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®.
Similar content being viewed by others
References
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Author information
Authors and Affiliations
Corresponding author
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00405-022-07313-x