Lewin Jan S, Baumgart Leah M, Barrow Martha P, Hutcheson Katherine A
Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston.
JAMA Otolaryngol Head Neck Surg. 2017 Jan 1;143(1):65-71. doi: 10.1001/jamaoto.2016.2771.
Voice prosthesis (VP) device life is a limiting factor of tracheoesophageal (TE) voice restoration that drives patient satisfaction, health care costs, and overall burden. Historic data suggest that TE VPs have an average device life of generally 3 to 6 months, but these data are typically derived from small samples using only 1 or 2 devices.
To reexamine current device life in a large, contemporary cancer hospital in the United States that uses a wide assortment of VPs.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective observational study included 390 laryngectomized patients with a tracheoesophageal puncture (TEP) who had VP management at MD Anderson Cancer Center between July 1, 2003, and December 31, 2013.
Tracheoesophageal voice-related outcomes were: (1) device life duration to VP removal, and (2) treatment-related and prosthetic-related factors influencing device failure. Primary independent variables included treatment history (extent of surgery and radiation history), VP type (indwelling vs nonindwelling, size, specialty features), and reason for removal (leakage, complication, other). Duration was examined using Kaplan-Meier analysis. Disease, treatment, and patient-specific factors were analyzed as predictors of duration.
Overall, 3648 VPs were placed in the 390 patients (median [range] age, 62 [34-92] years). Indwelling prostheses accounted for more than half (56%) of the devices placed (55%, 20-Fr diameter; 33%, 8-mm length). More than two-thirds (69%) of prostheses were removed because of leakage, while the rest were removed for other reasons. Median device life was 61 days for all prostheses. Indwelling and nonindwelling VPs had median device lives of 70 and 38 days, respectively. There was no significant difference between specialty prostheses compared with standard devices (median duration, 61 vs 70 days, respectively). The Provox ActiValve (Atos Medical) had the longest life. Neither radiation therapy nor extent of surgery had a meaningful impact on device life.
Our data suggest that VP duration demonstrates a lower durability than historically reported. This may reflect the intensification of treatment regimens that complicate TEP management in an era of organ preservation; however, further investigation is needed.
语音假体（VP）的使用寿命是气管食管（TE）语音恢复的一个限制因素，它影响患者满意度、医疗成本和总体负担。历史数据表明，TE VP的平均使用寿命一般为3至6个月，但这些数据通常来自仅使用1或2种设备的小样本。
在美国一家大型现代癌症医院重新审视当前使用多种VP的设备使用寿命。
设计、地点和参与者：这项回顾性观察研究纳入了2003年7月1日至2013年12月31日期间在MD安德森癌症中心接受VP管理的390例接受喉切除术并进行气管食管穿刺（TEP）的患者。
与气管食管语音相关的结局为：（1）至VP取出的设备使用寿命，以及（2）影响设备故障的治疗相关和假体相关因素。主要自变量包括治疗史（手术范围和放疗史）、VP类型（留置型与非留置型、尺寸、特殊特征）以及取出原因（渗漏、并发症、其他）。使用Kaplan-Meier分析检查持续时间。将疾病、治疗和患者特异性因素作为持续时间的预测因素进行分析。
总体而言，390例患者共置入3648个VP（中位[范围]年龄，62[34 - 92]岁）。留置假体占置入设备的一半以上（56%）（55%，直径20Fr；33%，长度8mm）。超过三分之二（69%）的假体因渗漏而取出，其余因其他原因取出。所有假体的中位设备使用寿命为61天。留置型和非留置型VP的中位设备使用寿命分别为70天和38天。特殊假体与标准设备相比无显著差异（中位持续时间分别为61天和70天）。Provox ActiValve（阿托斯医疗公司）使用寿命最长。放疗和手术范围对设备使用寿命均无显著影响。
我们的数据表明，VP的持续时间显示出比历史报道更低的耐用性。这可能反映了在器官保留时代治疗方案的强化使TEP管理变得复杂；然而，仍需进一步研究。
