Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.

BACKGROUND: Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions. METHODS: NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing. RESULTS: ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively. CONCLUSIONS: One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield. TRIAL REGISTRATION: ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.

Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy.

BACKGROUND: Electromagnetic navigation bronchoscopy (ENB) procedures allow physicians to access peripheral lung lesions beyond the reach of conventional bronchoscopy. However, published research is primarily limited to small, single-center studies using previous-generation ENB software. The impact of user experience, patient factors, and lesion/procedural characteristics remains largely unexplored in a large, multicenter study. METHODS/DESIGN: NAVIGATE (Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy) is a prospective, multicenter, global, cohort study. The study aims to enroll up to 2,500 consecutive subjects presenting for evaluation of lung lesions utilizing the ENB procedure at up to 75 clinical sites in the United States, Europe, and Asia. Subjects will be assessed at baseline, at the time of procedure, and at 1, 12, and 24 months post-procedure. The pre-test probability of malignancy will be determined for peripheral lung nodules. Endpoints include procedure-related adverse events, including pneumothorax, bronchopulmonary hemorrhage, and respiratory failure, as well as quality of life, and subject satisfaction. Diagnostic yield and accuracy, repeat biopsy rate, tissue adequacy for genetic testing, and stage at diagnosis will be reported for biopsy procedures. Complementary technologies, such as fluoroscopy and endobronchial ultrasound, will be explored. Success rates of fiducial marker placement, dye marking, and lymph node biopsies will be captured when applicable. Subgroup analyses based on geography, demographics, investigator experience, and lesion and procedure characteristics are planned. DISCUSSION: Study enrollment began in April 2015. As of February 19, 2016, 500 subjects had been enrolled at 23 clinical sites with enrollment ongoing. NAVIGATE will be the largest prospective, multicenter clinical study on ENB procedures to date and will provide real-world experience data on the utility of the ENB procedure in a broad range of clinical scenarios. TRIAL REGISTRATION: ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.

Do we measure pleural fluid pH correctly?

PURPOSE OF REVIEW: This review analyzes the current literature available on appropriate measurement of pleural fluid pH and currently used methods of measurement. RECENT FINDINGS: Current literature continues to support the superiority of blood gas analyzers (BGAs) in the accurate measurement of pleural fluid pH. Despite the compelling evidence, roughly 30-50% of the laboratories across the United States continue to use inaccurate methods for pleural fluid pH measurement. Nearly 40% of pulmonologists were incorrect in believing their laboratory uses BGA for the analysis of pleural fluid pH. SUMMARY: It is apparent that the clinical utility of pleural fluid pH is often undermined by its inappropriate measurement. Physicians must be made aware of their laboratory's method of measurement if pleural fluid pH is to be used in the evaluation of pleural diseases. If pleural fluid pH measurement is not done accurately, then other pleural fluid characteristics may be used to aid the clinician.

Chronic obstructive pulmonary disease: epidemiology, management, and impact on North Carolina.

Chronic obstructive pulmonary disease (COPD) affects millions of people worldwide, resulting in morbidity, mortality, and substantial utilization of health care resources. This review focuses on the epidemiology of COPD, management strategies, and the health and economic impact of this condition in North Carolina.

Assessing a biomarker's ability to reduce invasive procedures in patients with benign lung nodules: Results from the ORACLE study.

A blood-based integrated classifier (IC) has been clinically validated to improve accuracy in assessing probability of cancer risk (pCA) for pulmonary nodules (PN). This study evaluated the clinical utility of this biomarker for its ability to reduce invasive procedures in patients with pre-test pCA ≤ 50%. This was a propensity score matching (PSM) cohort study comparing patients in the ORACLE prospective, multicenter, observational registry to control patients treated with usual care. This study enrolled patients meeting the intended use criteria for IC testing: pCA ≤ 50%, age ≥40 years, nodule diameter 8-30 mm, and no history of lung cancer and/or active cancer (except for non-melanomatous skin cancer) within 5 years. The primary aim of this study was to evaluate invasive procedure use on benign PNs of registry patients as compared to control patients. A total of 280 IC tested, and 278 control patients met eligibility and analysis criteria and 197 were in each group after PSM (IC and control groups). Patients in the IC group were 74% less likely to undergo an invasive procedure as compared to the control group (absolute difference 14%, p <0.001) indicating that for every 7 patients tested, one unnecessary invasive procedure was avoided. Invasive procedure reduction corresponded to a reduction in risk classification, with 71 patients (36%) in the IC group classified as low risk (pCA < 5%). The proportion of IC group patients with malignant PNs sent to surveillance were not statistically different than the control group, 7.5% vs 3.5% for the IC vs. control groups, respectively (absolute difference 3.91%, p 0.075). The IC for patients with a newly discovered PN has demonstrated valuable clinical utility in a real-world setting. Use of this biomarker can change physicians' practice and reduce invasive procedures in patients with benign pulmonary nodules. Trial registration: Clinical trial registration: ClinicalTrials.gov NCT03766958.

Evaluation of Electromagnetic Navigational Bronchoscopy Using Tomosynthesis-Assisted Visualization, Intraprocedural Positional Correction and Continuous Guidance for Evaluation of Peripheral Pulmonary Nodules.

BACKGROUND: Electromagnetic navigational bronchoscopy (ENB) has been shown to have variable diagnostic accuracy for the assessment of peripheral pulmonary nodules. This may be because of discrepancies between the preplanned computed tomography of chest target lesion location versus actual target location (computed tomography-to-body divergence), and the lack of a continuous navigational image. The ILLUMISITE (Medtronic, Minneapolis, MN) is a newly developed ENB platform that utilizes tomosynthesis, an imaging technology that can visualize the target location using fluoroscopy (F-ENB). This new system also allows for intraprocedural positional correction and continuous navigation guidance during sampling to overcome these limitations and improve diagnostic yield. We report our first experience in a single center, single proceduralist using this new technology. METHODS: We conducted a retrospective, single center, single operator study reviewing 72 consecutive patients (78 nodules) over a 3-month period. We investigated the overall diagnostic yield and diagnostic yield by nodule location, size, and sedation type using this new F-ENB system. RESULTS: The overall diagnostic yield was 87% and pnemothoraces occurred in 2/78 procedures. We did not find any statistically significant difference when comparing pulmonary nodule location, size or sedation method utilized ( P =0.231, 0.338, and 0.112, respectively). Sixty-nine percent of the pulmonary nodules biopsied were 2 to 3 cm in size. The average distance corrected after tomosynthesis visualization was 15.4 mm (0.4 to 29.8 mm). CONCLUSION: We report our initial experience with the ILLUMISITE system using fluoroscopic tomosynthesis-assisted visualization with continuous navigational guidance at our institution. This new technology allows the operator to correct for better target lesion alignment and real time positional correction and may improve diagnostic yields with minimal complications for evaluation of peripheral pulmonary nodules.

NAVIGATE 24-Month Results: Electromagnetic Navigation Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States.

INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive, image-guided approach to access lung lesions for biopsy or localization for treatment. However, no studies have reported prospective 24-month follow-up from a large, multinational, generalizable cohort. This study evaluated ENB safety, diagnostic yield, and usage patterns in an unrestricted, real-world observational design. METHODS: The NAVIGATE single-arm, pragmatic cohort study (NCT02410837) enrolled subjects at 37 academic and community sites in seven countries with prospective 24-month follow-up. Subjects underwent ENB using the superDimension navigation system versions 6.3 to 7.1. The prespecified primary end point was procedure-related pneumothorax requiring intervention or hospitalization. RESULTS: A total of 1388 subjects were enrolled for lung lesion biopsy (1329; 95.7%), fiducial marker placement (272; 19.6%), dye marking (23; 1.7%), or lymph node biopsy (36; 2.6%). Concurrent endobronchial ultrasound-guided staging occurred in 456 subjects. General anesthesia (78.2% overall, 56.6% Europe, 81.4% United States), radial endobronchial ultrasound (50.6%, 4.0%, 57.4%), fluoroscopy (85.0%, 41.7%, 91.0%), and rapid on-site evaluation use (61.7%, 17.3%, 68.5%) differed between regions. Pneumothorax and bronchopulmonary hemorrhage occurred in 4.7% and 2.7% of subjects, respectively (3.2% [primary end point] and 1.7% requiring intervention or hospitalization). Respiratory failure occurred in 0.6%. The diagnostic yield was 67.8% (range: 61.9%-70.7%; 55.2% Europe, 69.8% United States). Sensitivity for malignancy was 62.6%. Lung cancer clinical stage was I to II in 64.7% (55.3% Europe, 65.8% United States). CONCLUSIONS: Despite a heterogeneous cohort and regional differences in procedural techniques, ENB demonstrates low complications and a 67.8% diagnostic yield while allowing biopsy, staging, fiducial placement, and dye marking in a single procedure.

Current management of salicylate-induced pulmonary edema.

Salicylate-induced pulmonary edema (SIPE) can occur in both acute and chronic users of aspirin or salicylate products. The medical history, especially when it reveals the use of salicylates, is critical when considering this diagnosis. Unfortunately, the neurologic and systemic effects of salicylate toxicity may hinder the ability to obtain a reliable medical history. SIPE should be considered in patients who present with pulmonary edema and neurological changes, anion-gap metabolic acidosis, or possible sepsis. Some patients may be treated for "pseudosepsis" or other conditions, thereby delaying the diagnosis of salicylate intoxication. Misdiagnosis and possibly delayed diagnosis of SIPE can lead to a significant increase in morbidity and mortality. Serum and urine alkalinization by administration of intravenous sodium bicarbonate are commonly utilized therapeutic strategies. Finally, hemodialysis is a therapy which should be considered early in the course of treatment. The objective of this review was to emphasize the importance of rapid diagnosis and appropriate treatment in patients with SIPE, and summarize the current literature as it relates to the adult population.

Standardized Definitions of Bleeding After Transbronchial Lung Biopsy: A Delphi Consensus Statement From the Nashville Working Group.

BACKGROUND: Transbronchial lung biopsies are commonly performed for a variety of indications. Although generally well tolerated, complications such as bleeding do occur. Description of bleeding severity is crucial both clinically and in research trials; to date, there is no validated scale that is widely accepted for this purpose. Can a simple, reproducible tool for categorizing the severity of bleeding after transbronchial biopsy be created? METHODS: Using the modified Delphi method, an international group of bronchoscopists sought to create a new scale tailored to assess bleeding severity among patients undergoing flexible bronchoscopy with transbronchial lung biopsies. Cessation criteria were specified a priori and included reaching > 80% consensus among the experts or three rounds, whichever occurred first. RESULTS: Thirty-six expert bronchoscopists from eight countries, both in academic and community practice settings, participated in the creation of the scale. After the live meeting, two iterations were made. The second and final scale was vetted by all 36 participants, with a weighted average of 4.47/5; 53% were satisfied, and 47% were very satisfied. The panel reached a consensus and proposes the Nashville Bleeding Scale. CONCLUSIONS: The use of a simplified airway bleeding scale that can be applied at bedside is an important, necessary tool for categorizing the severity of bleeding. Uniformity in reporting clinically significant airway bleeding during bronchoscopic procedures will improve the quality of the information derived and could lead to standardization of management. In addition to transbronchial biopsies, this scale could also be applied to other bronchoscopic procedures, such as endobronchial biopsy or endobronchial ultrasound-guided needle aspiration.

Perceptions vs. reality: measuring of pleural fluid pH in North Carolina.

BACKGROUND: Pleural fluid pH anaerobically handled and measured by a blood gas analyzer (BGA) is used to define a pleural space infection as complicated and predict the life expectancy of patients with malignant pleural effusions. Pleural fluid pH can also be measured by other less accurate methods. It is unknown whether physicians who use pleural fluid pH measurements are aware of the method used by their laboratories. METHODS: We surveyed 90 pulmonary physicians in North Carolina about their use of pleural fluid pH and their hospital laboratory's approach (pH indicator stick, pH meter, or BGA). We then contacted their hospital laboratories to determine the actual method of pH measurement. RESULTS: Twenty-eight (31%) pulmonologists in 11 North Carolina hospitals responded on their use of pleural fluid pH. Of the 20 pulmonologists who order pleural fluid pH, 90% reported that their hospital measures pleural fluid pH via BGA, but the majority (72%) were inaccurate. Only two of 11 hospitals reported that they measure pleural fluid pH with a BGA. CONCLUSION: Almost two-thirds of the chest physicians that order pleural fluid pH to help manage pleural effusions were using information that is not substantiated by the literature and, despite previous reports, hospitals still use suboptimal methods to measure pleural fluid pH. Further information is needed concerning the barriers to physicians and laboratory practices concerning the use of BGA for the measurement of pleural fluid pH.

Malignant pleural effusion and cancer of unknown primary site: a review of literature.

Malignant pleural effusions (MPE) are most frequently (50-65%) noted from lung and breast cancers. They are commonly unilateral and are reflective of poorer prognosis. Cancer of unknown primary (CUP) account for 4-5% of all invasive cancers. These are metastatic tumors in which the primary is unknown despite an extensive medical evaluation. About 11% of MPE are from CUP. These MPEs present a clinical dilemma to physicians as there is a paucity of literature on their management and no consensus or guideline statement. This paper provides an overview of MPE from CUP in regard to diagnosis, prognosis, and treatment options. A selective search was performed in Medline and PubMed, with the keywords "Malignant pleural effusion" and "Cancer of unknown primary" up to December 2018. A review of literature would suggest that a thoracentesis is the first step in all cases but additional work up such as thoracoscopy & pleural biopsies is frequently warranted. With advances in immunohistochemical staining and biomarker development, MPE with CUP maybe profiled in a similar manner as lung cancer. Similarly, liquid biopsy or identification of circulating tumor cell free DNA may have a role in the work up of CUP in the future. There is some experience in managing these patients with gene directed therapies and immune checkpoint inhibitors, however, with mixed results. Given the poor prognosis associated with MPE from CUP, symptom alleviating measures such as indwelling pleural catheters should be part of the management strategy.

Pleural dye marking of lung nodules by electromagnetic navigation bronchoscopy.

INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB)-guided pleural dye marking is useful to localize small peripheral pulmonary nodules for sublobar resection. OBJECTIVE: To report findings on the use of ENB-guided dye marking among participants in the NAVIGATE study. METHODS: NAVIGATE is a prospective, multicentre, global and observational cohort study of ENB use in patients with lung lesions. The current subgroup report is a prespecified 1-month interim analysis of ENB-guided pleural dye marking in the NAVIGATE United States cohort. RESULTS: The full United States cohort includes 1215 subjects from 29 sites (April 2015 to August 2016). Among those, 23 subjects (24 lesions) from seven sites underwent dye marking in preparation for surgical resection. ENB was conducted for dye marking alone in nine subjects while 14 underwent dye marking concurrent with lung lesion biopsy, lymph node biopsy and/or fiducial marker placement. The median nodule size was 10 mm (range 4-22) and 83.3% were <20 mm in diameter. Most lesions (95.5%) were located in the peripheral third of the lung, at a median of 3.0 mm from the pleura. The median ENB-specific procedure time was 11.5 minutes (range 4-38). The median time from dye marking to resection was 0.5 hours (range 0.3-24). Dye marking was adequate for surgical resection in 91.3%. Surgical biopsies were malignant in 75% (18/24). CONCLUSION: In this study, ENB-guided dye marking to localize lung lesions for surgery was safe, accurate and versatile. More information is needed about surgical practice patterns and the utility of localization procedures.

Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study.

BACKGROUND: Fiducial markers (FMs) help direct stereotactic body radiation therapy (SBRT) and localization for surgical resection in lung cancer management. We report the safety, accuracy, and practice patterns of FM placement utilizing electromagnetic navigation bronchoscopy (ENB). METHODS: NAVIGATE is a global, prospective, multicenter, observational cohort study of ENB using the superDimension™ navigation system. This prospectively collected subgroup analysis presents the patient demographics, procedural characteristics, and 1-month outcomes in patients undergoing ENB-guided FM placement. Follow up through 24 months is ongoing. RESULTS: Two-hundred fifty-eight patients from 21 centers in the United States were included. General anesthesia was used in 68.2%. Lesion location was confirmed by radial endobronchial ultrasound in 34.5% of procedures. The median ENB procedure time was 31.0 min. Concurrent lung lesion biopsy was conducted in 82.6% (213/258) of patients. A mean of 2.2 ± 1.7 FMs (median 1.0 FMs) were placed per patient and 99.2% were accurately positioned based on subjective operator assessment. Follow-up imaging showed that 94.1% (239/254) of markers remained in place. The procedure-related pneumothorax rate was 5.4% (14/258) overall and 3.1% (8/258) grade ⩾ 2 based on the Common Terminology Criteria for Adverse Events scale. The procedure-related grade ⩾ 4 respiratory failure rate was 1.6% (4/258). There were no bronchopulmonary hemorrhages. CONCLUSION: ENB is an accurate and versatile tool to place FMs for SBRT and localization for surgical resection with low complication rates. The ability to perform a biopsy safely in the same procedure can also increase efficiency. The impact of practice pattern variations on therapeutic effectiveness requires further study. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02410837.

Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study.

INTRODUCTION: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive technology that guides endoscopic tools to pulmonary lesions. ENB has been evaluated primarily in small, single-center studies; thus, the diagnostic yield in a generalizable setting is unknown. METHODS: NAVIGATE is a prospective, multicenter, cohort study that evaluated ENB using the superDimension navigation system (Medtronic, Minneapolis, Minnesota). In this United States cohort analysis, 1215 consecutive subjects were enrolled at 29 academic and community sites from April 2015 to August 2016. RESULTS: The median lesion size was 20.0 mm. Fluoroscopy was used in 91% of cases (lesions visible in 60%) and radial endobronchial ultrasound in 57%. The median ENB planning time was 5 minutes; the ENB-specific procedure time was 25 minutes. Among 1157 subjects undergoing ENB-guided biopsy, 94% (1092 of 1157) had navigation completed and tissue obtained. Follow-up was completed in 99% of subjects at 1 month and 80% at 12 months. The 12-month diagnostic yield was 73%. Pathology results of the ENB-aided tissue samples showed malignancy in 44% (484 of 1092). Sensitivity, specificity, positive predictive value, and negative predictive value for malignancy were 69%, 100%, 100%, and 56%, respectively. ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher pneumothoraces (requiring admission or chest tube placement) occurred in 2.9%. The ENB-related Common Terminology Criteria for Adverse Events grade 2 or higher bronchopulmonary hemorrhage and grade 4 or higher respiratory failure rates were 1.5% and 0.7%, respectively. CONCLUSIONS: NAVIGATE shows that an ENB-aided diagnosis can be obtained in approximately three-quarters of evaluable patients across a generalizable cohort based on prospective 12-month follow-up in a pragmatic setting with a low procedural complication rate.

Endobronchial ultrasound in the evaluation of lung cancer: a practical review and cost analysis for the practicing pulmonologist.

Flexible bronchoscopy remains an important tool in the staging, diagnosis, and treatment of primary and metastatic lung malignancies. Endobronchial ultrasound is a new technology utilized with bronchoscopy that has been shown to identify bronchial wall invasion by malignant tumors, aid in the fine needle aspiration of peripheral lung lesions and mediastinal/hilar lymph nodes, and determine the course of treatment in patients with pulmonary carcinoma in situ. The decision to invest both time and money in this technology is determined by several factors such as the cost of the equipment, reimbursement for the procedure, availability of training, the number of bronchoscopies one performs in a year, and access to endoscopic ultrasound and mediastinoscopy. This article reviews the literature to determine the utility of endobronchial ultrasound in the management of patients with lung cancer and to provide information to practicing pulmonologists that may aid in determining whether and where this technology fits into their clinical armamentarium.

Malignancy in the tracheal bronchus: A case series and review of the literature.

BACKGROUND/AIMS: The tracheal bronchus is a rare congenital abnormality with incidence reported in a range of 0.1%-2%. Infrequently, malignancy has been reported as occurring in the tracheal bronchus. In order to ascertain a relationship between malignancy and the tracheal bronchus, we performed a literature review and present a case series. METHODS: We reviewed 21 case reports of malignancy occurring in the tracheal bronchus. CONCLUSION: Although the number of cases is limited, it appears that bronchoscopy is the most frequently utilized diagnostic tool. Surgery portends the best clinical results even in higher stages of malignancy. Squamous cell carcinoma is the most common type of malignancy to occur in the tracheal bronchus.

Therapeutic bronchoscopy in the era of genotype directed lung cancer management.

Lung cancer is the leading cause of cancer related deaths. Non-small cell lung cancer (NSCLC) accounts for ~85% of lung cancers. Our understanding of driver mutations and genotype directed therapy has revolutionized the management of advanced NSCLC. Commonly described mutations include mutations in epidermal growth factor (EGFR) & BRAF and translocations in anaplastic lymphoma kinase (ALK) & rat osteosarcoma (ROS1). Drugs directed against these translocations have significantly improved progression free survival individually and have shown a survival benefit when studied in the Lung Cancer Mutation Consortium (median survival 3.5 vs. 2.4 years compared to standard therapy). In a related yet parallel universe, the number of bronchoscopic ablative modalities available for management of cancer related airway obstruction have increased exponentially over the past decade. A wealth of literature has given us a better understanding of the technical aspects, benefits and risks associated with these procedures. While they all show benefits in terms of relieving airway obstruction, symptom control, quality of life and lung function testing, their complication rates vary based on the modality. The overall complication rate was ~4% in the AQuIRE registry. Bronchoscopic therapeutic modalities include rigid bronchoscopy with mechanical debulking, laser, thermo-coagulation [electrocautery & argon plasma coagulation (APC)], cryotherapy, endobronchial brachytherapy (EBT), photodynamic therapy (PDT), intratumoral chemotherapy (ITC) and transbronchial needle injection (TBNI) of chemotherapy. Intuitively, one would assume that the science of driver mutations would crisscross with the science of bronchoscopic ablation as they overlap in the same patient population. Sadly, this is not the case and there is a paucity of literature looking at these fields together. This results in several unanswered questions about the interplay between these two therapies.

Feasibility and Safety of the Transbronchial Access Tool for Peripheral Pulmonary Nodule and Mass.

BACKGROUND: Navigational bronchoscopy and other imaging modalities have improved the ability to evaluate pulmonary nodules/mass. Many of these lesions are located outside the bronchial airway and are difficult to access even with these devices. The Transbronchial Access Tool (Medtronic, Minneapolis, MN) allows the bronchoscopist to create a pathway from the bronchial airway, across the lung parenchyma, and into the target lesion. We are reporting the feasibility and safety of this new device. METHODS: Patients with peripheral pulmonary nodules/mass with an absence of an air bronchogram on thoracic imaging underwent a navigational bronchoscopy in a hybrid operating room under general anesthesia. A navigational system located predetermined areas in the bronchial tree to deploy the Transbronchial Access Tool, and cone beam computed tomography confirmed that the target lesion was accessed. A standard protocol was developed and followed in the last 7 patients directing cone beam computed tomography use. The ability to enter the target lesion, diagnostic yield, radiation exposure, and procedural complications were recorded. RESULTS: The Transbronchial Access Tool was used in 14 patients who underwent an electromagnetic navigational bronchoscopy-guided biopsy from September 2015 to January 2016. The overall diagnostic yield was 71% (10 of 14) and 100% (7 of 7) when the standard protocol was instituted. Access was achieved in 75% (9 of 12) of the targeted lesions, with a diagnostic yield of 66% (8 of 12). One complication, a pneumothorax, occurred. The average radiation exposure during the procedure was 4.3 mSv (range, 3 to 5 mSv), and fluoroscopic time was 17 minutes (range, 2 to 44 minutes). CONCLUSIONS: The Transbronchial Access Tool is safe and permits access to pulmonary nodules/masses with navigational bronchoscopy.

The effect of general anesthesia versus intravenous sedation on diagnostic yield and success in electromagnetic navigation bronchoscopy.

BACKGROUND: Navigational bronchoscopy is utilized to guide biopsies of peripheral lung nodules and place fiducial markers for treatment of limited stage lung cancer with stereotactic body radiotherapy. The type of sedation used for this procedure remains controversial. We performed a retrospective chart review to evaluate the differences of diagnostic yield and overall success of the procedure based on anesthesia type. METHODS: Electromagnetic navigational bronchoscopy was performed using the superDimension software system. Once the targeted lesion was within reach, multiple tissue samples were obtained. Statistical analysis was used to correlate the yield with the type of sedation among other factors. A successful procedure was defined if a diagnosis was made or a fiducial marker was adequately placed. RESULTS: Navigational bronchoscopy was performed on a total of 120 targeted lesions. The overall complication rate of the procedure was 4.1%. The diagnostic yield and success of the procedure was 74% and 87%, respectively. Duration of the procedure was the only significant difference between the general anesthesia and IV sedation groups (mean, 58 vs. 43 min, P=0.0005). A larger tumor size was associated with a higher diagnostic yield (P=0.032). All other variables in terms of effect on diagnostic yield and an unsuccessful procedure did not meet statistical significance. CONCLUSIONS: Navigational bronchoscopy is a safe and effective pulmonary diagnostic tool with relatively low complication rate. The diagnostic yield and overall success of the procedure does not seem to be affected by the type of sedation used.

The air apparent: a rare complication during flexible bronchoscopy.

Flexible bronchoscopy is a common and safe outpatient procedure, with complications arising in less than 1% of cases. The case presented herein details the occurrence of pneumomediastinum, pneumopericardium, pneumoperitoneum, interstitial lung emphysema and subcutaneous emphysema during flexible bronchoscopy. Although these complications have been reported individually in various circumstances, they have not been reported concomitantly in this setting. Recovery was rapid and complete, requiring only supplemental oxygen and monitoring. After a literature and chart review, the authors postulate that the complications were not a direct result of bronchoscopy but rather the simple act of placing an oxygen delivery cannula in a patient with possible prior trauma to the site.