Use of a Novel Hypercrosslinked Carbohydrate Scaffold for Vocal Fold Medialization in an Ovine Model.

Objectives: Vocal fold medialization is commonly performed for glottic insufficiency and vocal fold immobility. Currently available materials are temporary injectables or synthetic implants. Acellular scaffolds may allow vocal fold augmentation with autologous tissue via host cell migration. The purpose of this investigation was to evaluate the use of a novel carbohydrate scaffold as a medialization implant. Study Design: Animal model. Setting: Academic medical center. Methods: Unilateral type I medialization thyroplasty was performed in 3 Dorper cross ewes using a hypercrosslinked carbohydrate polymer (HCCP) scaffold. Animals were monitored for 4 weeks for general well-being, dyspnea, and weight loss. The animals were euthanized at 4 weeks and the larynges harvested. Histologic evaluation was performed to assess for adverse tissue reaction, migration, degradation, and biocompatibility. Results: No adverse events were reported. No animals lost weight or displayed evidence of dyspnea. Histology demonstrated ingrowth of host cells and neovascularization with minimal peri-implant inflammatory reaction. Cellular ingrowth into the scaffold was predominately made up of fibroblasts and early inflammatory cells. Scaffold shape was grossly maintained as it underwent degradation and replacement with host tissue. Migration of the implant material was not observed. Conclusion: Vocal fold medialization in an ovine model with an HCCP scaffold resulted in the ingrowth of host cells with minimal peri-implant inflammation. Scaffold shape was maintained without evidence of migration as it underwent replacement with host tissue. Further research is required to assess long-term efficacy in comparison to currently available implants.