Systemic Air Embolism After CT-guided Lung Biopsy (SAE)

Systemic Air Embolism After CT-guided Lung Biopsy: Incidence and Risk Factors Assessment

Systemic air embolism is traditionally considered as an extremely rare complication of percutaneous lung biopsy. Current literature includes mainly case reports or small case series of SAE. Majority of cases resulted in cardiac and/or neurological symptoms, often causing death. In most reported cases, the diagnosis of systemic air embolism referred to clinical manifestations without radiological diagnosis at the time of the procedure. Hence, its incidence might be underestimated in case of asymptomatic patients. Immediate recognition of air embolism during the procedure has been reported as the main factor to minimize severe complications since specific management of patient can be initiated earlier.

The purpose of this study is to retrospectively assess the incidence of systemic air embolism depicted at the time of the procedure on a whole thoracic CT, systematically performed after transthoracic lung biopsy in a large cohort of consecutive patients. Secondary objectives are to determine possible influencing factors and to evaluate clinical outcomes.

Study Overview

• Status: Completed
• Conditions: Patients Who Underwent Percutaneous Lung Biopsy Under CT Guidance; Patients Who Presented Systemic Air Embolism After Percutaneous Lung Biopsy Under CT Guidance Depicted at the Time of the Procedure on a Whole Thoracic CT
• Intervention / Treatment: Procedure: Percutaneous lung biopsy under CT guidance

Detailed Description

In this retrospective cohort study, all consecutive lung biopsies performed between April 2014 to May 2016 at our department of cardiothoracic interventional radiology were included using the local thoracic biopsy database. Biopsies were scheduled after the weekly multidisciplinary lung cancer meeting approval. Pleural, parietal and mediastinal lesions were excluded due to the absence of intra-parenchymal pathway. Radiofrequency ablation and peripheral nodule marking procedure were also excluded.

A complete retrospective imaging review of the procedures was performed on a PACS workstation by an experienced chest radiologist. Clinical data was also collected from the electronic medical record system.

Variables analyzed were age, sex, spirometry data, emphysema on CT, therapeutics previously done, target lesion characteristics (location, depth, and nodule size and feature), patient position, length of intrapulmonary biopsy path, number of pleural needle passes, biopsy length and number of biopsy passes. Procedural air embolism and other associated complications (hemoptysis and pneumothorax) and their management and consequences (length of hospitalization and additional action) were recorded.

Patient's characteristics with and without air embolism were compared using Student or Wilcoxon rank test for continuous variables and Chi-square or Fisher test for categorical ones. To determine the relative importance of air embolism occurrence influencing factors, multivariate logistic regression analysis was performed on variables according to significance level or clinical coherence. A backward selection was used; the α-to-enter and the α-to-exit were set, respectively, at 0.20 and 0.10. Statistical bilateral significance threshold was set at 5%. Statistical analyses were performed using SAS version 9.1 (SAS Institute, Cary, North Carolina).

• Study Type: Observational
• Enrollment (Actual): 559

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive lung biopsies performed between April 2014 to May 2016 at our department of cardiothoracic interventional radiology were included using the local thoracic biopsy database.

Description

Inclusion Criteria:

- percutaneous CT guided lung biopsies

Exclusion criteria:

• absence of intra-parenchymal pathway (pleural, parietal or mediastinal lesions)
• radiofrequency ablation
• peripheral nodule marking procedure

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of systemic air embolism	Systemic air embolism was depicted on the CT scan performed on the whole chest in the same position as for the biopsy at the end of the procedure. Air embolism was defined as an air collection in the left cardiac cavities or vascular systemic structure, visible in at least two consecutive slices, that was not present on the pre-therapeutic CT	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors of systemic air embolism	Variables were recorded using a retrospective imaging review of the biopsy procedures. Clinical data was also collected from the electronic medical record system.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Valérie Monnin-Bares, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: CT; Lung biopsy; Interventional radiology; Transthoracic biopsy; Systemic air embolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Embolism; Embolism, Air
• Other Study ID Numbers: RECHMPL17_0326

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No