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Electromagnetic navigation transthoracic needle aspiration for the diagnosis of pulmonary nodules: a safety and feasibility pilot study

STUDY
Yarmus LB, Arias S, Feller-Kopman D, et al. Electromagnetic navigation transthoracic needle aspiration for the diagnosis of pulmonary nodules: a safety and feasibility pilot study. J Thorac Dis. 2016;8(1):186-194. doi: 10.3978/j. issn.2072‑1439.2016.01.47.

OVERVIEW

  • + First human prospective pilot study of ETTNA (SPiN Perc™)
    • Primary end points: safety and feasibility
    • Secondary end point: diagnostic yield
  • + Inclusion criteria:
    • SPN ≥10mm and ≤30mm
    • Accessible by anterior or lateral chest percutaneous approach
    • Clinical indication for bronchoscopy for SPN diagnosis
  • + Exclusion criteria:
    • PET positive mediastinal lymphadenopathy
    • Mediastinal lymphadenopathy ≥10mm
  • + Average nodule size was 20.3mm

OBJECTIVE
Evaluate the safety, feasibility and diagnostic yield of a “…technology [that] incorporates a unique electromagnetic guidance system allowing clinicians to track SPN and target them for ETTNA without utilizing real time CT in the operating room or bronchoscopy suite.”

92%

diagnostic yield using ETTNA (SPiN Perc™)+ NB + EBUS

AUTHORS’ CONCLUSION
“The combination of performing ETTNA,NB and EBUS in a single procedural setting resulted in a 92% overall diagnostic yield.”

KEY FINDINGS

  • + Diagnostic yield for ETTNA (SPiN Perc™) was 83%, and 87% (P=0.0016) when combined
    with navigated bronchoscopy (NB)
  • + Diagnostic yield increased to 92% (P=0.0001) when SPiN Perc™ and NB were performed with EBUS for mediastinal staging
DIAGNOSTIC METHOD DIAGNOSTIC YIELD
ETTNA (SPiN Perc™) 83%
ETTNA (SPiN Perc™) + NB 87%
ETTNA (SPiN Perc™) + NB + EBUS 92%
  • + Additional time to perform the ETTNA was less than EBUS or NB
DIAGNOSTIC METHOD MINUTES
ETTNA (SPiN Perc™) 18.3
Linear EBUS 20.5
NB 22.9
SPiN Perc - Electromagnetic navigation transthoracic needle aspiration for the diagnosis of pulmonary nodules: a safety and feasibility pilot study

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