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4.
JAMA Neurol ; 80(8): 833-842, 2023 08 01.
Article in English | MEDLINE | ID: mdl-37330974

ABSTRACT

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.


Subject(s)
Aneurysm , Brain Ischemia , Subarachnoid Hemorrhage , Adult , Humans , Female , Middle Aged , Male , Subarachnoid Hemorrhage/complications , Subarachnoid Hemorrhage/surgery , Drainage/adverse effects , Drainage/methods , Cerebral Infarction/complications , Brain Ischemia/complications , Aneurysm/complications , Treatment Outcome
5.
Eur J Trauma Emerg Surg ; 49(3): 1171-1181, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37022377

ABSTRACT

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.


Subject(s)
Brain Injuries, Traumatic , Brain Injuries , Male , Humans , Middle Aged , Female , Registries , Brain Injuries, Traumatic/diagnostic imaging , Brain Injuries, Traumatic/therapy , Treatment Outcome , Germany/epidemiology
6.
Neurosurgery ; 92(5): 1021-1028, 2023 05 01.
Article in English | MEDLINE | ID: mdl-36700686

ABSTRACT

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.


Subject(s)
Cerebellum , Cerebral Hemorrhage , Humans , Treatment Outcome , Cerebral Hemorrhage/surgery , Prognosis , Hospital Mortality , Retrospective Studies
7.
Trials ; 23(1): 703, 2022 Aug 22.
Article in English | MEDLINE | ID: mdl-35996195

ABSTRACT

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.


Subject(s)
Embolization, Therapeutic , Hematoma, Subdural, Chronic , Craniotomy , Embolization, Therapeutic/adverse effects , Female , Hematoma, Subdural, Chronic/diagnostic imaging , Hematoma, Subdural, Chronic/surgery , Humans , Male , Meningeal Arteries/diagnostic imaging , Meningeal Arteries/surgery , Randomized Controlled Trials as Topic , Recurrence , Treatment Outcome
8.
J Health Monit ; 7(Suppl 3): 2-19, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35892088

ABSTRACT

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.

10.
J Neurol Surg A Cent Eur Neurosurg ; 83(1): 66-68, 2022 Jan.
Article in English | MEDLINE | ID: mdl-33540456

ABSTRACT

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.


Subject(s)
Dura Mater , Spine , Cerebrospinal Fluid Leak/etiology , Cerebrospinal Fluid Leak/surgery , Dura Mater/surgery , Humans , Neurosurgical Procedures , Postoperative Complications
11.
World Neurosurg ; 159: e221-e231, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34954440

ABSTRACT

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.


Subject(s)
Hydrocephalus , Smartphone , Catheters , Cerebrospinal Fluid Shunts/methods , Humans , Hydrocephalus/surgery , Prospective Studies
12.
Neuroradiology ; 64(4): 745-752, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34825966

ABSTRACT

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.


Subject(s)
Hydrocephalus, Normal Pressure , Hydrocephalus , Humans , Hydrocephalus/diagnostic imaging , Hydrocephalus/surgery , Hydrocephalus, Normal Pressure/diagnostic imaging , Hydrocephalus, Normal Pressure/surgery , Reoperation/adverse effects , Retrospective Studies , Treatment Outcome , Ventriculoperitoneal Shunt/adverse effects
13.
PLoS One ; 16(11): e0260560, 2021.
Article in English | MEDLINE | ID: mdl-34843559

ABSTRACT

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).


Subject(s)
Deep Learning , Intracranial Hemorrhages/diagnostic imaging , Tomography, X-Ray Computed , Aged , Aged, 80 and over , Algorithms , Diagnosis, Computer-Assisted/methods , Female , Humans , Intracranial Hemorrhages/diagnosis , Male , Middle Aged , Retrospective Studies , Tomography, X-Ray Computed/methods
14.
Acta Neurochir (Wien) ; 163(10): 2641-2672, 2021 10.
Article in English | MEDLINE | ID: mdl-34235589

ABSTRACT

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.


Subject(s)
Hydrocephalus, Normal Pressure , Cerebrospinal Fluid Shunts , Diagnostic Tests, Routine , Drainage , Humans , Hydrocephalus, Normal Pressure/diagnosis , Hydrocephalus, Normal Pressure/surgery , Monitoring, Physiologic
15.
BMJ Open ; 11(6): e045771, 2021 06 04.
Article in English | MEDLINE | ID: mdl-34088707

ABSTRACT

OBJECTIVES: Since 2000/2001, no large-scale prospective studies addressing traumatic brain injury (TBI) epidemiology in Germany have been published. Our aim was to look for a possible shift in TBI epidemiology described in other European countries, to look for possible changes in TBI management and to identify predictors of 1-year outcome especially in patients with mild TBI. DESIGN: Observational cohort study. SETTING: All patients suffering from a TBI of any degree between 1 October 2014 and 30 September 2015, and who arrived in one of the seven participating BG hospitals within 24 hours after trauma, were included. PARTICIPANTS: In total, 3514 patients were included. OUTCOME MEASURES: Initial care, acute hospital care and rehabilitation were documented using standardised documentation forms. A standardised telephone interview was conducted 3 and 12 months after TBI in order to obtain information on outcome. RESULTS: Peaks were identified in males in the early 20s and mid-50s, and in both sexes in the late 70s, with 25% of all patients aged 75 or older. A fall was the most frequent cause of TBI, followed by traffic accidents (especially bicyclists). The number of head CT scans increased, and the number of conventional X-rays of the skull decreased compared with 2000/2001. Besides, more patients were offered rehabilitation than before. Though most TBI were classified as mild, one-third of the patients participating in the telephone interview after 12 months still reported troubles attributed to TBI. Negative predictors in mild TBI were female gender, intracranial bleeding and Glasgow Coma Scale (GCS) 13/14. CONCLUSION: The observed epidemiologic shift in TBI (ie, elderly patients, more falls, more bicyclists) calls for targeted preventive measures. The heterogeneity behind the diagnosis 'mild TBI' emphasises the need for defining subgroups not only based on GCS.


Subject(s)
Brain Injuries, Traumatic , Aged , Brain Injuries, Traumatic/epidemiology , Brain Injuries, Traumatic/therapy , Cohort Studies , Europe , Female , Germany/epidemiology , Glasgow Coma Scale , Hospitals , Humans , Male , Prospective Studies , Treatment Outcome
16.
J Health Monit ; 6(3): 66-79, 2021 Sep.
Article in English | MEDLINE | ID: mdl-35146317

ABSTRACT

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.

17.
Expert Rev Med Devices ; 17(11): 1155-1168, 2020 Nov.
Article in English | MEDLINE | ID: mdl-33176494

ABSTRACT

INTRODUCTION: In hydrocephalus treatment, ventriculo-peritoneal shunts (VPS) have become the most relevant therapy for seven decades among other treatment options. Due to the hydrostatic pressure in vertical position, CSF diversion is somehow non-physiological. The integration of gravitational valves in VPS was established to counteract the hydrostatic draining force and to approach a physiological condition of the cerebrospinal diverting system. Numerous clinical studies have shown that gravitational valves are able to reduce secondary complications of VPS treatment. It remains a challenge for the treating neurosurgeon to select the correct valve resistance based on individual anatomies and different etiologies of hydrocephalus as well as varying levels of activity of the patient. AREAS COVERED: This review covers the development of gravitational shunt valves from historical, theoretical and clinical aspects for pediatric and adult etiologies of hydrocephalus. We discuss the role of gravitational shunt valves in preventing over-drainage issues and present the state-of-the-art literature. Furthermore, ongoing prospective trials are presented. EXPERT OPINION: Counteracting the hydrostatic force by selecting the correct valve in a VPS system to achieve physiological balance in CSF diversion during vertical and horizontal body changes has become the current standard for hydrocephalus management. Gravitational shunt valves reliably address this need to minimize over-drainage events in the vertical position without affecting the CSF flow in the horizontal position. The results of ongoing prospective studies on the safety and efficacy of adjustable gravitational valves are still pending. Due to the complexity of the CSF flow, lifelong follow-up care for patients with VPS is critical.


Subject(s)
Cerebrospinal Fluid Shunts , Drainage , Gravitation , Hydrocephalus/surgery , Clinical Trials as Topic , Humans , Hydrocephalus/complications
18.
JMIR Form Res ; 4(4): e14747, 2020 Apr 15.
Article in English | MEDLINE | ID: mdl-32305950

ABSTRACT

BACKGROUND: Germany is a popular destination for immigrants, and migration has increased in recent years. It is therefore important to collect reliable data on migrants' health. The Robert Koch Institute, Berlin, Germany, has launched the Improving Health Monitoring in Migrant Populations (IMIRA) project to sustainably integrate migrant populations into health monitoring in Germany. OBJECTIVE: One of IMIRA's objectives is to implement a feasibility study (the IMIRA survey) that focuses on testing various interventions to increase the reachability of migrants with health interview surveys. Possible causes of nonresponse should be identified so as to increase participation in future surveys. METHODS: The survey target populations were Turkish, Polish, Romanian, Syrian, and Croatian migrants, who represent the biggest migrant groups living in Germany. We used probability sampling, using data from the registration offices in 2 states (Berlin and Brandenburg); we randomly selected 9068 persons by nationality in 7 sample points. We applied age (3 categories: 18-44, 45-64, and ≥65 years) and sex strata. Modes and methods used to test their usability were culturally sensitive materials, online questionnaires, telephone interviews, personal contact, and personal interviews, using multilingual materials and interviewers. To evaluate the effectiveness of the interventions, we used an intervention group (group A) and a control group (group B). There were also focus groups with the interviewers to get more information about the participants' motivation. We used the European Health Interview Survey, with additional instruments on religious affiliation, experience of discrimination, and subjective social status. We evaluated results according to their final contact result (disposition code). RESULTS: We collected data from January to May 2018 in Berlin and Brandenburg, Germany. The survey had an overall response rate of 15.88% (1190/7494). However, final disposition codes varied greatly with regard to citizenship. In addition to the quantitative results, interviewers reported in the focus groups a "feeling of connectedness" to the participants due to the multilingual interventions. The interviewers were particularly positive about the home visits, because "if you are standing at the front door, you will be let in for sure." CONCLUSIONS: The IMIRA survey appraised the usability of mixed-mode or mixed-method approaches among migrant groups with a probability sample in 2 German states. When conducting the survey, we were confronted with issues regarding the translation of the questionnaire, as well as the validity of some instruments in the survey languages. A major result was that personal face-to-face contact was the most effective intervention to recruit our participants. We will implement the findings in the upcoming health monitoring study at the Robert Koch Institute.

19.
JMIR Form Res ; 4(2): e14747, 2020 Feb 24.
Article in English | MEDLINE | ID: mdl-32293576

ABSTRACT

BACKGROUND: Germany is a popular destination for immigrants, and migration has increased in recent years. It is therefore important to collect reliable data on migrants' health. The Robert Koch Institute, Berlin, Germany, has launched the Improving Health Monitoring in Migrant Populations (IMIRA) project to sustainably integrate migrant populations into health monitoring in Germany. OBJECTIVE: One of IMIRA's objectives is to implement a feasibility study (the IMIRA survey) that focuses on testing various interventions to increase the reachability of migrants with health interview surveys. Possible causes of nonresponse should be identified so as to increase participation in future surveys. METHODS: The survey target populations were Turkish, Polish, Romanian, Syrian, and Croatian migrants, who represent the biggest migrant groups living in Germany. We used probability sampling, using data from the registration offices in 2 states (Berlin and Brandenburg); we randomly selected 9068 persons by nationality in 7 sample points. We applied age (3 categories: 18-44, 45-64, and ≥65 years) and sex strata. Modes and methods used to test their usability were culturally sensitive materials, online questionnaires, telephone interviews, personal contact, and personal interviews, using multilingual materials and interviewers. To evaluate the effectiveness of the interventions, we used an intervention group (group A) and a control group (group B). There were also focus groups with the interviewers to get more information about the participants' motivation. We used the European Health Interview Survey, with additional instruments on religious affiliation, experience of discrimination, and subjective social status. We evaluated results according to their final contact result (disposition code). RESULTS: We collected data from January to May 2018 in Berlin and Brandenburg, Germany. The survey had an overall response rate of 15.88% (1190/7494). However, final disposition codes varied greatly with regard to citizenship. In addition to the quantitative results, interviewers reported in the focus groups a "feeling of connectedness" to the participants due to the multilingual interventions. The interviewers were particularly positive about the home visits, because "if you are standing at the front door, you will be let in for sure." CONCLUSIONS: The IMIRA survey appraised the usability of mixed-mode or mixed-method approaches among migrant groups with a probability sample in 2 German states. When conducting the survey, we were confronted with issues regarding the translation of the questionnaire, as well as the validity of some instruments in the survey languages. A major result was that personal face-to-face contact was the most effective intervention to recruit our participants. We will implement the findings in the upcoming health monitoring study at the Robert Koch Institute.

20.
Fluids Barriers CNS ; 17(1): 18, 2020 Mar 04.
Article in English | MEDLINE | ID: mdl-32127017

ABSTRACT

BACKGROUND: After ventriculoperitoneal shunt surgery for idiopathic normal pressure hydrocephalus (iNPH) with adjustable gravitational valves, a certain proportion of patients develop secondary clinical worsening after initial improvement of clinical symptoms. The aim of this study was to analyze this group of patients with secondary deterioration and to evaluate the performed shunt management. METHODS: For this investigation, we retrospectively reviewed our NPH registry for patients included between 1999 and 2013 with a decrease by a minimum of two points in the Kiefer score in the first year of follow up and an increase of two points in the Kiefer score between the second and the fifth year after shunt surgery (secondary deterioration). Then, we analyzed the patient's shunt management (adapting the valve pressure setting, shuntography, valve replacement, catheter replacement, implant an adjustable gravitational unit). Additionally, we searched for risk factors for secondary deterioration. RESULTS: Out of 259 iNPH patients, 53 (20%) patients showed secondary deterioration on an average of 2.7 (2-4 years) years after shunt surgery. Fourteen (26%) patients with secondary deterioration improved after shunt or valve management and 58% remained without clinical benefit after management. We had a drop-out rate of 15% due to incomplete datasets. Our shunt management reduced the rate of secondary deterioration from 20 to 15%. On the basis of our findings, we developed an algorithm for shunt management. Risk factors for secondary deterioration are the age of the patient at the time of shunting, newly diagnosed neurodegenerative diseases, and overdrainage requiring adjusting the valve to higher-pressure levels. CONCLUSION: Twenty percent of patients with iNPH were at risk for secondary clinical worsening about 3 years after shunt surgery. About one-fourth of these patients benefited for additional years from pressure level management and/or shunt valve revision. Our findings underline the need for long-term follow-ups and intensive shunt management to achieve a favorable long-term outcome for patients with iNPH and VPS.


Subject(s)
Hydrocephalus, Normal Pressure/physiopathology , Hydrocephalus, Normal Pressure/surgery , Neurodegenerative Diseases/complications , Registries , Ventriculoperitoneal Shunt/adverse effects , Aged , Aged, 80 and over , Algorithms , Female , Follow-Up Studies , Humans , Hydrocephalus, Normal Pressure/etiology , Male , Middle Aged , Retrospective Studies , Risk Factors , Symptom Flare Up
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