A randomised trial of high and low pressure level settings on an adjustable ventriculoperitoneal shunt valve for idiopathic normal pressure hydrocephalus: results of the Dutch evaluation programme Strata shunt (DEPSS) trial

Delwel, Ernst J.; Jong, D. A. de; Dammers, Rúben; Kurt, Erkan; Brink, Wimar van den; Dirven, Clemens

doi:10.1136/jnnp-2012-302935

Cited by 27 publications

(26 citation statements)

References 25 publications

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“…In Boon and colleagues' study, 2 the clinical effect of shunt treatment was better in the group treated with a low opening pressure than in the group treated with a medium opening pressure, which contradicts the results in the study by Delwel et al, 5 where the clinical effect was the same in both groups (low/medium valve setting group and high valve setting group). The purpose of the latter study was to lower the valve setting until the optimal level was reached.…”

Section: Discussioncontrasting

confidence: 54%

“…This is not supported by our study, in which the patients in the 20-4 group that ended up at a low valve setting (4 cm H 2 O) presented with the same rate of SDH as the group with a medium valve setting (12 cm H 2 O). The discrepancy between the results could be interpreted to mean that gradual lowering of the opening pressure might have prevented the development of SDH, which thus might even support the recommendations presented in the iNPH guidelines.2 However, one should take into account that the 3 studies were conducted using different methodologies and 3 different valve types, which makes the conclusion speculative, but interesting.In Boon and colleagues' study, 2 the clinical effect of shunt treatment was better in the group treated with a low opening pressure than in the group treated with a medium opening pressure, which contradicts the results in the study by Delwel et al,5 where the clinical effect was the same in both groups (low/medium valve setting group and high valve setting group). The purpose of the latter study was to lower the valve setting until the optimal level was reached.…”

contrasting

confidence: 54%

“…The group with the low opening pressure experienced more complications than the group with the medium opening pressure. Similarly, Delwel et al 5 observed a higher rate of SDH in the group that started at a low/medium valve setting (Strata performance level [PL] 1.0) compared with the group that started at a high valve setting (Strata PL 2.5), which was gradually lowered. This is not supported by our study, in which the patients in the 20-4 group that ended up at a low valve setting (4 cm H 2 O) presented with the same rate of SDH as the group with a medium valve setting (12 cm H 2 O).…”

Section: Discussionmentioning

confidence: 99%

“…The results differ from those in the 2 Dutch studies. 2,5 In the study by Boon et al, 2 2 fixed valves with a medium or low opening pressure were investigated. The group with the low opening pressure experienced more complications than the group with the medium opening pressure.…”

Section: Discussionmentioning

confidence: 99%

“…2 Similarly, in a randomized controlled study Delwel et al found more SDHs in a lowpressure group than in a high pressure group 5 but the same outcome in the 2 groups. No controlled study has addressed the question of how to use adjustable valves for optimal prevention of complications and optimal effect.…”

mentioning

confidence: 99%

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A randomized controlled dual-center trial on shunt complications in idiopathic normal-pressure hydrocephalus treated with gradually reduced or “fixed” pressure valve settings

Sæhle

Farahmand

Eide

et al. 2014

JNS

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I dIopathIc normal pressure hydrocephalus (iNPH) is a treatable condition, first described by Hakim in 1965. 10 It is characterized clinically by gait disturbance, cognitive impairment, and urinary incontinence and radiologically by ventriculomegaly. The condition is typically diagnosed in the elderly and most often treated by insertion of a ventriculoperitoneal (VP) shunt with either a fixed or an adjustable pressure valve. Adjustable valves were designed to lower the complication rate and optimize the effect of shunting. 26 After shunt surgery in iNPH patients, improvement rates between 61% and 90% have been reported, 6,[11][12][13][14]16,18,23 with recent studies revealing a rate above 80%. 13,24 The complication rates are high, up to 50%, 3,8,22 although a rate of 20% is evident in recent studies. 8,26 The major complications are mechanical obstruction, infection, and subdural hematoma (SDH); the frequency of SDH is between 2% and 16%. 7,13,23 A Dutch NPH study recommended the use of a low A randomized controlled dual-center trial on shunt complications in idiopathic normal-pressure hydrocephalus treated with gradually reduced or "fixed" pressure valve settings Object. This study was undertaken to investigate whether a gradual reduction of the valve setting (opening pressure) decreases the complication rate in patients with idiopathic normal-pressure hydrocephalus (iNPH) treated with a ventriculoperitoneal (VP) shunt.Methods. In this prospective double-blinded, randomized, controlled, dual-center study, a VP shunt with an adjustable valve was implanted in 68 patients with iNPH, randomized into two groups. In one group (the 20-4 group) the valve setting was initially set to 20 cm H 2 O and gradually reduced to 4 cm H 2 O over the course of the 6-month study period. In the other group (the 12 group), the valve was kept at a medium pressure setting of 12 cm H 2 O during the whole study period. The time to and type of complications (hematoma, infection, and mechanical problems) as well as overdrainage symptoms were recorded. Symptoms, signs, and outcome were assessed by means of the iNPH scale and the NPH grading scale.Results. Six patients in the 20-4 group (22%) and 7 patients in the 12 group (23%) experienced a shunt complication; 9 had subdural hematomas, 3 mechanical obstructions, and 1 infection (no significant difference between groups). The frequency of overdrainage symptoms was significantly higher for a valve setting ≤ 12 cm H 2 O compared with a setting > 12 cm H 2 O. The 20-4 group had a higher improvement rate (88%) than the 12 group (62%) (p = 0.032). There was no significant relationship between complications and body mass index, the use of an antisiphon device, or the use of anticoagulants.Conclusions. Gradual lowering of the valve setting to a mean of 7 cm H 2 O led to the same rate of shunt complications and overdrainage symptoms as a fixed valve setting at a mean of 13 cm H 2 O but was associated with a significantly better outcome. (http://thejns.org/doi/abs/10.3171/2014.7.JNS14283) Key Wo...

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Section: Discussioncontrasting

confidence: 54%

contrasting

confidence: 54%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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A randomized controlled dual-center trial on shunt complications in idiopathic normal-pressure hydrocephalus treated with gradually reduced or “fixed” pressure valve settings

Sæhle

Farahmand

Eide

et al. 2014

JNS

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Deconstructing normal pressure hydrocephalus: Ventriculomegaly as early sign of neurodegeneration

Espay

Prat

Dwivedi

et al. 2017

Annals of Neurology

149

150

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Idiopathic normal pressure hydrocephalus (NPH) remains both oversuspected on clinical grounds and underconfirmed when based on immediate and sustained response to cerebrospinal fluid diversion. Poor long-term postshunt benefits and findings of neurodegenerative pathology in most patients with adequate follow-up suggest that hydrocephalic disorders appearing in late adulthood may often result from initially unapparent parenchymal abnormalities. We critically review the NPH literature, highlighting the near universal lack of blinding and controls, absence of specific clinical, imaging, or pathological features, and ongoing dependence for diagnostic confirmation on variable cutoffs of gait response to bedside fluid-drainage testing. We also summarize our long-term institutional experience, in which postshunt benefits in patients with initial diagnosis of idiopathic NPH persist in only 32% of patients at 36 months, with known revised diagnosis in over 25% (Alzheimer's disease, dementia with Lewy bodies, and progressive supranuclear palsy). We postulate that previously reported NPH cases with "dual" pathology (ie, developing a "second" disorder) more likely represent ventriculomegalic presentations of selected neurodegenerative disorders in which benefits from shunting may be short-lived, with a consequently unfavorable risk-benefit ratio. Ann Neurol 2017;82:503-513.

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Symptoms and signs did not predict outcome after surgery: a prospective study of 143 patients with idiopathic normal pressure hydrocephalus

Andrén,

Wikkelsø,

Laurell

et al. 2024

J Neurol

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Objective To determine the utility of symptoms, signs, comorbidities and background variables for the prediction of outcome of treatment in iNPH. Methods A prospective observational study of consecutively included iNPH patients, who underwent neurological, physiotherapeutic and neuropsychological assessments before and after shunt surgery. The primary outcome measure was the total change on the iNPH scale, and patients were defined as improved postoperatively if they had improved by at least five points on that scale. Results 143 iNPH patients were included, and 73% of those were improved after surgery. None of the examined symptoms or signs could predict which patients would improve after shunt surgery. A dominant subjective complaint of memory problems at baseline was predictive of non-improvement. The reported comorbidities, duration of symptoms and BMI were the same in improved and non-improved patients. Each of the symptom domains (gait, neuropsychology, balance, and continence) as well as the total iNPH scale score improved significantly (from median 53 to 69, p < 0.001). The proportions of patients with shuffling gait, broad-based gait, paratonic rigidity and retropulsion all decreased significantly. Discussion This study confirms that the recorded clinical signs, symptoms, and impairments in the adopted clinical tests are characteristic findings in iNPH, based on that most of them improved after shunt surgery. However, our clinical data did not enable predictions of whether patients would respond to shunt surgery, indicating that the phenotype is unrelated to the reversibility of the iNPH state and should mainly support diagnosis. Absence of specific signs should not be used to exclude patients from treatment.

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A randomised trial of high and low pressure level settings on an adjustable ventriculoperitoneal shunt valve for idiopathic normal pressure hydrocephalus: results of the Dutch evaluation programme Strata shunt (DEPSS) trial

Cited by 27 publications

References 25 publications

A randomized controlled dual-center trial on shunt complications in idiopathic normal-pressure hydrocephalus treated with gradually reduced or “fixed” pressure valve settings

A randomized controlled dual-center trial on shunt complications in idiopathic normal-pressure hydrocephalus treated with gradually reduced or “fixed” pressure valve settings

Deconstructing normal pressure hydrocephalus: Ventriculomegaly as early sign of neurodegeneration

Symptoms and signs did not predict outcome after surgery: a prospective study of 143 patients with idiopathic normal pressure hydrocephalus

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