The custom-fit voice prosthesis, for treatment of periprothetic leakage after tracheoesophageal voice restoration

BACKGROUND: Leakage around an indwelling voice prosthesis is detected during 13% up to 27% of all replacement procedures of voice prosthesis and causes serious complications in further voice restoration of the laryngectomee. Lots of therapeutic options to stop periprothetic leakage have been described (Injection of Bioplastique, autologous fat or collagen, suture techniques, spacer therapy) without convincing success rates. METHODS: Custom-fit voice prostheses are ordinary indwelling voice prostheses (Blom-Singer low pressure Indwelling 20 fr) with enlarged flanges and reduced shaft length that are individually sized for the shunt of the laryngectomee. Especially enlarging the esophageal flange provides a tight sealing of leakage around the prosthesis. PATIENTS: In a one year lasting clinical trial 692 voice prostheses were changed. In 77 cases periprothetic leakage was detected and fistulas were fitted with individually sized voice prostheses. RESULTS: In 76 cases total control of leakage was achieved without any specific complications taking place. Moreover two types of leaking tracheoesophageal fistulas were distinguished, a dilated-atrophic and an infected-necrotic type. 57% of the fistulas were dilated-atrophic type and 43% of the fistulas were classified infected-necrotic type. Infected-necrotic fistulas needed enlarged flanges tracheal an esophageal for tight sealing in 91% of the cases whereas dilated-atrophic fistulas needed double flanges only in 45%. 70% of infected-necrotic type fistulas needed only one singular history of a custom-fit prosthesis and could be changed back to ordinary indwelling prostheses after healing had taken place. CONCLUSIONS: As the insertion of a modified prosthesis is only slightly more effort than an ordinary voice prosthesis insertion, the success rate is high und complications are rare we recommend the custom-fit voice prosthesis for treatment of periprothetic leakage.