Provox 2® and Provox Vega® device life-time: a case-crossover study with multivariate analysis of possible influential factors and duration.

Abstract

Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. Current literature is limited and contradictory about the possible causes of device failure. The aim of the study is to compare the device life-time between the Provox 2 and Provox Vega and to examine possible related factors that influence their duration. Retrospective case-crossover study in 34 laryngectomized patients who had undergone tracheoesophageal voice rehabilitation using indwelling Provox 2 and Provox Vega voice prostheses between 2010 and 2016 in a tertiary care centre. A total of 440 prostheses were evaluated. The most frequent reason for replacement was due to an endoprosthesis leakage (n = 221, 64.2%) in both models. Radiotherapy increases the risk of prosthesis replacement (IRR = 1.88, p = 0.007) as well as bilateral neck dissection (IRR = 1.56, p = 0.017) in Provox 2. Age and unilateral neck dissection do not seem to influence the duration of the prosthesis. Mean life-time of Provox 2 was 106.64 days and 124.19 days for Provox Vega (p = 0.261). Complementary treatment with radiotherapy demonstrated a lower device survival (p < 0.001). Results confirmed the non-significant differences on device life between Provox Vega and Provox 2, as well as the relevant role of radiotherapy treatment in the increase of replacements and diminution of the device duration.