Pharyngoseal® adjustable prosthesis for salivary fistula treatment, a STROBE study.

OBJECTIVES: To assess the effectiveness and reliability of the adjustable double-flanged Pharyngoseal® prosthesis (Blom-Singer®, Collin Medical) as a temporary solution or alternative to surgery for post-laryngectomy salivary fistula or enlarged tracheoesophageal fistula after voice prosthesis implantation. MATERIALS AND METHODS: A single-center retrospective observational study (2021-2025) included all patients who underwent Pharyngoseal® implantation under local or general anesthesia. The primary objective was to compare quality-of-life scores on a Visual Analogue Scale (VAS) before and after implantation. Secondary endpoints comprised reduction in salivary leakage (VAS), implant-related complications and resumption of solid or liquid oral feeding. RESULTS: Ten patients were included: 5 with postoperative fistula after total pharyngolaryngectomy, and 5 with enlarged tracheoesophageal fistula exceeding the maximum dimensions of available voice prostheses. Seven patients were awaiting or deemed unsuitable for surgical closure, and 3 were in palliative care. Thirteen prostheses were implanted, including 11 (85%) under local anesthesia, mostly via a retrograde approach (55%). Median implant use was 45 days [range, 31-153.5]. There was significant improvement in quality of life, with VAS decreasing from 8/10 to 4/10 (P=0.01), and salivary leakage from 7/10 to 2.5/10 (P<0.01). Two prostheses had to be removed (20%). Fistula closure was complete for 3 patients (30%). Six patients resumed solid oral feeding and 4 resumed liquid feeding. CONCLUSION: The Pharyngoseal® implant appeared to be a reliable option for salivary fistula management while awaiting surgery or in palliative situations.