Safety and major adverse events of endobronchial ultrasound performed under conscious sedation: Insights from 3,454 procedures over 14 years and a systematic review of literature

Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is widely used for evaluating mediastinal lymphadenopathy. However, its safety profile requires comprehensive evaluation. This study aimed to determine the prevalence of complications associated with EBUS-TBNA and to conduct a systematic review and meta-analysis to estimate the pooled complication rates. Methods: We retrospectively analysed a prospectively maintained database of patients who underwent EBUS between April 2011 and April 2025. We extracted demographic, procedural, and complication-related data. Major complications were defined as events necessitating endotracheal intubation, cardiopulmonary arrest, hospitalization ≥24 h, mediastinitis, significant bleeding requiring intervention, pneumothorax unrelated to transbronchial biopsy, or death. A systematic review and meta-analysis were performed using the Der Simonian and Laird random-effects model to determine pooled complication rates from studies with ≥1000 EBUS procedures. Results: Of the 3,454 patients included 77 (2.2%) experienced complications, with 10 (0.3%) classified as major. Major events included severe bleeding ( n = 4), respiratory arrest ( n = 2), mediastinal cyst rupture, mediastinitis, temporomandibular joint dislocation, and one death. The meta-analysis included 27,560 patients from seven studies and yielded a pooled complication rate of 1.21%. The pooled complication rates from our meta-analysis were 26.2 for major bleeding, 9.6 for mediastinitis, 5.5 for pneumothorax, and 1.52 for procedure-related mortality per 10,000 EBUS procedures. Conclusions: EBUS-TBNA is a safe diagnostic procedure with a rare incidence of major complications. Bleeding, infectious complications, and respiratory events constitute the most significant risks.