A new problem-solving indwelling voice prosthesis, eliminating the need for frequent Candida- and "underpressure"-related replacements: Provox ActiValve.
OBJECTIVE
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.


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.
Hilgers
Frans J M
FJ
Department of Otolaryngology-Head & Neck Oncology and Surgery, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands. fhilgers@nki.nl
Ackerstaff
Annemieke H
AH
Balm
Alfons J M
AJ
Van den Brekel
Michiel W M
MW
Bing Tan
I
I
Persson
Jan-Ove
JO
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002177:Candidiasis / Q000517:prevention & control*; D003679:Deglutition / Q000502:physiology; D005260:Female; D006801:Humans; D001239:Inhalation / Q000502:physiology; D007825:Laryngectomy; D007831:Larynx, Artificial; D008280:Magnetics; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene / Q000627:therapeutic use*; D011312:Pressure; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D013071:Speech, Alaryngeal / Q000295:instrumentation*
D011138:Polytetrafluoroethylene