Abstract

Rationale: The diagnostic yield of electromagnetic navigational bronchoscopy to access lung lesions remains low. The multicenter NAVIGATE study showed the diagnostic yield to be 71% for lesions up to 3 cm and 67% for lesions up to 2 cm. The introduction of robotic-assisted navigational platforms may overcome some of the traditional barriers encountered with previous approaches. We aim to assess the navigational and diagnostic yield of the Ion™ endoluminal system (Intuitive Surgical, Inc., Sunnyvale, California) regarding pulmonary lesions that could not previously be biopsied using conventional white light bronchoscopy. Methods: We retrospectively reviewed and analyzed data from our first 76 consecutive robotic-assisted navigational bronchoscopy (RAB) cases performed by a single proceduralist at our single center between March 11, 2020, to November 25, 2020. Secondary endpoints included the safety of the platform, such as incidences of pneumothoraces and significant bleeding events. Results: The ability to localize the lesion using the shape sensing technology was 100% (n=76). Navigational success, as determined by lesion visualization using radial endobronchial ultrasound confirmation, was 76% (n=58) of the nodules. The additional use of 2D-fluoroscopy for needle-in-lesion guidance and Rapid Onsite Evaluation to assess for adequate tissue sampling resulted in a diagnostic yield of 92% (n=70). There was a 0% complication rate for pneumothorax and significant bleeding events in the postoperative phase. Conclusions: Our study supports the current literature regarding the safety and efficacy of the Ion™ RAB for use in obtaining biopsy of peripheral lung lesions. Depending on the definition of navigational success, based on our results, the Ion™ RAB is comparable to or better than flexible bronchoscopy. The diagnostic yield is comparable to or better than flexible bronchoscopy but slightly lower than the gold standard computed tomography-guided transthoracic biopsy (CTTB) for peripheral lung lesions. However, in contrast to CTTB, the Ion™ RAB has lower complication rates for pneumothoraces and major bleeding. Further studies are needed to directly compare the current two robotic systems with a third system, Galaxy System™ by Noah Medical that is pending FDA approval.

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