Shape-Sensing Robotic-Assisted Bronchoscopy: A Meta-Analysis of Diagnostic Performance and Safety

OBJECTIVES: Shape-sensing robotic-assisted bronchoscopy (ssRAB) has potential to improve diagnostic accuracy and maximize yield, while ultimately shortening time to treatment and delivering better outcomes for patients. This single-arm meta-analysis investigated the diagnostic performance and safety of ssRAB.

METHODS: A targeted search was conducted for papers published between January 2019 and December 2023. Studies were included if they reported outcomes of interest in adult populations undergoing lung biopsy with ssRAB. Studies were excluded if they reported data from cadaver or animal studies, were case reports, review articles, scientific letters, or conference abstracts. Articles were not restricted based on the definition of diagnostic yield or use of adjunctive technologies. A meta-analysis was conducted using R software. Pooled diagnostic outcomes and complications were estimated using the Freeman-Tukey transformation. A random effects model was used in the presence of significant heterogeneity (I²>50% or p<0.05). Systematic literature reviews of alternative biopsy modalities were reviewed for an indirect comparison of results.

RESULTS: 146 records were screened in which 16 peer-reviewed publications reporting diagnostic yield, sensitivity, and safety outcomes were included. Data was available from 1931 patients and 2134 nodules. Median nodule size was 12 mm – 22 mm with the majority of nodules in the upper lobes. Pooled diagnostic yield across all studies was 86% (95% CI; 84-88), (I²=44%). Pooled sensitivity was 86% (95% CI; 82-89), (I²=61%). The overall rate of pneumothorax across studies was 2.2% (95% CI; 1.5-2.9), (I²=0%). The rate of pneumothorax requiring intervention was 1% (95% CI; 0.5-1.6), (I²=0%). Bleeding events occurred in less than 0.01% of patients, (I²=0%).

CONCLUSIONS: ssRAB presents an effective and safe advancement in navigation bronchoscopy. The pooled results for diagnostic yield are higher than reported values for traditional bronchoscopy. These results also demonstrate significant benefit in terms of safety when compared to transthoracic needle biopsy.