Burr-hole drainage with or without irrigation for chronic subdural haematoma (FINISH): a Finnish, nationwide, parallel-group, multicentre, randomised, controlled, non-inferiority trial.

BACKGROUND: Chronic subdural haematoma is a common surgically treated intracranial emergency. Burr-hole drainage surgery, to evacuate chronic subdural haematoma, involves three elements: creation of a burr hole for access, irrigation of the subdural space, and insertion of a subdural drain. Although the subdural drain has been established as beneficial, the therapeutic effect of subdural irrigation has not been addressed. METHODS: The FINISH trial was an investigator-initiated, pragmatic, multicentre, nationwide, randomised, controlled, parallel-group, non-inferiority trial in five neurosurgical units in Finland that enrolled adults aged 18 years or older with a chronic subdural haematoma requiring burr-hole drainage. Patients were randomly assigned (1:1) by computer-generated block randomisation with block sizes of four, six, or eight, stratified by site, to burr-hole drainage either with or without subdural irrigation. All patients and staff were masked to treatment assignment apart from the neurosurgeon and operating room staff. A burr hole was drilled at the site of maximum haematoma thickness in both groups, and the subdural space was either irrigated or not irrigated before inserting a subdural drain, which remained in place for 48 h. Reoperations, functional outcome, mortality, and adverse events were recorded for 6 months after surgery. The primary outcome was the reoperation rate within 6 months. The non-inferiority margin was set at 7·5%. Key secondary outcomes that were also required to conclude non-inferiority were the proportion of participants with unfavourable functional outcomes (ie, modified Rankin Scale score of 4-6, where 0 indicates no symptoms and 6 indicates death) and mortality rate at 6 months. The primary and key secondary analyses were done in both the intention-to-treat and per-protocol populations. The trial was registered with ClinicalTrials.gov (NCT04203550) and is completed. FINDINGS: From Jan 1, 2020, to Aug 17, 2022, we assessed 1644 patients for eligibility and 589 (36%) patients were randomly assigned to a treatment group and treated (294 assigned to drainage with irrigation and 295 assigned to drainage without irrigation; 165 [28%] women and 424 [72%] men). The 6-month follow-up period extended until Feb 14, 2023. In the intention-to-treat analysis, 54 (18·3%) of 295 participants required reoperation in the group assigned to receive no irrigation versus 37 (12·6%) of 294 in the group assigned to receive irrigation (difference of 6·0 percentage points, 95% CI 0·2-11·7; p=0·30; adjusted for study site). There were no significant between-group differences in the proportion of people with modified Rankin Scale score of 4-6 (37 [13·1%] of 283 in the no-irrigation group vs 36 [12·6%] of 285 in the irrigation group; p=0·89) or mortality rate (18 [6·1%] of 295 in the no-irrigation group vs 21 [7·1%] of 294 in the irrigation group; p=0·58). The findings of the primary intention-to-treat analysis were not materially altered in the per-protocol analysis. There were no significant between-group differences in the number of adverse events, and the most frequent severe adverse events were systemic infections (26 [8·8%] of 295 participants who did not receive irrigation vs 22 [7·5%] of 294 participants who received irrigation), intracranial haemorrhage (13 [4·4%] vs seven [2·4%]), and epileptic seizures (five [1·7%] vs nine [3·1%]). INTERPRETATION: We could not conclude non-inferiority of burr-hole drainage without irrigation. The reoperation rate was 6·0 percentage points higher after burr-hole drainage without subdural irrigation than with subdural irrigation. Considering that there were no differences in functional outcome or mortality between the groups, the trial favours the use of subdural irrigation. FUNDING: State Fund for University Level Health Research (Helsinki University Hospital), Finska Läkaresällskapet, Medicinska Understödsföreningen Liv och Hälsa, and Svenska Kulturfonden.

Baclofen Stability up to One Year in In Vivo Intrathecal Infusion Pumps.

OBJECTIVES: Commercial intrathecal baclofen treatment (ITBT) infusion pumps are recommended to be refilled within a maximum of 180 days, thus necessitating at least twice-yearly outpatient visits and refill injections. In particular, pumps with 40-mL reservoir volumes would allow much longer refill intervals. We investigated baclofen stability in active implanted ITBT infusion pumps in vivo with refill intervals up to 367 days to study the feasibility of lengthening refill intervals beyond six months. MATERIALS AND METHODS: We obtained 25 baclofen samples from 19 patients receiving ITBT with varying pump refill intervals. All patients had a baclofen infusion system delivering undiluted 2 mg/mL baclofen at continuous rates of 96.1 to 673.7 µg/d with a concentration of 2.002 mg/mL. Baclofen concentrations of the infusate samples acquired during the refill procedures were analyzed using a validated high-performance liquid chromatography with diode-array detection (HPLC-DAD) assay, later complemented with repeat assay with pH and physical measurements. We also present the validation data of the HPLC-DAD assay. RESULTS: During the mean refill interval of 247 days (SD 90, range 54-367 days), the mean change in baclofen concentration was -0.0156 mg/mL (-0.8%, SD 0.14, range -0.30 to 0.32 mg/mL, paired t-test p = 0.57, t24 = 0.57). Only a low negative correlation was found between the baclofen concentration and the refill interval (Pearson's r = -0.32, p = 0.12). CONCLUSIONS: We could not show a significant change in baclofen concentration over the time studied; 2 mg/mL baclofen ITBT refill intervals could be lengthened to up to one year-the theoretical maximum refill interval in our cohort would have been 489 days. Further studies with larger sample sizes and other baclofen brands are warranted.

Favourable long-term recovery after decompressive craniectomy: the Northern Finland experience with a predominantly adolescent patient cohort.

PURPOSE: Decompressive craniectomy (DC) is an effective treatment of intracranial hypertension. Correspondingly, the procedure is increasingly utilised worldwide. The number of patients rendered vegetative following surgery has been a concern-a matter especially important in children, due to long anticipated lifetime. Here, we report the long-term outcomes of all paediatric DC patients from an 11-year period in a tertiary-level centre that geographically serves half of Finland. METHODS: We identified all patients younger than 18 years who underwent DC in the Oulu University Hospital between the years 2009 and 2019. Outcomes and clinicoradiological variables were extracted from the patient records. RESULTS: Mean yearly prevalence of brain injury requiring DC was 1.34/100 000 children-twenty-four patients underwent DC during the study period and 21 (88%) survived. The median age of the patients was 16.0 years, and the median preoperative GCS was 5.0 (IQR 5.0). Fifteen patients (63%) had made a good recovery (Extended Glasgow Outcome Scale ≥ 7). Of the surviving patients, two (9.5%) had not returned to school. After traumatic brain injury (n = 20), the Rotterdam CT score (mean 3.0, range 1 to 5) was not associated with mortality, poor recovery or inability to continue school (p = 0.13, p = 0.41, p = 0.43, respectively). Absent basal cisterns were associated with mortality (p = 0.005), but not with poor recovery if the patient survived DC (p = 0.81). Hydrocephalus was associated with poor recovery and inability to continue school (p = 0.01 and p = 0.03, respectively). CONCLUSION: Most of our patients made a favourable recovery and were able to continue school. No late mortality was observed. Thus, even in clinically and radiologically severely brain-injured children, decompressive craniectomy appears to yield favourable outcomes.

Classification of bone flap resorption after cranioplasty: a proposal for a computed tomography-based scoring system.

BACKGROUND: Bone flap resorption (BFR) is the most prevalent complication resulting in autologous cranioplasty failure, but no consensus on the definition of BFR or between the radiological signs and relevance of BFR has been established. We set out to develop an easy-to-use scoring system intended to standardize the interpretation of radiological BFR findings. METHODS: All 45 autologous cranioplasty patients operated on at Oulu University Hospital from 2004 to 2014 were identified, and the bone flap status of all the available patients was evaluated using the new scoring system. Derived from previous literature, a three-variable score for the detection of BFR changes is proposed. The variables "Extent" (estimated remaining bone volume), "Severity" (possible perforations and their measured diameter), and "Focus" (the number of BFR foci within the flap) are scored from 0 to 3 individually. Using the sum of these scores, a score of 0-9 is assigned to describe the degree of BFR. Additionally, independent neurosurgeons assessed the presence and relevance of BFR from the same data set. These assessments were compared to the BFR scores in order to find a score limit for relevant BFR. RESULTS: BFR was considered relevant by the neurosurgeons in 11 (26.8%) cases. The agreement on the relevance of BFR demonstrated substantial strength (κ 0.64, 95%CI 0.36 to 0.91). The minimum resorption score in cases of relevant BFR was 5. Thus, BFR with a resorption score ≥ 5 was defined relevant (grades II and III). With this definition, grade II or III BFR was found in 15 (36.6%) of our patients. No risk factors were found to predict relevant BFR. CONCLUSIONS: The score was proven to be easy to use and we recommend that only cases with grades II and III BFR undergo neurosurgical consultation. However, general applicability can only be claimed after validation in independent cohorts.

Reduced temporal muscle thickness predicts shorter survival in patients undergoing chronic subdural haematoma drainage.

BACKGROUND: Chronic subdural haematoma (CSDH) drainage is a common neurosurgical procedure. CSDHs cause excess mortality, which is exacerbated by frailty. Sarcopenia contributes to frailty - its key component, low muscle mass, can be assessed using cross-sectional imaging. We aimed to examine the prognostic role of temporal muscle thickness (TMT) measured from preoperative computed tomography head scans among patients undergoing surgical CSDH drainage. METHODS: We retrospectively identified all patients who underwent CSDH drainage within 1 year of February 2019. We measured their mean TMT from preoperative computed tomography scans, tested the reliability of these measurements, and evaluated their prognostic value for postoperative survival. RESULTS: One hundred and eighty-eight (122, 65% males) patients (median age 78 years, IQR 70-85 years) were included. Thirty-four (18%) patients died within 2 years, and 51 (27%) died at a median follow-up of 39 months (IQR 34-42 months). Intra- and inter-observer reliability of TMT measurements was good-to-excellent (ICC 0.85-0.97, P < 0.05). TMT decreased with age (Pearson's r = -0.38, P < 0.001). Females had lower TMT than males (P < 0.001). The optimal TMT cut-off values for predicting two-year survival were 4.475 mm for males and 3.125 mm for females. TMT below these cut-offs was associated with shorter survival in both univariate (HR 3.24, 95% CI 1.85-5.67) and multivariate (HR 1.86, 95% CI 1.02-3.36) analyses adjusted for age, ASA grade and bleed size. The effect of TMT on mortality was not mediated by age. CONCLUSIONS: In patients with CSDH, TMT measurements from preoperative imaging were reliable and contained prognostic information supplemental to previously known predictors of poor outcomes.

Consensus-Based Development of a Global Registry for Traumatic Brain Injury: Establishment, Protocol, and Implementation.

BACKGROUND AND OBJECTIVES: Global disparity exists in the demographics, pathology, management, and outcomes of surgically treated traumatic brain injury (TBI). However, the factors underlying these differences, including intervention effectiveness, remain unclear. Establishing a more accurate global picture of the burden of TBI represents a challenging task requiring systematic and ongoing data collection of patients with TBI across all management modalities. The objective of this study was to establish a global registry that would enable local service benchmarking against a global standard, identification of unmet need in TBI management, and its evidence-based prioritization in policymaking. METHODS: The registry was developed in an iterative consensus-based manner by a panel of neurotrauma professionals. Proposed registry objectives, structure, and data points were established in 2 international multidisciplinary neurotrauma meetings, after which a survey consisting of the same data points was circulated within the global neurotrauma community. The survey results were disseminated in a final meeting to reach a consensus on the most pertinent registry variables. RESULTS: A total of 156 professionals from 53 countries, including both high-income countries and low- and middle-income countries, responded to the survey. The final consensus-based registry includes patients with TBI who required neurosurgical admission, a neurosurgical procedure, or a critical care admission. The data set comprised clinically pertinent information on demographics, injury characteristics, imaging, treatments, and short-term outcomes. Based on the consensus, the Global Epidemiology and Outcomes following Traumatic Brain Injury (GEO-TBI) registry was established. CONCLUSION: The GEO-TBI registry will enable high-quality data collection, clinical auditing, and research activity, and it is supported by the World Federation of Neurosurgical Societies and the National Institute of Health Research Global Health Program. The GEO-TBI registry ( https://geotbi.org ) is now open for participant site recruitment. Any center involved in TBI management is welcome to join the collaboration to access the registry.

Early versus delayed cranioplasty after decompressive craniectomy in traumatic brain injury: a multicenter observational study within CENTER-TBI and Net-QuRe.

OBJECTIVE: The aim of this study was to compare the outcomes of early (≤ 90 days) and delayed (> 90 days) cranioplasty following decompressive craniectomy (DC) in patients with traumatic brain injury (TBI). METHODS: The authors analyzed participants enrolled in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) and the Neurotraumatology Quality Registry (Net-QuRe) studies who were diagnosed with TBI and underwent DC and subsequent cranioplasty. These prospective, multicenter, observational cohort studies included 5091 patients enrolled from 2014 to 2020. The effect of cranioplasty timing on functional outcome was evaluated with multivariable ordinal regression and with propensity score matching (PSM) in a sensitivity analysis of functional outcome (Glasgow Outcome Scale-Extended [GOSE] score) and quality of life (Quality of Life After Brain Injury [QOLIBRI] instrument) at 12 months following DC. RESULTS: Among 173 eligible patients, 73 (42%) underwent early cranioplasty and 100 (58%) underwent delayed cranioplasty. In the ordinal logistic regression and PSM, similar 12-month GOSE scores were found between the two groups (adjusted odds ratio [aOR] 0.87, 95% CI 0.61-1.21 and 0.88, 95% CI 0.48-1.65, respectively). In the ordinal logistic regression, early cranioplasty was associated with a higher risk for hydrocephalus than that with delayed cranioplasty (aOR 4.0, 95% CI 1.2-16). Postdischarge seizure rates (early cranioplasty: aOR 1.73, 95% CI 0.7-4.7) and QOLIBRI scores (ß -1.9, 95% CI -9.1 to 9.6) were similar between the two groups. CONCLUSIONS: Functional outcome and quality of life were similar between early and delayed cranioplasty in patients who had undergone DC for TBI. Neurosurgeons may consider performing cranioplasty during the index admission (early) to simplify the patient's chain of care and prevent readmission for cranioplasty but should be vigilant for an increased possibility of hydrocephalus. Clinical trial registration nos.: CENTER-TBI, NCT02210221 (clinicaltrials.gov); Net-QuRe, NTR6003 (trialsearch.who.int) and NL5761 (onderzoekmetmensen.nl).

Two-center validation of the Oulu resorption score for bone flap resorption after autologous cranioplasty.

OBJECTIVE: Autologous bone has been the gold standard of cranioplasty materials for decades. Unique to autologous cranioplasty, bone flap resorption is a poorly understood and unclearly defined complication. Even further, it has been unclear, whether the resorption process eventually stabilizes over time. Thus, the sufficient follow-up period after autologous cranioplasty is unknown. The Oulu Resorption Score (ORS) is a straight-forward classification system for the radiological interpretation of bone flap resorption. The aims of the present study were to evaluate the reliability of the ORS using intra-class correlation coefficient (ICC) and to assess the temporal progression of the resorption process. METHODS: We identified 108 consecutive autologous cranioplasty patients treated between 2005 and 2018 in two tertiary referral centers. All 365 head CT scans the patients had undergone were evaluated using the ORS in a blinded, independent two-center setting. Intra- and inter-observer reliabilities were calculated. The ORS was applied to study the temporal progression of the resorption process. RESULTS: The intra-observer reliability of the ORS was excellent (ICC 0.94, 95%CI 0.93-0.95). Inter-observer reliability was good-to-excellent (ICCs 0.87 and 0.89, 95%CIs 0.84-0.89 and 0.87-0.91, respectively). In scatterplot smoothing analyses, the progression of bone flap resorption appeared to stabilize 12-24 months after cranioplasty. CONCLUSIONS: ORS is the only validated radiological tool for the standardized analysis of bone flap resorption after autologous cranioplasty. Evaluated using the ORS, the resorption process seemed to stabilize during the first two postoperative years after cranioplasty, suggesting that the sufficient follow-up time after autologous cranioplasty is two years.

Quantitative and qualitative analysis of bone flap resorption in patients undergoing cranioplasty after decompressive craniectomy.

OBJECTIVE: Autologous bone cranioplasty after decompressive craniectomy entails a notable burden of difficult postoperative complications, such as infection and bone flap resorption (BFR), leading to mechanical failure. The prevalence and significance of asymptomatic BFR is currently unclear. The aim of this study was to radiologically monitor the long-term bone flap survival and bone quality change in patients undergoing autologous cranioplasty. METHODS: The authors identified all 45 patients who underwent autologous cranioplasty at Oulu University Hospital, Finland, between January 2004 and December 2014. Using perioperative and follow-up CT scans, the volumes and radiodensities of the intact bone flap prior to surgery and at follow-up were calculated. Relative changes in bone flap volume and radiodensity were then determined to assess cranioplasty survival. Sufficient CT scans were obtainable from 41 (91.1%) of the 45 patients. RESULTS: The 41 patients were followed up for a median duration of 3.79 years (25th and 75th percentiles = 1.55 and 6.66). Thirty-seven (90.2%) of the 41 patients had some degree of BFR and 13 (31.7%) had a remaining bone flap volume of less than 80%. Patients younger than 30 years of age had a mean decrease of 15.8% in bone flap volume compared with the rest of the cohort. Bone flap volume was not found to decrease linearly with the passing of time, however. The effects of lifestyle factors and comorbidities on BFR were nonsignificant. CONCLUSIONS: In this study BFR was a very common phenomenon, occurring at least to some degree in 90% of the patients. Decreases in bone volume were especially prominent in patients younger than 30 years of age. Because the progression of resorption during follow-up was nonlinear, routine follow-up CT scans appear unnecessary in monitoring the progression of BFR; instead, clinical follow-up with mechanical stability assessment is advised. Partial resorption is most likely a normal physiological phenomenon during the bone revitalization process.

Predictors of primary autograft cranioplasty survival and resorption after craniectomy.

OBJECTIVECraniectomy is a common neurosurgical procedure that reduces intracranial pressure, but survival necessitates cranioplasty at a later stage, after recovery from the primary insult. Complications such as infection and resorption of the autologous bone flap are common. The risk factors for complications and subsequent bone flap removal are unclear. The aim of this multicenter, retrospective study was to evaluate the factors affecting the outcome of primary autologous cranioplasty, with special emphasis on bone flap resorption.METHODSThe authors identified all patients who underwent primary autologous cranioplasty at 3 tertiary-level university hospitals between 2002 and 2015. Patients underwent follow-up until bone flap removal, death, or December 31, 2015.RESULTSThe cohort comprised 207 patients with a mean follow-up period of 3.7 years (SD 2.7 years). The overall complication rate was 39.6% (82/207), the bone flap removal rate was 19.3% (40/207), and 11 patients (5.3%) died during the follow-up period. Smoking (OR 3.23, 95% CI 1.50-6.95; p = 0.003) and age younger than 45 years (OR 2.29, 95% CI 1.07-4.89; p = 0.032) were found to independently predict subsequent autograft removal, while age younger than 30 years was found to independently predict clinically relevant bone flap resorption (OR 4.59, 95% CI 1.15-18.34; p = 0.03). The interval between craniectomy and cranioplasty was not found to predict either bone flap removal or resorption.CONCLUSIONSIn this large, multicenter cohort of patients with autologous cranioplasty, smoking and younger age predicted complications leading to bone flap removal. Very young age predicted bone flap resorption. The authors recommend that physicians extensively inform their patients of the pronounced risks of smoking before cranioplasty.