First clinical results with the da Vinci FC
"PURPOSE: Navigational bronchoscopic methods include integrated CT data and some means of driving a bronchoscope or catheter towards a target. A new, investigational robotic-assisted system by Intuitive Surgical, Inc. has a remote controlled 3mm diameter catheter capable of potentially accessing all small peripheral bronchi. Real-time navigational driving and distal tip articulation of this catheter in pre-clinical studies showed the ability to target peripheral lesions. Importantly the robotic-assisted catheter remains completely stationary during sampling once a target position is reached. Furthermore, a newly developed, investigational flexible biopsy needle designed to accommodate a tight bend radius was utilized with this system.
METHODS: A safety and feasibility study in sequential patients with small peripheral lesions between 1 and 3 cm with no contraindication to general anaesthesia and endotracheal intubation or bronchoscopy were screened according to study criteria and consented for the study which had Institutional Review Board approval. Pre-procedure CT scans were uploaded to the system and navigational pathways were semi-automatically created. Side-by-side viewing of actual and virtual bronchi was used real-time during navigation to the target. Prior to biopsy under fluoroscopy control, an endobronchial ultrasound mini probe was used to con fi rm lesion location, if Bronchus-sign positive. Specifically-designed flexible transbronchial needle aspiration (TBNA) needles up to 19G were used along with forceps and brushes.
RESULTS: The 30 study subjects included 15 males and 15 females, mean age 62y (range 22-79y). Mean lesion size in the axial, coronal and sagittal planes were 12.5 ± 4.3 mm, 12.9 ± 4.0 mm and 12.3 ± 4.7 mm, respectively. The mean of the largest diameter in all dimensions was 15.3 mm ± 4.8 mm. The lesions were located at the 7th ± 1.5 generation of bronchi. In 29 cases, biopsy samples from the pre-planned target location, suitable for tissue diagnosis, were obtained. The mean indicated distance between catheter tip and centre of the target lesion was 9.7 ± 3.4 mm. The flexible TBNA needle performed well even in very angulated positions. Lesions were visible by EBUS mini-probe in 24 cases; 15 extrinsic and 9 concentric. Pathology showed 16 subjects with a malignant result; 8 with benign and 5 subjects inconclusive. Of the subjects with benign or inconclusive results, 3 underwent an additional diagnostic intervention, 9 have undergone a 3-month visit and one result is pending. One example was a semi-solid lesion of 10 x 21 x 8mm (3 planes) with biopsy showing adenocarcinoma with EGFR mutation. Overall diagnostic yield for these cases was 83% and diagnostic yield for malignancy was 89%. Sensitivity, Specificity, PPV and NPV (95% CI) were 88.9% [67.2.1%, 96.9%], 27.3 % [9.8%, 56.6%], 66.7% [46.7%, 82.1%] and 60% [23.1%, 88.2%] respectively. No device related adverse events occurred; in particular, no instances of pneumothorax or excessive bleeding were observed.
CONCLUSIONS: This robotic-assisted navigation system has safely navigated deep into the lung under continuous visualisation.
CLINICAL IMPLICATIONS: The ability of the catheter and needle to reach distal airways and maintain static position allows unique sampling capability."