Neurochirurgie最新文献

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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。

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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。

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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

Comment on “Performance of magnetic resonance imaging in discriminating between intra- and extradural versus extradural-only nerve sheath tumor” 对“磁共振成像在鉴别硬膜内和硬膜外与仅硬膜外神经鞘肿瘤中的表现”的评论。

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-11-30 DOI: 10.1016/j.neuchi.2025.101757

Ankur Sharma , Janvi Patel , Pankaj Nainwal , Hariharan Srinivasan

引用次数: 0

Can Microsurgery be Standardized? Quantifying Technique in Intracerebral Hemorrhage 显微外科手术能标准化吗？脑出血定量技术

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-11-27 DOI: 10.1016/j.neuchi.2025.101756

Catherine Veilleux, Matthew Skarsgard, Garnette R. Sutherland, Andrew M. Demchuk, Michael D. Hill, Sanju Lama

引用次数: 0

Permanent ventricular shunt and risk of meningitis: Challenges in weaning from external ventricular drain 永久性脑室分流和脑膜炎的风险：从外脑室引流中断奶的挑战。

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-11-24 DOI: 10.1016/j.neuchi.2025.101748

Elisabeth Garrido , Mathieu Lozouet , Vianney Gilard , Pauline Garel , Jean Glenisson , Julien Burel , Stéphane Derrey

Background

Aneurysmal subarachnoid hemorrhage (SAH) is a severe condition associated with high mortality and morbidity. Acute hydrocephalus is a common complication that often necessitates external ventricular drainage (EVD) and, in some cases, permanent shunt placement. Determining the optimal timing for EVD weaning remains challenging, as it requires balancing the need for permanent shunting against the risk of meningitis.

Methods

This retrospective cohort study analysed aneurysmal SAH patients requiring EVD at Rouen University Hospital between January 2020 and December 2022. Predictive factors for successful weaning, the risk of meningitis, and the impact of weaning attempt timing on outcomes were assessed.

Results

A total of 63 patients were included. Successful weaning was achieved in 37 cases (58.7%), while 26 patients (41.3%) required a ventriculoperitoneal shunt (VPS). Younger age, minimal comorbidities, higher Glasgow Coma Scale (GCS) scores (≥10), and limited intraventricular haemorrhage were significantly associated with weaning success. Meningitis cases exhibited a bimodal distribution, with an early peak related to procedural factors, and a second peak which coincided with EVD failure attempt. Most weaning attempts performed within the first 14 days post-SAH resulted in false failure attempts, and repeated attempts were sometimes successful.

Conclusion

These findings underscore that EVD weaning remains a complex clinical challenge, characterized by multifaceted risks requiring careful management and highlighting the need for refined weaning strategies.

背景：动脉瘤性蛛网膜下腔出血（SAH）是一种死亡率和发病率高的严重疾病。急性脑积水是一种常见的并发症，通常需要外脑室引流术（EVD），在某些情况下，需要永久性分流术。确定埃博拉病毒病断奶的最佳时机仍然具有挑战性，因为它需要平衡永久性分流的需要和脑膜炎的风险。方法：这项回顾性队列研究分析了2020年1月至2022年12月在鲁昂大学医院接受EVD治疗的动脉瘤性SAH患者。评估了成功断奶的预测因素、脑膜炎的风险以及尝试断奶时间对结果的影响。结果：共纳入63例患者。37例（58.7%）患者成功脱机，26例（41.3%）患者需要脑室腹腔分流术（VPS）。年龄较小、合并症最少、格拉斯哥昏迷评分（GCS）评分较高（≥10）和有限的脑室内出血与断奶成功显著相关。脑膜炎病例呈双峰分布，早期高峰与程序因素有关，第二个高峰与EVD失败尝试相吻合。大多数在sah后的前14天内进行的断奶尝试导致错误的失败尝试，重复尝试有时会成功。结论：这些研究结果强调，EVD断奶仍然是一个复杂的临床挑战，其特点是多方面的风险需要仔细管理，并强调需要完善的断奶策略。

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引用次数: 0

Globalizing Neurotrauma Prognostication: Integrating Cultural Context and Computational Intelligence in Pediatric TBI Research 全球化的神经创伤预测：在儿童脑外伤研究中整合文化背景和计算智能。

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-11-22 DOI: 10.1016/j.neuchi.2025.101750

Riza Amalia

引用次数: 0

The Neurosurgical Exodus — A Loss for Latin American Science and Public Health 神经外科的外流——拉丁美洲科学和公共卫生的损失

IF 1.4 4区医学 Q4 CLINICAL NEUROLOGY

Neurochirurgie

Pub Date : 2025-11-21 DOI: 10.1016/j.neuchi.2025.101749

Jack Váscones-Román , Fritz Fidel Váscones-Román

引用次数: 0

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