OBJECTIVES: To assess the long-term results of the Provox ActiValve, a prosthesis for voice rehabilitation after total laryngectomy that was designed to lessen the need for frequent replacements caused by Candida and "underpressure." PATIENTS AND METHODS: Retrospective assessment of device lifetime, indications for replacement, voice quality, and maintenance issues, measured by a structured trial specific questionnaire, in a cohort of 42 laryngectomized patients, experiencing a short Provox2 device lifetime (median, 21 days). RESULTS: The median device lifetime of Provox ActiValve, replaced for leakage through the device and those still in situ at the date of data collection (N = 32), was 337 days (mean 376 days): a statistically significant 16-fold increase compared to the Provox2 prosthesis (P < .001). In 10 patients, replacement was fistula-related (median after 86 days): esophageal pouch (N = 4), fistula granulation (N = 3), extrusion of the device (N = 2), and periprosthetic leakage (N = 1). Eighty-six percent of the patients used a special lubricant to diminish "stickiness" of the valve. Provox ActiValve was preferred by 90% of the patients who completed the trial-specific questionnaire. CONCLUSIONS: For patients requiring frequent device-related replacements, Provox ActiValve, also long-term, provides a true solution and thereby is a valuable addition to prosthetic voice rehabilitation.
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Soolsma et al. (2008) studied this question.