Prevention of periprosthetic leakage with double flange voice prosthesis: a systematic review and management protocol proposal.

Objective: To conduct a systematic review of the use and results of the Provox^®Vega^TMXtraSeal^TM in the prevention of periprosthetic leakage and to propose a management protocol for this voice prosthesis.

Methods: Systematic search based on the PRISMA Statement during February 2020. Keywords were double flange, periprosthetic leakage, voice prosthesis, and laryngectomy.

Results: Four articles with 315 voice prosthesis (94 XtraSeal and 221 controls) in 55 patients were found. The XtraSeal mean duration was 114.28 ± 73.2 (CI 95%, 98.29-130.26) days compared to 102.98 ± 17.74 (CI 95%, 100.62-105.35) days of the control group. Out of 266 replacements, endoprosthetic leakage was the most frequent cause in both groups (62.41%). Periprosthetic leaks were less frequent in the XtraSeal (9.62%) than in the control group (22.43%).

Conclusions: The XtraSeal could be effective in preventing periprosthetic leakage and lengthening the time between replacements. Studies with a robust methodology are necessary to confirm these results. Managing voice prosthesis is complex and requires a multidisciplinary and systematic approach by experienced professionals to reduce replacements and complications. Incorrect placement of the XtraSeal could cause a foreign body reaction and consequently inflammation, extrusion, or pressure lesions. The Tower of Hercules protocol: (1) Measurement of the tracheoesophageal fistula using the Provox^® Measure, (2) Minimization of XtraSeal slack by avoiding the complete visualization of the prosthesis' blue ring, (3) Nasofibroscopic examination of the oesophageal wall confirming both flanges are in correct position; could prevent or minimize complications derived from the use of the XtraSeal.