Accuracy and efficacy of Ion robotic-assisted bronchoscopic fine needle aspiration of lung lesions

J Am Soc Cytopathol. 2024 Aug 22:S2213-2945(24)00191-1. doi: 10.1016/j.jasc.2024.08.129. Online ahead of print.

Abstract

Introduction: The Ion Endoluminal Platform (ION) (IEPI Intuitive, Sunnyvale, CA), a minimally invasive robotic-assisted bronchoscopy platform, was recently US Food and Drug Administration approved for the performance of fine needle aspirations (FNAs) and biopsies of peripheral lung lesions. Rapid on-site intraoperative diagnosis (IOD) of FNAs and/or frozen section of biopsies help surgeons confirm adequate sampling of the targeted lesion and allow definitive treatment in selected cases.

Materials and methods: We retrospectively reviewed our experience with all FNAs of lung lesions sampled by interventional pulmonologists and thoracic surgeons using Ion from September 2020 to December 2022. IOD rendered during adequacy assessment were compared with final cytology diagnoses (Cyto-FD) and the ultimate final diagnoses (U-FD). The U-FD was based on the sum of all clinical, imaging, cytologic, and histologic diagnoses of the lung lesion which the clinical team used to treat the patient.

Results: The IOD and Cyto-FD were concordant in 62% of the 423 lesions that underwent intraoperative evaluation, yielding a sensitivity of 67% and a specificity of 99% for malignancy. The Cyto-FD and U-FD were concordant in 51% of the lesions with a sensitivity and specificity for malignancy of 66% and 100%, respectively.

Conclusions: IODs rendered during Ion were highly accurate but only moderately sensitive for a diagnosis of malignancy.

Keywords: Fine needle aspiration cytology; Intraoperative evaluation; Ion endoluminal platform; Pulmonary cytopathology; Rapid on-site evaluation (ROSE); Robotic assisted bronchoscopy; Shape sensing technology.