First-in-human use of a new robotic electromagnetic navigation bronchoscopic platform with integrated Tool-in-Lesion Tomosynthesis (TiLT) technology for peripheral pulmonary lesions: The FRONTIER study.

BACKGROUND AND OBJECTIVE: As the presentation of pulmonary nodules increases, the importance of a safe and accurate method of sampling peripheral pulmonary nodules is highlighted. First-generation robotic bronchoscopy has successfully assisted navigation and improved peripheral reach during bronchoscopy. Integrating tool-in-lesion tomosynthesis (TiLT) may further improve yield. METHODS: We performed a first-in-human clinical trial of a new robotic electromagnetic navigation bronchoscopy system with integrated digital tomosynthesis technology (Galaxy System, Noah Medical). Patients with moderate-risk peripheral pulmonary nodules were enrolled in the study. Robotic bronchoscopy was performed using electromagnetic navigation with TiLT-assisted lesion guidance. Non-specific results were followed up until either a clear diagnosis was achieved or repeat radiology at 6 months demonstrated stability. RESULTS: Eighteen patients (19 nodules) were enrolled. The average lesion size was 20 mm, and the average distance from the pleura was 11.6 mm. The target was successfully reached in 100% of nodules, and the biopsy tool was visualized inside the target lesion in all cases. A confirmed specific diagnosis was achieved in 17 nodules, 13 of which were malignant. In one patient, radiological monitoring confirmed a true non-malignant result. This translates to a yield of 89.5% (strict) to 94.7% (intermediate). Complications included one pneumothorax requiring observation only and another requiring an overnight chest drain. There was one case of severe pneumonia following the procedure. CONCLUSION: In this first-in-human study, second-generation robotic bronchoscopy using electromagnetic navigation combined with integrated digital tomosynthesis was feasible with an acceptable safety profile and demonstrated a high diagnostic yield for small peripheral lung nodules.

Breaking New Ground in Interventional Pulmonology: Integrating Cone Beam CT and Robotic-Assisted Bronchoscopy for High-Risk Pneumothorax in Peripherally Located Solitary Pulmonary Nodules.

Lung cancer, a leading cause of global cancer-related deaths, necessitates the development of innovative diagnostic techniques. Traditional bronchoscopy, while useful, has limitations in diagnosing peripheral pulmonary lesions (PPLs) and carries a higher risk of complications such as pneumothorax. However, the field of interventional pulmonology has seen significant advancements, including the introduction of robotic-assisted bronchoscopy (RAB), cone-beam computed tomography (CBCT), radial endobronchial ultrasound (R-EBUS), and rapid on-site evaluation (ROSE). These advancements have greatly improved the precision of diagnosing high-risk PPLs. This report presents the case of a 60-year-old female smoker with chronic obstructive pulmonary disease and extensive centrilobular emphysema, who had a peripherally located high-risk pulmonary nodule. She was successfully diagnosed with metastatic adenocarcinoma using an integrated approach, despite the challenging location of the lesion and high risk of pneumothorax. The integration of RAB with CBCT and augmented fluoroscopy offers a groundbreaking approach for diagnosing and managing difficult-to-reach, high-risk pulmonary nodules, marking a significant stride in the field of interventional pulmonology.

Shape-Sensing Robotic-Assisted Bronchoscopy in the Multiple Pulmonary Nodule Diagnosis during a Single Anesthetic Event.

INTRODUCTION: The widespread use of computed tomography as a screening tool for early lung cancer has increased detection of pulmonary lesions. It is common to encounter patients with more than one peripheral pulmonary nodule (PPN) of uncertain etiology. Shape-sensing robotic-assisted bronchoscopy (ssRAB) emerges as a potential alternative to biopsy multiple PPN, in addition to mediastinal staging in single anesthetic procedure. METHODS: This is a single-center, retrospective review of 22 patients who underwent ssRAB for evaluation of two or more PPN, between November 2021 and April 2023 at Mayo Clinic, FL, USA. RESULTS: A total of 46 PPNs were biopsied in 22 patients. All lesions were ≤2 cm with a median minimum and maximum cross-sectional lesion size of 1.40 cm and 1.05 cm, respectively. Diagnostic yield was 86.9% (n = 40), and target reach was 91.3% (n = 42). Most lesions were in the upper lobes, a solid pattern was found in 78.3% (n = 36), bronchus sign was present in 82.6% of cases (n = 38), 54.4% (n = 25) were malignant nodules, and 32.6% (n = 15) were benign. Fourteen patients had at least one malignant lesion out of two or more nodules sampled, and 10 patients had a malignant diagnosis for all sampled lesions. The complication rate was 9% (n = 2) with one case of bleeding and one of pneumothorax. CONCLUSION: This study is, to our knowledge, the first to assess the use and safety of ssRAB for diagnosis of multiple PPN in a single anesthetic event. This procedure will mainly impact management decisions and subsequently shorten the time from diagnosis to treatment.

Shape-Sensing Robotic-Assisted Bronchoscopy versus Computed Tomography-Guided Transthoracic Biopsy for the Evaluation of Subsolid Pulmonary Nodules.

INTRODUCTION: Lung cancer remains the leading cause of cancer death worldwide. Subsolid nodules (SSN), including ground-glass nodules (GGNs) and part-solid nodules (PSNs), are slow-growing but have a higher risk for malignancy. Therefore, timely diagnosis is imperative. Shape-sensing robotic-assisted bronchoscopy (ssRAB) has emerged as reliable diagnostic procedure, but data on SSN and how ssRAB compares to other diagnostic interventions such as CT-guided transthoracic biopsy (CTTB) are scarce. In this study, we compared diagnostic yield of ssRAB versus CTTB for evaluating SSN. METHODS: A retrospective study of consecutive patients who underwent either ssRAB or CTTB for evaluating GGN and PSN with a solid component less than 6 mm from February 2020 to April 2023 at Mayo Clinic Florida and Rochester. Clinicodemographic information, nodule characteristics, diagnostic yield, and complications were compared between ssRAB and CTTB. RESULTS: A total of 66 nodules from 65 patients were evaluated: 37 PSN and 29 GGN. Median size of PSN solid component was 5 mm (IQR: 4.5, 6). Patients were divided into two groups: 27 in the ssRAB group and 38 in the CTTB group. Diagnostic yield was 85.7% for ssRAB and 89.5% for CTTB (p = 0.646). Sensitivity for malignancy was similar between ssRAB and CTTB (86.4% vs. 88.5%; p = 0.828), with no statistical difference. Complications were more frequent in CTTB with no significant difference (8 vs. 2; p = 0.135). CONCLUSION: Diagnostic yield for SSN was similarly high for ssRAB and CTTB, with ssRAB presenting less complications and allowing mediastinal staging within the same procedure.

Robotic-Assisted Bronchoscopy: A Comprehensive Review of System Functions and Analysis of Outcome Data.

The past two decades have witnessed a revolutionary era for peripheral bronchoscopy. Though the initial description of radial endobronchial ultrasound can be traced back to 1992, it was not until the mid-2000s that its utilization became commonplace, primarily due to the introduction of electromagnetic navigation (EMN) bronchoscopy. While the diagnostic yield of EMN-assisted sampling has shown substantial improvement over historical fluoroscopy-assisted bronchoscopic biopsy, its diagnostic yield plateaued at around 70%. Factors contributing to this relatively low diagnostic yield include discrepancies in computed tomography to body divergence, which led to unsuccessful lesion localization and resultant unsuccessful sampling of the lesion. Furthermore, much of peripheral bronchoscopy utilized a plastic extended working channel whose tips were difficult to finely aim at potential targets. However, the recent introduction of robotic-assisted bronchoscopy, and its associated stability within the peripheral lung, has ignited optimism for its potential to significantly enhance the diagnostic performance for peripheral lesions. Moreover, some envision this technology eventually playing a pivotal role in the therapeutic delivery to lung tumors. This review aims to describe the currently available robotic-assisted bronchoscopy technologies and to discuss the existing scientific evidence supporting these.

Advanced Bronchoscopic Diagnostic Techniques in Lung Cancer.

The increasing incidence of incidental pulmonary nodules necessitates effective biopsy techniques for accurate diagnosis and treatment planning. This paper reviews the widely used advanced bronchoscopic techniques, such as radial endobronchial ultrasound-guided transbronchial lung biopsy, electromagnetic navigation bronchoscopy, and the cutting-edge robotic-assisted bronchoscopy. In addition, the cryobiopsy technique, which can enhance diagnostic yield by combination with conventional biopsy tools, is described for application to peripheral pulmonary lesions and mediastinal lesions, respectively.

Robotic-assisted bronchoscopy for the diagnosis of peripheral pulmonary lesions: A systematic review and meta-analysis.

Robotic-assisted bronchoscopy (RAB) is a newly developed bronchoscopic technique for the diagnosis of peripheral pulmonary lesions (PPLs). The objective of this meta-analysis was to analyze the diagnostic yield and safety of RAB in patients with PPLs. Five databases (PubMed, Embase, Web of Science, CENTRAL, and ClinicalTrials.gov) were searched from inception to April 2023. Two independent investigators screened retrieved articles, extracted data, and assessed the study quality. The pooled diagnostic yield and complication rate were estimated. Subgroup analysis was used to explore potential sources of heterogeneity. Publication bias was assessed using funnel plots and the Egger test. Sensitivity analysis was also conducted to assess the robustness of the synthesized results. A total of 725 lesions from 10 studies were included in this meta-analysis. No publication bias was found. Overall, RAB had a pooled diagnostic yield of 80.4% (95% CI: 75.7%-85.1%). Lesion size of >30 mm, presence of a bronchus sign, and a concentric radial endobronchial ultrasound view were associated with a statistically significantly higher diagnostic yield. Heterogeneity exploration showed that studies using cryoprobes reported better yields than those without cryoprobes (90.0%, 95% CI: 83.2%-94.7% vs. 79.0%, 95% CI: 75.8%-82.2%, p < 0.01). The pooled complication rate was 3.0% (95% CI: 1.6%-4.4%). In conclusion, RAB is an effective and safe technique for PPLs diagnosis. Further high-quality prospective studies still need to be conducted.

Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.

BACKGROUND: Robotic-assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic-assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy. METHODS: Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center. Each operating room (OR) is assigned to either robotic-assisted or electromagnetic navigational bronchoscopy each morning, with each OR day considered one cluster. All patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion in one of the two operating rooms are eligible. Schedulers, patients, and proceduralists are blinded to daily group allocations until randomization is revealed for each operating room each morning. The primary endpoint is the diagnostic yield defined as the proportion of cases yielding lesional tissue. Secondary and safety endpoints include procedure duration and procedural complications. Enrolment began on March 6, 2023, and will continue until 202 clusters have been accrued, with expected enrolment of approximately 400 patients by the time of completion in March of 2024. DISCUSSION: RELIANT is a pragmatic randomized controlled trial that will compare the diagnostic yield of the two most commonly used bronchoscopic approaches for sampling peripheral pulmonary lesions. This will be the first known cluster randomized pragmatic trial in the interventional pulmonology field and the first randomized controlled trial of robotic-assisted bronchoscopy. TRIAL REGISTRATION: ClinicalTrials.gov registration (NCT05705544) on January 30, 2023.

Robotic-assisted bronchoscopy in the diagnosis of peripheral pulmonary lesions.

More peripheral pulmonary lesions (PPLs) are detected by low-dose helical computed tomography (CT) either incidentally or via dedicated lung cancer screening programs. Thus, using methods for safe and accurate diagnosis of these lesions has become increasingly important. Transthoracic needle aspiration (TTNA) and transbronchial lung biopsy (TBLB) are routinely performed during the diagnostic workup for PPLs. However, TTNA often carries the risk of pneumothorax, uncontrollable airway hemorrhage, and does not allow mediastinal staging in one procedure. In contrast, traditional TBLB often has a poorer diagnostic yield despite fewer complications. With the ongoing development of technology applied to bronchoscopy, guided bronchoscopy has become widely used and the diagnostic yield of TBLB has improved. Additionally, guided bronchoscopy continues to demonstrate a better safety profile than TTNA. In recent years, robotic-assisted bronchoscopy (RAB) has been introduced and implemented in the diagnosis of PPLs. At present, RAB has two platforms that are commercially available: Monarch™ and Ion™; several other platforms are under development. Both systems differ in characteristics, advantages, and limitations and offer features not seen in previous guided bronchoscopy. Several studies, including cadaveric model studies and clinical trials, have been conducted to examine the feasibility and performance of RAB using these two systems; large multicenter studies are underway. In this review, published experimental results, focusing on diagnostic yield and complications of RAB, are analyzed and the potential clinical application of RAB is discussed, which will enable the operators to have a clear overview of RAB.