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BACKGROUND: Image-guided percutaneous thermal ablation is an established treatment option for early-stage lung cancer in medically inoperable patients but carries a high risk of pleura-related complications, particularly pneumothorax. OBJECTIVE: This study aimed to determine if image-guided transbronchial microwave ablation (tMWA) is a feasible approach to treat peripheral stage 1 lung cancer. METHOD: A prospective, single-arm, multicenter study sought to enroll 40 adults who were medically inoperable or declined surgery for peripheral stage 1 lung tumors (≤20 mm). Ablation was performed using navigational bronchoscopy and a flexible MWA probe, guided by cone-beam CT with augmented fluoroscopy. Follow-up at 1, 6, and 12 months included CT imaging of the ablation zone and possible tumor recurrence, adverse events (AEs), pulmonary function, and quality of life. RESULTS: Across 2 sites, 11 tumors (10 NSCLC, 1 carcinoid) were treated in 10 enrolled patients. Median tumor diameter was 13 × 14 mm (7-19 mm) and median minimum ablative margin was 11 mm (5-19 mm). Technical success and technique efficacy were achieved in all patients. No tumor recurrence was seen during 12-month follow-up. No pneumothorax, pleural effusion, or bronchopleural fistula were noted. Minor AEs included scant hemoptysis, pain, cough, and dyspnea. Two serious AEs occurred ≤30 days of ablation and included a COPD exacerbation (day 9) and a death of unknown cause (day 15). The death led the sponsor to halt enrollment. Pulmonary function and quality-of-life indices remained stable. CONCLUSIONS: Image-guided tMWA is a technically feasible approach for peripheral early-stage lung cancer but warrants further evaluation of safety and efficacy in larger cohorts.
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Ablação por Cateter , Neoplasias Pulmonares , Pneumotórax , Adulto , Humanos , Micro-Ondas/uso terapêutico , Estudos Prospectivos , Qualidade de Vida , Ablação por Cateter/efeitos adversos , Recidiva Local de Neoplasia/etiologia , Recidiva Local de Neoplasia/patologia , Recidiva Local de Neoplasia/cirurgia , Neoplasias Pulmonares/patologia , Pneumotórax/etiologia , Pneumotórax/cirurgia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
The process of detection, diagnosis, and management of lung nodules is complex due to the heterogeneity of lung pathology and a relatively low malignancy rate. Technological advances in bronchoscopy have led to less-invasive diagnostic procedures and advances in imaging technology have helped to improve nodule localization and biopsy confirmation. Future research is required to determine which modality or combination of complimentary modalities is best suited for safe, accurate, and cost-effective management of lung nodules.
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Broncoscopia , Procedimentos Cirúrgicos Robóticos , Biópsia , Broncoscopia/métodos , Diagnóstico por Imagem , HumanosRESUMO
Partnership between anesthesia providers and proceduralists is essential to ensure patient safety and optimize outcomes. A renewed importance of this axiom has emerged in advanced bronchoscopy and interventional pulmonology. While anesthesia-induced atelectasis is common, it is not typically clinically significant. Advanced guided bronchoscopic biopsy is an exception in which anesthesia protocols substantially impact outcomes. Procedure success depends on careful ventilation to avoid excessive motion, reduce distortion causing computed tomography (CT)-to-body-divergence, stabilize dependent areas, and optimize breath-hold maneuvers to prevent atelectasis. Herein are anesthesia recommendations during guided bronchoscopy. An FiO2 of 0.6 to 0.8 is recommended for pre-oxygenation, maintained at the lowest tolerable level for the entire the procedure. Expeditious intubation (not rapid-sequence) with a larger endotracheal tube and non-depolarizing muscle relaxants are preferred. Positive end-expiratory pressure (PEEP) of up to 10-12 cm H2O and increased tidal volumes help to maintain optimal lung inflation, if tolerated by the patient as determined during recruitment. A breath-hold is required to reduce motion artifact during intraprocedural imaging (e.g., cone-beam CT, digital tomosynthesis), timed at the end of a normal tidal breath (peak inspiration) and held until pressures equilibrate and the imaging cycle is complete. Use of the adjustable pressure-limiting valve is critical to maintain the desired PEEP and reduce movement during breath-hold maneuvers. These measures will reduce atelectasis and CT-to-body divergence, minimize motion artifact, and provide clearer, more accurate images during guided bronchoscopy. Following these recommendations will facilitate a successful lung biopsy, potentially accelerating the time to treatment by avoiding additional biopsies. Application of these methods should be at the discretion of the anesthesiologist and the proceduralist; best medical judgement should be used in all cases to ensure the safety of the patient.
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Anestesia Geral/métodos , Broncoscopia/efeitos adversos , Complicações Intraoperatórias/prevenção & controle , Pulmão/diagnóstico por imagem , Atelectasia Pulmonar/prevenção & controle , Suspensão da Respiração , Broncoscopia/métodos , Humanos , Complicações Intraoperatórias/etiologia , Respiração com Pressão Positiva/métodos , Atelectasia Pulmonar/etiologia , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: Traditional 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? METHODS: The 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). RESULTS: Sixty 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. CONCLUSIONS: Bronchoscopists 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.
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Broncoscopia/métodos , Nódulos Pulmonares Múltiplos/patologia , Procedimentos Cirúrgicos Robóticos/métodos , Nódulo Pulmonar Solitário/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Biópsia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Estados UnidosRESUMO
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.
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Broncoscopia/métodos , Neoplasias Pulmonares/diagnóstico , Pulmão/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Diagnóstico Diferencial , Fenômenos Eletromagnéticos , Europa (Continente) , Feminino , Humanos , Biópsia Guiada por Imagem/métodos , Linfonodos/patologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Pneumotórax/epidemiologia , Pneumotórax/etiologia , Estudos Prospectivos , Tomografia Computadorizada por Raios X , Estados Unidos , Adulto JovemRESUMO
SMARCAL1, a DNA remodeling protein fundamental to genome integrity during replication, is the only gene associated with the developmental disorder Schimke immuno-osseous dysplasia (SIOD). SMARCAL1-deficient cells show collapsed replication forks, S-phase cell cycle arrest, increased chromosomal breaks, hypersensitivity to genotoxic agents, and chromosomal instability. The SMARCAL1 catalytic domain (SMARCAL1(CD)) is composed of an SNF2-type double-stranded DNA motor ATPase fused to a HARP domain of unknown function. The mechanisms by which SMARCAL1 and other DNA translocases repair replication forks are poorly understood, in part because of a lack of structural information on the domains outside of the common ATPase motor. In the present work, we determined the crystal structure of the SMARCAL1 HARP domain and examined its conformation and assembly in solution by small angle X-ray scattering. We report that this domain is conserved with the DNA mismatch and damage recognition domains of MutS/MSH and NER helicase XPB, respectively, as well as with the putative DNA specificity motif of the T4 phage fork regression protein UvsW. Loss of UvsW fork regression activity by deletion of this domain was rescued by its replacement with HARP, establishing the importance of this domain in UvsW and demonstrating a functional complementarity between these structurally homologous domains. Mutation of predicted DNA-binding residues in HARP dramatically reduced fork binding and regression activities of SMARCAL1(CD). Thus, this work has uncovered a conserved substrate recognition domain in DNA repair enzymes that couples ATP-hydrolysis to remodeling of a variety of DNA structures, and provides insight into this domain's role in replication fork stability and genome integrity.
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DNA Helicases/química , DNA Helicases/metabolismo , Reparo do DNA/genética , Modelos Moleculares , Ácidos Nucleicos/metabolismo , Trifosfato de Adenosina/metabolismo , Animais , Cromatografia de Afinidade , Cromatografia em Agarose , Cromatografia em Gel , Cromatografia por Troca Iônica , Clonagem Molecular , Cristalização , DNA Helicases/biossíntese , Hidrólise , Funções Verossimilhança , Camundongos , Estrutura Terciária de Proteína , Espalhamento a Baixo Ângulo , Difração de Raios XRESUMO
Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.Patients were randomised to ELS plus medical treatment or medical treatment alone. Despite early termination for business reasons and inability to assess the primary 12-month end-point, 95 out of 300 patients were successfully randomised, providing sufficient data for 3- and 6-month analysis.57 patients (34 treatment and 23 control) had efficacy results at 3â months; 34 (21 treatment and 13 control) at 6â months. In the treatment group, 3-month lung function, dyspnoea, and quality of life improved significantly from baseline when compared to control. Improvements persisted at 6â months with >50% of treated patients experiencing clinically important improvements, including some whose lung function improved by >100%. 44% of treated patients experienced adverse events requiring hospitalisation (2.5-fold more than control, p=0.01), with two deaths in the treated cohort. Treatment responders tended to be those experiencing respiratory adverse events.Despite early termination, results show that minimally invasive ELS may be efficacious, yet significant risks (probably inflammatory) limit its current utility.
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Adesivo Tecidual de Fibrina/uso terapêutico , Pneumonectomia/métodos , Enfisema Pulmonar/tratamento farmacológico , Enfisema Pulmonar/cirurgia , Qualidade de Vida , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Enfisema Pulmonar/diagnóstico , Enfisema Pulmonar/mortalidade , Testes de Função Respiratória , Medição de Risco , Índice de Gravidade de Doença , Taxa de Sobrevida , Fatores de Tempo , Tomografia Computadorizada por Raios X/métodos , Resultado do TratamentoRESUMO
BACKGROUND: Cone-beam computed tomography (CBCT) and augmented fluoroscopy (AF), in which intraprocedural CBCT data is fused with fluoroscopy, have been utilized as a novel image-guidance technique for biopsy of peripheral pulmonary lesions. The aim of this clinical study is to determine the safety and diagnostic performance of CBCT-guided bronchoscopy with advanced software tools for procedural planning and navigational guidance with AF of the airways for biopsy of peripheral pulmonary nodules. METHODS: Fifty-two consecutive subjects were prospectively enrolled in the AIRWAZE study (December 2018 to October 2019). Image-guided bronchoscopic biopsy procedures were performed under general anesthesia with specific ventilation protocols in a hybrid operating room equipped with a ceiling-mounted C-arm system. Procedural planning and image-guided bronchoscopy with CBCT and AF were performed using the Airwaze investigational device. RESULTS: A total of 58 pulmonary lesions with a median size of 19.0 mm (range 7 to 48 mm) were biopsied. The overall diagnostic yield at index procedure was 87.9% (95% CI: 77.1%-94.0%). No severe adverse events related to CBCT-guided bronchoscopy, such as pneumothorax, bleeding, or respiratory failure, were observed. CONCLUSION: CBCT-guided bronchoscopic biopsy with augmented fluoroscopic views of the airways and target lesion for navigational guidance is technically feasible and safe. Three-dimensional image-guided navigation biopsy is associated with high navigational success and a high diagnostic yield for peripheral pulmonary nodules.
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Biópsia Guiada por Imagem , Neoplasias Pulmonares , Humanos , Estudos Prospectivos , Biópsia Guiada por Imagem/métodos , Pulmão/diagnóstico por imagem , Pulmão/patologia , Tomografia Computadorizada de Feixe Cônico/métodos , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/patologia , Fluoroscopia/métodos , Broncoscopia/métodos , Estudos RetrospectivosRESUMO
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.
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Neoplasias Pulmonares , Nódulos Pulmonares Múltiplos , Humanos , Adulto , Estudos de Coortes , Estudos Prospectivos , Neoplasias Pulmonares/diagnóstico , Grupos Controle , Nódulos Pulmonares Múltiplos/diagnóstico por imagem , Pontuação de PropensãoRESUMO
RATIONALE: Stereotactic body radiation therapy (SBRT) is the standard of care for inoperable early stage non-small cell lung cancer (NSCLC). Use of image guided thermal ablation (IGTA; including microwave ablation [MWA] and radiofrequency ablation [RFA]) has increased in NSCLC, however there are no studies comparing all three. OBJECTIVE: To compare the efficacy of IGTA (including MWA and RFA) and SBRT for the treatment of NSCLC. METHODS: Published literature databases were systematically searched for studies assessing MWA, RFA, or SBRT. Local tumor progression (LTP), disease-free survival (DFS), and overall survival (OS) were assessed with single-arm pooled analyses and meta-regressions in NSCLC patients and a stage IA subgroup. Study quality was assessed with a modified methodological index for non-randomized studies (MINORS) tool. RESULTS: Forty IGTA study-arms (2,691 patients) and 215 SBRT study-arms (54,789 patients) were identified. LTP was lowest after SBRT at one and two years in single-arm pooled analyses (4% and 9% vs. 11% and 18%) and at one year in meta-regressions when compared to IGTA (OR = 0.2, 95%CI = 0.07-0.63). MWA patients had the highest DFS of all treatments in single-arm pooled analyses. In meta-regressions at two and three-years, DFS was significantly lower for RFA compared to MWA (OR = 0.26, 95%CI = 0.12-0.58; OR = 0.33, 95%CI = 0.16-0.66, respectively). OS was similar across modalities, timepoints, and analyses. Older age, male patients, larger tumors, retrospective studies, and non-Asian study region were also predictors of worse clinical outcomes. In high-quality studies (MINORS score ≥ 7), MWA patients had better clinical outcomes than the overall analysis. Stage IA MWA patients had lower LTP, higher OS, and generally lower DFS, compared to the main analysis of all NSCLC patients. CONCLUSIONS: NSCLC patients had comparable outcomes after SBRT and MWA, which were better than those with RFA.
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Carcinoma Pulmonar de Células não Pequenas , Ablação por Cateter , Neoplasias Hepáticas , Neoplasias Pulmonares , Radiocirurgia , Humanos , Masculino , Carcinoma Pulmonar de Células não Pequenas/radioterapia , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Ablação por Cateter/métodosRESUMO
BACKGROUND: Computed tomography-to-body divergence caused by respiratory motion, atelectasis, diaphragmatic motion and other factors is an obstacle to peripheral lung biopsies. We examined a conventional ventilation strategy versus a lung navigation ventilation protocol (LNVP) optimized for intraprocedural 3-dimensional image acquisition and bronchoscopic biopsy of peripheral lung nodules. METHODS: A retrospective, single center study was conducted in consecutive subjects with peripheral lung lesions measuring <30 mm. Effects of ventilation strategies including atelectasis and tool-in-lesion confirmation were assessed using cone beam computed tomography images. Diagnostic yield was also evaluated. Complications were assessed through 7 days. RESULTS: Fifty subjects were included (25 per group) with 27 nodules in the conventional group and 25 nodules in the LNVP group. Atelectasis was assessed by 2 blinded readers: [reader 1 (R1) and reader 2 (R2)]. Atelectasis was more prevalent in the conventional ventilation group, both for dependent atelectasis (R1: 64% and R2: 68% vs. R1: 36% and R2: 16%, P=0.00014) and sublobar/lobar atelectasis (R1: 48% and R2: 56% vs. R1: 20% and R2: 32%, P=0.01). Similarly, the target lesion was obscured due to atelectasis more often in the conventional ventilation group (R1: 36% and R2: 36% vs. R1: 4% and R2: 8%, P=0.01). Diagnostic yield was 70% for conventional ventilation and 92% for LNVP (P=0.08). CONCLUSION: LNVP demonstrated markedly reduced dependent and sublobar/lobar atelectasis and lesions either partially or completely obscured by atelectasis compared with conventional ventilation. Future prospective studies are necessary to understand the impact of protocolized ventilation strategies for bronchoscopic biopsy of peripheral lung lesions.
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Broncoscopia , Atelectasia Pulmonar , Biópsia , Humanos , Pulmão/diagnóstico por imagem , Estudos Prospectivos , Atelectasia Pulmonar/diagnóstico por imagem , Estudos RetrospectivosRESUMO
PURPOSE: This report describes the Ion Endoluminal System (Intuitive Surgical, Inc, Sunnyvale, CA) and practices for safe and effective use in patients with small peripheral pulmonary nodules (PPNs). DESCRIPTION: This shape-sensing robotic-assisted bronchoscopy system allows airway visualization and navigation to reach and biopsy small PPNs through a stable platform. The system provides 3-dimensional mapping and visualization of the airways, a flexible and fully articulating 3.5-mm (outer diameter) catheter, a peripheral vision probe, and system-specific biopsy needles. EVALUATION: The Ion Endoluminal System was evaluated in an ongoing prospective, multicenter trial including 241 patients with 270 PPNs (largest mean cardinal measurement, 18.8 ± 6.5 mm). Mean time to register and navigate decreased from 10 minutes in the first 10 cases to 7 minutes in the subsequent cases. Asymptomatic pneumothorax occurred in 8 patients (3.3%), 1 (0.4%) with pigtail catheter placement. Two patients (0.8%) experienced airway bleeding; both cases of bleeding resolved within 5 minutes of tamponade. CONCLUSIONS: The Ion Endoluminal System's unique shape-sensing technology can be leveraged to facilitate localization and sampling of PPNs and potentially improve diagnostic accuracy.
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Broncoscopia/instrumentação , Broncoscopia/métodos , Nódulos Pulmonares Múltiplos/cirurgia , Procedimentos Cirúrgicos Robóticos/instrumentação , Adulto , Desenho de Equipamento , Feminino , Humanos , Masculino , Estudos ProspectivosRESUMO
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.
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Neoplasias Pulmonares , Pneumotórax , Broncoscopia/métodos , Estudos de Coortes , Fenômenos Eletromagnéticos , Humanos , Pulmão/patologia , Neoplasias Pulmonares/complicações , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/cirurgia , Pneumotórax/epidemiologia , Pneumotórax/etiologia , Pneumotórax/patologia , Estudos Prospectivos , Estados UnidosRESUMO
BACKGROUND: Navigational bronchoscopy has improved upon traditional bronchoscopy to identify suspicious pulmonary lesions, but wide variability exists in the diagnostic yield of various modalities. The aim of this study was to measure localization accuracy and diagnostic yield of a novel endobronchial augmented fluoroscopic navigation system (first-generation LungVision system) for peripheral pulmonary lesions (PPLs). METHODS: This prospective single-center study included adults undergoing guided bronchoscopy to evaluate PPLs. Preprocedure computed tomography (CT) images were obtained, and planning software calculated a pathway to the lesion. A flexible bronchoscope was used to navigate along the pathway overlaid on the intraprocedural fluoroscopic image. When real-time display indicated the catheter tip had reached the lesion, cone-beam computed tomography (CBCT) was used to measure the actual location of the tip. Biopsy and rapid on-site cytopathologic evaluation were performed. RESULTS: Fifty-one patients were included in the analysis. The median lesion diameter was 18.0 mm (range: 7.0 to 48.0 mm). Localization success was 96.1%. The average distance between lesion location as shown by LungVision augmented fluoroscopy and actual location measured by CBCT was 5.9 mm (range: 2.1 to 10.0 mm). Diagnostic yield at the index procedure was 78.4%. Diagnostic accuracy assessed at 12 months follow-up was 88.2%. Average CT-to-body divergence was 14.5 mm (range: 2.6 to 33.0 mm) from preprocedure CT to intraprocedural CBCT images. CONCLUSION: Augmented fluoroscopy for navigation and biopsy of PPLs with the LungVision system showed a high localization success rate and corresponding high diagnostic yield. Navigation and biopsy with real-time visualization can improve diagnostic yield for PPLs.
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Neoplasias Pulmonares , Adulto , Biópsia , Broncoscopia , Fluoroscopia , Humanos , Pulmão/diagnóstico por imagem , Neoplasias Pulmonares/diagnóstico por imagemRESUMO
BACKGROUND: Electromagnetic navigation bronchoscopy (ENB) aids in lung lesion biopsy. However, anatomic divergence between the preprocedural computed tomography (CT) and the actual bronchial anatomy during the procedure can limit localization accuracy. An advanced ENB system has been designed to mitigate CT-to-body divergence using a tomosynthesis-based software algorithm that enhances nodule visibility and allows for intraprocedural local registration. MATERIALS AND METHODS: A prospective, 2-center study was conducted in subjects with single peripheral lung lesions ≥10 mm to assess localization accuracy of the superDimension navigation system with fluoroscopic navigation technology. Three-dimensional accuracy was confirmed by cone-beam computed tomography. Complications were assessed through 7 days. RESULTS: Fifty subjects were enrolled (25 per site). Lesions were <20 mm in 61.2% (30/49). A bronchus sign was present in 53.1% (26/49). Local registration was completed in 95.9% (47/49). Three-dimensional target overlap (primary endpoint) was achieved in 59.6% (28/47) and 83.0% (39/47) before and after location correction, respectively. Excluding subjects with unevaluable video files, target overlap was achieved 68.3% (28/41) and 95.1% (39/41), respectively. Malignant results were obtained in 53.1% (26/49) by rapid on-site evaluation and 61.2% (30/49) by final pathology of the ENB-aided sample. Diagnostic yield was not evaluated. Procedure-related complications were pneumothorax in 1 subject (no chest tube required) and scant hemoptysis in 3 subjects (no interventions required). CONCLUSION: ENB with tomosynthesis-based fluoroscopic navigation improved the 3-dimensional convergence between the virtual target and actual lung lesion as confirmed by cone-beam computed tomography. Future studies are necessary to understand the impact of this technology on diagnostic yield.
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Broncoscopia , Neoplasias Pulmonares , Tomografia Computadorizada de Feixe Cônico , Fenômenos Eletromagnéticos , Feminino , Humanos , Neoplasias Pulmonares/diagnóstico por imagem , Masculino , Estudos ProspectivosRESUMO
BACKGROUND: The diagnostic yield of electromagnetic navigation bronchoscopy (ENB) is impacted by biopsy tool strategy and rapid on-site evaluation (ROSE) use. This analysis evaluates usage patterns, accuracy, and safety of tool strategy and ROSE in a multicenter study. METHODS: NAVIGATE (NCT02410837) evaluates ENB using the superDimension navigation system (versions 6.3 to 7.1). The 1-year analysis included 1215 prospectively enrolled subjects at 29 United States sites. Included herein are 416 subjects who underwent ENB-aided biopsy of a single lung lesion positive for malignancy at 1 year. Use of a restricted number of tools (only biopsy forceps, standard cytology brush, and/or bronchoalveolar lavage) was compared with an extensive multimodal strategy (biopsy forceps, cytology brush, aspirating needle, triple needle cytology brush, needle-tipped cytology brush, core biopsy system, and bronchoalveolar lavage). RESULTS: Of malignant cases, 86.8% (361/416) of true positive diagnoses were obtained using extensive multimodal strategies. ROSE was used in 300/416 cases. The finding of malignancy by ROSE reduced the total number of tools used. A malignant ROSE call was obtained in 71% (212/300), most (88.7%; 188/212) by the first tool used (49.5% with aspirating needle, 20.2% with cytology brush, 17.0% with forceps). True positive rates were highest for the biopsy forceps (86.9%) and aspirating needle (86.6%). Use of extensive tool strategies did not increase the rates of pneumothorax (5.5% restricted, 2.8% extensive) or bronchopulmonary hemorrhage (3.6% restricted, 1.1% extensive). CONCLUSION: These results suggest that extensive biopsy tool strategies, including the aspirating needle, may provide higher true positive rates for detecting lung cancer without increasing complications.
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Neoplasias Pulmonares , Pneumotórax , Biópsia , Broncoscopia , Fenômenos Eletromagnéticos , Humanos , Neoplasias Pulmonares/diagnóstico , Estudos ProspectivosRESUMO
Guided bronchoscopy offers a minimally invasive and safe method for accessing indeterminate pulmonary nodules. However, all current guided bronchoscopy systems rely on a preprocedural computed tomography (CT) scan to create a virtual map of the patient's airways. Changes in lung anatomy between the preprocedural CT scan and the bronchoscopy procedure can lead to a divergence between the expected and actual location of the target lesion. Termed "CT-to-body divergence", this effect reduces diagnostic yield, adds time to the procedure, and can be challenging for the operator. The objective of this paper is to describe the concept of CT-to-body divergence, its contributing factors, and methods and technologies that might minimize its deleterious effects on diagnostic yield.
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[This corrects the article DOI: 10.21037/jtd.2020.01.35.].
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The COVID-19 pandemic has profoundly affected health care delivery worldwide. A small yet significant number of patients with respiratory failure will require prolonged mechanical ventilation while recovering from the viral-induced injury. The majority of reports thus far have focused on the epidemiology, clinical factors, and acute care of these patients, with less attention given to the recovery phase and care of those patients requiring extended time on mechanical ventilation. In this paper, we review the procedures and methods to safely care for patients with COVID-19 who require tracheostomy, gastrostomy, weaning from mechanical ventilation, and final decannulation. The guiding principles consist of modifications in the methods of airway care to safely prevent iatrogenesis and to promote safety in patients severely affected by COVID-19, including mitigation of aerosol generation to minimize risk for health care workers.
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Infecções por Coronavirus , Remoção de Dispositivo/métodos , Gastrostomia , Controle de Infecções , Pandemias , Pneumonia Viral , Traqueostomia , Desmame do Respirador/métodos , Betacoronavirus , COVID-19 , Infecções por Coronavirus/complicações , Infecções por Coronavirus/cirurgia , Infecções por Coronavirus/terapia , Cuidados Críticos/métodos , Cuidados Críticos/normas , Gastrostomia/instrumentação , Gastrostomia/métodos , Humanos , Controle de Infecções/instrumentação , Controle de Infecções/métodos , Controle de Infecções/normas , Pneumonia Viral/complicações , Pneumonia Viral/cirurgia , Pneumonia Viral/terapia , Respiração Artificial/métodos , Risco Ajustado , SARS-CoV-2 , Traqueostomia/instrumentação , Traqueostomia/métodosRESUMO
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.