Rodríguez-Lorenzana Pedro, Mayo-Yáñez Miguel, Chiesa-Estomba Carlos M, Vaira Luigi Angelo, Lechien Jérôme R, Maniaci Antonino, Cabo-Varela Irma
Otorhinolaryngology-Head and Neck Surgery Department, Complexo Hospitalario Universitario A Coruña (CHUAC), 15006 A Coruña, Spain.
Young-Otolaryngologists of the International Federations of Oto-Rhino-Laryngological Societies (YO-IFOS) Study Group, 75000 Paris, France.
J Pers Med. 2023 Jun 29;13(7):1064. doi: 10.3390/jpm13071064.
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 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 and Provox XtraSeal prostheses used in these patients in a tertiary university hospital.
A prospective crossover case study of laryngectomees with Provox Vega who underwent Provox XtraSeal 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.
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 and 68 Provox XtraSeal. The mean duration of Provox Vega was 119.75 ± 148.8 days and that of Provox XtraSeal was 181.99 ± 166.07 days ( = 0.002). The most frequent reason for replacement was endoprosthetic leakage in both groups: 283 (60.86%) in the case of Provox Vega and 29 (48.33%) in that of XtraSeal ( < 0.000). To obtain no cost differences (ICE ~ 0) between Provox Vega and Provox XtraSeal, the latter should cost EUR 551.63.
The Provox XtraSeal 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.
带发音钮的气管食管语音被认为是喉切除患者的首选康复治疗方法。发音钮失败的主要原因是内置发音钮泄漏和发音钮周围泄漏。Provox XtraSeal支架在食管侧增加了一个双凸缘，以防止发音钮周围泄漏。本研究的目的是比较在一所三级大学医院中，这些患者使用Provox Vega和Provox XtraSeal发音钮的使用时长和成本。
一项对使用Provox Vega的喉切除患者进行的前瞻性交叉病例研究，这些患者因发音钮周围反复泄漏和理论上发音钮使用寿命缩短而接受了Provox XtraSeal植入。使用Kaplan-Meier曲线和Cox回归研究影响发音钮的使用时长及可能因素。从西班牙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。
共招募了38例患者，其中男性35例，女性3例，平均年龄66.26±9.36岁。收集了551个发音钮的信息，其中484个Provox Vega和68个Provox XtraSeal。Provox Vega的平均使用时长为119.75±148.8天，Provox XtraSeal的平均使用时长为181.99±166.07天（P = 0.002）。两组中最常见的更换原因是内置发音钮泄漏：Provox Vega组为283例（60.86%），XtraSeal组为29例（48.33%）（P<0.000）。为使Provox Vega和Provox XtraSeal之间无成本差异（增量成本效益比~0），后者的成本应为551.63欧元。
对于因发音钮周围泄漏而需要增加发音钮更换次数的患者，Provox XtraSeal是一种具有成本效益的选择，与Provox Vega相比，它减少了更换次数，延长了发音钮的使用时长，并节省了费用。
