What is it about?
This study was conducted to evaluate the performance and safety of the newly developed Laryngeal Pacemaker System (LP System) for the treatment of bilateral vocal fold paralysis (BVFP). STUDY DESIGN: Feasibility, first-in-human, single-arm, open-label, prospective, multicenter study with a group sequential design and a 6-month follow-up period. METHODS: Nine symptomatic BVFP subjects were implanted unilaterally with the LP System. Pre- and 6-month post implantation evaluations consisted of the 6-Minute Walk Test (6MWT), the Peak Expiratory and Inspiratory Flow (PEF and PIF) evaluation, the PEF meter analysis, the 36-Item Short Form Health Survey (SF-36), the Glasgow Benefit Inventory (GBI), the 12-Item Voice Handicap Index (VHI-12), and the Fiberoptic Endoscopic Evaluation of Swallowing. The safety profile of the LP System was continuously monitored. RESULTS: The LP System implantation was achieved in 8/9 cases. Seven of the nine subjects completed the study. Absolute PEF and PIF values improved significantly 6 months post implantation (P < .05). 6MWT results showed a non-statistically significant improvement (P = .09). The mental component of the SF-36 showed a significant improvement (P = .043), whereas the other SF-36 components, the GBI, and the VHI-12 results did not changed significantly. The LP System did not affect the voice and swallowing quality and maintained a reliable safety profile for the duration of the study. CONCLUSIONS: This feasibility study showed that the LP System has the potential to become an effective and safe treatment for BVFP subjects without compromising the patients' voice.
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Why is it important?
The LP System is the first attempt to develop a selective laryngeal stimulator associated with a minimally invasive surgical procedure. The LP System has the potential to become an effective and safe treatment for bilateral vocal cord paresis/palsy (BVFP, BVCP).
Read the Original
This page is a summary of: Laryngeal pacing via an implantable stimulator for the rehabilitation of subjects suffering from bilateral vocal fold paralysis: A prospective first-in-human study, The Laryngoscope, November 2015, Wiley, DOI: 10.1002/lary.25792.
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Laryngeal pacing for bilateral vocal fold paralysis: Voice and respiratory aspects
The aim of this article was 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.
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