Otorhinolaryngology - Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña, Spain.
Clinical Research in Medicine, International Center for Doctorate and Advanced Studies (CIEDUS), Universidade de Santiago de Compostela (USC), Santiago de Compostela, Spain.
Clin Otolaryngol. 2020 May;45(3):389-393. doi: 10.1111/coa.13513. Epub 2020 Feb 20.
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.
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.
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).
Provox XtraSeal seems to be effective reducing the number of changes due to periprosthetic leakage, thus increasing the survival of voice prosthesis.
气管食管语音被认为是全喉切除术后康复的金标准。语音假体的主要问题之一是假体周围漏。Provox Vega XtraSeal 在假体的咽侧增加了一个双凸缘，以避免这些故障。本研究旨在比较 Provox Vega 和 Provox Vega XtraSeal 之间的装置寿命，并研究可能影响其持续时间的相关因素。
对 20 例因假体周围漏而接受 Provox Vega 治疗的喉切除患者进行前瞻性病例交叉研究，并为其放置 Provox Vega XtraSeal。使用 Kaplan-Meier 曲线和 Cox 比例风险回归与 Schoenfeld 残差检验来研究生存和可能影响语音假体的因素，以检验可能的假设。
共评估了 230 个假体。更换的最常见原因是两种型号的内假体漏（n=146，67%）。Provox Vega 的平均寿命为 104.474±7.29 天（95%CI 90.19-118.76），Provox XtraSeal 的平均寿命为 176.76±26.46 天（95%CI 124.9-228.61）（P=0.012）。放射治疗的补充治疗显示出更高的装置生存率（P=0.007）。
Provox XtraSeal 似乎能有效减少因假体周围漏而导致的更换次数，从而提高语音假体的生存率。
