Safety profile of office-based Hyadex® injection laryngoplasty: a 146-procedure single-center experience.

PURPOSE: To evaluate the safety profile of dextranomer/cross-linked hyaluronic acid (Hyadex®) administered via an office-based trans-cervical approach for glottic insufficiency, and to characterize the incidence, features, timing, and management of procedure-related complications. METHODS: We retrospectively analyzed, at a single center, all patients who underwent office-based trans-cervical vocal fold augmentation with Hyadex® between January 2021 and December 2023, performed by a single laryngologist using a standardized technique. Complications were defined as any adverse event within 30 days requiring medical intervention beyond routine care. Complicated and uncomplicated cases were compared using Fisher's exact test. RESULTS: Among 146 injection sessions in 138 patients (80 male, 58 female; mean age 48.8 years), unilateral vocal fold paralysis was the most common etiology (84.1%). Seven sessions (4.8%; 95% CI: 2.3-9.6%) involved complications. The predominant symptom was dyspnea, with one patient presenting with dysphagia; the associated finding was vocal fold edema in six patients and arytenoid edema in one. Mean symptom onset was 2.5 days, and six patients (85.7%) needed inpatient corticosteroids. One patient developed colonic perforation secondary to diverticulitis during high-dose corticosteroid therapy. All patients achieved full clinical resolution without permanent sequelae. No significant differences were found by sex (p = 0.454) or etiology (p = 0.597). CONCLUSIONS: Office-based trans-cervical Hyadex® injection carries a complication rate of 4.8%, consistent with published HA-based rates. Adverse events are predominantly early-onset, particulate-mediated inflammatory reactions that respond to corticosteroid therapy. Serious systemic complications of corticosteroid treatment must be carefully considered, particularly in patients with gastrointestinal comorbidities. Hyaluronidase should be recognized as a rescue option in refractory cases.