Experiences with a gravity-assisted valve in hydrocephalic children

Abstract

<jats:sec> <jats:title>Object</jats:title> <jats:p>Over the past decade, a gravity-assisted valve (GAV) has become a standard device in many European pediatric hydrocephalus centers. Because past comparative clinical outcome studies on valve design have not included any GAV, the authors in this trial evaluated the early results of GAV applications in a pediatric population.</jats:p></jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p></jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>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.</jats:p></jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>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.</jats:p></jats:sec>

Pediatric hydrocephalus: systematic literature review and evidence-based guidelines. Part 5: Effect of valve type on cerebrospinal fluid shunt efficacy

“…Twenty-two articles were included in the final evidentiary table. Reasons for exclusion of fulltext articles included the absence of a valid comparison group (n = 14), [1][2][3][7][8][9][10]12,13,20,25,26,28,35 the absence of a valid outcome variable (n = 4), 14,18,22,32 invalid study design (n = 2), 30,31 and redundant patient population (n = 1) (Fig. 1).…”

“…The majority of excluded papers did not include a comparison group or control group. [1][2][3][7][8][9][10]12,13,20,25,26,28,35 Other reasons for exclusion included invalid study design (questionnaire survey), 30,31 redundant patient population 5 (only the paper with the longest reported follow-up was included), and absence of a valid outcome variable (change in ventricle size, development of spinal canal stenosis, historical description, and frequency of hospital visits). 14,18,22,32 Conclusions recommendation: There is insufficient evidence to demonstrate an advantage of one shunt hardware design over another for the treatment of pediatric hydrocephalus.…”

Long-term survival rates of gravity-assisted, adjustable differential pressure valves in infants with hydrocephalus

“…The death of 1 child was related to shunt malfunction. After a Another aspect is to compare our data with those of nonadjustable, gravity-assisted valves collected in a multicenter prospective study of 169 patients, including 86 infants (< 1 year) who received the paediGAV; 20 this study reported shunt survival rates of 65.6% and 57.4% and valve survival rates of 72.4% and 71.1% after 12 and 24 months, respectively. However, the comparison of a single-center retrospective study with a multicenter prospective study is limited.…”

“…Nevertheless, the feasibility of using this shunt system in an infant population is demonstrated, which has similarly been shown for a general pediatric population. 20,43,48 The use of the gravitational unit of the system to try to counteract severe overdrainage is also well tolerated by infants. Clinical observation has shown that during long-term follow-up, signs and symptoms of overdrainage (e.g., decreased ventricular size on imaging, diminished development of head circumference, and headaches) may develop with the advancing growth and activity of the child.…”

Experience with a gravitational valve in the management of symptomatic overdrainage in children with shunts

“…5,7,8,14 Gravitational valve systems compensate for increased pressure differences in the upright position and may therefore have a positive impact on symptoms related to overdrainage. 5,14 However, the use of a gravitational valve for relieving symptoms associated with overdrainage has not yet been addressed. The present study was designed to evaluate the effect of a gravitational valve system on the treatment of children with shunts and problems attributed to overdrainage.…”