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.
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.
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.
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.
Bronchoscopy is a useful tool for the diagnosis of lesions near central airways; however, the diagnostic accuracy of these procedures for peripheral pulmonary lesions (PPLs) is a matter of ongoing ...debate. In this setting, electromagnetic navigation bronchoscopy (ENB) is a technique used to navigate and obtain samples from these lesions. This systematic review and meta-analysis aims to explore the sensitivity of ENB in patients with PPLs suspected of lung cancer.
In patients with peripheral pulmonary lesion suspected of lung cancer, what is the sensitivity and safety of electromagnetic navigation bronchoscopy compared to surgery or longitudinal follow up?
A comprehensive search of several databases was performed. Extracted data included sensitivity of ENB for malignancy, adequacy of the tissue sample, and complications. The study quality was assessed using the QUADAS-2 tool, and the combined data were meta-analyzed using a bivariate method model. A summary receiver operatic characteristic curve (sROC) was created. Finally, the quality of evidence was rated using the Grading of Recommendations Assessment, Development and Evaluation approach.
Forty studies with a total of 3,342 participants were included in our analysis. ENB reported a pooled sensitivity of 77% (95% CI, 72%-82%; I
= 80.6%) and a specificity of 100% (95% CI, 99%-100%; I
= 0%) for malignancy. The sROC showed an area under the curve of 0.955 (P = .03). ENB achieved a sufficient sample for ancillary tests in 90.9% (95% CI, 84.8%-96.9%; I
= 80.7%). Risk of pneumothorax was 2.0% (95% CI, 1.0-3.0; I
= 45.2%). We found subgroup differences according to the risk of bias and the number of sampling techniques. Meta-regression showed an association between sensitivity and the mean distance of the sensor tip to the center of the nodule, the number of tissue sampling techniques, and the cancer prevalence in the study.
ENB is very safe with good sensitivity for diagnosing malignancy in patients with PPLs. The applicability of our findings is limited because most studies were done with the superDimension navigation system and heterogeneity was high.
PROSPERO; No.: CRD42019109449; URL: https://www.crd.york.ac.uk/prospero/.
The diagnosis of peripheral pulmonary lesions (PPL) continues to present clinical challenges. Despite extensive experience with guided bronchoscopy, the diagnostic yield has not improved ...significantly. Robotic-assisted bronchoscopic platforms have been developed potentially to improve the diagnostic yield for PPL. Presently, limited data exist that evaluate the performance of robotic systems in live human subjects.
What is the safety and feasibility of robotic-assisted bronchoscopy in patients with PPLs?
This was a prospective, multicenter pilot and feasibility study that used a robotic bronchoscopic system with a mother-daughter configuration in patients with PPL 1 to 5 cm in size. The primary end points were successful lesion localization with the use of radial probe endobronchial ultrasound (R-EBUS) imaging and incidence of procedure related adverse events. Robotic bronchoscopy was performed in patients with the use of direct visualization, electromagnetic navigation, and fluoroscopy. After the use of R-EBUS imaging, transbronchial needle aspiration was performed. Rapid on-site evaluation (ROSE) was used on all cases. Transbronchial needle aspiration alone was sufficient when ROSE was diagnostic; when ROSE was not diagnostic, transbronchial biopsy was performed with the use of the robotic platform, followed by conventional guided bronchoscopic approaches at the discretion of the investigator.
Fifty-five patients were enrolled at five centers. One patient withdrew consent, which left 54 patients for data analysis. Median lesion size was 23 mm (interquartile range, 15 to 29 mm). R-EBUS images were available in 53 of 54 cases. Lesion localization was successful in 51 of 53 patients (96.2%). Pneumothorax was reported in two of 54 of the cases (3.7%); tube thoracostomy was required in one of the cases (1.9 %). No additional adverse events occurred.
This is the first, prospective, multicenter study of robotic bronchoscopy in patients with PPLs. Successful lesion localization was achieved in 96.2% of cases, with an adverse event rate comparable with conventional bronchoscopic procedures. Additional large prospective studies are warranted to evaluate procedure characteristics, such as diagnostic yield.
ClinicalTrials.gov; No.: NCT03727425; URL: www.clinicaltrials.gov.
Airway complications following lung transplantation result in considerable morbidity and are associated with a mortality of 2% to 4%. The incidence of lethal and nonlethal airway complications has ...decreased since the early experiences with double- and single-lung transplantation. The most common risk factor associated with post-lung transplantation airway complications is anastomotic ischemia. Airway complications include the development of exophytic granulation tissue, bronchial stenosis, bronchomalacia, airway fistula, endobronchial infection, and anastomotic dehiscence. The broadening array of bronchoscopic therapies has enhanced treatment options for lung transplant recipients with airway complications. This article reviews the risk factors, clinical manifestations, and treatments of airway complications following lung transplantation and provides our expert opinion when evidence is lacking.
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?
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.
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.
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.
Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions.
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.
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.
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.
ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.
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.
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.
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).
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.
Interventional pulmonology programs provide clinical benefit to patients and are financially sustainable. To appreciate and illustrate the economic value of interventional pulmonology programs to ...hospital systems, physicians must have an understanding of basic health-care finance. Total revenue, adjusted gross revenue, contribution margin, variable direct costs, and indirect costs are terms that are essential for understanding the finances of bronchoscopy. Command of such vocabulary and its application is crucial for interventional pulmonologists to successfully establish financially sustainable bronchoscopy programs. Two significant features of an economically sustainable bronchoscopy program are high procedural volume and low direct cost per case. Interventional pulmonology programs are valuable to the patients being served and hospitals as a whole. Consideration of the various factors needed to maintain financial sustainability is essential to improve the quality of care for patients because the cost of care remains a critical driver in defining value.
Our institution implemented a protocol known as thoracic enhanced recovery with ambulation after surgery (T-ERAS) in thoracic operations. The objective was early ambulation starting in the ...postoperative ambulatory care unit.
Video-assisted thoracoscopic surgery lobectomy patients are placed on a chair in the preoperative area and then walked to the operating room. Postoperatively, patients are placed on a chair as soon as possible. Our target ambulation goal was 250 feet within 1 h of extubation. Patients then walk to their hospital room. T-ERAS adoption and outcomes were compared to a pre-T-ERAS period, in addition to the comparing early and late T-ERAS cohorts.
Over 6 years, 304 patients on T-ERAS underwent a planned video-assisted thoracoscopic surgery lobectomy. Median age was 67 years (range 41-87 years). The target goal was achieved in 187 of 304 (61.5%) patients and 277 of 304 (91.1%) patients ambulated 250 feet at any time in the postoperative ambulatory care unit. The T-ERAS period had a median length of stay of 1 day vs 2 days in the pre-T-ERAS period (P < 0.001). There were low rates of pneumonia (2/304, 0.7%), atrial fibrillation (12/304, 4.0%) and no postoperative mortalities for T-ERAS. The target goal was achieved at a greater rate in the late (92/132, 72.0%) versus early (28/75, 37%) T-ERAS cohort. The mean time to ambulation was reduced in the late cohort (46-81 min).
Early postoperative ambulation was feasible and considered key in achieving low morbidity after video-assisted thoracoscopic surgery lobectomy. Adoption of T-ERAS improved over time. Further studies will help define adoptability at other sites and validate impact on improving outcomes.
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