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ISHLT Consensus Statement on Short Telomere Syndrome and Lung Transplantation: Authors’ Perspective 短端粒综合征和肺移植:作者的观点
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-16 DOI: 10.1016/j.healun.2025.10.027
Andrew M. Courtwright , John A. Mackintosh , Jonathan K. Alder , Christine Kim Garcia , Antoine Froidure , Erin Lowery , Don Hayes Jr. , Pali Shah , Quentin Philippot , Raphael Borie , John R. Greenland , Hannah Mannem , Mark E. Snyder , Merel Hellemons , Laurie D. Snyder , John McDyer
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引用次数: 0
Information for Readers 读者资讯
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-16 DOI: 10.1016/S1053-2498(25)02502-1
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引用次数: 0
Considerations for Endpoints in Lung Transplant Clinical Trials: Perspective on the ISHLT Consensus Statement 肺移植临床试验终点的考虑:从ISHLT共识声明的角度看
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-16 DOI: 10.1016/j.healun.2025.09.016
John R. Greenland MD, PhD , Michael Perch MD , Kieran Halloran MD, MSc , Deborah J. Levine MD , Eric D. Morrell MD, MA , Anna Reed MBChB , Ciara M. Shaver MD, PhD , Jonathan P. Singer MD, MS , Stuart C. Sweet MD, PhD , Robin Vos MD, PhD , Shambhu Aryal MD, FCCP , Nicholas Avdimiretz MD, FRCPC , Fay Burrows Bpharm , Daniel Calabrese MD , Fiorella Calabrese MD , Silvia Campos PhD , Michael Combs MD, MS , Marc de Perrot MD, MSc, FRCSC , Göran Dellgren MD, PhD , Joshua M. Diamond MD, MS , Jamie L. Todd MD, MHS
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引用次数: 0
Letter to Carnicelli et al. outcomes with Impella CP in acute myocardial infarction vs heart failure cardiogenic shock 致Carnicelli等人的信。Impella CP治疗急性心肌梗死与心力衰竭心源性休克的结果
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-16 DOI: 10.1016/j.healun.2025.09.007
Jacob E. Møller , Norman Mangner , Vasileios Panoulas , Christian Hassager
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引用次数: 0
ISHLT Consensus Statement on Short Telomere Syndrome and Lung Transplantation 短端粒综合征与肺移植的ISHLT共识声明。
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-08 DOI: 10.1016/j.healun.2025.10.028
Andrew M. Courtwright MD, PhD , John A. Mackintosh , Jonathan K. Alder , Christine Kim Garcia , Antoine Froidure , Erin Lowery , Don Hayes Jr. , Shah Pali , Quentin Philippot , Raphael Borie , John R. Greenland , Hannah Mannem , Mark E. Snyder , Merel Hellemons , Laurie D. Snyder , John McDyer
Motivated by growing evidence that the presence of critically shortened telomeres influences interstitial lung disease (ILD) trajectories and is associated with extrapulmonary conditions relevant to lung transplant candidacy and post-transplant complications, this Consensus Statement aims to address gaps in the evaluation and management of patients with short telomere syndrome (STS). These considerations reflect the work of an international Writing Committee with expertise in STS and are grounded in current literature and expert consensus. The need for this document arises from the recognition that STS is an underdiagnosed contributor to ILD, and that its presence introduces complexities that require dedicated, multidisciplinary attention in the transplant setting.
越来越多的证据表明,严重缩短的端粒会影响间质性肺病(ILD)的发展轨迹,并与肺移植候选资格和移植后并发症相关的肺外条件有关,因此,本共识声明旨在解决短端粒综合征(STS)患者评估和管理方面的空白。这些考虑反映了具有STS专业知识的国际写作委员会的工作,并以当前文献和专家共识为基础。由于认识到STS是ILD的一个未被诊断的因素,并且它的存在引入了复杂性,需要在移植环境中进行专门的多学科关注,因此需要编写此文件。
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引用次数: 0
VENOPULMONARY EXTRACORPOREAL LIFE SUPPORT: AN ELSO REGISTRY ANALYSIS. 静脉体外生命支持:另一个注册表分析。
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-06 DOI: 10.1016/j.healun.2025.12.024
Luca Baldetti, Domenico Pontillo, Massimo Capoccia, Mariusz Kowalewski, Joseph E Tonna, Mikael Broman, Steven A Conrad, Justyna Swol, Anna Mara Scandroglio, J Michael Brewer, Marc O Maybauer, Roberto Lorusso

Background: There is a paucity of data informing on the current use, adverse events, outcomes, and prognostic drivers for patients receiving venopulmonary extracorporeal life support (VP ECLS). We aimed to provide a contemporary, large sample size study to describe the real-world outcomes of adults supported with VP ECLS across different clinical conditions.

Methods: We queried the Extracorporeal Life Support Organization (ELSO) Registry to retrieve all adult patients who received VP ECLS as the first support modality from July 2020 to July 2024. Study population was grouped according to hospital death outcome and to the diagnosis leading to VP ECLS use. Adverse outcomes are reported according to primary diagnosis leading to VP ECLS use. A time-to-event Cox regression model was applied to identify predictors of death.

Results: A total of 838 patients [32.3% females; age 8 (46, 67) years] were included. Patients were treated for heart failure/cardiogenic shock (HF/CS) in 54.4%, for acute respiratory failure/acute respiratory distress syndrome (ARF/ARDS) in 26.6%, for post-cardiotomy shock in 6.7%, for acute coronary syndrome/ischemic heart disease in 5.3%, for valvular heart disease/complications of intracardiac devices in 4.2%, and for pulmonary embolism in 2.9%. Most common adverse events included continuous renal replacement therapy (CRRT) use or acute kidney injury (37.4%), infections (35.4%), cardiac arrhythmias (13.5%), surgical site bleeding (12.1%), gastrointestinal (GI) bleeding (6.1%). Complications were more common in non-survivors and patterns of complications differed among diagnosis groups. The Kaplan-Meier estimated 60-day mortality was 49.3 (45.3, 53.1)%. Age (HRadj 1.15 for 5 years increase; 95%CI 1.11, 1.20; p<0.001), female sex (HRadj 1.40; 95%CI 1.12, 1.76; p=0.003), BMI (HRadj 1.02 for 3 kg/m2 increase; 95%CI 1.01, 1.04; p<0.018), CRRT use prior VP ECLS cannulation (HRadj 1.44; 95%CI 1.11, 1.86; p<0.006) were independent predictors of death.

Conclusions: In this large ELSO registry analysis, VP ECLS was chiefly used for HF/CS and ARF/ARDS. Hospital outcomes, complications and survival differed according to the diagnosis leading to VP ECLS use. Younger age, male sex, lower BMI, and no CRRT use prior to VP ECLS cannulation confer a lower risk of death and provide targets for future research and potential domains for clinical improvement.

背景:目前关于接受静脉肺体外生命支持(VP ECLS)患者的使用、不良事件、结局和预后驱动因素的数据缺乏。我们的目的是提供一项当代的、大样本量的研究,以描述在不同临床条件下支持VP ECLS的成人的现实结果。方法:我们查询了体外生命支持组织(ELSO)注册表,检索了2020年7月至2024年7月期间接受VP ECLS作为第一支持方式的所有成年患者。研究人群根据医院死亡结局和导致VP ECLS使用的诊断进行分组。不良后果报告根据初步诊断导致VP ECLS的使用。采用时间-事件Cox回归模型确定死亡预测因子。结果:共838例患者,其中女性32.3%;年龄为8岁(46,67岁)。因心力衰竭/心源性休克(HF/CS)治疗的患者占54.4%,因急性呼吸衰竭/急性呼吸窘迫综合征(ARF/ARDS)治疗的患者占26.6%,因开心术后休克治疗的患者占6.7%,因急性冠状动脉综合征/缺血性心脏病治疗的患者占5.3%,因瓣膜病/心脏内装置并发症治疗的患者占4.2%,因肺栓塞治疗的患者占2.9%。最常见的不良事件包括持续肾替代治疗(CRRT)或急性肾损伤(37.4%)、感染(35.4%)、心律失常(13.5%)、手术部位出血(12.1%)、胃肠道出血(6.1%)。并发症在非幸存者中更为常见,并发症的模式在不同的诊断组中有所不同。Kaplan-Meier估计60天死亡率为49.3%(45.3%,53.1%)。年龄(HRadj 1.15,增加5年;95%CI 1.11, 1.20; padj 1.40; 95%CI 1.12, 1.76; p=0.003), BMI (HRadj 1.02,增加3 kg/m2; 95%CI 1.01, 1.04; padj 1.44; 95%CI 1.11, 1.86; p=0.003)结论:在这项大型ELSO注册分析中,VP ECLS主要用于HF/CS和ARF/ARDS。根据诊断导致使用VP ECLS的住院结果、并发症和生存率不同。较年轻的年龄、男性、较低的BMI和在VP ECLS插管前未使用CRRT赋予较低的死亡风险,并为未来的研究和临床改善的潜在领域提供了目标。
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引用次数: 0
Randomized Evaluation of Heart Graft Preservation: Comparative Effects of Optimized Static Cold Storage, Hypothermic and Normothermic Machine Perfusion, and Colchicine Pretreatment on Ischemia-Reperfusion Injury in a porcine model. 心脏移植保存的随机评价:优化静态冷藏、低温和恒温机器灌注和秋水仙碱预处理对猪模型缺血-再灌注损伤的比较效果。
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-30 DOI: 10.1016/j.healun.2025.12.023
Aurore Ughetto, Clément Delmas, Lison Benezech, Pascal Battistella, Philippe Gaudard, Adrien Molina, Guillaume Andre, Soumaya Maamar, Julien Guihaire, Rachel Audo, Carmen Martinez, Celine Guilbeau-Frugier, Demaria Roland, Fanchon Herman, Alain Lacampagne, François Roubille

Background: Heart transplantation remains limited by ischemia-reperfusion injury (IRI). Optimizing graft preservation and modulating inflammation may improve early graft quality. We compared optimized static cold storage (SCS), hypothermic machine perfusion (HMP), and normothermic machine perfusion (NMP), and evaluated colchicine pretreatment as an adjunct anti-inflammatory strategy.

Methods: Thirty-six pigs were randomized to colchicine or placebo (n=18 each) and subsequently assigned to SCS, HMP, or NMP (n=12 per group). After 4 hours of preservation, all hearts underwent 1 hour of normothermic reperfusion. Myocardial injury, lactate extraction, systemic cytokines, and histological assessments were performed. Mixed-effects models accounting for repeated measures and treatment-preservation interactions were used for all longitudinal analyses.

Results: HMP was associated with lower H-FABP levels than SCS (β -92.6; 95% CI -183 to -2.6; p=0.04), while NMP showed no difference. Troponin I release was significantly higher in NMP versus SCS (β 97.9; 95% CI 63.4-132; p<0.001). Lactate extraction was greater with HMP compared with SCS (β 10.2; 95% CI -0.2 to 20.6; p=0.05), with no difference for NMP. Preservation modality strongly influenced inflammation: IL-6 (β 3.72; p<0.001) and TNF-α (β 0.25; p=0.003) were markedly increased in NMP, whereas IL-10 was reduced in HMP versus SCS (β -0.38; p<0.001). Colchicine had no significant effect on any biomarker. Oxidative stress proteins, apoptosis markers, and histological injury scores did not differ across preservation modalities or treatment groups.

Conclusions: In this randomized large-animal model, hypothermic preservation (SCS, HMP) provides superior metabolic and inflammatory profiles compared with NMP. Colchicine did not confer additional benefit under these conditions.

背景:心脏移植仍然受到缺血再灌注损伤(IRI)的限制。优化移植物保存和调节炎症可改善早期移植物质量。我们比较了优化的静态冷藏(SCS)、低温机器灌注(HMP)和恒温机器灌注(NMP),并评估了秋水仙碱预处理作为辅助抗炎策略。方法:36头猪随机分为秋水仙碱组和安慰剂组(每组18只),随后分为SCS组、HMP组和NMP组(每组12只)。保存4小时后,所有心脏进行1小时常温再灌注。进行心肌损伤、乳酸提取、全身细胞因子和组织学评估。所有的纵向分析都使用了考虑重复测量和处理-保存相互作用的混合效应模型。结果:HMP组H-FABP水平低于SCS组(β -92.6; 95% CI -183 ~ -2.6; p=0.04),而NMP组无差异。结论:在这个随机的大型动物模型中,低温保存(SCS, HMP)与NMP相比提供了更好的代谢和炎症特征。秋水仙碱在这些条件下没有额外的益处。
{"title":"Randomized Evaluation of Heart Graft Preservation: Comparative Effects of Optimized Static Cold Storage, Hypothermic and Normothermic Machine Perfusion, and Colchicine Pretreatment on Ischemia-Reperfusion Injury in a porcine model.","authors":"Aurore Ughetto, Clément Delmas, Lison Benezech, Pascal Battistella, Philippe Gaudard, Adrien Molina, Guillaume Andre, Soumaya Maamar, Julien Guihaire, Rachel Audo, Carmen Martinez, Celine Guilbeau-Frugier, Demaria Roland, Fanchon Herman, Alain Lacampagne, François Roubille","doi":"10.1016/j.healun.2025.12.023","DOIUrl":"https://doi.org/10.1016/j.healun.2025.12.023","url":null,"abstract":"<p><strong>Background: </strong>Heart transplantation remains limited by ischemia-reperfusion injury (IRI). Optimizing graft preservation and modulating inflammation may improve early graft quality. We compared optimized static cold storage (SCS), hypothermic machine perfusion (HMP), and normothermic machine perfusion (NMP), and evaluated colchicine pretreatment as an adjunct anti-inflammatory strategy.</p><p><strong>Methods: </strong>Thirty-six pigs were randomized to colchicine or placebo (n=18 each) and subsequently assigned to SCS, HMP, or NMP (n=12 per group). After 4 hours of preservation, all hearts underwent 1 hour of normothermic reperfusion. Myocardial injury, lactate extraction, systemic cytokines, and histological assessments were performed. Mixed-effects models accounting for repeated measures and treatment-preservation interactions were used for all longitudinal analyses.</p><p><strong>Results: </strong>HMP was associated with lower H-FABP levels than SCS (β -92.6; 95% CI -183 to -2.6; p=0.04), while NMP showed no difference. Troponin I release was significantly higher in NMP versus SCS (β 97.9; 95% CI 63.4-132; p<0.001). Lactate extraction was greater with HMP compared with SCS (β 10.2; 95% CI -0.2 to 20.6; p=0.05), with no difference for NMP. Preservation modality strongly influenced inflammation: IL-6 (β 3.72; p<0.001) and TNF-α (β 0.25; p=0.003) were markedly increased in NMP, whereas IL-10 was reduced in HMP versus SCS (β -0.38; p<0.001). Colchicine had no significant effect on any biomarker. Oxidative stress proteins, apoptosis markers, and histological injury scores did not differ across preservation modalities or treatment groups.</p><p><strong>Conclusions: </strong>In this randomized large-animal model, hypothermic preservation (SCS, HMP) provides superior metabolic and inflammatory profiles compared with NMP. Colchicine did not confer additional benefit under these conditions.</p>","PeriodicalId":15900,"journal":{"name":"Journal of Heart and Lung Transplantation","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145889190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Radiologist- and computer-based chest imaging quantification at 12 months post transplant correlates with baseline lung allograft dysfunction. 移植后12个月的放射科医生和基于计算机的胸部成像量化与基线同种异体肺移植功能障碍相关。
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-30 DOI: 10.1016/j.healun.2025.12.018
Mikail Malik, Gauri Rani Karur, Apoorva Muralidhar, Nour Hanafi, Anastasiia Vasileva, Joyce K Y Wu, Ella Huszti, Tereza Martinu, Chung-Wai Chow, Micheal C McInnis

Background: Baseline lung allograft dysfunction (BLAD), defined as failure to achieve ≥ 80% predicted spirometry after lung transplant, is associated with reduced survival. This study aimed to determine the prevalence and character of computed tomography (CT) abnormalities in BLAD.

Methods: In this retrospective cohort study, we analyzed adult first-time double-lung transplant recipients (12/2017-10/2021) who had 12-month CT chest and concurrent BLAD/non-BLAD status assigned. Three radiologists used a semi-quantitative ordinal score to evaluate ground glass opacities (GGO), reticulation, consolidation, pleural effusion, bronchiectasis and air-trapping. Machine learning-trained lung texture analysis provided CT radiomic data: CT-measured total lung capacity (CTTLC), pulmonary vessel volume (PVV), GGO, reticulation, and hyperlucency. Parametric response mapping measured functional small airways disease. ROC analysis and logistic regression identified radiologic features of BLAD.

Results: BLAD patients (n=59, 46%) had longer intubation duration, longer index hospitalization post-transplant, and lower donor-to-recipient total lung capacity (TLC) ratio than non-BLAD patients (n=69, 54%). Radiologist-assessed scoring identified more pleural effusions in BLAD with no significant differences in GGO or air trapping. Computer-aided CT demonstrated more reticulation, GGO, and parenchymal density in BLAD, with no difference in functional small airways disease. CTTLC indexed for height was lower in BLAD while PVV was higher. PVV was significantly associated with BLAD in univariable analysis (OR 2.30, 95% CI 1.38-3.83, p<0.001), and remained strong after adjusting for age, sex, and native disease (OR=2.65,95% CI 1.45-4.84, p=0.002).

Conclusions: Computer-aided CT elicited structural changes in BLAD not captured by limited-slice radiologist review. CTTLC and PVV were the strongest radiologic predictors of BLAD, likely reflecting restrictive physiology and vascular remodelling.

背景:基线肺同种异体移植功能障碍(BLAD),定义为肺移植后肺活量未能达到≥80%预测值,与生存率降低相关。本研究旨在确定BLAD中计算机断层扫描(CT)异常的患病率和特征。方法:在这项回顾性队列研究中,我们分析了成人首次双肺移植受者(2017年12月至2021年10月),他们接受了12个月的胸部CT检查,并同时确定了BLAD/非BLAD状态。三位放射科医生使用半定量序数评分来评估磨玻璃混浊(GGO)、网状、实变、胸腔积液、支气管扩张和空气潴留。机器学习训练的肺结构分析提供了CT放射学数据:CT测量的总肺活量(CTTLC)、肺血管容积(PVV)、GGO、网状结构和高通透性。参数化反应映射测量功能性小气道疾病。ROC分析和logistic回归确定了BLAD的放射学特征。结果:与非BLAD患者相比,BLAD患者(n=59, 46%)插管时间更长,移植后指数住院时间更长,供受体总肺容量(TLC)比更低(n=69, 54%)。放射科医师评估的评分显示,BLAD患者胸膜积液较多,而GGO或空气潴留无显著差异。计算机辅助CT显示BLAD有更多的网状、GGO和实质密度,在功能性小气道疾病中无差异。BLAD患者CTTLC的高度指数较低,而PVV的高度指数较高。在单变量分析中,PVV与BLAD显著相关(OR 2.30, 95% CI 1.38-3.83)。结论:计算机辅助CT引起的BLAD的结构改变未被有限层放射科医师复查捕获。CTTLC和PVV是BLAD最强的放射学预测因子,可能反映了限制性生理和血管重构。
{"title":"Radiologist- and computer-based chest imaging quantification at 12 months post transplant correlates with baseline lung allograft dysfunction.","authors":"Mikail Malik, Gauri Rani Karur, Apoorva Muralidhar, Nour Hanafi, Anastasiia Vasileva, Joyce K Y Wu, Ella Huszti, Tereza Martinu, Chung-Wai Chow, Micheal C McInnis","doi":"10.1016/j.healun.2025.12.018","DOIUrl":"https://doi.org/10.1016/j.healun.2025.12.018","url":null,"abstract":"<p><strong>Background: </strong>Baseline lung allograft dysfunction (BLAD), defined as failure to achieve ≥ 80% predicted spirometry after lung transplant, is associated with reduced survival. This study aimed to determine the prevalence and character of computed tomography (CT) abnormalities in BLAD.</p><p><strong>Methods: </strong>In this retrospective cohort study, we analyzed adult first-time double-lung transplant recipients (12/2017-10/2021) who had 12-month CT chest and concurrent BLAD/non-BLAD status assigned. Three radiologists used a semi-quantitative ordinal score to evaluate ground glass opacities (GGO), reticulation, consolidation, pleural effusion, bronchiectasis and air-trapping. Machine learning-trained lung texture analysis provided CT radiomic data: CT-measured total lung capacity (CT<sub>TLC</sub>), pulmonary vessel volume (PVV), GGO, reticulation, and hyperlucency. Parametric response mapping measured functional small airways disease. ROC analysis and logistic regression identified radiologic features of BLAD.</p><p><strong>Results: </strong>BLAD patients (n=59, 46%) had longer intubation duration, longer index hospitalization post-transplant, and lower donor-to-recipient total lung capacity (TLC) ratio than non-BLAD patients (n=69, 54%). Radiologist-assessed scoring identified more pleural effusions in BLAD with no significant differences in GGO or air trapping. Computer-aided CT demonstrated more reticulation, GGO, and parenchymal density in BLAD, with no difference in functional small airways disease. CT<sub>TLC</sub> indexed for height was lower in BLAD while PVV was higher. PVV was significantly associated with BLAD in univariable analysis (OR 2.30, 95% CI 1.38-3.83, p<0.001), and remained strong after adjusting for age, sex, and native disease (OR=2.65,95% CI 1.45-4.84, p=0.002).</p><p><strong>Conclusions: </strong>Computer-aided CT elicited structural changes in BLAD not captured by limited-slice radiologist review. CT<sub>TLC</sub> and PVV were the strongest radiologic predictors of BLAD, likely reflecting restrictive physiology and vascular remodelling.</p>","PeriodicalId":15900,"journal":{"name":"Journal of Heart and Lung Transplantation","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145889232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Letter to the editor: Impact of right ventricular reserve during exercise on aortic valve opening in patients with a left ventricular assist device. 致编辑:运动时右心室储备对左心室辅助装置患者主动脉瓣开度的影响。
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-22 DOI: 10.1016/j.healun.2025.11.033
Veraprapas Kittipibul, Jason N Katz
{"title":"Letter to the editor: Impact of right ventricular reserve during exercise on aortic valve opening in patients with a left ventricular assist device.","authors":"Veraprapas Kittipibul, Jason N Katz","doi":"10.1016/j.healun.2025.11.033","DOIUrl":"https://doi.org/10.1016/j.healun.2025.11.033","url":null,"abstract":"","PeriodicalId":15900,"journal":{"name":"Journal of Heart and Lung Transplantation","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145933584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Considerations for Endpoints in Lung Transplant Clinical Trials: An ISHLT Consensus Statement 肺移植临床试验终点的考虑:一项ISHLT共识声明。
IF 6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-16 DOI: 10.1016/j.healun.2025.09.017
John R. Greenland MD, PhD , Michael Perch MD , Kieran Halloran MD, MSc , Deborah J. Levine MD , Eric D. Morrell MD, MA , Anna Reed MBChB , Ciara M. Shaver MD, PhD , Jonathan P. Singer MD, MS , Stuart C. Sweet MD, PhD , Robin Vos MD, PhD , Shambhu Aryal MD, FCCP , Nicholas Avdimiretz MD, FRCPC , Fay Burrows BPharm , Daniel Calabrese MD , Fiorella Calabrese MD , Silvia Campos PhD , Michael Combs MD, MS , Marc de Perrot MD, MSc, FRCSC , Göran Dellgren MD, PhD , Joshua M. Diamond MD, MS , Jamie L. Todd MD, MHS
Clinical trials in lung transplantation have been hindered by a lack of clarity on the formulation and significance of endpoints for evaluating therapeutic efficacy. To address this challenge, a multidisciplinary working group from the International Society for Heart and Lung Transplantation developed consensus recommendations on endpoints beyond mortality. These endpoints include primary graft dysfunction (PGD), chronic lung allograft dysfunction (CLAD), acute cellular rejection (ACR), antibody-mediated rejection (AMR), immunosuppression-related complications, patient-reported outcomes (PROs), and pediatric-specific considerations. For each endpoint, a subgroup reviewed measurement best practices, assessed links to clinical benefit, and evaluated the evidence supporting their utility in clinical trial settings. Consensus was established through a Delphi process involving three rounds of voting. This document provides practical guidance for operationalizing these endpoints and outlines their optimal use in clinical trials. By standardizing trial design, these recommendations aim to accelerate the development of urgently needed therapies to improve lung transplantation outcomes.
肺移植的临床试验一直受阻于缺乏明确的配方和终点的重要性,以评估治疗效果。为了应对这一挑战,国际心肺移植学会的一个多学科工作组就死亡率以外的终点提出了共识建议。这些终点包括原发性移植物功能障碍(PGD)、慢性同种异体肺移植物功能障碍(CLAD)、急性细胞排斥反应(ACR)、抗体介导的排斥反应(AMR)、免疫抑制相关并发症、患者报告的结局(PROs)和儿科特异性考虑。对于每个终点,一个亚组回顾了测量最佳实践,评估了与临床获益的联系,并评估了支持其在临床试验环境中的效用的证据。通过涉及三轮投票的德尔菲程序建立了协商一致意见。本文档为这些终点的操作提供了实用指导,并概述了它们在临床试验中的最佳使用。通过标准化试验设计,这些建议旨在加速开发急需的治疗方法,以改善肺移植的结果。
{"title":"Considerations for Endpoints in Lung Transplant Clinical Trials: An ISHLT Consensus Statement","authors":"John R. Greenland MD, PhD ,&nbsp;Michael Perch MD ,&nbsp;Kieran Halloran MD, MSc ,&nbsp;Deborah J. Levine MD ,&nbsp;Eric D. Morrell MD, MA ,&nbsp;Anna Reed MBChB ,&nbsp;Ciara M. Shaver MD, PhD ,&nbsp;Jonathan P. Singer MD, MS ,&nbsp;Stuart C. Sweet MD, PhD ,&nbsp;Robin Vos MD, PhD ,&nbsp;Shambhu Aryal MD, FCCP ,&nbsp;Nicholas Avdimiretz MD, FRCPC ,&nbsp;Fay Burrows BPharm ,&nbsp;Daniel Calabrese MD ,&nbsp;Fiorella Calabrese MD ,&nbsp;Silvia Campos PhD ,&nbsp;Michael Combs MD, MS ,&nbsp;Marc de Perrot MD, MSc, FRCSC ,&nbsp;Göran Dellgren MD, PhD ,&nbsp;Joshua M. Diamond MD, MS ,&nbsp;Jamie L. Todd MD, MHS","doi":"10.1016/j.healun.2025.09.017","DOIUrl":"10.1016/j.healun.2025.09.017","url":null,"abstract":"<div><div>Clinical trials in lung transplantation have been hindered by a lack of clarity on the formulation and significance of endpoints for evaluating therapeutic efficacy. To address this challenge, a multidisciplinary working group from the International Society for Heart and Lung Transplantation developed consensus recommendations on endpoints beyond mortality. These endpoints include primary graft dysfunction (PGD), chronic lung allograft dysfunction (CLAD), acute cellular rejection (ACR), antibody-mediated rejection (AMR), immunosuppression-related complications, patient-reported outcomes (PROs), and pediatric-specific considerations. For each endpoint, a subgroup reviewed measurement best practices, assessed links to clinical benefit, and evaluated the evidence supporting their utility in clinical trial settings. Consensus was established through a Delphi process involving three rounds of voting. This document provides practical guidance for operationalizing these endpoints and outlines their optimal use in clinical trials. By standardizing trial design, these recommendations aim to accelerate the development of urgently needed therapies to improve lung transplantation outcomes.</div></div>","PeriodicalId":15900,"journal":{"name":"Journal of Heart and Lung Transplantation","volume":"45 2","pages":"Pages e104-e128"},"PeriodicalIF":6.0,"publicationDate":"2025-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145762271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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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Journal of Heart and Lung Transplantation
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