A multicenter observational study assessing the safety, feasibility, and complications of Bonastent in central airway...

Self-expandable metallic stents (SEMS) are increasingly used in the management of both malignant and nonmalignant airway stenosis. There are multiple stents available in the market; however, the current literature on the efficacy and safety of newly available 3rd generation SEMS (Bonastent) is extremely limited and only has data from single center studies.

To report the efficacy and early (<7 days) and late (⩾7 days) complications in patients with central airway obstruction (CAO) treated with Bonastent placement at two institutions.

We performed a retrospective analysis of data of consecutive patients who underwent therapeutic bronchoscopy and Bonastent placement at two tertiary care university hospitals between January 2019 and November 2023.

Bonastent deployment was performed in the operating room. Stents were deployed using rigid or flexible bronchoscopy under direct visualization with a flexible bronchoscope and in conjunction with fluoroscopic guidance. We then analyzed the effectiveness, short-term, and long-term complications of Bonastent placement.

A total of 107 Bonastents® were placed in 96 patients. The most common etiology of CAO was malignancy, 92.7% (n = 89), followed by excessive dynamic airway collapse (EDAC) and post-intubation tracheal stenosis. Seventy-three patients (76%) had improvement in symptoms or imaging within 7 days of stent placement, including successful liberation from mechanical ventilation in a patient with CAO. Early complications occurred in seven patients (two-airway bleeding, two-mucus plugging that improved with airway clearance, two-stent migrations, and one-cough).Late complications occurred in 23 patients (1-stent migration requiring revision bronchoscopy and replacement of airway stent, 11-mucus plugging, 6-granulation tissue, 2-pneumonia, 1-cough, 1-tumor ingrowth/stent fracture, 1-airway emergency due to excessive granulation tissue obstructing the distal end of the stent and had a failed cricothyroidotomy leading to death). Overall, the early complication rate was 7.3% (7/96) and late complication rate was 23.9% (23/96).

Our study is the first multicenter study that found a good safety profile with a low complication rate after tracheobronchial Bonastent placement with improvement in symptoms soon after stent placement.