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  • Title: Voice restoration with the advantage tracheoesophageal voice prosthesis.
    Author: Leder SB, Acton LM, Kmiecik J, Ganz C, Blom ED.
    Journal: Otolaryngol Head Neck Surg; 2005 Nov; 133(5):681-4. PubMed ID: 16274792.
    Abstract:
    OBJECTIVES: To determine whether the Blom-Singer indwelling Advantage tracheoesophageal voice prosthesis (TEP) extends prosthesis life span significantly in patients with documented premature device failure due to fungal colonization. STUDY DESIGN AND SETTING: Data were collected in a prospective manner on a total of 42 standard indwelling TEP users who exhibited early device failure, that is, between 2 weeks and 6 months, due to fungal colonization of the flap valve despite appropriate use of oral antifungal agents. There were 29 men and 13 women, whose ages ranged from 36 years 10 months to 86 years 8 months. METHODS: Baseline data were derived from the average number of days 3 previous standard indwelling prostheses functioned before leaking. An Advantage indwelling TEP was placed after the third change, oral antifungal agents stopped, and routine care implemented, that is, flush and brush the device in situ twice each day. Each participant was assigned to 1 of 3 groups. Group 1 had device failure equal to or less than 2 months (n = 12). Group 2 had device failure between 2 and 4 months (n = 19). Group 3 had device failure between 4 and 6 months (n = 11). RESULTS: Groups 1 and 2 exhibited significantly longer device life span, that is, 77 and 82 days, respectively (P < 0.01), and group 3 exhibited device life span that was longer but not significantly so, that is, 12 days (P > 0.05), after the change from standard to Advantage TEP. Individual data indicated that the majority of participants, that is, 32 of 42 (76.2%), experienced longer device life span after changing to the Advantage prosthesis. Specifically, 9 of 12 (75.0%) users in group 1, 17 of 19 (89.5%) users in group 2, and 6 of 11 (54.5%) users in group 3 exhibited longer device life span. The combination of using an Advantage TEP, discontinuing oral antifungal agents, and reducing the number of both TEP changes and clinic visits resulted in overall cost benefits for both the user and the health care system. The cost benefit for group 1 was dollar 520.00; group 2, dollar 393.00; and group 3, dollar 204.25. CONCLUSIONS: The Advantage TEP extended device life span significantly for standard indwelling device users with documented premature device failure due to fungal colonization, reduced costs associated with tracheoesophageal voice restoration rehabilitation, and enhanced user satisfaction by eliminating use of oral antifungal agents and reducing clinic visits. SIGNIFICANCE: Use of an Advantage indwelling voice prosthesis is warranted from both cost and user satisfaction perspectives when early and repeated device failure occurs as a result of fungal colonization. EBM RATING: B-3.
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