Miguel Mayo-Yáñez1,2, Irma Cabo-Varela1, Jorge Suanzes-Hernández3, Christian Calvo-Henríquez2,4, Carlos Chiesa-Estomba5, Jesús Herranz González-Botas1,6. 1. Otorhinolaryngology - Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña, Spain. 2. Clinical Research in Medicine, International Center for Doctorate and Advanced Studies (CIEDUS), Universidade de Santiago de Compostela (USC), Santiago de Compostela, Spain. 3. Support Investigation Unit, Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña, Spain. 4. Otorhinolaryngology - Head and Neck Surgery Department, Complexo Hospitalario Universitario Santiago de Compostela (CHUS), Santiago de Compostela, Spain. 5. Otorhinolaryngology - Head and Neck Surgery Department, Hospital Universitario Donostia, Donostia, Spain. 6. School of Medicine and Odontology, Universidade de Santiago de Compostela (USC), Santiago de Compostela, Spain.
Abstract
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.
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.
Authors: Miguel Mayo-Yáñez; Carlos Chiesa-Estomba; Jérôme R Lechien; Christian Calvo-Henríquez; Luigi A Vaira; Irma Cabo-Varela Journal: Eur Arch Otorhinolaryngol Date: 2022-02-26 Impact factor: 2.503
Authors: Stéphane Hans; Grégoire Vialatte de Pemille; Robin Baudouin; Aude Julien-Laferriere; Florent Couineau; Lise Crevier-Buchman; Marta P Circiu; Jérôme R Lechien Journal: J Clin Med Date: 2022-07-15 Impact factor: 4.964