Pub Date : 2025-11-17DOI: 10.1097/sla.0000000000006986
Abbas M Hassan,Rachel E Patzer,Andrew M Ibrahim,Jennifer F Waljee
{"title":"The One Big Beautiful Bill Act: Implications for Surgical Practice, Training, and Patient Care.","authors":"Abbas M Hassan,Rachel E Patzer,Andrew M Ibrahim,Jennifer F Waljee","doi":"10.1097/sla.0000000000006986","DOIUrl":"https://doi.org/10.1097/sla.0000000000006986","url":null,"abstract":"","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"19 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145531225","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}
Pub Date : 2025-11-17DOI: 10.1097/sla.0000000000006984
Cody Lendon Mullens,Samantha L Savitch,Jyothi R Thumma,Justin B Dimick,Kyle H Sheetz
{"title":"Resource Utilization and Medicare Spending Among Beneficiaries with Bile Duct Injuries.","authors":"Cody Lendon Mullens,Samantha L Savitch,Jyothi R Thumma,Justin B Dimick,Kyle H Sheetz","doi":"10.1097/sla.0000000000006984","DOIUrl":"https://doi.org/10.1097/sla.0000000000006984","url":null,"abstract":"","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"54 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145531213","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}
Pub Date : 2025-11-14DOI: 10.1097/SLA.0000000000006976
Antonio Gangemi, Amir Ebadinejad, Anthony P Lisi, Lisa Argnani, Marianna Negri, Matteo Cescon, Riccardo Casadei, Marco Seri, Gilberto Poggioli
Objective: To compare the rate of conversion to open surgery (OC) between robotic-assisted surgery (RAS) and laparoscopy (LAP) across 15 abdominal procedures.
Background: OC worsens outcomes and costs; a cross-disciplinary estimate of OC risk in RAS versus LAP across general surgery and subspecialties has been lacking.
Methods: PRISMA-guided systematic review (PubMed, Web of Science, Scopus; 2000-2023). Primary endpoint: pooled random-effects odds ratio (OR) for OC (RAS vs LAP) with 95% CIs; heterogeneity quantified by I² and τ². Meta-regression tested age, BMI, and sex.
Results: 360 studies (14 RCTs, 36 prospective, 310 retrospective; 211,078 RAS and 1,358,201 LAP) from 30 countries met inclusion. RAS had lower pooled odds of OC than LAP across procedures and study types. Meta-regression showed no significant effect of age, BMI, or sex on OC. Heterogeneity was moderate-to-high overall and varied by procedure (full metrics and forest plots in SDC, http://links.lww.com/SLA/F670).
Conclusions: Across diverse abdominal procedures, RAS is associated with lower OC risk. Findings support multi-specialty decision-making, while acknowledging heterogeneity, learning-curve effects, and procedure-specific evidence gaps.
目的:比较机器人辅助手术(RAS)和腹腔镜手术(LAP)在15种腹部手术中转向开放手术(OC)的比率。背景:OC使结果和成本恶化;在普通外科和亚专科中,RAS与LAP的OC风险的跨学科评估一直缺乏。方法:prisma引导的系统评价(PubMed, Web of Science, Scopus; 2000-2023)。主要终点:OC (RAS vs LAP)的合并随机效应优势比(OR), 95% ci;异质性由I²和τ²量化。meta回归测试了年龄、BMI和性别。结果:来自30个国家的360项研究(14项随机对照试验,36项前瞻性研究,310项回顾性研究,211,078项RAS和1,358,201项LAP)符合纳入标准。RAS在手术和研究类型上的总OC几率低于LAP。meta回归显示年龄、BMI和性别对OC无显著影响。异质性总体上为中等至高度,并因手术而异(SDC的完整指标和森林图,http://links.lww.com/SLA/F670).Conclusions):在不同的腹部手术中,RAS与较低的OC风险相关。研究结果支持多专业决策,同时承认异质性、学习曲线效应和特定程序的证据差距。
{"title":"The CONVERSION Study: Open Conversion Risk in Robotic vs Laparoscopic Surgery-A 20-Year Meta-analysis.","authors":"Antonio Gangemi, Amir Ebadinejad, Anthony P Lisi, Lisa Argnani, Marianna Negri, Matteo Cescon, Riccardo Casadei, Marco Seri, Gilberto Poggioli","doi":"10.1097/SLA.0000000000006976","DOIUrl":"https://doi.org/10.1097/SLA.0000000000006976","url":null,"abstract":"<p><strong>Objective: </strong>To compare the rate of conversion to open surgery (OC) between robotic-assisted surgery (RAS) and laparoscopy (LAP) across 15 abdominal procedures.</p><p><strong>Background: </strong>OC worsens outcomes and costs; a cross-disciplinary estimate of OC risk in RAS versus LAP across general surgery and subspecialties has been lacking.</p><p><strong>Methods: </strong>PRISMA-guided systematic review (PubMed, Web of Science, Scopus; 2000-2023). Primary endpoint: pooled random-effects odds ratio (OR) for OC (RAS vs LAP) with 95% CIs; heterogeneity quantified by I² and τ². Meta-regression tested age, BMI, and sex.</p><p><strong>Results: </strong>360 studies (14 RCTs, 36 prospective, 310 retrospective; 211,078 RAS and 1,358,201 LAP) from 30 countries met inclusion. RAS had lower pooled odds of OC than LAP across procedures and study types. Meta-regression showed no significant effect of age, BMI, or sex on OC. Heterogeneity was moderate-to-high overall and varied by procedure (full metrics and forest plots in SDC, http://links.lww.com/SLA/F670).</p><p><strong>Conclusions: </strong>Across diverse abdominal procedures, RAS is associated with lower OC risk. Findings support multi-specialty decision-making, while acknowledging heterogeneity, learning-curve effects, and procedure-specific evidence gaps.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2025-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145511517","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}
Pub Date : 2025-11-13DOI: 10.1097/sla.0000000000006981
Cody Lendon Mullens,Vanessa S Niba,Reagan A Collins,Nicholas Kunnath,Erika A Newman,Andrew M Ibrahim,Samir K Gadepalli
{"title":"Quality of General Surgery Procedures in Children at Small Rural Hospitals.","authors":"Cody Lendon Mullens,Vanessa S Niba,Reagan A Collins,Nicholas Kunnath,Erika A Newman,Andrew M Ibrahim,Samir K Gadepalli","doi":"10.1097/sla.0000000000006981","DOIUrl":"https://doi.org/10.1097/sla.0000000000006981","url":null,"abstract":"","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"6 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145499552","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}
Pub Date : 2025-11-13DOI: 10.1097/sla.0000000000006982
Daniel Azoulay,Noémie Ammar-Khodja,Marc-Antoine Allard,Daniel Pietrasz,Antonio Sa Cunha,Gabriella Pittau,Sophie Laroche,Nicolas Golse,Oriana Ciacio,Daniel Cherqui,Eric Vibert,René Adam,Philippe Ichai,Faouzi Saliba,Chady Salloum
OBJECTIVETo propose a surgical strategy guiding the total vascular exclusion (TVE) subtype during liver resection under hypothermic perfusion (LR-HypoT); to analyze the latter's outcome futility, the risk of severe postoperative liver failure (POLF); and whether LT could have been an alternative treatment.BACKGROUNDSeries on LR-HypoT lack granularity, and none analyzed outcome futility or liver transplantation (LT) as an alternative treatment.METHODSSingle-center retrospective analysis of 110 consecutive LR-HypoT performed between 1997 and 2024 for malignant (n=100) or benign tumors (n=10). The subtypes of TVE used, 90-D mortality, and outcome futility (90-D death or tumor recurrence within six months of surgery) were analyzed. Risk of POLF was analyzed by recursive partitioning analysis.RESULTSLR-HypoT was performed in situ in 108 (98.2%) patients and ex situ in 2 (1.8%). 90-D mortality was 15.5% (n=17). POLF, the leading cause of 90-D mortality (14/17, 82.3%), occurred in 32 (29%) patients. Biliary reconstruction (P=0.023) and the need for extended hepatectomy (P=0.033) were the two risk factors for POLF. In patients with cancer, early tumor recurrence and outcome futility rate was 17.2% and 30.0%, respectively. With a median follow-up of 100 (3-183) months, 5-years survival was 36.8%, 30.0%, and 100% for the study population, patients with malignant or benign tumors, respectively. LT criteria were not met by 92% (92/100) of patients with cancer.CONCLUSIONSLR-HypoT can be performed in situ in most cases. In patients presenting otherwise unresectable or untransplantable malignant tumors, encouraging long-term results can be obtained in one third of patients.
{"title":"Hepatectomies under Hypothermic Perfusion of the Liver: Analysis of 110 Cases from a Single Center.","authors":"Daniel Azoulay,Noémie Ammar-Khodja,Marc-Antoine Allard,Daniel Pietrasz,Antonio Sa Cunha,Gabriella Pittau,Sophie Laroche,Nicolas Golse,Oriana Ciacio,Daniel Cherqui,Eric Vibert,René Adam,Philippe Ichai,Faouzi Saliba,Chady Salloum","doi":"10.1097/sla.0000000000006982","DOIUrl":"https://doi.org/10.1097/sla.0000000000006982","url":null,"abstract":"OBJECTIVETo propose a surgical strategy guiding the total vascular exclusion (TVE) subtype during liver resection under hypothermic perfusion (LR-HypoT); to analyze the latter's outcome futility, the risk of severe postoperative liver failure (POLF); and whether LT could have been an alternative treatment.BACKGROUNDSeries on LR-HypoT lack granularity, and none analyzed outcome futility or liver transplantation (LT) as an alternative treatment.METHODSSingle-center retrospective analysis of 110 consecutive LR-HypoT performed between 1997 and 2024 for malignant (n=100) or benign tumors (n=10). The subtypes of TVE used, 90-D mortality, and outcome futility (90-D death or tumor recurrence within six months of surgery) were analyzed. Risk of POLF was analyzed by recursive partitioning analysis.RESULTSLR-HypoT was performed in situ in 108 (98.2%) patients and ex situ in 2 (1.8%). 90-D mortality was 15.5% (n=17). POLF, the leading cause of 90-D mortality (14/17, 82.3%), occurred in 32 (29%) patients. Biliary reconstruction (P=0.023) and the need for extended hepatectomy (P=0.033) were the two risk factors for POLF. In patients with cancer, early tumor recurrence and outcome futility rate was 17.2% and 30.0%, respectively. With a median follow-up of 100 (3-183) months, 5-years survival was 36.8%, 30.0%, and 100% for the study population, patients with malignant or benign tumors, respectively. LT criteria were not met by 92% (92/100) of patients with cancer.CONCLUSIONSLR-HypoT can be performed in situ in most cases. In patients presenting otherwise unresectable or untransplantable malignant tumors, encouraging long-term results can be obtained in one third of patients.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"73 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145499550","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}
OBJECTIVEAsian Americans and Pacific Islanders (AAPI) have historically had limited representation in academic surgery leadership. Recent years witnessed a rise in professional organizations, like the Society of Asian Academic Surgeons (SAAS), to support AAPI surgeons' careers. The aim of this project was to evaluate changes in AAPI representation in academic surgical leadership since 2009 and to explore the influence of SAAS on these trends.SUMMARY OF BACKGROUND DATAAsian Americans and Pacific Islanders (AAPI) have historically been underrepresented in academic surgical leadership. Recent initiatives, including the Society of Asian Academic Surgeons (SAAS), have sought to address this gap.METHODSData on AAPI surnames were collected from US academic institutions, professional societies, and editorial boards of surgical journals databases and compared with data from a 2009 study to track representation trends over time.RESULTSOur study revealed a remarkable transformation in AAPI representation within academic surgery. AAPI chairs of surgery surged from 8 in 2009 to 32 in 2024, marking a notable 300% rise. AAPI representation on top five journal boards grew substantially, from 2% in 2009 to 13.5% in 2024, with JAMA Surgery now boasting a one-third AAPI representation. In 2009, seven out of ten professional organizations lacked AAPI members on their governing boards, contrasting with AAPI individuals constituting 25% of all governing board members across these organizations in 2024.CONCLUSIONSOver the past 15 years, AAPI representation in academic surgical leadership has grown substantially, including increases in the number of chairs of surgery and members of editorial and governing boards. These gains align with intentional initiatives to support AAPI surgeons, particularly the establishment of SAAS, which has provided mentorship, sponsorship, and recognition opportunities. While multiple factors likely contributed, the temporal association and mission of SAAS strongly suggest it has played an important role. Sustained efforts in diversity, equity, and inclusion will be essential to maintain and expand these advancements.
{"title":"Shaping Tomorrow's Leaders: Society of Asian Academic Surgeon's Role in Asian Americans and Pacific Islanders Surgeon Leadership.","authors":"Sanjana Balachandra,Niranjna Swaminathan,Julia Kasmirski,Raj Roy,Zhixing Song,Grace Kennedy,Herbert Chen,Jessica Fazendin","doi":"10.1097/sla.0000000000006978","DOIUrl":"https://doi.org/10.1097/sla.0000000000006978","url":null,"abstract":"OBJECTIVEAsian Americans and Pacific Islanders (AAPI) have historically had limited representation in academic surgery leadership. Recent years witnessed a rise in professional organizations, like the Society of Asian Academic Surgeons (SAAS), to support AAPI surgeons' careers. The aim of this project was to evaluate changes in AAPI representation in academic surgical leadership since 2009 and to explore the influence of SAAS on these trends.SUMMARY OF BACKGROUND DATAAsian Americans and Pacific Islanders (AAPI) have historically been underrepresented in academic surgical leadership. Recent initiatives, including the Society of Asian Academic Surgeons (SAAS), have sought to address this gap.METHODSData on AAPI surnames were collected from US academic institutions, professional societies, and editorial boards of surgical journals databases and compared with data from a 2009 study to track representation trends over time.RESULTSOur study revealed a remarkable transformation in AAPI representation within academic surgery. AAPI chairs of surgery surged from 8 in 2009 to 32 in 2024, marking a notable 300% rise. AAPI representation on top five journal boards grew substantially, from 2% in 2009 to 13.5% in 2024, with JAMA Surgery now boasting a one-third AAPI representation. In 2009, seven out of ten professional organizations lacked AAPI members on their governing boards, contrasting with AAPI individuals constituting 25% of all governing board members across these organizations in 2024.CONCLUSIONSOver the past 15 years, AAPI representation in academic surgical leadership has grown substantially, including increases in the number of chairs of surgery and members of editorial and governing boards. These gains align with intentional initiatives to support AAPI surgeons, particularly the establishment of SAAS, which has provided mentorship, sponsorship, and recognition opportunities. While multiple factors likely contributed, the temporal association and mission of SAAS strongly suggest it has played an important role. Sustained efforts in diversity, equity, and inclusion will be essential to maintain and expand these advancements.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"117 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145499553","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}
Pub Date : 2025-11-12DOI: 10.1097/sla.0000000000006983
Benjamin D Wagner,Andrea V Barrio,Michelle R Coriddi,Jonathan Rubin,Lillian A Boe,Ronnie L Shammas,Jacob Levy,Geoffrey E Hespe,Hidehiko Yoshimatsu,Stanley G Rockson,Babak J Mehrara
OBJECTIVETo empirically determine a normative, distribution-based threshold for diagnosing breast cancer-related lymphedema (BCRL) and compare its diagnostic accuracy with the conventional 10% interlimb volume difference criterion.SUMMARY BACKGROUND DATABCRL is a common and morbid sequela of breast cancer treatment; however, diagnostic thresholds remain inconsistent and inadequately validated. The widely used threshold of ≥10% interlimb volume difference may miss clinically relevant cases.METHODSThis prospective cohort study analyzed preoperative bilateral limb measurements in 858 female breast cancer patients undergoing axillary surgery to derive a normative, distribution-based interlimb volume difference threshold. A threshold corresponding to 2 standard deviations (SD) above the mean (7.5%) was identified. Diagnostic performance of this proposed threshold was then compared with the conventional 10% cutoff in a subgroup of 167 patients who underwent axillary lymph node dissection (ALND) with up to 36 months of postoperative follow-up.RESULTSAmong 858 patients (median [IQR] age, 48 [40-56] years; median BMI, 25.5 [22.3-30.0] kg/m²), preoperative interlimb volume differences were normally distributed (mean, 0.24%; SD, 3.74%), supporting a proposed diagnostic threshold of 7.5%. In the 167 patients who underwent ALND, 72 (43.1%) met the ≥7.5% threshold versus 53 (31.7%) meeting the 10% threshold, yielding 19 additional diagnoses (+11.4%; P<0.001). Of those meeting the 7.5% threshold, 94.4% (68/72) reported symptoms and/or used compression garments.CONCLUSIONSA normative, distribution-based threshold of 7.5% interlimb volume difference improves the identification of clinically meaningful BCRL compared with the traditional 10% cutoff. Adopting this empirically validated threshold may enhance early detection, intervention, and patient outcomes.
{"title":"Redefining the Diagnostic Threshold for Breast Cancer-related Lymphedema.","authors":"Benjamin D Wagner,Andrea V Barrio,Michelle R Coriddi,Jonathan Rubin,Lillian A Boe,Ronnie L Shammas,Jacob Levy,Geoffrey E Hespe,Hidehiko Yoshimatsu,Stanley G Rockson,Babak J Mehrara","doi":"10.1097/sla.0000000000006983","DOIUrl":"https://doi.org/10.1097/sla.0000000000006983","url":null,"abstract":"OBJECTIVETo empirically determine a normative, distribution-based threshold for diagnosing breast cancer-related lymphedema (BCRL) and compare its diagnostic accuracy with the conventional 10% interlimb volume difference criterion.SUMMARY BACKGROUND DATABCRL is a common and morbid sequela of breast cancer treatment; however, diagnostic thresholds remain inconsistent and inadequately validated. The widely used threshold of ≥10% interlimb volume difference may miss clinically relevant cases.METHODSThis prospective cohort study analyzed preoperative bilateral limb measurements in 858 female breast cancer patients undergoing axillary surgery to derive a normative, distribution-based interlimb volume difference threshold. A threshold corresponding to 2 standard deviations (SD) above the mean (7.5%) was identified. Diagnostic performance of this proposed threshold was then compared with the conventional 10% cutoff in a subgroup of 167 patients who underwent axillary lymph node dissection (ALND) with up to 36 months of postoperative follow-up.RESULTSAmong 858 patients (median [IQR] age, 48 [40-56] years; median BMI, 25.5 [22.3-30.0] kg/m²), preoperative interlimb volume differences were normally distributed (mean, 0.24%; SD, 3.74%), supporting a proposed diagnostic threshold of 7.5%. In the 167 patients who underwent ALND, 72 (43.1%) met the ≥7.5% threshold versus 53 (31.7%) meeting the 10% threshold, yielding 19 additional diagnoses (+11.4%; P<0.001). Of those meeting the 7.5% threshold, 94.4% (68/72) reported symptoms and/or used compression garments.CONCLUSIONSA normative, distribution-based threshold of 7.5% interlimb volume difference improves the identification of clinically meaningful BCRL compared with the traditional 10% cutoff. Adopting this empirically validated threshold may enhance early detection, intervention, and patient outcomes.","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":"89 1","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145491462","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}
Pub Date : 2025-11-11DOI: 10.1097/SLA.0000000000006980
Dimitrios Moris, Ioannis Ziogas, Emmanouil Giorgakis, Paulo N Martins
{"title":"Reimagining Academic Surgery: The Case for International Medical Graduates Leadership.","authors":"Dimitrios Moris, Ioannis Ziogas, Emmanouil Giorgakis, Paulo N Martins","doi":"10.1097/SLA.0000000000006980","DOIUrl":"https://doi.org/10.1097/SLA.0000000000006980","url":null,"abstract":"","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2025-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145487621","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}
Pub Date : 2025-11-11DOI: 10.1097/SLA.0000000000006979
Olamide Alabi, Gheorghe Doros, Mohammed Hamouda, Michael S Conte, Alik Farber, Lee Kirksey, Matthew T Menard, Amber Kernodle, Katharine McGinigle, Carla Moreira, Kenneth Rosenfield, Michael B Strong, Jesus G Ulloa, John A Kaufman, Mahmoud Malas, Vincent L Rowe
Summary background data: We examined the Best Endovascular versus Best Surgical Therapy in patients with chronic limb threatening ischemia (BEST-CLI) Trial to determine if ethnoracial disparities persist in the setting of a contemporary randomized controlled trial.
Methods: Designed as a comparative effectiveness trial evaluating surgical bypass against endovascular therapy in adults with between 2014-2019, this secondary analysis examines Hispanic, Black, and White participants. Exposure variable is ethnoracial identity and primary outcome is major adverse limb events (MALE) or all-cause death (referred to as MALE-free survival). Secondary endpoints include index limb major amputation, major reintervention, mortality, MALE, major adverse cardiac events (MACE).
Results: Among 1677 patients (median follow-up 2.4 years [IQR 1.0-3.5]), 350(20.9%) identified as Black and 225(13.4%) as Hispanic. Compared to White patients, Black and Hispanic patients were younger, more likely to be female, have diabetes and/or dialysis dependence (ESKD), and present with advanced disease severity. There were no differences in preoperative guideline directed medical therapy. On univariable analysis, compared to White patients, Black and Hispanic patients had increased likelihood of major amputation. There were no differences noted for MALE-free survival, major reintervention, mortality, MALE, or MACE. After controlling for age, sex, diabetes, ESKD, smoking history, prior revascularization, presenting WIfI stage, anatomic segment of disease treated, revascularization method, there was no association between ethnoracial identity and MALE-free survival, amputation, major reintervention, mortality, MALE, or MACE.
Conclusions: Disparities are mitigated when evidence-based care (e.g., appropriate surgical conduits, early access to care) is provided to Black and Hispanic patients in the BEST-CLI trial.
{"title":"Examination of Race and Ethnicity After Revascularization in the BEST-CLI Trial.","authors":"Olamide Alabi, Gheorghe Doros, Mohammed Hamouda, Michael S Conte, Alik Farber, Lee Kirksey, Matthew T Menard, Amber Kernodle, Katharine McGinigle, Carla Moreira, Kenneth Rosenfield, Michael B Strong, Jesus G Ulloa, John A Kaufman, Mahmoud Malas, Vincent L Rowe","doi":"10.1097/SLA.0000000000006979","DOIUrl":"https://doi.org/10.1097/SLA.0000000000006979","url":null,"abstract":"<p><strong>Summary background data: </strong>We examined the Best Endovascular versus Best Surgical Therapy in patients with chronic limb threatening ischemia (BEST-CLI) Trial to determine if ethnoracial disparities persist in the setting of a contemporary randomized controlled trial.</p><p><strong>Methods: </strong>Designed as a comparative effectiveness trial evaluating surgical bypass against endovascular therapy in adults with between 2014-2019, this secondary analysis examines Hispanic, Black, and White participants. Exposure variable is ethnoracial identity and primary outcome is major adverse limb events (MALE) or all-cause death (referred to as MALE-free survival). Secondary endpoints include index limb major amputation, major reintervention, mortality, MALE, major adverse cardiac events (MACE).</p><p><strong>Results: </strong>Among 1677 patients (median follow-up 2.4 years [IQR 1.0-3.5]), 350(20.9%) identified as Black and 225(13.4%) as Hispanic. Compared to White patients, Black and Hispanic patients were younger, more likely to be female, have diabetes and/or dialysis dependence (ESKD), and present with advanced disease severity. There were no differences in preoperative guideline directed medical therapy. On univariable analysis, compared to White patients, Black and Hispanic patients had increased likelihood of major amputation. There were no differences noted for MALE-free survival, major reintervention, mortality, MALE, or MACE. After controlling for age, sex, diabetes, ESKD, smoking history, prior revascularization, presenting WIfI stage, anatomic segment of disease treated, revascularization method, there was no association between ethnoracial identity and MALE-free survival, amputation, major reintervention, mortality, MALE, or MACE.</p><p><strong>Conclusions: </strong>Disparities are mitigated when evidence-based care (e.g., appropriate surgical conduits, early access to care) is provided to Black and Hispanic patients in the BEST-CLI trial.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2025-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145487541","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}
Pub Date : 2025-11-07DOI: 10.1097/SLA.0000000000006974
Christopher C Thompson, Pichamol Jirapinyo, Thomas R McCarty, Stacy Brethauer, Nicholas Shaheen, Shelby A Sullivan, Timothy Koch, Kevin M Reavis, Barham K Abu Dayyeh, Erik B Wilson, Allison R Schulman, W Scott Butsch, Keith S Gersin, Caroline M Apovian, Philip Schauer
Objective: An endoscopically placed duodenal-jejunal bypass liner (DJBL) may provide a safe adjunctive therapy for those with poorly controlled type 2 diabetes mellitus (T2DM) and obesity.
Summary background data: While some endoscopic therapies have been shown to improve glycemic indices secondary to weight loss, small bowel interventions may have direct metabolic effects. A meta-analysis of observational studies demonstrated reduction in HbA1c by 1.3% at one year following DJBL in patients with T2DM and obesity.
Methods: This was a multicenter, double-blind, randomized, sham-controlled trial comparing DJBL to sham procedure with medical management and lifestyle modification. Primary endpoints included mean difference in changes in HbA1c at 12 months between arms, and device-related serious adverse events (SAEs). Secondary endpoints included percent total weight loss (%TWL) and subjects achieving HbA1c≤7% and TWL≥5% at 12 months.
Results: 320 subjects were randomized to DJBL (n=212) and sham (n=108). Baseline HbA1c and BMI were 8.79±0.92% and 38.45±5.75 kg/m2. On modified intent-to-treat analysis, change in HbA1c at 12 months was -1.10±1.45% and -0.28±1.54% for DJBL and sham groups, respectively (P=0.0004). Rate of device-related SAEs was 9.4% including intolerance (3.7%), hemorrhage (2.8%) and hepatic abscess (2.3% stopping study early). At 12 months, DJBL group experienced greater weight loss compared to sham (7.7±9.6% TWL and 2.1±5.4% TWL, respectively; P<0.0001), with significantly more patients achieving HbA1c ≤ 7% (28.3% vs. 9.4%; P<0.0003) and TWL ≥ 5% (60.4% vs. 21.3%; P<0.0001).
Conclusions: DJBL met primary glycemic control efficacy and primary safety endpoints, while providing clinically significant weight loss, and comorbidity improvement.
{"title":"A Multicenter Double-blind Randomized Sham-controlled Trial Assessing the EndoBarrier Duodenal-jejunal Bypass Liner for the Treatment of Poorly Controlled type 2 Diabetes Mellitus with Concomitant Obesity: The ENDO Trial.","authors":"Christopher C Thompson, Pichamol Jirapinyo, Thomas R McCarty, Stacy Brethauer, Nicholas Shaheen, Shelby A Sullivan, Timothy Koch, Kevin M Reavis, Barham K Abu Dayyeh, Erik B Wilson, Allison R Schulman, W Scott Butsch, Keith S Gersin, Caroline M Apovian, Philip Schauer","doi":"10.1097/SLA.0000000000006974","DOIUrl":"https://doi.org/10.1097/SLA.0000000000006974","url":null,"abstract":"<p><strong>Objective: </strong>An endoscopically placed duodenal-jejunal bypass liner (DJBL) may provide a safe adjunctive therapy for those with poorly controlled type 2 diabetes mellitus (T2DM) and obesity.</p><p><strong>Summary background data: </strong>While some endoscopic therapies have been shown to improve glycemic indices secondary to weight loss, small bowel interventions may have direct metabolic effects. A meta-analysis of observational studies demonstrated reduction in HbA1c by 1.3% at one year following DJBL in patients with T2DM and obesity.</p><p><strong>Methods: </strong>This was a multicenter, double-blind, randomized, sham-controlled trial comparing DJBL to sham procedure with medical management and lifestyle modification. Primary endpoints included mean difference in changes in HbA1c at 12 months between arms, and device-related serious adverse events (SAEs). Secondary endpoints included percent total weight loss (%TWL) and subjects achieving HbA1c≤7% and TWL≥5% at 12 months.</p><p><strong>Results: </strong>320 subjects were randomized to DJBL (n=212) and sham (n=108). Baseline HbA1c and BMI were 8.79±0.92% and 38.45±5.75 kg/m2. On modified intent-to-treat analysis, change in HbA1c at 12 months was -1.10±1.45% and -0.28±1.54% for DJBL and sham groups, respectively (P=0.0004). Rate of device-related SAEs was 9.4% including intolerance (3.7%), hemorrhage (2.8%) and hepatic abscess (2.3% stopping study early). At 12 months, DJBL group experienced greater weight loss compared to sham (7.7±9.6% TWL and 2.1±5.4% TWL, respectively; P<0.0001), with significantly more patients achieving HbA1c ≤ 7% (28.3% vs. 9.4%; P<0.0003) and TWL ≥ 5% (60.4% vs. 21.3%; P<0.0001).</p><p><strong>Conclusions: </strong>DJBL met primary glycemic control efficacy and primary safety endpoints, while providing clinically significant weight loss, and comorbidity improvement.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2025-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145457551","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}