Prophylactic Scheduled Voice Prosthesis Replacement for Improved Outcomes

Clinical Publications of Interest 2026-08

This issue covers a retrospective single-center cohort study, in which two different voice prosthesis replacement approaches were employed to determine the effects on the incidence and rate of tracheoesophageal fistula complications. One approach involved performing voice prosthesis replacements in an unscheduled, reactive fashion, while the other utilized a prophylactic, scheduled regimen, where voice prostheses were replaced every 3 months. The results of the study show that scheduled voice prosthesis replacement is a cost-neutral approach and reduces fistula complications and hospitalizations.

Okla S, Spalek J, Kaliniak S, Strzelecka A, Chrobot M, Macek P, et al. Benefits of prophylactic voice prosthesis replacement: a retrospective study. Front Oncol. 2025;15:1566697.

Scheduled & unscheduled VP replacement approaches were associated with different device lifetimes

• The retrospective single-center study in Poland evaluated two VP replacement approaches between 2017-2022. An unscheduled, reactive VP replacement approach (UVPR) was employed between 2017-2019. During 2020-2022, a scheduled VP replacement approach (PVPR) was implemented, in which VPs were routinely replaced every 3 months in the clinic.
• VP replacement technique and VPs used (Provox 2, Provox Vega, Provox Vega XtraSeal) were unchanged during the UVPR and PVPR periods. No difference was noted in prior treatment, primary tumour location or clinical stage of cancer between the patient groups. The main difference was that VPRs were carried out only by the most experienced physicians during the PVPR period.
• During the UVPR period, the average DL was 209 days, with a median of 1-2 VPs per patient. The PVPR period had an average DL of 133 days, and a median of 3-4 VPs per patient.

Number of patients without complications was significantly lower in the PVPR group

• The number of patients in the UVPR and PVPR periods was comparable, 246 and 250 patients, respectively.
• The number of patients that experienced TEF-related complications was significantly lower in the PVPR period (p < 0.001). During the UVPR period, 54% of patients experienced complications, compared to 14% of patients having complications in the PVPR period.
• The types of TEF complications were the same for both the UVPR and PVPR periods, with TE fistula widening being the most common TEF-related complication during both periods, 80% and 78%, respectively.

More VPRs were carried out in the PVPR period, but with fewer complications

• A total of 1520 VP replacements were carried out in the PVPR period, compared to 911 in the UVPR period.
• During the PVPR period, there were fewer VPRs procedures with TEF-related complications. Almost half of all VPRs during the UVPR period gave rise to TEF-related complications (47%). This complication rate fell to 6% during the entire PVPR period.
• The median number of VPR procedures with complications was 1.0 in the UVPR period and 0 in the PVPR period.

Total number of hospitalization days due to complications was higher in the UVPR period

• In accordance with the National Healthcare System requirements, all VP replacements were carried out as a hospital procedure. As such, any hospitalization of more than 1 day was considered a complication.
• During the UVPR period, the total number of hospitalization days due to all causes was 2731. Out of the 2731 hospitalization days, 1820 were due to TEF-related complications.
• The total number of hospitalization days was 1956 during the entire PVPR period, with only 436 being due to fistula complications.
• For both the UVPR and PVPR period, the median number of hospitalization days per patient was 7. However, median number of hospitalizations due to TEF-related complications per patient was 5 for the UVPR group and 0 for the PVPR group.

PVPR was cost-neutral while reducing TEF-related complications in the Polish healthcare setting

• The total cost of the UVPR period, accounting for the cost per VP, the number of VP replacement hospitalizations, and the number of hospitalizations due to complications, was €1,069,875. The total cost of the PVPR period was €1,069,900, making this a cost-neutral approach. *
• A scheduled VP regimen reduces the organization burden of the clinic and ensures that the most experienced physicians are available for patients’ procedures. Additionally, scheduling visits allows for oncological monitoring of patients at risk of cancer recurrence.

*The reported costs in this study should be interpreted in the context of the Polish healthcare setting, where VP replacement is performed as an in-hospital procedure and therefore involves hospitalization. This differs from many other countries, where VP replacement is typically performed in an outpatient clinic without hospitalization. As a result, the Polish local care pathway has a substantial impact on the overall cost analysis.

A homogenous cohort also showed a reduction in the incidence of complications

• Of the total 327 patients that participated, 84 were present during the entire 6-year span of the study, and these were analyzed separately as a homogenous study group.
• During the UVPR period 21.4% of these patients did not experience TEF-related complications. This number rose to 72.6% of the patients being complication-free during the PVPR period.
• The incidence of TEF complications dropped from 0.861 incidences per patient per year in the UVPR period to 0.119 incidences per patient per year in the PVPR period.

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