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
