OBJECTIVES: To evaluate the long-term effectiveness of calcium hydroxylapatite (CaHA) vocal fold injection for patients with glottal insufficiency. STUDY DESIGN: Multicenter, open-label, prospective clinical study of CaHA vocal fold injection. METHODS: Each patient served as his/her own control. Voice-related outcome measures were collected for pre-injection, 1, 3, 6, and 12 months. RESULTS: Sixty-three patients were available for evaluation. Fifty-three percent of the injection procedures were done in the office. Fifty-seven percent of patients were diagnosed with unilateral paralysis and 43% with glottal incompetence with mobile vocal folds. Patient satisfaction 12 months after injection showed 67% reporting a significant improvement in voice and 81% reporting at least a moderate improvement in voice. Utilizing the Voice Handicap Index-10, visual analog scale (vocal effort), Consensus Assessment Perceptual Evaluation V (judgments of voice severity), and objective voice measures of glottal closure (maximum phonation time and S:Z ratio), paired t tests showed significant improvements after treatment. A 22% further treatment rate was found at the 12-month time point. CONCLUSIONS: One-year results in this large cohort of patients with glottal incompetence treated with CaHA vocal fold injection demonstrate that excellent clinical results were achieved.
OBJECTIVES: To evaluate the long-term effectiveness of calcium hydroxylapatite (CaHA) vocal fold injection for patients with glottal insufficiency. STUDY DESIGN: Multicenter, open-label, prospective clinical study of CaHA vocal fold injection. METHODS: Each patient served as his/her own control. Voice-related outcome measures were collected for pre-injection, 1, 3, 6, and 12 months. RESULTS: Sixty-three patients were available for evaluation. Fifty-three percent of the injection procedures were done in the office. Fifty-seven percent of patients were diagnosed with unilateral paralysis and 43% with glottal incompetence with mobile vocal folds. Patient satisfaction 12 months after injection showed 67% reporting a significant improvement in voice and 81% reporting at least a moderate improvement in voice. Utilizing the Voice Handicap Index-10, visual analog scale (vocal effort), Consensus Assessment Perceptual Evaluation V (judgments of voice severity), and objective voice measures of glottal closure (maximum phonation time and S:Z ratio), paired t tests showed significant improvements after treatment. A 22% further treatment rate was found at the 12-month time point. CONCLUSIONS: One-year results in this large cohort of patients with glottal incompetence treated with CaHA vocal fold injection demonstrate that excellent clinical results were achieved.
Authors: Anna-Katharina Rohlfs; Eric Goodyer; Till Clauditz; Markus Hess; Malte Kob; Susan Koops; Klaus Püschel; Frank W Roemer; Frank Müller Journal: Eur Arch Otorhinolaryngol Date: 2013-03-28 Impact factor: 2.503