Treatment of aerodigestive fistulas with a novel covered metallic Y-shaped segmented airway stent customized with the assistance of 3D printing.

BACKGROUND

The management of aerodigestive fistula remains challenging. An airway stent that matches well with the individual geometry of the airway is needed for the treatment of the aerodigestive fistula. This study aimed to evaluate the feasibility of a novel covered metallic segmented Y-shaped airway stent customized with the assistance of 3D printing in aerodigestive fistulas involving the carina and distal bronchi and to compare the flexibility of the novel stent with the conventional wholly knitted stent.

METHODS

In the flexibility study, we measured the longitudinal bending force and spring-back force of the segmented stent and wholly knitted stent. Patient-specific stents that were individually customized with the assistance of 3D printing technology were implanted in 26 patients with aerodigestive fistulas. The technical success, clinical success, Karnofsky performance status (KPS), and stent-related complications were recorded.

RESULTS

The bending force and spring-back force of the segmented stent were significantly lower than those of the wholly knitted stent. Stent deployment was technically successful in all patients. Clinical success was obtained in 21 patients. The KPS of patients after the stenting procedure improved significantly compared with that before stenting (P<0.001). During follow-up, granulation tissue proliferation, sputum retention, stent migration, and intolerance of the stent were found in 2, 5, 1, and 1 patient, respectively.

CONCLUSIONS

The segmented metallic Y-shaped airway stent had greater flexibility than the wholly knitted stent in an ex vivo setting. Implantation of the segmented stent individually customized with the aid of 3D printing is feasible in treating aerodigestive fistulas involving the carina and bronchi distal to the carina.