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Safety and Clinical Efficacy

Jin-Young Min, MD; Sang-Duk Hong, MD; Kwhanmien Kim, MD; Young-Ik Son, MD

Arch Otolaryngol Head Neck Surg. 2008;134(5):490-496.

Objective  To determine the long-term clinical efficacy and safety of injections of Artecoll, a soft-tissue filler consisting of a suspension of polymethyl methacrylate microspheres in a 3.5% solution of bovine collagen, into a vocal fold for managing glottal insufficiency secondary to unilateral vocal fold motion impairment.

Design  Single-institution retrospective study.

Setting  A single tertiary care teaching hospital of Sungkyunkwan University School of Medicine.

Patients  Ninety-six patients with unilateral vocal fold motion impairment.

Interventions  Percutaneous Artecoll injection laryngoplasty under local anesthesia.

Main Outcome Measures  Acoustic, aerodynamic, and stroboscopic analyses were performed before injection and 1 week and 3, 6, and 12 months after injection. Two speech-language pathologists performed the perceptual assessment, and we used the subjective rating of hoarseness by the patients.

Results  The maximal phonation time, shimmer (amplitude variation), jitter (frequency variation), and ratio of noise to harmonic showed significant improvement 3 months after injection; these improvements were maintained 12 months after injection (P < .05). The GRBAS scale (overall grade of hoarseness, roughness, breathiness, asthenicity, and strain) grades and subjective patient-rated scores of hoarseness improved from 1 week after injection, and the improvements were maintained 12 months after injection (P < .05). We observed no significant early or delayed adverse events.

Conclusion  Injection laryngoplasty with Artecoll is a safe, useful, and durable treatment option for the management of glottal insufficiency secondary to unilateral vocal fold motion impairment.

Author Affiliations: Departments of Otorhinolaryngology–Head and Neck Surgery (Drs Min, Hong, and Son) and Thoracic and Cardiovascular Surgery (Dr Kim), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.