Bolliger Chris T, Breitenbuecher Albrecht, Brutsche Martin, Heitz Markus, Stanzel Franz
Lung Unit, Department of Internal Medicine, University of Stellenbosch, Tygerberg, Cape Town, South Africa.
Respiration. 2004 Jan-Feb;71(1):83-7. doi: 10.1159/000075654.
The Polyflex 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.
To study the performance of an newer version of the Polyflex stent with a studded outer surface, which should improve anchorage.
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.
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 FEV(1): 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).
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.
Polyflex是一种市售的硅橡胶气道支架,其疗效已得到证实。由于其外表面光滑,在气道壁中的固定较浅,这可能导致支架移位。
研究一种具有带钉外表面的新型Polyflex支架的性能,这种设计应能改善固定效果。
在一项5中心国际研究中,对患有肿瘤性中央气道狭窄且狭窄程度超过正常直径50%的有症状患者前瞻性地测试了这种新型支架。记录了支架置入前、置入后1个月和3个月的置入技术、支架置入效果及与支架相关的并发症。
在全身麻醉和硬质支气管镜检查下,26例患者置入了27枚支架,平均年龄62岁(范围:37 - 83岁),男性16例。诊断包括18例支气管源性癌、4例食管癌、2例转移瘤、1例气管癌和1例神经鞘瘤。支架置入位置如下: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)到置入后1个月(B)和3个月(C),所有评估的功能参数均有显著改善。测量值(均值±标准差)如下:世界卫生组织(WHO)量表:A:2.7(0.8),B:1.5(0.9),C:1.6(1.0);卡诺夫斯基(Karnofsky)量表: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);第1秒用力呼气容积(FEV₁):A:1.2(0.5),B:1.9(0.6),C:1.5(0.5);用力肺活量(FVC):A:2.1(0.7),B:2.8(0.7),C:2.5(1.0)。与支架相关的并发症包括4例因分泌物导致的可逆性支架阻塞和1例移位。观察期平均为4.3个月(范围:2天至23个月)。
带钉的Polyflex显示出优异的疗效,耐受性良好,移位率很低。与旧的光滑型号相比有改进,可被视为最广泛使用的硅橡胶支架——Dumon支架的真正替代品。