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CC BY-NC-ND 4.0 · Asian J Neurosurg 2023; 18(03): 548-556
DOI: 10.1055/s-0043-1771370
Original Article

Treatment of Idiopathic Normal Pressure Hydrocephalus with a Novel Programmable Valve: Prospective Evaluation of Costs, Efficacy, and Safety

Rodolfo Casimiro Reis 
1   Department of Neurosurgery, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil
,
Renata Harumi Gobbato Yamashita
1   Department of Neurosurgery, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil
,
Davi Jorge Fontoura Solla
1   Department of Neurosurgery, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil
,
Laís Fajardo Ramin
2   Neuroradiology Section, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil
,
Manoel Jacobsen Teixeira
1   Department of Neurosurgery, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil
,
Fernando Campos Gomes Pinto
1   Department of Neurosurgery, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil
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Abstract

Objective Programmable valves provide an equal or superior neurological outcome when compared with fixed pressure ones, with fewer complications, in treating idiopathic normal pressure hydrocephalus (iNPH) patients. Long-term costs of these treatments have not been properly compared in literature. We sought to compare costs, efficacy, and safety of 1-year treatment of iNPH patients with programmable valve Sphera Pro and a fixed pressure valve.

Materials and Methods A prospective cohort of iNPH patients treated with programmable valve was compared with a historical cohort of iNPH patients treated with fixed pressure valve. Our primary outcome was mean direct cost of treating iNPH up to 1 year. Efficacy in treating iNPH and safety were assessed as secondary outcomes.

Statistical Analysis Proportions were compared using chi-square or Fisher's exact tests. Normally distributed variables were compared using the Student's t-test or the Mann–Whitney's U test. Differences in the evolution of the variables over time were assessed using generalized estimating equations. All tests were two-sided, with an α of 0.05.

Results A total of 19 patients were analyzed in each group (mean age 75 years, the majority male). Comorbidities and clinical presentation were similar between groups. Both fixed pressure and programmable valve patients had neurological improvement over time (p < 0.001), but no difference was seen between groups (p = 0.104). The fixed pressure valve group had more complications than the programmable valve group (52.6% vs. 10.5%, respectively, p = 0.013). Annual treatment cost per patient was US$ 3,820 ± 2,231 in the fixed pressure valve group and US$ 3,108 ± 553 in the programmable valve group. Mean difference was US$712 (95% confidence interval, 393–1,805) in favor of the programmable valve group.

Conclusion The Sphera Pro valve with gravitational unit had 1 year treatment cost not higher than that of fixed pressure valve, and resulted in similar efficacy and fewer complications.

Keywords

cost analysis - efficacy - normal pressure hydrocephalus - safety - ventriculoperitoneal shunt


Publication History

Article published online:
22 September 2023

© 2023. Asian Congress of Neurological Surgeons. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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  • References

  • 1 Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci 1965; 2 (04) 307-327
    CrossrefPubMedSearch in Google Scholar
  • 2 Factora R. When do common symptoms indicate normal pressure hydrocephalus?. Cleve Clin J Med 2006; 73 (05) 447-450 , 452, 455–456 passim
    CrossrefPubMedSearch in Google Scholar
  • 3 McGirt MJ, Woodworth G, Coon AL, Thomas G, Williams MA, Rigamonti D. Diagnosis, treatment, and analysis of long-term outcomes in idiopathic normal-pressure hydrocephalus. Neurosurgery 2008; 62 (2, Suppl 2): 670-677
    CrossrefPubMedSearch in Google Scholar
  • 4 Nakajima M, Yamada S, Miyajima M. et al. Guidelines for management of idiopathic normal pressure hydrocephalus (third edition): endorsed by the Japanese Society of normal pressure hydrocephalus. Neurol Med Chir (Tokyo) 2021; 61: 63-97
    CrossrefPubMedSearch in Google Scholar
  • 5 Mihalj M, Dolić K, Kolić K, Ledenko V. CSF tap test - obsolete or appropriate test for predicting shunt responsiveness? A systemic review. J Neurol Sci 2016; 362: 78-84
    CrossrefPubMedSearch in Google Scholar
  • 6 Pinto FCG, Saad F, Oliveira MF. et al. Role of endoscopic third ventriculostomy and ventriculoperitoneal shunt in idiopathic normal pressure hydrocephalus: preliminary results of a randomized clinical trial. Neurosurgery 2013; 72 (05) 845-853 , discussion 853–854
    CrossrefPubMedSearch in Google Scholar
  • 7 Kazui H, Miyajima M, Mori E, Ishikawa M. SINPHONI-2 Investigators. Lumboperitoneal shunt surgery for idiopathic normal pressure hydrocephalus (SINPHONI-2): an open-label randomised trial. Lancet Neurol 2015; 14 (06) 585-594
    CrossrefPubMedSearch in Google Scholar
  • 8 Zemack G, Romner B. Adjustable valves in normal-pressure hydrocephalus: a retrospective study of 218 patients. Neurosurgery 2002; 51 (06) 1392-1400 , discussion 1400–1402
    CrossrefPubMedSearch in Google Scholar
  • 9 Zemack G, Romner B. Seven years of clinical experience with the programmable Codman Hakim valve: a retrospective study of 583 patients. J Neurosurg 2000; 92 (06) 941-948
    CrossrefPubMedSearch in Google Scholar
  • 10 Oliveira MF, Saad F, Reis RC, Rotta JM, Pinto FC. Programmable valve represents an efficient and safe tool in the treatment of idiopathic normal-pressure hydrocephalus patients. Arq Neuropsiquiatr 2013; 71 (04) 229-236
    CrossrefPubMedSearch in Google Scholar
  • 11 Giordan E, Palandri G, Lanzino G, Murad MH, Elder BD. Outcomes and complications of different surgical treatments for idiopathic normal pressure hydrocephalus: a systematic review and meta-analysis. J Neurosurg 2018;
    CrossrefPubMedSearch in Google Scholar
  • 12 Serarslan Y, Yilmaz A, Çakır M. et al. Use of programmable versus nonprogrammable shunts in the management of normal pressure hydrocephalus: a multicenter retrospective study with cost-benefit analysis in Turkey. Medicine (Baltimore) 2017; 96 (39) e8185
    CrossrefPubMedSearch in Google Scholar
  • 13 Lopes MIR, Tornai JB, Jeng FLM. et al. Development of the Brazilian Portuguese version of the “Grading scale for idiopathic normal pressure hydrocephalus”: cross-cultural adaptation, reliability and validity. Arq Neuropsiquiatr 2018; 76 (10) 692-696
    Thieme ConnectPubMedSearch in Google Scholar
  • 14 Brucki SM, Nitrini R, Caramelli P, Bertolucci PH, Okamoto IH. Suggestions for utilization of the mini-mental state examination in Brazil. [in Portuguese]. Arq Neuropsiquiatr 2003; 61 (3B): 777-781
    CrossrefPubMedSearch in Google Scholar
  • 15 Miyamoto ST, Lombardi Junior I, Berg KO, Ramos LR, Natour J. Brazilian version of The Berg Balance Scale. Braz J Med Biol Res 2004; 37 (09) 1411-1421
    CrossrefPubMedSearch in Google Scholar
  • 16 Riberto M, Miyazaki MH, Jorge Filho D, Sakamoto H, Battistella LR. Reprodutibilidade da versão brasileira da medida de independência funcional. Acta Fisiátrica 2001; 8: 45-52
    CrossrefSearch in Google Scholar
  • 17 De Castro SM, Perracini MR, Ganança FF. Dynamic Gait Index–Brazilian version. Rev Bras Otorrinolaringol (Engl Ed) 2006; 72 (06) 817-825
    CrossrefSearch in Google Scholar
  • 18 Mendes GAS, de Oliveira MF, Pinto FCG. The timed up and go test as a diagnostic criterion in normal pressure hydrocephalus. World Neurosurg 2017; 105: 456-461
    CrossrefPubMedSearch in Google Scholar
  • 19 Boon AJ, Tans JT, Delwel EJ. et al. Dutch Normal-Pressure Hydrocephalus Study: randomized comparison of low- and medium-pressure shunts. J Neurosurg 1998; 88 (03) 490-495
    CrossrefPubMedSearch in Google Scholar
  • 20 Matsubara T, Ishikawa E, Hirata K. et al. A new mechanism of cerebrospinal fluid leakage after lumboperitoneal shunt: a theory of shunt side hole–case report. Neurol Med Chir (Tokyo) 2014; 54 (07) 572-577
    CrossrefPubMedSearch in Google Scholar
  • 21 McGovern RA, Kelly KM, Chan AK, Morrissey NJ, McKhann II GM. Should ventriculoatrial shunting be the procedure of choice for normal-pressure hydrocephalus?. J Neurosurg 2014; 120 (06) 1458-1464
    CrossrefPubMedSearch in Google Scholar
  • 22 Pujari S, Kharkar S, Metellus P, Shuck J, Williams MA, Rigamonti D. Normal pressure hydrocephalus: long-term outcome after shunt surgery. J Neurol Neurosurg Psychiatry 2008; 79 (11) 1282-1286
    CrossrefPubMedSearch in Google Scholar
  • 23 Meier U, Lemcke J. First clinical experiences in patients with idiopathic normal-pressure hydrocephalus with the adjustable gravity valve manufactured by Aesculap (proGAV(Aesculap)). Acta Neurochir Suppl (Wien) 2006; 96: 368-372
    CrossrefPubMedSearch in Google Scholar
  • 24 Pinto FCG, Pereira RM, Saad F, Teixeira MJ. Performance of fixed-pressure valve with antisiphon device SPHERA(®) in hydrocephalus treatment and overdrainage prevention. Arq Neuropsiquiatr 2012; 70 (09) 704-709
    CrossrefPubMedSearch in Google Scholar
  • 25 Bozhkov Y, Roessler K, Hore N, Buchfelder M, Brandner S. Neurological outcome and frequency of overdrainage in normal pressure hydrocephalus directly correlates with implanted ventriculo-peritoneal shunt valve type. Neurol Res 2017; 39 (07) 601-605
    CrossrefPubMedSearch in Google Scholar
  • 26 Suchorska B, Kunz M, Schniepp R. et al. Optimized surgical treatment for normal pressure hydrocephalus: comparison between gravitational and differential pressure valves. Acta Neurochir (Wien) 2015; 157 (04) 703-709
    CrossrefPubMedSearch in Google Scholar
  • 27 Kameda M, Yamada S, Atsuchi M. et al; SINPHONI and SINPHONI-2 Investigators. Cost-effectiveness analysis of shunt surgery for idiopathic normal pressure hydrocephalus based on the SINPHONI and SINPHONI-2 trials. Acta Neurochir (Wien) 2017; 159 (06) 995-1003
    CrossrefPubMedSearch in Google Scholar
  • 28 Hashimoto M, Ishikawa M, Mori E, Kuwana N. Study of INPH on neurological improvement (SINPHONI). Diagnosis of idiopathic normal pressure hydrocephalus is supported by MRI-based scheme: a prospective cohort study. Cerebrospinal Fluid Res 2010; 7: 18
    CrossrefPubMedSearch in Google Scholar
  • 29 Agarwal N, Kashkoush A, McDowell MM, Lariviere WR, Ismail N, Friedlander RM. Comparative durability and cost analysis of ventricular shunts. J Neurosurg 2018;
    CrossrefPubMedSearch in Google Scholar
  • 30 Marmarou A, Bergsneider M, Klinge P, Relkin N, Black PM. The value of supplemental prognostic tests for the preoperative assessment of idiopathic normal-pressure hydrocephalus. Neurosurgery 2005; 57 (03) S17-S28 , discussion ii–v
    PubMedSearch in Google Scholar
  • 31 Ijzerman MJ, Creasey GH. Economic evaluation of neuro-prostheses: a review of outcome assessment and valuation techniques. Technol Disabil 2004; 16: 33-40
    CrossrefSearch in Google Scholar
  • 32 Mogyorosy Z, Smith P. The Main Methodological Issues in Costing Health Care Services: A Literature Review. York: The University of York; 2005
    Search in Google Scholar