Determining the efficacy and cost-effectiveness of the ActiValve: results of a long-term prospective trial.

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.