First clinical results with the da Vinci FC
A most recent study at the Canadian CHEST meeting revealed the first clinical results with the da Vinci FC from Fielding et al. (Royal Brisbane and Womens Hospital, Brisbane):
"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."
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