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Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Intracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI (fMRI) has been reported to be used for the preoperative evaluation of AVMs in small case series. The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial. METHODS AND ANALYSIS:The study is a prospective, randomised controlled clinical trial. This study will enrol a total of 600 eligible patients. These eligible patients will be randomised to the standard microsurgery group and the fMRI-guided microsurgery group in a 1:1 ratio. Patient baseline characteristics and AVM architecture and characteristics will be described. In the fMRI-guided group, fMRI mapping of an eloquent cortex in all AVMs will be identified. Surgical complications and outcomes at pretreatment, post-treatment, at discharge and at 1-month, 3-month and 6-month follow-up intervals will be analysed using the modified Rankin Scale (mRS). This trial will determine whether fMRI-guided microsurgery could improve outcomes in patients with AVMs and also identify the safety and efficacy of fMRI-guided microsurgery. ETHICS AND DISSEMINATION:The study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (ky2012-016-02). Study findings will be disseminated in the printed media. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov NCT01758211.

SUBMITTER: Zhao B

PROVIDER: S-EPMC4208052 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial.

Zhao Bing B Cao Yong Y Zhao Yuanli Y Wu Jun J Wang Shuo S

BMJ open 20141023 10

<h4>Introduction</h4>Intracranial arteriovenous malformations (AVMs) are associated with high morbidity and mortality. Modern microsurgery has improved the results of surgical treatment of AVMs; however, the treatment of AVMs, particularly eloquently located AVMs, still carries a high risk. Functional MRI (fMRI) has been reported to be used for the preoperative evaluation of AVMs in small case series. The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a la ...[more]

PMID: 25341453

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Project description:IntroductionAlthough microsurgical resection is currently the first-line treatment modality for arteriovenous malformations (AVMs), microsurgery of these lesions is complicated due to the fact that they are very heterogeneous vascular anomalies. The Spetzler-Martin grading system and the supplementary grading system have demonstrated excellent performances in predicting the risk of AVM surgery. However, there are currently no predictive models based on multimodal MRI techniques. The purpose of this study is to propose a predictive model based on multimodal MRI techniques to assess the microsurgical risk of intracranial AVMs.Methods and analysisThe study consists of 2 parts: the first part is to conduct a single-centre retrospective analysis of 201 eligible patients to create a predictive model of AVM surgery based on multimodal functional MRIs (fMRIs); the second part is to validate the efficacy of the predictive model in a prospective multicentre cohort study of 400 eligible patients. Patient characteristics, AVM features and multimodal fMRI data will be collected. The functional status at pretreatment and 6 months after surgery will be analysed using the modified Rankin Scale (mRS) score. The patients in each part of this study will be dichotomised into 2 groups: those with improved or unchanged functional status (a decreased or unchanged mRS 6 months after surgery) and those with worsened functional status (an increased mRS). The first part will determine the risk factors of worsened functional status after surgery and create a predictive model. The second part will validate the predictive model and then a new AVM grading system will be proposed.Ethics and disseminationThe study protocol and informed consent form have been reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (KY2016-031-01). The results of this study will be disseminated through printed media.Trial registration numberNCT02868008.

Project description:PurposeTo evaluate the safety and outcome of image-guided embolotherapy of extracranial arteriovenous malformations (AVMs) primarily affecting the face.Materials and methodsA multicenter cohort of 28 patients presenting with AVMs primarily affecting the face was retrospectively investigated. Fifty image-guided embolotherapies were performed, mostly using ethylene-vinyl alcohol copolymer-based embolic agents. Clinical and imaging findings were assessed to evaluate response during follow-up (symptom-free, partial relief of symptoms, no improvement, and progression despite embolization), lesion devascularization (total, 100%; substantial, 76-99%; partial, 51-75%; failure, < 50%; and progression), and complication rates (classified according to the CIRSE guidelines). Sub-analyses regarding clinical outcome (n = 24) were performed comparing patients with (n = 12) or without (n = 12) subsequent surgical resection after embolotherapy.ResultsThe median number of embolotherapy sessions was 2.0 (range, 1-4). Clinical outcome after a mean follow-up of 12.4 months (± 13.3; n = 24) revealed a therapy response in 21/24 patients (87.5%). Imaging showed total devascularization in 14/24 patients (58.3%), including the 12 patients with subsequent surgery and 2 additional patients with embolotherapy only. Substantial devascularization (76-99%) was assessed in 7/24 patients (29.2%), and partial devascularization (51-75%) in 3/24 patients (12.5%). Complications occurred during/after 12/50 procedures (24.0%), including 18.0% major complications. Patients with subsequent surgical resections were more often symptom-free at the last follow-up compared to the group having undergone embolotherapy only (p = 0.006).ConclusionImage-guided embolotherapy is safe and effective for treating extracranial AVMs of the face. Subsequent surgical resections after embolization may substantially improve patients' clinical outcome, emphasizing the need for multimodal therapeutic concepts.Level of evidenceLevel 4, Retrospective study.

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Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial.

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Functional MRI-guided microsurgery of intracranial arteriovenous malformations: study protocol for a randomised controlled trial.

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