Laryngeal Pacing for the treatment of bilateral vocal fold paralysis: 24m results of aprospective first-in-human study

Introduction Bilateral vocal fold paralysis (BVFP) is a potentially life-threatening disease causing persistent moderate to severe dyspnea with a significant negative impact on the patients’ quality of life. Surgical glottal enlargement is its current state-of-art treatment. Laryngeal pacing is emerging as potential conservative alternative when at least one of the 2 posterior cricoarytenoid (PCA) muscles shows a partial normal or synkinetic reinnervation. Our study monitored the performance of a not-yet-on-the-market Laryngeal Pacemaker (LP) System over 24m after unilateral implantation.

Methods 7/9 patients were successfully implanted with the LP System. Respiration quality; swallowing capacity; quality of life (SF-36 and GBI); six-minute walk test (6MWT); jitter; maximum phonation time (MPT); voice range profile (VRP); Voice Handicap Index-12 (VHI-12); roughness, breathiness and hoarseness (RBH) were evaluated pre-operatively, 1-, 6-, 12-, and 24m after implantation.

Results In 3/7 patients an electrode breakage occurred after 14 and in 2/7 after 53m. 2/7 patients are currently implanted (>5y). Peak Expiratory Flow, MPT, Sound Pressure Level Range, and 6MWT showed a significant improvement within 6m upon implantation, while Peak Inspiratory Flow and quality of life questionnaires within 12m upon implantation. The other parameters did not significantly change in the 2y after implantation.

Conclusions Although evaluated in a limited sample size, the results on the performance of the LP System are encouraging. The electrode design has been changed to improve its expected life and resistance to fatigue and mechanical stress. The upcoming pivotal study will evaluate a new design in a larger group of patients to confirm the safety and clinical benefits of the LP System.

Poster-PDF A-1740.PDF

Publication History

Article published online:
10 June 2020