Laryngeal Pacing for Bilateral Vocal Fold Paralysis: Voice and Respiratory Aspects
Laryngeal Pacing for Bilateral Vocal Fold Paralysis: Voice and Respiratory Aspects
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DOI：
10.1002/lary.26428
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发表时间：
2017-08-01
期刊：
影响因子：
2.6
通讯作者：
Nawka, Tadeus
中科院分区：
文献类型：
--
作者：
Mueller, Andreas H.;Hagen, Rudolf;Nawka, Tadeus
目的：评价双侧声带麻痹（BVFP）患者使用喉起搏器（LP）系统进行神经刺激对嗓音质量和呼吸功能的影响。研究设计：可行性研究，首次人体试验，单臂，开放标签，前瞻性，多中心研究，采用组序贯设计和6个月随访期，详见我们以前的出版物。方法：在德国和奥地利的3家研究中心，9名症状性BVFP受试者单侧植入LP系统。主观和客观的语音功能，肺功能参数以外的呼气峰/吸气流量（PEF/PIF），和PEF计自我评估进行了评价前和6个月postimplantation.Results：在一般情况下，LP系统没有显着改变植入患者的语音质量。仅声压级范围在植入后6个月显著改善（P = 0.018）。LP系统植入不影响声门闭合构型、闭合相持续时间和植入侧的粘膜波。评估的肺功能参数没有显着影响喉起搏，而PEF计自我评估显示一个稳定的和显着的（P = 0.028）改善的PEF在一周内激活LP system.Conclusion：神经刺激LP系统的结果在一个立即和稳定的PEF改善，没有负面影响的声音质量。PEF仪自我评估证实了PEF的肺功能测定结果。刺激外展并不影响声门闭合发声。这些结果应该在更大和更同质的患者队列中得到证实。
Objective: To evaluate the effects of neurostimulation with the laryngeal pacemaker (LP) system in patients with bilateral vocal fold paralysis (BVFP) in terms of voice quality and respiratory function.Study Design: Feasibility study, first-in-human, single-arm, open-label, prospective, multicenter study with group-sequential design and 6-month follow-up period, as described in details in our previous publication.Methods: Nine symptomatic BVFP subjects were unilaterally implanted with the LP system at three study sites in Germany and Austria. Subjective and objective voice function, spirometric parameters other than peak expiratory/inspiratory flow (PEF/PIF), and PEF-meter self-assessment were evaluated pre- and 6 months postimplantation.Results: In general, the LP system did not considerably change the voice quality of the implanted patients. Only the sound pressure level range improved significantly 6 months postimplantation (P = 0.018). The LP system implantation did not affect the glottal closure configuration, the duration of the closed phase, and the mucosal wave of the implanted side. The evaluated spirometric parameters were not significantly affected by laryngeal pacing, whereas PEF meter self-assessment showed a stable and significant (P = 0.028) improvement of the PEF within a week upon activation of the LP system.Conclusion: Neurostimulation with the LP system results in an immediate and stable PEF improvement, without negative effects on the voice quality. The PEF meter self-assessment confirmed the spirometry results of the PEF. The stimulated abduction did not affect the glottal closure during phonation. These results should be confirmed in larger and more homogenous patient cohorts.