Objectives/hypothesis: 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 postimplantation 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 postimplantation (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.
Level of evidence: 2b Laryngoscope, 126:1810-1816, 2016.
Keywords: Bilateral vocal fold paralysis; first-in-human; laryngeal pacing; neurostimulation; prospective study; safety; treatment outcome.
© 2016 The American Laryngological, Rhinological and Otological Society, Inc.