Skip to main content
Log in

Long-term outcomes and cost-effectiveness of a magnet-based valve voice prosthesis for endoprosthesis leakage treatment

  • Head and Neck
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Purpose

Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. The main reason of voice prosthesis failure is the endoprosthesis leakage. Provox ActiValve® incorporates a magnet-based valve system to achieve active closure of the valve to treat these leakages, with the drawback of being significantly more expensive. The aim of the study was to compare the Provox Vega® and Provox ActiValve® duration and costs in patients with replacements increase due to endoprosthetic leakage.

Methods

Prospective case-crossover study in laryngectomized patients with Provox Vega® and endoprosthesis leakage to whom a Provox ActiValve® was placed. Survival and possible factors that affect voice prosthesis were studied using Kaplan–Meier curves and Cox Proportional Hazards Regression. Cost-effectiveness analysis from the perspective of the Spanish Public National Health System with incremental cost-effectiveness calculation was performed.

Results

A total of 159 prostheses were evaluated. The most frequent reason for replacement was the endoprosthesis leakage (N = 129; 83.77%) in both models. The mean duration-time of Provox Vega® was 44.77 ± 2.82 days (CI 95%, 39.18–50.35; median 36 days), and 317.34 ± 116.8 days (CI 95% 86.66–548; median 286 days) for the Provox ActiValve® (p < 0.000). For every replacement not made thanks to the Provox ActiValve® there was saving of 133.97€

Conclusions

The Provox ActiValve® is a cost-effective solution in patients with increased prosthesis replacements due to endoprosthetic leakage, reducing the number of changes and cost compared to Provox Vega®.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. van Sluis KE, van der Molen L, van Son RJJH et al (2018) Objective and subjective voice outcomes after total laryngectomy: a systematic review. Eur Arch Otorhinolaryngol 275:11–26. https://doi.org/10.1007/s00405-017-4790-6

    Article  PubMed  Google Scholar 

  2. Coffey MM, Tolley N, Howard D, Hickson M (2018) Evaluating the effect of different voice prostheses on alaryngeal voice quality. Laryngoscope 128:2460–2466. https://doi.org/10.1002/lary.27171

    Article  PubMed  Google Scholar 

  3. Mayo-Yáñez M, Cabo-Varela I, Dovalo-Carballo L et al (2018) Provox 2®and Provox Vega®device life-time: a case-crossover study with multivariate analysis of possible influential factors and duration. Eur Arch Otorhinolaryngol 275:1827–1830. https://doi.org/10.1007/s00405-018-5008-2

    Article  PubMed  Google Scholar 

  4. Hilgers FJM, Ackerstaff AH, Balm AJM et al (2003) A new problem-solving indwelling voice prosthesis, eliminating the need for frequent Candida- and “Underpressure”-related replacements: Provox ActiValve. Acta Otolaryngol 123:972–979. https://doi.org/10.1080/00016480310015371

    Article  PubMed  Google Scholar 

  5. Graville DJ, Palmer AD, Andersen PE, Cohen JI (2011) Determining the efficacy and cost-effectiveness of the activalve: results of a long-term prospective trial. Laryngoscope 121:769–776. https://doi.org/10.1002/lary.21380

    Article  PubMed  Google Scholar 

  6. Evangelista L, Andrews T, Nativ-Zeltzer N et al (2021) Association of functional outcomes in tracheoesophageal voicing with intratracheal pressures and esophagram findings. JAMA Otolaryngol Head Neck Surg 147:1065–1070. https://doi.org/10.1001/jamaoto.2021.2409

    Article  PubMed  Google Scholar 

  7. Provox ActiValve® (Internet). Atos medical. (cited December, 2021). Available in: https://d1a743corqz1mw.cloudfront.net/wp-content/uploads/2015/10/10660_ifu-provox-activalve-clinicians_2020-12-04_web.pdf

  8. Soolsma J, van den Brekel MW, Ackerstaff AH et al (2008) Long-term results of provox activalve, solving the problem of frequent Candida- and “Underpressure”-related voice prosthesis replacements. Laryngoscope 118:252–257. https://doi.org/10.1097/MLG.0b013e318159ebde

    Article  PubMed  Google Scholar 

  9. Schuldt T, Ovari A, Dommerich S (2013) The costs for different voice prostheses depending on the lifetime. Laryngorhinootologie 92:389–393. https://doi.org/10.1055/s-0033-1337951

    Article  CAS  Google Scholar 

  10. Provox Vega® (Internet). Atos medical. (cited December, 2021). Available in: https://d1a743corqz1mw.cloudfront.net/wp-content/uploads/2015/10/11468_clin.ifu-provox-vega_2020-01-21_web.pdf

  11. Maclure M, Mittleman MA (2000) Should we use a case-crossover design? Annu Rev Public Health 21:193–221. https://doi.org/10.1146/annurev.publhealth.21.1.193

    Article  CAS  Google Scholar 

  12. Mayo-Yáñez M, Cabo-Varela I, Suanzes-Hernández J et al (2020) Use of double flange voice prosthesis for periprosthetic leakage in laryngectomized patients: a prospective case-crossover study. Clin Otolaryngol 45:389–393. https://doi.org/10.1111/coa.13513

    Article  PubMed  Google Scholar 

  13. Prieto L, Sacristán JA, Antoñanzas F et al (2004) Análisis coste-efectividad en la evaluación económica de intervenciones sanitarias. Med Clin 122:505–510. https://doi.org/10.1016/S0025-7753(04)74288-8

    Article  Google Scholar 

  14. Parrilla C, Longobardi Y, Paludetti G et al (2020) A one-year time frame for voice prosthesis management. What should the physician expect? Is it an overrated job? Acta Otorhinolryngol Ital 40:270–276. https://doi.org/10.14639/0392-100X-N0587

    Article  Google Scholar 

  15. Kress P, Schäfer P, Schwerdtfeger FP, Rösler S (2014) Are modern voice prostheses better? A lifetime comparison of 749 voice prostheses. Eur Arch Otorhinolaryngol 271:133–140. https://doi.org/10.1007/s00405-013-2611-0

    Article  CAS  PubMed  Google Scholar 

  16. Petersen JF, Lansaat L, Timmermans AJ et al (2019) Postlaryngectomy prosthetic voice rehabilitation outcomes in a consecutive cohort of 232 patients over a 13 year period. Head Neck 41:623–631. https://doi.org/10.1002/hed.25364

    Article  PubMed  PubMed Central  Google Scholar 

  17. Lorenz KJ (2015) The development and treatment of periprosthetic leakage after prosthetic voice restoration. A literature review and personal experience part I: the development of periprosthetic leakage. Eur Arch Otorhinolaryngol 272:641–659. https://doi.org/10.1007/s00405-014-3394-7

    Article  PubMed  Google Scholar 

  18. Hutcheson KA, Lewin JS, Sturgis EM, Risser J (2012) Multivariable analysis of risk factors for enlargement of the tracheoesophageal puncture after total laryngectomy. Head Neck 34:557–567. https://doi.org/10.1002/hed.21777

    Article  PubMed  Google Scholar 

  19. Hutcheson KA, Lewin JS, Sturgis EM et al (2011) Enlarged tracheoesophageal puncture after total laryngectomy: a systematic review and meta-analysis. Head Neck 33:20–30. https://doi.org/10.1002/hed.21399

    Article  PubMed  PubMed Central  Google Scholar 

  20. Serra A, Spinato G, Spinato R et al (2017) Multicenter prospective crossover study on new prosthetic opportunities in post-laryngectomy voice rehabilitation. J Biol Regul Homeost Agents 31:803–809

    CAS  PubMed  Google Scholar 

  21. Lewin JS, Baumgart LM, Barrow MP, Hutcheson KA (2017) Device life of the tracheoesophageal voice prosthesis revisited. JAMA Otolaryngol Head Neck Surg 143:65–71. https://doi.org/10.1001/jamaoto.2016.2771

    Article  PubMed  PubMed Central  Google Scholar 

  22. Parrilla C, Longobardi Y, Galli J et al (2021) Periprosthetic leakage in tracheoesophageal prosthesis: proposal of a standardized therapeutic algorithm. Otolaryngol Head Neck Surg. https://doi.org/10.1177/0194599820983343

    Article  PubMed  Google Scholar 

  23. Drummond MF, Sculpher MJ, Claxton K et al (2015) Methods for the economic evaluation of health care programmes, 4th edn. Oxford University Press, Oxford, New York

    Google Scholar 

  24. Richardson J (1994) Cost utility analysis: what should be measured? Soc Sci Med 39:7–21. https://doi.org/10.1016/0277-9536(94)90162-7

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Miguel Mayo-Yáñez.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Mayo-Yáñez, M., Chiesa-Estomba, C., Lechien, J.R. et al. Long-term outcomes and cost-effectiveness of a magnet-based valve voice prosthesis for endoprosthesis leakage treatment. Eur Arch Otorhinolaryngol 279, 4167–4172 (2022). https://doi.org/10.1007/s00405-022-07313-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00405-022-07313-x

Keywords

Navigation