Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients.

BACKGROUND

Tracheoesophageal speech with a voice prosthesis is considered the rehabilitation treatment of choice in laryngectomized patients. The main reasons for prosthesis failure are endoprosthetic leakage and periprosthetic leakage. The Provox XtraSeal stent incorporates an additional double flange on the esophageal side to prevent periprosthetic leakage. The objective of this study is to compare the duration and costs of the Provox Vega and Provox XtraSeal prostheses used in these patients in a tertiary university hospital.

MATERIALS AND METHODS

A prospective crossover case study of laryngectomees with Provox Vega who underwent Provox XtraSeal placement due to recurrent periprosthetic leaks and decreased theoretical prosthesis life. The duration and possible factors affecting voice prostheses were studied using Kaplan-Meier curves and Cox regression. A cost-effectiveness analysis was carried out from the perspective of the Spanish National Health System with an incremental cost-effectiveness calculation.

RESULTS

A total of 38 patients were recruited, 35 men and 3 women, with a mean age of 66.26 ± 9.36 years old. Information was collected from 551 voice prostheses, 484 Provox Vega and 68 Provox XtraSeal. The mean duration of Provox Vega was 119.75 ± 148.8 days and that of Provox XtraSeal was 181.99 ± 166.07 days ( = 0.002). The most frequent reason for replacement was endoprosthetic leakage in both groups: 283 (60.86%) in the case of Provox Vega and 29 (48.33%) in that of XtraSeal ( < 0.000). To obtain no cost differences (ICE ~ 0) between Provox Vega and Provox XtraSeal, the latter should cost EUR 551.63.

CONCLUSIONS

The Provox XtraSeal is a cost-effective option in patients with increased prosthesis replacements due to periprosthetic leakage, reducing the number of replacements, increasing the duration of the prosthesis, and providing savings compared to Provox Vega.