The role of shuntography in diagnosis of mechanic complications after implantation of ventriculoperitoneal shunts in patients with idiopathic normal pressure hydrocephalus: a retrospective clinical evaluation.

BACKGROUND: Mechanical obstruction of ventriculoperitoneal shunt (VPS) during the first year after shunt implantation is a common complication and is widely described in the literature. In this paper, we evaluated the suitability of the shuntography for the diagnosis of mechanical complications of the VPS in patients with idiopathic normal pressure hydrocephalus (iNPH). METHODS: We retrospectively identified 49 patients with pathologic shuntography over of a period of 20 years in our hospital. The percentage of procedure-associated complications was determined. RESULTS: Ninety-eight percent (n = 48) of the patients who underwent shuntography showed clinical and radiographic signs of underdrainage prior to examination. Shuntography revealed mechanical complications of the VP shunt in 37% (n = 18) as a cause of clinical deterioration and following revision operation. During shuntography, mechanical obstruction was discovered in 78% (n = 14) and disconnection of shunt components in 22% (n = 4). In the obstruction group, in 50% (n = 7) the closure was detected in the ventricular catheter, in 29% (n = 4) in the distal catheter of the VPS, and in 21% (n = 3) in both sides of the VPS. In the case of an inconspicuous shuntography (63%, n = 31), the patients received symptomatic therapy (32%, n = 10) or re-adjustment of the valve setting (68%, n = 21). Fifty-seven percent of the patients who underwent surgical treatment improved clinically by at least one point according to the Kiefer score. CONCLUSION: Shuntography can produce valuable clinical information uncovering mechanic complications after implantation VPS in patients with idiopathic normal-pressure hydrocephalus. Patients with mechanical complications of their VPS needed revision surgery and showed clinical benefit after treatment.

Clinical predictors of shunt response in the diagnosis and treatment of idiopathic normal pressure hydrocephalus: a systematic review and meta-analysis.

BACKGROUND: Positive shunt response (SR) remains the gold standard for diagnosing idiopathic normal pressure hydrocephalus (iNPH). However, multiple pathologies mimic iNPH symptoms, making it difficult to select patients who will respond to shunt surgery. Although presenting features, extended lumbar drainage (ELD), infusion test (IT), intracranial pressure monitoring (ICPM), and tap test (TT) have been used to predict SR, uncertainty remains over which diagnostic test to choose. OBJECTIVE: To conduct a systematic review and meta-analysis to identify clinical predictors of shunt responsiveness, evaluate their diagnostic effectiveness, and recommend the most effective diagnostic tests. METHODS: Embase, MEDLINE, Scopus, PubMed, Google Scholar, and JSTOR were searched for original studies investigating clinical predictors of SR in iNPH patients. Included studies were assessed using the QUADAS-2 tool, and eligible studies were evaluated using univariate and bivariate meta-analyses. RESULTS: Thirty-five studies were included. Nine studies discussed the diagnostic use of presenting clinical features, 8 studies ELD, 8 studies IT, 11 studies ICPM, and 6 studies TT. A meta-analysis of 21 eligible studies was conducted for TT, ELD, IT, and ICPM. ICPM yielded the highest diagnostic effectiveness, with diagnostic odds ratio (DOR) = 50.9 and area under curve (AUC) = 0.836. ELD yielded DOR = 27.70 and AUC = 0.753, IT had DOR = 5.70 and AUC = 0.729, and TT scored DOR = 3.86 and AUC = 0.711. CONCLUSION: Intraparenchymal ICPM is statistically the most effective diagnostic test, followed by ELD, IT, and lastly TT. Due to the higher accessibility of TT and IT, they are recommended to be used first line, using a timed-up-and-go improvement ≥ 5.6 s or a Rout cut-off range between 13 and 16 mmHg, respectively. Patients who test negative should ideally be followed up with ICPM, using mean ICP wave amplitude [Formula: see text] 4 mmHg, or 1- to 4-day ELD with an MMSE cut-off improvement [Formula: see text] 3. Future research must use standardized methodologies for each diagnostic test and uniform criteria for SR to allow better comparison.

Expression and activity of hyaluronidases HYAL-1, HYAL-2 and HYAL-3 in the human intervertebral disc.

PURPOSE: Hyaluronic acid plays an essential role in water retention of the intervertebral disc (IVD) and thus provides flexibility and shock absorbance in the spine. Hyaluronic acid gets degraded by hyaluronidases (HYALs), and some of the resulting fragments were previously shown to induce an inflammatory and catabolic response in human IVD cells. However, no data currently exist on the expression and activity of HYALs in IVD health and disease. METHODS: Gene expression, protein expression and activity of HYALs were determined in human IVD biopsies with different degrees of degeneration (n = 50 total). Furthermore, freshly isolated human IVD cells (n = 23 total) were stimulated with IL-1ß, TNF-α or H2O2, followed by analysis of HYAL-1, HYAL-2 and HYAL-3 gene expression. RESULTS: Gene expression of HYAL-1 and protein expression of HYAL-2 significantly increased in moderate/severe disc samples when compared to samples with no or low IVD degeneration. HYAL activity was not significantly increased due to high donor-donor variation, but seemed overall higher in the moderate/severe group. An inflammatory environment, as seen during IVD disease, did not affect HYAL-1, HYAL-2 or HYAL-3 expression, whereas exposure to oxidative stress (100 µM H2O2) upregulated HYAL-2 expression relative to untreated controls. CONCLUSION: Although HYAL-1, HYAL-2 and HYAL-3 are all expressed in the IVD, HYAL-2 seems to have the highest pathophysiological relevance. Nonetheless, further studies will be needed to comprehensively elucidate its significance and to determine its potential as a therapeutic target. These slides can be retrieved under Electronic Supplementary Material.

Do we know the outcome predictors for cauda equine syndrome (CES)? A retrospective, single-center analysis of 60 patients with CES with a suggestion for a new score to measure severity of symptoms.

OBJECTIVE: Despite the awareness and familiarity of almost every medical professional with the cauda equine compression syndrome (CES), risk factors for a poor prognosis of the disease remain elusive. Even the relationship between subsequent outcome and the time elapsed from the time of appearance of symptoms to surgery taking place remain obscure. The aim of our study, therefore, was to analyze a relatively large population of our own patients studied consecutively, to identify outcome predictors for CES and to propose a clinical score for CES symptoms (Berlin CES score). METHODS: We screened the hospital's electronic database retrospectively for patients admitted with CES between 2001 and 2010. Since our hospital is a superregional trauma center with standardized emergency room procedures, all patients included in the study underwent the same routine. Using baseline data, we analyzed the following parameters: duration of symptoms, period of time between diagnosis and imaging, respectively, surgery; pre- and postoperative pain, motor deficits, reflex changes, urinary and bowl dysfunctions, reduced anal wink, saddle anesthesia, genital or perianal sensations and residual urine. The semi-quantitative assessment of the neurological outcome was performed by application of the Berlin CES score. RESULTS: Surprisingly, we were not able to identify any single parameters that could reliably predict the outcome of the disease. We were able to show statistically significant correlations between a high preoperatively Berlin CES score (i.e., a weighted summation of bladder dysfunction, rectal dysfunction, genital sensation, perianal sensation, rectal tone and saddle anesthesia) and a poor outcome regarding the postoperative existence of perianal (p < 0.001) and genital (p = 0.001) hypoesthesia, as well as reduced rectal tone (p = 0.0047). There was no significant interference of bladder or bowel function. Further analysis, in which we considered the time between diagnosis and surgery, revealed that both patients operated within 24 h and after 48 h could benefit from the intervention. Consequently, we were not able to show a correlation between speed of surgical treatment and outcome. CONCLUSION: Although we analyzed a relatively large cohort, we were not able to identify single parameters that were capable of reliably predicting the outcome of patients with CES. Nonetheless, we were able to show that consideration of multiple parameters of symptomatology would enable an improvement in making a prognosis. In conclusion, we propose establishing a simple semi-quantitative clinical score of the main symptoms of CES.

Corrigendum: Health in Germany: Establishment of a population-based health panel.

[This corrects the article DOI: 10.25646/11992.2.].

Erratum: Health in Germany: Establishment of a population-based health panel.

[This corrects the article on p. 2,21 in vol. 9, PMID: 38282983.].

Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA).

OBJECTIVES: To investigate whether gravitational valves reduce the risk of overdrainage complications compared with programmable valves in ventriculoperitoneal (VP) shunt surgery for idiopathic normal pressure hydrocephalus (iNPH). BACKGROUND: Patients with iNPH may benefit from VP shunting but are prone to overdrainage complications during posture changes. Gravitational valves with tantalum balls are considered to reduce the risk of overdrainage but their clinical effectiveness is unclear. METHODS: We conducted a pragmatic, randomised, multicentre trial comparing gravitational with non-gravitational programmable valves in patients with iNPH eligible for VP shunting. The primary endpoint was any clinical or radiological sign (headache, nausea, vomiting, subdural effusion or slit ventricle) of overdrainage 6 months after randomisation. We also assessed disease specific instruments (Black and Kiefer Scale) and Physical and Mental Component Scores of the Short Form 12 (SF-12) generic health questionnaire. RESULTS: We enrolled 145 patients (mean (SD) age 71.9 (6.9) years), 137 of whom were available for endpoint analysis. After 6 months, 29 patients in the standard and five patients in the gravitational shunt group developed overdrainage (risk difference -36%, 95% CI -49% to -23%; p<0.001). This difference exceeded predetermined stopping rules and resulted in premature discontinuation of patient recruitment. Disease specific outcome scales did not differ between the groups although there was a significant advantage of the gravitational device in the SF-12 Mental Component Scores at the 6 and 12 month visits. CONCLUSIONS: Implanting a gravitational rather than another type of valve will avoid one additional overdrainage complication in about every third patient undergoing VP shunting for iNPH.

Development and first results of a national databank on care and treatment outcome after traumatic brain injury.

PURPOSE: In absence of comprehensive data collection on traumatic brain injury (TBI), the German Society for Neurosurgery (DGNC) and the German Society for Trauma Surgery (DGU) developed a TBI databank for German-speaking countries. METHODS: From 2016 to 2020, the TBI databank DGNC/DGU was implemented as a module of the TraumaRegister (TR) DGU and tested in a 15-month pilot phase. Since its official launch in 2021, patients from the TR-DGU (intermediate or intensive care unit admission via shock room) with TBI (AIS head ≥ 1) can be enrolled. A data set of > 300 clinical, imaging, and laboratory variables, harmonized with other international TBI data collection structures is documented, and the treatment outcome is evaluated after 6- and 12 months. RESULTS: For this analysis, 318 patients in the TBI databank could be included (median age 58 years; 71% men). Falls were the most common cause of injury (55%), and antithrombotic medication was frequent (28%). Severe or moderate TBI were only present in 55% of patients, while 45% suffered a mild injury. Nevertheless, intracranial pathologies were present in 95% of brain imaging with traumatic subarachnoid hemorrhages (76%) being the most common. Intracranial surgeries were performed in 42% of cases. In-hospital mortality after TBI was 21% and surviving patients could be discharged after a median hospital stay of 11 days. At the 6-and 12 months follow-up, a favorable outcome was achieved by 70% and 90% of the participating TBI patients, respectively. Compared to a European cohort of 2138 TBI patients treated in the ICU between 2014 and 2017, patients in the TBI databank were already older, frailer, fell more commonly at home. CONCLUSION: Within five years, the TBI databank DGNC/DGU of the TR-DGU could be established and is since then prospectively enrolling TBI patients in German-speaking countries. With its large and harmonized data set and a 12-month follow-up, the TBI databank is a unique project in Europe, already allowing comparisons to other data collection structures and indicating a demographic change towards older and frailer TBI patients in Germany.

Effectiveness of Lumbar Cerebrospinal Fluid Drain Among Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial.

Importance: After aneurysmal subarachnoid hemorrhage, the use of lumbar drains has been suggested to decrease the incidence of delayed cerebral ischemia and improve long-term outcome. Objective: To determine the effectiveness of early lumbar cerebrospinal fluid drainage added to standard of care in patients after aneurysmal subarachnoid hemorrhage. Design, Setting, and Participants: The EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation conducted at 19 centers in Germany, Switzerland, and Canada. The first patient entered January 31, 2011, and the last on January 24, 2016, after 307 randomizations. Follow-up was completed July 2016. Query and retrieval of data on missing items in the case report forms was completed in September 2020. A total of 20 randomizations were invalid, the main reason being lack of informed consent. No participants meeting all inclusion and exclusion criteria were excluded from the intention-to-treat analysis. Exclusion of patients was only performed in per-protocol sensitivity analysis. A total of 287 adult patients with acute aneurysmal subarachnoid hemorrhage of all clinical grades were analyzable. Aneurysm treatment with clipping or coiling was performed within 48 hours. Intervention: A total of 144 patients were randomized to receive an additional lumbar drain after aneurysm treatment and 143 patients to standard of care only. Early lumbar drainage with 5 mL per hour was started within 72 hours of the subarachnoid hemorrhage. Main Outcomes and Measures: Primary outcome was the rate of unfavorable outcome, defined as modified Rankin Scale score of 3 to 6 (range, 0 to 6), obtained by masked assessors 6 months after hemorrhage. Results: Of 287 included patients, 197 (68.6%) were female, and the median (IQR) age was 55 (48-63) years. Lumbar drainage started at a median (IQR) of day 2 (1-2) after aneurysmal subarachnoid hemorrhage. At 6 months, 47 patients (32.6%) in the lumbar drain group and 64 patients (44.8%) in the standard of care group had an unfavorable neurological outcome (risk ratio, 0.73; 95% CI, 0.52 to 0.98; absolute risk difference, -0.12; 95% CI, -0.23 to -0.01; P = .04). Patients treated with a lumbar drain had fewer secondary infarctions at discharge (41 patients [28.5%] vs 57 patients [39.9%]; risk ratio, 0.71; 95% CI, 0.49 to 0.99; absolute risk difference, -0.11; 95% CI, -0.22 to 0; P = .04). Conclusion and Relevance: In this trial, prophylactic lumbar drainage after aneurysmal subarachnoid hemorrhage lessened the burden of secondary infarction and decreased the rate of unfavorable outcome at 6 months. These findings support the use of lumbar drains after aneurysmal subarachnoid hemorrhage. Trial Registration: ClinicalTrials.gov Identifier: NCT01258257.

Reappraisal of Intracerebral Hemorrhages and Intracerebral Hemorrhage Grading Scale Score in Surgically and Medically Managed Cerebellar Intracerebral Hemorrhage.

BACKGROUND: As compared with supratentorial intracerebral hemorrhages (ICH), bleeds that occur within the cerebellum require special consideration given the nature of the posterior fossa. OBJECTIVE: To validate ICH and ICH grading scale (ICH-GS) scores in patients with cerebellar hemorrhage and examine the outcomes of patients managed surgically as compared with those who underwent conservative treatment. METHODS: This observational multicenter study included 475 patients with cerebellar hemorrhage from 9 different neurosurgical departments in Germany between 2005 and 2021. The prognostic accuracy of ICH and ICH-GS scores were calculated by the area under the curve of the receiver operating characteristic curves. Analyzed outcomes were the in-hospital mortality, mortality at 6 months, in-hospital outcome, and outcome at 6 months. RESULTS: Of 403 patients, 252 patients (62.5%) underwent surgical treatment and 151 patients (37.5%) conservative treatment. Both ICH and ICH-GS scores demonstrated good prognostic accuracy regarding both overall mortality and functional outcomes. In those patients presenting with severe cerebellar hemorrhages, ie, ICH score >3 and ICH-GS score >11, overall mortality was significantly lower in surgically treated patients. Mortality was significantly higher in those patients managed surgically who presented with ICH scores 3; in such patients, improved outcomes were noted when the hematoma was treated conservatively. CONCLUSION: ICH and ICH scores are useful tools for prediction of survival and outcome in patients with cerebellar ICH. Surgical management may be beneficial for those who present with severe cerebellar ICH as reflected by ICH scores >3, while conservative management seems reasonable in patients with lower ICH scores.

Idiopathic normal pressure hydrocephalus (iNPH) and co-morbidity: an outcome analysis of 134 patients.

OBJECTIVE: The diagnosis and management of idiopathic normal-pressure hydrocephalus (iNPH) remains controversial, particularly in selecting patients for shunt insertion. Diagnostic criteria target the pathological features of the dynamics of the cerebrospinal fluid (CSF); however, the effectiveness in predicting the shunt success has room for improvement. The aim of our study was to systematically assess the influence of the co-morbidity determining the benefit from shunt surgery. METHODS: Between 1997 and 2006 134 patients suffering from iNPH were treated with a ventriculo-peritoneal shunt with a gravity-controlled valve. The coincident disease processes were recorded. Shunt outcome was assessed at 2 years postsurgery in 116 patients (follow up rate 87%). The results of this follow-up examination (Kiefer score, NPH recovery rate) were compared using the preoperative co-morbidity index (CMI). RESULTS: Of the 134 patients 76 (56.7%) had a CMI of 0-3 and 58 patients (43.3%) had a CMI of 4-8. Two years after surgery 65 out of 70 shunt responders (93%) could be identified in the patients group with a CMI of 0-3 and only 29 of 46 (63%) in group with a CMI of 4-8. This difference was significant (p < 0.0001). Remarkably few patients scoring between 6 and 8 on the CMI scale experienced a favourable outcome. The patients in this latter group showed excellent outcomes in only 1% and poor outcomes in 33%. CONCLUSION: Data in this report affirm that co-morbidity is a statistically significant predictor of the quality of the clinical outcome for patients with iNPH undergoing shunt therapy. A CMI of more than 3 significantly decreases the chance of a favourable outcome and this should form part of the assessment when the risks and benefits of surgery are considered. According to these data, a successful outcome in patients with a CMI of 6 or more is not to be expected.

The impact of silver nanoparticle-coated and antibiotic-impregnated external ventricular drainage catheters on the risk of infections: a clinical comparison of 95 patients.

BACKGROUND: Infection, i.e. meningitis or ventriculitis, is a major complication of external ventricular drainage (EVD). In order to prevent this complication rifampin-impregnated and clindamycin-impregnated silicone catheters and EVDs impregnated with nanoparticles of silver and an insoluble silver salt have been developed. Sparse data are published concerning the efficacy of these catheters in reducing bacterial colonization. METHODS: Between July 2003 and June 2006, 95 patients (age range 12-84 years, mean 53.6 years) underwent implantation of an EVD catheter for CSF diversion for several indications. All surgeries were performed in a standardized way at a single medical center. We used standard polyurethane catheters in 32 patients, Codman Bactiseal silicone catheters in 31 patients, and Spiegelberg Silverline catheters in 32 patients. Samples of the cerebrospinal fluid (CSF) were taken at the time of implantation, every 10 days and at the time of removal. The samples were microbiologically analyzed. RESULTS: In 32 standard catheters we saw infections in 5 patients (15.6%). By contrast, 2 of the 31 patients with a Bactiseal catheter (6.5%) and 3 with a Silverline catheter (9.4%) developed an infection. CONCLUSION: Rifampin-impregnated and clindamycin-impregnated EVDs as well as silver-impregnated EVDs decreased the infection rate. Randomized studies are needed to assess the advantage of these catheters compared with standard polyurethane catheters.

On the method of a randomised comparison of programmable valves with and without gravitational units: the SVASONA study.

OBJECTIVE: The supremacy of low-pressure valves (LPV) in the therapy of patients with idiopathic normal pressure hydrocephalus (iNPH) has been proven by the Dutch NPH study. The downside of LPVs is the high rate of overdrainage complications. In the meantime gravitational units have been developed with the objective of minimising overdrainage complications. Do these gravitational units allow the same favourable outcomes as in the Dutch NPH study without overdrainage complications? The goal of this prospective randomised controlled multicentre trial is to compare the rate of overdrainage complications after shunt surgery with programmable valves with or without a gravitational unit. METHOD: Patients suspected with iNPH with gait ataxia and one or two other symptoms of Hakim's triad and enlarged ventricles on CT or MRI underwent a cerebrospinal fluid (CSF) infusion test, CSF tap test and/or continuous ICP measurement in seven experienced centres. If iNPH was diagnosed the patients were randomised to receive a ventriculoperitoneal shunt with a programmable valve with or without a gravitational unit. The patients were followed up for 3, 6 and 12 months after surgery. The primary hypothesis of the study was that programmable valves with gravitational units will reduce the rate of overdrainage from 25% to 10%. The outcome measured by iNPH-specific outcome scales (Kiefer score, Black grading scale) and the generic quality of life (short form 12, SF12) was defined as the secondary endpoint. To detect the hypothesised difference in the incidence of overdrainage with a type I error of 5% and a type II error of 20%, correcting for multiple testing and an anticipated drop-out rate of 10%, we planned to enrol 250 patients. To ensure safety and efficacy we performed a planned interim analysis halfway. RESULTS: The study design has been found to be effective with regard to the primary hypothesis. CONCLUSION: The design of the SVASONA study was developed to be able to confirm the primary hypothesis. Thus, the method of the study should solve the dilemma of the Dutch NPH study by the randomised comparison of LPVs with and without gravitational units.

Step Back in Order to Go Forward: Willful Enlargement and Sandwich Closure Technique for Spinal Dura Repair after Several Unsuccessful Closure Attempts.

A CSF leak is a common complication in spine surgery which is usually closed effectivly by suture and/or epidural patches. There is currently no algorithm to treat a recurrent CSF leak that fails to be closed initially. We describe the case of a recurrent cerebrospinal fluid leak that we have successfully treated using an inlay-onlay dural repair technique.

Angulation Toward Coronal Convexity Measure and Catheter Length Indication Improves the Quality of Ventricular Catheter Placement-A Smartphone-Assisted Guidance Technique.

BACKGROUND: Accurate placement of a ventricular catheter (VC) is crucial to reduce the risk of shunt failure. In the randomized, prospective, multicenter GAVCA (guided application of ventricular catheters) trial, which evaluated the quality of VC placement, the subgroup of patients with detailed length-marked VCs (dVCs) reflected a difference in the primary endpoint of optimal VC placement compared with the subgroup of patients with simplified length-marked VCs (sVCs). The objective of the present analysis was to compare the dVC and sVC groups and the smartphone-assisted guidance technique (GA) with the standard freehand technique (FH) for VC placement. METHODS: We performed a further analysis of the GAVCA trial in 2 steps. First, we compared the dVCs, which provided a detailed distance from the tip to the base (3-13 cm) in 0.5-cm intervals, with the sVCs with a length indication at 5 and 10 cm from the tip to base. Second, we compared the GA technique with the FH in the dVC group. RESULTS: The data from 137 patients (104 dVC patients vs. 33 sVC patients) were eligible for the present analysis. Optimal VC placement was achieved in 72.1% of the dVC group and 39.4% of the sVC group (odds ratio, 3.9; 95% confidence interval, 1.7-9.3; P ≤ 0.001). In addition, we performed a subgroup analysis of the 104 dVC patients concerning the accuracy of catheter placement using 2 different techniques (GA, n = 54; and FH, n = 50). Optimal catheter placement was achieved in 81.5% of the GA group and 62.0% of the FH group (odds ratio, 2.7; 95% confidence interval, 1.1-6.8; P = 0.03). VC placement using the GA technique was successful in all patients at the primary puncture. In contrast, for 8.7% of the patients in the FH group, multiple attempts were necessary (P = 0.03). CONCLUSIONS: The results from the present analysis suggest that the combination of a GA technique and the use of a dVC will improve the rate of accurate VC placement. Compared with the FH technique, patient safety was increased by the reduction of unsuccessful VC placement attempts using the GA technique and dVCs.

Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial.

BACKGROUND: Chronic subdural hematoma (cSDH) is the most common complication of mild traumatic brain injury demanding neurosurgery in high-income countries. If undetected and untreated, cSDH may increase intracranial pressure and cause neurological deficiencies. The first-line intervention of choice is burr hole trepanation and hematoma evacuation. However, any third patient may experience rebleeding, demanding craniotomy with excess morbidity. Adjunct endovascular embolization of the frontal and parietal branches of the middle meningeal artery (MMA) is a promising approach to avoid relapse and revision but was hitherto not studied in a randomized trial. METHODS: MEMBRANE is an investigator-initiated, single-center, randomized controlled trial. Male, female, and diverse patients older than 18 years scheduled for surgical evacuation of a first cSDH will be assigned in a 1:1 fashion by block randomization to the intervention (surgery plus endovascular MMA embolization) or the control group (surgery alone). The primary trial endpoint is cSDH recurrence within 3 months of follow-up after surgery. Secondary endpoints comprise neurological deficits assessed by the modified Rankin Scale (mRS) and recurrence- or intervention-associated complications during 3 months of follow-up. Assuming a risk difference of 20% of rebleeding and surgical revision, a power of 80%, and a drop-out rate of 10%, 154 patients will be enrolled onto this trial, employing an adaptive O'Brien-Fleming approach with a planned interim analysis halfway. DISCUSSION: The MEMBRANE trial will provide first clinical experimental evidence on the effectiveness of endovascular embolization of the MMA as an adjunct to surgery to reduce the risk of recurrence after the evacuation of cSDH. TRIAL REGISTRATION: German Clinical Trials Registry (Deutsches Register Klinischer Studien [DRKS]) DRKS00020465. Registered on 18 Nov 2021. CLINICALTRIALS: gov NCT05327933 . Registered on 13 Apr 2022.

Health situation in Germany during the COVID-19 pandemic. Developments over time for selected indicators of GEDA 2019/2020 - An update.

The spread of the coronavirus SARS-CoV-2 in 2020 and the containment measures associated therewith have changed many aspects of daily life. An impact on health even beyond infections itself is assumed as well. The health situation of the population in the first phase of the pandemic was thus analysed using data from the German Health Update (GEDA 2019/2020-EHIS). By continuing the survey, the analyses for 2020 are completed (n=26,507 participants), whereby the focus is now on the third phase of the pandemic (second wave of infection, gradual reintroduction of containment measures). The health indicators are presented on a monthly basis. As in the first phase of the pandemic, no pandemic-related changes were observed for tobacco smoking/ second-hand smoke exposure and for received/lack of/provided support. In contrast to the first phase of the pandemic, declines in utilisation of medical services and depressive symptoms are not observed in the third phase. The increase in body weight/body mass index after the first phase of the pandemic did not continue. The survey period allows for a comparison of the periods before and as of the pandemic situation. A decrease in the medical services utilisation and depressive symptoms as well as an increase in the body weight/body mass index is observed in the period from March 2020 to January 2021 compared to the pre-pandemic period from April 2019 to March 2020.

Deep learning algorithm in detecting intracranial hemorrhages on emergency computed tomographies.

BACKGROUND: Highly accurate detection of intracranial hemorrhages (ICH) on head computed tomography (HCT) scans can prove challenging at high-volume centers. This study aimed to determine the number of additional ICHs detected by an artificial intelligence (AI) algorithm and to evaluate reasons for erroneous results at a level I trauma center with teleradiology services. METHODS: In a retrospective multi-center cohort study, consecutive emergency non-contrast HCT scans were analyzed by a commercially available ICH detection software (AIDOC, Tel Aviv, Israel). Discrepancies between AI analysis and initial radiology report (RR) were reviewed by a blinded neuroradiologist to determine the number of additional ICHs detected and evaluate reasons leading to errors. RESULTS: 4946 HCT (05/2020-09/2020) from 18 hospitals were included in the analysis. 205 reports (4.1%) were classified as hemorrhages by both radiology report and AI. Out of a total of 162 (3.3%) discrepant reports, 62 were confirmed as hemorrhages by the reference neuroradiologist. 33 ICHs were identified exclusively via RRs. The AI algorithm detected an additional 29 instances of ICH, missed 12.4% of ICH and overcalled 1.9%; RRs missed 10.9% of ICHs and overcalled 0.2%. Many of the ICHs missed by the AI algorithm were located in the subarachnoid space (42.4%) and under the calvaria (48.5%). 85% of ICHs missed by RRs occurred outside of regular working-hours. Calcifications (39.3%), beam-hardening artifacts (18%), tumors (15.7%), and blood vessels (7.9%) were the most common reasons for AI overcalls. ICH size, image quality, and primary examiner experience were not found to be significantly associated with likelihood of incorrect AI results. CONCLUSION: Complementing human expertise with AI resulted in a 12.2% increase in ICH detection. The AI algorithm overcalled 1.9% HCT. TRIAL REGISTRATION: German Clinical Trials Register (DRKS-ID: DRKS00023593).

German Health Update (GEDA 2019/2020-EHIS) - Background and methodology.

Between April 2019 and September 2020, 23,001 people aged 15 or over responded to questions about their health and living conditions for the German Health Update (GEDA 2019/2020-EHIS). The results are representative of the German resident population aged 15 or above. The response rate was 21.6%. The study used a questionnaire based on the third wave of the European Health Interview Survey (EHIS), which was carried out in all EU member states. EHIS consists of four modules on health status, health care provision, health determinants, and socioeconomic variables. The data are collected in a harmonised manner and therefore have a high degree of international comparability. They constitute an important source of information for European health policy and health reporting and are made available by the Statistical Office of the European Union (Eurostat). They also form the basis of the Federal Health Reporting undertaken in Germany. Data collection began in April 2019, just under a year before the beginning of the SARS-CoV-2 pandemic, and continued into its initial phase, as of March 2020. As such, data from the current GEDA wave can also be used to conduct research into the health impact of the SARS-CoV-2 pandemic.