de Varebeke S P Janssens, Govaerts P, Cox T, Deben K, Ketelslagers K, Waelkens B
Department of ENT Head and Neck Surgery, Jessa Hospital, Campus Virga Jesse, Hasselt, Belgium.
B-ENT. 2012;8(2):85-94.
There are numerous cochlear implant fixation techniques to prevent soft tissue complications related to device migration. The literature does not provide sufficient evidence to determine the most suitable fixation method.
Cochlear implants (CI) are becoming a routine treatment for patients with severe to profound deafness. Steadily growing numbers of implant centres and surgeons worldwide are inevitably leading to higher rates of complications, including device migration. It is currently unknown whether this can be prevented by proper implant fixation during surgery. The low prevalence of this complication makes it challenging to interpret publications regarding CI fixation techniques.
An exhaustive literature review reveals a variety of different fixation techniques. Most authors advocate the creation of a bony well for the CI receiver/stimulator (R/S); however, an increasing number of surgeons no longer secure implants at all. Here we give an overview of all published fixation methods, with special attention to the evidence-based quality and descriptions of the advantages and drawbacks of each.
Literature review reveals an absence of level I evidence-based publications addressing device migration. Existing publications report on too few cases to draw a conclusion on whether surgical fixation prevents implant migration. To have statistical power, studies of alternative or new fixation methods should include high numbers of implantations in each study arm and the studies should be longitudinal and prospective. In default of other evidence, it seems fair to define good practice as the creation of at least a bony well and/or (bony) sutures.
有多种人工耳蜗固定技术可预防与装置移位相关的软组织并发症。文献并未提供足够证据来确定最合适的固定方法。
人工耳蜗(CI)正成为重度至极重度耳聋患者的常规治疗手段。全球范围内,植入中心和外科医生数量稳步增加,不可避免地导致包括装置移位在内的并发症发生率上升。目前尚不清楚手术中适当的植入固定能否预防这种情况。这种并发症的低发生率使得解读有关人工耳蜗固定技术的出版物具有挑战性。
全面的文献综述揭示了多种不同的固定技术。大多数作者主张为人工耳蜗的接收器/刺激器(R/S)创建一个骨槽;然而,越来越多的外科医生根本不再固定植入物。在此,我们概述所有已发表的固定方法,特别关注基于证据的质量以及每种方法优缺点的描述。
文献综述表明缺乏关于装置移位的I级循证出版物。现有出版物报道的病例过少,无法就手术固定是否能防止植入物移位得出结论。为了具有统计学效力,对替代或新固定方法的研究应在每个研究组中纳入大量植入病例,且研究应具有纵向性和前瞻性。在缺乏其他证据的情况下,将至少创建一个骨槽和/或(骨)缝线定义为良好做法似乎是合理的。