Real-World Impact of Robotic-Assisted Bronchoscopy on the Staging and Diagnosis of Lung Cancer: The Shape of Current and Potential Opportunities.
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SUBMITTER: Ortiz-Jaimes G
PROVIDER: S-EPMC10492559 | biostudies-literature | 2023
REPOSITORIES: biostudies-literature
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Real-World Impact of Robotic-Assisted Bronchoscopy on the Staging and Diagnosis of Lung Cancer: The Shape of Current and Potential Opportunities.
Ortiz-Jaimes Gabriel G Reisenauer Janani J
Pragmatic and observational research 20230905
The approach to peripheral pulmonary lesions (PPL) has been evolving continuously. Advanced bronchoscopic navigational techniques have improved the airway-based approaches to these lesions. Robotic Assisted Bronchoscopy (RAB) can be considered the current pinnacle of this evolution; allowing for a safer approach to sampling lesions previously considered outside of bronchoscopic reach. We present a comprehensive review of the changing epidemiology of lung cancer and the importance of early tissue ...[more]
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Project description:BackgroundThe landscape of guided bronchoscopy for the sampling of pulmonary parenchymal lesions is evolving rapidly. Shape-sensing robotic-assisted bronchoscopy (ssRAB) recently was introduced as means to allow successful sampling of traditionally challenging lesions.Research questionWhat are the feasibility, diagnostic yield, determinants of diagnostic sampling, and safety of ssRAB in patients with pulmonary lesions?Study design and methodsData from 131 consecutive ssRAB procedures performed at a US-based cancer center between October 2019 and July 2020 were captured prospectively and analyzed retrospectively. Definitions of diagnostic procedures were based on prior standards. Associations of procedure- and lesion-related factors with diagnostic yield were examined by univariate and multivariate generalized linear mixed models.ResultsA total of 159 pulmonary lesions were targeted during 131 ssRAB procedures. The median lesion size was 1.8 cm, 59.1% of lesions were in the upper lobe, and 66.7% of lesions were beyond a sixth-generation airway. The navigational success rate was 98.7%. The overall diagnostic yield was 81.7%. Lesion size of ≥ 1.8 cm and central location were associated significantly with a diagnostic procedure in the univariate analysis. In the multivariate model, lesions of ≥ 1.8 cm were more likely to be diagnostic compared with lesions < 1.8 cm, after adjusting for lung centrality (OR, 12.22; 95% CI, 1.66-90.10). The sensitivity and negative predictive value of ssRAB for primary thoracic malignancies were 79.8% and 72.4%, respectively. The overall complication rate was 3.0%, and the pneumothorax rate was 1.5%.InterpretationThis study was the first to provide comprehensive evidence regarding the usefulness and diagnostic yield of ssRAB in the sampling of pulmonary parenchymal lesions. ssRAB may represent a significant advancement in the ability to access and sample successfully traditionally challenging pulmonary lesions via the bronchoscopic approach, while maintaining a superb safety profile. Lesion size seems to remain the major predictor of a diagnostic procedure.
| S-EPMC8941601 | biostudies-literature
Project description:BackgroundRobot-assisted bronchoscopy (RAB) is among the newest bronchoscopic technologies, allowing improved visualization and access for small and hard-to-reach nodules. RAB studies have primarily been conducted at academic centers, limiting the generalizability of results to the broader real-world setting, while variability in diagnostic yield definitions has impaired the validity of cross-study comparisons. The objective of this study was to determine the diagnostic yield and sensitivity for malignancy of RAB in patients with pulmonary lesions in a community setting and explore the impact of different definitions on diagnostic yield estimates.MethodsData were collected retrospectively from medical records of patients ≥ 21 years who underwent bronchoscopy with the Monarch® Platform (Auris Health, Inc., Redwood City, CA) for biopsy of pulmonary lesions at three US community hospitals between January 2019 and March 2020. Diagnostic yield was calculated at the index RAB and using 12-month follow-up data. At index, all malignant and benign (specific and non-specific) diagnoses were considered diagnostic. After 12 months, benign non-specific cases were considered diagnostic only when follow-up data corroborated the benign result. An alternative definition at index classified benign non-specific results as non-diagnostic, while an alternative 12-month definition categorized index non-diagnostic cases as diagnostic if no malignancy was diagnosed during follow-up.ResultsThe study included 264 patients. Median lesion size was 19.3 mm, 58.9% were peripherally located, and 30.1% had a bronchus sign. Samples were obtained via Monarch in 99.6% of patients. Pathology led to a malignant diagnosis in 115 patients (43.6%), a benign diagnosis in 110 (41.7%), and 39 (14.8%) non-diagnostic cases. Index diagnostic yield was 85.2% (95% CI: [80.9%, 89.5%]) and the 12-month diagnostic yield was 79.4% (95% CI: [74.4%, 84.3%]). Alternative definitions resulted in diagnostic yield estimates of 58.7% (95% CI: [52.8%, 64.7%]) at index and 89.0% (95% CI: [85.1%, 92.8%]) at 12 months. Sensitivity for malignancy was 79.3% (95% CI: [72.7%, 85.9%]) and cancer prevalence was 58.0% after 12 months.ConclusionsRAB demonstrated a high diagnostic yield in the largest study to date, despite representing a real-world community population with a relatively low prevalence of cancer. Alternative definitions had a considerable impact on diagnostic yield estimates.
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Project description:We describe a first reported case of shape-sensing robotic-assisted bronchoscopy using ION-intuitive platform done successfully under moderate sedation. A 76-year-old woman was found to have a right upper lobe mass measuring 3 × 2.9 cm. Diagnostic robotic navigational bronchoscopy was successfully performed under moderate sedation. Pathologic examination later revealed adenocarcinoma consistent with primary pulmonary malignancy. Conscious sedation allows the use of robotic bronchoscopy with minimal CT-to-body divergence and systems error. Robotic bronchoscopy under moderate sedation is feasible and seems to be safe and can be done without immediate complications.
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Project description:Background and objectiveRobotic-assisted bronchoscopy (RAB) has emerged as an advanced technology for lung cancer diagnosis. This review explores the three approved robotic bronchoscopy systems: Ion™ Endoluminal (Intuitive Surgical, Sunnyvale, CA, USA), Monarch™ (Johnson & Johnson, Redwood City, CA, USA), and Galaxy System™ (Noah Medical, San Carlos, CA, USA), and their different operational systems. This narrative review aims to summarize their findings and outcomes for sampling peripheral pulmonary lesions (PPL) suspected of lung cancer.MethodsA search in PubMed and Google Scholar databases was conducted for articles and abstracts published between January 2018 to May 2024 using the terms "robotic bronchoscopy" or "robotic-assisted bronchoscopy" for biopsy of PPL.Key content and findingsLung cancer is the leading cause of cancer-related mortality. The introduction of RAB aims to improve the feasibility and safety of sampling PPL. Current literature describes high diagnostic yields with low risk of complications, allowing concurrent hilar and mediastinal staging within the same procedure. RAB can potentially improve early diagnosis and treatment of pulmonary malignancies and survival rate in long term, while progressing towards therapeutic applications in the near future.ConclusionsAs RAB evolves, its potential as a "one-stop shop" for diagnosis, staging, and treatment can positively impact lung cancer detection, focusing on improved patient-centered outcomes and reducing multiple diagnostic and therapeutic procedures.
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Project description:BackgroundTraditional bronchoscopy provides limited approach to peripheral nodules. Shape-sensing robotic-assisted bronchoscopy (SSRAB, Ion™ Endoluminal System) is a new tool for minimally invasive peripheral nodule biopsy. We sought to answer the research question: Does SSRAB facilitate sampling of pulmonary nodules during bronchoscopists' initial experience?MethodsThe lead-in stage of a multicenter, single-arm, prospective evaluation of the Ion Endoluminal System (PRECIsE) is described. Enrolled subjects ≥ 18 years old had recent computed tomography evidence of one or more solid or semi-solid pulmonary nodules ≥ 1.0 to ≤ 3.5 cm in greatest dimension and in any part of the lung. Subjects were followed at 10- and 30-days post-procedure. This stage provided investigators and staff their first human experience with the SSRAB system; safety and procedure outcomes were analyzed descriptively. Neither diagnostic yield nor sensitivity for malignancy were assessed in this stage. Categorical variables are summarized by percentage; continuous variables are summarized by median/interquartile range (IQR).ResultsSixty subjects were enrolled across 6 hospitals; 67 nodules were targeted for biopsy. Median axial, coronal and sagittal diameters were < 18 mm with a largest cardinal diameter of 20.0 mm. Most nodules were extraluminal and distance from the outer edge of the nodule to the pleura or nearest fissure was 4.0 mm (IQR: 0.0, 15.0). Median bronchial generation count to the target location was 7.0 (IQR: 6.0, 8.0). Procedure duration (catheter-in to catheter-out) was 66.5 min (IQR: 50.0, 85.5). Distance from the catheter tip to the closest edge of the virtual nodule was 7.0 mm (IQR: 2.0, 12.0). Biopsy completion was 97.0%. No pneumothorax or airway bleeding of any grade was reported.ConclusionsBronchoscopists leveraged the Ion SSRAB's functionality to drive the catheter safely in close proximity of the virtual target and to obtain biopsies. This initial, multicenter experience is encouraging, suggesting that SSRAB may play a role in the management of pulmonary nodules. Clinical Trial Registration identifier and date NCT03893539; 28/03/2019.
| S-EPMC8520632 | biostudies-literature
Project description: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.
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Project description:AimsHeart failure (HF) is a leading cause of hospitalization worldwide. An early HF diagnosis is key to reducing hospitalizations. We used electronic health records (EHRs) to characterize HF pathways at the primary care physician (PCP) level prior to a first HF hospitalization (hHF). This study aimed to identify missed opportunities for HF diagnosis and management at the PCP level before a first hHF.Methods and resultsThis cohort study used EHRs of a large health care organization in Portugal. Patients with incident hHF between 2017 and 2020 were identified. Missed opportunities were defined by the absence of any of the following work-up in the 6 months after signs or symptoms had been recorded: lab results and electrocardiogram, natriuretic peptides, echocardiogram, referral to HF specialist, or HF medication initiation. A total of 2436 patients with a first hHF were identified. The median (interquartile range) age at the time of hospitalization was 81 (14) years, and 1361 (56%) were women. Most patients were treated with cardiovascular drugs prior or at index event. A total of 720 (30%) patients had records of HF signs or symptoms, 94% (n = 674) within 6 months prior to hHF. Among patients with recorded HF signs or symptoms, 410 (57%) had clinical management considered adequate before signs and symptoms were recorded. Of the 310 remaining patients, 155 (50%) had a follow-up that was considered inadequate.ConclusionsRelatively few patients with a first hHF had primary care records of signs or symptoms prior to admission. Of these, nearly half had inadequate management considering diagnosis and treatment. These data suggest the need to improve PCP HF awareness.
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Project description:BACKGROUND:Robotic bronchoscopy may offer alternative approaches to address limitations of current bronchoscopic techniques for biopsy of suspected peripheral lung lesions. This study sought to evaluate complications and feasibility of robotic bronchoscopy performed with the Robotic Endoscopy System (RES). METHODS:Adult patients from a single institution underwent bronchoscopy of suspected lesions with a bronchus sign with the RES. The primary outcome was complication rate, as assessed by the incidence of related serious adverse events (SAE). The secondary outcome was technical feasibility. Data are presented as median (range), counts, and percentage. P-value was calculated using the Mann-Whitney U test. RESULTS:Of 17 screened patients, 15 were eligible. The median age was 67 (38 to 79) years. The lesions (12 peripheral and 3 central) were located in the right lower lobe (33%), right upper lobe (27%), left upper lobe (27%), and left lower lobe (13%). No SAE, including pneumothorax and significant bleeding, occurred. Biopsy samples were obtained from 93% of patients. One sampling (right upper lobe) required conventional bronchoscopy and another required surgery to confirm malignancy. Cancer was confirmed in 60% (9/15) of patients. Benign features were found in 5 of 6 patients. Time to biopsy location reduced from 45 (21 to 84) minutes (first 5 cases) to 20 (7 to 47) minutes (last 9 cases), P=0.039. CONCLUSIONS:The study results and absence of SAE support feasibility of the RES in accessing the periphery of the lung. The RES has potential to address challenges associated with biopsy of peripheral lung lesions.
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Project description:BackgroundIncidental and screen-detected pulmonary nodules are common. The increasing capabilities of advanced diagnostic bronchoscopy will increase bronchoscopists' procedural volume necessitating optimization of procedural scheduling and workflow.ObjectivesThe objectives of this study were to determine total time in the procedure room, total bronchoscopy procedure time, and robotic-assisted bronchoscopy procedure time longitudinally and per specific procedure performed.DesignA single-center observational study of all consecutive patients undergoing shape-sensing robotic-assisted bronchoscopy (RAB) biopsy procedures for the evaluation of pulmonary lesions with variable probability for malignancy.MethodsChart review to collect patient demographics, lesion characteristics, and procedural specifics. Descriptive and comparative statistics are reported.ResultsActual bronchoscopy procedure time may decrease with increased institutional experience over time, however, there is limited ability to reduce non-bronchoscopy related time within the procedure room. The use of cone beam computed tomography (CBCT), rapid on-site evaluation (ROSE), and performance of staging endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) in a single procedure are each associated with additional time requirements.ConclusionInstitutional procedural block times should adapt to the nature of advanced diagnostic bronchoscopy procedures to allow for the accommodation of new modalities such as RAB combined with other technologies including radial endobronchial ultrasound, CBCT, ROSE, and staging linear EBUS. Identifying institutional median procedural times may assist in scheduling and ideal block time utilization.
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Project description:The incidence of lung nodules has increased with improved diagnostic imaging and screening protocols. Despite improvements for diagnosing pulmonary nodules with technologies such as electromagnetic navigational bronchoscopy (ENB), several limitations still exist including adequate visualization, localization, and diagnostic yield. Robotic-assisted bronchoscopy with ENB has been introduced as a method to overcome these shortcomings. We describe our initial experience in evaluating lung nodules with robotic assisted bronchoscopy. We retrospectively reviewed data on the first 25 patients that underwent robotic-assisted bronchoscopy and biopsy. We analyzed success with localization, diagnostic yield, and post procedural morbidity. Diagnostic yield was 96% (24/25) with no periprocedural morbidity. The majority of nodules were malignant or atypical (76%) and were located in the right upper lobe. Diameter ranged between 0.8-6.9 cm (median size 1-2 cm). Seventy-five percent of patients underwent subsequent treatment for cancer based on these results, with 25% having continued surveillance. Robotic assisted bronchoscopy is safe and accurate. Studies with larger numbers will allow better understanding of the diagnostic yield and clinical utility of this approach in comparison to other diagnostic tools for lung nodules.
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