Otorhinolaryngology-Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), As Xubias 84, 15006, A Coruña, Galicia, Spain.
Clinical Research in Medicine, International Center for Doctorate and Advanced Studies (CIEDUS), Universidade de Santiago de Compostela (USC), 15782, Santiago de Compostela, Galicia, Spain.
Eur Arch Otorhinolaryngol. 2022 Aug;279(8):4167-4172. doi: 10.1007/s00405-022-07313-x. Epub 2022 Feb 26.
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.
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.
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.
气管食管语音是全喉切除术后康复的金标准。人工喉假体失败的主要原因是假体漏。Provox ActiValve 采用基于磁铁的阀系统实现主动关闭阀以治疗这些泄漏，但缺点是价格明显更高。本研究旨在比较因假体漏导致更换增加的患者的 Provox Vega 和 Provox ActiValve 的持续时间和成本。
对患有 Provox Vega 和假体漏的喉切除患者进行前瞻性病例交叉研究，对其植入 Provox ActiValve。使用 Kaplan-Meier 曲线和 Cox 比例风险回归研究生存和可能影响人工喉假体的因素。从西班牙公立国家卫生系统的角度进行成本效益分析，并进行增量成本效益计算。
共评估了 159 个假体。更换的最常见原因是两种型号的假体漏（N=129；83.77%）。Provox Vega 的平均持续时间为 44.77±2.82 天（95%CI 39.18-50.35；中位数 36 天），Provox ActiValve 为 317.34±116.8 天（95%CI 86.66-548；中位数 286 天）（p<0.000）。由于 Provox ActiValve，每一次未进行的更换都节省了 133.97 欧元。
对于因假体漏导致假体更换增加的患者，Provox ActiValve 是一种具有成本效益的解决方案，与 Provox Vega 相比，可减少更换次数和成本。
