Surgical complications of pediatric auditory brain stem implantation in patients with narrow internal auditory canal following retrosigmoid approach

Kim, Joo Pyung; Chung, Jong Chul; Chang, Won Seok; Choi, Jae Young; Chang, Jin Woo

doi:10.1007/s00381-011-1675-7

Cited by 4 publications

(3 citation statements)

References 22 publications

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“…There have been many well designed studies of these devices reported in both animal models [ 66 – 70 ] and patients [ 71 – 75 ]. As briefly mentioned here, one of the primary pathologies that occured with ABI is CSF leak [ 76 , 77 ], while with the CI it is temporal bone fibrosis and ossification [ 54 ]. Regarding the latter, although meningeal fibrosis is commonly seen at the site of implanted intradural electrodes in the central nervous system, there do not appear to be any reports of ossification of this tissue.…”

Section: Discussionmentioning

confidence: 99%

Postsurgical Pathologies Associated with Intradural Electrical Stimulation in the Central Nervous System: Design Implications for a New Clinical Device

Gibson‐Corley

Flouty

Oya

et al. 2014

BioMed Research International

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Spinal cord stimulation has been utilized for decades in the treatment of numerous conditions such as failed back surgery and phantom limb syndromes, arachnoiditis, cancer pain, and others. The placement of the stimulating electrode array was originally subdural but, to minimize surgical complexity and reduce the risk of certain postsurgical complications, it became exclusively epidural eventually. Here we review the relevant clinical and experimental pathologic findings, including spinal cord compression, infection, hematoma formation, cerebrospinal fluid leakage, chronic fibrosis, and stimulation-induced neurotoxicity, associated with the early approaches to subdural electrical stimulation of the central nervous system, and the spinal cord in particular. These findings may help optimize the safety and efficacy of a new approach to subdural spinal cord stimulation now under development.

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Section: Discussionmentioning

confidence: 99%

Postsurgical Pathologies Associated with Intradural Electrical Stimulation in the Central Nervous System: Design Implications for a New Clinical Device

Gibson‐Corley

Flouty

Oya

et al. 2014

BioMed Research International

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“…For the ABI to be considered a feasible treatment going forward, the number of serious expected surgical events could not exceed the known rate of retrosigmoid craniotomy events. Retrosigmoid craniotomy carries with it the risk of cerebrospinal fluid leak, 31 –33 meningitis, 34 hematoma, 31 facial palsy, 35 cerebellar edema, and hydrocephalus. 36 Each of these risks, in and of themselves, has well-established treatment protocols and do not increase the benefit/risk tradeoff adversely.…”

Section: Clinical Trial Protocol: Mitigation Of Riskmentioning

confidence: 99%

Regulatory and Funding Strategies to Develop a Safety Study of an Auditory Brainstem Implant in Young Children Who Are Deaf

Fisher

Eisenberg

Krieger

et al. 2015

Ther Innov Regul Sci

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Background: In the US, a child born deaf with abnormal inner ear anatomy and for whom a cochlear implant fails to provide benefit has no approved surgical treatment options. The auditory brainstem implant (ABI) was developed in the US for patients with Neurofibromatosis 2. A European surgical team has advanced ABI use in young children, with promising outcomes. Clinical teams face a number of challenges, from regulatory issues to funding. The strategic decisions leading to the safety and early efficacy protocol of the ABI for young children with congenital deafness are described. Methods: A sponsor-investigator pre–Investigational Device Exemption (IDE) was significantly altered in discussion with the Food and Drug Administration (FDA), followed by approval of a revised protocol. A critical step involved securing external funding through an NIH U01 clinical trial grant, and enrollment began in 2014. Early Results: The protocol focused on strict inclusion criteria, clear stopping rules, and rigorous interim safety data review before proceeding with enrollment. To date, 4 of the 7 enrolled subjects met criteria for implantation. A single expected serious adverse event occurred, which resolved completely without sequela. Conclusions: Promising innovative treatments face a number of obstacles along the pathway to full commercialization. A strategy that included early conversations with the FDA and the device manufacturer, and successfully obtaining external funding, resulted in an approved IDE protocol. Early results indicated that the risks, though not minimal, can be successfully mitigated. These young children appear to benefit audiologically from the ABI.

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“…Regarding the surgical procedure, 4 patients [13] were fitted with ABIs with the retrolabyrinthine approach, 8 with the suboccipital approach [14] , 49 with the retrosigmoid approach, [10,18,21] and 2 with the translabyrinthine approach [1,3,6,7,9,[13][14][15][22][23][24] . Both patients with bilateral schwannomas and tumors caused by NF2 received the retrosigmoid and transmeatal combined approaches for tumor removal.…”

Section: Review Of the Literaturementioning

confidence: 99%

Auditory Brainstem Implants in Children: Results Based on a Review of the Literature

Monsanto¹,

Bittencourt

Neto³

et al. 2015

Int Adv Otol

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The objective of this study is to review the literature regarding Auditory Brainstem Implant (ABI) indications, surgical techniques, activation methods, and post-surgery follow-up in children. A search was performed in the LILACS, MEDLINE, SciELO, and PubMed databases in June 2014, and the key words used in the search were (("auditory brain stem implant" OR "auditory brainstem implants") OR ("auditory" AND "brainstem" AND ("implants" OR "implant")). Forty-two studies that met the criteria described in "Study Selection" were read in full; 24 studies referred to the ABI fitting process in children, and were selected for appraisal. The studies showed 120 children (younger than 18 years old) fitted with ABIs. Evaluation after surgery showed that 112 (93.3%) of the patients improved in their ability to recognize environmental sounds and speech perception. Patients with tumors or those with cochlear or cochlear nerve malformations had good outcomes as well. Two of the children did not achieve any sound perception upon ABI activation. The results obtained in 120 children fitted with an ABI showed that the patients globally improved in their ability to detect sounds and communication skills. The phenomenon could be seen both in patients with tumoral diseases of the inner ear and those with malformations of the cochlea or cochlear nerve, although patients with non-tumoral issues achieved better results than patients with schwannomas. We propose that the Food and Drug Administration (FDA) ABI indications should be extended to patients younger than 12 years old with NT diseases of the cochlea and cochlear nerve.

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Surgical complications of pediatric auditory brain stem implantation in patients with narrow internal auditory canal following retrosigmoid approach

Cited by 4 publications

References 22 publications

Postsurgical Pathologies Associated with Intradural Electrical Stimulation in the Central Nervous System: Design Implications for a New Clinical Device

Postsurgical Pathologies Associated with Intradural Electrical Stimulation in the Central Nervous System: Design Implications for a New Clinical Device

Regulatory and Funding Strategies to Develop a Safety Study of an Auditory Brainstem Implant in Young Children Who Are Deaf

Auditory Brainstem Implants in Children: Results Based on a Review of the Literature

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