Early shunting using the parallel shunt system in hemorrhagic hydrocephalus: in vitro testing of handling, technical complications and clogging rate.

In order to minimize the duration of external cerebrospinal fluid (CSF) drainage after hemorrhagic hydrocephalus we are testing a parallel shunt system that can be implanted very early after bleeding. It should be able to tolerate a high load of protein and blood in the CSF. After clearance of the CSF, the valveless arm of the shunt is closed by a percutaneous manipulation and the valve-arm is opened.

Outcome of patients with severe head injury after decompressive craniectomy.

Decompressive craniectomy is an operative option for the neurosurgeon in cases of generalized traumatic brain edema. While the outcome of patients after decompressive craniectomy is often poor, we tried to identify predictors of a favorable course of the injury. Therefore, 131 patients who received a decompressive craniectomy at the Unfallkrankenhaus Berlin (ukb) between September 1997 and September 2005 due to severe traumatic brain injury were followed up. Overall outcome was measured using the Glasgow Outcome Scale (GOS). Sixty-three patients (48%) died during their initial hospital stay and another 27 (21%) were discharged in a vegetative state (GOS 2). Thirty-two patients (24%) were discharged with severe disability, while another nine (7%) had moderate disability at discharge. At an average of 49 months after surgery, 75 patients (68%) were either dead or in a vegetative state (GOS 1 and 2). The results stress again that the prognosis after traumatic brain injury (TBI) with decompressive craniectomy (DC) is unfavorable. Age, midline shift, and status of the basal cisterns on cranial computed tomography (cCT) were associated with the long-term outcome. When weighing whether to initiate the last resort intervention of decompressive craniectomy, the predictive factors detailed here should be taken into consideration.

Is it possible to minimize overdrainage complications with gravitational units in patients with idiopathic normal pressure hydrocephalus? Protocol of the randomized controlled SVASONA Trial (ISRCTN51046698).

Overdrainage is a common complication observed after shunting patients with idiopathic normal-pressure hydrocephalus (iNPH), with an estimated incidence up to 25%. Gravitational units that counterbalance intracranial pressure changes were developed to overcome this problem. We will set out to investigate whether the combination of a programmable valve and a gravitational unit (proGAV, Aesculap/Miethke, Germany) is capable of reducing the incidence of overdrainage and improving patient-centered outcomes compared to a conventional programmable valve (Medos-Codman, Johnson & Johnson, Germany). SVASONA is a pragmatic randomized controlled trial conducted at seven centers in Germany. Patients with a high probability of iNPH (based on clinical signs and symptoms, lumbar infusion and/or tap test, cranial computed tomography [CCT]) and no contraindications for surgical drainage will randomly be assigned to receive (1) a shunt assistant valve (proGAV) or (2) a conventional, programmable shunt valve (programmable Medos-Codman).We will test the primary hypothesis that the experimental device reduces the rate of overdrainage from 25% to 10%. As secondary analyses, we will measure iNPH-specific outcomes (i.e., the Black grading scale and the NPH Recovery Rate), generic quality of life (Short Form 36), and complications and serious adverse events (SAE). One planned interim analysis for safety and efficacy will be performed halfway through the study. To detect the hypothesized 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 dropout rate of 10%, 200 patients will be enrolled.The presented trial is currently recruiting patients, with the first results predicted to be available in late 2008.

Minimally invasive spinal surgery using nucleoplasty and the Dekompressor tool: a comparison of two methods in a one year follow-up.

OBJECT: The Disc Dekompressor and Nucleoplasty are 2 different, minimally invasive, percutaneous methods in the therapy for chronic discogenic low back pain. The aim of this study is to compare the effectiveness of both methods concerning the outcome one year after surgery. METHODS: We included patients with MRI-proven disc protrusion suffering from low back pain and/or radiating pain in the lower extremities. The pain perception of the patients was documented using the visual analogue pain scale (VAS). Furthermore, the patients were queried about analgesic consumption, disability in daily life and ability to work. Percutaneous minimally invasive nucleotomy using the Nucleoplasty or the Disc Dekompressor was carried out under fluoroscopic and CT-guidance. We carried out a follow-up examination at 6 and 12 months after the operation. RESULTS: From April 2005 to November 2007 a total of 126 patients underwent percutaneous minimally invasive nucleotomy using Nucleoplasty (April 2005 - December 2006) or the Disk Dekompressor (February 2006 - November 2007) and were followed up after 6 and 12 months. In the Nucleoplasty group the mean age of the 27 females (39%) and 42 males (61%) was 42 years (range: 18-74). In the Disc Dekompressor group the mean age of the 22 females (39%) and 35 males (61%) was 44 years (range: 16-76). The mean duration of symptoms in the Nucleoplasty group was 30.5 months (range: 1-120), and in the Disc Dekompressor group 16.3 months (range: 1-72). Statistically significant postoperative improvement concerning the VAS score was evident in both groups. Whereas the VAS score slightly increased in the Nucleoplasty group comparing the early postoperative score and the score after 12 months, the VAS score stayed on a low level in the Disc Dekompressor group. A statistically significant reduction in analgesic consumption, disability and occupational incapacitation was observed in the Nuceloplasty group and the Disc Dekompressor group. CONCLUSIONS: Both Nucleoplasty and Disc Dekompressor are effective therapies for chronic, discogenic back pain. Regardless of the different mechanism no significant differences in the outcomes were found. Both techniques result in significant reductions in levels of disability and incapacity for work as well as decreased analgesic consumption.

Comparative investigation of different telemetric methods for measuring intracranial pressure: a prospective pilot study.

OBJECTIVES: Measurement of intracranial pressure (ICP) plays an important role in long-term monitoring and neuro-intensive treatment of patients with a cerebral shunt. Currently, only two complete telemetric implants with different technical features are available worldwide. This prospective pilot study aims to examine patients who had both probes implanted at overlapping times for clinical reasons and represents the first in vivo comparison of both measurement methods. MATERIALS AND METHODS: Patients with a primary subarachnoid hemorrhage or a spontaneous intracerebral hemorrhage with ventricular hemorrhage who had received a telemetric ICP probe (Raumedic® NEUROVENT®-P-tel) were included in the study. Conventional external ventricular drainages (EVD) and ventriculoperitoneal shunts with a telemetric ICP probe (Miethke Sensor Reservoir) were implanted in patients with hydrocephalus who required CSF (cerebrospinal fluid) drainage. Absolute ICP values from all systems were obtained. Due to the overlapping implantation time, parallel ICP measurements were performed via two devices simultaneously. ICP measurements via the sensor reservoir were repeated after 3 and 9 months. Differences between the absolute ICP values measured via the NEUROVENT®-P-tel probe, the Miethke sensor reservoir®, and the EVD were analyzed. RESULTS: Seventeen patients were included in the present study between 2016 and 2018. 63% of all patients were male. In 11 patients the ICP measurements were followed up with both devices for 3 months. ICP measurements of the sensor reservoir showed corresponding trends in 9 cases compared to ICP measurement via the telemetry probe or EVD. Difference in absolute ICP values ranged between 14.5 mmHg and 0.0 mmHg. The average difference of the absolute ICP values in 8 cases was ≤ 3.5 mmHg. CONCLUSION: ICP measurements with both systems continuously showed synchronous absolute ICP values, however absolute values of ICP measurement with the different systems did not match.

The clinical application of a new absorbable fixation clamp in craniotomy closure. A technical note after first experiences with 29 patients.

BACKGROUND: Several efforts have been made to provide safe and convenient systems for craniotomy closure. In the past, the only alternative to suture fixation was metal implants. In order to afford a bone flap fixation without leaving durable implants an absorbable fixation system has been developed by Aesculap. METHODS: In a prospective clinical evaluation we analysed intraoperative handling, position of the bone flap and stability of the connection. The planarity of the bone flaps were analysed in CT-scans on average 2 days after operation. RESULTS: Between September 2006 and October 2007 we performed craniotomy closures with the absorbable craniofix system in 29 patients. The intraoperative handling is easy when using up to 3 craniofix clamps. To ensure stability, 3 or in some cases 2, clamps are needed. Smaller bone flaps with an equal thickness of the bone tend to show a better position in the CT. We observed no complications. CONCLUSIONS: The absorbable fixation clamp is safe and convenient in small craniotomies which are properly fixed with 3 clamps. More than 3 clamps are unwieldly to use.

The influence of co-morbidity on the postoperative outcomes of patients with idiopathic normal pressure hydrocephalus (iNPH).

BACKGROUND: A critical question in the diagnosis and treatment of idiopathic normal pressure hydrocephalus (iNPH) is that of which preoperative factors can most reliably predict outcomes following shunt insertion. The number and type of co-morbidities are increasingly being viewed as important predictive indicators. METHODS: Between 1997 and 2004, 95 patients were implanted with a gravitational ventriculo-peritoneal shunt as treatment for iNPH. All coincident disease processes were recorded. Eighty-two of these patients underwent follow-up 2 years postoperatively. The results of this prospective follow-up examination (Kiefer Score, NPH Recovery Rate) were compared with the preoperative CoMorbidity Index (CMI). FINDINGS: Of the patients with a CMI score of 0-1 (n = 18), 67% experienced an excellent outcome, 28% a good outcome and 5% and 0% a fair and poor outcome respectively. A CMI score of 2-3 was associated with markedly poorer outcomes (n = 33); 42% excellent, 30% good, 18% fair and 10% poor. A score of 4-5 was related to 14% excellent, 27% good, 23% fair and 36% poor outcomes (n = 22). Remarkably few patients scoring between 6 and 8 on the CMI scale experienced a favourable outcome. The outcomes for this latter group were 0% excellent, 10% good, 45% fair and 45% poor (n = 9) significant predictor of the quality of clinical outcome for patients with iNPH undergoing shunt therapy.

Course of disease in patients with idiopathic normal pressure hydrocephalus (iNPH): a follow-up study 3, 4 and 5 years following shunt implantation.

BACKGROUND: In spite of recent advances in the diagnosis and treatment of iNPH, favorable outcomes following CSF diversion continue to be limited by complications, both valve dependent and valve independent, as well as by a reduction, over time, in the response to shunting. MATERIALS AND METHODS: Between September 1997 and December 2006, 148 patients underwent ventriculo-peritoneal shunt surgery in our department. All patients underwent the implantation of gravitational valves. These patients were followed-up 3, 6 and 12 months after surgery and then at annual intervals. FINDINGS: The mean age of the 94 men and 54 women in our study was 68 years. The perioperative mortality was 0.7% (one patient died from a pulmonary embolism). A further 23 patients died during the follow-up period from causes unrelated to iNPH or the surgery. This study reports on groups of patients followed-up for 2 years (n = 92), 3 years (n = 62), 4 years (n = 38) and 5 years (n = 21) postoperatively. Valve independent complications occurred postoperatively in 6% of patients (n = 10). Of these, five patients (3% of the total) had an infection and catheter displacement was recorded in a further five. Valve dependent complications occurred in 24 patients (16%), with overdrainage found in seven patients (5%) and underdrainage apparent in 17 (11%). Responder rates were 79% at 2 years, 79% at 3 years, 64% at 4 years and 60% at 5 years. The optimal valve opening pressure in programmable valves with a gravitational unit was between 30 and 70 mmHg. CONCLUSIONS: Sixty percent of patients with iNPH who underwent a ventriculo-peritoneal shunt using a gravitational valve continue to benefit from surgery 5 years postoperatively.

Long-term outcomes following decompressive craniectomy for severe head injury.

BACKGROUND: Severe head injury is one of the commonest indications for neurosurgical intervention. For the neurosurgeon, the operative last resort in cases of generalised brain oedema of traumatic origin is the decompressive craniectomy. Is it possible to use predictive factors to ascertain what degree of success, in terms of both the acute and long-term outcome, is to be expected in patients who undergo this treatment? METHODS: The clinical records of 131 patients treated with decompressive craniectomy for severe head injury were evaluated. All patients were operated on between September 1997 and September 2005 in the neurosurgical department of the Unfallkrankenhaus Berlin. A follow-up examination was carried out 49 +/- 25 months after the initial trauma. The clinical outcome was compared with several patient and radiographic factors to establish if any of these showed a relationship to the long-term outcome. FINDINGS: A significant relationship was demonstrated between quality of outcome and the Glasgow Coma Scale score on admission. Quality of outcome was similarly related to the age of the patient, the condition of the basal cisterns and the degree of midline shift in the initial cranial computed tomography. Factors which correlated with poor outcome included pupil reactivity on admission, established clotting disorders and posttraumatic hydrocephalus internus. Hyperglycaemia and initial acidosis were also associated with a poor outcome. CONCLUSIONS: The clinical outcome in patients with a severe head injury is to a great degree determined by the extent and type of the primary injury. When considering decompressive hemicraniectomy as a treatment for raised intracranial pressure following traumatic brain injury, the predictive factors detailed here should be taken into consideration.

The role of cerebrospinal fluid flow study using phase contrast MR imaging in diagnosing idiopathic normal pressure hydrocephalus.

BACKGROUND: The purpose of this prospective study was to identify the ability of cerebrospinal fluid flow study using phase contrast MR imaging to replace the invasive methods currently used to establish the diagnosis of idiopathic normal pressure hydrocephalus (iNPH). MATERIALS AND METHODS: Between January 2003 and April 2005, 61 patients with clinical symptoms fitting the Hakim triad and a dilated ventricular system on CT underwent a intrathecal infusion test and cerebrospinal tap test. All patients also had a phase contrast MRI to determine the CSF flow rate in the aqueduct. Shunted patients were followed postoperatively up to 12 months. The pre- and postoperative symptomatic condition was evaluated using the clinical Kiefer score. The outcome was calculated by the NPH Recovery Rate. FINDINGS: Patients were classified into 41 with iNPH and 20 patients with brain atrophy. Thirty-nine iNPH patients were shunted and two patients refused surgery. The mean Kiefer score of the shunted patients was statistically significantly lower after surgery. In patients screened for clinical symptoms and ventriculomegaly on CT imaging, an aqueduct-CSF flow rate greater than 24.5 ml/min was found to be statistically specific for a diagnosis of iNPH. CONCLUSIONS: The measurement of the CSF flow rate in the aqueduct by using the phase contrast MRI technique is a highly specific pre-selective method for diagnosing iNPH.

First clinical experiences in patients with idiopathic normal-pressure hydrocephalus with the adjustable gravity valve manufactured by Aesculap (proGAV(Aesculap)).

OBJECTIVE: Improved clinical outcomes after implantation of a low pressure valve in patients with idiopathic normal-pressure hydrocephalus is usually achieved at the expense of a higher overdrainage rate. Can an adjustable valve with a gravitational unit provide optimal results? METHOD: In a prospective clinical outcome study conducted in the Unfallkrankenhaus Berlin, 30 patients with idiopathic normal-pressure hydrocephalus were treated surgically between June 2004 and May 2005 with the valve combination described above, and reexamination 3 months or 6 months postoperatively. RESULTS: Clinical outcome correlates with opening pressure level of the valve. Controlled adjustment of the valve from 100 mmH2O to 70 mmH2O, and then to 50 mmH2O after 3 months, permits optimum adaptation of the brain to the implanted valve without overdrainage complications. CONCLUSIONS: Advantages of this programmable gravity valve include: 1) the absence of unintentional readjustment through external magnets, and 2) the possibility of controlling the valve setting using an accessory instrument without the need for x-ray monitoring. A significant disadvantage is adjusting the valve after implantation. From the clinical point of view, this new "proGAV(Aesculap)" valve is a necessary development in the right direction, but at the moment it is still beset with technical problems.

Clinical outcome of patients with idiopathic normal pressure hydrocephalus three years after shunt implantation.

OBJECTIVE: To investigate the outcomes of surgical treatment of idiopathic normal pressure hydrocephalus (iNPH). PATIENTS AND METHODS: We prospectively investigated 51 patients treated for iNPH by insertion of a ventriculoperitoneal shunt with gravitational valve. RESULTS: The proportion of excellent, good, and satisfactory outcomes immediately following surgery was 80%; the same clinical outcome was later verified in 67% of patients on average of 34 months postoperatively. These results are similar to those reported in the literature. Ventricle volume decreased minimally during the course of treatment using Evans' index, which was concordant with recent literature and with current understanding of hydrocephalus treatment. CONCLUSIONS: A gravitational valve for treatment of iNPH is the logical implementation of current knowledge of the pathophysiology of this illness enabling us to solve the problem of cerebrospinal fluid drainage with the lowest possible opening pressure while simultaneously protecting from overdrainage. The use of programmable valves, in combination with a gravitational component, is the next evolutionary stage, potentially making revision operations unnecessary.

Is it possible to optimize treatment of patients with idiopathic normal pressure hydrocephalus by implanting an adjustable Medos Hakim valve in combination with a Miethke shunt assistant?

A better course of the disease after implantation of a low-pressure valve in patients with idiopathic normal pressure hydrocephalus normally comes at the cost of a distinctly higher rate of overdrainage. Can combining an adjustable valve with a gravity unit produce optimization of treatment results? In a prospective observation of the course of the disease, 18 patients with idiopathic normal pressure hydrocephalus were surgically treated with the aforementioned valve combination during the period January to June 2004 at the Unfallkrankenhaus Berlin and examined after 6 and 12 months. The course of the disease correlates with the opening pressure level of the valve. The controlled setting of the valve from 100 mmH2O to 70 mmH2O, then to 50 mmH2O after 3 months permits the brain to adapt optimally to the implanted valve without complications from overdrainage. In our view, combining an adjustable differential pressure valve with a gravity unit currently represents the optimal treatment variant for patients with idiopathic normal pressure hydrocephalus. In the future, the gravity valve should also be adjustable.

Predictors of outcome in patients with normal-pressure hydrocephalus.

From 1982 until 2000 we examined 200 patients diagnosed with normal-pressure hydrocephalus (NPH) in a prospective study. From the patients who were surgically treated by a shunt implantation we could re-examine 155 (78%) at a mean time interval of 7 months after the operation. NPH differed in severity according to the results of the intrathecal infusion test in an early state NPH (without brain atrophy) and late state NPH (with brain atrophy). In our study, we focused on the possible predictors: patient age; length of disease; clinical signs including gait ataxia, dementia, and bladder incontinence; idiopathic vs. secondary origin; implanted valve type and the resistance of the valve to cerebrospinal fluid outflow. In 80 patients without cerebral atrophy and a short course of disease (< 1 year), a slight amount of dementia and an implanted Miethke Dualswitch-Valve were significant predictors for a positive postoperative outcome. The outflow resistance measured in the intrathecal infusion test showed only minimal relevance for outcome. Seventy-five patients with cerebral atrophy had a better outcome when dementia was not present, outflow resistance was above 20 mmHg/mL/min, the CSF tap-test was positive, and a Miethke Dualswitch-Valve was implanted.

On the optimal opening pressure of hydrostatic valves in cases of idiopathic normal-pressure hydrocephalus: a prospective randomized study with 123 patients.

Does the opening pressure of hydrostatic shunts influence the clinical outcome for patients suffering from idiopathic normal-pressure hydrocephalus (NPH)? Between September 1997 and January 2003, 123 patients with idiopathic NPH were surgically treated by implanting a hydrostatic shunt at the Departments of Neurosurgery of the Unfallkrankenhaus Berlin and the University Homburg/Saar. As part of a prospective randomized study, all patients were examined preoperatively, postoperatively, and 1 year after the intervention. Forty-three percent of the patients showed a very good outcome, 25% good outcome, 20% fair outcome, and 12% poor outcome 1 year after the shunt implantation. Patients treated with an opening pressure rating of 50 mmH2O in the low-pressure stage of the gravitational valve showed a better outcome than those with an opening pressure of 100 or 130 mmH2O. According to present knowledge, hydrostatic shunts with an opening pressure of 50 mmH2O for the low-pressure stage are the best option for patients with idiopathic NPH. Due to the prompt switching function when the patient changes posture (lying down, standing, sitting, slanting etc.), the Miethke gravity-assisted valve (GAV) is more suitable in such cases than the Miethke Dual-Switch valve (DSV).

Decompressive craniectomy for severe head injury in patients with major extracranial injuries.

Neurosurgical therapy aims to minimize secondary brain damage after a severe head injury. This includes the evacuation of intracranial space-occupying hematomas, the reduction of intracranial volumes, external ventricular drainage, and aggressive therapy in order to influence increased intracranial pressure (ICP) and decreased P(ti)O2. When conservative treatment fails, a decompressive craniectomy might be successful in lowering ICP. From September 1997 until December 2004, we operated on 836 patients with severe head injuries, of whom 117 patients (14%) were treated by means of a decompressive craniectomy. The prognosis after decompression depends on the clinical signs and symptoms at admission, patient age, and the existence of major extracranial injuries. Our guidelines for decompressive craniectomy after failure of conservative interventions and evacuation of space-occupying hematomas include: patient age below 50 years without multiple trauma, patient age below 30 years in the presence of major extracranial injuries, severe brain swelling on CT scan, exclusion of a primary brainstem lesion or injury, and intervention before irreversible brain stem damage.

Improved outcome in shunted iNPH with a combination of a Codman Hakim programmable valve and an Aesculap-Miethke ShuntAssistant.

INTRODUCTION: Low pressure valves with ventriculoperitoneal shunts have been proven to lead to good outcomes in the treatment of idiopathic normal pressure hydrocephalus. However, overdrainage complications are often seen with low opening pressures. Efforts have been made to obtain good outcomes without overdrainage complications by decreasing the hydrostatic pressure component using special valve constructions. The aim of this study was to ascertain whether it is possible to optimise outcome with the implantation of both an adjustable valve and a gravitational unit. MATERIALS AND METHODS: Between July 2003 and July 2006, 42 patients underwent ventriculoperitoneal shunt surgery with a Codman Hakim programmable valve (Codman, Johnson & Johnson, Raynham, USA) and a Miethke ShuntAssistant (Miethke Gmbh, Potsdam, Germany). These patients were followed up for a period between 2 years (35 patients) and 4 years (18 patients) after surgery. RESULTS: The systematic re-programming of the valves from 100 mmH(2)O to 70 mmH(2)O and then to 50 mmH(2)O after 3 months allowed the brain to adapt to the implanted valve without the complication of overdrainage. The responder rates were 86% after two years and 83% after four years. Overdrainage was seen in 3% of the cases, mechanical complications occurred in 6%. CONCLUSION: Our results indicate that the combination of a Codman Hakim programmable valve with a Miethke ShuntAssistant could improve outcomes in shunted iNPH. This finding has yet to be proven in a larger, prospective randomized trial.

[PLIF and ALIF for the degenerative spondylolisthesis of the lumbar spine]. / PLIF und ALIF zur operativen Therapie der degenerativen lumbalen Instabilität.

AIM: The aim of this study is to compare the course of disease of patients with a degenerative instability of the lumbar spine after PLIF or ALIF. MATERIALS AND METHODS: Between October 1995 and January 2000 115 patients underwent a ventral or dorsal spondylodesis due to a degenerative instability in the Department of Neurosurgery of the Unfallkrankenhaus Berlin Hospital and in the Department of Neurosurgery of the Friedrichshain Hospital in Berlin. At an average of 25 (13-64) months after surgery these patients were followed up in a clinical examination and a questionnaire concerning their sense of pain and quality of life. RESULTS: Significant improvement after surgery has been shown in both groups. The recovery rate was 52 % which is a beneficial result. The fusion rate was 91 %. The postoperative sense of pain declined with regard to the visual pain scale. The intake of analgetics decreased in a quantitative as well as in a qualitative way. With 94 % the acceptance of the operation was comparatively high. The number of complications was low in comparison with the literature (4 %). There was no operative lethality. CONCLUSIONS: With regard to the indications and contraindications the PLIF as well as the ALIF is accepted unquestioningly as an up-to-date method.

[Outcome after cervical anterior fusion--a clinical study of 368 patients]. / Outcomes nach ventraler Spondylodese der Halswirbelsäule--eine klinische Untersuchung von 368 Patienten.

AIM: The object of this study was to identify those factors with a direct influence on the treatment outcome of anterior cervical fusion. The clinical relevance of intervertebral cage subsidence in the course of disease is discussed. MATERIAL AND METHODS: In a prospective clinical study we followed up 368 patients with degenerative disease of the cervical spine one year after anterior fusion and cage implantation. RESULTS: We found a statistically significant association between a good outcome and young adults with monosegmental fusion of the lower cervical spine. CONCLUSIONS: Early treatment of moderate degenerative cervical disc diseases using an intervertebral cage and anterior fusion leads to a good outcome. Subsidence of the cage does not correlate with a poor outcome.