title: Endosonography-related mortality and morbidity for pulmonary indications: a nationwide survey in the Netherlands.
abstract: 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.
  
  
  METHODS
  Nationwide, retrospective survey by using questionnaires.
  
  
  METHODS
  All hospitals in the Netherlands.
  
  
  METHODS
  All patients undergoing EUS-FNA and EBUS-TBNA for intrathoracic analysis in the period 1999 to 2011.
  
  
  METHODS
  EUS-FNA and EBUS-TBNA.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Retrospective study, possible recall bias, overrepresentation of EUS-FNA cases.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Respiratory Medicine, Leiden University Medical Center, Leiden, the Netherlands.
authors.forename: Martin B
authors.initials: MB
authors.lastname: von Bartheld
authors.affiliation: Department of Respiratory Medicine, Leiden University Medical Center, Leiden, the Netherlands; Department of Respiratory Medicine, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Jouke T
authors.initials: JT
authors.lastname: Annema
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000009:adverse effects / Q000401:mortality*; D005260:Female; D019538:Health Care Surveys; D006801:Humans; D008169:Lung Abscess / Q000209:etiology* / Q000401:mortality; D008171:Lung Diseases / Q000175:diagnosis*; D008297:Male; D008480:Mediastinitis / Q000209:etiology* / Q000401:mortality; D008875:Middle Aged; D009426:Netherlands; D017063:Outcome Assessment, Health Care; D012189:Retrospective Studies; D011795:Surveys and Questionnaires