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Determining the efficacy and cost-effectiveness of the activalve: Results of a long-term prospective trial

Authors

  • Donna J. Graville PhD,

    Corresponding author
    1. From the NW Clinic for Voice and Swallowing, Department of Otolaryngology–Head and Neck Surgery, Portland, Oregon
    • Dept. of Otolaryngology–Head and Neck Surgery, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239-3098
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  • Andrew D. Palmer MS,

    1. Department of Otolaryngology–Head and Neck Surgery, Oregon Health and Science University, Portland, Oregon
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  • Peter E. Andersen MD,

    1. Department of Otolaryngology–Head and Neck Surgery, Oregon Health and Science University, Portland, Oregon
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  • James I. Cohen MD, PhD

    1. Department of Otolaryngology–Head and Neck Surgery, Portland Veterans Affairs Medical Center, Portland, Oregon, U.S.A.
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  • The devices used in this study were provided by Atos Medical at reduced cost in order to make this trial possible. The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Abstract

Objectives/Hypothesis:

To investigate 1) whether the Provox ActiValve results in increased device-life in individuals with below average device-life, 2) whether it is cost-effective, and 3) whether it has any impact on voice-related quality of life.

Study Design:

Prospective study.

Methods:

Individuals who experienced below-average tracheoesophageal prosthesis (TEP) life were studied.

Results:

Individuals with persistent below-average TEP life were enrolled in the study and underwent periodic re-evaluation. The majority (73%) experienced significant improvement as a result of use of the device. Those who continued to wear the device were followed for an average of 30.45 months (range, 14.70–43.49 months) and wore a total of 31 devices over this time. They demonstrated an average increase in device-life of more than 500%, going from an average of 1.93 months with a traditional indwelling device to 10.30 months with the ActiValve. The majority of individuals found that voicing with the ActiValve was either the same or better than with their previous indwelling TEP. Voice-related quality of life was not significantly different from that of a group of controls. Overall satisfaction with the device was high, and the majority would have chosen the ActiValve in the future. Overall, there were estimated to be cost savings to third-party payers through use of the ActiValve in this population.

Conclusions:

The ActiValve is effective in increasing device-life in selected patients who have failed conservative measures. Our protocol for use of the device requires individuals to meet several usage criteria before initial placement and to return for periodic monitoring.

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