Authors: |
Rosen CA, Gartner-Schmidt J, Casiano R, Anderson TD, Johnson F, Reussner L, Remacle M, Sataloff RT, Abitbol J, Shaw G, Archer S, McWhorter A |
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Abstract: |
OBJECTIVES: Evaluate the effectiveness of CaHA injection for patients with glottal incompetence. METHODS: Multi-center, open-label, prospective clinical study with each patient serving as his/her own control. Voice-related outcome measures were collected for pre-injection and 1, 3, and 6 months. RESULTS: Sixty-eight patients were available for evaluation. Fifty percent of the injection procedures were done in office. Fifty-seven percent were diagnosed with unilateral paralysis and 42% with glottal incompetence with mobile vocal folds. Patient satisfaction 6 months post showed 56% had significantly improved voice and 38% reported moderately improved voice. Paired t tests from baseline to 6 months showed significant improvements on the VHI and VAS (vocal effort), CAPE-V judgments of voice severity and videoendostroboscopy ratings of glottal closure, and objective voice measures of glottal closure (MPT and S:Z ratio). CONCLUSIONS: Preliminary results in this large cohort of patients demonstrate excellent clinical results. |