Miethke Paedi-Gav
Case series
For a minimum of 2 years the authors monitored 169 of 182 hydrocephalic children who received a pediatric GAV at their first CSF shunt insertion (61.5%) or as a substitute for any differential pressure valve (38.5%) at 1 of 7 European pediatric hydrocephalus centers. Outcomes were categorized as valve survival (primary outcome) or shunt survival (secondary outcome). The end point was defined as valve explantation.
Within a follow-up period of 2 years, the valve remained functional in 130 (76.9%) of 169 patients. One hundred eight of these patients (63.9%) had an uncomplicated clinical course without any subsequent surgery, and 22 (13%) were submitted to a valve-preserving catheter revision without any further complications during the follow-up period. Thirty-nine patients (23.1%) reached an end point of valve explantation: 13 valve failures from infection (7.7%), 8 (4.7%) from overdrainage, and 18 (10.6%) from underdrainage.
Compared with nongravitational shunt designs, a GAV does not substantially affect the early complication rate. Valve-preserving shunt revisions do not increase the risk of subsequent valve failure and therefore should not be defined as an end point in studies on valve design. A significant impact of any well-established valve design on the early complication rate in shunt surgery is not supported by any current data; therefore, this correlation should be dismissed. As overdrainage-related complications have been shown to occur late, the presumed advantages of a pediatric GAV remain to be shown in a long-term study 1).
Eymann et al. goal in a paper was to evaluate prospectively the efficacy and safety of a new pediatric gravitational shunt to determine whether it warrants inclusion in a randomized, controlled trial with other shunts.
A total of 55 children between the ages of 0 and 6 years (median age 0.5 years, average age 4+/-6 years) underwent primary shunt implantation; all received the Miethke Paedi-GAV. The follow-up period ranged between 12 and 77 months (mean 47+/-21 months). The primary end point of the study was the first shunt failure necessitating revision. The 1- and 2-year shunt survival rates were 75 and 68%, respectively. The average failure-free shunt survival duration was 1423 +/- 641 days. Based on imaging findings, no slitlike ventricles occurred. The complication rate was 33%, and the median time to shunt failure was 45 days. Underdrainage occurred in one child (1.8%) and overdrainage in two children (3.6%).
These preliminary results prove the Miethke Paedi-GAV to be a safe and effective pediatric shunt worthy of inclusion in a randomized comparison with other shunts in the pediatric population 2)
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) 3).
A total of 32 patients were enrolled onto the study, with 2 undergoing first shunt insertion after failed ventriculostomy and 30 undergoing shunt revisions. On average, the patients had had 3.3 shunt procedures prior to insertion of a Paedi-Gav valve.
During a follow-up interval of minimum 52 weeks and a median of 24 months after the first implantation on-study, shunt revisions were required in 17 (53.1%) of the 32 patients. The 12-month shunt-survival rate without revision of any component was 53%, with a median shunt-survival time of 388 days. The most common reasons for shunt revision were shunt obstructions (12/17) and overdrainage (3/17). Shunt obstructions were caused by valve-related failures (9/12) and distal obstructions (3/12).
Although the small number of patients enrolled in this study warrants cautious conclusions, the overall results are comparable to those reported for primary shunt insertions with conventional valves in pediatric patients with hydrocephalus. Although this study provides a rationale for examining the Paedi-Gav gravity-assisted shunt valve in a larger prospective randomized controlled trial, the shunt failure pattern, with a rather high frequency of valve-related failures, may indicate potential for further improvements in the valve design and/or manufacturing 4).
In this study 32 children with hydrocephali due to different etiologies were treated with hydrostatic valves, the so called Pädi GAV (pediatric hydrostatic valve) valves developed by Miethke. In addition to mechanical occlusions and shunt infections, the overdrainage related complications, such as subdural hematomas/ fluid collections, slit ventricles and secondary craniosynostoses were taken into consideration. None of the patients showed these complications. On the contrary, postoperative MRI or the ultrasound demonstrated prominent ventricles comparing these with those of non-hydrocephalic children as measured by the Evans-Index and FOR (fronto-to-occipital ratio). Whether the overdrainage-related complications actually reduced using Pädi GAV valves will be shown by further long-term follow ups. This study aims to evaluate the initial experience with the Pädi GAV shunt system, particularly with respect to the overdrainage-related problems 5).