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

doi:10.1016/j.gie.2015.03.1973

Gastrointestinal Endoscopy

Volume 82, Issue 6, December 2015, Pages 1009-1015

https://doi.org/10.1016/j.gie.2015.03.1973 Get rights and content

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.

Section snippets

Data collection

We conducted a nationwide survey by sending questionnaires to all 89 hospitals (both performing and referring EBUS/EUS-FNA centers) in the Netherlands during 2010 to 2011. The questionnaires requested that respondents report SAEs. One questionnaire was designed for those clinics performing EUS-FNA and/or EBUS, the other for those referring patients for the procedures. In case SAEs were reported, additional detailed information including endoscopy and radiologic reports as well as relevant

Results

Completed questionnaires from all 89 Dutch hospitals were collected. Forty-three of 89 clinics (48%) performed endosonography (EUS-FNA alone 21%, EBUS alone 1%, both EBUS and EUS-FNA 26%). An estimated 16,750 procedures were performed (14,075 EUS-FNA, 2675 EBUS).

Seven cases of endosonography-associated fatal outcomes (5 after EUS-FNA, 2 after EBUS) and 65 SAEs were reported. Eleven identical SAE cases were reported by both the executing and referring centers. One patient was reported to present

Discussion

In this nationwide, retrospective survey spanning a 12-year period in the Netherlands, we found that the rate of endosonography-associated SAEs for mediastinal analysis was low (0.15%), but with a few fatal outcomes (0.04%). SAEs were mostly of infectious origin.

In 4 cases, endosonography was judged as the primary cause of death because death occurred shortly after the diagnostic investigation; in 3 patients endosonography contributed to the fatal outcome.

In medical literature, reports of fatal

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Citation Excerpt :
In a retrospective study based on a survey conducted by the Japanese Society of Respiratory Endoscopy, including more than 7350 EBUS-TBNA cases, the overall complication rate was 1.2%, and the bleeding rate was 0.7%.6 Another study based on a nationwide survey in The Netherlands found only 3 cases of significant bleeding in more than 16,000 procedures.29 To our knowledge, mortality due to massive bleeding after EBUS-TBNA has been reported in only 3 patients to date, and in none of these cases was transvascular access used to biopsy the lesion.
Endoscopic ultrasound–guided biopsy techniques, including endobronchial ultrasound–guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound–guided fine-needle aspiration (EUS-FNA), are currently the standard of care for the assessment of mediastinal lymphadenopathy. Traditionally, passing the needle through and through vascular structures has been avoided owing to the risk of bleeding. In this study, we evaluated the safety and diagnostic accuracy of transvascular endosonographic-guided biopsies of mediastinal, hilar and lung lesions. Our hypothesis is that the approach is safe and adds to the endoscopic armamentarium, avoiding the need for surgical biopsy in specifically selected cases.
One hundred patients who underwent transvascular EBUS- or EUS-guided biopsy between 2012 and 2018 were identified from a prospective interventional endoscopy database.
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Transvascular endosonographic-guided biopsy is an important adjunct to conventional endoscopic techniques and allows the thoracic endoscopist to obtain biopsy specimens from intrathoracic lesions that are not accessible without vascular puncture.
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: DISCLOSURE: This research project was supported by a government grant of ZonMW: The Netherlands Organisation for Health Research and Development (grant number 945144071) (J.T.A.). All other authors disclosed no financial relationships relevant to this article.

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Original articleClinical endoscopyEndosonography-related mortality and morbidity for pulmonary indications: a nationwide survey in the Netherlands

Background

Objective

Design

Setting

Patients

Interventions

Main Outcome Measurements

Results

Limitations

Conclusion

Section snippets

Data collection

Results

Discussion

Chest

Eur J Cancer

J Thorac Oncol

Gastrointest Endosc

Gastrointest Endosc

J Visc Surg

Revised ESTS guidelines for preoperative mediastinal lymph node staging for non-small-cell lung cancer

Eur J Cardiothorac Surg

Endosonography vs conventional bronchoscopy for the diagnosis of sarcoidosis: the GRANULOMA randomized clinical trial

JAMA

EBUS-centred versus EUS-centred mediastinal staging in lung cancer: a randomised controlled trial

Thorax

Original article
Clinical endoscopy
Endosonography-related mortality and morbidity for pulmonary indications: a nationwide survey in the Netherlands