Endosonography-related mortality and morbidity for pulmonary indications: a nationwide survey in the Netherlands.

BACKGROUND

Endosonography is being implemented rapidly in pulmonary medicine for the diagnosis and staging of lung cancer, the assessment of sarcoidosis, and the assessment of mediastinal lesions. Although serious adverse events (SAEs) have been described, safety data outside cohort studies are scarce.

OBJECTIVE

To assess the SAE and mortality rate of EUS-guided FNA (EUS-FNA) and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) for mediastinal and/or hilar analysis.

DESIGN

Nationwide, retrospective survey by using questionnaires.

SETTING

All hospitals in the Netherlands.

PATIENTS

All patients undergoing EUS-FNA and EBUS-TBNA for intrathoracic analysis in the period 1999 to 2011.

INTERVENTIONS

EUS-FNA and EBUS-TBNA.

MAIN OUTCOME MEASUREMENTS

Occurrence of fatal outcomes and SAEs. Detailed information was obtained for each reported case, and all cases were reviewed independently by 2 investigators, including identification of risk factors.

RESULTS

All 89 hospitals (100%) responded. An estimated 14,075 EUS-FNA and 2675 EBUS procedures were performed. Seven patients died after endosonography (5 EUS-FNA, 2 EBUS [mortality rate 0.04%]). All fatalities occurred in patients of poor performance status (American Society of Anesthesiologists Physical Status Classification System score of III/IV). Twenty-five SAEs were reported (22 EUS-FNA, 3 EBUS [SAE rate of 0.15%; EUS-FNA 0.16%, EBUS 0.11%]). SAEs were mostly (64%) of infectious origin. No specific risk factors for infectious adverse events could be identified.

LIMITATIONS

Retrospective study, possible recall bias, overrepresentation of EUS-FNA cases.

CONCLUSION

Endosonography appears to be a safe technique for the analysis of mediastinal and/or hilar lesions. Poor performance status is a risk factor for fatal outcomes. Mediastinitis and/or mediastinal abscess formation is rare but is a potential and dangerous adverse event of endosonography.