Over the past 25 years, we have demonstrated the feasibility of airway bioengineering using stented aortic matrices experimentally then in a first-in-human trial (n = 13). The present TRITON-01 study analyzed all the patients who had airway replacement at our center to confirm that this innovative approach can be now used as usual care. For each patient, the following data were prospectively collected: postoperative mortality and morbidity, late airway complications, stent removal and status at last follow-up on November 2, 2021. From October 2009 to October 2021, 35 patients had airway replacement for malignant (n = 29) or benign (n = 6) lesions. The 30-day postoperative mortality and morbidity rates were 2.9% (n = 1/35) and 22.9% (n = 8/35) respectively. At a median follow-up of 29.5 months (range 1–133 months), 27 patients were alive. There have been no deaths directly related to the implanted bioprosthesis. Eighteen patients (52.9%) had stent-related granulomas requiring a bronchoscopic treatment. Ten among 35 patients (28.6%) achieved a stent free survival. The actuarial 2- and 5-year survival rates (Kaplan–Meier estimates) were respectively 88% and 75%. The TRITON-01 study confirmed that airway replacement using stented aortic matrices can be proposed as usual care at our center.

中文翻译：

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使用带支架的主动脉基质进行气道置换：TRITON-01 研究对 35 名成年患者的长期随访和结果

在过去的 25 年中，我们已经通过实验证明了使用支架主动脉基质进行气道生物工程的可行性，然后是首次人体试验 ( n  = 13)。目前的 TRITON-01 研究分析了在我们中心接受气道置换术的所有患者，以确认这种创新方法现在可以用作常规护理。对于每位患者，前瞻性收集了以下数据：术后死亡率和发病率、晚期气道并发症、支架取出情况和最后一次随访时间为 2021 年 11 月 2 日的状态。从 2009 年 10 月到 2021 年 10 月，35 名患者因恶性肿瘤进行了气道置换术（n  = 29) 或良性 ( n  = 6) 病变。术后 30 天死亡率和发病率分别为 2.9% ( n  = 1/35) 和 22.9% (n  = 8/35) 分别。中位随访 29.5 个月（范围 1-133 个月）时，有 27 名患者存活。没有与植入的生物假体直接相关的死亡。18 名患者 (52.9%) 患有需要支气管镜治疗的支架相关肉芽肿。35 名患者中有 10 名 (28.6%) 实现了无支架生存。精算 2 年和 5 年生存率（Kaplan-Meier 估计）分别为 88% 和 75%。TRITON-01 研究证实，我们中心可以建议将使用带支架的主动脉基质进行气道置换作为常规护理。