Laryngeal pacing via an implantable stimulator for the rehabilitation of subjects suffering from bilateral vocal fold paralysis: A prospective first-in-human study.

Abstract

To evaluate the performance and safety of the newly developed Laryngeal Pacemaker System (LP System) for the treatment of bilateral vocal fold paralysis (BVFP). Feasibility, first-in-human, single-arm, open-label, prospective, multicenter study with a group sequential design and a 6-month follow-up period. 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. 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. 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. 2b Laryngoscope, 126:1810-1816, 2016.