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.