Electromagnetic navigation transthoracic needle aspiration for the diagnosis of pulmonary nodules: a safety and feasibility pilot study
Yarmus LB, Arias S., Feller-Kopman D., et al
Journal of Thoracic Disease
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 |
