Use of Double Flange Voice Prosthesis for Periprosthetic Leakage in Laryngectomised Patients: A Prospective Case-Crossover Study.

Introduction Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. One of the main problems of voice prosthesis is the periprosthesis leakage. Provox Vega XtraSeal incorporates a double flange on the pharyngeal side of the prosthesis in order to avoid these failures. The aim of the study is to compare the device lifetime between the Provox Vega and Provox Vega XtraSeal and to examine possible related factors that influence their duration. Methods Prospective case-crossover study in 20 laryngectomised patients with Provox Vega and periprothesis leakage to whom a Provox Vega XtraSeal was placed. Survival and possible factors that affect voice prosthesis were studied using Kaplan-Meier curves and Cox Proportional Hazards Regression with Schoenfeld residuals to test the possible assumptions. Results A total of 230 prostheses were evaluated. The most frequent reason for replacement was due to an endoprosthesis leakage (n = 146, 67%) in both models. Mean lifetime of Provox Vega was 104.474 +/- 7.29 days (CI 95% 90.19-118.76) and of Provox XtraSeal was 176.76 +/- 26.46 days (CI 95% 124.9-228.61) (P = .012). Complementary treatment with radiotherapy demonstrated a higher device survival (P = .007). Discussion Provox XtraSeal seems to be effective reducing the number of changes due to periprosthetic leakage, thus increasing the survival of voice prosthesis.