Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT.

Background: Posterior cervical foraminotomy and anterior cervical discectomy are routinely used operations to treat cervical brachialgia, although definitive evidence supporting superiority of either is lacking. Objective: The primary objective was to investigate whether or not posterior cervical foraminotomy is superior to anterior cervical discectomy in improving clinical outcome. Design: This was a Phase III, unblinded, prospective, United Kingdom multicentre, parallel-group, individually randomised controlled superiority trial comparing posterior cervical foraminotomy with anterior cervical discectomy. A rapid qualitative study was conducted during the close-down phase, involving remote semistructured interviews with trial participants and health-care professionals. Setting: National Health Service trusts. Participants: Patients with symptomatic unilateral cervical brachialgia for at least 6 weeks. Interventions: Participants were randomised to receive posterior cervical foraminotomy or anterior cervical discectomy. Allocation was not blinded to participants, medical staff or trial staff. Health-care use from providing the initial surgical intervention to hospital discharge was measured and valued using national cost data. Main outcome measures: The primary outcome measure was clinical outcome, as measured by patient-reported Neck Disability Index score 52 weeks post operation. Secondary outcome measures included complications, reoperations and restricted American Spinal Injury Association score over 6 weeks post operation, and patient-reported Eating Assessment Tool-10 items, Glasgow-Edinburgh Throat Scale, Voice Handicap Index-10 items, PainDETECT and Numerical Rating Scales for neck and upper-limb pain over 52 weeks post operation. Results: The target recruitment was 252 participants. Owing to slow accrual, the trial closed after randomising 23 participants from 11 hospitals. The qualitative substudy found that there was support and enthusiasm for the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial and randomised clinical trials in this area. However, clinical equipoise appears to have been an issue for sites and individual surgeons. Randomisation on the day of surgery and processes for screening and approaching participants were also crucial factors in some centres. The median Neck Disability Index scores at baseline (pre surgery) and at 52 weeks was 44.0 (interquartile range 36.0-62.0 weeks) and 25.3 weeks (interquartile range 20.0-42.0 weeks), respectively, in the posterior cervical foraminotomy group (n = 14), and 35.6 weeks (interquartile range 34.0-44.0 weeks) and 45.0 weeks (interquartile range 20.0-57.0 weeks), respectively, in the anterior cervical discectomy group (n = 9). Scores appeared to reduce (i.e. improve) in the posterior cervical foraminotomy group, but not in the anterior cervical discectomy group. The median Eating Assessment Tool-10 items score for swallowing was higher (worse) after anterior cervical discectomy (13.5) than after posterior cervical foraminotomy (0) on day 1, but not at other time points, whereas the median Glasgow-Edinburgh Throat Scale score for globus was higher (worse) after anterior cervical discectomy (15, 7, 6, 6, 2, 2.5) than after posterior cervical foraminotomy (3, 0, 0, 0.5, 0, 0) at all postoperative time points. Five postoperative complications occurred within 6 weeks of surgery, all after anterior cervical discectomy. Neck pain was more severe on day 1 following posterior cervical foraminotomy (Numerical Rating Scale - Neck Pain score 8.5) than at the same time point after anterior cervical discectomy (Numerical Rating Scale - Neck Pain score 7.0). The median health-care costs of providing initial surgical intervention were £2610 for posterior cervical foraminotomy and £4411 for anterior cervical discectomy. Conclusions: The data suggest that posterior cervical foraminotomy is associated with better outcomes, fewer complications and lower costs, but the trial recruited slowly and closed early. Consequently, the trial is underpowered and definitive conclusions cannot be drawn. Recruitment was impaired by lack of individual equipoise and by concern about randomising on the day of surgery. A large prospective multicentre trial comparing anterior cervical discectomy and posterior cervical foraminotomy in the treatment of cervical brachialgia is still required. Trial registration: This trial is registered as ISRCTN10133661. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 21. See the NIHR Journals Library website for further project information.

Cervical brachialgia is pain that starts in the neck and passes down into the arm. Although most people with cervical brachialgia recover quickly, in some patients pain persists, and in 15% of patients pain is so severe that they are unable to work. In the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial, we investigated two neck surgeries used to treat this problem: posterior cervical foraminotomy (surgery from the back of the neck) and anterior cervical discectomy (surgery from the front of the neck). This trial aimed to find out if one of them is better than the other at relieving pain and more cost-effective for the National Health Service. We assessed patients' quality of life 1 year after their surgery and how their pain changed over the course of the year. We also measured the number of complications patients had in the first 6 weeks after their operation. Recruitment was slow and so the trial was stopped early, after only 23 patients from 11 hospitals had been randomly allocated to the two surgery groups. We had planned to recruit 252 participants to the trial; the number of participants we were able to recruit in practice was too small to enable us to determine which surgery is better at relieving pain. To find out why the trial had struggled to recruit, we asked hospital staff and participants about their experiences. We found that hospital staff sometimes struggled to organise everything needed to randomise patients on the day of surgery. Some staff also found it difficult to randomise patients as they had an opinion on which surgery they thought the patient should receive. The data collected in the trial will still be useful to help design future research. Finding out which surgery is better at relieving pain remains important, and the data we have collected will support answering this question in future.

A systematic review of middle meningeal artery embolization for minimally symptomatic chronic subdural haematomas that do not require immediate evacuation.

Introduction: Embolization of the Middle Meningeal Artery (EMMA) is an emerging treatment option for patients with Chronic Subdural Haematoma (CSDH). Questions: (1) Can EMMA change the natural history of untreated minimally symptomatic CSDH which do not require immediate evacuation? (2) What is the role of EMMA in the prevention of recurrence following surgical treatment? (3) Can the procedure be performed under local anaesthetic? Material and methods: Systematic literature review. No randomised clinical trials available on EMMA for meta-analysis. Results: Six unique large cohorts with more than 50 embolisations were identified (evidence: 3b-4). EMMA can control the progression of surgically naïve CSDH in 91.1-100% of the patients, in which haematoma expansion is halted, or the lesion decreases and resolves. Treatment failure requiring surgery occurs in 0-4.1% of the patients having EMMA as the primary and only treatment. Treatment failure requiring surgery goes up slightly to 6.8% if post-surgical patients are included. When EMMA is used as postsurgical adjunctive the risk of recurrence is 1.4-8.9% compared to 10-20% in surgical series. EMMA has minimal morbidity and it is feasible under local anaesthesia or slight sedation in the majority of cases. Conclusion: There is cumulative low-quality evidence in the literature that EMMA may be able to modify the natural course of the disease. It appears effective in controlling progression of CSDHs in patients having it as a primary standing alone treatment and it reduces the risk of recurrence and the need for surgical intervention in refractory postsurgical cases or as a postsurgical adjunctive treatment with minimal morbidity (recommendation: C).

Feasibility of comparing medical management and surgery (with neurosurgery or stereotactic radiosurgery) with medical management alone in people with symptomatic brain cavernoma - protocol for the Cavernomas: A Randomised Effectiveness (CARE) pilot trial.

INTRODUCTION: The top research priority for cavernoma, identified by a James Lind Alliance Priority setting partnership was 'Does treatment (with neurosurgery or stereotactic radiosurgery) or no treatment improve outcome for people diagnosed with a cavernoma?' This pilot randomised controlled trial (RCT) aims to determine the feasibility of answering this question in a main phase RCT. METHODS AND ANALYSIS: We will perform a pilot phase, parallel group, pragmatic RCT involving approximately 60 children or adults with mental capacity, resident in the UK or Ireland, with an unresected symptomatic brain cavernoma. Participants will be randomised by web-based randomisation 1:1 to treatment with medical management and with surgery (neurosurgery or stereotactic radiosurgery) versus medical management alone, stratified by prerandomisation preference for type of surgery. In addition to 13 feasibility outcomes, the primary clinical outcome is symptomatic intracranial haemorrhage or new persistent/progressive focal neurological deficit measured at 6 monthly intervals. An integrated QuinteT Recruitment Intervention (QRI) evaluates screening logs, audio recordings of recruitment discussions, and interviews with recruiters and patients/parents/carers to identify and address barriers to participation. A Patient Advisory Group has codesigned the study and will oversee its progress. ETHICS AND DISSEMINATION: This study was approved by the Yorkshire and The Humber-Leeds East Research Ethics Committee (21/YH/0046). We will submit manuscripts to peer-reviewed journals, describing the findings of the QRI and the Cavernomas: A Randomised Evaluation (CARE) pilot trial. We will present at national specialty meetings. We will disseminate a plain English summary of the findings of the CARE pilot trial to participants and public audiences with input from, and acknowledgement of, the Patient Advisory Group. TRIAL REGISTRATION NUMBER: ISRCTN41647111.

Risk of Aneurysm Rupture (ROAR) study: protocol for a long-term, longitudinal, UK multicentre study of unruptured intracranial aneurysms.

INTRODUCTION: Unruptured intracranial aneurysms (UIA) are common in the adult population, but only a relatively small proportion will rupture. It is therefore essential to have accurate estimates of rupture risk to target treatment towards those who stand to benefit and avoid exposing patients to the risks of unnecessary treatment. The best available UIA natural history data are the PHASES study. However, this has never been validated and given the known heterogeneity in the populations, methods and biases of the constituent studies, there is a need to do so. There are also many potential predictors not considered in PHASES that require evaluation, and the estimated rupture risk is largely based on short-term follow-up (mostly 1 year). The aims of this study are to: (1) test the accuracy of PHASES in a UK population, (2) evaluate additional predictors of rupture and (3) assess long-term UIA rupture rates. METHODS AND ANALYSIS: The Risk of Aneurysm Rupture study is a longitudinal multicentre study that will identify patients with known UIA seen in neurosurgery units. Patients will have baseline demographics and aneurysm characteristics collected by their neurosurgery unit and then a single aggregated national cohort will be linked to databases of hospital admissions and deaths to identify all patients who may have subsequently suffered a subarachnoid haemorrhage. All matched admissions and deaths will be checked against medical records to confirm the diagnosis of aneurysmal subarachnoid haemorrhage. The target sample size is 20 000 patients. The primary outcome will be aneurysm rupture resulting in hospital admission or death. Cox regression models will be built to test each of the study's aims. ETHICS AND DISSEMINATION: Ethical approval has been given by South Central Hampshire A Research Ethics Committee (21SC0064) and Confidentiality Advisory Group support (21CAG0033) provided under Section 251 of the NHS Act 2006. The results will be disseminated in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN17658526.

A survey of the radiological follow-up of unruptured intracranial aneurysms in the United Kingdom.

OBJECTIVE: Unruptured intracranial aneurysms (UIA) are common. For many the treatment risks outweigh their risk of subarachnoid haemorrhage and patients undergo surveillance imaging. There is little data to inform if and how to monitor UIAs resulting in widely varying practices. This study aimed to determine the current practice of unruptured UIA surveillance in the United Kingdom. METHODS: A questionnaire was designed to address the themes of surveillance protocols for UIA including when surveillance is initiated, how frequently it is performed, and when it is terminated. Additionally, how aneurysm growth is managed and how clinically meaningful growth is defined were explored. The questionnaire was distributed to members of the British Neurovascular Group using probability-based cluster and non-probability purposive sampling methods. RESULTS: Responses were received from 30 of the 30 (100.0%) adult neurosurgical units in the United Kingdom of which 27 (90.0%) routinely perform surveillance for aneurysm growth. Only four units had a unit policy. The mean patient age up to which a unit would initiate follow-up of a low-risk UIA was 65.4 ± 9.0 years. The time points at which imaging is performed varied widely. There was an even split between whether units use a fixed duration of follow-up or an age threshold for terminating surveillance. Forty percent of units will follow-up patients more than 5 years from diagnosis. The magnitude in the change in size that was felt to constitute growth ranged from 1 to 3mm. No units routinely used vessel wall imaging although 27 had access to 3T MRI capable of performing it. CONCLUSIONS: There is marked heterogeneity in surveillance practices between units in the United Kingdom. This study will help units better understand their practice relative to their peers and provide a framework forplanning further research on aneurysm growth.

Radiological follow-up of endovascularly treated intracranial aneurysms: a survey of current practice in the UK and Ireland.

PURPOSE: Due to the risk of intracranial aneurysm (IA) recurrence and the potential requirement for re-treatment following endovascular treatment (EVT), radiological follow-up of these aneurysms is necessary. There is little evidence to guide the duration and frequency of this follow-up. The aim of this study was to establish the current practice in neurosurgical units in the UK and Ireland. METHODS: A survey was designed with input from interventional neuroradiologists and neurosurgeons. Neurovascular consultants in each of the 30 neurosurgical units providing a neurovascular service in the UK and Ireland were contacted and asked to respond to questions regarding the follow-up practice for IA treated with EVT in their department. RESULTS: Responses were obtained from 28/30 (94%) of departments. There was evidence of wide variations in the duration and frequency of follow-up, with a minimum follow-up duration for ruptured IA that varied from 18 months in 5/28 (18%) units to 5 years in 11/28 (39%) of units. Young patient age, previous subarachnoid haemorrhage and incomplete IA occlusion were cited as factors that would prompt more intensive surveillance, although larger and broad-necked IA were not followed-up more closely in the majority of departments. CONCLUSIONS: There is a wide variation in the radiological follow-up of IA treated with EVT in the UK and Ireland. Further standardisation of this aspect of patient care is likely to be beneficial, but further evidence on the behaviour of IA following EVT is required in order to inform this process.

Middle meningeal artery embolisation for chronic subdural haematomas: the first prospective UK study.

Background/Objectives: MMA embolisation has emerged in recent years as a safe endovascular treatment for chronic subdural haematoma. We report the first UK series of endovascular treatment of chronic subdural haematomas.Design: Prospective case series.Subjects: All adult patients referred with midline shift ≤10 mm and GCS ≥13 were considered. Patients had to be mobile with a standard origin of Middle Meningeal and Ophthalmic arteries. Patients with GCS < 13 or profound weakness (MRC grade ≤ 3) were treated with burr hole drainage and placement of subdural drains.Methods: Patients were recruited over a 14-month period from 25 October 2020 to 25 December 21 through our electronic referral system. Patients' demographics, pre-morbid modified Rankin Score (mRS), symptoms; anticoagulation and co-morbidities were prospectively collected. Suitability for endovascular treatment was discussed with the interventional neuroradiologist and neurosurgeon. SQUID-12 embolic material was used for all MMA embolisations, which was performed under general anaesthetic. Baseline CT/MRI characteristics were collected. Further imaging was obtained at 7, 21, 90 and 180 days. Clinical assessment and mRS was completed at three months.Results: Fifteen patients underwent endovascular embolisation of MMA in the study period. Of these 13 were male, median age was 79 years. Median length of stay was four days. Follow-up CT at three months has demonstrated significant reduction in both midline shift (p = 0.002) and maximum thickness of haematoma (p = 0.001). Nine patients had reached the three months' follow-up period. All of them had complete or near-complete resolution of the CSDH. One patient required surgical rescue at two months post procedure due to progression of CSDH. We report one mortality due to COVID-19.Conclusions: For select patients, MMA embolisation is a safe alternative treatment option for chronic subdural haematoma. As we gain more experience, the procedure could be performed under local anaesthetic.

Treatment of low flow, indirect cavernous sinus dural arteriovenous fistulas with external manual carotid compression - the UK experience.

Introduction: External manual carotid compression (EMCC) is a treatment option for indirect cavernous sinus dural arteriovenous fistulas (CS-DAVF). The exact mechanism of how this works is unclear but compression of the carotid and jugular produces thrombus in the cavernous sinus (CS). Although compression of the superior ophthalmic vein (SOV) has been described as a treatment option this technique is not always amenable. We studied the clinical features, imaging studies, complications and resolution of CS-DAVF in a series seven patients.Materials and methods: Between 2011 and 2017 we treated 7 patients (4 female, 3 male, age range: 60-86 years) with EMCC for an indirect, low-flow CS-DAVF (Barrow B-D). Patients compressed the cervical carotid artery on the side of the CS-DAVF using the contralateral hand for 5-10 seconds 5-10 times per day. Using gradually increasing pressure they compressed the carotid artery and jugular vein until the pulse was no longer palpable.Results: 6 patients had complete resolution of their CS-DAVF within a range of 5-24 months of symptom onset (median 8 months). 5 of our patients had complete resolution of their clinical symptoms at final follow-up. One patient had a failed endovascular procedure, and subsequently underwent surgery to cannulate the SOV for a transvenous endovascular approach to the fistula but in the meantime she had performed EMCC, which is thought to have resolved the fistula. One patient remains under follow-up and is performing EMCC.Conclusion: EMCC is a safe and low risk technique for low-flow indirect CS-DAVF and should be considered as a first line treatment for patients unable to have endovascular treatment. Although compression of the SOV has been described this can often be difficult to perform in the context of periorbital oedema. EMCC should always be performed using the contralateral hand, because this will ensure that the compressing hand falls away should cerebral ischaemia develop.

Observed rupture of unruptured intracranial aneurysms.

Aim: To study the aneurysms where pre and post-rupture imaging was available to determine the impact of rupture on morphology and size of the aneurysm.Methods: A retrospective case series where all cases of ruptured aneurysms over a 5-year period were evaluated and cases identified where pre and post rupture imaging was available. These were then studied in detail.Results: The actual change in the volume of the aneurysm pre and post rupture was quite small and the underlying shape/morphology did not change at all.Conclusion: Post-rupture morphology of aneurysms can be used as representative of pre-rupture morphology. Further larger studies in collaboration with other neurosurgical centres to corroborate this view would be helpful.

Case Report of a Novel Technique for Repair of the Vertebral Artery During Cranial Surgery.

Surgery of complex cranial base lesions carries a high risk of damage to main vessels, often resulting in life-changing or even life-threatening injuries. We describe a rapid, effective, and noninvasive application of a collagen-based hemostatic patch to repair the vertebral artery during cranial surgery. A 61-year-old male patient underwent retrosigmoid craniotomy to remove a foramen magnum meningioma that encased the vertebral artery. A linear incision was made behind the ear and standard retrosigmoid craniotomy was performed with preservation of the transverse and sigmoid sinuses. The dura was opened in a Y-shaped fashion and the cerebellum was retracted with cerebrospinal fluid being released. Removing the exposed tumor from the artery resulted in a small arterial bleed. Two pieces of an N-hydroxysuccinimide-functionalized polyethylene glycol-coated collagen patch (Hemopatch®, Baxter Healthcare Ltd.) were applied sequentially and were pressed to the bleed site for 2 min each. Hemostasis of the vertebral artery was achieved at the patient's regular blood pressure. There was no postoperative bleeding, dissection or pseudoaneurysm. The patient recovered gradually with several cranial nerve deficits. There was no brain stem stroke. Twelve months on, the patient has made an excellent recovery from surgery, is independently mobile and has minimal cranial nerve deficits. Application of the collagen-based hemostatic patch proved to be an efficient, safe, and noninvasive technique that achieved rapid hemostasis, confirming its effectiveness in complicated surgery, where risk of hemorrhage can be critical for the surgery outcome.Funding: There was no funding for this case report. Baxter Healthcare Ltd. provided funding for preparation of this manuscript and the journal's Rapid Service Fee.

Meningioma and mood: exploring the potential for meningioma to affect psychological distress before and after surgical removal.

Background: Much of the research exploring psychological distress with meningioma stem from studies including several brain tumour types (including malignant tumours) meaning that focus on meningioma is limited and that conclusions are based on small samples. Moreover, contradictory findings have been reported regarding the effects of meningioma on mood. Here, the authors present a study exploring pre and post mood scores in meningioma only patients using a sample size larger than any previous research attempt. Method: The Hospital Anxiety and Depression Scale (HADS) was used as an objective measure of mood in a clinical sample of 184 UK patients pre and post meningioma removal surgery. Repeated measures designs were used to assess for significant differences in depression and anxiety scores before and after surgery, chi-squared analyses were used to establish for clinically significant change. Results: The study revealed a significant decrease, and a medium effect size, in mean depression scores after surgery to remove the meningioma (p = .002, g = 0.35). However, no significant effect was found following meningioma removal and anxiety scores (p = .113, g = 0.17). Discussion: No significant effects were determined between mood and meningioma location. A discussion of the findings, and potential implications, is presented.