Diagnostic yield and safety of biopsy guided by electromagnetic navigation bronchoscopy for high-risk pulmonary nodules.
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ABSTRACT: Background
Electromagnetic navigation bronchoscopy (ENB) is a useful method to obtain tissue for peripheral lung nodules. We aimed to understand the diagnostic yield and safety profile in high-risk pulmonary nodules that cannot be accessed by percutaneous transthoracic needle biopsy.Methods
In this single-center retrospective study, we reviewed patients who underwent ENB for high-risk pulmonary nodules. All procedures were performed under moderate sedation using intravenous midazolam and fentanyl.Results
A total of 100 pulmonary nodules in 90 patients were subjected to ENB between October 2018 and May 2020. The median age of the study population was 66 (59-73). The mean diameter of the lung nodules was 27.9 mm. The diagnostic yield of ENB-guided biopsy was 53.0%. Although the nodule size (odds ratio: 1.055, p = 0.007) and positive bronchus sign (odds ratio: 2.918, p = 0.020) were associated with the diagnostic yield during univariate analysis, nodule size was the only independent variable on the multivariable analysis. Interestingly, the diagnostic yield showed an upward trend after 60 cases, from 45%-65%. Procedure-related complications were reported in 16 cases; among these, pneumothorax occurred in three cases, and four cases experienced moderate bleeding. No instance of major bleeding or death was linked to ENB-guided biopsy.Conclusion
ENB-guided biopsy for high-risk pulmonary nodules demonstrated an acceptable diagnostic yield and good safety profile. Moreover, the diagnostic yield was associated with nodule size and procedure experience.
SUBMITTER: Oh JH
PROVIDER: S-EPMC8107026 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundElectromagnetic navigation bronchoscopy (ENB) has been widely adopted as a guidance technique for biopsy of peripheral lung nodules. However, ENB is limited by the lack of real-time confirmation of the biopsy devices. Intraprocedural cone-beam computed tomography (CBCT) imaging can be utilized to assess or confirm the location of biopsy devices. The aim of this study is to determine the safety and diagnostic yield (DY) of image fusion of intraprocedural CBCT data with live fluoroscopy (augmented fluoroscopy) during ENB-guided biopsy of peripheral lung nodules.MethodsData from 75 consecutive patients who underwent biopsy with ENB was collected retrospectively. Patients underwent CBCT imaging while temporarily suspending mechanical ventilation. CBCT data were acquired and 3-dimensional segmentation of nodules was performed using commercially available software (OncoSuite). During ENB, the segmented lesions were projected and fused with live fluoroscopy enabling real-time 3-dimensional guidance.ResultsA total of 93 lesions with a median size of 16.0 mm were biopsied in 75 consecutive patients. The overall DY by lesion was 83.7% (95% confidence interval, 74.8%-89.9%). Multivariate regression analysis showed no independent correlation between lesion size, lesion location, lesion visibility under standard fluoroscopy, and the presence of a bronchus sign with DY. Pneumothorax occurred in 3 patients (4%).ConclusionIntraprocedural CBCT imaging with augmented fluoroscopy is feasible and effective and is associated with high DY during ENB-guided biopsies.
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Project description:Background: Electromagnetic navigational bronchoscopy (ENB) and robotic-assisted bronchoscopy (RB) require a high degree of decision-making and psychomotor skill. Cognitive load theory is the overall effort expended by individuals in response to a task and is closely related to the usability of devices for medical procedures. High cognitive workload leads to poor surgical outcomes and represents a bottleneck for learning that affects performance.Objective: To analyze the cognitive load associated with ENB and RB in experienced ENB practitioners learning RB.Methods: Six experienced ENB bronchoscopists performed ENB and RB on a human cadaver model of peripheral pulmonary nodules. To assess cognitive load, we used the Surgery Task Load Index (SURG-TLX) and biometric changes. The SURG-TLX questionnaire was given to the provider after every peripheral pulmonary nodule biopsy with ENB and RB. Pupillary dilation and screen changes were continuously measured throughout the procedure for each biopsy attempt to collect biometric measures of cognitive load. Procedural time and biopsy outcome were also recorded.Results: Forty procedures (ENB and RB) were analyzed. Task complexity (23%) and mental demand (21.4%) were the highest contributors to cognitive load in ENB and RB. The cumulative SURG-TLX was significantly lower for the RB (69.25 vs. 101.25; P < 0.01). Total procedure time was greater for ENB (6.7 min; SD 1.5) compared with RB (4.4 min; SD 1.5; P = 0.01). Pupillary diameter was similar across the modalities (RB vs. ENB), but the diameter was higher during the biopsy portion (4.25 mm) than the navigation portion (4.01 mm).Conclusion: The intrinsic cognitive load of RB was highly manageable by existing ENB practitioners, and in this study, RB appeared to be less mentally demanding. Future development and training should focus on task complexity and mental demand for RB. The biopsy portion, regardless of bronchoscopic modality, should be a focus for education and training.
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Project description:BackgroundCurrent medical society guidelines recommend a procedural number for obtaining electromagnetic navigational bronchoscopy (ENB) competency and for institutional volume for training.ObjectiveTo assess learning curves and estimate the number of ENB procedures for interventional pulmonology (IP) fellows to reach competency.MethodsWe conducted a prospective multicenter study of IP fellows in the United States learning ENB. A tool previously validated in a similar population was used to assess IP fellows by their local faculty and two blinded independent reviewers using virtual recording of the procedure. Competency was determined by performing three consecutive procedures with a competency score on the assessment tool. Procedural time, faculty global rating scale, and periprocedural complications were also recorded.ResultsA total of 184 ENB procedures were available for review with assessment of 26 IP fellows at 16 medical centers. There was a high correlation between the two blinded independent observers (rho = 0.8776). There was substantial agreement for determination of procedural competency between the faculty assessment and blinded reviewers (kappa = 0.7074; confidence interval, 0.5667-0.8482). The number of procedures for reaching competency for ENB bronchoscopy was determined (median, 4; mean, 5; standard deviation, 3.83). There was a wide variation in the number of procedures to reach competency, ranging from 2 to 15 procedures. There were six periprocedural complications reported, four (one pneumomediastinum, three pneumothorax) of which occurred before reaching competence and two pneumothoraces after achieving competence.ConclusionThere is a wide variation in acquiring competency for ENB among IP fellows. Virtual competency assessment has a potential role but needs further studies.
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Project description:BackgroundElectromagnetic navigation bronchoscopy (ENB) is a navigation technology intended to improve the diagnostic yield of pulmonary nodules. However, nodule displacement due to respiratory motion may compromise the accuracy of the navigation guidance. The Veran SPiNDrive ENB system employs respiratory-gating (4D-tracking) to compensate for this motion. The aim of the present study was to evaluate the diagnostic performance and safety of the Veran SPiNDrive system for biopsy of pulmonary nodules.MethodsAdult patients with pulmonary nodules of ≥1 cm were enrolled at a single center. Both conventional bronchoscopy and 4D-tracking ENB were performed in one procedure session under general anesthesia, with the procedure order being randomly assigned. Radial probe endobronchial ultrasound and fluoroscopy were used in both groups. The diagnostic performance, safety, total procedure time, and total fluoroscopy time of the ENB phase were compared to the corresponding conventional bronchoscopy phase.ResultsThe study was terminated due to poor accrual; a total of eleven patients were enrolled. The mean size of pulmonary nodules was 2.1 cm. The sensitivity for malignancy was 67% (6/9) and 56% (5/9) with conventional bronchoscopy and with 4D-tracking ENB, respectively. Two cases developed minor bleeding after conventional bronchoscopy, while no complications were observed after 4D-tracking ENB. The mean procedure time was 16.1 and 21.7 min (P=0.090), and the mean duration time for fluoroscopy use was 77 and 44 sec (P=0.056) for the conventional bronchoscopy and the 4D-tracking ENB phases, respectively.ConclusionsThe diagnostic performance of the Veran SPiNDrive 4D-tracking ENB did not exceed that of conventional bronchoscopy for pulmonary nodules. No complications were seen during 4D-tracking ENB. A study with a larger number of participants is required for further assessment.
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