An improved reservoir for the flushing test to diagnose shunt insufficiency.

OBJECTIVE Reservoirs integrated into hydrocephalus shunts are commonly used for the removal of CSF and for intra-ventricular pressure measurement. Pumping with the reservoir to diagnose shunt sufficiency is still a matter of controversy. The authors describe an improved flushing device and its characteristic features in vitro and in vivo. METHODS The flushing reservoir is constructed with a sapphire ball in a cage as a nonresistance valve to also enable the detection of distal occlusions. The most important reservoir parameters were investigated in vitro, simulating total and partial proximal and distal shunt occlusions. Then the expected advantages were assessed in vivo by evaluating the pump test data of 360 implanted reservoirs. The results were compared with those found in the literature. RESULTS The optimization of the technical parameters of the device, such as the high stroke volume in combination with moderate suction force, are obvious advantages compared with other flushing devices. Total occlusion of the ventricular catheter and the valve could be assessed with high certainty. The detection of a total obstruction of the peritoneal catheter or any partial obstruction is also possible, depending on its exact grade and location. CONCLUSIONS Shunt obstructions can be assessed using the pumping test. The reservoir construction presented here provides a clear enhancement of that diagnostic test.

Flow-related noise in patients with ventriculoperitoneal shunt using gravitational adjustable valves.

BACKGROUND: Noise disturbance arising from the valve is a rare event of ventriculoperitoneal shunts. We queried and investigated shunt patients for occurrence and evaluated the possible factors related to noise development. METHODS: Fifty ambulatory patients with implanted proGAV valve were investigated consecutively. Patients were asked for any noise arising from the shunt. In all cases, the valve was auscultated in sitting and upright position. The position of the gravitational unit (GU) was determined in respect to the Frankfurt horizontal plane (FHP) and in head reclination. Ten valves were perfused in vitro at different settings. One valve was opened for video documentation, and a frequency analysis of the noise was performed in nine valves. RESULTS: Eight percent (4/50) of the patients reported a noise arising from the valve only in upright position in combination with maximum head reclination, and immediately stopped when performing Vasalva's maneuver. In three out of four of these patients, the noise was also audible for the investigator (FS) with a prepared stethoscope. Patients complaining about a noise had a larger GU deviation from vertical during head reclination (median: -80 vs -43°, p = 0.0007, t-test). A deviations threshold of less than -58.4° excluding audible noise by a negative predictive value of 1 (95 % confidence interval [CI] 0.9 to 1.0). In an experimental setting, the noise came from vibrations of the ball in the cone of the adjustable unit and was restricted to a flow of at least 220 ml/h. The noise frequencies tended to be higher at higher opening pressures. CONCLUSIONS: Valve-related noise development may occur in patients with proGAV valves. This event could be prevented during shunt placement by avoiding posterior tilt of the gravitational unit, especially in patients with a good cervical mobility. The noise might indicate transient peak flows and was not associated with clinical or radiological signs of overdrainage.

The Frankfurt horizontal plane as a reference for the implantation of gravitational units: a series of 376 adult patients.

BACKGROUND: The in-line combination of adjustable differential pressure valves with fixed gravitational units is increasingly recommended in the literature. The spatial positioning of the gravitational unit is thereby decisive for the valve opening pressure. We aimed at providing data on factors contributing to primary overdrainage and underdrainage of cerebrospinal fluid (CSF), with special attention paid to the implantation angle of the gravitational unit. METHODS: Weretrospectively analyzed the postoperative course of 376 consecutive patients who received a ventriculoperitoneal shunt with a proGAV valve. The incidence of both primary CSF overdrainage and underdrainage was correlated with the implantation angle of the gravitational unit in regard to the Frankfurt horizontal plane and the patients' general parameters. RESULTS: Primary overdrainage was found in 41 (10.9 %) patients. Primary underdrainage was found in 113 (30.1 %) patients. A mean deviation of 10° (±7.8) for the gravitational unit in regard to the vertical line to the Frankfurt horizontal plane was found. In 95 % of the cases the deviation was less than 25°. No significant correlation between the implantation angle and the incidence of overdrainage or underdrainage of CSF was found. The patients' age and having single hydrocephalus entities were identified as factors significantly predisposing patients to overdrainage or underdrainage. CONCLUSION: The implantation of the gravitational unit of the proGAV valve within a range of at least 10° in regard to the vertical line to the Frankfurt horizontal plane does not seem to predispose patients to primary overdrainage or underdrainage in ventriculoperitoneal shunting. The plane may serve as a useful reference for the surgeon's orientation.

Large-scale referencing of the telemetric neurovent-P-tel intracranial pressure sensor in a porcine model.

The Neurovent-P-tel sensor is a promising device for telemetric intracranial pressure (ICP) measurements in cases of complex hydrocephalus. Data on its accuracy within a broad ICP range are missing. We applied a porcine model for large-scale manipulation of the ICP values. The telemetric ICP sensor was referenced against ICP values measured directly from a water column within a riser tube. A total of 34 comparative ICP measurements within an ICP range from 2 cm H2O to 31 mm Hg were performed. The mean difference between both measurement techniques was 0.4 mm Hg. The limits of agreement, where 95% of differences between both methods are expected, were from -2.4 to 3.1 mm Hg. The telemetric Neurovent-P-tel sensor system provides good accuracy within a broad range exceeding normal ICP values and might be useful in clinical practice.

Alteration of brain viscoelasticity after shunt treatment in normal pressure hydrocephalus.

INTRODUCTION: Normal pressure hydrocephalus (NPH) represents a chronic neurological disorder with increasing incidence. The symptoms of NPH may be relieved by surgically implanting a ventriculoperitoneal shunt to drain excess cerebrospinal fluid. However, the pathogenesis of NPH is not yet fully elucidated, and the clinical response of shunt treatment is hard to predict. According to current theories of NPH, altered mechanical properties of brain tissue seem to play an important role. Magnetic resonance elastography (MRE) is a unique method for measuring in vivo brain mechanics. METHODS: In this study cerebral MRE was applied to test the viscoelastic properties of the brain in 20 patients with primary (N = 14) and secondary (N = 6) NPH prior and after (91 ± 16 days) shunt placement. Viscoelastic parameters were derived from the complex modulus according to the rheological springpot model. This model provided two independent parameters µ and α, related to the inherent rigidity and topology of the mechanical network of brain tissue. RESULTS: The viscoelastic parameters µ and α were found to be decreased with -25% and -10%, respectively, compared to age-matched controls (P < 0.001). Interestingly, α increased after shunt placement (P < 0.001) to almost normal values whereas µ remained symptomatically low. CONCLUSION: The results indicate the fundamental role of altered viscoelastic properties of brain tissue during disease progression and tissue repair in NPH. Clinical improvement in NPH is associated with an increasing complexity of the mechanical network whose inherent strength, however, remains degraded.

Diffusion tensor imaging in hydrocephalus--findings before and after shunt surgery.

BACKGROUND: To evaluate changes in diffusion tensor imaging (DTI)-derived parameters in patients with hydrocephalus (HC) before and several weeks after shunt surgery. METHODS: Thirteen HC patients were examined with DTI before and after shunt surgery. In a combined region of interest and whole brain voxel-based analysis, different DTI parameters were compared with an age-matched control group. RESULTS: Alteration of DTI parameters in HC patients and changes after shunt surgery are regionally different. HC patients show an increase in fractional anisotropy values based on increases in parallel diffusivity in the corticospinal tract. On the other hand, reduced fractional anisotropy values are found in the corpus callosum of HC patients. Following shunt surgery, all DTI parameters showed a trend towards normalization, yet differences to healthy control subjects remained. CONCLUSION: Our results show that DTI parameter changes are regionally dependent and need a careful interpretation of the underlying diffusivities to serve as a diagnostic or follow-up measure in patients with hydrocephalus.

In vivo viscoelastic properties of the brain in normal pressure hydrocephalus.

Nearly half a century after the first report of normal pressure hydrocephalus (NPH), the pathophysiological cause of the disease still remains unclear. Several theories about the cause and development of NPH emphasize disease-related alterations of the mechanical properties of the brain. MR elastography (MRE) uniquely allows the measurement of viscoelastic constants of the living brain without intervention. In this study, 20 patients (mean age, 69.1 years; nine men, 11 women) with idiopathic (n = 15) and secondary (n = 5) NPH were examined by cerebral multifrequency MRE and compared with 25 healthy volunteers (mean age, 62.1 years; 10 men, 15 women). Viscoelastic constants related to the stiffness (µ) and micromechanical connectivity (α) of brain tissue were derived from the dynamics of storage and loss moduli within the experimentally achieved frequency range of 25-62.5 Hz. In patients with NPH, both storage and loss moduli decreased, corresponding to a softening of brain tissue of about 20% compared with healthy volunteers (p < 0.001). This loss of rigidity was accompanied by a decreasing α parameter (9%, p < 0.001), indicating an alteration in the microstructural connectivity of brain tissue during NPH. This disease-related decrease in viscoelastic constants was even more pronounced in the periventricular region of the brain. The results demonstrate distinct tissue degradation associated with NPH. Further studies are required to investigate the source of mechanical tissue damage as a potential cause of NPH-related ventricular expansions and clinical symptoms.

Arachnoid cysts of the middle cranial fossa accompanied by subdural effusions--experience with 60 consecutive cases.

BACKGROUND: Subdural effusions (SDEs) can complicate arachnoid cysts of the middle cranial fossa (ACMFs). While there is a consensus that at least in adults asymptomatic ACMFs should not be operated, those with concomitant subdural and/or intracystic effusions are clinically apparent in the majority of cases and should be surgically treated. But it remains unclear, which surgical procedure is best. METHODS: Since 1980, 60 out of 343 patients with an ACMF presented with accompanying SDEs. Four categories of SDEs were differentiated radiologically. This collective was controlled in a follow-up study up to 60 months after conservative or operative treatment by clinical and radiological means. RESULTS: In 54 of the 60 patients, we saw an indication for surgical treatment. Twenty-nine patients received a burr hole, 13 cases were treated by craniotomy, seven by endoscopical means, three patients underwent shunting and two combined procedures. Six patients were treated conservatively. An excellent final clinical outcome was observed in 55 cases. While craniotomy succeeded best to reduce the cyst volume in postoperative CT, the final clinical outcome did not differ significantly compared with burr hole trepanation. CONCLUSIONS: Patients with small effusions can be treated conservatively in selected cases. Based on our experience, we prefer a differentiated therapy. As first procedure, burr hole and subdural drainage were performed, leaving the cyst alone, seeming sufficient for the majority of cases. Craniotomy or endoscopical means should be reserved as treatment of choice for special cases, depending on category and acuteness of SDE and size/localisation of the ACMF.

Perforation holes in ventricular catheters--is less more?

OBJECTIVE: Obstruction is a common cause of cerebrospinal fluid (CSF) shunt failure. Risk factors for proximal obstructive malfunction are suboptimal ventricular catheter positioning and slit-like ventricles. A new ventricular catheter design to decrease risk of obstruction was evaluated. METHODS: A review of histopathological tissue investigation from occluded ventricular catheters (n = 70) was performed. A new ventricular catheter design was realized with six perforation holes. These catheters were compared to regular catheters (16 holes, Miethke, Aesculap) for flow characteristics using ink studies and flow velocity at hydrostatic pressure levels from 14 to 2 cmH(2)O in an experimental setup. The six-hole catheters were implanted in hydrocephalic patients with slit-like ventricles (n = 55). A follow-up was performed to evaluate the need of catheter revisions. RESULTS: Histological evaluation showed that obstructive tissue involved 43-60% extraventricular tissue, including gliosis, connective and inflammatory cells. In flow characteristic studies, the 16-hole catheters showed that only proximal perforations are of functional relevance. For six-hole catheters, all perforations were shown to be relevant with remaining reserve capacity. Flow velocity however showed no significant differences between six and 16 perforations. The six-hole catheter was implanted in 55 patients with a mean follow-up period of 15 +/- 9 months. A total of 12 catheters were explanted, revealing an overall survival proportion of 77.4%. CONCLUSION: In narrow ventricles, we assume that catheter perforations that are located also in the tissue might be a risk for CSF shunt obstruction. Fewer amounts of perforations in the catheters with equal flow features might decrease this risk when catheters can be implanted with adequate precision.

Evaluation of the Miethke dual- switch valve in patients with normal pressure hydrocephalus.

OBJECTIVE: Especially in patients with normal pressure hydrocephalus (NPH), conventional differential-pressure valves are known to create nonphysiological negative intraventricular pressure values (IVP) when the patient moves into the upright position, with the consequence of numerous, sometimes severe, complications. The recently presented gravitational devices promise improvement, primarily in respect to this disadvantage. METHODS: In a prospective multicenter study the new Miethke dual- switch valve (DSV) has been implanted in 128 patients with NPH. The patients have been assessed before operation, at discharge, and re-evaluated 6 to 9 months after surgery. The technical principle of the new device is presented. RESULTS: The clinical follow-up showed excellent results in 63% of the patients, satisfactory results in 16%, and a bad outcome in 21% of the cases. The infection rate was 5%; the rate of mechanical complications including overdrainage and dislocations has been in total 9%, and underdrainage was suspected in 7 cases. The outcome correlated with the preoperative severity of NPH. Despite the clinical outcome, the computed tomography scans showed only minimal or no reduction of the ventricular size in the majority of cases. We found a valve-related rate of overdrainage of 2.5%, which is clearly lower than results of comparable series in the literature. CONCLUSION: The clinical course of patients suffering from NPH is mainly influenced by the stage of the disease, the time of beginning of the therapy, and the gravitational function of the implanted device. Based on our clinical experiences with the Miethke dual-switch valve (MD-SV), we underscore the advantages of this valve for the treatment of hydrocephalus, especially for patients with NPH.

Patients benefit from low-pressure settings enabled by gravitational valves in normal pressure hydrocephalus.

OBJECTIVE: The ability of siphon regulatory devices to improve overdrainage control despite low-pressure settings of the valve for the horizontal body position has been described previously. We aim to provide a systematic investigation on the ability of gravitational units as siphon regulatory devices to improve clinical outcome in shunt therapy. METHODS: We analyzed retrospectively postoperative complications, type and frequency of valve adjustments and the clinical outcome using Black's outcome scale at different time points of all iNPH patients operated in our center between January 2007 and December 2010. They had received either a proGAV® valve with an integrated gravitational unit, or a programmable Codman Hakim® valve without an integrated siphon regulatory device. RESULTS: The postoperative course of 55 proGAV® and 45 programmable Codman Hakim® patients was analyzed. The latest documented valve setting of the proGAV® group and Codman Hakim® group was median 50mm H2O and 120 mm H2O, respectively. Overdrainage occurred among both groups in 20% of the patients, while surgical intervention for overdrainage-related complications was seen to be necessary only in 7% of the cases in the Codman Hakim® group. Clinical outcome differed in an increasing manner over the observation period (median 4 points after 3, 12 months and at final presentation in the proGAV®; median 4 points after 3 and 12 months and 3 points at final presentation in Codman Hakim® group (p=0.001)). CONCLUSION: Adjustable and gravity-assisted valves like the proGAV® improve overdrainage control and enable thus low-pressure settings for the horizontal body position. We observed an improved and more sustainable functional outcome for iNPH patients with an adjustable and gravity-assisted valve compared to iNPH patients without an integrated siphon regulatory device.

Differential pressure in shunt therapy: investigation of position-dependent intraperitoneal pressure in a porcine model.

OBJECT: The differential pressure between the intracranial and intraperitoneal cavities is essential for ventriculoperitoneal shunting. A determination of the pressure in both cavities is decisive for selecting the appropriate valve type and opening pressure. The intraperitoneal pressure (IPP)-in contrast to the intracranial pressure-still remains controversial with regard to its normal level and position dependency. METHODS: The authors used 6 female pigs for the experiments. Two transdermal telemetric pressure sensors (cranial and caudal) were implanted intraperitoneally with a craniocaudal distance of 30 cm. Direct IPP measurements were supplemented with noninvasive IPP measurements (intragastral and intravesical). The IPP was measured with the pigs in the supine (0°), 30°, 60°, and vertical (90°) body positions. After the pigs were euthanized, CT was used to determine the intraperitoneal probe position. RESULTS: With pigs in the supine position, the mean (± SD) IPP was 10.0 ± 3.5 cm H2O in a mean vertical distance of 4.5 ± 2.8 cm to the highest level of the peritoneum. The difference between the mean IPP of the cranially and the caudally implanted probes (Δ IPP) increased according to position, from 5.5 cm H2O in the 0° position to 11.5 cm H2O in the 30° position, 18.3 cm H2O in the 60° position, and 25.6 cm H2O in the vertical body position. The vertical distance between the probe tips (cranially implanted over caudally implanted) increased 3.4, 11.2, 19.3, and 22.3 cm for each of the 4 body positions, respectively. The mean difference between the Δ IPP and the vertical distance between both probe tips over all body positions was 1.7 cm H2O. CONCLUSIONS: The IPP is subject to the position-dependent hydrostatic force. Normal IPP is able to reduce the differential pressure in patients with ventriculoperitoneal shunts.

Shunting with gravitational valves--can adjustments end the era of revisions for overdrainage-related events?: clinical article.

OBJECT: Overdrainage of CSF remains an unsolved problem in shunt therapy. The aim of the present study was to evaluate treatment options on overdrainage-related events enabled by the new generation of adjustable gravity-assisted valves. METHODS: The authors retrospectively studied the clinical course of 250 consecutive adult patients with various etiologies of hydrocephalus after shunt insertion for different signs and symptoms of overdrainage. Primary and secondary overdrainage were differentiated. The authors correlated the incidence of overdrainage with etiology of hydrocephalus, opening valve pressure, and patient parameters such as weight and size. Depending on the severity of overdrainage, they elevated the opening pressure, and follow-up was performed until overdrainage was resolved. RESULTS: The authors found 39 cases (15.6%) involving overdrainage-related problems--23 primary and 16 secondary overdrainage. The median follow-up period in these 39 patients was 2.1 years. There was no correlation between the incidence of overdrainage and any of the following factors: sex, age, size, or weight of the patients. There was also no statistical significance among the different etiologies of hydrocephalus, with the exception of congenital hydrocephalus. All of the "complications" could be resolved by readjusting the opening pressure of the valve in one or multiple steps, avoiding further operations. CONCLUSIONS: Modern adjustable and gravity-assisted valves enable surgeons to set the opening pressure relatively low to avoid underdrainage without significantly raising the incidence of overdrainage and to treat overdrainage-related clinical and radiological complications without surgical intervention.

Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

OBJECTIVE: Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. METHODS: 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. RESULTS: Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. CONCLUSIONS: The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated.

The adjustable proGAV shunt: a prospective safety and reliability multicenter study.

OBJECTIVE: To evaluate the reliability of the gravitation-assisted adjustable proGAV shunt system with a prospective multicenter study conducted in 10 German hospitals. METHODS: Enrollment for this observational study began in April 2005 and concluded in February 2006. The protocol required re-examinations 3 and 6 months postoperatively and fixed the endpoint of follow-up at 12 months after implantation. Patients with different types of adult, juvenile, and pediatric hydrocephalus were included and 165 patients were enrolled; 9 died and 12 had incomplete follow-up. RESULTS: Of the assessable 144 patients, 130 completed the protocol after 12 months, whereas 14 failed because of the need to explant the device, mainly because of infection. In 12 patients, components of the shunt, not the valve, were revised. In 65 of the 144 patients, there were 102 readjustments of the valve in 67 incidences because of underdrainage and in 35 because of overdrainage. In 1 case, readjustment was not possible. Determination of pressure level with the verification instrument was safe and corresponded to the required x-ray controls after adjustments. No unintended readjustments were noted. CONCLUSION: The proGAV is a safe and reliable device.