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The effects of low-dose colchicine on the progression of aortic valve stenosis: Rationale, design, and baseline characteristics of the Colchicine and Inflammation in Aortic Stenosis (CHIANTI) trial. 低剂量秋水仙碱对主动脉瓣狭窄进展的影响:秋水仙碱与主动脉瓣狭窄炎症(CHIANTI)试验的基本原理、设计和基线特征
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-01 Epub Date: 2025-07-12 DOI: 10.1016/j.ahj.2025.07.010
Niekbachsh Mohammadnia, Lucas T W Vestjens, Neil J Craig, Jan G P Tijssen, Remco J J Knol, Sergiy V Lazarenko, Mariëlle G J Duffels, Jeroen Jaspers Focks, Martin E W Hemels, Iris Oving, Hanke J Schalkx, John W Eikelboom, Aysun Cetinyurek-Yavuz, Erik H J G Aarntzen, Damini Dey, Piotr J Slomka, Robin Nijveldt, Niels P Riksen, Niels van Royen, Michael C Honigberg, Marc R Dweck, Jan H Cornel, Saloua El Messaoudi

Background: Aortic valve stenosis (AS) is one of the most common valvular heart diseases worldwide. Its prevalence increases with age and is expected to rise further as the population ages. Untreated severe AS carries a 2-year mortality rate exceeding 50%. Furthermore, surveillance and management of AS impose a significant burden on healthcare systems. Therefore, effective pharmacological strategies are urgently needed to slow or halt the progression of AS.

Rationale and design: Inflammation plays a central role in the pathogenesis of both atherosclerosis and AS. Anti-inflammatory therapy with low-dose colchicine reduces cardiovascular events in patients with coronary artery disease, but its efficacy has not been tested in AS. Colchicine and Inflammation in Aortic Stenosis (CHIANTI) is an investigator-initiated, placebo-controlled, double-blind, multicenter, randomized trial involving 150 patients with moderate AS. After confirming tolerance during a two-week run-in phase, eligible participants underwent coronary computed tomography (CT) angiography, 18F-sodium fluoride (18F-NaF) positron emission tomography (PET)-CT, and echocardiography. Thereafter, participants were randomized 1:1 to colchicine 0.5 mg once daily or a matching placebo. All baseline imaging is repeated after 24 months. The primary endpoint is the change in aortic valve calcium score on CT. Secondary endpoints are (1) the change in aortic valve 18F-NaF uptake on PET-CT and corrected for target-to-background ratio, and (2) the change in peak aortic jet velocity on echocardiography.

Conclusion: The CHIANTI trial evaluates whether anti-inflammatory therapy with low-dose colchicine can slow or halt the progression of moderate AS. If successful, it would offer the first effective pharmacological treatment for AS.

Trial registration: Registered on ClinicalTrials.gov (https://clinicaltrials.gov/), ID: NCT05162742.

背景:主动脉瓣狭窄(Aortic valve stenosis, AS)是世界上最常见的瓣膜性心脏病之一。它的流行率随着年龄的增长而增加,预计随着人口老龄化将进一步上升。未经治疗的严重AS两年内死亡率超过50%。此外,AS的监测和管理给医疗保健系统带来了沉重的负担。因此,迫切需要有效的药物策略来减缓或停止AS的进展。原理和设计:炎症在动脉粥样硬化和AS的发病机制中都起着核心作用。低剂量秋水仙碱抗炎治疗可减少冠状动脉疾病患者的心血管事件,但其疗效尚未在AS中进行试验。秋水仙碱和主动脉狭窄炎症(CHIANTI)是一项研究者发起的、安慰剂对照、双盲、多中心、随机试验,涉及150例中度AS患者。在两周的磨合阶段确认耐受性后,符合条件的参与者接受了冠状动脉计算机断层扫描(CT)血管造影、18f -氟化钠(18F-NaF)正电子发射断层扫描(PET)-CT和超声心动图检查。此后,参与者以1:1的比例随机分配到秋水仙碱0.5 mg,每日一次或匹配的安慰剂。24个月后重复所有基线成像。主要终点是CT上主动脉瓣钙评分的变化。次要终点是(I) PET-CT上主动脉瓣18F-NaF摄取的变化,并根据靶本比进行校正;(II)超声心动图上主动脉喷射速度峰值的变化。结论:CHIANTI试验评估了低剂量秋水仙碱抗炎治疗是否可以减缓或停止中度AS的进展。如果成功,它将提供首个有效的AS药物治疗方法。试验注册:在ClinicalTrials.gov (https://clinicaltrials.gov/)注册,ID: NCT05162742。
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引用次数: 0
Active Monitoring for AtriaL FIbrillation (AMALFI): Rationale, protocol, and pilot for a pragmatic, randomized, controlled trial of remote screening for asymptomatic atrial fibrillation. 房颤主动监测(AMALFI):一项实用的、随机的、对照的无症状房颤远程筛查试验的基本原理、方案和试点。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-01 Epub Date: 2025-07-16 DOI: 10.1016/j.ahj.2025.07.004
Rohan Wijesurendra, Guilherme Pessoa-Amorim, Georgina Buck, Charlie Harper, Richard Bulbulia, Nicholas R Jones, Christine A'Court, Rijo Kurien, Karen Taylor, Barbara Casadei, Louise Bowman
<p><strong>Objectives: </strong>Screening for asymptomatic atrial fibrillation (AF) might reduce cardioembolic strokes and screening for asymptomatic AF is recommended by some international guidelines. However, any impact of AF screening on clinical outcomes depends on a sustained increase in AF detection and anticoagulation use over time than would have occurred with routine care alone, highlighting the importance of long-term studies to generate the evidence needed to justify establishing formal screening programs. AMALFI aims to establish the long-term efficacy and cost-effectiveness of remote screening for asymptomatic AF in older individuals at increased risk of stroke using a noninvasive 14-day continuous ECG monitoring patch in UK primary care. This paper describes the study protocol and baseline characteristics of included participants.</p><p><strong>Methods: </strong>AMALFI (ISCRTN 15544176) recruited individuals aged ≥65 years with CHA<sub>2</sub>DS<sub>2</sub>-VASc score ≥3 (men) or ≥4 (women) with no previous diagnosis of AF/atrial flutter from 27 UK primary care practices. Participants were randomized to ECG monitoring (Zio XT, iRhythm Technologies; intervention) or usual care (control). Those allocated to ECG monitoring were sent and returned the patch by mail. After wear, participants returned the patch to the device manufacturer where ECG data were analyzed via a deep-learned AI algorithm and confirmed by qualified cardiographic technicians. A final report was sent to study investigators, and those indicating AF or other arrhythmias considered by the study team to be clinically actionable were communicated to general practitioners (GPs) immediately by secure email. Additionally, GPs were notified by mail of the presence or absence of AF episodes ≥30 seconds, and of the burden of AF for each of their participants who wore a patch. The letter included signposting to relevant guidelines and findings were managed at the GP's discretion. Participants allocated to the control group were not required to undertake any action. The primary study outcome is the rate of new AF detection at 2.5 years, with secondary outcomes including time spent with a known AF diagnosis at 5 years of follow-up, and analyses of these outcomes by predefined age and sex subgroups. Exploratory outcomes will assess randomized assessments of time to AF detection within 2.5 and 5 years after randomization, time spent with a known AF diagnosis up to 2.5 years from randomization, and anticoagulation exposure within 2.5 and 5 years after randomization. Other exploratory long-term assessments include randomized comparisons of numbers and proportions of hospitalizations (total and cardiovascular), ischemic stroke, major bleed, and death (all-cause and cardiovascular) in both groups.</p><p><strong>Results: </strong>Between 2019 and 2022, AMALFI randomized 5,040 people in England to screening versus usual care using mail-based invitations. Participant mean age was 77 ± 6 y
目的:筛查无症状房颤(AF)可能会减少心脏栓塞性卒中,一些国际指南推荐筛查无症状房颤。然而,房颤筛查对临床结果的任何影响都取决于房颤检测和抗凝使用的持续增加,而不是单纯的常规护理,这强调了长期研究的重要性,以产生必要的证据来证明建立正式筛查计划的合理性。AMALFI旨在确定在英国初级保健中使用无创14天连续ECG监测贴片对卒中风险增加的老年人进行无症状房颤远程筛查的长期疗效和成本效益。本文描述了研究方案和纳入参与者的基线特征。方法:AMALFI (ISCRTN 15544176)从27个英国初级保健诊所招募年龄≥65岁、CHA2DS2-VASc评分≥3(男性)或≥4(女性)、既往无房颤/心房扑动诊断的个体。参与者被随机分配到心电图监测组(Zio XT, irhyth Technologies;干预)或常规护理(控制)。分配到心电监护组的患者通过邮件发送和返回贴片。佩戴后,参与者将贴片交还给设备制造商,在那里,心电图数据通过深度学习的人工智能算法进行分析,并由合格的心脏病技术人员进行确认。最终报告被发送给研究人员,研究小组认为临床可采取行动的房颤或其他心律失常的报告立即通过安全电子邮件传达给全科医生(gp)。此外,通过邮件通知全科医生是否存在≥30秒的房颤发作,以及每位佩戴贴片的参与者的房颤负担。这封信包括了相关指导方针的路标,调查结果由全科医生自行决定。被分配到对照组的参与者不需要采取任何行动。主要研究结果是2.5年时新发现房颤的比率,次要结果包括5年随访时已知房颤诊断的时间,并按预先定义的年龄和性别亚组对这些结果进行分析。探索性结果将评估随机化后2.5年和5年内检测到房颤的时间,随机化后2.5年内已知房颤诊断的时间,以及随机化后2.5年和5年内抗凝暴露的时间。其他探索性长期评估包括随机比较两组住院人数和比例(总体和心血管)、缺血性中风、大出血和死亡(全因和心血管)。结果:在2019年至2022年期间,AMALFI在英国随机分配了5040人,使用邮件邀请进行筛查和常规护理。参与者平均年龄77±6岁,女性2360人(46.8%);CHA2DS2-VASc评分中位数为4分(IQR 3-5)。目前正在从初级保健实践中收集有关房颤诊断、其他临床诊断、口服抗凝剂和其他药物处方、初级保健就诊、二级保健转诊和临床事件的随访数据,并通过与国家级数据库的联系进行补充,包括配药数据、住院情况和死亡记录。将在随机分组后2.5年和5年评估房颤检出率,并分析长期成本效益。结论:AMALFI将提供随机证据,证明在英国使用无创长期连续监测ECG贴片远程筛查无症状房颤所产生的干预的可行时间窗口,以及该方法的成本效益。这些数据可能进一步阐明现有的房颤常规诊断和管理模式,并为指导英国全国房颤筛查的未来讨论提供重要见解。AMALFI结果将于2025年和2027年报告。
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引用次数: 0
Efficacy and safety of postoperative autologous blood transfusion in cardiac surgery (RESCUE): Rationale, design, and study protocol of a multicenter randomized controlled trial 心脏手术术后自体输血的疗效和安全性:一项多中心随机对照试验的基本原理、设计和研究方案。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-27 DOI: 10.1016/j.ahj.2025.107313
Jiachen Shan MD , Jie Gao MD , Yuye Chen MD , Hongwen Ji MD

Background

Postoperative bleeding is a major concern in cardiac surgery, often leading to significant transfusion requirements. Despite this high transfusion demand, the use of postoperative autologous blood transfusion (PABT) remains underexplored.

Methods and Results

This large-scale, single-blind randomized controlled trial with a 30-day follow-up enrolls patients undergoing elective on- or off-pump coronary artery bypass grafting. Patients with shed mediastinal blood volumes over 500 mL within the first 6 hours postoperatively are randomly assigned 1:1 to either the PABT group or the standard care group. The PABT group receives postoperative autotransfusion and additional allogeneic RBC transfusions if needed, while the standard care group receives allogeneic RBC transfusions only when clinically necessary, without postoperative autotransfusion. The primary efficacy endpoint is the postoperative allogeneic RBC transfusion volume, defined as the cumulative amount transfused from the day of surgery to discharge. Secondary efficacy endpoints include postoperative allogeneic RBC and non-RBC transfusion rates, perioperative hematologic recovery, drainage volume, mechanical ventilation duration, ICU and hospital length of stay. The primary safety endpoint is the incidence of a composite of postoperative infections (pneumonia, bloodstream infections, and surgical site infections). Secondary safety endpoints include a composite of other postoperative complications (renal dysfunction, myocardial infarction, stroke, deep vein thrombosis, and all-cause mortality), individual components of these composites, and 30-day mortality and morbidity. The estimated sample size is 1,232 participants. Patient recruitment is planned from January 2026 to December 2029 and is currently in the preparatory phase. The study is registered at the Chinese Clinical Trial Registry (ChiCTR2500103269, https://www.chictr.org.cn/) and was registered on May 27, 2025.

Conclusions

The study is designed to identify the efficacy and safety of PABT after cardiac surgery. We hypothesize that PABT has superior efficacy and noninferior safety to the standard care.
背景:术后出血是心脏手术的主要问题,经常导致大量输血。尽管有如此高的输血需求,但术后自体输血(PABT)的使用仍未得到充分探索。方法和结果:这项大规模、单盲、随机对照试验,随访30天,纳入了接受选择性体外循环或体外循环冠状动脉旁路移植术的患者。术后前6 小时纵膈血流量超过500 mL的患者按1:1的比例随机分为PABT组和标准治疗组。PABT组术后接受自体输血,并在需要时补充异体红细胞输注,而标准护理组仅在临床需要时接受异体红细胞输注,术后不接受自体输血。主要疗效终点是术后异体红细胞输血量,定义为从手术当天到出院的累计输血量。次要疗效终点包括术后异体红细胞和非红细胞输血率、围手术期血液学恢复、引流量、机械通气时间、ICU和住院时间。主要安全终点是术后感染(肺炎、血流感染和手术部位感染)的发生率。次要安全终点包括其他术后并发症(肾功能障碍、心肌梗死、中风、深静脉血栓形成和全因死亡率)、这些并发症的个别组成部分以及30天死亡率和发病率。估计样本量为1232人。患者招募计划于2026年1月至2029年12月进行,目前处于准备阶段。该研究已在中国临床试验注册中心注册(ChiCTR2500103269, https://www.chictr.org.cn/),于2025年5月27日注册。结论:本研究旨在确定心脏手术后PABT的有效性和安全性。我们假设PABT具有优于标准治疗的疗效和良好的安全性。
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引用次数: 0
Effects of supersaturated oxygen therapy on infarct size and microvascular obstruction following myocardial infarction: A systematic review and meta-analysis 过饱和氧治疗对心肌梗死后梗死面积和微血管阻塞的影响:系统回顾和荟萃分析。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-24 DOI: 10.1016/j.ahj.2025.107311
Shanmukh Sai Pavan Lingamsetty MD , Ravi Venkata Sai Krishna Medarametla MD , Kesar Prajapati MD , Sahas Reddy Jitta MD , Mohamed Doma MD , Harshith Thyagaturu MD , Mangesh Kritya MD , Jaswanth Jasti MD , Mohan Chandra Vinay Bharadwaj Gudiwada MD , Chenna Reddy Tera MD , Tirumala Nischal Jasty MD , Pradeep Kumar Devarakonda MD , Vikramaditya Reddy Samala Venkata MD , Mir B Basir DO , Michael S Megaly MD, MSc , Amir Lotfi MD , Andrew M Goldsweig MD, MS

Background

Supersaturated oxygen (SSO₂) therapy is an emerging intervention to minimize myocardial damage and improve outcomes in patients with ST-segment elevation myocardial infarction (STEMI). This meta-analysis evaluated the efficacy of SSO₂ therapy to reduce infarct size and microvascular obstruction (MVO).

Methods

PubMed, Embase, and Cochrane databases were systematically searched for studies comparing percutaneous coronary intervention (PCI) plus SSO2 to PCI alone for STEMI. Outcomes of interest included infarct size, MVO, and subsequent major adverse cardiovascular events (MACE), all-cause mortality, re-infarction, and target vessel revascularization (TVR). Mean differences (MD) with 95% confidence intervals (CIs) were calculated using random-effects models.

Results

Six studies (n = 1660) were included with 548 patients (33%) receiving SSO₂ therapy. Pooled analysis showed that PCI plus SSO₂ significantly reduced infarct size (MD −4.31; 95% CI −6.70 to −1.92; P < .01) and MVO (SMD −0.72; 95% CI −1.11 to −0.34; P < .01) compared with PCI alone. MACE, all-cause mortality, re-infarction, and TVR were comparable between the groups.

Conclusion

SSO₂ therapy significantly reduced infarct size and MVO in patients undergoing PCI for STEMI.
背景:过饱和氧(SSO₂)治疗是st段抬高型心肌梗死(STEMI)患者减少心肌损伤和改善预后的一种新兴干预措施。该荟萃分析评估了SSO 2治疗减少梗死面积和微血管阻塞(MVO)的疗效。方法:系统检索PubMed、Embase和Cochrane数据库,比较经皮冠状动脉介入治疗(PCI) + SSO2与单独PCI治疗STEMI的研究。研究结果包括梗死面积、MVO和随后的主要不良心血管事件(MACE)、全因死亡率、再梗死和靶血管重建术(TVR)。使用随机效应模型计算95%置信区间(ci)的平均差异(MD)。结果:纳入6项研究(n=1660), 548例(33%)患者接受SSO₂治疗。合并分析显示,PCI + SSO 2治疗可显著降低梗死面积(MD -4.31; 95% CI -6.70 ~ -1.92)。结论:SSO 2治疗可显著降低STEMI PCI患者的梗死面积和MVO。
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引用次数: 0
Towards an understanding of best practice: The good, the bad and the future of cardiogenic shock teams 对最佳实践的理解——心源性休克团队的好、坏和未来。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-22 DOI: 10.1016/j.ahj.2025.107310
Balimkiz Senman MD , Shashank S. Sinha MD, MSc , Alexander G. Truesdell MD , Israel Safiriyu MD , Stavros Drakos MD, PhD , Allison G. Dupont MD , Mir Babar Basir DO , P. Elliott Miller MD, MHS , Aniket S. Rali MD , Courtney Bennett DO , Behnam Tehrani MD , Jennifer Cowger MD, MS , Shelley A. Hall MD , Carolyn Rosner RN, BSN, MSN, NP-C, MBA , Amy E. Hackmann MD , David E. Wang MD , Alexander I. Papolos MD , Bernard S. Kadosh MD , Saraschandra Vallabhajosyula MD, MSc , Michelle Ferri MS, ACNP-BC , Jason N. Katz MD, MHS
Cardiogenic shock (CS) remains a high-mortality condition that demands rapid diagnosis, coordinated multidisciplinary management, and timely initiation of mechanical circulatory support. As more institutions implement dedicated CS teams, substantial heterogeneity has emerged in how these teams are structured, activated, and sustained. To better characterize this variability and begin defining the components of an optimal CS team, the Society of Critical Care Cardiology (SoCCC), in partnership with the Society for Cardiovascular Angiography and Interventions (SCAI), convened the Inaugural Cardiogenic Shock Teams Think Tank. Held on October 17, 2024, as a preconference program to SCAI SHOCK 2024 in Washington, DC, the meeting brought together national leaders in CS care, mechanical circulatory support, and resuscitation to identify shared challenges and propose practical solutions.
This manuscript summarizes key insights from this inaugural Think Tank, which represents the first in an ongoing series of collaborative efforts aimed at informing the standardization and optimization of CS teams nationwide. Specifically, we review the ideal composition and core competencies of a CS team; the rationale and emerging evidence supporting dedicated team-based CS care; activation algorithms and operational workflows; and common barriers to establishing and sustaining such teams. We also outline future directions and opportunities to strengthen collaborative infrastructure, refine clinical pathways, and enhance the reliability, responsiveness, and effectiveness of cardiogenic shock teams across diverse healthcare settings.
心源性休克(CS)仍然是一种高死亡率的疾病,需要快速诊断,协调多学科管理,及时启动机械循环支持。随着越来越多的机构实施专门的CS团队,这些团队的结构、激活和维持方式出现了实质性的异质性。为了更好地表征这种可变性并开始定义最佳CS团队的组成部分,重症监护心脏病学会(SoCCC)与心血管血管造影和干预学会(SCAI)合作,召集了首届心源性休克团队智囊团。会议于2024年10月17日在华盛顿特区举行,作为SCAI SHOCK 2024的会前计划,会议汇集了CS护理,机械循环支持和复苏方面的国家领导人,以确定共同的挑战并提出切实可行的解决方案。这份手稿总结了这个首届智库的关键见解,它代表了一系列正在进行的合作努力中的第一个,旨在为全国CS团队的标准化和优化提供信息。具体来说,我们回顾了CS团队的理想组成和核心能力;支持以团队为基础的专业CS护理的基本原理和新证据;激活算法和操作工作流;以及建立和维持这种团队的常见障碍。我们还概述了未来的方向和机会,以加强协作基础设施,完善临床途径,并提高可靠性,反应能力和有效性的心源性休克团队在不同的医疗保健设置。
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引用次数: 0
Incidence and risk factors for malignancy after heart transplantation- Analysis of the UNOS Registry 心脏移植术后恶性肿瘤的发生率和危险因素-美国器官移植中心注册的分析。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-21 DOI: 10.1016/j.ahj.2025.107308
Benjamin L. Magod MD , Zachary H. Hughes MD , Anusha Manjunath MD , Tingqing Wu , Rebecca Harrap , Benjamin Bryner MD , Sabra Lewsey MD, MPH , Kambiz Ghafourian MD, MPH , Olise Oputa , Duc Pham MD , Kiersten Rasberry , Anjan Tibrewala MD, MS , Jane Wilcox MD, MSc , Quentin R. Youmans MDMSc , Ike S. Okwuosa MD

Background

Malignancy threatens to limit survival in heart transplant recipients. Improved understanding of cancer risk is needed to direct prevention and screening strategies following heart transplantation. This study aims to describe the incidence, demographics, and risk factors associated with de novo malignancy, lymphoproliferative disorders, and solid-organ malignancy subtypes.

Methods

We analyzed the incidence, types, and predictors of malignancy in 50,370 heart transplant recipients from the United Network for Organ Sharing registry.

Results

The incidence of de novo post-transplant malignancy at 10 years was 20.6%. The incidence at 10 years by malignancy type was: nonmelanoma skin cancer (9.0%), solid-organ cancer (6.2%), and lymphoproliferative disorder (1.2%). Older age (OR, 1.05; 95%CI, 1.049-1.060), male gender (female vs male; OR, 0.63; 95%CI, 0.58-0.68), induction immunosuppression with OKT3 (OR, 1.47; 95%CI, 1.23-1.76) or >1 induction agent (OR, 1.44; 95%CI, 1.14-1.82), history of cigarette use (OR, 1.19; 95%CI, 1.11-1.28) and hospitalization for infection (OR, 1.26; 95% CI, 1.18-1.34) were associated with increased incidence of de novo malignancy.

Conclusions

De novo malignancy is common, occurring in one-fifth of recipients after heart transplant. Risk factors for de novo malignancy included older age, male gender, induction immunosuppression, and history of cigarette use. Hospitalization for infection is a risk factor that has not been previously described. Improved prevention and personalized screening strategies are needed to reduce the adverse outcome of post-transplant malignancy.
背景:恶性肿瘤威胁到心脏移植受者的生存。需要提高对癌症风险的了解,以指导心脏移植后的预防和筛查策略。本研究旨在描述与新生恶性肿瘤、淋巴增生性疾病和实体器官恶性肿瘤亚型相关的发病率、人口统计学和危险因素。方法:我们分析了来自器官共享联合网络登记的50,370名心脏移植受者的恶性肿瘤的发生率、类型和预测因素。结果:移植后10年新生恶性肿瘤发生率为20.6%。10年恶性肿瘤类型的发病率为:非黑色素瘤皮肤癌(9.0%)、实体器官癌(6.2%)和淋巴细胞增生性疾病(1.2%)。年龄较大(OR, 1.05; 95%CI, 1.049-1.060)、男性(女性vs男性;OR, 0.63; 95%CI, 0.58-0.68)、OKT3诱导免疫抑制(OR, 1.47; 95%CI, 1.23-1.76)或bbb1诱导剂(OR, 1.44; 95%CI, 1.14-1.82)、吸烟史(OR, 1.19; 95%CI, 1.11-1.28)和感染住院(OR, 1.26; 95%CI, 1.18-1.34)与新发恶性肿瘤发生率增加相关。结论:新发恶性肿瘤是常见的,发生在五分之一的心脏移植后受者。新发恶性肿瘤的危险因素包括年龄较大、男性、诱导免疫抑制和吸烟史。因感染住院是一个以前未被描述过的危险因素。需要改进预防和个性化筛查策略,以减少移植后恶性肿瘤的不良后果。
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引用次数: 0
Prospective, multicenter, randomized controlled study on the efficacy and safety of intravascular ultrasound-guided drug-coated balloon for de novo small-vessel coronary lesions: Design and rationale of the DCB-IVUS trial 超声血管内引导药物包被球囊治疗新生小血管冠状动脉病变的有效性和安全性的前瞻性、多中心、随机对照研究:DCB-IVUS试验的设计和基本原理
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-19 DOI: 10.1016/j.ahj.2025.107307
Jing Li MD , Zhen-Yu Wang MD , Ju Yan MD , Wen-Hao Li MD , Feng-Chao Wu MD , Ji-Zhao Deng MD , Li Yan MD , Hao-Yu Wu MD , Lei Liang MD

Background

The effectiveness and safety of drug-coated balloon (DCB) have been extensively studied in the treatment of de novo small-vessel coronary lesions. Proper lesion preparation is essential prior to performing DCB angioplasty; however, the optimal approach for intravascular ultrasound (IVUS)-guided lesion preparation remains unclear. The safety and efficacy of IVUS-guided DCB treatment for de novo small-vessel coronary lesions continue to be uncertain. To address these gaps, this trial has been designed to evaluate the efficacy and safety of IVUS-guided DCB angioplasty for de novo small-vessel coronary lesions. Additionally, the trial seeks to establish optimal critical values for IVUS-derived lumen parameters (such as minimum lumen area, plaque burden, and the length and thickness of dissection) prior to the use of DCB for de novo small-vessel coronary lesions.

Methods and Design

This trial is designed to test the hypothesis that IVUS-guided DCB results in a lower rate of major adverse cardiac events (MACE) for de novo small-vessel coronary lesions. It is a prospective, multicenter, randomized controlled study involving 998 patients indicated for PCI with de novo coronary lesions suitable for DCB treatment. Participants will be randomly allocated in a 1:1 ratio to either the research group (IVUS-guided group) or the control group (angiography-guided group). The primary endpoint is defined as the incidence of MACE (comprising cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at the 12-month follow-up. Secondary endpoints include clinical outcomes such as all-cause mortality, any myocardial infarction, or ischemia-driven target vessel revascularization at the 12-month follow-up. Additionally, periprocedural outcomes, including the angiographic success rate, clinical procedural success rate, and target vessel drug-eluting stent implantation rate, will also be assessed.

Conclusions

This clinical trial aims to provide evidence on whether IVUS-guided DCB reduces the incidence of MACE in de novo small-vessel coronary lesions.

Trial Registration

ChiCTR2300073877, URL: https://www.chictr.org.cn/indexEN.html.
背景:药物包被球囊(DCB)治疗新发小血管冠状动脉病变的有效性和安全性已被广泛研究。在行DCB血管成形术之前,适当的病变准备是必不可少的;然而,血管内超声(IVUS)引导下病变准备的最佳方法仍不清楚。ivus引导的DCB治疗新发小血管冠状动脉病变的安全性和有效性仍然不确定。为了解决这些空白,本试验旨在评估ivus引导的DCB血管成形术治疗新生小血管冠状动脉病变的有效性和安全性。此外,该试验寻求在使用DCB治疗新发小血管冠状动脉病变之前,为ivus衍生的管腔参数(如最小管腔面积、斑块负荷、夹层长度和厚度)建立最佳临界值。方法和设计:本试验旨在验证ivus引导的DCB导致新生小血管冠状动脉病变的主要不良心脏事件(MACE)发生率较低的假设。这是一项前瞻性、多中心、随机对照研究,涉及998例适合DCB治疗的新发冠状动脉病变患者。参与者将按1:1的比例随机分配到研究组(ivus引导组)或对照组(血管造影引导组)。主要终点定义为12个月随访时MACE(包括心源性死亡、靶血管相关性心肌梗死或缺血驱动靶病变血运重建)的发生率。次要终点包括临床结果,如12个月随访期间的全因死亡率、任何心肌梗死或缺血驱动的靶血管重建术。此外,还将评估围手术期结果,包括血管造影成功率、临床手术成功率和靶血管药物洗脱支架植入率。结论:本临床试验旨在为ivus引导下的DCB是否能降低新生小血管冠状动脉病变的MACE发生率提供证据。试用注册:ChiCTR2300073877, URL: https://www.chictr.org.cn/indexEN.html。
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引用次数: 0
Early oral anticoagulation monotherapy after PCI: Insights from the POEM trial PCI术后早期口服抗凝单药治疗:来自POEM试验的见解。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-19 DOI: 10.1016/j.ahj.2025.107309
Carlo A. Pivato MD, PhD , Gianluca Mincione MD , Leon Gramss MD , Andrea Pacchioni MD , Raffaele Piccolo MD, PhD , Carmine Musto MD, PhD , Gennaro Sardella MD , Ciro Indolfi MD , Giulia Antonelli MD , Damiano Regazzoli MD , Valeria Paradies MD, PhD , Bernhard Reimers MD , Gianluigi Condorelli MD, PhD , Luca Testa MD, PhD , Carlo Briguori MD, PhD , Giulio Stefanini MD, MSc, PhD

Background

In high-bleeding-risk (HBR) patients undergoing percutaneous coronary intervention (PCI), shortening dual antiplatelet therapy (DAPT) is essential, but the optimal approach in those requiring oral anticoagulation (OAC) is uncertain. We evaluated a 1-month dual antithrombotic regimen in HBR patients with and without OAC indication in a prespecified sub-analysis of the POEM trial.

Method

POEM enrolled HBR patients treated with a bioresorbable polymer everolimus-eluting stent. Patients were stratified by OAC indication: the non-OAC group (n = 281) received 1-month DAPT followed by single antiplatelet therapy; the OAC group (n = 158) received 1-month OAC plus a P2Y12 inhibitor followed by OAC monotherapy. Time-to-event outcomes were analyzed using the log-rank test, and hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using Cox regression models. The primary analysis was conducted according to the intention-to-treat principle. A per-protocol analysis, excluding patients with DAPT duration >1 month, was performed as a sensitivity analysis.

Results

At 1 year, the primary endpoint, a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis, occurred in 6.1% of the non-OAC group versus 2.6% of the OAC group (HR 0.41, 95% CI 0.14–1.22; P = .097). Secondary ischemic outcomes were similar. BARC type 3–5 bleeding was infrequent (2.6% vs 1.3%; P = .369). The per-protocol analysis showed consistent results.

Conclusions

In HBR patients after PCI, transition to OAC monotherapy at 1 month was associated with low ischemic and bleeding risks, comparable to single antiplatelet therapy. These findings support early OAC monotherapy as a feasible strategy warranting randomized investigation.

Trial Registration

EudraCT Number: 2016‐004510‐99; clinicaltrials.gov: NCT03112707.
背景:在接受经皮冠状动脉介入治疗(PCI)的高风险(HBR)患者中,缩短双重抗血小板治疗(DAPT)是必不可少的,但对于需要口服抗凝(OAC)的患者,最佳方法尚不确定。我们在预先指定的POEM试验亚分析中评估了有和没有OAC适应症的HBR患者1个月的双重抗血栓治疗方案。方法:POEM纳入了接受生物可吸收聚合物依维莫司洗脱支架治疗的HBR患者。根据OAC适应症对患者进行分层:非OAC组(n=281)接受1个月DAPT治疗,随后接受单次抗血小板治疗;OAC组(n=158)接受1个月的OAC + P2Y12抑制剂治疗,然后接受OAC单药治疗。使用log-rank检验分析事件发生时间结局,使用Cox回归模型计算95%置信区间的风险比(hr)。根据意向治疗原则进行初步分析。每个方案分析,排除DAPT持续时间为bb10 - 1个月的患者,进行敏感性分析。结果:1年后,主要终点为心源性死亡、心肌梗死或明确/可能的支架血栓形成,非OAC组为6.1%,OAC组为2.6% (HR 0.41, 95% CI 0.14-1.22; p=0.097)。继发性缺血结果相似。BARC 3-5型出血不常见(2.6% vs. 1.3%; p=0.369)。每个方案分析显示一致的结果。结论:在接受PCI治疗的HBR患者中,在1个月时过渡到OAC单药治疗与低缺血和出血风险相关,与单一抗血小板治疗相当。这些发现支持早期OAC单药治疗是可行的策略,需要随机调查。试验注册:稿号:2016-004510-99;clinicaltrials.gov: NCT03112707。
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引用次数: 0
Occlusion vs subocclusion of the left main. The ECG pattern has the word 左主干闭塞与亚闭塞。心电模式有词。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-17 DOI: 10.1016/j.ahj.2025.107303
Miquel Fiol MD, PhD , Alberto Rodríguez MD , Andrés Carrillo MD, PhD
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引用次数: 0
Re. response to “Occlusion vs subocclusion of the left main, the ECG pattern has the word” 对“左主干闭塞与亚闭塞,心电图模式有意义”的回应。
IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-11-15 DOI: 10.1016/j.ahj.2025.107304
Scott W. Sharkey MD , Frank Aguirre MD , Balaj Rai MD , Timothy D Henry MD
{"title":"Re. response to “Occlusion vs subocclusion of the left main, the ECG pattern has the word”","authors":"Scott W. Sharkey MD ,&nbsp;Frank Aguirre MD ,&nbsp;Balaj Rai MD ,&nbsp;Timothy D Henry MD","doi":"10.1016/j.ahj.2025.107304","DOIUrl":"10.1016/j.ahj.2025.107304","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"293 ","pages":"Article 107304"},"PeriodicalIF":3.5,"publicationDate":"2025-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145534112","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
期刊
American heart journal
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