Tracheobronchial Replacement Using Cryopreserved Aortic Allografts: Results in 50 Patients (TRITON-01 Registry)

Tracheal replacement remains a major challenge in thoracic surgery. We report the outcomes of the TRITON-01 registry, which includes 50 patients who underwent tracheal replacement using a cryopreserved aortic allograft performed by our surgical team.

Prospective data were collected for each patient, including indication for surgery, operative details, postoperative mortality and morbidity, late complications, stent management, and patient status at last follow-up on January 2, 2025.

Between October 2009 and January 2025, 50 patients (25 females) with a mean age of 55.1 years (range, 20-79 years) underwent tracheal replacement. Extensive tracheobronchial lesions were malignant in 41 cases and benign in 9 cases. Veno-venous extracorporeal membrane oxygenation (ECMO) was used intraoperatively in 13 patients. Tracheobronchial reconstructions were classified as type 1, 2, 3, and 4 in 20, 15, 4, and 11 patients, respectively. Additional lung resections (lobectomy, bilobectomy, or pneumonectomy) were performed in 12 cases. Incomplete (R1) resection was observed in 3 patients. Thirty-day postoperative mortality was 4% (n = 2). Major complications occurred in 15 patients (30%). At the last follow-up (ranging from 1 month to 14 years), 74% of patients (n = 37) were alive. Stent-related granuloma formation was the most common late complication (n = 26), and stent removal was successfully achieved in 15 (30%) patients due to the development of functional neocartilage.

Tracheal replacement with cryopreserved aortic allografts appears to be an effective and sustainable technique, with acceptable mortality and morbidity rates. Ongoing investigations aim to optimize cartilage regeneration and enhance the bioavailability of grafts.

Clinicaltrials.gov Identifier: NCT04263129.