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Preliminary Communication
June 5, 2018

Feasibility of Bioengineered Tracheal and Bronchial Reconstruction Using Stented Aortic Matrices

Author Affiliations
  • 1Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Chirurgie Thoracique et Vasculaire, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France
  • 2Université Paris Descartes, Fondation Alain Carpentier, Laboratoire de Recherche Bio-chirurgicale, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France
  • 3Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Oncologie, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France
  • 4Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Pneumologie, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France
  • 5B2OA UMR CNRS 7052, Université Paris Diderot, Sorbonne Paris Cité, CNRS, F-75010 Paris, France
  • 6Ecole Nationale Vétérinaire d’Alfort, Université, Paris-Est, Maisons-Alfort, France
  • 7Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Anesthésie-Réanimation, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France
  • 8Assistance Publique–Hôpitaux de Paris, EFS Ile de France, Banque des Tissus, Creteil, France
  • 9Hôpital Le Raincy-Montfermeil, Pneumologie, Montfermeil, France
  • 10Université Côte d’Azur, Centre Hospitalier Universitaire de Nice, Pneumologie, Chirurgie Thoracique, Oto-Rhino-Laryngologie, Nice, France
  • 11Assistance Publique–Hôpitaux de Paris, Hôpital La Pitié-Salpêtrière, Chirurgie Digestive et Endocrinienne, Université Paris 6 Pierre et Marie Curie, Paris, France
  • 12Assistance Publique–Hôpitaux de Marseille, Pneumologie, Hôpital Universitaire Nord, Marseille, France
  • 13Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Paris Seine-Saint-Denis, Hôpital Avicenne, Gériatrie, Université Paris 13, Sorbonne Paris Cité, UFR Santé, Médecine et Biologie Humaine, Bobigny, France
  • 14Division of Vascular Surgery, West Virginia University, Morgantown
  • 15Assistance Publique–Hôpitaux de Paris, Unité de Recherche Clinique, Hôpitaux Saint Louis-Lariboisière-Fernand Widal, Université Paris Diderot, Paris, France
JAMA. 2018;319(21):2212-2222. doi:10.1001/jama.2018.4653
Key Points

Question  Is airway bioengineering using stented aortic matrices for complex tracheal and bronchial reconstruction feasible in humans?

Findings  In this uncontrolled cohort study that included 20 patients, 13 were able to undergo tracheal, bronchial, or carinal transplantation. The overall 90-day mortality rate was 5%.

Meaning  This preliminary study suggests feasibility of human airway bioengineering using stented aortic matrices for tracheal and bronchial reconstruction.

Abstract

Importance  Airway transplantation could be an option for patients with proximal lung tumor or with end-stage tracheobronchial disease. New methods for airway transplantation remain highly controversial.

Objective  To establish the feasibility of airway bioengineering using a technique based on the implantation of stented aortic matrices.

Design, Setting, and Participants  Uncontrolled single-center cohort study including 20 patients with end-stage tracheal lesions or with proximal lung tumors requiring a pneumonectomy. The study was conducted in Paris, France, from October 2009 through February 2017; final follow-up for all patients occurred on November 2, 2017.

Exposures  Radical resection of the lesions was performed using standard surgical techniques. After resection, airway reconstruction was performed using a human cryopreserved (−80°C) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. To prevent airway collapse, a custom-made stent was inserted into the allograft. In patients with proximal lung tumors, the lung-sparing intervention of bronchial transplantation was used.

Main Outcomes and Measures  The primary outcome was 90-day mortality. The secondary outcome was 90-day morbidity.

Results  Twenty patients were included in the study (mean age, 54.9 years; age range, 24-79 years; 13 men [65%]). Thirteen patients underwent tracheal (n = 5), bronchial (n = 7), or carinal (n = 1) transplantation. Airway transplantation was not performed in 7 patients for the following reasons: medical contraindication (n = 1), unavoidable pneumonectomy (n = 1), exploratory thoracotomy only (n = 2), and a lobectomy or bilobectomy was possible (n = 3). Among the 20 patients initially included, the overall 90-day mortality rate was 5% (1 patient underwent a carinal transplantation and died). No mortality at 90 days was observed among patients who underwent tracheal or bronchial reconstruction. Among the 13 patients who underwent airway transplantation, major 90-day morbidity events occurred in 4 (30.8%) and included laryngeal edema, acute lung edema, acute respiratory distress syndrome, and atrial fibrillation. There was no adverse event directly related to the surgical technique. Stent removal was performed at a postoperative mean of 18.2 months. At a median follow-up of 3 years 11 months, 10 of the 13 patients (76.9%) were alive. Of these 10 patients, 8 (80%) breathed normally through newly formed airways after stent removal. Regeneration of epithelium and de novo generation of cartilage were observed within aortic matrices from recipient cells.

Conclusions and Relevance  In this uncontrolled study, airway bioengineering using stented aortic matrices demonstrated feasibility for complex tracheal and bronchial reconstruction. Further research is needed to assess efficacy and safety.

Trial Registration  clinicaltrials.gov Identifier: NCT01331863

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