Use of studded polyflex™ stents in patients with neoplastic obstructions of the central airways

Use of studded polyflex™ stents in patients with neoplastic obstructions of the central airways
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DOI:
10.1159/000075654
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发表时间:
2004-01-01
期刊:
影响因子:
3.7
通讯作者:
Stanzel, F
Stanzel, F
中科院分区:
医学3区
文献类型:
--
作者:
Bolliger, CT;Breitenbuecher, A;Stanzel, F

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背景:Polyflex(TM)是一种市售的硅橡胶气道支架,已证实有效。由于外表面光滑,其在气道壁中的锚固是浅表的,这可能导致支架移位。目的:研究新型Polyflex支架的性能,该支架具有带铆钉的外表面,可改善锚定。研究方法:在一项5中心国际研究中,在肿瘤性中心气道狭窄超过正常直径50%的症状性患者中前瞻性测试了新型支架。分别于支架置入前、支架置入后1个月、支架置入后3个月记录支架置入技术、支架置入效果及支架相关并发症。结果:在全身麻醉和刚性支气管镜下,26例患者共置入27个支架,平均年龄:62岁(范围:37-83),16例男性。肺癌18例,食管癌4例,转移癌2例,气管癌1例,神经鞘瘤1例。支架插入以下位置:右主支气管10例,左主支气管8例,气管7例,气管支气管2例。从支架置入前(A)到支架置入后1个月(B)和3个月(C),评估的所有功能参数均显著改善。测量值(平均值+/- SD)为WHO量表:A:2.7(0.8),B:1.5(0.9),C:1.6(1.0);卡氏评分:A:44(19),B:72(18),C:71(21);呼吸困难指数:A:3.3(0.7),B:1.5(0.8),C:1.9(1.2); FEV1:A:1.2(0.5),B:1.9(0.6),C:1.5(0.5); FVC:A:2.1(0.7),B:2.8(0.7),C:2.5(1.0)。支架相关并发症为4例分泌物导致的可逆性支架阻塞,1例移位。观察期平均为4.3个月(范围2天至23个月)。结论:带钉Polyflex显示出优异的疗效,耐受性良好,迁移率极低。它对较旧的光滑模型进行了改进,可以被视为最广泛使用的硅橡胶支架Dumon支架的真正替代品。版权所有(C)2004 S. Karger AG,巴塞尔。
Background: The Polyflex(TM) is a commercially available silastic airway stent with proven efficacy. Due to a smooth outer surface its anchorage in the airway wall is superficial which may lead to stent migration. Objective: To study the performance of an newer version of the Polyflex stent with a studded outer surface, which should improve anchorage. Methods: In a 5-centre international study the new stent was prospectively tested in symptomatic patients with neoplastic central airway stenosis of more that 50% of normal diameter. Insertion technique, efficacy of stent placement and stent-related complications were recorded before, 1 month and 3 months post stent placement. Results: Under general anaesthesia and rigid bronchoscopy 27 stents were inserted in 26 patients, mean age: 62 years (range: 37-83), 16 men. Diagnoses were 18 bronchogenic carcinoma, 4 oesophageal carcinoma, 2 metastases, 1 tracheal carcinoma, and 1 schwannoma. The stents were inserted in the following locations: 10 right main bronchus, 8 left main bronchus, 7 trachea, and 2 tracheo-bronchial. There was significant improvement in all functional parameters assessed from before (A), to 1 month (B) and 3 months (C) after stent placement. The measured values (mean +/- SD) were for the WHO scale: A: 2.7 (0.8), B: 1.5 (0.9), C: 1.6 (1.0); for the Karnofsky scale: A: 44 (19), B: 72 (18), C: 71 (21); for the Dyspnoea Index: A: 3.3 (0.7), B: 1.5 (0.8), C: 1.9 (1.2); for FEV1: A: 1.2 (0.5), B: 1.9 (0.6), C: 1.5 (0.5), and for FVC: A: 2.1 (0.7), B: 2.8 (0.7), C: 2.5 (1.0). Stent-related complications were 4 reversible stent obstructions by secretions, 1 migration. The observation period was mean 4.3 months (range 2 days to 23 months). Conclusion: The studded Polyflex showed excellent efficacy, was very well tolerated, and had a very low migration rate. It presents an improvement over the older smooth model and can be considered a true alternative to the most widely used silastic stent, the Dumon stent. Copyright (C) 2004 S. Karger AG, Basel.