Folch, Erik E.

ABSTRACT Background Shape‐sensing robotic‐assisted bronchoscopy (ssRAB) is a navigation platform for biopsy of indeterminate pulmonary lesions. Large‐scale, real‐world evidence confirming the safety profile of ssRAB compared to transthoracic needle biopsy (TTNB) is needed. Study Design and Methods A retrospective cohort study was performed using the PINC AI healthcare database among patients who underwent ssRAB or TTNB lung lesion biopsy at participating hospitals between April 2019 and March 2023. Outcomes were rates of pneumothorax and pneumothorax requiring chest‐tube intervention within 3 days, and rates of in‐hospital bleeding or all‐cause death. Quasi‐binomial logistic regression analysis was performed after one‐to‐five propensity score matching (PSM) accounting for patient‐ and hospital‐related characteristics. Results A total of 119 424 patients (5121 ssRAB, 114 303 TTNB) were identified with 4554 ssRAB and 14 319 TTNB patients after PSM. Relative to ssRAB, TTNB had significantly higher risk of pneumothorax (18.4% vs. 2.6%, OR = 7.10, p < 0.001) and pneumothorax requiring chest‐tube (10.8% vs. 1.4%, OR = 7.62, p < 0.001). TTNB was associated with a higher risk for bleeding (1.5% vs. 0.6%, OR = 2.20, p < 0.001) and all‐cause death (0.48% vs. 0.15%, OR = 2.47, p = 0.023); however, rates for both outcomes were relatively low. Interpretation In this large‐scale, real‐world database analysis with diverse patient populations, physician experience, and health care settings, ssRAB demonstrated a better safety profile compared to TTNB. Superior safety combined with a potentially comparable performance profile and known advantages of bronchoscopy, including concurrent staging, support ssRAB as an optimal choice for non‐surgical biopsies for suspicious pulmonary lesions.

Abstract INTRODUCTION Guidelines recommend non-surgical biopsy for indeterminate pulmonary lesions &gt; 8 mm. Shape-sensing robotic-assisted bronchoscopy (ssRAB) is growing in use to biopsy small pulmonary nodules; however current literature is limited to single center studies with limited follow-up. This study, PRECIsE, assessed safety and performance of the first ssRAB iteration across multiple sites and nascent users. METHODS Prospective, multicenter, observational study evaluating ssRAB without cone-beam CT guidance in patients with nodules 10–30 mm located in or beyond the sub-segmental airways. Patients were followed for 2 years; the primary endpoint was sensitivity for malignancy with diagnostic yield, and safety as secondary endpoints. Multilevel logistic regression models were used to control for factors associated with sensitivity and diagnostic yield. RESULTS A total of 305 procedures were performed across 6 centers. Median nodule size was 17.0 mm (IQR: 14.0–23.0) with bronchus sign present in 37% of cases. Sensitivity for malignancy through 2 years was 81.3% (95% CI: 75.7, 86.1). Multi-level modelling demonstrated female sex, smaller nodule size, lower lobe location, semi-solid density, and higher body-mass-index were associated with lower sensitivity. Diagnostic yield was 74.1% (95% CI: 68.8, 78.9) according to the ATS/ACCP criteria and 77.5% [95% CI: 72.4, 81.8] according to the intermediate criteria. Multi-level modeling demonstrated a non-significant site/center level effect on ATS/ACCP diagnostic yield (P = .36). Pneumothorax requiring intervention was 1.6% (5/305); bleeding was 1.0% (3/305) with two (2) Nashville grade 2 and one (1) Nashville grade 3 events. CONCLUSIONS The first iteration of ssRAB demonstrated encouraging performance and a strong safety profile among nascent users for the biopsy of small peripheral nodules.

AbstractBackground and ObjectiveShape‐sensing robotic‐assisted bronchoscopy (ssRAB) has expanded as an important diagnostic tool for peripheral pulmonary nodules (PPNs), with diagnostic yields ranging from 60% to 88%. However, sampling and diagnosing PPN less than 2 cm in size has historically been challenging. Mobile cone‐beam computed tomography (mCBCT) has been recently integrated into ssRAB to improve diagnostic accuracy, but its added value remains uncertain. We aim to describe the role of mCBCT and determine if it provides any diagnostic advantage.MethodsA multicentre, retrospective study on the use of ssRAB and mCBCT in two tertiary care institutions: Mayo Clinic Florida and Massachusetts General Hospital. The primary outcome was diagnostic yield and sensitivity for malignancy of ssRAB complemented with mCBCT, compared to ssRAB with the standard 2D fluoroscopy.ResultsA total of 192 nodules were biopsied from 173 patients. mCBCT was used in 117 (60.9%) nodules. The overall diagnostic yield was 85.4%. Diagnostic yield between subgroups with and without mCBCT was 83.8% and 88% (p = 0.417), respectively. The mCBCT group had fewer solid nodules (65.8% vs. 81.3%, p = 0.020) and a higher number of ground‐glass nodules (10.3% vs. 1.3%, p = 0.016).ConclusionOverall, diagnostic yield between subgroups with and without mCBCT was similar. The complementary use of mCBCT to ssRAB allows proceduralists to target more complex and subsolid PPNs with a diagnostic yield comparable to simple solid PPNs while maintaining an excellent safety profile.

AbstractBronchoscopy in thrombocytopenic patients remains a controversial topic as traditionally varying platelet thresholds have been stablished as “safe,” ranging from 20,000 to 50,000. A lower threshold may be safe for a routine airway inspection with bronchoalveolar lavage but will be far from safe for more invasive interventions such as needle biopsy, transbronchial biopsy, or cryo‐biopsy. Currently, a minimal platelet threshold during robotic‐assisted bronchoscopy (RAB) has not been established. In addition, the absolute platelet number does not guarantee appropriate platelet function. The literature regarding the safety of bronchoscopy and its bleeding risk, considering broader and more functional tests such as thromboelastography (TEG), is also lacking. We present our RAB approach to safely sample lung nodules in a patient with thrombocytopenia. Our precautionary strategy for high‐risk bleeding cases during RAB utilizing TEG and parallel flexible bronchoscopy with segmental balloon occlusion may be an appropriate technique to minimize bleeding risk.

Abstract Rationale Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive method used to diagnose suspected mediastinal lymph nodes or masses. However, the accuracy of the diagnosis in patients with suspected lymphoma is unclear. Objectives To evaluate the diagnostic yield of EBUS-TBNA in patients with suspected lymphoma. Methods A literature search including EMBASE, MEDLINE, Cochrane Library, and Google Scholar was performed by two reviewers. Included articles were evaluated using the QUADAS-2 tool and meta-analysis with a binary method model to compare the sensitivity, specificity, and summary receiver operating characteristic curve in patients with suspected lymphoma. Results Fourteen studies (425 participants) were pooled in the analysis. EBUS-TBNA reported an overall sensitivity of 66.2% (confidence interval [CI], 55–75.8%; I 2 = 76.2%) and specificity of 99.3% (CI, 98.2–99.7%; I 2 = 40%). For a new diagnosis of lymphoma, 13 studies including 243 participants reported sensitivity of 67.1% (CI, 54.2–77.9%; I 2 = 66.8%) and specificity of 99.6% (CI, 99.1–99.8%; I 2 = 0%). For recurrence of lymphoma, 11 studies including 166 participants reported sensitivity of 77.8% (CI, 68.1–85.2%; I 2 = 20.2%) and specificity of 99.5% (CI, 98.9–99.8%; I 2 = 0%). In the recurrence group, we found the use of rapid onsite examination, sample size, and flow cytometry increased the sensitivity of EBUS-TBNA, albeit a potential source of heterogeneity. Conclusions EBUS-TBNA has fair sensitivity for identifying a new diagnosis of lymphoma and fair to good sensitivity for identifying recurrence. Trial Registry PROSPERO CRD42018102773 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=102773.

Abstract Rationale Endobronchial ultrasound and transbronchial needle aspiration (EBUS-TBNA) are commonly used for the diagnosis and mediastinal staging of lung cancer. Molecular markers are becoming increasingly important in patients with lung cancer to define targetable mutations suitable for personalized therapy, such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species proto-oncogene (ROS1), and programmed death-ligand 1 (PD-L1). Objectives To evaluate the adequacy of EBUS-TBNA–derived tissue for molecular analysis. Methods We searched the MEDLINE, LILACS, www.clinicaltrials.gov, and Epistemonikos databases through January 2018. Data Extraction Two independent reviewers performed the data search, quality assessment, and data extraction. We included both prospective and retrospective studies; risk of bias was evaluated using the ROBINS-I tool. The primary outcome was the proportion of adequate samples obtained by EBUS-TBNA for molecular analysis. Data were pooled by using a binary random effects model. Finally, evidence was rated by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Results A total of 33 studies including 2,698 participants were analyzed. In 28 studies that evaluated EBUS-TBNA for the identification of EGFR mutations, the pooled probability of obtaining a sufficient sample was 94.5% (95% confidence interval CI], 93.2–96.4%). For identification of ALK mutations, the pooled probability was 94.9% (95% CI, 89.4–98.8%). Finally, the prevalence of EGFR mutation was 15.8% (95% CI, 12.1–19.4%), and the prevalence of ALK mutation was 2.77% (95% CI, 1.0–4.8%). Data for ROS1 and PD-L1 mutations were not suitable for meta-analysis. Conclusions EBUS-TBNA has a high yield for molecular analysis of both EGFR and ALK mutations. However, the suitability of TBNA samples for next-generation sequencing is uncertain and should be explored in further studies. Clinical trial registered with PROSPERO (CRD42017080008).