Prospective Short-Term Outcomes of Allograft Adipose Matrix (AAM) for Vocal Fold Augmentation.

Abstract

Injection laryngoplasty is a common procedure to improve glottic closure following unilateral vocal fold paralysis (UVFP) or vocal fold atrophy. Allograft adipose matrix (AAM, Renuva, MTF Biologics) supports neoadipogenesis making it a potentially permanent solution. Given the known favorable properties of vocal fold lipoinjection, we hypothesize AAM to be a useful injection material with possible durable results following injection laryngoplasty. A prospective clinical trial of patients with UVFP underwent injection augmentation laryngoplasty with AAM. Blinded independent laryngologists and expert listeners used pretreatment and 3-month postinjection videostroboscopy and CAPE-V assessments to evaluate glottic closure, pliability and voice quality changes. Patient-reported outcome measures (PROMs) were evaluated. A total of 21 patients underwent AAM injection; 16 had a diagnosis of unilateral vocal fold paralysis and were included for analysis. There were no adverse reactions. The raters observed an improvement in post-treatment voice in 81.3% of cases, and CAPE-V scores showed an average reduction of 32.3 points (p < 0.01). There was an average reduction in VHI-10 scores of 11.3 (p = 0.02). The raters perceived the post-AAM treatment videostroboscopy exams to be better in 68.8% of cases. Thirty-seven percent of incomplete glottic closure was considered complete, and there was no change in pliability at 3 months post-AAM injection. This is the first study on AAM as an injection material in the vocal fold for augmentation laryngoplasty in unilateral vocal fold paralysis. It appears to be safe and effective on early follow-up. Additional studies with longer follow-up are needed.