Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients
Background: Tracheoesophageal speech with a voice prosthesis is considered the rehabilitation treatment of choice in laryngectomized patients. The main reasons for prosthesis failure are endoprosthetic leakage and periprosthetic leakage. The Provox XtraSeal<sup>®</sup> stent incorporates...
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MDPI AG
2023-06-01
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| Series: | Journal of Personalized Medicine |
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| Online Access: | https://www.mdpi.com/2075-4426/13/7/1064 |
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| author | Pedro Rodríguez-Lorenzana Miguel Mayo-Yáñez Carlos M. Chiesa-Estomba Luigi Angelo Vaira Jérôme R. Lechien Antonino Maniaci Irma Cabo-Varela |
| author_facet | Pedro Rodríguez-Lorenzana Miguel Mayo-Yáñez Carlos M. Chiesa-Estomba Luigi Angelo Vaira Jérôme R. Lechien Antonino Maniaci Irma Cabo-Varela |
| author_sort | Pedro Rodríguez-Lorenzana |
| collection | DOAJ |
| description | Background: Tracheoesophageal speech with a voice prosthesis is considered the rehabilitation treatment of choice in laryngectomized patients. The main reasons for prosthesis failure are endoprosthetic leakage and periprosthetic leakage. The Provox XtraSeal<sup>®</sup> stent incorporates an additional double flange on the esophageal side to prevent periprosthetic leakage. The objective of this study is to compare the duration and costs of the Provox Vega<sup>®</sup> and Provox XtraSeal<sup>®</sup> prostheses used in these patients in a tertiary university hospital. Materials and methods: A prospective crossover case study of laryngectomees with Provox Vega<sup>®</sup> who underwent Provox XtraSeal<sup>®</sup> placement due to recurrent periprosthetic leaks and decreased theoretical prosthesis life. The duration and possible factors affecting voice prostheses were studied using Kaplan–Meier curves and Cox regression. A cost-effectiveness analysis was carried out from the perspective of the Spanish National Health System with an incremental cost-effectiveness calculation. Results: A total of 38 patients were recruited, 35 men and 3 women, with a mean age of 66.26 ± 9.36 years old. Information was collected from 551 voice prostheses, 484 Provox Vega<sup>®</sup> and 68 Provox XtraSeal<sup>®</sup>. The mean duration of Provox Vega<sup>®</sup> was 119.75 ± 148.8 days and that of Provox XtraSeal<sup>®</sup> was 181.99 ± 166.07 days (<i>p</i> = 0.002). The most frequent reason for replacement was endoprosthetic leakage in both groups: 283 (60.86%) in the case of Provox Vega<sup>®</sup> and 29 (48.33%) in that of XtraSeal<sup>®</sup> (<i>p</i> < 0.000). To obtain no cost differences (ICE ~ 0) between Provox Vega and Provox XtraSeal, the latter should cost EUR 551.63. Conclusions: The Provox XtraSeal<sup>®</sup> is a cost-effective option in patients with increased prosthesis replacements due to periprosthetic leakage, reducing the number of replacements, increasing the duration of the prosthesis, and providing savings compared to Provox Vega<sup>®</sup>. |
| first_indexed | 2024-03-11T00:56:17Z |
| format | Article |
| id | doaj.art-fd92a187b69c4a94908305cffae51158 |
| institution | Directory Open Access Journal |
| issn | 2075-4426 |
| language | English |
| last_indexed | 2024-03-11T00:56:17Z |
| publishDate | 2023-06-01 |
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| spelling | doaj.art-fd92a187b69c4a94908305cffae511582023-11-18T20:03:02ZengMDPI AGJournal of Personalized Medicine2075-44262023-06-01137106410.3390/jpm13071064Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized PatientsPedro Rodríguez-Lorenzana0Miguel Mayo-Yáñez1Carlos M. Chiesa-Estomba2Luigi Angelo Vaira3Jérôme R. Lechien4Antonino Maniaci5Irma Cabo-Varela6Otorhinolaryngology—Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), 15006 A Coruña, SpainOtorhinolaryngology—Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), 15006 A Coruña, SpainYoung-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies (YO-IFOS) Study Group, 75000 Paris, FranceYoung-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies (YO-IFOS) Study Group, 75000 Paris, FranceYoung-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies (YO-IFOS) Study Group, 75000 Paris, FranceYoung-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies (YO-IFOS) Study Group, 75000 Paris, FranceOtorhinolaryngology—Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), 15006 A Coruña, SpainBackground: Tracheoesophageal speech with a voice prosthesis is considered the rehabilitation treatment of choice in laryngectomized patients. The main reasons for prosthesis failure are endoprosthetic leakage and periprosthetic leakage. The Provox XtraSeal<sup>®</sup> stent incorporates an additional double flange on the esophageal side to prevent periprosthetic leakage. The objective of this study is to compare the duration and costs of the Provox Vega<sup>®</sup> and Provox XtraSeal<sup>®</sup> prostheses used in these patients in a tertiary university hospital. Materials and methods: A prospective crossover case study of laryngectomees with Provox Vega<sup>®</sup> who underwent Provox XtraSeal<sup>®</sup> placement due to recurrent periprosthetic leaks and decreased theoretical prosthesis life. The duration and possible factors affecting voice prostheses were studied using Kaplan–Meier curves and Cox regression. A cost-effectiveness analysis was carried out from the perspective of the Spanish National Health System with an incremental cost-effectiveness calculation. Results: A total of 38 patients were recruited, 35 men and 3 women, with a mean age of 66.26 ± 9.36 years old. Information was collected from 551 voice prostheses, 484 Provox Vega<sup>®</sup> and 68 Provox XtraSeal<sup>®</sup>. The mean duration of Provox Vega<sup>®</sup> was 119.75 ± 148.8 days and that of Provox XtraSeal<sup>®</sup> was 181.99 ± 166.07 days (<i>p</i> = 0.002). The most frequent reason for replacement was endoprosthetic leakage in both groups: 283 (60.86%) in the case of Provox Vega<sup>®</sup> and 29 (48.33%) in that of XtraSeal<sup>®</sup> (<i>p</i> < 0.000). To obtain no cost differences (ICE ~ 0) between Provox Vega and Provox XtraSeal, the latter should cost EUR 551.63. Conclusions: The Provox XtraSeal<sup>®</sup> is a cost-effective option in patients with increased prosthesis replacements due to periprosthetic leakage, reducing the number of replacements, increasing the duration of the prosthesis, and providing savings compared to Provox Vega<sup>®</sup>.https://www.mdpi.com/2075-4426/13/7/1064voice prosthesistracheoesophageal speechdevice lifelaryngectomyProvox XtraSealProvox Vega |
| spellingShingle | Pedro Rodríguez-Lorenzana Miguel Mayo-Yáñez Carlos M. Chiesa-Estomba Luigi Angelo Vaira Jérôme R. Lechien Antonino Maniaci Irma Cabo-Varela Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients Journal of Personalized Medicine voice prosthesis tracheoesophageal speech device life laryngectomy Provox XtraSeal Provox Vega |
| title | Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients |
| title_full | Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients |
| title_fullStr | Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients |
| title_full_unstemmed | Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients |
| title_short | Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients |
| title_sort | cost effectiveness study of double flange voice prostheses in the treatment of periprosthetic leakage in laryngectomized patients |
| topic | voice prosthesis tracheoesophageal speech device life laryngectomy Provox XtraSeal Provox Vega |
| url | https://www.mdpi.com/2075-4426/13/7/1064 |
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