Small intestinal submucosa covered expandable Z stents for treatment of TrachEal injury: An experimental pilot study in swine

PURPOSE: To evaluate efficacy of small intestinal submucosa (SIS) as a stent covering in healing experimentally created tracheal defects and to explore the trachea's reaction to placement of SIS-covered stents. MATERIAL AND METHODS: A tracheal defect with a diameter of approximately 10 mm was created in six swine with use of a blade or electrocauterization. A double-body, self-expandable SIS-covered Gianturco Rösch Z stent was placed into the trachea to cover the defect. The animals were observed, and were killed when they developed respiratory problems. Autopsy and histologie studies were performed. RESULTS: The SIS-covered stents were accurately placed without immediate complications related to placement. All animals developed respiratory problems on follow-up. One animal died 9 days after procedure because of pneumonia, the others five were killed at 12, 17, 18, 28, and 56 days because of stridor, wheezing, and cough. At autopsy and histology, the tracheal defects were found to be completely healed, with epithelial lining and regeneration of submucosal glands. Animals whose defects were created with a blade demonstrated cartilage remodeling between 9 and 18 days, and apparent deposition of new cartilage at 28 days after SIS placement. The defects made by electrocauterization showed only fibrous tissue with no cartilage regeneration. The tracheal lumen was narrowed by. overgrowth of granulation tissue, particularly at the end wires of the stents. In three animals, polypoid masses caused 60%, 70%, and 80% tracheal obstruction, respectively. CONCLUSION: Placement of SIS-covered stents contributed to rapid and effective healing of large tracheal defects. Rigidity and oversi/ing of Gianturco Rösch Z stents led to secondary changes of the tracheal wall, causing significant airway obstructions. Smaller size and flexible stents should be selected for future work.