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Experience with Berlin heart support in children with a focus on device removal 柏林心脏支持儿童的经验,重点是设备移除
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.09.025
Valerii Iaprintsev MD , Igor E. Konstantinov MD, PhD, FRACS , Edward Buratto MD, PhD, FRACS , Tyson A. Fricke MBBS, PhD, FRACS , Lucas Eastaugh MBBS, FRACP , Christian P. Brizard MD, MS , Stephanie Perrier MD , Jacob Mathew MBBS, FRACP

Objective

The Berlin Heart EXCOR is the only durable ventricular assist device available for infants and small children. A subset of patients supported by the Berlin Heart EXCOR device experience cardiac recovery. This study aimed to evaluate the outcomes of Berlin Heart EXCOR support at our center and identify the factors associated with successful device explantation.

Methods

This retrospective observational study included all consecutive patients who underwent Berlin Heart EXCOR implantation at the Royal Children's Hospital from 2009 to 2024.

Results

A total of 72 patients received Berlin Heart EXCOR support during the study period. The median age at implantation was 1.0 year (interquartile range, 0.44-2.92), median body surface area was 0.43 m2 (interquartile range, 0.30-0.56), and median support duration was 127 days (interquartile range, 59-219). Heart transplantation was performed in 47 patients (65.3%), and 10 patients (13.9%) achieved device explantation without transplantation—4 with dilated cardiomyopathy and 6 with myocarditis. Fourteen patients (19.4%) died on support, and 1 patient remained supported at analysis. There were no significant differences in age, body surface area at implantation, or duration of support between those who recovered and those who died or underwent transplantation. Of 30 patients aged less than 2 years with body surface area between 0.35 and 0.55 m2, 9 achieved recovery. In contrast, none of the 23 patients with body surface area less than 0.35 m2 and only 1 of 18 patients with body surface area more than 0.55 m2 successfully underwent explantation. In multivariable Cox regression, myocarditis was significantly associated with successful explantation (hazard ratio, 11.6, 95% CI, 0.987-135.1; P = .05). Because of the low number of recovery events and near-complete separation by body surface area category, Firth's penalized Cox regression was applied. Within this model, body surface area between 0.35 and 0.55 m2 was strongly associated with recovery (hazard ratio, 27.4, 95% CI, 3.46-3539.5; P = .0003).

Conclusions

This study demonstrates that a strategy focused on evaluation of myocardial recovery may increase the rate of device removal. The majority of successful device removals occurred in children younger than 2 years of age with a body surface area of 0.35 to 0.55 m2. Patients with myocarditis are more likely to have a successful device removal. We believe that every patient must be evaluated for myocardial recovery and device removal before committing the patient to heart transplantation.
目的Berlin Heart EXCOR是目前唯一一款适用于婴幼儿的耐用心室辅助装置。在柏林心脏EXCOR装置的支持下,一部分患者经历了心脏恢复。本研究旨在评估柏林心脏EXCOR支持在我们中心的结果,并确定成功的装置外植的相关因素。方法本回顾性观察性研究纳入2009年至2024年在皇家儿童医院接受柏林心脏EXCOR植入的所有连续患者。结果在研究期间,共有72例患者接受了柏林心脏EXCOR支持。种植年龄中位数为1.0岁(四分位数范围为0.44-2.92),体表面积中位数为0.43 m2(四分位数范围为0.30-0.56),支撑时间中位数为127天(四分位数范围为59-219)。47例(65.3%)患者进行了心脏移植,10例(13.9%)患者实现了无移植装置外植,其中扩张型心肌病4例,心肌炎6例。14例患者(19.4%)在支持期间死亡,1例患者在分析时仍然支持。康复者和死亡或接受移植者在年龄、植入时体表面积或支持时间方面没有显著差异。30例年龄小于2岁,体表面积在0.35 ~ 0.55 m2之间的患者中,9例恢复。相比之下,23例体表面积小于0.35 m2的患者中没有一例成功移植,18例体表面积大于0.55 m2的患者中只有1例成功移植。在多变量Cox回归中,心肌炎与成功外植体显著相关(风险比,11.6,95% CI, 0.987-135.1; P = 0.05)。由于恢复事件的数量较少,并且按体表面积类别几乎完全分离,因此采用Firth的惩罚性Cox回归。在该模型中,体表面积在0.35至0.55 m2之间与康复密切相关(风险比,27.4,95% CI, 3.46-3539.5; P = 0.0003)。结论本研究表明,以心肌恢复评估为重点的策略可能会增加器械移除率。大多数成功取出装置的儿童年龄小于2岁,体表面积为0.35至0.55 m2。心肌炎患者更有可能成功移除装置。我们认为,在进行心脏移植之前,必须对每位患者进行心肌恢复和器械移除评估。
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引用次数: 0
Are there different phenotypes of thoracic surgery patients? A latent class analysis of pretreatment patient-reported outcomes 胸外科患者有不同的表型吗?对患者报告的预处理结果进行潜在分类分析
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.10.015
Eagan J. Peters MD , Brenden Dufault MSc , Sadeesh K. Srinathan MD, MSc , Gordon Buduhan MD, MSc , Lawrence Tan MD , Biniam Kidane MD, MSc

Background

Among patients undergoing thoracic surgery, quality of life is associated with multiple perioperative outcomes. Whether patients suffer reduced quality of life in certain areas compared to others is unclear. Knowing this could direct risk mitigation interventions for patients who share common symptoms. The objective of this study was to determine whether patients can be subdivided into groups based on preoperative quality of life.

Methods

This is a secondary analysis of a retrospective cohort study of consecutive patients undergoing thoracic surgery between January 2018 and January 2019 at a Canadian tertiary center. Latent class analysis was conducted according to 3-level EuroQol-5 dimension (EQ-5D-3L) scores. The number of latent classes was selected by comparing different models using the Akaike information criterion, Bayesian information criterion, and G2 statistic. Class separation was measured using normalized entropy statistics.

Results

Among 482 patients, models with 2 to 5 classes were constructed. The 3-class model demonstrated the lowest Akaike and Bayesian information criterion values. The G2 statistic and entropy showed increased preference for models as the number of classes decreased. Within the 3-class model, class 1 demonstrated a 73% to 100% probability of endorsing low impairment across all EQ-5D-3L dimensions, class 2 demonstrated a 93% probability of at least some impairment in mobility, and class 3 showed an 81% probability of moderate pain.

Conclusions

There is evidence that patients undergoing thoracic surgery can be divided into 3 latent classes based on EQ-5D-3L score: low symptom burden, mobility-pain complex, and pain predominant. By identifying patients using these latent classes, targeted supportive interventions may be offered in the pretreatment period to improve perioperative outcomes.
背景:在接受胸外科手术的患者中,生活质量与多种围手术期结局相关。与其他患者相比,患者在某些方面的生活质量是否下降尚不清楚。了解这一点可以指导对有共同症状的患者进行风险缓解干预。本研究的目的是确定是否可以根据术前生活质量对患者进行分组。方法:本研究是对2018年1月至2019年1月在加拿大某三级中心连续接受胸外科手术的患者进行回顾性队列研究的二次分析。根据3级EuroQol-5维度(EQ-5D-3L)评分进行潜在类分析。采用赤池信息准则、贝叶斯信息准则和G2统计量对不同模型进行比较,选择潜在类数。使用归一化熵统计量测量类分离。结果对482例患者建立了2 ~ 5个分类的模型。3类模型的赤池和贝叶斯信息准则值最低。G2统计量和熵显示,随着类别数量的减少,对模型的偏好增加。在3级模型中,1级在EQ-5D-3L的所有维度上显示出73%至100%的可能性为低损伤,2级显示出93%的可能性至少有一些活动障碍,3级显示出81%的可能性为中度疼痛。结论根据EQ-5D-3L评分,胸外科手术患者可分为症状负担低、活动-疼痛复合、疼痛为主3个潜在类型。通过识别使用这些潜在类别的患者,可以在预处理期间提供有针对性的支持干预措施,以改善围手术期的预后。
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引用次数: 0
A structured, competency-based framework for aspiring cardiothoracic surgeons 为有抱负的心胸外科医生提供结构化的、基于能力的框架
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.10.005
Adham Ahmed MD , Samantha Colon BS , Gianna J. Dafflisio BS , Purab Kothari BS , Nina Uzoigwe BS , Alice Zhou MD , Juli Buchwald BS , Betemariam Sharew BS , Carter Glenn MD , Steven Medvedovsky BS , Justin Olivera MD , Ryan Kramer MD , Gabrielle Colon BS , Jonathan M. Tomasko MD , Sara J. Pereira MD , Mara Antonoff MD , Marc Pelletier MD , Irbaz Hameed MD, PhD

Objective

Cardiothoracic surgery requires mastery of a broad knowledge base and advanced skillset to manage critically ill patients. Although competency-based assessment frameworks have been developed in several specialties, there remains a paucity of resources to guide practical progression for early cardiothoracic surgical trainees.

Methods

Members of the Thoracic Surgery Residents Association, Thoracic Surgery Medical Student Association, and attending cardiothoracic surgeons with a strong track record of surgical education were invited to share their insights and experiences. A structured, milestone-driven roadmap was developed on the basis of their contributions.

Results

We developed a structured, competency-based framework for early surgical trainees, with an emphasis on progressive development of clinical knowledge, technical skills, and academic proficiency. Key milestones and applicable resources were curated to help guide independent learning and skill acquisition.

Conclusions

This structured roadmap offers early-stage cardiothoracic surgery trainees a competency-guided path toward proficiency. By providing clear guidance and granular action points, this guide may help facilitate independent learning and prepare residents for advanced cardiothoracic surgical training.
目的心胸外科需要掌握广泛的知识基础和先进的技能来管理危重病人。尽管基于能力的评估框架已经在几个专业中发展起来,但仍然缺乏资源来指导早期心胸外科受训者的实际进展。方法邀请胸外科住院医师协会、胸外科医学生协会的成员以及在外科教育方面有较强经验的胸外科主治医生分享他们的见解和经验。一个结构化的、里程碑驱动的路线图是在他们贡献的基础上制定的。结果:我们为早期外科受训者制定了一个结构化的、基于能力的框架,重点是临床知识、技术技能和学术水平的逐步发展。关键的里程碑和适用的资源被策划,以帮助指导独立学习和技能获取。结论:该结构化的路线图为早期心胸外科受训者提供了一条能力引导的熟练路径。通过提供清晰的指导和细化的动作点,本指南可以帮助住院医师独立学习,为高级心胸外科培训做好准备。
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引用次数: 0
Internal thoracic artery grafting confers a survival benefit even in the most elderly population undergoing coronary artery bypass grafting 胸内动脉移植术即使在大多数接受冠状动脉旁路移植术的老年人群中也能获得生存优势
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.09.030
Paul Kurlansky MD , Ernest A. Traad MD , Sameer Singh MD , David L. Galbut MD , George Ebra EdD, PhD

Objective

Although the use of the left thoracic artery (LITA) is well accepted as the optimal conduit in coronary artery bypass graft surgery to improve survival, the survival benefit for the most elderly population is less well defined. Herein, we explore the lifetime benefit for use of the LITA versus saphenous vein grafting (SVG) only in a matched population of patients aged 80 years and older.

Methods

Retrospective review was conducted of consecutive patients aged 80 years and older who underwent isolated coronary artery bypass graft procedures using either SVG only or ITA + SVG grafting between June 1982 and December 2011. Propensity score matching, logistic regression, Kaplan-Meier survival analysis, and Cox regression were used to examine perioperative and long-term survival outcomes.

Results

There were 923 SVG patients and 1217 ITA + SVG patients. After propensity score matching there were 923 in each group. Follow-up ranged from 5 weeks to 25 years and was 99% complete. For matched patients, the operative mortality was 10.9% (101 out of 923) for SVG only and 7.8% (72 out of 923) (P = .021) for ITA + SVG. When examining long-term outcomes for hospital survivors, ITA + SVG was associated with improved survival (hazard ratio of mortality, 0.88; 95% CI, 0.80-0.97; P = .009). When stratifying the patients by age, it appeared that the survival benefit for ITA + SVG persisted well into the eighth decade of life but may be attenuated as patients approach age 90 years.

Conclusions

Despite their advanced age and limited life expectancy, our data suggest that after adjusting for factors associated with selection bias, octogenarians enjoy long-term survival benefits from the use of ITA grafting.
目的:尽管左胸动脉(LITA)作为冠状动脉搭桥手术中提高生存率的最佳导管已被广泛接受,但大多数老年人的生存效益尚不明确。在此,我们探讨了仅在80岁及以上的匹配人群中使用LITA与隐静脉移植(SVG)的终生获益。方法回顾性分析1982年6月至2011年12月期间连续行单纯SVG或ITA + SVG离体冠状动脉搭桥术的80岁及以上患者。采用倾向评分匹配、逻辑回归、Kaplan-Meier生存分析和Cox回归检查围手术期和长期生存结果。结果SVG患者923例,ITA + SVG患者1217例。倾向评分匹配后,每组923人。随访时间从5周到25年,99%完成。对于匹配的患者,仅SVG的手术死亡率为10.9%(923人中有101人),ITA + SVG的手术死亡率为7.8%(923人中有72人)(P = 0.021)。在检查医院幸存者的长期结果时,ITA + SVG与生存率的提高相关(死亡率的危险比为0.88;95% CI为0.80-0.97;P = 0.009)。当按年龄对患者进行分层时,ITA + SVG的生存获益似乎持续到生命的第八个十年,但可能随着患者接近90岁而减弱。结论:尽管耄耋老人年事已高,预期寿命有限,但我们的数据表明,在调整了与选择偏差相关的因素后,使用ITA移植术仍可使他们获得长期的生存益处。
{"title":"Internal thoracic artery grafting confers a survival benefit even in the most elderly population undergoing coronary artery bypass grafting","authors":"Paul Kurlansky MD ,&nbsp;Ernest A. Traad MD ,&nbsp;Sameer Singh MD ,&nbsp;David L. Galbut MD ,&nbsp;George Ebra EdD, PhD","doi":"10.1016/j.xjon.2025.09.030","DOIUrl":"10.1016/j.xjon.2025.09.030","url":null,"abstract":"<div><h3>Objective</h3><div>Although the use of the left thoracic artery (LITA) is well accepted as the optimal conduit in coronary artery bypass graft surgery to improve survival, the survival benefit for the most elderly population is less well defined. Herein, we explore the lifetime benefit for use of the LITA versus saphenous vein grafting (SVG) only in a matched population of patients aged 80 years and older.</div></div><div><h3>Methods</h3><div>Retrospective review was conducted of consecutive patients aged 80 years and older who underwent isolated coronary artery bypass graft procedures using either SVG only or ITA + SVG grafting between June 1982 and December 2011. Propensity score matching, logistic regression, Kaplan-Meier survival analysis, and Cox regression were used to examine perioperative and long-term survival outcomes.</div></div><div><h3>Results</h3><div>There were 923 SVG patients and 1217 ITA + SVG patients. After propensity score matching there were 923 in each group. Follow-up ranged from 5 weeks to 25 years and was 99% complete. For matched patients, the operative mortality was 10.9% (101 out of 923) for SVG only and 7.8% (72 out of 923) (<em>P</em> = .021) for ITA + SVG. When examining long-term outcomes for hospital survivors, ITA + SVG was associated with improved survival (hazard ratio of mortality, 0.88; 95% CI, 0.80-0.97; <em>P</em> = .009). When stratifying the patients by age, it appeared that the survival benefit for ITA + SVG persisted well into the eighth decade of life but may be attenuated as patients approach age 90 years.</div></div><div><h3>Conclusions</h3><div>Despite their advanced age and limited life expectancy, our data suggest that after adjusting for factors associated with selection bias, octogenarians enjoy long-term survival benefits from the use of ITA grafting.</div></div>","PeriodicalId":74032,"journal":{"name":"JTCVS open","volume":"28 ","pages":"Pages 180-190"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145698079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Distal anastomotic new-entry tear after type A aortic dissection repair: Incidence patterns and long-term outcomes by extent of aortic replacement A型主动脉夹层修复后远端吻合口新入口撕裂:发生率模式和主动脉置换程度的长期预后
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.09.018
Go Yamashita MD, Shingo Hirao MD, PhD, Koh Yaegashi MD, Takumi Takauchi MD, Atsushi Sugaya MD, Jiro Sakai MD, Tatsuhiko Komiya MD, PhD

Objective

The study objective was to investigate the incidence patterns, anatomic distribution, and long-term outcomes of distal anastomotic new-entry tear in acute type A aortic dissection according to the extent of aortic replacement.

Methods

This retrospective study analyzed 409 patients with acute type A aortic dissection who underwent surgical repair between 2003 and 2023. Patients were categorized by the extent of aortic replacement: hemiarch replacement (n = 173), partial arch replacement (n = 126), and total arch replacement (n = 110). Distal anastomotic new-entry tear was identified using postoperative contrast-enhanced computed tomography. Long-term outcomes were distal anastomotic new-entry tear status (distal anastomotic new-entry tear vs nondistal anastomotic new-entry tear) and the extent of aortic replacement (hemiarch replacement, partial arch replacement, and total arch replacement).

Results

Distal anastomotic new-entry tears occurred in 27.4% of the patients, predominantly in the greater curve of aortic arch across all replacement types. Supra-aortic branch dissection was an independent risk factor for distal anastomotic new-entry tear occurrence (odds ratio, 2.80, P < .001). Patients with distal anastomotic new-entry tear were younger and predominantly male. Long-term survival was similar between the distal anastomotic new-entry tear and nondistal anastomotic new-entry tear groups; distal anastomotic new-entry tear significantly increased the cumulative incidence of distal aortic reoperation, particularly in patients with hemiarch replacement and partial arch replacement, but not in those with total arch replacement. Multivariate analysis identified distal anastomotic new-entry tear (hazard ratio, 3.95, P < .001) and Marfan syndrome (hazard ratio, 7.46, P = .005) as independent predictors of distal reoperation.

Conclusions

Distal anastomotic new-entry tear commonly develops at the greater curve of the aortic arch after acute type A aortic dissection repair and substantially increases the risk of distal reoperation after hemiarch replacement and partial arch replacement but not total arch replacement, suggesting that total arch replacement may protect against distal anastomotic new-entry tear-related reoperations, particularly in patients with supra-aortic branch dissection. Careful surgical planning and long-term surveillance are crucial for optimizing outcomes.
目的探讨急性A型主动脉夹层吻合口远端新入口撕裂的发生规律、解剖分布及远期预后。方法回顾性分析2003 ~ 2023年间409例急性A型主动脉夹层手术修复患者。根据主动脉置换术的范围对患者进行分类:主动脉弓置换术(173例)、部分主动脉弓置换术(126例)和全主动脉弓置换术(110例)。术后对比增强计算机断层扫描发现吻合口远端新入口撕裂。长期结果是远端吻合口新入口撕裂状态(远端吻合口新入口撕裂vs非远端吻合口新入口撕裂)和主动脉置换程度(血弓置换、部分弓置换和全弓置换)。结果27.4%的患者发生远端吻合口新入口撕裂,主要发生在主动脉弓较大弯曲处。主动脉上分支剥离是吻合口远端新入口撕裂发生的独立危险因素(优势比为2.80,P < 0.001)。吻合口远端新入口撕裂患者以年轻、男性为主。远端吻合口新入口撕裂组和非远端吻合口新入口撕裂组的长期生存率相似;远端吻合口新入口撕裂明显增加主动脉远端再手术的累计发生率,特别是在主动脉弓置换术和部分主动脉弓置换术患者中,而在全主动脉弓置换术患者中无明显增加。多因素分析发现,远端吻合口新入口撕裂(风险比3.95,P < .001)和马凡综合征(风险比7.46,P = .005)是远端再手术的独立预测因素。结论急性A型主动脉夹层修复术后,远端吻合口新入口撕裂通常发生在主动脉弓更大的弯曲处,大大增加了半动脉弓置换术和部分动脉弓置换术后远端再手术的风险,而不是全动脉弓置换术,提示全动脉弓置换术可以预防远端吻合口新入口撕裂相关的再手术,特别是对主动脉上分支夹层患者。仔细的手术计划和长期监测是优化结果的关键。
{"title":"Distal anastomotic new-entry tear after type A aortic dissection repair: Incidence patterns and long-term outcomes by extent of aortic replacement","authors":"Go Yamashita MD,&nbsp;Shingo Hirao MD, PhD,&nbsp;Koh Yaegashi MD,&nbsp;Takumi Takauchi MD,&nbsp;Atsushi Sugaya MD,&nbsp;Jiro Sakai MD,&nbsp;Tatsuhiko Komiya MD, PhD","doi":"10.1016/j.xjon.2025.09.018","DOIUrl":"10.1016/j.xjon.2025.09.018","url":null,"abstract":"<div><h3>Objective</h3><div>The study objective was to investigate the incidence patterns, anatomic distribution, and long-term outcomes of distal anastomotic new-entry tear in acute type A aortic dissection according to the extent of aortic replacement.</div></div><div><h3>Methods</h3><div>This retrospective study analyzed 409 patients with acute type A aortic dissection who underwent surgical repair between 2003 and 2023. Patients were categorized by the extent of aortic replacement: hemiarch replacement (n = 173), partial arch replacement (n = 126), and total arch replacement (n = 110). Distal anastomotic new-entry tear was identified using postoperative contrast-enhanced computed tomography. Long-term outcomes were distal anastomotic new-entry tear status (distal anastomotic new-entry tear vs nondistal anastomotic new-entry tear) and the extent of aortic replacement (hemiarch replacement, partial arch replacement, and total arch replacement).</div></div><div><h3>Results</h3><div>Distal anastomotic new-entry tears occurred in 27.4% of the patients, predominantly in the greater curve of aortic arch across all replacement types. Supra-aortic branch dissection was an independent risk factor for distal anastomotic new-entry tear occurrence (odds ratio, 2.80, <em>P &lt; .</em>001). Patients with distal anastomotic new-entry tear were younger and predominantly male. Long-term survival was similar between the distal anastomotic new-entry tear and nondistal anastomotic new-entry tear groups; distal anastomotic new-entry tear significantly increased the cumulative incidence of distal aortic reoperation, particularly in patients with hemiarch replacement and partial arch replacement, but not in those with total arch replacement. Multivariate analysis identified distal anastomotic new-entry tear (hazard ratio, 3.95, <em>P &lt; .</em>001) and Marfan syndrome (hazard ratio, 7.46, <em>P =</em> .005) as independent predictors of distal reoperation.</div></div><div><h3>Conclusions</h3><div>Distal anastomotic new-entry tear commonly develops at the greater curve of the aortic arch after acute type A aortic dissection repair and substantially increases the risk of distal reoperation after hemiarch replacement and partial arch replacement but not total arch replacement, suggesting that total arch replacement may protect against distal anastomotic new-entry tear-related reoperations, particularly in patients with supra-aortic branch dissection. Careful surgical planning and long-term surveillance are crucial for optimizing outcomes.</div></div>","PeriodicalId":74032,"journal":{"name":"JTCVS open","volume":"28 ","pages":"Pages 73-86"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145698147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Spinal cord–protective effect of resorcimoline for ischemia-reperfusion injury in a rabbit model 间苯二胺对兔缺血再灌注损伤模型的脊髓保护作用
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.10.017
Yu Kawahara MD , Takayuki Kawashima MD, PhD , Kenshi Yoshimura MD, PhD , Kazuki Mori MD , Ryotaro Nagashima MD , Tadashi Umeno MD, PhD , Haruto Nishida MD, PhD , Hiroki Sato MD, PhD , Akihiro Higuchi PhD , Osamu Tokumaru MD, PhD , Shinji Miyamoto MD, PhD

Objectives

Spinal cord injury can occur after aortic surgery as a result of reactive oxygen species (ROS) generated during ischemia-reperfusion. Resorcimoline is a novel and potent antioxidant that has demonstrated ROS-scavenging activity in vitro. We evaluated the spinal cord–protective effects of resorcimoline and compared its efficacy with that of edaravone, a free-radical scavenger currently used clinically in Japan.

Methods

A spinal cord injury model was established via infrarenal aortic occlusion for 20 minutes in 30 Japanese white rabbits. The animals received saline (control), resorcimoline (6 mg/kg), or edaravone (6 mg/kg) immediately after reperfusion. Neurologic function was assessed using the modified Tarlov score, and a linear mixed model was used to analyze the modified Tarlov score data. Logistic regression analysis was used to compare the risk of paraplegia between groups. After 5 days, spinal cord segments (L3-L5) were harvested. The number of residual normal neurons was evaluated histologically, and oxidative DNA damage was assessed via immunostaining for 8-hydroxy-2-deoxyguanosine.

Results

Compared with the control group, resorcimoline treatment resulted in significantly greater modified Tarlov score improvement (regression coefficient; 2.025; 95% confidence interval, 0.267-3.782; P = .025), lower incidence of paraplegia (odds ratio, 0.04; 95% confidence interval, 0.002-0.4; P = .004), greater number of residual normal neurons (P = .018), and greater percentage of 8-hydroxy-2-deoxyguanosine−negative neurons (P < .001). Conversely, these parameters did not differ significantly between the edaravone and control groups.

Conclusions

Resorcimoline demonstrated spinal cord–protective effects, likely associated with its antioxidant ability to eliminate ROS generated during ischemia-reperfusion.
目的:缺血再灌注过程中活性氧(ROS)的产生可导致主动脉手术后脊髓损伤。间苯二胺是一种新型有效的抗氧化剂,在体外已显示出清除ros的活性。我们评估了间苯莫啉的脊髓保护作用,并将其与依达拉奉(一种目前在日本临床使用的自由基清除剂)的疗效进行了比较。方法30只大白兔经肾下主动脉阻断20分钟建立脊髓损伤模型。再灌注后立即给予生理盐水(对照组)、间苯胺啉(6mg /kg)或依达拉奉(6mg /kg)。采用改进的Tarlov评分评估神经功能,并采用线性混合模型分析改进的Tarlov评分数据。采用Logistic回归分析比较两组患者截瘫发生风险。5天后,取脊髓节段(L3-L5)。用组织学方法评估残馀正常神经元数量,用8-羟基-2-脱氧鸟苷免疫染色法评估DNA氧化损伤。结果与对照组相比,间苯二胺治疗组改良Tarlov评分改善显著(回归系数为2.025,95%可信区间为0.265 ~ 3.782,P = 0.025),截瘫发生率显著降低(优势比为0.04,95%可信区间为0.002 ~ 0.4,P = 0.004),正常神经元残数显著增加(P = 0.018), 8-羟基-2-脱氧鸟苷−阴性神经元比例显著增加(P < 0.001)。相反,这些参数在依达拉奉组和对照组之间没有显著差异。间苯二胺具有脊髓保护作用,可能与其抗氧化能力有关,可消除缺血-再灌注过程中产生的ROS。
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引用次数: 0
A real-time rapid cycle process improvement tool for accelerated quality improvement in coronary artery bypass grafting surgery 一种实时快速循环过程改进工具,用于加速冠状动脉搭桥术质量的提高
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.08.010
John G. Byrne MD , Farhaan Chaugle BS , Waheed Asger BS , Aaliyah Willis MD , Shelby DeRose MHA , Rachel Jones RN , Hannan Chaugle MD

Background

We report a custom-designed visual feedback tool integrated into a comprehensive quality improvement (QI) program to drive accelerated, real-time advances in coronary artery bypass grafting (CABG) surgery.

Methods

The Society of Thoracic Surgeons (STS) risk profiles of 977 consecutive patients who underwent CABG between January 1, 2021, and December 31, 2024 risk profiles were analyzed. For 2021-2022, the mortality observed-to-expected ratio (O/E) was 2.5. In 2023, we started a real-time, rapid cycle process improvement program. We designed a QI tool to calculate in real time the O/Es for death, stroke, renal failure, prolonged ventilation, reoperation, deep sternal wound infection, prolonged length of stay, and failure of left internal mammary artery (LIMA) use or medication compliance. We developed a final composite score in which we assigned 80% to mortality, 7% to LIMA use, 3% to medications, and 10% to nonfatal STS adverse outcomes as a rough estimate of the STS 3-star CABG construct. For a final composite grade, we assigned “good” (O/E < 0.65), “fair” (O/E = 0.65-1.0), or “poor” (O/E > 1.0) for each adverse outcome.

Results

The CABG mortality O/E improved from 1.5 in 2021-2022 to 0.25 in 2023-2024 (P < .0001; z = 327,991). The final composite O/E for 2023-2024 was 0.55 (“good”). This resulted in a final composite grade of “good,” coinciding with our 3-star STS status for isolated CABG.

Conclusions

Our custom-designed QI tool enabled rapid improvement of our CABG outcomes (P < .0001). This report is unique because it uses the publicly available STS risk calculator for real-time rapid cycle process improvement, integrated into a comprehensive QI program.
我们报告了一种定制设计的视觉反馈工具集成到综合质量改进(QI)程序中,以推动冠状动脉旁路移植术(CABG)手术的加速、实时进展。方法对2021年1月1日至2024年12月31日期间连续接受CABG的977例胸外科学会(STS)患者的风险特征进行分析。2021-2022年,观察死亡率与预期死亡率之比(O/E)为2.5。2023年,我们启动了一项实时、快速循环的工艺改进计划。我们设计了一个QI工具来实时计算死亡、中风、肾功能衰竭、延长通气时间、再手术、深胸骨伤口感染、延长住院时间、左内乳动脉(LIMA)使用失败或药物依从性的O/ e。我们制定了一个最终的综合评分,其中80%为死亡率,7%为LIMA使用,3%为药物治疗,10%为非致命性STS不良结果,作为STS三星级CABG结构的粗略估计。对于最终的综合评分,我们为每个不良结果分配了“良好”(O/E < 0.65)、“一般”(O/E = 0.65-1.0)或“差”(O/E > 1.0)。结果CABG死亡率O/E由2021-2022年的1.5提高到2023-2024年的0.25 (P < .0001; z = 327,991)。2023-2024年的最终综合O/E为0.55(“良好”)。这导致最终的综合评分为“良好”,与孤立性CABG的3星STS状态一致。我们定制设计的QI工具能够快速改善我们的CABG结果(P < .0001)。该报告的独特之处在于,它使用了公开可用的STS风险计算器,用于实时快速循环过程改进,并集成到一个全面的QI计划中。
{"title":"A real-time rapid cycle process improvement tool for accelerated quality improvement in coronary artery bypass grafting surgery","authors":"John G. Byrne MD ,&nbsp;Farhaan Chaugle BS ,&nbsp;Waheed Asger BS ,&nbsp;Aaliyah Willis MD ,&nbsp;Shelby DeRose MHA ,&nbsp;Rachel Jones RN ,&nbsp;Hannan Chaugle MD","doi":"10.1016/j.xjon.2025.08.010","DOIUrl":"10.1016/j.xjon.2025.08.010","url":null,"abstract":"<div><h3>Background</h3><div>We report a custom-designed visual feedback tool integrated into a comprehensive quality improvement (QI) program to drive accelerated, real-time advances in coronary artery bypass grafting (CABG) surgery.</div></div><div><h3>Methods</h3><div>The Society of Thoracic Surgeons (STS) risk profiles of 977 consecutive patients who underwent CABG between January 1, 2021, and December 31, 2024 risk profiles were analyzed. For 2021-2022, the mortality observed-to-expected ratio (O/E) was 2.5. In 2023, we started a real-time, rapid cycle process improvement program. We designed a QI tool to calculate in real time the O/Es for death, stroke, renal failure, prolonged ventilation, reoperation, deep sternal wound infection, prolonged length of stay, and failure of left internal mammary artery (LIMA) use or medication compliance. We developed a final composite score in which we assigned 80% to mortality, 7% to LIMA use, 3% to medications, and 10% to nonfatal STS adverse outcomes as a rough estimate of the STS 3-star CABG construct. For a final composite grade, we assigned “good” (O/E &lt; 0.65), “fair” (O/E = 0.65-1.0), or “poor” (O/E &gt; 1.0) for each adverse outcome.</div></div><div><h3>Results</h3><div>The CABG mortality O/E improved from 1.5 in 2021-2022 to 0.25 in 2023-2024 (<em>P</em> &lt; .0001; z = 327,991). The final composite O/E for 2023-2024 was 0.55 (“good”). This resulted in a final composite grade of “good,” coinciding with our 3-star STS status for isolated CABG.</div></div><div><h3>Conclusions</h3><div>Our custom-designed QI tool enabled rapid improvement of our CABG outcomes (<em>P</em> &lt; .0001). This report is unique because it uses the publicly available STS risk calculator for real-time rapid cycle process improvement, integrated into a comprehensive QI program.</div></div>","PeriodicalId":74032,"journal":{"name":"JTCVS open","volume":"28 ","pages":"Pages 242-249"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145698238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-term survival for preoperative versus postoperative treatment of N2 lung cancer: The importance of complete adjuvant therapy for occult N2 disease N2肺癌术前与术后治疗的长期生存率:完全辅助治疗对隐匿性N2疾病的重要性
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.09.008
Fatemehsadat Pezeshkian MD , Chandana Adhikarla MD, MPH , Emanuele Mazzola PhD , Hao Li MD , Carla Vega MD , Anupama Singh MD , Fatemeh Hooshmand MSc , Miles McAllister BA , Rafael Ribeiro Barcelos MD , Elias Bou Farhat MD , Abby A. White DO , Matthew M. Rochefort MD , Raphael Bueno MD , Desiree Steimer MD , Matthew J. Pommerening MD , Paula A. Ugalde Figueroa MD , Michael T. Jaklitsch MD , Scott J. Swanson MD

Background

Unsuspected (defined here as occult) N2-positive lung cancer impacts overall survival (OS), and treatment patterns likely influence outcomes. We aimed to evaluate factors that could improve the long-term outcomes of patients with occult N2 disease compared to biopsy-proven, pre-resectional N2 disease.

Methods

Our institutional prospective database was queried for N2 non–small cell lung cancer (NSCLC) at presentation (biopsy-proven) prior to surgical resection or postoperatively diagnosed N2 (occult N2), excluding stage IV disease or patients with insufficient follow-up. In occult N2 group, postoperative therapy was stratified into complete (≥3 cycles), incomplete (1-2 cycles), or no adjuvant treatment. Propensity score weighting adjusted for age, comorbidities, tumor size, and N2 involvement. Kaplan-Meier analysis assessed 5-year overalls survival (OS).

Results

Between 2006-2023, 483 patients met inclusion criteria, stratified into 325 patients (67.2%) with biopsy-proven N2 and 158 (32.8%) with occult N2. The biopsy-proven N2 group primarily received neoadjuvant therapy (chemo/chemoimmunotherapy ± radiation). In the occult N2 group, 86 patients (54.4%) received full-dose adjuvant therapy, 31 (19.6%) received incomplete adjuvant therapy, and 41 (26%) received no adjuvant therapy. After propensity score weighting, the occult N2 group had significantly lower OS (P = .03); however, when the cohort was stratified by completeness of adjuvant treatment, those who received full adjuvant therapy had OS comparable to that of the biopsy-proven group (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.65-1.48; P = .9). Incomplete therapy provided some survival benefits but was associated with worse OS compared to complete therapy (HR, 1.54; 95% CI, 0.9-2.6; P = .1). The no-therapy group had the lowest OS.

Conclusions

Patients with occult N2 treated with adjuvant treatment may achieve improved survival rates compared to those not fully treated. Neoadjuvant treatment is optimal to ensure delivery of therapy as prescribed, and thus every effort should be made to identify N2 disease prior to resection.
疑似(此处定义为隐匿性)n2阳性肺癌影响总生存期(OS),治疗模式可能影响预后。我们的目的是评估可以改善隐匿性N2疾病患者的长期预后的因素,与活检证实的切除前N2疾病相比。方法查询机构前瞻性数据库,排除IV期疾病或随访不足的患者,在手术切除前出现(活检证实)或术后诊断为N2(隐匿性N2)的N2非小细胞肺癌(NSCLC)。隐匿性N2组术后治疗分为完全治疗(≥3个周期)、不完全治疗(1-2个周期)和无辅助治疗。倾向评分加权根据年龄、合并症、肿瘤大小和N2累及进行调整。Kaplan-Meier分析评估5年总生存率(OS)。结果2006-2023年间,483例患者符合纳入标准,其中活检证实N2患者325例(67.2%),隐匿性N2患者158例(32.8%)。活检证实的N2组主要接受新辅助治疗(化疗/化疗免疫治疗±放疗)。隐匿性N2组86例(54.4%)患者接受了全剂量辅助治疗,31例(19.6%)患者接受了不完全辅助治疗,41例(26%)患者未接受辅助治疗。倾向评分加权后,隐匿N2组OS显著低于对照组(P = 0.03);然而,当根据辅助治疗的完整性对队列进行分层时,接受完全辅助治疗的患者的OS与活检证实组相当(风险比[HR], 0.98; 95%可信区间[CI], 0.65-1.48; P = .9)。与完全治疗相比,不完全治疗提供了一些生存益处,但与更差的OS相关(HR, 1.54; 95% CI, 0.9-2.6; P = 0.1)。无治疗组的OS最低。结论隐匿性N2患者接受辅助治疗的生存率高于未接受充分治疗的患者。新辅助治疗是确保治疗如期进行的最佳选择,因此在切除前应尽一切努力确定N2病变。
{"title":"Long-term survival for preoperative versus postoperative treatment of N2 lung cancer: The importance of complete adjuvant therapy for occult N2 disease","authors":"Fatemehsadat Pezeshkian MD ,&nbsp;Chandana Adhikarla MD, MPH ,&nbsp;Emanuele Mazzola PhD ,&nbsp;Hao Li MD ,&nbsp;Carla Vega MD ,&nbsp;Anupama Singh MD ,&nbsp;Fatemeh Hooshmand MSc ,&nbsp;Miles McAllister BA ,&nbsp;Rafael Ribeiro Barcelos MD ,&nbsp;Elias Bou Farhat MD ,&nbsp;Abby A. White DO ,&nbsp;Matthew M. Rochefort MD ,&nbsp;Raphael Bueno MD ,&nbsp;Desiree Steimer MD ,&nbsp;Matthew J. Pommerening MD ,&nbsp;Paula A. Ugalde Figueroa MD ,&nbsp;Michael T. Jaklitsch MD ,&nbsp;Scott J. Swanson MD","doi":"10.1016/j.xjon.2025.09.008","DOIUrl":"10.1016/j.xjon.2025.09.008","url":null,"abstract":"<div><h3>Background</h3><div>Unsuspected (defined here as occult) N2-positive lung cancer impacts overall survival (OS), and treatment patterns likely influence outcomes. We aimed to evaluate factors that could improve the long-term outcomes of patients with occult N2 disease compared to biopsy-proven, pre-resectional N2 disease.</div></div><div><h3>Methods</h3><div>Our institutional prospective database was queried for N2 non–small cell lung cancer (NSCLC) at presentation (biopsy-proven) prior to surgical resection or postoperatively diagnosed N2 (occult N2), excluding stage IV disease or patients with insufficient follow-up. In occult N2 group, postoperative therapy was stratified into complete (≥3 cycles), incomplete (1-2 cycles), or no adjuvant treatment. Propensity score weighting adjusted for age, comorbidities, tumor size, and N2 involvement. Kaplan-Meier analysis assessed 5-year overalls survival (OS).</div></div><div><h3>Results</h3><div>Between 2006-2023, 483 patients met inclusion criteria, stratified into 325 patients (67.2%) with biopsy-proven N2 and 158 (32.8%) with occult N2. The biopsy-proven N2 group primarily received neoadjuvant therapy (chemo/chemoimmunotherapy ± radiation). In the occult N2 group, 86 patients (54.4%) received full-dose adjuvant therapy, 31 (19.6%) received incomplete adjuvant therapy, and 41 (26%) received no adjuvant therapy. After propensity score weighting, the occult N2 group had significantly lower OS (<em>P</em> = .03); however, when the cohort was stratified by completeness of adjuvant treatment, those who received full adjuvant therapy had OS comparable to that of the biopsy-proven group (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.65-1.48; <em>P</em> = .9). Incomplete therapy provided some survival benefits but was associated with worse OS compared to complete therapy (HR, 1.54; 95% CI, 0.9-2.6; <em>P</em> = .1). The no-therapy group had the lowest OS.</div></div><div><h3>Conclusions</h3><div>Patients with occult N2 treated with adjuvant treatment may achieve improved survival rates compared to those not fully treated. Neoadjuvant treatment is optimal to ensure delivery of therapy as prescribed, and thus every effort should be made to identify N2 disease prior to resection.</div></div>","PeriodicalId":74032,"journal":{"name":"JTCVS open","volume":"28 ","pages":"Pages 541-553"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145697717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-term survival after superior vena cava resection and reconstruction for locally advanced epithelial thymic tumors invading superior vena cava 侵袭上腔静脉的局部晚期胸腺上皮性肿瘤切除和重建后的长期生存率
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.10.012
Jiahao Jiang MD, Jian Gao MD, Yongqiang Ao MD, Shuai Wang MD, Xifei Jiang MD, Lijie Tan MD, Jianyong Ding MD

Objectives

Thymic epithelial tumors (TETs) invading superior vena cava have traditionally posed significant surgical challenges. However, advances in surgical techniques have expanded treatment options. This study aimed to evaluate the long-term survival outcomes following superior vena cava resection and reconstruction in patients with locally advanced TETs.

Methods

We retrospectively analyzed 50 consecutive patients with TETs invading superior vena cava who underwent surgical resection and vascular reconstruction at our center between March 2015 and September 2023. Survival outcomes were assessed by Kaplan-Meier methods, and prognostic factors were analyzed using Cox regression.

Results

All patients achieved complete resection. The mean patient age was 53.0 years, with 68.0% male predominance. Thymomas accounted for 50% of cases. The median follow-up time was 41 months. The 5-year disease-free survival and overall survival rates were 32.2% and 71.4%, respectively. There were no statistical differences between thymomas and thymic carcinomas in disease-free survival (mean, 40.1 ± 5.2 vs 35.5 ± 6.4 months; P = .502) or overall survival (mean, 72.3 ± 6.7 vs 59.0 ± 5.9 months; P = .363). Patients with Masaoka stage IV demonstrated a trend toward poorer disease-free survival compared with those with stage IIIB disease (mean, 26.8 ± 7.3 vs 42.3 ± 5.3 months; P = .086), yet their long-term overall survival rates were similar (mean, 69.3 ± 9.7 vs 63.6 ± 4.8 months; P = .968). Univariate analysis showed nonsignificant trends for poorer disease-free survival in higher Masaoka stages (hazard ratio, 1.971; P = .094) and reduced overall survival associated with older age (hazard ratio, 4.739; P = .053). No independent predictors were confirmed on multivariate analysis.

Conclusions

Aggressive surgical resection with superior vena cava reconstruction is feasible and offers favorable long-term survival in selected patients with locally advanced TETs.
目的胸腺上皮肿瘤(TETs)侵袭上腔静脉历来是外科治疗的一大挑战。然而,外科技术的进步扩大了治疗的选择。本研究旨在评估局部晚期tet患者上腔静脉切除和重建后的长期生存结果。方法回顾性分析2015年3月至2023年9月在我中心连续行手术切除和血管重建的50例tet侵入上腔静脉患者。生存结果采用Kaplan-Meier法评估,预后因素采用Cox回归分析。结果所有患者均获得完全切除。患者平均年龄53.0岁,男性占68.0%。胸腺瘤占50%。中位随访时间为41个月。5年无病生存率和总生存率分别为32.2%和71.4%。胸腺瘤和胸腺癌的无病生存期(平均40.1±5.2个月vs 35.5±6.4个月,P = 0.502)和总生存期(平均72.3±6.7个月vs 59.0±5.9个月,P = 0.363)无统计学差异。与IIIB期患者相比,Masaoka IV期患者无病生存期较差(平均26.8±7.3个月vs 42.3±5.3个月,P = 0.086),但其长期总生存率相似(平均69.3±9.7个月vs 63.6±4.8个月,P = .968)。单因素分析显示,Masaoka分期较高的无病生存率较差(风险比为1.971,P = 0.094),总生存率随年龄增大而降低(风险比为4.739,P = 0.053)。多变量分析未发现独立预测因素。结论积极手术切除合并上腔静脉重建是可行的,并可为局部晚期TETs患者提供良好的长期生存。
{"title":"Long-term survival after superior vena cava resection and reconstruction for locally advanced epithelial thymic tumors invading superior vena cava","authors":"Jiahao Jiang MD,&nbsp;Jian Gao MD,&nbsp;Yongqiang Ao MD,&nbsp;Shuai Wang MD,&nbsp;Xifei Jiang MD,&nbsp;Lijie Tan MD,&nbsp;Jianyong Ding MD","doi":"10.1016/j.xjon.2025.10.012","DOIUrl":"10.1016/j.xjon.2025.10.012","url":null,"abstract":"<div><h3>Objectives</h3><div>Thymic epithelial tumors (TETs) invading superior vena cava have traditionally posed significant surgical challenges. However, advances in surgical techniques have expanded treatment options. This study aimed to evaluate the long-term survival outcomes following superior vena cava resection and reconstruction in patients with locally advanced TETs.</div></div><div><h3>Methods</h3><div>We retrospectively analyzed 50 consecutive patients with TETs invading superior vena cava who underwent surgical resection and vascular reconstruction at our center between March 2015 and September 2023. Survival outcomes were assessed by Kaplan-Meier methods, and prognostic factors were analyzed using Cox regression.</div></div><div><h3>Results</h3><div>All patients achieved complete resection. The mean patient age was 53.0 years, with 68.0% male predominance. Thymomas accounted for 50% of cases. The median follow-up time was 41 months. The 5-year disease-free survival and overall survival rates were 32.2% and 71.4%, respectively. There were no statistical differences between thymomas and thymic carcinomas in disease-free survival (mean, 40.1 ± 5.2 vs 35.5 ± 6.4 months; <em>P</em> = .502) or overall survival (mean, 72.3 ± 6.7 vs 59.0 ± 5.9 months; <em>P</em> = .363). Patients with Masaoka stage IV demonstrated a trend toward poorer disease-free survival compared with those with stage IIIB disease (mean, 26.8 ± 7.3 vs 42.3 ± 5.3 months; <em>P</em> = .086), yet their long-term overall survival rates were similar (mean, 69.3 ± 9.7 vs 63.6 ± 4.8 months; <em>P</em> = .968). Univariate analysis showed nonsignificant trends for poorer disease-free survival in higher Masaoka stages (hazard ratio, 1.971; <em>P</em> = .094) and reduced overall survival associated with older age (hazard ratio, 4.739; <em>P</em> = .053). No independent predictors were confirmed on multivariate analysis.</div></div><div><h3>Conclusions</h3><div>Aggressive surgical resection with superior vena cava reconstruction is feasible and offers favorable long-term survival in selected patients with locally advanced TETs.</div></div>","PeriodicalId":74032,"journal":{"name":"JTCVS open","volume":"28 ","pages":"Pages 665-671"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145697858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Regadenoson in the rehabilitation of marginal donor lungs on ex vivo lung perfusion: A blinded multicenter randomized controlled clinical trial Regadenoson在体外肺灌注边缘供肺康复中的作用:一项多中心盲法随机对照临床试验
IF 1.9 Pub Date : 2025-12-01 DOI: 10.1016/j.xjon.2025.09.017
Emily Fleischmann BS , Mark Conaway PhD , Joseph Rabin MD , Kaitlyn Vecere MBA, RN, CCRC , Kaitlyn Masih BSN , Yunge Zhao PhD , Ashling Zhang MD , Mohammad Khan PhD , Valeria Mas MS, PhD , Alexander Krupnick MD , Joel Linden PhD , Toshihiro Okamoto MD, PhD , Kamal Ayyat MD, PhD , Kenneth McCurry MD , Christine Lau MD, MBA

Objective

We hypothesized that regadenoson, an adenosine A2A receptor agonist, will increase the use rate after ex vivo lung perfusion and reduce ischemic reperfusion injury.

Methods

This randomized (2:1), multicenter, blinded, placebo-controlled trial (NCT04521569) treated donor lungs with a regadenoson infusion (1.44 μg/kg/h, n = 26) or placebo (n = 8) during ex vivo lung perfusion. Eligibility criteria were adapted from the NOVEL trial. The rate of use of donor lungs was the primary end point. Secondary end points were primary graft dysfunction scores and 30-day safety.

Results

Comparing regadenoson with placebo, 10 of 26 (38%) versus 0 of 8 (0%) donor lungs had a PaO2/Fio2 less than 300 (P = .04), the use rates were not significantly different with 17 of 26 (65%) and 6 of 8 (75%) lungs accepted after study treatment protocol (95% CI, −35 to 26; P = .62), and there was no significant difference in the proportion of recipients with at least 1 adverse event (12/17 [71%] vs 6/7 [86%], 95% CI, −25 to 42, P = .45), serious adverse event (11/17 [65%] vs 4/7 [57%], 95% CI, −36 to 51, P = .73), major lung event (10/17 [59%] vs 4/7 [57%], 95% CI, −34 to 59, P = .94), or grade 3 primary graft dysfunction (5/17 [29%] vs 2/7 [29%], 95% CI, −43 to 28, P = .87). No adverse events were related to the study treatment.

Conclusions

There was no significant increase in the use of marginal donor lungs or a decrease in ischemic reperfusion injury in lungs undergoing ex vivo lung perfusion with regadenoson compared with placebo. Regadenoson is a safe ex vivo lung perfusion adjunct. The use rate of the placebo group was greater than the expectation set in the NOVEL trial of 51%, making it difficult for the regadenoson group to have a significant increase in use.
目的推测腺苷A2A受体激动剂regadenoson能提高体外肺灌注后的使用率,减轻缺血再灌注损伤。方法:该随机(2:1)、多中心、盲法、安慰剂对照试验(NCT04521569)在离体肺灌注期间给供肺输注regadenoson (1.44 μg/kg/h, n = 26)或安慰剂(n = 8)。入选标准改编自NOVEL试验。供体肺的使用率是主要终点。次要终点是原发性移植物功能障碍评分和30天安全性。结果将regadenoson与安慰剂进行比较,26个供肺中有10个(38%)和8个供肺中有0个(0%)的PaO2/Fio2低于300 (P = 0.04),在研究治疗方案后接受的26个供肺中有17个(65%)和8个供肺中有6个(75%)的使用率无显著差异(95% CI, - 35至26;P = .62),没有显著差异在接受者的比例至少1不良事件(12/17 [71%]vs 6/7 (86%), 95% CI,−25 - 42,P =。45),严重不良事件(11/17 [65%]vs 4/7 (57%), 95% CI,−36 51,P = =收),重大肺事件(10/17(59%)和4/7 (57%),95% CI,−34 - 59,P =总收入),或三年级原发性移植物功能障碍(5/17 [29%]vs 2/7 (29%), 95% CI,−43至28日,P = .87点)。没有与研究治疗相关的不良事件。结论与安慰剂相比,瑞格腺苷松体外肺灌注组边缘供肺的使用没有显著增加,肺缺血再灌注损伤也没有显著减少。Regadenoson是一种安全的体外肺灌注辅助药物。安慰剂组的使用率大于NOVEL试验中设定的51%的预期,使得regadenoson组的使用率难以显著增加。
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引用次数: 0
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