSc , ADRIAAN A. VOORS MD, PhD , G. MICHAEL FELKER MD, MHS , JEFFREY A. BAKAL PhD, PStat , ROBERT O. BLAUSTEIN MD, PhD , RICHARD NKULIKIYINKA MD , CHRISTOPHER M. O'CONNOR MD , PAUL W. ARMSTRONG MD , VICTORIA Study Group

Background

In VICTORIA (Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction), participants with heart failure (HF) and reduced ejection fraction, vericiguat decreased the primary composite outcome (time to first HF hospitalization [HFH] or cardiovascular death [CVD]) (897 events) compared with placebo (972 events) (hazard ratio, 0.90; 95% confidence interval [CI], 0.82–0.98; P = .02). In this prespecified secondary analysis, we applied the weighted composite end point (WCE) and the win ratio (WR) methods to provide complementary assessments of treatment effect.

Methods and Results

The WCE method estimated the mean HFH-adjusted survival based on prespecified weights from a Delphi panel of the VICTORIA executive committee and national leaders: mild (weight per event, 0.39), moderate (0.5), or severe (0.67) HFH, and CVD (1.0). The unmatched WR was estimated for the descending hierarchy of CVD, then recurrent HFH. The WCE used all 3412 primary clinical events: 875 severe HFH (vericiguat, 416/ placebo, 459), 1614 moderate HFH (767/847), 68 mild HFH (38/30), and 855 CVD (414/441). Improved HFH-adjusted survival occurred with vericiguat (mean 78.2% vs 75.6%, difference 2.4%, 95% CI, 1.7%–3.2%, P < .0001). Based on a comparison of 6,375,624 pairs, the WR of 1.13 (95% CI 1.03–1.24, P = .01) also indicated improved clinical outcomes with vericiguat.

Conclusions

The results of the WCE and WR methods were consistent with the primary analysis of the time to first HFH or CVD. Although both WCE and WR assessed recurrent events, the WCE allowed inclusion of all recurrent events, insights on the severity of HFH events, and an absolute measure of the participant–treatment experience. This approach complements conventional assessment, better informing consumers of new therapeutics and future trial designs.

背景与目的在针对射血分数降低的心力衰竭（HF）患者进行的VICTORIA试验中，与安慰剂（P）（972例）相比，维力吉（V）减少了主要复合结局[首次HF住院（HFH）或心血管死亡（CVD）时间]（897例）（危险比为0.90；95%置信区间[CI]为0.82-0.98；P=0.02）。在这项预先指定的二次分析中，我们采用了加权综合终点法（WCE）和获胜比法（WR）对治疗效果进行补充评估：WCE方法根据VICTORIA执行委员会和国家领导人组成的德尔菲小组预先确定的权重估算出HFH调整后的平均生存率：轻度（每个事件的权重：0.39）、中度（0.5）或重度（0.67）HFH和心血管疾病（1.0）。未匹配的 WR 是根据心血管疾病的降序排列进行估算的，然后是复发性 HFH。WCE 使用了所有 3412 个主要临床事件：875例（V:416/P:459）重度HFH，1614例（767/847）中度HFH和68例（38/30）轻度HFH，855例（414/441）心血管疾病。维力古特提高了HFH调整后生存率[平均78.2% vs. 75.6%；差异（95% CI）：2.4% (1.7%-3.2%)；p结论：WCE和WR方法的结果与首次高频心动过速或心血管疾病发生时间的主要分析结果一致。WCE 和 WR 方法都对复发事件进行评估，而 WCE 方法允许纳入所有复发事件、对高频心房颤动事件严重程度的深入了解以及对参与者治疗经历的绝对衡量。这种方法是对传统评估的补充，能更好地为消费者提供新疗法和未来试验设计的信息。

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引用次数: 0

FINEARTS Restoration: Revisiting the Role of Steroidal Mineralocorticoid Receptor Antagonists in Heart Failure with Mildly Reduced or Preserved Ejection Fraction Following FINEARTS-HF FINEARTS 恢复：重新审视类固醇类矿物皮质激素受体拮抗剂在 FINEARTS-HF 后射血分数轻度降低或保留的心力衰竭患者中的作用。

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2024.09.011

RICKY D. TURGEON BSc(Pharm), ACPR, PharmD , CRAIG J. BEAVERS PharmD

引用次数: 0

Patient-Centered Research Design to Increase Representativeness of Diverse Populations in Clinical Trials 以患者为中心的研究设计，提高不同人群在临床试验中的代表性。

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2024.10.438

TRACY Y. WANG MD, MHS, MSc

引用次数: 0

Integration of Palliative Care into Heart Failure Care: Consensus-Based Recommendations from the Heart Failure Society of America 将姑息治疗纳入心力衰竭治疗：美国心力衰竭学会基于共识的建议。

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2024.10.435

SARAH CHUZI MD, MSc , MARTHA ABSHIRE SAYLOR PhD, RN , LARRY A. ALLEN MD , AKSHAY S. DESAI MD, MPH , SHELLI FEDER PhD, APRN, FNP-C , NATHAN E. GOLDSTEIN MD , HUNTER GRONINGER MD , JAMES N. KIRKPATRICK MD , JAMES A. TULSKY MD , JILL M. STEINER MD, MS , NATASHA LEVER MSN, ACNP-BC , ELDRIN LEWIS MD, MPH , JOSEPH G. ROGERS MD , HAIDER J. WARRAICH MD

Heart failure (HF) is characterized by significant symptoms, compromised quality of life, frequent hospital admissions, and high mortality rates; palliative care (PC) is, therefore, highly relevant for patients with HF and their clinicians. Multiple guidelines and consensus statements recommend the provision of PC alongside HF management. However, few resources exist to guide the integration of PC into HF care, for both primary PC (provided by HF clinicians in the course of HF care) and specialty PC (provided by PC specialists). Through this consensus statement, the Heart Failure Society of America aims to provide a contemporary, practical guide for clinicians and institutions about how PC should be operationalized in the context of comprehensive HF care. Key components of high-quality, integrated HF-PC are described, with a focus on clinical and operational considerations for providing primary and specialty PC, quality measurement and value demonstration, reimbursement and incentive concerns, and the provision of hospice care.

心衰（HF）的特点是症状显著、生活质量下降、频繁住院和高死亡率；因此，姑息治疗（PC）与心衰患者及其临床医生高度相关。多个指南和共识声明建议在心衰管理的同时提供PC。然而，对于初级PC（由心衰临床医生在心衰护理过程中提供）和专业PC（由心衰专家提供），指导将PC整合到心衰护理中的资源很少。通过这一共识声明，美国心力衰竭协会旨在为临床医生和机构提供一个现代实用的指南，指导如何在心衰综合护理的背景下实施PC。本文描述了高质量、集成的HF-PC的关键组成部分，重点是提供初级和专业PC的临床和操作考虑，质量测量和价值演示，报销和激励问题，以及临终关怀的提供。

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引用次数: 0

Intra-aortic Entrainment Pump for LV unloading: What Phase of the Cardiac Cycle Does the Device Unload?

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2025.01.006

SAMTA VEERA MS, KENJI WATANABE MD, KIYOTAKE ISHIKAWA MD, PhD

引用次数: 0

HF Seminar HFSA Society Page

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2025.02.008

引用次数: 0

Left Ventricular Unloading Using Intra-aortic Entrainment Pumping Before Reperfusion Reduces Post-AMI Infarct Size 再灌注前使用主动脉内调节泵进行左心室减压可缩小急性心肌梗死后的梗死面积

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2024.07.022

MARAT FUDIM MD, MHS , FILIP KONECNY DVM, PhD , JASON J. HEURING PhD , CHRISTOPHER A. DURST PhD , ERIC S. FAIN MD , MANESH R. PATEL MD

Background

Anterior myocardial infarction standard of care prioritizes swift coronary reperfusion. Recent studies show left ventricular (LV) unloading with transvalvular axial flow pumps for 30 minutes before reperfusion (vs immediate reperfusion) decreases 28-day infarct size. Intra-aortic entrainment pumping, using hardware located away from the heart to provide support throughout the cardiac cycle, decreases effective systemic vascular resistance and augments visceral blood flow and pressure, and may reproduce this benefit with a decreased risk. This study characterized the hemodynamic effects of unloading before and during reperfusion using intra-aortic entrainment pumping and investigated whether unloading decreased anterior myocardial infarction scar size.

Methods and Results

Yorkshire swine were subjected to 90 minutes of left anterior descending artery balloon occlusion and randomly assigned to immediate reperfusion (n = 6) vs 30 minutes unloading before reperfusion followed by 120 minutes of further unloading (n = 7). Unloading was achieved using percutaneous entrainment pumping in the descending aorta. The anterior myocardial infarction model matches that used in recent transvalvular pumping studies. Mortality before randomization was 22%. After randomization, mortality was 36% for immediate reperfusion and 0% for unloading. Unloading showed immediate hemodynamic benefit that increased through reperfusion and continued support, leading to distinct differences in cardiac function between groups after 30 minutes of reperfusion. Unloading increased stroke volume and cardiac efficiency at this timepoint relative to preocclusion baseline and reduced 28-day LV scar size by 37%–45%.

Conclusions

We present the first preclinical data showing extracardiac LV unloading before coronary reperfusion using intra-aortic entrainment pumping decreases 28-day infarct size. Extracardiac unloading to decrease LV scar size may provide an alternative to transvalvular pumping with potential advantages, including reduced risk.

背景：前壁心肌梗死的标准治疗优先考虑快速冠状动脉再灌注。最近的研究表明，在再灌注前 30 分钟使用经瓣轴流泵为左心室（LV）减压（与立即再灌注相比）可减少 28 天的梗死面积。主动脉内夹带泵使用远离心脏的硬件在整个心动周期提供支持，降低有效的全身血管阻力，增加内脏血流和压力，可能会在降低风险的同时再现这种益处。这项研究描述了使用主动脉内夹带泵在再灌注前和再灌注过程中卸载的血流动力学效应，并研究了卸载是否能减少前心肌梗死（AMI）瘢痕的大小：对约克郡猪进行90分钟的左前降支动脉球囊闭塞，随机分配立即再灌注（6头）和再灌注前30分钟卸载，然后再卸载120分钟（7头）。通过降主动脉经皮夹带泵实现卸载。AMI 模型与近期经瓣泵研究中使用的模型一致。随机化前的死亡率为 22%。随机分组后，立即再灌注的死亡率为36%，卸载的死亡率为0%。卸压疗法可立即改善血流动力学，并在再灌注和持续支持过程中不断增强，导致再灌注 30 分钟后各组心脏功能出现明显差异。相对于闭塞前的基线，卸载在这一时间点增加了搏出量和心脏效率，并将28天的左心室瘢痕大小减少了37-45%：我们首次提出了临床前数据，表明在冠状动脉再灌注前使用主动脉内夹带泵进行心外左心室减压可减少 28 天的心肌梗死面积。通过心外卸载来减少左心室瘢痕面积可能是经瓣泵的一种替代方法，具有降低风险等潜在优势。

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引用次数: 0

Association of Double-Blind Reviews With Increases in Women as First Authors: An Initial Report From the Journal of Cardiac Failure 双盲评审与女性第一作者增加的关系：心力衰竭杂志》的初步报告。

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2024.09.004

ERSILIA M. DEFILIPPIS MD , ELENA DONALD MD , LOGAN CHO MD , ANDREW SAUER MD , JENNIFER MANING MD , VANESSA BLUMER MD , ALEXANDER HAJDUCZOK MD , QUENTIN YOUMANS MD , MARTHA GULATI MD , MEREDITH T. HURT MPS , ALAYNA HUMPHREY , NOSHEEN REZA MD , ROBERT MENTZ MD , ANURADHA LALA MD

Introduction

Women continue to remain under-represented in academic publishing in the field of cardiology. Some evidence suggests that double-blind peer reviews may mitigate the impact of gender bias. In July 2021, the Journal of Cardiac Failure implemented a process for the conduct of double-blind reviews after previously using single-blind reviews, with the aim of improving author diversity. The purpose of the current study was to examine the association between changes in authorship characteristics and implementation of double-blind reviews.

Methods

Manuscripts were stratified into 3 Eras: March–September 2021 (Era 1: prior to double-blind reviews); March–September 2022 (Era 2); and March–September 2023 (Era 3). All article types except invited editorials were included. Data were abstracted, including names, genders, ranks, and disciplines of the first and senior authors.

Results

A total of 310 manuscripts were included in the analysis. The proportion of women first authors increased from 24% in Era 1 to 34% in Era 2 to 39% in Era 3, while the percentage of women authors serving in a senior authorship role remained fairly stable over time–around 21%–22%. Even after adjusting for region, article type, first-author discipline, and last-author gender, there was an increase in female first authors over time (P = 0.015). Manuscripts with a female senior author were significantly more likely to have a female first author.

Conclusions

Our findings suggest that double-blind peer review may contribute to increased gender diversity of first authors and may highlight areas for future improvement by the Journal and academic publishing in general.

导言：女性在心脏病学学术出版领域的代表性仍然不足。一些证据表明，双盲同行评审可减轻性别偏见的影响。2021 年 7 月，《心力衰竭杂志》实施了双盲审稿流程，此前采用的是单盲审稿，目的是提高作者的多样性。本稿件旨在研究作者特征的变化与实施双盲审稿之间的关联：将稿件分为 3 个时代：方法：将稿件分为 3 个时代：2021 年 3 月至 9 月（时代 1--双盲审稿之前）、2022 年 3 月至 9 月（时代 2）和 2023 年 3 月至 9 月（时代 3）。除特邀社论外，所有文章类型均包括在内。数据摘要包括第一作者和资深作者的姓名、性别、职级和学科：共有 310 篇稿件被纳入分析。女性第一作者的比例从时代1的24%上升到时代2的34%，再上升到时代3的39%，而女性资深作者的比例则一直保持在21-22%左右。即使对地区、文章类型、第一作者学科和最后作者性别进行调整后，女性第一作者的比例也随着时间的推移而增加（p= 0.015）。有女性资深作者的稿件中，女性第一作者的比例明显更高：我们的研究结果表明，双盲同行评审可能有助于提高第一作者的性别多样性，并强调了JCF和学术出版未来需要改进的领域。

{"title":"Association of Double-Blind Reviews With Increases in Women as First Authors: An Initial Report From the Journal of Cardiac Failure","authors":"ERSILIA M. DEFILIPPIS MD , ELENA DONALD MD , LOGAN CHO MD , ANDREW SAUER MD , JENNIFER MANING MD , VANESSA BLUMER MD , ALEXANDER HAJDUCZOK MD , QUENTIN YOUMANS MD , MARTHA GULATI MD , MEREDITH T. HURT MPS , ALAYNA HUMPHREY , NOSHEEN REZA MD , ROBERT MENTZ MD , ANURADHA LALA MD","doi":"10.1016/j.cardfail.2024.09.004","DOIUrl":"10.1016/j.cardfail.2024.09.004","url":null,"abstract":"<div><h3>Introduction</h3><div>Women continue to remain under-represented in academic publishing in the field of cardiology. Some evidence suggests that double-blind peer reviews may mitigate the impact of gender bias. In July 2021, the <em>Journal of Cardiac Failure</em> implemented a process for the conduct of double-blind reviews after previously using single-blind reviews, with the aim of improving author diversity. The purpose of the current study was to examine the association between changes in authorship characteristics and implementation of double-blind reviews.</div></div><div><h3>Methods</h3><div>Manuscripts were stratified into 3 Eras: March–September 2021 (Era 1: prior to double-blind reviews); March–September 2022 (Era 2); and March–September 2023 (Era 3). All article types except invited editorials were included. Data were abstracted, including names, genders, ranks, and disciplines of the first and senior authors.</div></div><div><h3>Results</h3><div>A total of 310 manuscripts were included in the analysis. The proportion of women first authors increased from 24% in Era 1 to 34% in Era 2 to 39% in Era 3, while the percentage of women authors serving in a senior authorship role remained fairly stable over time–around 21%–22%. Even after adjusting for region, article type, first-author discipline, and last-author gender, there was an increase in female first authors over time (<em>P</em> = 0.015). Manuscripts with a female senior author were significantly more likely to have a female first author.</div></div><div><h3>Conclusions</h3><div>Our findings suggest that double-blind peer review may contribute to increased gender diversity of first authors and may highlight areas for future improvement by the <em>Journal</em> and academic publishing in general.</div></div>","PeriodicalId":15204,"journal":{"name":"Journal of Cardiac Failure","volume":"31 3","pages":"Pages 592-597"},"PeriodicalIF":6.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142365360","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

“OK to Discharge to the Street”: Housing Insecurity and Heart Failure Outcomes

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2025.01.005

THOMAS M. CASCINO MD, MSc, MONICA COLVIN MD

引用次数: 0

Denial for Advanced Heart Failure Therapies Due to Psychosocial Stressors: Who Comes Back? 因社会心理压力而拒绝接受晚期心力衰竭治疗：谁会回来？

IF 6.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiac Failure

Pub Date : 2025-03-01 DOI: 10.1016/j.cardfail.2024.08.057

KAYLA BUTTAFUOCO MD , DANIEL DAUNIS MD , TANDRA CARTER LMSW , JOLAUNDA HOYE LMSW , MAURA WEBB LCSW , SHI HUANG PhD , MARSHALL BRINKLEY MD , JOANN LINDENFELD MD , JONATHAN MENACHEM MD , DAWN PEDROTTY MD PhD , ANIKET RALI MD , SUZANNE SACKS MD , KELLY SCHLENDORF MD MHS , HASAN SIDDIQI MD MSCI , LYNNE STEVENSON MD , SANDIP ZALAWADIYA MBBS , LYNN PUNNOOSE MD

Background

Psychosocial evaluations to assess candidacy for advanced heart failure therapies are not standardized across institutions, potentially contributing to disparities in approval for advanced therapies. Remediation rates of psychosocial stressors among patients with advanced HF and reconsideration for advanced therapies have not been well-described.

Methods and Results

We performed a retrospective, single-center study of 647 adults evaluated for heart transplant and ventricular assist device implantation between 2014 and 2020, of whom 89 (14%) were denied for psychosocial stressors, including caregiver, substance use, housing, financial, or mental health concerns. Later reevaluation occurred in 32 patients (36%), of whom 23 were then approved. Patients initially declined were mostly male (76%), White (74%), and urban (79%). Reevaluation occurred in more women than men (43% vs 34%), Black patients than White (43% vs 37%), and urban patients than rural (39% vs 28%). Patients had fewer psychosocial stressors at reevaluation (median 0.5) than at initial denial (median 2.0). Caregiver and substance use concerns were the most prevalent stressors in patients never returning for or subsequently denied at reevaluation.

Conclusions

Caregiver and substance use concerns were common in patients denied for psychosocial reasons. Future efforts should focus on early screening for these stressors and the implementation of a systematic reevaluation process.

背景：用于评估晚期心力衰竭治疗候选资格的社会心理评估在不同机构之间并不统一，这可能会导致晚期治疗获批方面的差异。对晚期心力衰竭患者社会心理压力的补救率以及重新考虑晚期疗法的情况还没有很好的描述：我们对 2014 年至 2020 年期间接受心脏移植和 VAD 评估的 647 名成人进行了回顾性单中心研究，其中 89 人（14%）因心理社会压力因素（包括照顾者、药物使用、住房、财务或心理健康问题）而被拒绝。后来对 32 名（36%）患者进行了重新评估，其中 23 人获得批准。最初被拒绝的患者多为男性（76%）、白人（74%）和城市居民（79%）。重新评估的患者中，女性多于男性（43% 对 34%），黑人患者多于白人（43% 对 37%），城市患者多于农村患者（39% 对 28%）。患者在重新评估时的社会心理压力（中位数=0.5）少于初次拒绝时（中位数=2）。照顾者和药物使用问题是从未复诊或随后在重新评估时被拒绝的患者最普遍的压力源：结论：在因社会心理原因而被拒绝的患者中，照顾者和药物使用问题很常见。今后的工作重点应是及早筛查这些压力源，并实施系统的再评估流程。

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