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

Abstract

Background: 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.

Objectives: 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.

Design: 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.

Methods: 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.

Results: 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).

Conclusion: 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.