Miguel Mayo-Yáñez1,2,3, Carlos Chiesa-Estomba4,5, Jérôme R Lechien4,6,7, Christian Calvo-Henríquez8,4,9, Luigi A Vaira4,10, Irma Cabo-Varela11. 1. Otorhinolaryngology-Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), As Xubias 84, 15006, A Coruña, Galicia, Spain. miguel.mayo.yanez@sergas.es. 2. Clinical Research in Medicine, International Center for Doctorate and Advanced Studies (CIEDUS), Universidade de Santiago de Compostela (USC), 15782, Santiago de Compostela, Galicia, Spain. miguel.mayo.yanez@sergas.es. 3. Young-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies (YO-IFOS) Study Group, Paris, France. miguel.mayo.yanez@sergas.es. 4. Young-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies (YO-IFOS) Study Group, Paris, France. 5. Otorhinolaryngology-Head and Neck Surgery Department, Hospital Universitario Donostia, 20014, Donostia, Euskadi, Spain. 6. Otolaryngology Department, Elsan Hospital, Paris, France. 7. Otorhinolaryngology and Head and Neck Surgery Department, Foch Hospital, Paris Saclay University, Paris, France. 8. Clinical Research in Medicine, International Center for Doctorate and Advanced Studies (CIEDUS), Universidade de Santiago de Compostela (USC), 15782, Santiago de Compostela, Galicia, Spain. 9. Otorhinolaryngology-Head and Neck Surgery Department, Complexo Hospitalario Universitario Santiago de Compostela (CHUS), 15706, Santiago de Compostela, Galicia, Spain. 10. Maxillofacial Surgery Operative Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. 11. Otorhinolaryngology-Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), As Xubias 84, 15006, A Coruña, Galicia, Spain.
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®.
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®.
Authors: Frans J M Hilgers; Annemieke H Ackerstaff; Alfons J M Balm; Michiel W M Van den Brekel; I Bing Tan; Jan-Ove Persson Journal: Acta Otolaryngol Date: 2003-10 Impact factor: 1.494
Authors: Klaske E van Sluis; Lisette van der Molen; Rob J J H van Son; Frans J M Hilgers; Patrick A Bhairosing; Michiel W M van den Brekel Journal: Eur Arch Otorhinolaryngol Date: 2017-10-31 Impact factor: 2.503
Authors: Japke F Petersen; Liset Lansaat; Adriana J Timmermans; Vincent van der Noort; Frans J M Hilgers; Michiel W M van den Brekel Journal: Head Neck Date: 2019-01-07 Impact factor: 3.147