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Design of the RadFree randomized controlled study comparing LumiGuide, powered by Fiber Optic RealShape Technology, with conventional fluoroscopy guidance in fenestrated endovascular aortic repair RadFree随机对照研究的设计,比较光纤RealShape技术驱动的LumiGuide与传统透视引导在开窗血管内主动脉修复中的作用
Pub Date : 2026-01-01 DOI: 10.1016/j.jvsvi.2026.100354
Andres Schanzer MD , Darren B. Schneider MD , Carlos Timaran MD , Adam W. Beck MD , Marc Schermerhorn MD , Geert Willem Schurink MD , Joost van Herwaarden MD, PhD , Bijan Modarai MD, PhD , Nathalie Moreels MD , Frédéric Cochennec MD , Tim Resch MD, PhD , Tilo Kölbel MD

Objective

To evaluate whether the use of LumiGuide, a novel real-time three-dimensional navigation system powered by Fiber Optic RealShape technology (Philips), reduces procedure fluoroscopy time compared with conventional fluoroscopic guidance during fenestrated endovascular aortic repair (FEVAR).

Methods

The RadFree study is a prospective, randomized, unblinded, multicenter clinical trial conducted at 11 vascular centers in Europe and the United States. Adults undergoing primary FEVAR with at least two target visceral vessels suitable for LumiGuide are randomized 1:1 to LumiGuide or conventional fluoroscopy. Stratification is performed by aneurysm extent. The primary endpoint is total procedure fluoroscopy time. Secondary outcomes include radiation exposure metrics (fluoroscopy time and rate, dose area product, and air kerma during navigation), cumulative procedural radiation dose, adverse LumiGuide device-related effects, and device deficiencies. Tertiary end points assess navigation efficiency and total procedure duration (first catheter/wire in to last catheter/wire out). The planned sample size of 182 subjects provides ≥80% power to detect a significant reduction in fluoroscopy time at a two-sided α of 0.05. Analyses follow an intention-to-treat approach.

Results

This report details the trial rationale, methods, and planned analyses. Enrollment is currently ongoing; interim analysis will occur at 50% recruitment to assess safety and efficacy signals.

Conclusions

RadFree is the first prospective, randomized multicenter trial evaluating the impact of LumiGuide on fluoroscopy time, radiation exposure and procedural efficiency in FEVAR. Its results will inform whether advanced three-dimensional navigation can safely and effectively reduce fluoroscopy dependence, improving safety for patients and endovascular teams.
目的评价采用光纤RealShape技术(Philips)的新型实时三维导航系统LumiGuide在开窗血管内主动脉修复(FEVAR)中,与传统透视引导相比,是否减少了手术透视时间。RadFree研究是一项前瞻性、随机、非盲、多中心临床试验,在欧洲和美国的11个血管中心进行。至少有两根靶血管适合使用LumiGuide的原发性FEVAR成人按1:1随机分配至LumiGuide或常规透视。分层是根据动脉瘤的范围进行的。主要终点是整个过程的透视时间。次要结果包括辐射暴露指标(透视时间和频率、剂量面积积和导航过程中的空气密度)、累积程序辐射剂量、LumiGuide设备相关的不良影响和设备缺陷。第三终点评估导航效率和总手术时间(第一个导管/导线插入到最后一个导管/导线取出)。182名受试者的计划样本量提供≥80%的能力来检测显着减少透视时间,双侧α为0.05。分析遵循意向治疗方法。结果本报告详细介绍了试验的基本原理、方法和计划分析。注册目前正在进行中;中期分析将在50%的招募时进行,以评估安全性和有效性信号。结论radfree是首个评估LumiGuide对FEVAR透视时间、辐射暴露和程序效率影响的前瞻性、随机多中心试验。其结果将为先进的三维导航是否可以安全有效地减少透视依赖,提高患者和血管内团队的安全性提供信息。
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引用次数: 0
Impact of body fat quality on long-term survival following endovascular repair for abdominal aortic aneurysms 体脂质量对腹主动脉瘤血管内修复术后长期生存的影响
Pub Date : 2026-01-01 DOI: 10.1016/j.jvsvi.2025.100323
Hirotsugu Ozawa MD, PhD, Takao Ohki MD, PhD, Kota Shukuzawa MD, PhD, Daisuke Yamagishi MD, Takehiro Suzuki MD, Ryo Nishide MD, Kentaro Kasa MD, Makiko Omori MD, Soichiro Fukushima MD

Objective

The aim of this study was to evaluate the impact of body fat quality and quantity on long-term survival following endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs).

Methods

A single-center, retrospective cohort study was performed on 237 patients who underwent primary EVAR for AAAs from 2016 to 2019. Fat quality was assessed by measuring the Hounsfield units (HUs) of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) at the level of the third lumbar vertebra on preoperative noncontrast computed tomography. Fat quantity was assessed by measuring the area (cm2) of SAT and VAT at the level of the umbilicus. Hazard ratios for all-cause mortality were calculated for each variable using univariate and multivariate analysis.

Results

This study included 237 patients with a mean age of 76.8 years, of whom 33 were female. The median body mass index was 23.4 kg/m2 (interquartile range, 21.6-26.0 kg/m2), and 226 patients (95.3%) were classified as nonobese. During the median follow-up period of 72 months, there were 107 all-cause deaths. In univariate analysis, overall survival was significantly lower in patients with higher SAT or VAT density or larger SAT or VAT area among body fat-related parameters. In a multivariate analysis, SAT density was an independent risk factor for all-cause mortality following EVAR (SAT density: hazard ratio, 1.02; 95% confidence interval, 1.01-1.03; P = .007), along with other variables including age, sarcopenia, osteoporosis, and aneurysm diameter.

Conclusions

Patients with higher SAT density showed increased all-cause mortality following EVAR. This finding suggests that fat quality, rather than fat quantity, may be more closely associated with long-term survival in post-EVAR patients.
目的探讨体脂肪质量和数量对腹主动脉瘤(AAAs)血管内动脉瘤修复(EVAR)术后长期生存的影响。方法采用单中心、回顾性队列研究方法,对2016 - 2019年237例AAAs患者进行原发性EVAR。通过术前非对比计算机断层扫描测量第三腰椎水平皮下脂肪组织(SAT)和内脏脂肪组织(VAT)的Hounsfield单位(HUs)来评估脂肪质量。通过测量脐部水平SAT和VAT的面积(cm2)来评估脂肪量。使用单因素和多因素分析计算每个变量的全因死亡率风险比。结果237例患者,平均年龄76.8岁,其中女性33例。中位体重指数为23.4 kg/m2(四分位数范围为21.6 ~ 26.0 kg/m2), 226例(95.3%)为非肥胖。在中位随访72个月期间,有107例全因死亡。在单因素分析中,在体脂相关参数中,SAT或VAT密度较高或SAT或VAT面积较大的患者的总生存率显著降低。在多变量分析中,SAT密度是EVAR后全因死亡率的独立危险因素(SAT密度:危险比1.02;95%可信区间1.01-1.03;P = .007),其他变量包括年龄、肌肉减少症、骨质疏松症和动脉瘤直径。结论高SAT密度患者EVAR后全因死亡率增高。这一发现表明,脂肪质量,而不是脂肪数量,可能与evar后患者的长期生存更密切相关。
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引用次数: 0
Office-based lab mesenteric angiography is safe for low- and moderate-risk patients 基于办公室的实验室肠系膜血管造影对中低危患者是安全的
Pub Date : 2026-01-01 DOI: 10.1016/j.jvsvi.2025.100331
John Fang DO, Niteesh Sundaram MD, Omer Riaz MD, Thomas Lee MD, Kevin James MD

Objective

There has been a significant shift of vascular care and intervention from the inpatient to the outpatient setting. The office-based laboratory (OBL) is an increasingly adopted treatment model following the 2008 payor reimbursement modifications for outpatient vascular intervention by the Centers for Medicare and Medicaid Services. Reports on this phenomenon largely focus on the financial effects, with a paucity of safety and outcomes data associated with this treatment setting. In this study, we examine treatment outcomes of elective mesenteric angiograms performed at an OBL, and factors affecting patient selection for safe outpatient intervention.

Methods

A retrospective study was performed of adult patients treated with diagnostic or interventional mesenteric angiography at a single OBL over 9 years. Patient and treatment variables were abstracted from outpatient and inpatient medical records. Primary outcomes of interest were 30-day adverse events (30D A/E) reported with the Clavien-Dindo (CD) classification system. Technical success was examined as a secondary outcome.

Results

Between September 2015 and February 2024, 80 patients underwent 115 mesenteric angiograms by seven vascular surgeons. Patients were 73 years old on average (standard deviation, 9.3 years; range, 44-89 years), predominantly female (53 of 80 patients), predominantly low risk (97 of 115 angiograms were performed on patients with Society for Vascular Surgery and the American Association for Vascular Surgery Medical Comorbidity Score <2), with a mean body mass index of 25.9 kg/m2 (range, 14.1-50.6 kg/m2; standard deviation, 6 kg/m2). The overall incidence of 30D A/Es was 6.1% (7 of 115), with a 5.2% 30D rate of morbidity (6 of 115), and 0.9% 30D rate of mortality (1 of 115). Six of seven cases with 30D A/Es were CD grade 3 or greater. An univariable comparison of mesenteric angiograms resulting in a 30D A/E with those without demonstrated no significant differences in mean age, race distribution, mean body mass index, preoperative Society for Vascular Surgery/American Association for Vascular Surgery Medical Comorbidity Score, smoking history, history of malignancy, use of antithrombotic medications, history of prior mesenteric stents, or whether the procedure was performed for reintervention. On multivariable regression, technical failure was a significant predictor for complications CD 3 or greater (odds ratio, 6.36; 95% confidence interval, 1.1-37.4; P = .04) when correcting for interoperator variability.

Conclusions

Variable complexity mesenteric angiography for primary and repeat intervention is safely performed at an OBL on selected low- and moderate-risk patients. Further study of anatomic and patient selection factors predicting technical failure is required.
目的血管护理和干预已经从住院到门诊有了显著的转变。在2008年医疗保险和医疗补助服务中心对门诊血管干预进行付款人报销修改后,办公室实验室(OBL)越来越多地采用治疗模式。关于这一现象的报告主要集中在经济影响上,缺乏与这种治疗环境相关的安全性和结果数据。在这项研究中,我们检查了选择性肠系膜血管造影在OBL进行的治疗结果,以及影响患者选择安全门诊干预的因素。方法回顾性分析9年来在单一OBL行诊断性或介入性肠系膜血管造影治疗的成年患者。从门诊和住院病历中提取患者和治疗变量。主要研究结果是Clavien-Dindo (CD)分类系统报告的30天不良事件(30D A/E)。技术上的成功是次要的结果。结果2015年9月至2024年2月,7位血管外科医生对80例患者进行了115次肠系膜造影。患者平均年龄73岁(标准差:9.3岁;范围:44-89岁),以女性为主(80例患者中53例),以低危为主(115例血管造影患者中有97例接受血管外科学会和美国血管外科协会医学共病评分<;2),平均体重指数25.9 kg/m2(范围:14.1-50.6 kg/m2;标准差:6 kg/m2)。30D A/ e总发病率为6.1% (7 / 115),30D发病率为5.2% (6 / 115),30D死亡率为0.9%(1 / 115)。7例30D A/ e中有6例为CD 3级或以上。单变量比较导致30D a /E的肠系膜血管造影与没有30D a /E的肠系膜血管造影在平均年龄、种族分布、平均体重指数、术前血管外科学会/美国血管外科协会医学合并症评分、吸烟史、恶性肿瘤史、抗血栓药物的使用、既往肠系膜支架史或手术是否为再干预方面没有显著差异。在多变量回归中,当校正操作者间的可变性时,技术故障是并发症CD 3或以上的显著预测因子(优势比6.36;95%置信区间1.1-37.4;P = 0.04)。结论可变复杂性肠系膜血管造影用于初次和重复干预是安全的,可在OBL对选定的中低风险患者进行。需要进一步研究预测技术失败的解剖和患者选择因素。
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引用次数: 0
Robot-assisted carotid stenting: Precision, ergonomics, and the next frontier in vascular surgery 机器人辅助颈动脉支架置入术:精确性、人体工程学和血管外科的下一个前沿
Pub Date : 2026-01-01 DOI: 10.1016/j.jvsvi.2025.100346
Clark J. Zeebregts MD, PhD , Emiel W.M. Huistra MD , Tomas Baltrunas MD, PhD , Alan B. Lumsden MD
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引用次数: 0
Scalene block as a predictor of surgical success for treatment of thoracic outlet syndrome 斜角肌烯阻滞作为胸廓出口综合征手术治疗成功的预测因子
Pub Date : 2026-01-01 DOI: 10.1016/j.jvsvi.2025.100343
Dorcie Ann Gillette MD , Linda Peng BS , Maen Aboul Hosn MD

Background

Neurogenic thoracic outlet syndrome (TOS) is a difficult pathology to accurately diagnose given the overlap between multiple causes of neuralgias of the upper extremity. Although scalene blocks are often used as diagnostic tools for brachial plexus compression at the level of the thoracic outlet, they can also be predictive of symptomatic relief after thoracic outlet decompression. Our objective is to evaluate the predictive value of preoperative scalene block for postoperative symptom improvement.

Methods

A retrospective review was performed for all patients who underwent a scalene block before first rib resection and at our institution between 2018 and 2023. Data on demographics, presenting symptoms, and preoperative workup were collected. Symptom resolution after scalene block and surgical decompression was assessed through chart review and direct patient contact. These were classified into three categories: complete resolution, partial resolution, and no resolution.

Results

A total of 98 patients were referred to the pain clinic for diagnostic scalene blocks after evaluation for TOS. Of these patients, 80 underwent diagnostic scalene block. A total of 63 patients who underwent a scalene block proceeded to undergo first rib resection. All patients experienced partial or complete improvement after the scalene block. Of these patients, 32 (63%) had complete improvement, 18 (35%) had partial improvement, and one patient (2%) had no improvement after first rib resection.

Conclusions

Neurogenic TOS is a complex pathology whose diagnosis can be challenging in patients presenting with nonclassical symptoms. Based on our findings, preoperative scalene block is an effective tool to accurately predict postoperative symptomatic improvement after first rib resection. The extent of predicted improvement remains variable and a harder measure to quantify given its subjective nature.
背景神经源性胸廓出口综合征(TOS)是一种难以准确诊断的病理,因为上肢神经痛的多种原因存在重叠。虽然斜角肌阻滞常被用作胸廓出口水平臂丛压迫的诊断工具,但它们也可以预测胸廓出口减压后症状的缓解。我们的目的是评估术前斜角肌阻滞对术后症状改善的预测价值。方法回顾性分析2018年至2023年在我院第一肋骨切除术前行斜角肌阻滞的所有患者。收集了人口统计学、出现症状和术前检查的数据。通过图表回顾和患者直接接触来评估斜角肌阻滞和手术减压后的症状缓解情况。这些被分为三类:完全分辨率,部分分辨率和无分辨率。结果98例患者经TOS评估后转诊至疼痛门诊诊断斜角肌阻滞。在这些患者中,80例诊断为斜角肌阻滞。共有63名接受斜角肌阻滞的患者接受了第一肋骨切除术。所有患者在斜角肌阻滞后均有部分或完全改善。在这些患者中,32例(63%)患者完全改善,18例(35%)患者部分改善,1例(2%)患者在第一肋骨切除术后没有改善。结论神经源性TOS是一种复杂的病理,在出现非典型症状的患者中诊断具有挑战性。基于我们的研究结果,术前斜角肌阻滞是准确预测第一肋骨切除术后症状改善的有效工具。预测改善的程度仍然是可变的,而且由于其主观性质,很难量化。
{"title":"Scalene block as a predictor of surgical success for treatment of thoracic outlet syndrome","authors":"Dorcie Ann Gillette MD ,&nbsp;Linda Peng BS ,&nbsp;Maen Aboul Hosn MD","doi":"10.1016/j.jvsvi.2025.100343","DOIUrl":"10.1016/j.jvsvi.2025.100343","url":null,"abstract":"<div><h3>Background</h3><div>Neurogenic thoracic outlet syndrome (TOS) is a difficult pathology to accurately diagnose given the overlap between multiple causes of neuralgias of the upper extremity. Although scalene blocks are often used as diagnostic tools for brachial plexus compression at the level of the thoracic outlet, they can also be predictive of symptomatic relief after thoracic outlet decompression. Our objective is to evaluate the predictive value of preoperative scalene block for postoperative symptom improvement.</div></div><div><h3>Methods</h3><div>A retrospective review was performed for all patients who underwent a scalene block before first rib resection and at our institution between 2018 and 2023. Data on demographics, presenting symptoms, and preoperative workup were collected. Symptom resolution after scalene block and surgical decompression was assessed through chart review and direct patient contact. These were classified into three categories: complete resolution, partial resolution, and no resolution.</div></div><div><h3>Results</h3><div>A total of 98 patients were referred to the pain clinic for diagnostic scalene blocks after evaluation for TOS. Of these patients, 80 underwent diagnostic scalene block. A total of 63 patients who underwent a scalene block proceeded to undergo first rib resection. All patients experienced partial or complete improvement after the scalene block. Of these patients, 32 (63%) had complete improvement, 18 (35%) had partial improvement, and one patient (2%) had no improvement after first rib resection.</div></div><div><h3>Conclusions</h3><div>Neurogenic TOS is a complex pathology whose diagnosis can be challenging in patients presenting with nonclassical symptoms. Based on our findings, preoperative scalene block is an effective tool to accurately predict postoperative symptomatic improvement after first rib resection. The extent of predicted improvement remains variable and a harder measure to quantify given its subjective nature.</div></div>","PeriodicalId":74034,"journal":{"name":"JVS-vascular insights","volume":"4 ","pages":"Article 100343"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146022800","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
Pub Date : 2026-01-01
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引用次数: 0
Pub Date : 2026-01-01
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引用次数: 0
Pub Date : 2026-01-01
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引用次数: 0
Pub Date : 2026-01-01
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引用次数: 0
Pub Date : 2026-01-01
{"title":"","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":74034,"journal":{"name":"JVS-vascular insights","volume":"4 ","pages":"Article 100342"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146472107","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
期刊
JVS-vascular insights
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