Respiratory Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Department of Pulmonary, Critical Care and Sleep Medicine, Case Western Reserve University, Cleveland, Ohio, USA.
Respiration. 2018;96(5):488-494. doi: 10.1159/000489669. Epub 2018 Sep 13.
Managing complex benign airway disease is a major challenge in interventional pulmonology. Airway stent placement can result in complications due to a variety of factors, including poor fit of the stent in the airway. We report the 1-year outcome of 2 patients with airway disease caused by granulomatosis with polyangiitis (Wegener's) affecting the left main bronchus and secondary carina. These patients had not responded to systemic therapy or standard bronchoscopic techniques and had complications with commercially available airway stents. We describe a first-in-human, clinical experience to address these issues. Using computed tomography (CT) imaging and 3D printing technology, we generated and implanted patient-specific silicone airway stents to address airway disease. 3D patient-specific stent prescription was created using a CT scan of the patient's chest and a proprietary software package originally developed for orthopedic surgical planning. Silicone stents were manufactured and implanted. Observation for > 1 year after implantation compared to the 6 months prior to patient-specific stent implant were compared for the number, clinically required stent changes, procedure time, and general clinical improvement per usual standard of care after airway stenting. Patients showed improved durability, a shorter procedure time, and improvement of patient-reported symptoms leading to a reduced need for stent changes and modifications. The use of 3D printing technology to make patient-specific silicone stents is feasible with early clinical proof of concept noting a durable improvement over 1 year of follow-up.
管理复杂的良性气道疾病是介入肺病学的一个主要挑战。气道支架置入可因多种因素导致并发症，包括支架在气道中的适配不良。我们报告了 2 例因肉芽肿伴多血管炎（韦格纳氏）引起的气道疾病患者的 1 年结果，这些患者的左主支气管和次级隆突受到影响。这些患者对全身治疗或标准支气管镜技术没有反应，并且与市售气道支架出现并发症。我们描述了一种用于解决这些问题的首例人体临床经验。使用计算机断层扫描（CT）成像和 3D 打印技术，我们生成并植入了患者特异性的硅酮气道支架来解决气道疾病。3D 患者特异性支架处方是使用患者胸部的 CT 扫描和最初为骨科手术计划开发的专有软件包创建的。制造并植入了硅酮支架。在植入患者特异性支架后超过 1 年与植入前 6 个月相比，观察了支架数量、临床需要的支架变化、手术时间以及气道支架植入后的常规护理标准下的总体临床改善。患者表现出更好的耐用性、更短的手术时间以及患者报告症状的改善，从而减少了支架更换和修改的需求。使用 3D 打印技术制造患者特异性硅酮支架是可行的，具有早期临床概念验证，在 1 年的随访中观察到持久的改善。
