Neurochirurgie最新文献

英文中文

Systematic intraoperative bacteriological testing in patients operated for primary chronic subdural hematoma – A prospective analysis 原发性慢性硬膜下血肿患者的系统性术中细菌学检查——一项前瞻性分析

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-19 DOI: 10.1016/j.neuchi.2025.101766

Kevin Comair , Adrien Galy , Karim Chirani , Tania Idriceanu , Hela Krimi , Amel Marniche , Anne-Sophie Montero , Lyes Rabia , Suhan Senova , Sanaa Tazi , Stéphane Palfi , Vincent Fihman , Paul-Louis Woerther , Florence Reibel , Caroline Apra

Introduction

Chronic subdural hematomas (CSDH), with an incidence of 20/100,000/year, often necessitates surgical intervention. Recurrence requiring redo surgery occurs in 12% of patients. This study aims to assess the presence of bacteria in CSDH by systematically collecting multiple tissue samples and analyzing the association between positive cultures, prognosis, and recurrence.

Methods

This prospective single-center study was conducted at Henri Mondor University Hospital, France, between January 2023 and June 2024. Adult patients operated for CSDH were included. Clinical, radiological, and microbiological data were analysed with a 6-months follow-up. Surgery involved burr-hole or mini-craniotomy with systematic postoperative drainage. Three independent subdural samples were collected intraoperatively.

Results

Eighty patients were included. Recurrence occurred in 20% of patients, with a median time to redo surgery of 15 days. Subdural germs were detected in 21% of patients, with a majority of positive samples in 53% and a majority of negative samples in 47%. The most common bacteria were Cutibacterium acnes and Staphylococcus species. No correlation was found between germ detection and hematoma recurrence or death. No patient developed postoperative empyema.

Discussion

This study is the first to report systematic bacteriological testing of subdural collection. Detection of skin microbiota bacteria was not uncommon, but there was no significant increase in recurrence if bacteria were detected. The findings suggest that bacterial contamination rather than infection is more likely.

Conclusion

Clinically inapparent infection of subdural hematoma is not common and should not be explored systematically. The decision to treat with antibiotics should be based on multiple positive bacterial samples and clinical data.

慢性硬膜下血肿（CSDH）的发病率为20/10万/年，通常需要手术治疗。复发需要重做手术的患者占12%。本研究旨在通过系统收集多个组织样本，分析阳性培养物、预后和复发之间的关系，评估CSDH中细菌的存在。方法本前瞻性单中心研究于2023年1月至2024年6月在法国亨利蒙多大学医院进行。包括因CSDH手术的成年患者。在6个月的随访中分析了临床、放射学和微生物学数据。手术包括钻孔或小开颅，术后系统引流。术中采集三个独立的硬膜下样本。结果共纳入80例患者。20%的患者出现复发，重做手术的中位时间为15天。在21%的患者中检测到硬膜下细菌，阳性样本占53%，阴性样本占47%。最常见的细菌是痤疮角质杆菌和葡萄球菌。细菌检测与血肿复发或死亡无相关性。术后无患者发生脓胸。本研究首次报道了硬膜下收集物的系统细菌学检测。皮肤微生物群细菌的检测并不罕见，但如果检测到细菌，复发率没有显著增加。研究结果表明，细菌污染而不是感染的可能性更大。结论临床上硬膜下血肿隐性感染并不常见，不应系统探讨。使用抗生素治疗的决定应基于多个阳性细菌样本和临床数据。

{"title":"Systematic intraoperative bacteriological testing in patients operated for primary chronic subdural hematoma – A prospective analysis","authors":"Kevin Comair , Adrien Galy , Karim Chirani , Tania Idriceanu , Hela Krimi , Amel Marniche , Anne-Sophie Montero , Lyes Rabia , Suhan Senova , Sanaa Tazi , Stéphane Palfi , Vincent Fihman , Paul-Louis Woerther , Florence Reibel , Caroline Apra","doi":"10.1016/j.neuchi.2025.101766","DOIUrl":"10.1016/j.neuchi.2025.101766","url":null,"abstract":"<div><h3>Introduction</h3><div>Chronic subdural hematomas (CSDH), with an incidence of 20/100,000/year, often necessitates surgical intervention. Recurrence requiring redo surgery occurs in 12% of patients. This study aims to assess the presence of bacteria in CSDH by systematically collecting multiple tissue samples and analyzing the association between positive cultures, prognosis, and recurrence.</div></div><div><h3>Methods</h3><div>This prospective single-center study was conducted at Henri Mondor University Hospital, France, between January 2023 and June 2024. Adult patients operated for CSDH were included. Clinical, radiological, and microbiological data were analysed with a 6-months follow-up. Surgery involved burr-hole or mini-craniotomy with systematic postoperative drainage. Three independent subdural samples were collected intraoperatively.</div></div><div><h3>Results</h3><div>Eighty patients were included. Recurrence occurred in 20% of patients, with a median time to redo surgery of 15 days. Subdural germs were detected in 21% of patients, with a majority of positive samples in 53% and a majority of negative samples in 47%. The most common bacteria were Cutibacterium acnes and Staphylococcus species. No correlation was found between germ detection and hematoma recurrence or death. No patient developed postoperative empyema.</div></div><div><h3>Discussion</h3><div>This study is the first to report systematic bacteriological testing of subdural collection. Detection of skin microbiota bacteria was not uncommon, but there was no significant increase in recurrence if bacteria were detected. The findings suggest that bacterial contamination rather than infection is more likely.</div></div><div><h3>Conclusion</h3><div>Clinically inapparent infection of subdural hematoma is not common and should not be explored systematically. The decision to treat with antibiotics should be based on multiple positive bacterial samples and clinical data.</div></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"72 1","pages":"Article 101766"},"PeriodicalIF":1.4,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145796592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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

Outcomes for Patients Undergoing Burr Holes for Subdural Hematoma Evacuation versus Craniotomies in the Middle Meningeal Artery Embolization Era 在中脑膜动脉栓塞时代，硬膜下血肿钻孔引流术与开颅术的疗效比较。

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-17 DOI: 10.1016/j.neuchi.2025.101762

Richard Cook, Laura Zima, Ryan Kitagawa

Introduction

Middle meningeal artery embolization (MMAE) has become increasingly utilized for the management of non-acute subdural hematomas (SDH). However, there is minimal literature comparing outcomes between patients undergoing burr holes versus craniotomy in conjunction with MMAE.

Methods

All patients undergoing craniotomy or burr hole operation for SDH with subsequent MMAE during the same admission within a 3-year period were included (n = 135). Binary logistic regression was used to assess association of craniotomy with SDH reoperation. Continuous and ordinal data were analyzed via Wilcoxon rank-sum test, and categorical data were analyzed via chi-squared test.

Results

Chi-squared analysis demonstrated no significant difference in SDH reoperation within 90 days based on surgical management. Further, 90-day readmission, length of stay, GCS, and modified Rankin Scale (mRS) at discharge were comparable between groups. Mean estimated blood loss was higher among those undergoing craniotomy compared to those undergoing burr holes (P = 0.042). Craniotomies also had longer surgery duration compared to burr holes (P < 0.001). Binary logistic regression showed no association between craniotomy and reoperation.

Conclusion

Among patients with SDH undergoing MMAE, there were no significant observed differences in outcomes between burr hole and craniotomy. These findings suggest that when the patient needs surgical evacuation in conjunction with MMAE, and SDH consistency is amenable to burr holes, this less invasive procedure may be considered.

脑膜中动脉栓塞术（MMAE）已越来越多地用于治疗非急性硬膜下血肿（SDH）。然而，很少有文献比较接受钻孔术与开颅术联合MMAE患者的结果。方法：选取3年内同一次住院期间接受SDH开颅或钻孔手术并随后MMAE的所有患者（n = 135）。采用二元logistic回归评估开颅手术与SDH再手术的关系。连续和有序资料采用Wilcoxon秩和检验，分类资料采用卡方检验。结果：卡方分析显示，根据手术处理，90天内SDH再手术无显著差异。此外，90天再入院、住院时间、出院时GCS和修正Rankin量表（mRS）在两组之间具有可比性。开颅术患者的平均估计失血量高于钻孔术患者（P = 0.042）。开颅术的手术时间也比钻孔术长（P < 0.001）。二元logistic回归分析显示开颅手术与再手术无相关性。结论：行MMAE的SDH患者，钻孔与开颅在预后上无显著差异。这些研究结果表明，当患者需要联合MMAE进行手术抽吸，并且SDH一致性适合钻孔时，可以考虑采用这种侵入性较小的手术。

{"title":"Outcomes for Patients Undergoing Burr Holes for Subdural Hematoma Evacuation versus Craniotomies in the Middle Meningeal Artery Embolization Era","authors":"Richard Cook, Laura Zima, Ryan Kitagawa","doi":"10.1016/j.neuchi.2025.101762","DOIUrl":"10.1016/j.neuchi.2025.101762","url":null,"abstract":"<div><h3>Introduction</h3><div>Middle meningeal artery embolization (MMAE) has become increasingly utilized for the management of non-acute subdural hematomas (SDH). However, there is minimal literature comparing outcomes between patients undergoing burr holes versus craniotomy in conjunction with MMAE.</div></div><div><h3>Methods</h3><div>All patients undergoing craniotomy or burr hole operation for SDH with subsequent MMAE during the same admission within a 3-year period were included (n = 135). Binary logistic regression was used to assess association of craniotomy with SDH reoperation. Continuous and ordinal data were analyzed via Wilcoxon rank-sum test, and categorical data were analyzed via chi-squared test.</div></div><div><h3>Results</h3><div>Chi-squared analysis demonstrated no significant difference in SDH reoperation within 90 days based on surgical management. Further, 90-day readmission, length of stay, GCS, and modified Rankin Scale (mRS) at discharge were comparable between groups. Mean estimated blood loss was higher among those undergoing craniotomy compared to those undergoing burr holes (P = 0.042). Craniotomies also had longer surgery duration compared to burr holes (P < 0.001). Binary logistic regression showed no association between craniotomy and reoperation.</div></div><div><h3>Conclusion</h3><div>Among patients with SDH undergoing MMAE, there were no significant observed differences in outcomes between burr hole and craniotomy. These findings suggest that when the patient needs surgical evacuation in conjunction with MMAE, and SDH consistency is amenable to burr holes, this less invasive procedure may be considered.</div></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"72 1","pages":"Article 101762"},"PeriodicalIF":1.4,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145783666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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

Idiopathic normal pressure hydrocephalus and caregiver burden 特发性常压脑积水和照顾者负担。

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-16 DOI: 10.1016/j.neuchi.2025.101761

James Kelbert , Ashley Kern , Robert W Bina , Ganesh Murthy

引用次数: 0

Efficacy and Safety of Stereotactic Radiosurgery for Cerebellopontine Angle Meningiomas: A Systematic Review and Meta-Analysis 立体定向放射治疗桥小脑角脑膜瘤的疗效和安全性：一项系统评价和荟萃分析：运行标题：SRS治疗CPA脑膜瘤。

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-13 DOI: 10.1016/j.neuchi.2025.101763

Bardia Hajikarimloo , Salem M. Tos , Ibrahim Mohammadzadeh , Dorsa Najari , Azin Ebrahimi , Mohammadamin Sabbagh Alvani , Alireza Kooshki , Fatemeh Ghorbanpouryami , Ehsan Bahrami Hezaveh , Mohammad Amin Habibi

Background

Management of cerebellopontine angle (CPA) meningiomas is challenging due to their proximity to critical neurovascular structures. Stereotactic radiosurgery (SRS) has been increasingly utilized for the management of individuals with CPA meningiomas; however, the comprehensive data on its effectiveness and safety profile are limited.

Methods

A systematic review and meta-analysis were conducted in accordance with the PRISMA guidelines. The local control (LC), progression-free survival (PFS), serviceable hearing preservation (SHP), facial nerve (FN) deterioration, trigeminal nerve (TN) deterioration, and adverse radiation effects (ARE) pooled estimates following SRS were calculated using R software.

Results

Thirteen studies, including 604 individuals with CPA meningioma, were included. The meta-analysis revealed a pooled LC rate of 98% (95% CI: 96–99%), 1-year PFS of 100% (95% CI: 100–100%), and 5-year PFS of 94% (95% CI: 81–100%) following SRS. The meta-analysis demonstrated a pooled SHP rate of 96% (95% CI: 86–100%). FN deterioration of 0% (95% CI: 0–2%), and TN deterioration of 1% (95% CI: 0–2%) with a pooled ARE rate of 1% (95% CI: 0–3%). The Meta-regression showed that greater prescribed doses and cochlear doses were correlated with lower SHP and higher ARE rates.

Conclusion

SRS provides a promising LC with functional outcomes concurrent with a favorable safety profile for CPA meningiomas. SRS should be considered as a primary option or as an adjunct to subtotal resection in CPA meningiomas.

背景：桥小脑角（CPA）脑膜瘤的治疗具有挑战性，因为它们靠近关键的神经血管结构。立体定向放射外科（SRS）已越来越多地用于治疗CPA脑膜瘤；然而，关于其有效性和安全性的综合数据有限。方法：根据PRISMA指南进行系统评价和荟萃分析。使用R软件计算SRS后的局部控制（LC）、无进展生存（PFS）、可用听力保存（SHP）、面神经（FN）恶化、三叉神经（TN）恶化和不良辐射效应（ARE）汇总估计。结果：纳入13项研究，包括604例CPA脑膜瘤患者。荟萃分析显示，SRS后合并LC率为98% (95% CI: 96-99%)， 1年PFS为100% (95% CI: 100-100%)， 5年PFS为94% （95% CI: 81-100%）。荟萃分析显示合并SHP率为96% （95% CI: 86-100%）。FN恶化为0% (95% CI: 0-2%)， TN恶化为1% (95% CI: 0-2%)，合并ARE率为1% （95% CI: 0-3%）。meta回归显示，较大的处方剂量和耳蜗剂量与较低的SHP和较高的ARE率相关。结论：SRS为CPA脑膜瘤提供了一种有前景的LC，具有功能结果和良好的安全性。SRS应作为CPA脑膜瘤次全切除术的主要选择或辅助选择。

{"title":"Efficacy and Safety of Stereotactic Radiosurgery for Cerebellopontine Angle Meningiomas: A Systematic Review and Meta-Analysis","authors":"Bardia Hajikarimloo , Salem M. Tos , Ibrahim Mohammadzadeh , Dorsa Najari , Azin Ebrahimi , Mohammadamin Sabbagh Alvani , Alireza Kooshki , Fatemeh Ghorbanpouryami , Ehsan Bahrami Hezaveh , Mohammad Amin Habibi","doi":"10.1016/j.neuchi.2025.101763","DOIUrl":"10.1016/j.neuchi.2025.101763","url":null,"abstract":"<div><h3>Background</h3><div>Management of cerebellopontine angle (CPA) meningiomas is challenging due to their proximity to critical neurovascular structures. Stereotactic radiosurgery (SRS) has been increasingly utilized for the management of individuals with CPA meningiomas; however, the comprehensive data on its effectiveness and safety profile are limited.</div></div><div><h3>Methods</h3><div>A systematic review and meta-analysis were conducted in accordance with the PRISMA guidelines. The local control (LC), progression-free survival (PFS), serviceable hearing preservation (SHP), facial nerve (FN) deterioration, trigeminal nerve (TN) deterioration, and adverse radiation effects (ARE) pooled estimates following SRS were calculated using R software.</div></div><div><h3>Results</h3><div>Thirteen studies, including 604 individuals with CPA meningioma, were included. The meta-analysis revealed a pooled LC rate of 98% (95% CI: 96–99%), 1-year PFS of 100% (95% CI: 100–100%), and 5-year PFS of 94% (95% CI: 81–100%) following SRS. The meta-analysis demonstrated a pooled SHP rate of 96% (95% CI: 86–100%). FN deterioration of 0% (95% CI: 0–2%), and TN deterioration of 1% (95% CI: 0–2%) with a pooled ARE rate of 1% (95% CI: 0–3%). The Meta-regression showed that greater prescribed doses and cochlear doses were correlated with lower SHP and higher ARE rates.</div></div><div><h3>Conclusion</h3><div>SRS provides a promising LC with functional outcomes concurrent with a favorable safety profile for CPA meningiomas. SRS should be considered as a primary option or as an adjunct to subtotal resection in CPA meningiomas.</div></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"72 1","pages":"Article 101763"},"PeriodicalIF":1.4,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145764571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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

Artificial intelligence in spine surgery: a scoping review 人工智能在脊柱外科中的应用：综述。

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-13 DOI: 10.1016/j.neuchi.2025.101764

Anis Choucha , Morgane Evin , Matteo de Simone , Guillaume Dannhoff , Henry Dufour , Valentin Avinens , Kaissar Farah , Florian Saby , Stephane Fuentes

Background

The integration of artificial intelligence (AI) into spinal surgery is gaining attention due to its potential to expand evidence-based medicine and provide personalized care. However, its application in day-to-day surgical practice is still in the developmental stage. This scoping review aims to map the landscape of AI applications in spinal surgery, draw current frontiers, and identify gaps in the literature.

Methods

Following PRISMA guidelines, a scoping review was conducted using PubMed and Cochrane databases up to January 2024. Included studies described AI models or validated AI applications in spinal surgery. A wide range of data was extracted, including objectives, outcomes, model architectures, validation techniques, the type of disease, the institutions involved, and journals.

Results

The United States led contributions (32%), followed by China (18%), Europe (15%), Japan (9%), and South Korea (9%). These publications reached journals with an average two-year impact factor of 3.4. Resource sharing was limited: 4 studies provided self-service applications, seven shared data, and 17 offered code access. The studies addressed diverse spinal pathologies, led by degenerative (24%) and oncological (19%) conditions. Deep learning methods dominated, alongside non-deep learning models. Validation was reported in 76% of studies, both internal (67%), or external (19%). An exhaustive table of all the articles' details is available in the supplementary material.

Conclusion

The lack of rigorous external validation and restricted access to AI models and datasets limits AI’s widespread adoption. To bridge this gap, stronger collaboration across disciplines, greater transparency in model development, and a concerted effort to ensure that validated models are made publicly accessible are needed.

背景：人工智能（AI）与脊柱外科的整合正受到关注，因为它有可能扩大循证医学和提供个性化护理。然而，其在日常外科实践中的应用仍处于发展阶段。这一范围审查旨在绘制人工智能在脊柱外科应用的景观，绘制当前的前沿，并确定文献中的空白。方法：遵循PRISMA指南，使用PubMed和Cochrane数据库进行范围综述，截止到2024年1月。纳入的研究描述了人工智能模型或验证了人工智能在脊柱外科中的应用。提取了广泛的数据，包括目标、结果、模型架构、验证技术、疾病类型、涉及的机构和期刊。结果：美国贡献最多（32%），其次是中国（18%）、欧洲（15%）、日本（9%）和韩国（9%）。这些出版物的平均两年影响因子为3.4。资源共享是有限的：4项研究提供自助服务应用程序，7项研究提供共享数据，17项研究提供代码访问。这些研究涉及多种脊柱病理，以退行性（24%）和肿瘤性（19%）疾病为主。深度学习方法和非深度学习模型占主导地位。76%的研究报告了验证，包括内部（67%）和外部（19%）。在补充材料中提供了所有条款细节的详尽表。结论：缺乏严格的外部验证以及对人工智能模型和数据集的限制访问限制了人工智能的广泛采用。为了弥合这一差距，需要更强的跨学科合作，模型开发中更大的透明度，以及确保公开访问经过验证的模型的一致努力。

{"title":"Artificial intelligence in spine surgery: a scoping review","authors":"Anis Choucha , Morgane Evin , Matteo de Simone , Guillaume Dannhoff , Henry Dufour , Valentin Avinens , Kaissar Farah , Florian Saby , Stephane Fuentes","doi":"10.1016/j.neuchi.2025.101764","DOIUrl":"10.1016/j.neuchi.2025.101764","url":null,"abstract":"<div><h3>Background</h3><div>The integration of artificial intelligence (AI) into spinal surgery is gaining attention due to its potential to expand evidence-based medicine and provide personalized care. However, its application in day-to-day surgical practice is still in the developmental stage. This scoping review aims to map the landscape of AI applications in spinal surgery, draw current frontiers, and identify gaps in the literature.</div></div><div><h3>Methods</h3><div>Following PRISMA guidelines, a scoping review was conducted using PubMed and Cochrane databases up to January 2024. Included studies described AI models or validated AI applications in spinal surgery. A wide range of data was extracted, including objectives, outcomes, model architectures, validation techniques, the type of disease, the institutions involved, and journals.</div></div><div><h3>Results</h3><div>The United States led contributions (32%), followed by China (18%), Europe (15%), Japan (9%), and South Korea (9%). These publications reached journals with an average two-year impact factor of 3.4. Resource sharing was limited: 4 studies provided self-service applications, seven shared data, and 17 offered code access. The studies addressed diverse spinal pathologies, led by degenerative (24%) and oncological (19%) conditions. Deep learning methods dominated, alongside non-deep learning models. Validation was reported in 76% of studies, both internal (67%), or external (19%). An exhaustive table of all the articles' details is available in the supplementary material.</div></div><div><h3>Conclusion</h3><div>The lack of rigorous external validation and restricted access to AI models and datasets limits AI’s widespread adoption. To bridge this gap, stronger collaboration across disciplines, greater transparency in model development, and a concerted effort to ensure that validated models are made publicly accessible are needed.</div></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"72 1","pages":"Article 101764"},"PeriodicalIF":1.4,"publicationDate":"2025-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145764594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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

Understanding the choice of the experimental and control groups: Thrombectomy under general anesthesia or conscious sedation 了解实验组和对照组的选择：全麻或清醒镇静下取栓

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-12 DOI: 10.1016/j.neuchi.2025.101758

William Boisseau , Tim E. Darsaut , Jean Raymond

Background

The choice of control group in randomized clinical trials (RCTs) is crucial, from both an ethical and a scientific perspective. Thrombectomy can be performed under general anesthesia (GA) or conscious sedation (CS). Non-randomized studies and the first thrombectomy trials showed worse outcomes with GA, but studies were obviously confounded: more severe strokes required intubation for airway protection. Thrombectomy centers advocating the use of GA had to compare GA and CS in a randomized fashion. But which arm should be ‘experimental’, and which ‘standard care’?

Methods

We review the design of RCTs comparing GA to CS during thrombectomy for acute stroke, paying particular attention to the trial hypothesis.

Results

In early trial centers GA was the standard approach, with CS considered ‘experimental’. Thus, most trials tested the potential superiority of CS over GA, but most trials were too small, yielding inconclusive results that were erroneously interpreted as equivalent. In principle, GA had the burden of proof and should have been considered the experimental intervention, as GA is more invasive and associated with worse outcomes. Interventions that introduce greater risk must be justified by evidence of benefit and should be tested as experimental treatments. However, in practice, centers routinely working under GA had a learning curve to use CS, and for them the experimental intervention was CS.

Conclusion

We need to integrate clinical trials into practice to optimize care but the best way to compare two active treatments remains a work in progress.

从伦理和科学的角度来看，随机临床试验（RCTs）中对照组的选择至关重要。取栓可以在全麻（GA）或清醒镇静（CS）下进行。非随机研究和第一次取栓试验显示GA的预后较差，但研究明显混淆：更严重的中风需要插管来保护气道。提倡使用GA的取栓中心必须以随机方式比较GA和CS。但是哪一组应该是“实验性”的，哪一组应该是“标准治疗”的呢？方法回顾急性脑卒中取栓过程中比较GA与CS的随机对照试验设计，特别注意试验假设。结果在早期的试验中心，GA是标准的方法，CS被认为是“实验性的”。因此，大多数试验测试了CS相对于GA的潜在优势，但大多数试验规模太小，结果不确定，被错误地解释为等效。原则上，GA有举证责任，应被视为实验性干预，因为GA更具侵入性，且与较差的结果相关。引入更大风险的干预措施必须以有益的证据来证明其合理性，并应作为实验性治疗进行测试。然而，在实践中，通常在GA下工作的中心有一个学习曲线来使用CS，对他们来说，实验干预就是CS。结论我们需要将临床试验与实践相结合，以优化护理，但比较两种积极治疗方法的最佳方法仍有待研究。

{"title":"Understanding the choice of the experimental and control groups: Thrombectomy under general anesthesia or conscious sedation","authors":"William Boisseau , Tim E. Darsaut , Jean Raymond","doi":"10.1016/j.neuchi.2025.101758","DOIUrl":"10.1016/j.neuchi.2025.101758","url":null,"abstract":"<div><h3>Background</h3><div>The choice of control group in randomized clinical trials (RCTs) is crucial, from both an ethical and a scientific perspective. Thrombectomy can be performed under general anesthesia (GA) or conscious sedation (CS). Non-randomized studies and the first thrombectomy trials showed worse outcomes with GA, but studies were obviously confounded: more severe strokes required intubation for airway protection. Thrombectomy centers advocating the use of GA had to compare GA and CS in a randomized fashion. But which arm should be ‘experimental’, and which ‘standard care’?</div></div><div><h3>Methods</h3><div>We review the design of RCTs comparing GA to CS during thrombectomy for acute stroke, paying particular attention to the trial hypothesis.</div></div><div><h3>Results</h3><div>In early trial centers GA was the standard approach, with CS considered ‘experimental’. Thus, most trials tested the potential superiority of CS over GA, but most trials were too small, yielding inconclusive results that were erroneously interpreted as equivalent. In principle, GA had the burden of proof and should have been considered the experimental intervention, as GA is more invasive and associated with worse outcomes. Interventions that introduce greater risk must be justified by evidence of benefit and should be tested as experimental treatments. However, in practice, centers routinely working under GA had a learning curve to use CS, and for them the experimental intervention was CS.</div></div><div><h3>Conclusion</h3><div>We need to integrate clinical trials into practice to optimize care but the best way to compare two active treatments remains a work in progress.</div></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"72 1","pages":"Article 101758"},"PeriodicalIF":1.4,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145747483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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

Understanding non-inferiority trials: Lessons from trials comparing thrombectomy with or without intravenous thrombolysis 了解非劣效性试验：从比较取栓与不进行静脉溶栓的试验中得到的教训

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-06 DOI: 10.1016/j.neuchi.2025.101759

William Boisseau , Tim E. Darsaut , Jean Raymond

Background

Non-inferiority (NI) trials are essential to evaluate whether new treatments which may offer some collateral benefit (such as less invasiveness, fewer side effects, availability, ease of administration, or lower cost) do so without significant loss of efficacy, as compared to treatments that are already established to be beneficial. NI trials pose specific design challenges, such as selecting appropriate NI margins, as well as unique problems of interpretation.

Methods

We examine six NI trials that compared thrombectomy with or without intravenous thrombolysis (IVT). We review fundamental problems with NI trials.

Results

Two of six trials reported that thrombectomy alone was non-inferior compared to thrombectomy combined with IVT. These trials used large NI margins or stopped recruitment prematurely after an interim analysis. The remaining four trials failed to demonstrate non-inferiority. In general, the chosen NI margins were unjustified and clinically unacceptable. A meta-analysis showed NI at a 10% margin, but not at a clinically pertinent 5% level. We examine (i) assay sensitivity, (ii) the constancy assumption and (iii) NI margins, three concepts that are crucial to understand NI trials. We question whether NI trials are appropriate in acute stroke, where there is little room to accept inferiority. Assessing superiority regarding surrogate outcome measures that have shown a causal relationship with clinical outcomes may be an alternative approach.

Conclusion

Thrombectomy alone has not properly been shown non-inferior to thrombectomy with IVT. The NI trial design is poorly adapted for use in acute stroke.

背景：非劣效性（NI）试验对于评估可能提供一些附带益处（如侵入性更小、副作用更少、可获得性、易于给药或成本更低）的新疗法是否与已经确定有益的治疗相比没有明显的疗效损失至关重要。NI试验提出了特定的设计挑战，例如选择适当的NI边缘，以及解释的独特问题。方法我们研究了6项NI试验，比较了静脉溶栓术（IVT）和静脉溶栓术（IVT）的效果。我们回顾NI试验的基本问题。结果6项试验中有2项报告单独取栓比取栓联合IVT效果更好。这些试验使用较大的NI边际或在中期分析后过早停止招募。其余四项试验未能证明非劣效性。一般来说，选择的NI边缘是不合理的，临床上是不可接受的。一项荟萃分析显示NI有10%的边际，但没有达到临床相关的5%的水平。我们检查(i)测定敏感性，（ii）恒常性假设和（iii） NI边际，这三个概念对理解NI试验至关重要。我们质疑NI试验是否适用于急性卒中，因为在急性卒中中几乎没有接受劣效性的余地。评估与临床结果有因果关系的替代结果测量的优越性可能是另一种方法。结论单纯取栓术并不能完全证明其优于静脉内腔静脉血栓切除术。NI试验设计不适用于急性脑卒中。

{"title":"Understanding non-inferiority trials: Lessons from trials comparing thrombectomy with or without intravenous thrombolysis","authors":"William Boisseau , Tim E. Darsaut , Jean Raymond","doi":"10.1016/j.neuchi.2025.101759","DOIUrl":"10.1016/j.neuchi.2025.101759","url":null,"abstract":"<div><h3>Background</h3><div>Non-inferiority (NI) trials are essential to evaluate whether new treatments which may offer some collateral benefit (such as less invasiveness, fewer side effects, availability, ease of administration, or lower cost) do so without significant loss of efficacy, as compared to treatments that are already established to be beneficial. NI trials pose specific design challenges, such as selecting appropriate NI margins, as well as unique problems of interpretation.</div></div><div><h3>Methods</h3><div>We examine six NI trials that compared thrombectomy with or without intravenous thrombolysis (IVT). We review fundamental problems with NI trials.</div></div><div><h3>Results</h3><div>Two of six trials reported that thrombectomy alone was non-inferior compared to thrombectomy combined with IVT. These trials used large NI margins or stopped recruitment prematurely after an interim analysis. The remaining four trials failed to demonstrate non-inferiority. In general, the chosen NI margins were unjustified and clinically unacceptable. A meta-analysis showed NI at a 10% margin, but not at a clinically pertinent 5% level. We examine (i) assay sensitivity, (ii) the constancy assumption and (iii) NI margins, three concepts that are crucial to understand NI trials. We question whether NI trials are appropriate in acute stroke, where there is little room to accept inferiority. Assessing superiority regarding surrogate outcome measures that have shown a causal relationship with clinical outcomes may be an alternative approach.</div></div><div><h3>Conclusion</h3><div>Thrombectomy alone has not properly been shown non-inferior to thrombectomy with IVT. The NI trial design is poorly adapted for use in acute stroke.</div></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"72 1","pages":"Article 101759"},"PeriodicalIF":1.4,"publicationDate":"2025-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145693620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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

Surgical versus endovascular treatment for idiopathic intracranial hypertension 特发性颅内高压的手术与血管内治疗

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-06 DOI: 10.1016/j.neuchi.2025.101755

William Boisseau , Manon Philibert , Catherine Vignal-Clermont , Koorosh Jeshrani , Amira Al Raaisi , Raphael Blanc , Jean-Philippe Desilles , Simon Escalard , Mikael Mazighi , Michel Piotin , Hocine Redjem , Erwan Robichon , Stanislas Samjda , Rabih Hage , Alexia Tran , Dorian Chauvet , Sorin Aldea , Samiya Abi-Jaoude , Pierre Bourdillon

引用次数: 0

Learning to design clinical trials that optimize care is a work in progress 学习设计临床试验以优化护理是一项正在进行的工作

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-06 DOI: 10.1016/j.neuchi.2025.101760

William Boisseau , Tim E. Darsaut , Jean Raymond

引用次数: 0

Comment on “Surgical versus endovascular treatment for idiopathic intracranial hypertension” 对“特发性颅内高压手术与血管内治疗”的评论。

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-12-01 DOI: 10.1016/j.neuchi.2025.101754

Georgios Tsermoulas , Nicholas Gikas , Alexandra J. Sinclair , Susan P. Mollan , Gabriele Berman

引用次数: 0

首页上一页

下一页尾页

类型

全部化学•材料生命科学医学物理工程技术环境•农林材料科学地球科学法学管理学化学环境科学与生态学计算机科学教育学经济学农林科学人文科学生物学数学物理与天体物理心理学综合性期刊其他工业工程理学历史学农学文学信息工程

数据库

全部 ACS Publications Elsevier ieeexplore Springer The Royal Society of Chemistry Wiley

期刊

Neurochirurgie

全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.

﹀