Programmable (proSA®) vs. fixed (SHUNTASSISTANT®) gravitational valves in pediatric patients with hydrocephalus: a 16-year retrospective single-center comparative study with biomechanical analysis.

PURPOSE: In pediatric hydrocephalus (HC) treatment, programmable gravitational valves offer greater flexibility to manage overdrainage during children's growth. However, it remains unclear whether these devices provide better outcomes rather than their precursors. The study assessed the benefit from programmability of gravitational valve, i.e., programmable-SHUNTASSISTANT (proSA®) vs. SHUNTASSISTANT® (SA®). METHODS: Clinical records and imaging of pediatric patients with hydrocephalus of non-tumoral etiology treated with fixed (SA®) or programmable (proSA®) gravitational valves between January 2006 and January 2022 were analyzed in a retrospective single-center study. Valve survival was compared in relation to age and etiology. Lately explanted valves received biomechanical analysis. RESULTS: A total of 391 gravitational valves (254 SA® and 137 proSA®) were inserted in 244 patients (n = 134 males). One hundred thirty-three SA® (52.4%) and 67 proSA® (48.9%) were explanted during a follow-up of 81.1 ± 46.3 months. Valve survival rate at 1 and 5 years with proSA® was 87.6% and 60.6% compared to 81.9% and 58.7% with SA®, with mean survival time 56.4 ± 35.01 and 51.4 ± 43.0 months, respectively (P = 0.245). Age < 2 years at implantation correlated with significantly lower valve survival rates (P < 0.001), while HC etiology showed no significant impact. Overdrainage alone accounted for more SA® revisions (39.8% vs. 3.1%, P < 0.001), while dysfunctions of the adjustment system represented the first cause of valve replacement in proSA® cohort (45.3%). The biomechanical analysis performed on 41 proSA® and 31 SA® showed deposits on the valve's internal surface in 97.6% and 90.3% of cases. CONCLUSION: Our comparative study between proSA® and SA® valves in pediatric HC demonstrated that both valves showed similar survival rates, regardless of etiology but only with young age at implantation. The programmability may be beneficial in preventing sequelae of chronic overdrainage but does not reduce need for valve revision and proSA® valve should be considered in selected cases in growing children older than 2 years.

Assessment of MRI issues for a new cerebral spinal fluid shunt, gravitational valve (GV).

PURPOSE: A gravitational valve (GV) may be used to treat hydrocephalus, offering possible advantages that include avoidance of over drainage and long-term complications. Because a GV is made from metal, there are potential safety and other problems related to the use of MRI. The objective of this investigation was to evaluate MRI-related issues (i.e., magnetic field interactions, heating, and artifacts) for a newly developed, metallic GV. METHODS: Tests were performed on the GV (GAV 2.0) using well-accepted techniques to assess magnetic field interactions (translational attraction and torque, 3-Tesla), MRI-related heating (1.5-T/64-MH and 3-T/128-MHz, whole body averaged SAR, 2.7-W/kg and 2.9-W/kg, respectively), artifacts (3-Tesla; gradient echo and T1-weighted, spin echo sequences), and possible functional changes related to exposures to different MRI conditions (exposing six samples each to eight different pulse sequences at 1.5-T/64-MHz and 3-T/128-MHz). RESULTS: Magnetic field interactions were not substantial (deflection angle 2°, no torque) and heating was minor (highest temperature rise, ≥1.9°C, highest background temperature rise, ≥1.7°C). Artifacts on the gradient echo pulse sequence extended approximately 10mm from the size and shape of the GV. The different exposures to 1.5-T/64-MHz and 3-T/128-MHz conditions did not alter or damage the operational aspects of the GV samples. CONCLUSIONS: The findings demonstrated that MRI can be safely used in patients with this GV and, thus, this metallic implant is deemed acceptable or "MR Conditional" (i.e., using current labeling terminology), according to the conditions used in this study.

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.

Predictors of outcome in patients with normal-pressure hydrocephalus.

Despite emerging knowledge of over 40 years, the postoperative results after shunt implantations in patients diagnosed for normal-pressure hydrocephalus (NPH) have not improved significantly in the last decade. For this reason, predictors have to be identified in order to preoperatively predict the course of disease. From 1982 to 2000, we examined in a prospective study 200 patients diagnosed for NPH. Of the patients who were surgically treated by a shunt implantation we could re-examine 155 (78%) in a mean time interval of 7 months after operation. The NPH was graduated 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 the study we focused our attention on the possible predictors: patient's age, length of disease, clinical signs--like gait ataxia, dementia and bladder incontinence, etiology idiopathic/secondary as well as implanted valve type and the value of resistance to cerebrospinal fluid outflow. To measure the outcome we used the NPH recovery rate, as statistical test the chi(2) according to Pearson. In 80 patients with an early stage NPH (without cerebral atrophy) and a short course of disease (<1 year), slightly distinct dementia and an implanted Miethke Dual-Switch valve were significant predictors for a positive postoperative outcome. The outflow resistance measured in the intrathecal infusion test showed only a minimal relevance for the outcome. Those 75 patients with a late state NPH (with cerebral atrophy) had a better outcome when dementia was not present, the outflow resistance was >20 mm Hg.min/ml, the CSF tap test was positive and a Miethke Dual-Switch valve was implanted.

Predictors of outcome in patients with normal-pressure hydrocephalus.

Despite knowledge emerging over the last 40 years, the postoperative results after shunt implantation in patients diagnosed with normal-pressure hydrocephalus (NPH) have not improved significantly over the last decade. For that reason predictors have to be identified in order to preoperatively predict outcome. From 1982 to 2000 we prospectively studied 200 patients diagnosed with NPH. From the patients, who were surgically treated by a shunt implantation we reexamined 155 (78%) postoperatively a mean time interval of 7 months. The NPH was graded according to the results of the intrathecal infusion test in an early stage NPH (without brain atrophy) and late stage NPH (with brain atrophy). In our study, we focussed attention on the possible predictors: patients age, length of disease, clinical signs (gait ataxia, dementia and bladder incontinence), aetiology idiopathic/secondary as well as implanted valve type and the value of resistance to cerebrospinal fluid outflow. To measure the outcome we used the NPH recovery rate and as the statistical test the chi(2) according to Pearson. In 80 patients with an early stage NPH (without cerebral atrophy), a short course of disease (<1 year), a slight degree of dementia and an implanted Miethke-Dual-Switch valve were significant predictors for a positive postoperative outcome. The outflow resistance measured in the intrathecal infusion test showed only a minimal relevance to outcome. Those 75 patients with a late state NPH (with cerebral atrophy) had a better outcome when dementia was not present, the outflow resistance was above 20mm Hg/min/ml, the CSF tap-test was positive and a Miethke-Dual-Switch valve was implanted.