Airway replacement using stented aortic matrices: Long-term follow-up and results of the TRITON-01 study in 35 adult patients

Abstract

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. http://clinicaltrials.gov Identifier: NCT04263129.

Human tracheal transplantation: A systematic review of case reports

“…Xu et al provided postoperative CT scan and bronchoscopy images, but did not report when these assessments were performed and which was the length of followup. 19 37 The authors reported only one post-operative death, and a 2-year overall survival rate of 88%, without any other death attributable to the implanted bio prostheses; although only 10 among 35 patients (28.6%) achieved a stent free survival. 37 Fabre et al reported their technique for tracheal replacement using autologous forearm fasciocutaneous free flap reinforced by rib cartilages.…”

“…Compared to the clinical experience reported for stented aortic allografts 37 and autologous tissue composites, 38 tracheal transplantation is still at an embryonic stage. The need for immunosuppression, at least temporarily, represents a contraindication for patients who are affected by malignant tumors, and poses an ethical concern also for patients affected by benign pathologies: besides the risks associated with the procedure, is lifelong immunosuppression preferable to longterm airway stenting?…”

Tracheal replacement: A never–ending search

“…Based on their more than 25-year experience in tissue regeneration with preclinical and first-in-human trials, Martinod and colleagues report the results of the prospective, single-institution study of airway replacement to reconstruct long-segment defects of the trachea and central bronchi by stented cryopreserved aortic matrices. 1 The aim of the study could potentially lead to a consensus recommendation: Airway Replacement Using Stented Aortic Matrices as usual care. Silicone or nitinol stents are deployed to support the allografts and maintain airway patency.…”

“…It is not clear to us why patients with central lung lesions were included in this study 1 . We do not consider central bronchial or carinal resections appropriate for aortic homograft reconstruction since standardized sleeve resection and bronchoplastic techniques are available to avoid pneumonectomy for centrally located lesions.…”

Management of airway complications after lung transplantation: is there an ideal stent?

“…Ram et al reported a hybrid reconstruction of the bronchus using an aortic homograft patch with stenting as a novel technique of management of ischemic airway injury following LT (20). This technique is based on previous works which have demonstrated since 1997 in animals and then in humans the interest of using stented aortic matrices for airway replacement (21,22). Izhakian et al demonstrated that SEMS insertion was associated with a positive sustained effect on lung function without increasing long-term mortality (23).…”