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Flow alteration surgery using a radial artery graft for recurrent ruptured vertebral artery dissecting aneurysm after stent-assisted coil embolization: A case report 使用桡动脉移植物进行血流改变手术,治疗支架辅助线圈栓塞术后复发的椎动脉剥脱动脉瘤:病例报告
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-06-08 DOI: 10.1016/j.neuchi.2024.101574
Masaru Abiko , Yukishige Hashimoto , Masakazu Mitsunobu , Nobutaka Horie

Background

Ruptured vertebral artery dissecting aneurysm (VADA) is often treated surgically with coil embolization and sometimes recurs. We herein report a case of recurrent ruptured VADA after stent-assisted coil embolization (SAC) that was successfully treated with flow alteration surgery using a radial artery (RA) graft.

Case Description

A 67-year-old woman presented with headache and coma. Enhanced CT revealed subarachnoid hemorrhage due to right VADA. Since the left VA was hypoplastic, the aneurysm was treated with SAC. However, follow-up angiography revealed recurrence of the aneurysm. Additional embolization was not considered due to the small size of the recurrent lesion and the presence of a stent; therefore, flow alteration surgery was performed using a RA graft. There were no neurological deficits after surgery or recurrence.

Conclusion

Flow alteration surgery using a RA graft is useful for recurrent VADA after SAC.

背景破裂的椎动脉剥脱性动脉瘤(VADA)通常采用线圈栓塞术进行手术治疗,但有时会复发。我们在此报告了一例支架辅助线圈栓塞术(SAC)后复发的椎动脉夹层动脉瘤,通过使用桡动脉(RA)移植物进行血流改变手术成功治疗了该患者。增强 CT 显示右侧 VADA 导致蛛网膜下腔出血。由于左侧 VA 发育不良,因此用 SAC 治疗了动脉瘤。然而,随访血管造影显示动脉瘤复发。由于复发病灶较小,且存在支架,因此没有考虑进行额外的栓塞治疗;因此,使用 RA 移植进行了血流改变手术。结论使用 RA 移植物进行血流改变手术对 SAC 后复发的 VADA 很有用。
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引用次数: 0
Surgical management of a rare giant sacral meningocele in a child 罕见的儿童巨大骶骨脑膜瘤的手术治疗。
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-05-30 DOI: 10.1016/j.neuchi.2024.101571
Adrien Chenneviere , Frederique Belloy , Aude Bessiere , Thierry Petit , Evelyne Emery , Alin Borha

Introduction

Anterior sacral meningocele is a rare congenital disorder, occurring isolated or in syndromic disease.

Case report

A 15-year-old patient who complained of abdominal pain and urinary dysfunction was managed surgically. Imaging diagnosed a giant presacral meningocele and agenesis of the coccyx.

Discussion

The presentation of sacral meningocele can be poorly symptomatic, which is why some patients are diagnosed late. Sometimes, diagnosis is suggested by non-specific abdominal symptoms or complications. Abdominal-pelvic radiological examination and lumbar spine MRI are essential, and treatment must be surgical. There are several surgical approaches, but currently no consensus.

Conclusion

An unusual huge presacral cystic mass in a young patient may be isolated or part of a syndrome, and can be asymptomatic for a long time, leading to late diagnosis. The surgical approach should be based on multidisciplinary discussion. We operated on a giant anterior sacral meningocele in a child using a posterior approach, with a satisfactory result.

导言:骶骨前脑膜囊肿是一种罕见的先天性疾病:骶骨前脑膜囊肿是一种罕见的先天性疾病,可单独或合并发生:一名 15 岁的患者主诉腹痛和排尿功能障碍,接受了手术治疗。影像学诊断为巨大骶前脑膜囊肿和尾骨发育不全:讨论:骶骨脑膜囊肿的症状不明显,这也是一些患者诊断较晚的原因。有时,非特异性腹部症状或并发症会提示诊断。腹盆腔放射学检查和腰椎核磁共振成像检查必不可少,治疗必须采用手术。目前有多种手术方法,但尚未达成共识:结论:年轻患者骶前异常巨大囊性肿块可能是孤立的,也可能是综合征的一部分,而且可能长期无症状,导致晚期诊断。手术方法应以多学科讨论为基础。我们采用后入路对一名儿童的巨大骶骨前脑膜囊肿进行了手术,结果令人满意。
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引用次数: 0
Auditory brainstem implants: an analysis of adverse events in the MAUDE database 听性脑干植入:MAUDE 数据库中的不良事件分析。
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-05-28 DOI: 10.1016/j.neuchi.2024.101570
Olivia E. Speed , Soroush Farsi , Kaersti Rickels , Vijay A. Patel , Anna Bareiss , John Dornhoffer , Robert A. Saadi

Objective

Auditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events.

Study design

This is a study of a multi-institutional database maintained by the US FDA.

Setting

A database analysis was performed via collaboration of multiple clinicians at tertiary referral centers.

Methods

The MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term “Implant, Auditory Brainstem” and reviewing all reports with the basic search term “Brainstem Implant”. All collected reports were individually reviewed.

Results

A total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation.

Conclusions

Poor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.

目的:听性脑干植入体(ABI)用于恢复缺乏适当耳蜗解剖结构和/或耳蜗神经的患者的听力。本研究的目的是检查制造和用户设施设备经验(MAUDE)数据库,分析不良事件:研究设计:这是一项对美国 FDA 维护的多机构数据库的研究:通过三级转诊中心多位临床医生的合作进行数据库分析:在 MAUDE 数据库中查询与 ABI 相关的医疗器械报告 (MDR)。使用高级检索词 "植入物,听性脑干 "确定MDR,并使用基本检索词 "脑干植入物 "审查所有报告。对收集到的所有报告进行逐一审查:结果:共审查了 265 份患者报告,其中 55 份符合纳入标准。有关听力结果的报告包括未能提供听力益处(n = 27)、植入失败/设备故障(n = 10)和设备未使用(n = 6)。术后并发症包括局部皮肤感染(3 例)、CSF 泄漏(3 例)、ICP 升高(1 例)、手术部位开裂(1 例)、肿胀(1 例)、需要引流的血清肿形成(1 例)和脑膜炎(2 例)。两名患者在 1.5 特斯拉磁共振成像采集过程中磁铁脱落。有 35 例完全拆卸设备,1 例部分拆卸;13 例患者在拆卸设备后植入了新设备:结论:在本次分析中,听力效果不佳、装置故障和未使用是常见的解释原因。这些信息有助于医生为患者和家属提供咨询,并管理他们对装置的期望。
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引用次数: 0
Recurrent artery of Heubner aneurysms in focus: insights into occurrence and current treatment paradigms 聚焦休布纳动脉瘤复发:对发生率和当前治疗模式的见解
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-05-24 DOI: 10.1016/j.neuchi.2024.101572
Oday Atallah , Zeinab Hammoud , Yasser F. Almealawy , Vivek Sanker , Wireko Andrew Awuah , Toufik Abdul-Rahman , Ahmed Muthana , Aalaa Saleh , Inibehe Ime Okon , Bipin Chaurasia , Moshiur Rahman , Ahmed Kertam , Amr Badary

Introduction

The recurrent artery of Heubner (RAH), also known as the medial striate artery, is the most clinically important perforator of the anterior cerebral artery. RAH aneurysm is relatively rare, with 11 cases found in the present literature review, but poses significant clinical challenges due to potential impact on cognitive and motor functions. This systematic review explored available case reports to comprehensively understand clinical presentation, diagnosis, management and outcome in RAH aneurysm.

Materials and methods

Following PRISMA guidelines, this systematic review extensively explored RAH aneurysms, covering demographics, symptoms, diagnosis, treatments and outcomes. Comprehensive searches on PubMed, Scopus, Google Scholar, and Science Direct employed keywords such as "recurrent artery of Heubner aneurysm" and "Heubner's artery."

Results

After extensive screening, 9 qualifying studies were identified, with 11 patients diagnosed with rare RAH aneurysm. Median age was 55 years (standard deviation, 15.3 years), with 54.5% males. 45.5% of patients presented risk factors, including Moyamoya disease in 2 patients. The majority were classified as grade I/II on the Hunt and Hess (H&H) and World Federation of Neurological Societies (WFNS) systems. Aneurysms were predominantly located in the A1 segment, with a mean size of 4.7 mm. Treatments varied, with clipping being the most frequent (63.6%). The mortality rate was 18.2%. Clipping was associated with favorable outcomes but higher rates of infarction.

Conclusion

This analysis highlighted the various symptoms, therapy methods and outcomes of RAH aneurysm, with A1 being the predominant origin. Future research should explore potential genetic predisposition factors and novel therapeutic interventions to address gaps in our knowledge.

导言霍布纳复发动脉(RAH)又称内侧纹状动脉,是大脑前动脉最重要的临床穿孔动脉。RAH 动脉瘤相对罕见,本文献综述共发现 11 例,但由于对认知和运动功能的潜在影响,给临床带来了巨大挑战。本系统性综述探讨了现有的病例报告,以全面了解 RAH 动脉瘤的临床表现、诊断、管理和预后。材料和方法本系统性综述遵循 PRISMA 指南,广泛探讨了 RAH 动脉瘤,内容包括人口统计学、症状、诊断、治疗和预后。在PubMed、Scopus、Google Scholar和Science Direct上进行了全面搜索,使用的关键词包括 "Recurrent artery of Heubner aneurysm "和 "Heubner's artery"。结果经过广泛筛选,确定了9项合格的研究,其中11名患者被诊断为罕见的RAH动脉瘤。中位年龄为 55 岁(标准差为 15.3 岁),男性占 54.5%。45.5%的患者存在风险因素,其中2名患者患有Moyamoya病。根据亨特和赫斯(Hunt and Hess,H&H)以及世界神经学会联合会(World Federation of Neurological Societies,WFNS)系统的分类,大多数患者的动脉瘤属于I/II级。动脉瘤主要位于A1节段,平均大小为4.7毫米。治疗方法各不相同,其中以剪除最为常见(63.6%)。死亡率为 18.2%。结论这项分析强调了 RAH 动脉瘤的各种症状、治疗方法和结果,其中 A1 是主要的起源。未来的研究应探索潜在的遗传易感因素和新型治疗干预措施,以弥补我们的知识空白。
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引用次数: 0
The use and abuse of survival analysis and Kaplan-Meier curves in surgical trials 外科试验中生存分析和卡普兰-梅耶曲线的使用与滥用。
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-05-17 DOI: 10.1016/j.neuchi.2024.101567
Tim E. Darsaut , Alan R. Rheaume , Miguel Chagnon , Jean Raymond

Background

Survival analysis based on Cox regression and Kaplan-Meier curves, initially devised for oncology trials, have frequently been used in other contexts where fundamental statistical assumptions (such as a constant hazard ratio) are not satisfied. This is almost always the case in trials that compare surgery with medical management.

Methods

We review a trial that compared extracranial-intracranial bypass surgery (EC-IC bypass) with medical management (MM) of patients with symptomatic occlusion of the carotid or middle cerebral artery, where it was claimed that surgery was of no benefit. We discuss a hypothetical study and review other neurovascular trials which have also used survival analysis to compare results.

Results

The trial comparing EC-IC bypass and MM did not satisfy the fundamental proportional hazard assumption necessary for valid analyses. This was also the case for two prior EC-IC bypass trials, as well as for other landmark neurovascular studies, such as the trials comparing endarterectomy with MM for carotid stenoses, or for the trial that compared intervention and MM for unruptured brain arteriovenous malformations. While minor deviations may have little effect on large trials, it may be impossible to show the benefits of surgery when trial size is small and deviations large.

Conclusion

Survival analyses are inappropriate in RCTs comparing surgery with conservative management, unless survival is calculated after the postoperative period. Alternative ways to compare final clinical outcomes, using for example a fixed follow-up period, should be planned for preventive surgical trials that compare intervention with conservative management.

背景:基于 Cox 回归和 Kaplan-Meier 曲线的生存分析最初是为肿瘤试验而设计的,但在其他情况下,当基本统计假设(如恒定的危险比)无法满足时,这些方法也经常被使用。在比较手术与药物治疗的试验中,几乎总是这种情况:我们回顾了一项对颈动脉或大脑中动脉无症状闭塞患者进行颅外-颅内搭桥手术(EC-IC 搭桥)与内科治疗(MM)比较的试验,该试验声称手术无益。我们讨论了一项假设性研究,并回顾了同样使用生存分析比较结果的其他神经血管试验:比较 EC-IC 搭桥术和 MM 的试验不符合有效分析所需的基本比例危险假设。之前的两项 EC-IC 搭桥术试验以及其他具有里程碑意义的神经血管研究也是如此,如比较颈动脉狭窄的内膜剥脱术和 MM 的试验,或比较干预和 MM 治疗未破裂脑动静脉畸形的试验。虽然微小的偏差可能对大型试验影响不大,但如果试验规模较小而偏差较大,则可能无法显示手术的益处:结论:在比较手术与保守治疗的研究中,除非计算术后存活率,否则不宜进行存活率分析。在比较干预与保守治疗的预防性手术试验中,应计划采用其他方法来比较最终临床结果,例如使用固定的随访期。
{"title":"The use and abuse of survival analysis and Kaplan-Meier curves in surgical trials","authors":"Tim E. Darsaut ,&nbsp;Alan R. Rheaume ,&nbsp;Miguel Chagnon ,&nbsp;Jean Raymond","doi":"10.1016/j.neuchi.2024.101567","DOIUrl":"10.1016/j.neuchi.2024.101567","url":null,"abstract":"<div><h3>Background</h3><p>Survival analysis based on Cox regression and Kaplan-Meier curves, initially devised for oncology trials, have frequently been used in other contexts where fundamental statistical assumptions (such as a constant hazard ratio) are not satisfied. This is almost always the case in trials that compare surgery with medical management.</p></div><div><h3>Methods</h3><p>We review a trial that compared extracranial-intracranial bypass surgery (EC-IC bypass) with medical management (MM) of patients with symptomatic occlusion of the carotid or middle cerebral artery, where it was claimed that surgery was of no benefit. We discuss a hypothetical study and review other neurovascular trials which have also used survival analysis to compare results.</p></div><div><h3>Results</h3><p>The trial comparing EC-IC bypass and MM did not satisfy the fundamental proportional hazard assumption necessary for valid analyses. This was also the case for two prior EC-IC bypass trials, as well as for other landmark neurovascular studies, such as the trials comparing endarterectomy with MM for carotid stenoses, or for the trial that compared intervention and MM for unruptured brain arteriovenous malformations. While minor deviations may have little effect on large trials, it may be impossible to show the benefits of surgery when trial size is small and deviations large.</p></div><div><h3>Conclusion</h3><p>Survival analyses are inappropriate in RCTs comparing surgery with conservative management, unless survival is calculated after the postoperative period. Alternative ways to compare final clinical outcomes, using for example a fixed follow-up period, should be planned for preventive surgical trials that compare intervention with conservative management.</p></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"70 4","pages":"Article 101567"},"PeriodicalIF":1.6,"publicationDate":"2024-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140960814","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 randomized trials: how to prevent the comic opera from becoming a tragedy 手术随机试验:如何防止喜剧变成悲剧?
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-05-14 DOI: 10.1016/j.neuchi.2024.101568
Jean Raymond , Tim E. Darsaut
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引用次数: 0
Impact of preaneurysmal M1 length in unruptured middle cerebral artery aneurysm: mid-term outcome and single-center experience 未破裂大脑中动脉动脉瘤瘤前 M1 长度的影响:中期结果和单中心经验。
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-05-14 DOI: 10.1016/j.neuchi.2024.101569
Lucas Ribeiro , Antoine Devalckeneer , Martin Bretzner , Philippe Bourgeois , Jean-Paul Lejeune , Rabih Aboukais

Objective

This study was design to investigate the surgical and functional outcome based on the preaneurysmal M1 length for unruptured MCA aneurysm.

Methods

Among 250 consecutive patients with unruptured aneurysms operated in our institution between 2015 and 2017, 72 were MCA aneurysms. Risk factors for IR (i.e., intraoperative rupture) were investigated including age, sex, preaneurysmal M1 length, maximal MCA aneurysm diameter, neck size, aneurysm shape, sphenoid ridge proximation sign. Outcome was measured at discharge, 1 yr and last follow-up. Outcome was compared according to the preaneurysmal M1 length.

Results

Among 68 patients included, five patients (7.3%) suffered IR. Mean maximal diameter of MCA aneurysm (7.9 mm ± 3.4 vs. 4.5 ± 1.8; p = 0.01) was significantly associated with IR risk. Mean M1 length seemed to be shorter in the IR group although not statistically significant (16.2 mm ± 5.1 vs. 11.5 mm ± 4.8; p = 0.053). Mid-term outcome was favorable for all patients at last follow-up but was worsen in case of short preaneurysmal M1 segment (10.7 mm ± 4.8 vs. 16.4 mm ± 5.3, p = 0.02). Complete aneurysm occlusion was achieved for sixty-nine patients (95.5%) with 6.9% of early postoperative complications.

Conclusions

The microsurgical treatment of unruptured MCA aneurysm was associated with favorable mid-term outcome in all patients and high rates of complete occlusion. Aneurysm size was significantly associated with the intraoperative rupture risk for unruptured MCA aneurysm and patients with a short preaneurysmal M1 segment seemed to have a greater risk of intraoperative rupture although not statistically significant. Short preaneurysmal M1 patients had worsen mid-term outcome.

研究目的本研究旨在探讨基于瘤前M1长度的未破裂MCA动脉瘤的手术和功能预后:2015年至2017年在我院手术的250例未破裂动脉瘤连续患者中,72例为MCA动脉瘤。调查了IR(即术中破裂)的风险因素,包括年龄、性别、瘤前M1长度、MCA动脉瘤最大直径、瘤颈大小、动脉瘤形状、蝶骨脊近端征。结果在出院、1 年和最后一次随访时测量。根据瘤前M1长度对结果进行比较:在纳入的 68 名患者中,有 5 名患者(7.3%)患有 IR。MCA动脉瘤的平均最大直径(7.9 mm ± 3.4 vs. 4.5 ± 1.8; p = 0.01)与IR风险显著相关。IR组的平均M1长度似乎更短(16.2 mm ± 5.1 vs. 11.5 mm ± 4.8; p = 0.053),但无统计学意义。在最后一次随访时,所有患者的中期预后均良好,但如果瘤前 M1 段较短,预后则会恶化(10.7 mm ± 4.8 vs. 16.4 mm ± 5.3,p = 0.02)。69例患者(95.5%)实现了动脉瘤完全闭塞,术后早期并发症发生率为6.9%:结论:显微手术治疗未破裂的 MCA 动脉瘤对所有患者都有良好的中期疗效,完全闭塞率高。动脉瘤大小与未破裂的 MCA 动脉瘤的术中破裂风险显著相关,瘤前 M1 节段较短的患者术中破裂风险似乎更大,但无统计学意义。瘤前 M1 段较短的患者中期预后较差。
{"title":"Impact of preaneurysmal M1 length in unruptured middle cerebral artery aneurysm: mid-term outcome and single-center experience","authors":"Lucas Ribeiro ,&nbsp;Antoine Devalckeneer ,&nbsp;Martin Bretzner ,&nbsp;Philippe Bourgeois ,&nbsp;Jean-Paul Lejeune ,&nbsp;Rabih Aboukais","doi":"10.1016/j.neuchi.2024.101569","DOIUrl":"10.1016/j.neuchi.2024.101569","url":null,"abstract":"<div><h3>Objective</h3><p>This study was design to investigate the surgical and functional outcome based on the preaneurysmal M<sub>1</sub> length for unruptured MCA aneurysm.</p></div><div><h3>Methods</h3><p>Among 250 consecutive patients with unruptured aneurysms operated in our institution between 2015 and 2017, 72 were MCA aneurysms. Risk factors for IR (i.e., intraoperative rupture) were investigated including age, sex, preaneurysmal M<sub>1</sub> length, maximal MCA aneurysm diameter, neck size, aneurysm shape, sphenoid ridge proximation sign. Outcome was measured at discharge, 1 yr and last follow-up. Outcome was compared according to the preaneurysmal M<sub>1</sub> length.</p></div><div><h3>Results</h3><p>Among 68 patients included, five patients (7.3%) suffered IR. Mean maximal diameter of MCA aneurysm (7.9 mm ± 3.4 vs. 4.5 ± 1.8; p = 0.01) was significantly associated with IR risk. Mean M<sub>1</sub> length seemed to be shorter in the IR group although not statistically significant (16.2 mm ± 5.1 vs. 11.5 mm ± 4.8; p = 0.053). Mid-term outcome was favorable for all patients at last follow-up but was worsen in case of short preaneurysmal M<sub>1</sub> segment (10.7 mm ± 4.8 vs. 16.4 mm ± 5.3, p = 0.02). Complete aneurysm occlusion was achieved for sixty-nine patients (95.5%) with 6.9% of early postoperative complications.</p></div><div><h3>Conclusions</h3><p>The microsurgical treatment of unruptured MCA aneurysm was associated with favorable mid-term outcome in all patients and high rates of complete occlusion. Aneurysm size was significantly associated with the intraoperative rupture risk for unruptured MCA aneurysm and patients with a short preaneurysmal M1 segment seemed to have a greater risk of intraoperative rupture although not statistically significant. Short preaneurysmal M1 patients had worsen mid-term outcome.</p></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"70 4","pages":"Article 101569"},"PeriodicalIF":1.6,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140946571","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
Reliability of study endpoint adjudication in a pragmatic trial on brain arteriovenous malformations 脑动静脉畸形实用试验中研究终点裁定的可靠性。
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-05-14 DOI: 10.1016/j.neuchi.2024.101566
Tim E. Darsaut , Anass Benomar , Elsa Magro , Jean-Christophe Gentric , Jonathan Heppner , Camille Lopez , Roland Jabre , Daniel Roy , Guylaine Gevry , Jean Raymond

Background

The results of a clinical trial are given in terms of primary and secondary outcomes that are obtained for each patient. Just as an instrument should provide the same result when the same object is measured repeatedly, the agreement of the adjudication of a clinical outcome between various raters is fundamental to interpret study results. The reliability of the adjudication of study endpoints determined by examination of the electronic case report forms of a pragmatic trial has not previously been tested.

Methods

The electronic case report forms of 62/434 (14%) patients selected to be observed in a study on brain AVMs were independently examined twice (4 weeks apart) by 8 raters who judged whether each patient had reached the following study endpoints: (1) new intracranial hemorrhage related to AVM or to treatment; (2) new non-hemorrhagic neurological event; (3) increase in mRS ≥1; (4) serious adverse events (SAE). Inter and intra-rater reliability were assessed using Gwet’s AC1 (κG) statistics, and correlations with mRS score using Cramer’s V test.

Results

There was almost perfect agreement for intracranial hemorrhage (92% agreement; κG = 0.84 (95%CI: 0.76−0.93), and substantial agreement for SAEs (88% agreement; κG = 0.77 (95%CI: 0.67−0.86) and new non-hemorrhagic neurological event (80% agreement; κG = 0.61 (95%CI: 0.50−0.72). Most endpoints correlated (V = 0.21−0.57) with an increase in mRS of ≥1, an endpoint which was itself moderately reliable (76% agreement; κG = 0.54 (95%CI: 0.43−0.64).

Conclusion

Study endpoints of a pragmatic trial were shown to be reliable. More studies on the reliability of pragmatic trial endpoints are needed.

背景:临床试验的结果是根据每位患者的主要和次要结果得出的。正如重复测量同一对象时仪器应提供相同的结果一样,不同评分者对临床结果的判定是否一致也是解释研究结果的基础。通过检查一项实用性试验的电子病例报告表来确定研究终点判定的可靠性,此前尚未进行过测试:方法:在一项脑动静脉畸形研究中,对 62/434 例(14%)入选患者的电子病例报告表进行了两次独立检查(间隔 4 周),由 8 名评分员判断每位患者是否达到了以下研究终点:(1)与动静脉畸形或治疗相关的新发颅内出血;(2)新发非出血性神经事件;(3)mRS ≥1;(4)严重不良事件(SAE)。使用 Gwet's AC1 (κG) 统计法评估评分者之间和评分者内部的可靠性,使用 Cramer's V 检验评估与 mRS 评分的相关性:颅内出血的评分几乎完全一致(92%一致;κG = 0.84(95%CI:0.76-0.93)),SAEs(88%一致;κG = 0.77(95%CI:0.67-0.86))和新的非出血性神经事件(80%一致;κG = 0.61(95%CI:0.50-0.72))的评分也基本一致。大多数终点与 mRS 增加≥1 相关(V = 0.21-0.57),而 mRS 增加≥1 这一终点本身具有中等可靠性(76% 的一致性;κG = 0.54(95%CI:0.43-0.64)):结论:一项实用性试验的研究终点被证明是可靠的。需要对实用性试验终点的可靠性进行更多研究。
{"title":"Reliability of study endpoint adjudication in a pragmatic trial on brain arteriovenous malformations","authors":"Tim E. Darsaut ,&nbsp;Anass Benomar ,&nbsp;Elsa Magro ,&nbsp;Jean-Christophe Gentric ,&nbsp;Jonathan Heppner ,&nbsp;Camille Lopez ,&nbsp;Roland Jabre ,&nbsp;Daniel Roy ,&nbsp;Guylaine Gevry ,&nbsp;Jean Raymond","doi":"10.1016/j.neuchi.2024.101566","DOIUrl":"10.1016/j.neuchi.2024.101566","url":null,"abstract":"<div><h3>Background</h3><p>The results of a clinical trial are given in terms of primary and secondary outcomes that are obtained for each patient. Just as an instrument should provide the same result when the same object is measured repeatedly, the agreement of the adjudication of a clinical outcome between various raters is fundamental to interpret study results. The reliability of the adjudication of study endpoints determined by examination of the electronic case report forms of a pragmatic trial has not previously been tested.</p></div><div><h3>Methods</h3><p>The electronic case report forms of 62/434 (14%) patients selected to be observed in a study on brain AVMs were independently examined twice (4 weeks apart) by 8 raters who judged whether each patient had reached the following study endpoints: (1) new intracranial hemorrhage related to AVM or to treatment; (2) new non-hemorrhagic neurological event; (3) increase in mRS ≥1; (4) serious adverse events (SAE). Inter and intra-rater reliability were assessed using Gwet’s AC1 (κG) statistics, and correlations with mRS score using Cramer’s V test.</p></div><div><h3>Results</h3><p>There was almost perfect agreement for intracranial hemorrhage (92% agreement; κG = 0.84 (95%CI: 0.76−0.93), and substantial agreement for SAEs (88% agreement; κG = 0.77 (95%CI: 0.67−0.86) and new non-hemorrhagic neurological event (80% agreement; κG = 0.61 (95%CI: 0.50−0.72). Most endpoints correlated (V = 0.21−0.57) with an increase in mRS of ≥1, an endpoint which was itself moderately reliable (76% agreement; κG = 0.54 (95%CI: 0.43−0.64).</p></div><div><h3>Conclusion</h3><p>Study endpoints of a pragmatic trial were shown to be reliable. More studies on the reliability of pragmatic trial endpoints are needed.</p></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"70 4","pages":"Article 101566"},"PeriodicalIF":1.6,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140946572","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
Corrigendum to ‘Pseudoaneurysm formation after placement of a FRED flow diverter stent in a patient with iatrogenic ICA injury during transsphenoidal surgery: A case report’ Neurochirurgie (2024) 101520 对 "经鼻手术中先天性 ICA 损伤患者置入 FRED 分流支架后形成假性动脉瘤:病例报告' Neurochirurgie (2024) 101520
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-05-04 DOI: 10.1016/j.neuchi.2024.101564
Mohammad Hasanpour , Navid Golchin , Hojjat Mirsardoo , Ahmad Alagha , Daniel Elyassirad , Ehsan Keykhosravi
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引用次数: 0
Fractured cervical spine, dissected vertebral artery, and life-threatening stroke: A challenging case report and literature review 颈椎骨折、椎动脉剥离和危及生命的中风:具有挑战性的病例报告和文献综述
IF 1.6 4区 医学 Q4 CLINICAL NEUROLOGY Pub Date : 2024-04-16 DOI: 10.1016/j.neuchi.2024.101561
Anis Choucha , Thomas Barraque , Mikael Meyer , Henry Dufour , Kaissar Farah , Stephane Fuentes

Introduction

Vertebral artery injury (VAI) following blunt trauma can lead to acute or delayed life-threatening posterior fossa ischemic stroke. Its management raises controversial issues and is still open to debate.

Material & method

We report the case of a 48-year-old male who presented a life-threatening posterior circulation ischemic stroke, secondary to a vertebral artery dissection caused by a cervical spine fracture. This case was successfully managed through intravenous thrombolysis and endovascular thrombectomy followed by antiplatelet therapy and an anterior cervical discectomy and fusion. At the one-year follow-up, the patient had no persisting deficit and was back working as a policeman.

Conclusion

Rapid management of patients with dramatic clinical presentation can lead to full recovery. Implications include a systematic screening of blunt trauma VAI through computed tomography angiography when dealing with high-risk cervical spine fractures; patients harboring both a cervical spine fracture and a VAI must be transferred to a tertiary referral hospital able to deal both with strokes and cervical spine surgery to ensure responsiveness in case of stroke.

导言钝性创伤后的椎动脉损伤(VAI)可导致急性或迟发性后窝缺血性卒中,危及生命。材料与amp; 方法我们报告了一例 48 岁男性患者的病例,他因颈椎骨折导致椎动脉夹层而引发危及生命的后循环缺血性卒中。该病例通过静脉溶栓和血管内血栓切除术成功治愈,随后进行了抗血小板治疗和颈椎前路椎间盘切除及融合术。在一年的随访中,患者没有出现持续的功能障碍,并重新回到了警察岗位。其意义包括:在处理高风险颈椎骨折时,通过计算机断层扫描血管造影系统筛查钝性外伤VAI;必须将同时患有颈椎骨折和VAI的患者转至既能处理中风又能进行颈椎手术的三级转诊医院,以确保在发生中风时反应迅速。
{"title":"Fractured cervical spine, dissected vertebral artery, and life-threatening stroke: A challenging case report and literature review","authors":"Anis Choucha ,&nbsp;Thomas Barraque ,&nbsp;Mikael Meyer ,&nbsp;Henry Dufour ,&nbsp;Kaissar Farah ,&nbsp;Stephane Fuentes","doi":"10.1016/j.neuchi.2024.101561","DOIUrl":"https://doi.org/10.1016/j.neuchi.2024.101561","url":null,"abstract":"<div><h3>Introduction</h3><p>Vertebral artery injury (VAI) following blunt trauma can lead to acute or delayed life-threatening posterior fossa ischemic stroke. Its management raises controversial issues and is still open to debate.</p></div><div><h3>Material &amp; method</h3><p>We report the case of a 48-year-old male who presented a life-threatening posterior circulation ischemic stroke, secondary to a vertebral artery dissection caused by a cervical spine fracture. This case was successfully managed through intravenous thrombolysis and endovascular thrombectomy followed by antiplatelet therapy and an anterior cervical discectomy and fusion. At the one-year follow-up, the patient had no persisting deficit and was back working as a policeman.</p></div><div><h3>Conclusion</h3><p>Rapid management of patients with dramatic clinical presentation can lead to full recovery. Implications include a systematic screening of blunt trauma VAI through computed tomography angiography when dealing with high-risk cervical spine fractures; patients harboring both a cervical spine fracture and a VAI must be transferred to a tertiary referral hospital able to deal both with strokes and cervical spine surgery to ensure responsiveness in case of stroke.</p></div>","PeriodicalId":51141,"journal":{"name":"Neurochirurgie","volume":"70 4","pages":"Article 101561"},"PeriodicalIF":1.6,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0028377024000328/pdfft?md5=1c87f354c6fcd2927841bcba8ad1fa4d&pid=1-s2.0-S0028377024000328-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140644246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Neurochirurgie
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