192 | Chapter 8 Abstract Background: The Provox Vega High Performance (PVHP) is a newly developed voice prosthesis (VP) with an aim to achieve a longer and more predictable lifetime. Objectives: This feasibility study aims to assess patient acceptance of the PVHP VP, evaluate adverse events, voice quality, and device lifetime. Methods: Laryngectomized patients previously using a Provox Vega or ActiValve Light were included. Acceptance and voice outcomes were evaluated at two time points with a two-week interval. Baseline measurements were taken with the standard VP, followed by placement of the PVHP for the two-week assessment. Results: Fifteen participants completed the study, with thirteen being initial Vegausers. PVHP acceptance was 87% two weeks after placement. Median device lifetime for all VPs was 64 days (range 14-370). In the subgroup without periprosthetic leakage, the median device lifetime was 101 days (range 31-370). Acceptance dropped to 40% after device failure. Voice quality did not differ between PVHP and baseline VP. The most reported adverse event was PVHP valve stickiness (46%). Conclusion and Significance: Acceptance of the PVHP is largely dependent on device lifetime, decreasing from 87% to 40% after leakage or replacement. Voice quality remains consistent across different VPs. Developing a long-lasting VP remains a challenge. Keywords: Voice prosthesis, rehabilitation, laryngectomy, head-and-neck oncology
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