OBJECTIVES: To develop and clinically assess a new prosthesis for voice rehabilitation after total laryngectomy that solves the problem of frequent Candida- and "underpressure"-related replacements. MATERIAL AND METHODS: We designed a voice prosthesis with a new valve mechanism, applying Candida-resistant fluoroplastic (Teflon-like) material for the valve and valve seat and magnets to generate an active closing force, preventing inadvertent opening of the valve during swallowing or deep inhalation. Several prototypes were tested in 13 laryngectomized patients and, subsequently, the final design was assessed in a prospective clinical trial in a cohort of 18 patients with a short device lifetime of their standard indwelling voice prosthesis (mean 30 days). RESULTS: Prototype testing and the long-term clinical trial confirmed that the new valve material remained free of Candida growth and that the use of magnets can prevent inadvertent opening of the valve during swallowing and/or deep inhalation. This resulted in a highly significant increase in device lifetime in the 18 laryngectomized patients in the prospective trial (14-fold increase on average, range 3-39-fold; p < 0.001). Lubrication with special medical-grade fluoridated silicone oil is favorable in patients who experience possible adhesion of the valve to the valve seat. CONCLUSIONS: This new voice prosthesis, the Provox ActiValve, represents a solution for patients who have the problem of requiring very frequent voice prosthesis replacements due to excessive Candida growth and/or inadvertent opening of the valve by swallowing and inhalation-related underpressure in the esophagus.
OBJECTIVES: To develop and clinically assess a new prosthesis for voice rehabilitation after total laryngectomy that solves the problem of frequent Candida- and "underpressure"-related replacements. MATERIAL AND METHODS: We designed a voice prosthesis with a new valve mechanism, applying Candida-resistant fluoroplastic (Teflon-like) material for the valve and valve seat and magnets to generate an active closing force, preventing inadvertent opening of the valve during swallowing or deep inhalation. Several prototypes were tested in 13 laryngectomized patients and, subsequently, the final design was assessed in a prospective clinical trial in a cohort of 18 patients with a short device lifetime of their standard indwelling voice prosthesis (mean 30 days). RESULTS: Prototype testing and the long-term clinical trial confirmed that the new valve material remained free of Candida growth and that the use of magnets can prevent inadvertent opening of the valve during swallowing and/or deep inhalation. This resulted in a highly significant increase in device lifetime in the 18 laryngectomized patients in the prospective trial (14-fold increase on average, range 3-39-fold; p < 0.001). Lubrication with special medical-grade fluoridated silicone oil is favorable in patients who experience possible adhesion of the valve to the valve seat. CONCLUSIONS: This new voice prosthesis, the Provox ActiValve, represents a solution for patients who have the problem of requiring very frequent voice prosthesis replacements due to excessive Candida growth and/or inadvertent opening of the valve by swallowing and inhalation-related underpressure in the esophagus.
Authors: Miguel Mayo-Yáñez; Carlos Chiesa-Estomba; Jérôme R Lechien; Christian Calvo-Henríquez; Luigi A Vaira; Irma Cabo-Varela Journal: Eur Arch Otorhinolaryngol Date: 2022-02-26 Impact factor: 2.503
Authors: Paolo Boscolo-Rizzo; Carlo Marchiori; Alessandro Gava; Maria Cristina Da Mosto Journal: Eur Arch Otorhinolaryngol Date: 2007-11-16 Impact factor: 2.503