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Randomized controlled trials in lung cancer surgery: How are we doing? 肺癌手术中的随机对照试验:我们做得怎么样?
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2024.01.008
Lye-Yeng Wong MD , Yanli Li PhD , Irmina A. Elliott MD , Leah M. Backhus MD , Mark F. Berry MD , Joseph B. Shrager MD , Daniel S. Oh MD

Objective

Randomized control trials are considered the highest level of evidence, yet the scalability and practicality of implementing randomized control trials in the thoracic surgical oncology space are not well described. The aim of this study is to understand what types of randomized control trials have been conducted in thoracic surgical oncology and ascertain their success rate in completing them as originally planned.

Methods

The ClinicalTrials.gov database was queried in April 2023 to identify registered randomized control trials performed in patients with lung cancer who underwent surgery (by any technique) as part of their treatment.

Results

There were 68 eligible randomized control trials; 33 (48.5%) were intended to examine different perioperative patient management strategies (eg, analgesia, ventilation, drainage) or to examine different intraoperative technical aspects (eg, stapling, number of ports, port placement, ligation). The number of randomized control trials was relatively stable over time until a large increase in randomized control trials starting in 2016. Forty-four of the randomized control trials (64.7%) were open-label studies, 43 (63.2%) were conducted in a single facility, 66 (97.1%) had 2 arms, and the mean number of patients enrolled per randomized control trial was 236 (SD, 187). Of 21 completed randomized control trials (31%), the average time to complete accrual was 1605 days (4.4 years) and average time to complete primary/secondary outcomes and adverse events collection was 2125 days (5.82 years).

Conclusions

Given the immense investment of resources that randomized control trials require, these findings suggest the need to scrutinize future randomized control trial proposals to assess the likelihood of successful completion. Future study is needed to understand the various contributing factors to randomized control trial success or failure.

目的随机对照试验被认为是最高级别的证据,但在胸部肿瘤外科领域实施随机对照试验的可扩展性和实用性却没有得到很好的描述。本研究旨在了解胸部肿瘤外科已开展了哪些类型的随机对照试验,并确定其按原计划完成试验的成功率。方法2023年4月,对ClinicalTrials.gov数据库进行了查询,以确定已注册的随机对照试验,试验对象为接受手术(任何技术)治疗的肺癌患者。结果共有68项符合条件的随机对照试验,其中33项(48.5%)旨在检查不同的围手术期患者管理策略(如镇痛、通气、引流)或检查不同的术中技术方面(如缝合、端口数量、端口放置、结扎)。随着时间的推移,随机对照试验的数量相对稳定,直到2016年随机对照试验开始大量增加。随机对照试验中有 44 项(64.7%)是开放标签研究,43 项(63.2%)在单一机构进行,66 项(97.1%)有两个臂,每项随机对照试验的平均入组患者人数为 236 人(SD,187)。在 21 项已完成的随机对照试验(31%)中,完成应计的平均时间为 1605 天(4.4 年),完成主要/次要结果和不良事件收集的平均时间为 2125 天(5.82 年)。未来的研究需要了解导致随机对照试验成功或失败的各种因素。
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引用次数: 0
Impact of maximum phonation time on postoperative dysphagia and prognosis after cardiac surgery 最大发音时间对心脏手术后吞咽困难和预后的影响
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2024.02.002
Masato Ogawa PT, PhD , Seimi Satomi-Kobayashi MD, PhD , Mari Hamaguchi MD , Kodai Komaki PT , Hifumi Kusu PT , Kazuhiro P. Izawa PT, PhD , Shunsuke Miyahara MD, PhD , Yoshitada Sakai MD, PhD , Ken-ichi Hirata MD, PhD , Kenji Okada MD, PhD

Objective

The incidence of postoperative complications, including dysphagia, increases as the population undergoing cardiovascular surgery ages. This study aimed to explore the potential of maximum phonation time (MPT) as a simple tool for predicting postextubation dysphagia (PED) and major adverse cardiac and cerebrovascular events (MACCEs).

Methods

This retrospective study included 442 patients who underwent elective cardiac surgery at a university hospital. MPT was measured before surgery, and patients were stratified into 2 groups based on normal and abnormal MPTs. Postoperative complications, including PED and MACCEs, were also investigated. Swallowing status was assessed using the Food Intake Level Scale.

Results

MPT predicted PED with prevalence of 11.0% and 18.0% in the normal and abnormal MPT groups, respectively (P = .01). During the follow-up period, MACCEs developed in 17.0% of patients. Frailty, European System for Cardiac Operative Risk Evaluation II score, PED, and MPT were markedly associated with MACCEs (adjusted hazard ratios: 2.25, 1.08, 1.96, and 0.96, respectively). Mediation analysis revealed that MPT positively influenced PED and MACCEs, whereas PED positively influenced MACCEs. The trend in restricted cubic spline analysis indicated that the hazard ratio for MACCEs increased sharply when MPT was <10 seconds.

Conclusions

These findings underscore the potential of MPT as a valuable tool in the preoperative assessment and management of patients undergoing cardiac surgery. By incorporating MPT into routine preoperative evaluations, clinicians can identify patients at a higher risk of PED and MACCEs, allowing for targeted interventions and closer postoperative monitoring. This may improve patient outcomes and reduce the health care costs associated with these complications.

目的随着心血管手术患者年龄的增长,包括吞咽困难在内的术后并发症的发生率也在增加。本研究旨在探索最大发音时间(MPT)作为预测拔管后吞咽困难(PED)和主要不良心脑血管事件(MACCE)的简单工具的潜力。术前测量 MPT,根据正常和异常 MPT 将患者分为两组。研究还调查了术后并发症,包括 PED 和 MACCE。结果 MPT预测PED的发生率在正常组和异常组分别为11.0%和18.0%(P = .01)。在随访期间,17.0%的患者出现了MACCE。虚弱程度、欧洲心脏手术风险评估系统 II 评分、PED 和 MPT 与 MACCE 明显相关(调整后危险比分别为 2.25、1.08、1.96 和 0.96)。中介分析显示,MPT 对 PED 和 MACCEs 有正向影响,而 PED 则对 MACCEs 有正向影响。限制性立方样条分析的趋势表明,当 MPT 为 10 秒时,MACCEs 的危险比急剧增加。通过将 MPT 纳入常规术前评估,临床医生可以识别 PED 和 MACCE 风险较高的患者,从而进行有针对性的干预和更密切的术后监测。这可能会改善患者的预后,降低与这些并发症相关的医疗费用。
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引用次数: 0
Patient-specific tissue engineered vascular graft for aortic arch reconstruction 用于主动脉弓重建的专为患者设计的组织工程血管移植物
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2024.02.012
Hidenori Hayashi MD , Jacqueline Contento BSE , Hiroshi Matsushita MD , Paige Mass MS , Vincent Cleveland MS , Seda Aslan MS , Amartya Dave BS , Raquel dos Santos , Angie Zhu , Emmett Reid , Tatsuya Watanabe MD, PhD , Nora Lee MPAP, PA-C , Tyler Dunn BS , Umar Siddiqi , Katherine Nurminsky BS , Vivian Nguyen BA , Keigo Kawaji PhD , Joey Huddle MS , Luka Pocivavsek MD, PhD , Jed Johnson PhD , Narutoshi Hibino MD, PhD

Objective(s)

The complexity of aortic arch reconstruction due to diverse 3-dimensional geometrical abnormalities is a major challenge. This study introduces 3-dimensional printed tissue-engineered vascular grafts, which can fit patient-specific dimensions, optimize hemodynamics, exhibit antithrombotic and anti-infective properties, and accommodate growth.

Methods

We procured cardiac magnetic resonance imaging with 4-dimensional flow for native porcine anatomy (n = 10), from which we designed tissue-engineered vascular grafts for the distal aortic arch, 4 weeks before surgery. An optimal shape of the curved vascular graft was designed using computer-aided design informed by computational fluid dynamics analysis. Grafts were manufactured and implanted into the distal aortic arch of porcine models, and postoperative cardiac magnetic resonance imaging data were collected. Pre- and postimplant hemodynamic data and histology were analyzed.

Results

Postoperative magnetic resonance imaging of all pigs with 1:1 ratio of polycaprolactone and poly-L-lactide-co-ε-caprolactone demonstrated no specific dilatation or stenosis of the graft, revealing a positive growth trend in the graft area from the day after surgery to 3 months later, with maintaining a similar shape. The peak wall shear stress of the polycaprolactone/poly-L-lactide-co-ε-caprolactone graft portion did not change significantly between the day after surgery and 3 months later. Immunohistochemistry showed endothelization and smooth muscle layer formation without calcification of the polycaprolactone/poly-L-lactide-co-ε-caprolactone graft.

Conclusions

Our patient-specific polycaprolactone/poly-L-lactide-co-ε-caprolactone tissue-engineered vascular grafts demonstrated optimal anatomical fit maintaining ideal hemodynamics and neotissue formation in a porcine model. This study provides a proof of concept of patient-specific tissue-engineered vascular grafts for aortic arch reconstruction.

由于三维几何形状异常,主动脉弓重建的复杂性成为一大挑战。本研究介绍了三维打印的组织工程血管移植物,它可以适应患者的特定尺寸,优化血液动力学,表现出抗血栓和抗感染特性,并能适应生长。方法 我们在手术前 4 周获得了猪原生解剖结构(n = 10)的四维血流心脏磁共振成像,并据此设计了主动脉弓远端的组织工程血管移植物。在计算流体动力学分析的基础上,我们使用计算机辅助设计技术设计出了最佳形状的弯曲血管移植物。制造出的移植物被植入猪模型的主动脉弓远端,并收集了术后心脏磁共振成像数据。结果所有猪的术后磁共振成像都显示,聚己内酯和聚-L-内酯-共-ε-己内酯的比例为 1:1,移植物没有特殊的扩张或狭窄,从术后第二天到 3 个月后,移植物的面积呈正增长趋势,形状保持相似。聚己内酯/聚左旋-右旋-ε-己内酯移植物部分的峰值壁剪切应力在术后一天到三个月之间没有明显变化。免疫组化结果显示,聚己内酯/聚 L-内酯-共ε-己内酯移植物的内皮化和平滑肌层形成,但没有钙化。这项研究证明了患者特异性组织工程血管移植物用于主动脉弓重建的概念。
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引用次数: 0
Enhanced Recovery After Surgery Cardiac Society turnkey order set for prevention and management of postoperative atrial fibrillation after cardiac surgery: Proceedings from the American Association for Thoracic Surgery ERAS Conclave 2023 ERAS心脏学会用于预防和管理心脏手术后心房颤动的统包订单集:美国心脏学会ERAS 2023年会议论文集
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2024.02.008
Subhasis Chatterjee MD , Busra Cangut MD , Amanda Rea DNP, CRNP, AGACNP-BC, CCRN, CMC, CSC, E-AEC , Rawn Salenger MD , Rakesh C. Arora MD , Michael C. Grant MD , Vicki Morton-Bailey DNP, MSN, AGNP-BC , Sameer Hirji MD, MPH , Daniel T. Engelman MD

Background

Postoperative atrial fibrillation (POAF) is a prevalent complication following cardiac surgery that is associated with increased adverse events. Several guidelines and expert consensus documents have been published addressing the prevention and management of POAF. We aimed to develop an order set to facilitate widespread implementation and adoption of evidence-based practices for POAF following cardiac surgery.

Methods

Subject matter experts were consulted to translate existing guidelines and literature into a sample turnkey order set (TKO) for POAF. Orders derived from consistent class I or IIA or equivalent recommendations across referenced guidelines and consensus manuscripts appear in the TKO in bold type. Selected orders that were inconsistently class I or IIA, class IIB, or supported by published evidence appear in italic type.

Results

Preoperatively, the recommendation is to screen patients for paroxysmal or chronic atrial fibrillation and initiate appropriate treatment based on individual risk stratification for the development of POAF. This may include the administration of beta-blockers or amiodarone, tailored to the patient's specific risk profile. Intraoperatively, surgical interventions such as posterior pericardiotomy should be considered in selected patients. Postoperatively, it is crucial to focus on electrolyte normalization, implementation strategies for rate or rhythm control, and anticoagulation management. These comprehensive measures aim to optimize patient outcomes and reduce the occurrence of POAF following cardiac surgery.

Conclusions

Despite the well-established benefits of implementing a multidisciplinary care pathway for POAF in cardiac surgery, its adoption and implementation remain inconsistent. We have developed a readily applicable order set that incorporates recommendations from existing guidelines.

背景术后心房颤动(POAF)是心脏手术后的一种常见并发症,与不良事件的增加有关。目前已发布了多份指南和专家共识文件,旨在预防和处理 POAF。我们的目标是制定一套医嘱,以促进心脏手术后 POAF 循证实践的广泛实施和采用。方法咨询相关专家,将现有指南和文献转化为 POAF 的整套医嘱样本 (TKO)。根据参考指南和共识手稿中一致的 I 级或 IIA 级或同等建议制定的医嘱以粗体字显示在 TKO 中。结果术前,建议筛查阵发性或慢性心房颤动患者,并根据发生 POAF 的个体风险分层启动适当的治疗。这可能包括根据患者的具体风险情况使用β-受体阻滞剂或胺碘酮。术中,应考虑对特定患者进行手术干预,如后心包切开术。术后重点关注电解质正常化、实施心率或心律控制策略以及抗凝管理,这一点至关重要。这些综合措施旨在优化患者预后,减少心脏手术后 POAF 的发生。结论尽管针对心脏手术后 POAF 实施多学科护理路径的益处已得到充分证实,但其采用和实施情况仍不一致。我们开发了一套易于应用的指令集,其中包含了现有指南中的建议。
{"title":"Enhanced Recovery After Surgery Cardiac Society turnkey order set for prevention and management of postoperative atrial fibrillation after cardiac surgery: Proceedings from the American Association for Thoracic Surgery ERAS Conclave 2023","authors":"Subhasis Chatterjee MD ,&nbsp;Busra Cangut MD ,&nbsp;Amanda Rea DNP, CRNP, AGACNP-BC, CCRN, CMC, CSC, E-AEC ,&nbsp;Rawn Salenger MD ,&nbsp;Rakesh C. Arora MD ,&nbsp;Michael C. Grant MD ,&nbsp;Vicki Morton-Bailey DNP, MSN, AGNP-BC ,&nbsp;Sameer Hirji MD, MPH ,&nbsp;Daniel T. Engelman MD","doi":"10.1016/j.xjon.2024.02.008","DOIUrl":"10.1016/j.xjon.2024.02.008","url":null,"abstract":"<div><h3>Background</h3><p>Postoperative atrial fibrillation (POAF) is a prevalent complication following cardiac surgery that is associated with increased adverse events. Several guidelines and expert consensus documents have been published addressing the prevention and management of POAF. We aimed to develop an order set to facilitate widespread implementation and adoption of evidence-based practices for POAF following cardiac surgery.</p></div><div><h3>Methods</h3><p>Subject matter experts were consulted to translate existing guidelines and literature into a sample turnkey order set (TKO) for POAF. Orders derived from consistent class I or IIA or equivalent recommendations across referenced guidelines and consensus manuscripts appear in the TKO in bold type. Selected orders that were inconsistently class I or IIA, class IIB, or supported by published evidence appear in italic type.</p></div><div><h3>Results</h3><p>Preoperatively, the recommendation is to screen patients for paroxysmal or chronic atrial fibrillation and initiate appropriate treatment based on individual risk stratification for the development of POAF. This may include the administration of beta-blockers or amiodarone, tailored to the patient's specific risk profile. Intraoperatively, surgical interventions such as posterior pericardiotomy should be considered in selected patients. Postoperatively, it is crucial to focus on electrolyte normalization, implementation strategies for rate or rhythm control, and anticoagulation management. These comprehensive measures aim to optimize patient outcomes and reduce the occurrence of POAF following cardiac surgery.</p></div><div><h3>Conclusions</h3><p>Despite the well-established benefits of implementing a multidisciplinary care pathway for POAF in cardiac surgery, its adoption and implementation remain inconsistent. We have developed a readily applicable order set that incorporates recommendations from existing guidelines.</p></div>","PeriodicalId":74032,"journal":{"name":"JTCVS open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666273624000433/pdfft?md5=2b7e73572aa7010d90b03e490b35ee9d&pid=1-s2.0-S2666273624000433-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140463874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The high-risk features among patients undergoing mitral valve operation for ischemic mitral regurgitation: The 3-strike score 因缺血性二尖瓣反流而接受二尖瓣手术的患者的高危特征:3-strike 评分
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2024.02.017
Makoto Mori MD, PhD , Christina Waldron BS , Sigurdur Ragnarsson MD , Markus Krane MD , Arnar Geirsson MD

Objective

Ischemic mitral regurgitation is prevalent and associated with high surgical risk. With the less-invasive option of transcatheter edge-to-edge repair, the optimal patient selection for mitral valve operation for ischemic mitral regurgitation remains unclear. We sought to identify high-risk features in this group to guide patient selection.

Methods

Using the Cardiothoracic Surgery Trial Network's severe ischemic mitral regurgitation trial data, we identified patient and echocardiographic characteristics associated with an increased risk of 2-year mortality using the support vector classifier and Cox proportional hazards model. We identified 6 high-risk features associated with 2-year survival. Patients were categorized into 3 groups, each having 1 or less, 2, or 3 or more of the 6 identified high-risk features.

Results

Among the 251 patients, the median age was 69 (Q1 62, Q3 75) years, and 96 (38%) were female. Two-year mortality was 21% (n = 53). We identified 6 high-risk preoperative features: age 75 years or more (n = 69, 28%), prior sternotomy (n = 49, 20%), renal insufficiency (n = 69, 28%), gastrointestinal bleeding (n = 15, 6%), left ventricular ejection fraction less than 40% (n = 131, 52%), and ventricular end-systolic volume index less than 50 mL/m2 (n = 93, 37%). In patients who had 1 or less, 2, and 3 or more high-risk features, 90-day mortality was 4.2% (n = 5), 9.9% (n = 4), and 20.0% (n = 10), respectively (P = .006), and 2-year mortality was 10% (n = 12), 22% (n = 18), and 46% (n = 23) (P < .001), respectively.

Conclusions

We developed the 3-strike score by identifying high-risk preoperative features for mitral valve surgery for ischemic mitral regurgitation. Patients having 3 or more of such high-risk features should undergo careful evaluation for surgical candidacy given the high early and late mortality after mitral valve operations.

目的缺血性二尖瓣反流很普遍,而且手术风险很高。由于经导管边缘对边缘修复术的创伤较小,缺血性二尖瓣反流二尖瓣手术的最佳患者选择仍不明确。方法利用心胸外科试验网络(Cardiothoracic Surgery Trial Network)的严重缺血性二尖瓣反流试验数据,我们使用支持向量分类器和 Cox 比例危险模型确定了与 2 年死亡率风险增加相关的患者和超声心动图特征。我们确定了与 2 年生存率相关的 6 个高风险特征。结果251名患者中,中位年龄为69岁(Q1为62岁,Q3为75岁),96人(38%)为女性。两年死亡率为 21%(n = 53)。我们发现了 6 个术前高危特征:75 岁或以上(n = 69,28%)、曾行胸骨切开术(n = 49,20%)、肾功能不全(n = 69,28%)、消化道出血(n = 15,6%)、左室射血分数低于 40%(n = 131,52%)和心室收缩末期容积指数低于 50 mL/m2 (n = 93,37%)。在具有 1 个或更少、2 个和 3 个或更多高危特征的患者中,90 天死亡率分别为 4.2%(n = 5)、9.9%(n = 4)和 20.0%(n = 10)(P = .006),2 年死亡率分别为 10%(n = 12)、22%(n = 18)和 46%(n = 23)(P < .结论我们通过识别缺血性二尖瓣反流二尖瓣手术的术前高危特征,制定了3-strike评分。鉴于二尖瓣手术后的早期和晚期死亡率较高,具有 3 个或 3 个以上此类高风险特征的患者应仔细评估是否适合手术。
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引用次数: 0
Donor heart refusal after circulatory death: An analysis of United Network for Organ Sharing refusal codes 循环死亡后拒绝捐献心脏:对联合器官共享网络拒绝代码的分析
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2024.02.010
Tyler M. Dann BS , Brianna L. Spencer MD , Spencer K. Wilhelm MD , Sarah K. Drake MA, MLIS , Robert H. Bartlett MD , Alvaro Rojas-Pena MD , Daniel H. Drake MD

Objective

Donor hearts procured after circulatory death (DCD) may significantly increase the number of hearts available for transplantation. The purpose of this study was to analyze current DCD and brain-dead donor (DBD) heart transplantation rates and characterize organ refusal using the most up-to-date United Network for Organ Sharing (UNOS) and Organ Procurement and Transplantation Network data.

Methods

We analyzed UNOS and Organ Procurement and Transplantation Network DBD and DCD candidate, transplantation, and demographic data from 2020 through 2022 and 2022 refusal code data to characterize DCD heart use and refusal. Subanalyses were performed to characterize DCD donor demographics and regional transplantation rate variance.

Results

DCD hearts were declined 3.37 times more often than DBD hearts. The most frequently used code for DCD refusal was neurologic function, related to concerns of a prolonged dying process and organ preservation. In 2022, 92% (1329/1452) of all DCD refusals were attributed to neurologic function. When compared with DBD, DCD donor hearts were more frequently declined as the result of prolonged warm ischemic time (odds ratio, 5.65; 95% confidence interval, 4.07-7.86) and other concerns over organ preservation (odds ratio, 4.06; 95% confidence interval, 3.33-4.94). Transplantation rate variation was observed between demographic groups and UNOS regions. DCD transplantation rates are currently experiencing second order polynomial growth.

Conclusions

DCD donor hearts are declined more frequently than DBD. DCD heart refusals result from concerns over a prolonged dying process and organ preservation. Heart transplantation rates may be substantially improved by ex situ hemodynamic assessment, adoption of normothermic regional perfusion guidelines, and quality initiatives.

目的循环死亡(DCD)后获取的供体心脏可显著增加可用于移植的心脏数量。方法我们分析了 2020 年至 2022 年联合国器官共享网络(UNOS)和器官采购与移植网络的 DBD 和 DCD 候选者、移植和人口统计学数据,以及 2022 年的拒绝代码数据,以描述 DCD 心脏使用和拒绝的特征。结果DCD心脏被拒绝的频率是DBD心脏的3.37倍。拒绝DCD最常用的代码是神经功能,这与担心死亡过程延长和器官保存有关。2022 年,92%(1329/1452)的 DCD 拒绝归因于神经功能。与 DBD 相比,DCD 供体心脏更常因温暖缺血时间延长(几率比为 5.65;95% 置信区间为 4.07-7.86)和对器官保存的其他担忧(几率比为 4.06;95% 置信区间为 3.33-4.94)而被拒绝。移植率在不同人口群体和 UNOS 地区之间存在差异。目前,DCD 的移植率呈二阶多项式增长。拒绝 DCD 心脏捐献的原因是对死亡过程延长和器官保存的担忧。通过原位血流动力学评估、采用常温区域灌注指南和质量措施,可大大提高心脏移植率。
{"title":"Donor heart refusal after circulatory death: An analysis of United Network for Organ Sharing refusal codes","authors":"Tyler M. Dann BS ,&nbsp;Brianna L. Spencer MD ,&nbsp;Spencer K. Wilhelm MD ,&nbsp;Sarah K. Drake MA, MLIS ,&nbsp;Robert H. Bartlett MD ,&nbsp;Alvaro Rojas-Pena MD ,&nbsp;Daniel H. Drake MD","doi":"10.1016/j.xjon.2024.02.010","DOIUrl":"10.1016/j.xjon.2024.02.010","url":null,"abstract":"<div><h3>Objective</h3><p>Donor hearts procured after circulatory death (DCD) may significantly increase the number of hearts available for transplantation. The purpose of this study was to analyze current DCD and brain-dead donor (DBD) heart transplantation rates and characterize organ refusal using the most up-to-date United Network for Organ Sharing (UNOS) and Organ Procurement and Transplantation Network data.</p></div><div><h3>Methods</h3><p>We analyzed UNOS and Organ Procurement and Transplantation Network DBD and DCD candidate, transplantation, and demographic data from 2020 through 2022 and 2022 refusal code data to characterize DCD heart use and refusal. Subanalyses were performed to characterize DCD donor demographics and regional transplantation rate variance.</p></div><div><h3>Results</h3><p>DCD hearts were declined 3.37 times more often than DBD hearts. The most frequently used code for DCD refusal was neurologic function, related to concerns of a prolonged dying process and organ preservation. In 2022, 92% (1329/1452) of all DCD refusals were attributed to neurologic function. When compared with DBD, DCD donor hearts were more frequently declined as the result of prolonged warm ischemic time (odds ratio, 5.65; 95% confidence interval, 4.07-7.86) and other concerns over organ preservation (odds ratio, 4.06; 95% confidence interval, 3.33-4.94). Transplantation rate variation was observed between demographic groups and UNOS regions. DCD transplantation rates are currently experiencing second order polynomial growth.</p></div><div><h3>Conclusions</h3><p>DCD donor hearts are declined more frequently than DBD. DCD heart refusals result from concerns over a prolonged dying process and organ preservation. Heart transplantation rates may be substantially improved by ex situ hemodynamic assessment, adoption of normothermic regional perfusion guidelines, and quality initiatives.</p></div>","PeriodicalId":74032,"journal":{"name":"JTCVS open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666273624000457/pdfft?md5=bb2b93ebb5efa998e7bc72b3d3a075f1&pid=1-s2.0-S2666273624000457-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140466789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Determining optimal air leak resolution criteria when using digital pleural drainage device after lung resection 确定肺切除术后使用数字胸膜引流装置时的最佳漏气解决标准
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2024.01.016
Mohsen Alayche BSc , Justen Choueiry BSc , Adnan Mekdachi BMSc , Donna E. Maziak MD , Andrew J.E. Seely MD, PhD , Sudhir R. Sundaresan MD , Patrick J. Villeneuve MD, PhD , Daniel Jones MD, MPH , William Klement PhD , Sebastien Gilbert MD

Objective

There is limited clinical evidence to support any specific parenchymal air leak resolution criteria when using digital pleural drainage devices following lung resection. The aim of this study is to determine an optimal air leak resolution criteria, where duration of chest tube drainage is minimized while avoiding complications from premature chest tube removal.

Methods

Airflow data averaged at 10-minute intervals was collected prospectively using a digital pleural drainage device (Thopaz; Medela) in 400 patients from 2015 to 2019. All permutations of air leak resolution criteria from <10 to 100 mL/minute for 4 to 12 hours were applied retrospectively to the pleural drainage data to determine air leak duration, and air leak recurrence frequency and volume. Air leak recurrence indicates potential for rather than occurrence of adverse events. Descriptive statistics were used to identify the optimal criteria based on patient safety (low frequency and volume of air leak recurrences), and efficiency (shortest initial air leak duration).

Results

The majority of the 400 patients underwent lobectomy (57% [227 out of 400]), wedge resections (29% [115 out of 400]), or segmentectomies (8% [32 out of 400]) for lung cancer (90% [360 out of 400]). An airflow threshold <50 mL/minute resulted in longer air leak duration before meeting the criteria for air leak resolution (P < .0001). Air leak recurrence frequency and volume were greater in patients with a monitoring period <8 consecutive hours (P < .0001).

Conclusions

When using a digital pleural drainage device, a postoperative air leak resolution criteria <50 mL/minute for 8 consecutive hours was associated with the best safety and efficiency profile.

目的在肺切除术后使用数字胸膜引流装置时,支持任何特定实质气漏解决标准的临床证据有限。本研究的目的是确定最佳气漏解决标准,在此标准下,胸管引流持续时间最短,同时避免过早拔除胸管引起的并发症。方法从 2015 年到 2019 年,使用数字胸膜引流装置(Thopaz; Medela)对 400 例患者进行了前瞻性气流数据收集,每隔 10 分钟收集一次平均值。对胸膜引流数据进行了回顾性应用,以确定漏气持续时间、漏气复发频率和漏气量。漏气复发表明可能发生不良事件,而不是已经发生。结果 400 名患者中的大多数因肺癌接受了肺叶切除术(57% [400例中的227例])、楔形切除术(29% [400例中的115例])或肺段切除术(8% [400例中的32例])(90% [400例中的360例])。气流阈值<50 毫升/分钟会导致在达到气漏解决标准之前的气漏持续时间更长(P< .0001)。结论在使用数字胸膜引流装置时,连续 8 小时达到 50 毫升/分钟的术后气流阈值与最佳安全性和效率相关。
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引用次数: 0
En bloc chest wall resection in locally advanced cT3N2 (stage IIIB) lung cancer involving the chest wall: Revisiting guidelines 涉及胸壁的局部晚期 cT3N2(IIIB 期)肺癌的胸壁内固定切除术:重新审视指南
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2023.12.007
Joseph F. Zywiciel BS , Raymond A. Verm MD , Wissam Raad MD , Marshall Baker MD, FACS , Richard Freeman MD, MBA , Zaid M. Abdelsattar MD, MS, FACS

Objectives

Current National Comprehensive Cancer Network guidelines recommend definitive chemoradiation rather than surgery for patients with locally advanced clinical stage T3 and N2 (stage IIIB) lung cancer involving the chest wall. The data supporting this recommendation are controversial. We studied whether surgery confers a survival advantage over definitive chemoradiation in the National Cancer Database.

Methods

We identified all patients with clinical stage T3 and N2 lung cancer in the National Cancer Database from 2004 to 2017 who underwent a lobectomy with en bloc chest wall resection and compared them with patients with clinical stage T3 and N2 lung cancer who had definitive chemoradiation. We used propensity score matching to minimize confounding by indication while excluding patients with tumors in the upper lobes to exclude Pancoast tumors. We used 1:1 propensity score matching and Kaplan–Meir survival analyses to estimate associations.

Results

Of 4467 patients meeting all inclusion/exclusion criteria, 210 (4.49%) had an en bloc chest wall resection. Patients undergoing surgical resection were younger (mean age = 60.3 ± 10.3 years vs 67.5 ± 10.4 years; P < .001) and had more adenocarcinoma (59.0% vs 44.5%; P < .001) but were otherwise similar in terms of sex (37.1% female vs 42.0%; P = .167) and race (Whites 84.3% vs 84.0%; P = .276) compared with the definitive chemoradiation group. After resection, there was an unadjusted 30- and 90-day mortality rate of 3.3% and 9.5%, respectively. A substantial survival benefit with surgical resection persisted after propensity score matching (log-rank P < .001).

Conclusions

In this large observational study, we found that in select patients, en bloc chest wall resection for locally advanced clinical stage T3 and N2 lung cancer was associated with improved survival compared with definitive chemoradiation. National Comprehensive Cancer Network guidelines should be revisited.

目的美国国家综合癌症网络(National Comprehensive Cancer Network)的现行指南建议,对于涉及胸壁的局部晚期临床分期为 T3 和 N2(IIIB 期)的肺癌患者,应进行明确的化疗而非手术治疗。支持这一建议的数据存在争议。我们在全国癌症数据库中研究了手术是否比确定性化疗更具生存优势。方法我们在全国癌症数据库中识别了2004年至2017年所有接受了胸壁全切的肺叶切除术的临床T3期和N2期肺癌患者,并与接受确定性化疗的临床T3期和N2期肺癌患者进行了比较。我们采用倾向得分匹配法来尽量减少适应症的混杂,同时排除上叶肿瘤患者,以排除潘氏肿瘤。我们使用 1:1 倾向性评分匹配和 Kaplan-Meir 生存分析来估计相关性。结果 在 4467 例符合所有纳入/排除标准的患者中,210 例(4.49%)进行了胸壁全切。接受手术切除的患者年龄较小(平均年龄 = 60.3 ± 10.3 岁 vs 67.5 ± 10.4 岁;P < .001),腺癌患者较多(59.0% vs 44.5%;P < .001),但在性别(37.1% 女性 vs 42.0%;P = .167)和种族(白人 84.3% vs 84.0%;P = .276)方面与化疗组相似。切除术后,未经调整的 30 天和 90 天死亡率分别为 3.3% 和 9.5%。结论在这项大型观察性研究中,我们发现与确定性化疗相比,对局部晚期临床分期为 T3 和 N2 的肺癌患者进行胸壁全块切除可提高生存率。应重新审视美国国家综合癌症网络指南。
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引用次数: 0
Shouldn’t we first follow the guidelines before implementing alternative mechanical circulatory support modalities? 在实施替代性机械循环支持模式之前,我们是否应该首先遵循指导原则?
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2024.01.001
Maximillian Vondran MD , Alexander Kaminski MD , Simon Schemke MD , Matthias Heringlake MD
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引用次数: 0
The necessity of preoperative planning and nodule localization in the modern era of thoracic surgery 现代胸外科手术中术前规划和结节定位的必要性
Pub Date : 2024-04-01 DOI: 10.1016/j.xjon.2024.01.004
Stijn Vanstraelen MD , Gaetano Rocco MD , Bernard J. Park MD , David R. Jones MD
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引用次数: 0
期刊
JTCVS open
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