A prospective, multi-center evaluation of the clinical utility of the ion endoluminal system-experience using a robotic-assisted bronchoscope system with shape-sensing technology
Folch EE, Pritchett M, Reisenauer J, Ost DE, Majid A, Fernandez-Bussy S, Keyes C, Parikh MS, Diaz-Mendoza J, Casal RF, and Simoff MJ. A prospective, multi-center evaluation of the clinical utility of the ion endoluminal system-experience using a robotic-assisted bronchoscope system with shape-sensing technology. American Journal of Respiratory and Critical Care Medicine 2020; 201(1).
American Journal of Respiratory and Critical Care Medicine
Rationale: Transthoracic lung biopsy remains a mainstay for pulmonary nodule diagnosis despite its safety profile. Existing guided bronchoscopic platforms have improved lung nodule diagnostic accuracy, but have plateaued around 73% when performed by experienced users in carefully selected patients. A robotic-assisted bronchoscopy system using shape-sensing technology aims to improve accuracy with precise navigation and use of biopsy tools through a stable catheter position with a favorable safety profile. To date, no multi-center data exists in live humans. We describe our early experience using this technology.
Methods: A prospective, multi-center study (NCT03893539) underway evaluates a robotic-assisted bronchoscopy system (Ion™ Endoluminal System, Intuitive Surgical, Sunnyvale, CA) on its ability to navigate to and biopsy pre-planned peripheral lung nodules between 10-30mm. A pre-procedure CT was loaded into planning software (PlanPoint™, Intuitive Surgical); the robotic catheter (3.5mm outer diameter) was driven to the planned target under direct visualization. Using shapesensing feedback, the catheter was parked in close proximity to the target. Radial endobronchial ultrasound (r-EBUS) confirmation was attempted, and biopsy was taken under fluoroscopy using flexible biopsy needles (Flexision™ Biopsy Needle, Intuitive Surgical) or other conventional biopsy tools. Complications are assessed post-procedure, and approximately 10 and 30 days. Investigators experienced in bronchoscopy received a minimum of 5 lead-in cases to get familiar with technology which will be described separately.
Results: Seventy subjects with a total of 74 nodules are included in this analysis. Mean axial, coronal and sagittal diameters were: 18.42 ± 5.44 mm, 16.75 ± 5.78 mm, and 17.36 ± 6.2 mm respectively. Most nodules were located in upper lobes (UL) (33% right UL and 28% left UL); median generation was 6.5 (IQR25-75: 5-8) and 57% located ≤ 10 mm from pleura. R-EBUS visualization was achieved in 66 (94%) cases; median procedure and r-EBUS visualization time was 47 (IQR25-75 35 - 67) and 11 (IQR25-75 7-18) minutes respectively. Navigation of the catheter within 2cm of the planned target location and biopsy completion was achieved in 69 (98%) cases, with the flexible needle used as first tool. No serious adverse event or pneumothorax requiring intervention has been reported. Sensitivity for malignancy and yield is part of the next stage and will be reported at study completion.
Conclusions: The safety profile of the robotic-assisted bronchoscopy platform with shape-sensing technology, is a promising new tool in the armamentarium to diagnose small peripheral lung nodules. These early results are encouraging but remain preliminary.