- Oral presentation
- Open Access
One-year outcome in patients with idiopathic normal-pressure hydrocephalus treated with a lumbo-peritoneal shunt (SINPHONI-2), compared to ventriculo-peritoneal shunt (SINPHONI) used as a historical control
© Miyajima et al. 2015
- Published: 18 September 2015
- Subarachnoid Space
- Historical Control
- Modify Rankin Scale
- Normal Pressure Hydrocephalus
Idiopathic normal pressure hydrocephalus (INPH) is treated with cerebrospinal fluid shunting, and ventriculo-peritoneal shunt (VPS) is the current standard treatment. The goal of this pooled analysis was to compare the efficacy and safety between VPS and lumbo-peritoneal shunt (LPS) in patients with INPH specified as disproportionately enlarged subarachnoid space hydrocephalus (DESH).
We conducted a multicenter prospective 3-month randomized controlled trial, and then a 1-year extension study, where all subjects received an LPS with a programmable valve and were examined periodically for 1 year. Eighty-three patients with INPH (60 to 85 years old) presenting with ventriculomegaly, high-convexity and medial subarachnoid space tightness in magnetic resonance imaging were recruited from 20 neurological or neurosurgical centers in Japan between March 1, 2010 and October 19, 2011. The primary outcome was the modified Rankin scale (mRS) score 1 year after surgery, and secondary outcome included the NPH grading scale (NPHGS). The VPS SINPHONI study was used as a historical control.
The proportion of patients with a favorable outcome (i.e., improvement of at least one level in mRS) was 63% (95% CI: 51-73%), and was comparable to that with VPS implantation (69%, 95% CI: 59-78%). In NPHGS, the one-year improvement rate was 75% (95% CI: 64-84%) and was comparable to that of VPS (77%, 95% CI: 68-84%). Serious adverse events (SAEs) occurred in 19 patients (22%), 10 of which were related to surgery. SAEs were more common with LPS than with VPS (15%).
Our results show that LPSs with programmable valves are effective for treating INPH as an alternative to VPSs.
- Miyajima M, Nakajima M, Ogino I, Miyata H, Motoi Y, Arai H: Soluble amyloid precursor protein α in the cerebrospinal fluid as a diagnostic and prognostic biomarker for idiopathic normal pressure hydrocephalus. Eur J Neurol. 2013, 20 (2): 236-242. 10.1111/j.1468-1331.2012.03781.x.View ArticlePubMedGoogle Scholar
- Watanabe M, Miyajima M, Ogino I, Nakajima M, Arai H: Cerebellar Purkinje Cells Exhibit Increased Expression of HMGB-1 and Apoptosis in Congenital Hydrocephalic H-Tx Rats. Neurosurgery. 2013, 72 (3): 459-467. 10.1227/NEU.0b013e31827fcd83.View ArticlePubMedGoogle Scholar
- Miyajima M, Nakajima M, Motoi Y, Moriya M, Sugano H, Ogino I, Nakamura E, Tada N, Kunichika M, Arai H: Leucine-rich α2-glycoprotein is a novel biomarker of neurodegenerative disease in human cerebrospinal fluid and causes neurodegeneration in mouse cerebral cortex. PLoS One. 2013, 8 (9): e74453-10.1371/journal.pone.0074453.PubMed CentralView ArticlePubMedGoogle Scholar
- Hoshi K, Kariya Y, Nara K, Ito H, Matsumoto K, Nagae M, Yamaguchi Y, Nakajima M, Miyajima M, Arai H, Kuno A, Narimatsu H, Shirotani K, Hashimoto Y: Lectin-dependent inhibition of antigen-antibody reaction: application for measuring α2,6-sialylated glycoforms of transferrin. J Biochem. 2013, 154 (3): 229-32. 10.1093/jb/mvt065.View ArticlePubMedGoogle Scholar
- Tsutsumi S, Ogino I, Miyajima M, Ikeda T, Shindo N, Yasumoto Y, Ito M, Arai H: Genomic causes of multiple cerebral cavernous malformations in a Japanese population. J Clin Neurosci. 2013, 20 (5): 667-9. 10.1016/j.jocn.2012.05.041.View ArticlePubMedGoogle Scholar
- Shimoji K, Kimura T, Kondo A, Tange Y, Miyajima M, Arai H: Genetic studies of myelomeningocele. Childs Nerv Syst. 2013, 29 (9): 1417-25. 10.1007/s00381-013-2197-2.View ArticlePubMedGoogle Scholar
- Nakanishi A, Fukunaga I, Hori M, Masutani Y, Takaaki H, Miyajima M, Aoki S: Microstructural changes of the corticospinal tract in idiopathic normal pressure hydrocephalus: a comparison of diffusion tensor and diffusional kurtosis imaging. Neuroradiology. 2013, 55 (8): 971-6. 10.1007/s00234-013-1201-6.View ArticlePubMedGoogle Scholar
- Nakajima M, Sugano H, Iimura Y, Higo T, Nakanishi H, Shimoji K, Karagiozov K, Miyajima M, Arai H: Sturge-Weber syndrome with spontaneous intracerebral hemorrhage in childhood. J Neurosurg Pediatr. 2014, 13 (1): 90-3. 10.3171/2013.9.PEDS133.View ArticlePubMedGoogle Scholar
- Kamiya K, Hori M, Miyajima M, Nakajima M, Suzuki Y, Kamagata K, Suzuki M, Arai H, Ohtomo K, Aoki S: Axon diameter and intra-axonal volume fraction of the corticospinal tract in idiopathic normal pressure hydrocephalus measured by q-space imaging. PLoS One. 2014, 9 (8): e103842-10.1371/journal.pone.0103842.PubMed CentralView ArticlePubMedGoogle Scholar
- Tsutsumi S, Ogino I, Miyajima M, Nakamura M, Yasumoto Y, Arai H, Ito M: Cranial Arachnoid Protrusions and Contiguous Diploic Veins in CSF Drainage. AJNR Am J Neuroradiol. 2014, 35 (9): 1735-9. 10.3174/ajnr.A4007.View ArticlePubMedGoogle Scholar
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.