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Bioengineered Human Arteries for the Repair of Vascular Injuries. 用于修复血管损伤的生物工程人体动脉。
IF 15.7 1区 医学 Q1 SURGERY Pub Date : 2024-11-20 DOI: 10.1001/jamasurg.2024.4893
Ernest E Moore, Michael Curi, Nicholas Namias, Rishi Kundi, Ying Wei Lum, Charles J Fox, Ravi R Rajani, Todd E Rasmussen, Oleksandr Sokolov, Laura E Niklason, Zakaria Khondker, Shamik J Parikh
<p><strong>Importance: </strong>Vascular injuries require urgent repair to minimize loss of limb and life. Standard revascularization relies on autologous vein or synthetic grafts, but alternative options are needed when adequate vein is not feasible and when clinical conditions preclude safe use of synthetic materials.</p><p><strong>Objective: </strong>To evaluate the performance of the acellular tissue engineered vessel (ATEV) in the repair of arterial injuries.</p><p><strong>Design, setting, and participants: </strong>Two open-label, single-arm, nonrandomized clinical trials, including 1 prospective civilian study (CLN-PRO-V005 [V005]) and 1 retrospective observational study in a war zone (CLN-PRO-V017 [V017]), were conducted from September 2018 to January 2024 (follow-up ongoing) at 19 level 1 trauma centers in the US and Israel and 5 frontline hospitals in Ukraine. Patients had vascular injury, no autologous vein available for emergent revascularization, and risk factors for wound infection. Data were analyzed from September 2023 to January 2024.</p><p><strong>Intervention: </strong>The ATEV is a bioengineered vascular conduit grown from human vascular cells, available off the shelf, and implantable without immunosuppression.</p><p><strong>Main outcomes and measures: </strong>Primary patency at day 30 was the primary outcome. Secondary outcomes included limb salvage, graft infection, and patient survival. A systematic literature review identified synthetic graft benchmarks in the treatment of arterial trauma for the same end points.</p><p><strong>Results: </strong>The V005 and V017 studies evaluated 69 and 17 patients, respectively, and included 51 in V005 and 16 in V017 with noniatrogenic arterial injuries of the extremities. The majority were male (V005, 38 [74.5%]; V017, 16 [100%]), the mean (SD) ages were similar (V005, 33.5 [13.6] years; V017, 34.2 [9.0] years), and the mean (SD) Injury Severity Scores were similar (V005, 20.8 [10.5]; V017, 20.1 [18.9]). Penetrating injuries dominated (V005, 29 patients [56.9%]; V017, 14 patients [87.5%]). At day 30 for the V005 and V017 trials, respectively, ATEV primary patency was 84.3% (95% CI, 72.0%-91.8%) and 93.8% (95% CI, 71.7%-98.9%); secondary patency was 90.2% (95% CI, 79.0%-95.7%) and 93.8% (95% CI, 71.7%-98.9%); amputation rate was 9.8% (95% CI, 4.3%-21.0%) and 0% (95% CI, 0.0%-19.4%); ATEV infection rate was 2.0% (95% CI, 0.4%-10.3%) and 0% (95% CI, 0.0%-19.4%); and death rate was 5.9% (95% CI, 2.0%-15.9%) and 0% (95% CI, 0.0%-19.4%) (no deaths attributed to the ATEV). Day 30 synthetic graft benchmarks were as follows: secondary patency, 78.9%; amputation, 24.3%; infection, 8.4%; and death, 3.4%.</p><p><strong>Conclusions and relevance: </strong>Results of 2 single-arm trials in civilian and real-world military settings suggest that the ATEV provides benefits in terms of patency, limb salvage, and infection resistance. Comparing ATEV outcomes with synthetic graft benchmarks demonstrates im
重要性:血管损伤需要紧急修复,以尽量减少肢体和生命损失。标准的血管再造术依赖于自体静脉或合成移植物,但当无法获得足够的静脉以及临床条件不允许安全使用合成材料时,就需要替代方案:评估无细胞组织工程血管(ATEV)在修复动脉损伤方面的性能:两项开放标签、单臂、非随机临床试验,包括 1 项前瞻性民用研究(CLN-PRO-V005 [V005])和 1 项战区回顾性观察研究(CLN-PRO-V017 [V017]),于 2018 年 9 月至 2024 年 1 月在美国和以色列的 19 家一级创伤中心以及乌克兰的 5 家前线医院进行(随访仍在进行中)。患者存在血管损伤、无自体静脉可供紧急血管再通,以及伤口感染的风险因素。数据分析时间为 2023 年 9 月至 2024 年 1 月:ATEV是一种由人类血管细胞培育而成的生物工程血管导管,现货供应,无需免疫抑制即可植入:主要结果和测量指标:第30天的主要通畅率是主要结果。次要结果包括肢体挽救率、移植物感染率和患者存活率。系统性文献综述确定了动脉创伤治疗中相同终点的合成移植物基准:V005 和 V017 两项研究分别对 69 名和 17 名患者进行了评估,其中 V005 和 V017 分别对 51 名和 16 名四肢非iatrogenic 动脉损伤患者进行了评估。大部分患者为男性(V005,38 [74.5%];V017,16 [100%]),平均(标清)年龄相似(V005,33.5 [13.6]岁;V017,34.2 [9.0]岁),平均(标清)损伤严重程度评分相似(V005,20.8 [10.5];V017,20.1 [18.9])。穿透性损伤占多数(V005,29 名患者 [56.9%];V017,14 名患者 [87.5%])。在 V005 和 V017 试验的第 30 天,ATEV 一级通畅率分别为 84.3%(95% CI,72.0%-91.8%)和 93.8%(95% CI,71.7%-98.9%);二级通畅率分别为 90.2%(95% CI,79.0%-95.7%)和 93.8%(95% CI,71.7%-98.9%);截肢率分别为 9.8%(95% CI,4.3%-21.0%)和 0%(95% CI,0.0%-19.4%);ATEV 感染率为 2.0%(95% CI,0.4%-10.3%)和 0%(95% CI,0.0%-19.4%);死亡率为 5.9%(95% CI,2.0%-15.9%)和 0%(95% CI,0.0%-19.4%)(没有因 ATEV 导致的死亡)。第30天合成移植物基准如下:二次通畅率78.9%;截肢率24.3%;感染率8.4%;死亡率3.4%:在民用和实际军事环境中进行的两项单臂试验结果表明,ATEV 在通畅性、肢体挽救和抗感染方面具有优势。将 ATEV 的疗效与合成移植物的基准进行比较后发现,治疗四肢急性血管损伤的效果更好:试验注册:ClinicalTrials.gov Identifiers:NCT03005418、NCT05873959。
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引用次数: 0
Long-Term Outcomes of Early Surgery vs Endoscopy First in Chronic Pancreatitis: Follow-Up Analysis of the ESCAPE Randomized Clinical Trial. 慢性胰腺炎患者早期手术与先行内镜检查的长期疗效对比:ESCAPE随机临床试验的随访分析。
IF 15.7 1区 医学 Q1 SURGERY Pub Date : 2024-11-20 DOI: 10.1001/jamasurg.2024.5182
Charlotte L van Veldhuisen, Marinus A Kempeneers, Florence E M de Rijk, Stefan A Bouwense, Marco J Bruno, Paul Fockens, Jan W Poley, Usama Ahmed Ali, Thomas L Bollen, Olivier R Busch, Peter van Duijvendijk, Hendrik M van Dullemen, Casper H van Eijck, Harry Van Goor, Muhanned Hadithi, Jan-Willem Haveman, Yolande Keulemans, Vincent B Nieuwenhuijs, Alexander C Poen, Rogier P Voermans, Adriaan C Tan, Willem Thijs, Robert C Verdonk, Ben J Witteman, Jeanin E van Hooft, Hjalmar C van Santvoort, Marcel G Dijkgraaf, Marc G Besselink, Marja A Boermeester, Yama Issa
<p><strong>Importance: </strong>Patients with painful chronic pancreatitis and a dilated pancreatic duct can be treated by early surgery or an endoscopy-first approach.</p><p><strong>Objective: </strong>To compare long-term clinical outcomes of early surgery vs an endoscopy-first approach using follow-up data from the ESCAPE randomized clinical trial.</p><p><strong>Design, setting, and participants: </strong>Between April 2011 and September 2018, 88 patients with painful chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach in 30 hospitals in the Netherlands collaborating in the Dutch Pancreatitis Study Group as part of the ESCAPE randomized clinical trial. For the present cohort study, long-term clinical data were collected after the initial 18-month follow-up. Follow-up was completed in June 2022, and data analysis was performed in June 2023.</p><p><strong>Exposure: </strong>Patients with chronic pancreatitis were randomly assigned to early surgery or an endoscopy-first approach.</p><p><strong>Main outcomes and measures: </strong>The primary end point was pain, assessed by the Izbicki pain score; secondary end points included patient-reported complete pain relief and satisfaction. Predefined subgroups included patients who progressed from endoscopy to surgery and those with ductal clearance obtained by endoscopy. Analysis was performed according to the intention-to-treat principle.</p><p><strong>Results: </strong>In this cohort study, 86 of 88 overall patients could be evaluated, with a mean (SD) follow-up period of 98 (16) months. Of 88 initial patients, 21 patients (24%) were female, and mean (SD) patient age was 61 (10) years. At the end of long-term follow-up, the mean (SD) Izbicki pain score was significant lower (33 [31] vs 51 [31]) in the early surgery group, as was the rate of patient-reported complete pain relief (14 of 31 patients [45%] vs 6 of 30 patients [20%]), compared to the endoscopy-first group. After the initial 18-month follow-up, 11 of 43 patients in the early surgery group (26%) underwent reinterventions vs 19 of 43 patients in the endoscopy-first group (44%). At the end of follow-up, more patients in the early surgery group were "very satisfied" with their treatment (22 of 31 patients [71%] vs 10 of 30 patients [33%]). Patients who progressed from endoscopy to surgery (22 of 43 patients [51%]) had significantly worse mean (SD) Izbicki pain scores (33 [31] vs 52 [24]) compared to the early surgery group and had a lower rate of complete pain relief (55% for early surgery vs 12% for endoscopy first). In the endoscopy-first group, patients with endoscopic ductal clearance had similar mean (SD) Izbicki pain scores as the remaining patients (49 [34] vs 53 [28]).</p><p><strong>Conclusions and relevance: </strong>In this cohort study evaluating long-term outcomes of the ESCAPE randomized clinical trial, after approximately 8 years of follow-up, early surgery was superior to an endoscopy-first
重要性:患有疼痛性慢性胰腺炎和胰管扩张的患者可通过早期手术或内镜先行方法进行治疗:利用ESCAPE随机临床试验的随访数据,比较早期手术与内镜先行方法的长期临床疗效:2011年4月至2018年9月期间,作为ESCAPE随机临床试验的一部分,荷兰胰腺炎研究小组(Dutch Pancreatitis Study Group)合作的30家医院将88名疼痛性慢性胰腺炎患者随机分配到早期手术或内镜先行方法治疗。本队列研究在最初的18个月随访后收集了长期临床数据。随访于2022年6月结束,数据分析于2023年6月进行:主要结果和测量指标:主要终点是疼痛,由伊兹比奇疼痛评分评估;次要终点包括患者报告的完全缓解疼痛和满意度。预定义亚组包括从内镜检查进展到手术的患者和内镜检查获得导管清除的患者。分析按照意向治疗原则进行:在这项队列研究中,88 位患者中有 86 位接受了评估,平均(标清)随访时间为 98(16)个月。在 88 名首发患者中,21 名患者(24%)为女性,平均(标清)年龄为 61(10)岁。在长期随访结束时,与先接受内窥镜检查的患者相比,早期手术组患者的平均(标度)伊兹比基疼痛评分显著降低(33 [31] vs 51 [31]),患者报告的疼痛完全缓解率也显著降低(31 例患者中的 14 例 [45%] vs 30 例患者中的 6 例 [20%])。在最初的18个月随访后,早期手术组43名患者中有11人(26%)接受了再干预,而先接受内镜检查组43名患者中有19人(44%)接受了再干预。在随访结束时,早期手术组有更多患者对治疗表示 "非常满意"(31 名患者中有 22 名患者表示 "非常满意"(71%),而 30 名患者中有 10 名患者表示 "非常满意"(33%))。与早期手术组相比,从内镜检查进展到手术的患者(43 例患者中的 22 例[51%])的平均(标度)伊兹比奇疼痛评分(33 [31] vs 52 [24])明显更差,完全缓解疼痛的比例也更低(早期手术为 55% vs 先进行内镜检查为 12%)。在内镜先行组中,内镜下导管清除患者的平均(标度)伊兹比奇疼痛评分与其余患者相似(49 [34] vs 53 [28]):在这项评估ESCAPE随机临床试验长期结果的队列研究中,经过约8年的随访,对于疼痛性慢性胰腺炎和主胰管扩张的患者,早期手术在疼痛评分和患者满意度方面优于先行内镜检查的方法。值得注意的是,与接受早期手术的患者相比,从内镜检查进展到手术的患者预后更差,而且获得内镜下胰管清除并不能改善预后。
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引用次数: 0
Sustainability in Surgery-Reinvesting in People Over Things. 外科手术的可持续性--重人轻物。
IF 15.7 1区 医学 Q1 SURGERY Pub Date : 2024-11-20 DOI: 10.1001/jamasurg.2024.4515
Neelima Tummala, Colleen M Fitzpatrick, Kelly N Wright
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引用次数: 0
Bioengineering on the Front Lines. 前线的生物工程。
IF 15.7 1区 医学 Q1 SURGERY Pub Date : 2024-11-20 DOI: 10.1001/jamasurg.2024.5137
Britt H Tonnessen, Alan Dardik
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引用次数: 0
The Quality of Evidence Supporting Clinical Practice Guidelines in General Surgery: A Meta-Analysis. 支持普外科临床实践指南的证据质量:一项 Meta 分析。
IF 15.7 1区 医学 Q1 SURGERY Pub Date : 2024-11-20 DOI: 10.1001/jamasurg.2024.4751
Ali B Abbasi, Adrian Valderrama, Hannah C Decker, Tasce Bongiovanni, Elizabeth C Wick
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引用次数: 0
Surgery-First for Painful Chronic Pancreatitis. 疼痛型慢性胰腺炎的首选手术。
IF 15.7 1区 医学 Q1 SURGERY Pub Date : 2024-11-20 DOI: 10.1001/jamasurg.2024.5181
Ville Sallinen, Arto Kokkola, Pauli Puolakkainen
{"title":"Surgery-First for Painful Chronic Pancreatitis.","authors":"Ville Sallinen, Arto Kokkola, Pauli Puolakkainen","doi":"10.1001/jamasurg.2024.5181","DOIUrl":"https://doi.org/10.1001/jamasurg.2024.5181","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":""},"PeriodicalIF":15.7,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675813","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
Histotripsy-A Novel and Intriguing Technique of Liver Ablation. 组织切削术--一种新颖而有趣的肝脏消融技术。
IF 15.7 1区 医学 Q1 SURGERY Pub Date : 2024-11-20 DOI: 10.1001/jamasurg.2024.2339
Colin J Rog, Mohamed Alassas, Evan Ong
{"title":"Histotripsy-A Novel and Intriguing Technique of Liver Ablation.","authors":"Colin J Rog, Mohamed Alassas, Evan Ong","doi":"10.1001/jamasurg.2024.2339","DOIUrl":"https://doi.org/10.1001/jamasurg.2024.2339","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":""},"PeriodicalIF":15.7,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675811","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
Is It Just Component Separation That Improves Reoperation Rates? 提高再手术率的仅仅是组件分离吗?
IF 15.7 1区 医学 Q1 SURGERY Pub Date : 2024-11-13 DOI: 10.1001/jamasurg.2024.5068
Wendy A Brown, Yit Leang, Kaleb R Lourensz
{"title":"Is It Just Component Separation That Improves Reoperation Rates?","authors":"Wendy A Brown, Yit Leang, Kaleb R Lourensz","doi":"10.1001/jamasurg.2024.5068","DOIUrl":"https://doi.org/10.1001/jamasurg.2024.5068","url":null,"abstract":"","PeriodicalId":14690,"journal":{"name":"JAMA surgery","volume":" ","pages":""},"PeriodicalIF":15.7,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620888","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
Travel to High-Volume Centers and Survival After Esophagectomy for Cancer 前往高流量中心就诊与癌症食管切除术后的存活率
IF 16.9 1区 医学 Q1 SURGERY Pub Date : 2024-11-13 DOI: 10.1001/jamasurg.2024.5009
Sara Sakowitz, Syed Shahyan Bakhtiyar, Saad Mallick, Jane Yanagawa, Peyman Benharash
ImportanceOngoing efforts have encouraged the regionalization of esophageal adenocarcinoma treatment to high-volume centers (HVCs). Yet such centralization has been linked with increased patient travel burden and reduced postoperative continuity of care.ObjectiveTo determine whether traveling to undergo esophagectomy at HVCs is linked with superior overall survival compared with receiving care locally at low-volume centers (LVC).Design, Setting, and ParticipantsThis cohort study considered data for all patients diagnosed with stage I through III esophageal adenocarcinoma in the 2010-2021 National Cancer Database. Patients were stratified based on distance traveled to receive care and the annual esophagectomy volume at the treating hospital: the travel-HVC cohort included patients in the top 25th percentile of travel burden who received care at centers in the top volume quartile, and the local-LVC cohort represented those in the bottom 25th percentile of travel burden who were treated at centers in the lowest volume quartile. Data were analyzed from July 2023 to January 2024.Main Outcomes and MeasuresThe primary end points were overall survival at 1 year and 5 years. Secondary end points included perioperative outcomes and factors linked with traveling to receive care.ResultsOf 17 970 patients, 2342 (13%) comprised the travel-HVC cohort, and 1969 (11%), the local-LVC cohort. The median (IQR) age was 65 (58-71) years; 3748 (87%) were male and 563 (13%) were female. After risk adjustment and with care at local LVCs as the reference, traveling to HVC was associated with superior survival at 1 year (hazard ratio for mortality [HR], 0.69; 95% CI, 0.58-0.83) and 5 years (HR, 0.80; 95% CI, 0.70-0.90). Stratifying by stage, traveling to HVCs was associated with comparable outcomes for stage I disease but reduced mortality for stage III (1-year HR, 0.72; 95% CI, 0.60-0.87; 5-year HR, 0.83; 95% CI, 0.74-0.93). Further, traveling to HVC was associated with greater lymph node harvest (β, 5.08 nodes; 95% CI, 3.78-6.37) and likelihood of margin-negative resection (adjusted odds ratio, 1.83; 95% CI, 1.29-2.60).Conclusions and RelevanceTraveling to HVCs for esophagectomy was associated with improved 1-year and 5-year survival compared with receiving care locally at LVCs, particularly among patients with locoregionally advanced disease. Future studies are needed to ascertain barriers to care and develop novel targeted pathways to ensure equitable access to high-volume facilities and high-quality oncologic care.
重要性目前正在鼓励将食管腺癌的治疗区域化,将其集中到高容量中心(HVC)。目标确定与在当地低流量中心(LVC)接受治疗相比,前往高流量中心接受食管切除术是否与较高的总生存率有关。这项队列研究考虑了 2010-2021 年国家癌症数据库中所有确诊为 I 期至 III 期食管腺癌患者的数据。根据患者接受治疗的旅行距离和治疗医院的年食管切除术量对患者进行分层:旅行-HVC队列包括旅行负担最高的第25个百分位数的患者,他们在治疗量最高的四分位数的中心接受治疗;当地-LVC队列代表旅行负担最低的第25个百分位数的患者,他们在治疗量最低的四分位数的中心接受治疗。主要结果和测量指标主要终点是1年和5年的总生存率。次要终点包括围手术期结果以及与出差接受治疗相关的因素。结果在17 970名患者中,有2342人(13%)属于出差-HVC队列,1969人(11%)属于本地-LVC队列。中位数(IQR)年龄为 65(58-71)岁;3748(87%)人为男性,563(13%)人为女性。经过风险调整后,以当地 LVC 的护理为参照,前往 HVC 与 1 年(死亡率危险比 [HR],0.69;95% CI,0.58-0.83)和 5 年(HR,0.80;95% CI,0.70-0.90)的较高生存率相关。根据分期进行分层,前往 HVC 与 I 期疾病的结果相当,但 III 期疾病的死亡率降低(1 年 HR,0.72;95% CI,0.60-0.87;5 年 HR,0.83;95% CI,0.74-0.93)。此外,前往 HVC 与更多的淋巴结切除(β,5.08 个结节;95% CI,3.78-6.37)和边缘阴性切除的可能性(调整后的几率比为 1.83;95% CI,1.29-2.60)相关。未来的研究需要确定治疗障碍,并开发新的有针对性的途径,以确保患者能公平地获得高容量设施和高质量的肿瘤治疗。
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引用次数: 0
Going the Distance-Whether the Outcome Is Worth the Travel. 长途跋涉--结果是否值得旅行。
IF 15.7 1区 医学 Q1 SURGERY Pub Date : 2024-11-13 DOI: 10.1001/jamasurg.2024.5004
Ngoc-Quynh Chu, Daniela Molena
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引用次数: 0
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