Supplementary Material for: Application of 3D Printing for Patient-Specific Silicone Stents: 1-Year Follow-Up on 2 Patients

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.复杂性良性气道疾病的诊疗是介入肺脏病学领域的一大挑战。气道支架置入术可因多种因素引发并发症，其中包括支架与气道适配不佳。本研究报告2例因肉芽肿性多血管炎（granulomatosis with polyangiitis，Wegener’s，原称韦格纳肉芽肿）累及左主支气管及二级隆突所致气道疾病患者的1年随访结局。上述患者对全身治疗及标准支气管镜技术均无应答，且使用商用气道支架时出现了并发症。我们首次开展了针对此类问题的人体临床研究，详述相关诊疗经验。本研究借助计算机断层扫描（CT）成像与3D打印技术，制备并置入患者定制型硅胶气道支架以治疗气道疾病。研究团队以患者胸部CT扫描结果为基础，结合最初为骨科手术规划开发的专有软件包（proprietary software package），生成患者定制型3D支架的设计方案。随后完成硅胶支架的制备与置入操作。本研究对比了患者接受定制支架置入前6个月与置入后超过1年的随访数据，评估指标包括支架更换次数、临床所需的支架调整操作、手术时长，以及气道支架置入术后常规标准护理下的整体临床改善情况。结果显示，患者的支架耐用性得到提升，手术时长缩短，且患者自述症状有所改善，因此支架更换与调整的需求显著降低。本研究的初步临床概念验证结果表明，利用3D打印技术制备患者定制型硅胶支架具备可行性，且经1年随访证实疗效持久。