Feasibility and Impact on Diagnosis of Peripheral Pulmonary Lesions under Real-Time Direct Vision by Iriscope®.

INTRODUCTION: Interventional pneumology plays a crucial role in the diagnosis of peripheral pulmonary lesions (PPLs), offering a minimally invasive approach with a low risk of complications. Iriscope® is a novel device that provides a direct and real-time image of PPLs. The objective of this study was to demonstrate the feasibility and impact of Iriscope® in diagnosing PPLs by analyzing its ability to directly visualize lesions and support accurate sampling during radial probe endobronchial ultrasound (rEBUS) and electromagnetic navigation bronchoscopy (ENB) combined with rEBUS. METHODS: A single-center prospective study was conducted from December 2022 to October 2023 on patients with suspicious PPLs. The diagnostic approach involved either rEBUS alone or in combination with ENB. In all cases, an additional novel technique called Iriscope® (Lys Medical, Charleroi, Belgium) was also applied. Iriscope® findings of each lesion were evaluated individually by three expert interventional pulmonologists. RESULTS: Seventy PPLs suspected of malignancy were included in the study. The PPLs underwent examination by ENB combined with rEBUS (55) or by rEBUS alone (15). Diagnosis was obtained in 68.6% (48/70) of cases. Iriscope® provided a direct, real-time view of 57.1% (40/70) of PPLs with a positive predictive value of 92.5% (37/40). This technique was able to visualize 72% (39/54) of malignant lesions, while only 6.1% (1/16) of benign lesions showed pathologic changes. The most common findings observed with Iriscope® were mucosal thickening and infiltration (92.5%), increased capillary vascularization (82%), pale or grayish mucosa (72.5%), obstruction with accumulation of secretions (50%), and cobblestone mucosa (15%). CONCLUSION: Iriscope® is a promising technique in the diagnostic process of PPLs, providing real-time pathologic imaging that facilitates accurate sampling. Further studies are needed to evaluate success rate of Iriscope-mediated repositioning and to establish predictive patterns for malignant or even benign diseases.

The effect of combining different sampling tools on the performance of electromagnetic navigational bronchoscopy for the evaluation of peripheral lung lesions and factors associated with its diagnostic yield.

BACKGROUND: We assessed the performance of Electromagnetic navigational bronchoscopy (ENB) as a standalone diagnostic technique and the performance of different sampling tools used during the procedure. METHODS: We recruited 160 consecutive patients who underwent ENB for peripheral lung lesions (PLL) at a tertiary care centre. The diagnostic performance of ENB and sampling tools was assessed using a logistic regression model and a ROC-curve in which the dependent variable was diagnostic success. A multivariate model was built to predict diagnostic success before performing ENB to select the best candidates for the procedure. RESULTS: Most patients with PLLs in the study were male (65%), with a mean age of 67.9 years. The yield was 66% when the most common techniques were used together as suction catheter + transbronchial biopsy forceps (TBBx) + bronchoalveolar lavage + bronchial washing (p < 0.001) and increased to 69% when transbronchial needle aspiration (TBNA) and cytology brush were added (p < 0.001). Adding diagnostic techniques such as TBBx and TBNA resulted in an increase in diagnostic performance, with a statistically significant trend (p = 0.002). The logistic model area-under the ROC-curve for diagnostic success during ENB was 0.83 (95% CI:0.75-0.90; p < 0.001), and a logit value ≥ 0.12 was associated with ≥ 50% probability of diagnostic success. CONCLUSIONS: ENB, as a stand-alone diagnostic tool for the evaluation of PLLs when performed by experienced operators using a multi-modality technique, has a good diagnostic yield. The probability of having a diagnostic ENB could be assessed using the proposed model.

Bronchoscopist's perception of the quality of the single-use bronchoscope (Ambu aScope4™) in selected bronchoscopies: a multicenter study in 21 Spanish pulmonology services.

BACKGROUND: The disposable bronchoscope is an excellent alternative to face the problem of SARS-CoV-2 and other cross infections, but the bronchoscopist's perception of its quality has not been evaluated. METHODS: To evaluate the quality of the Ambu-aScope4 disposable bronchoscope, we carried out a cross-sectional study in 21 Spanish pulmonology services. We use a standardized questionnaire completed by the bronchoscopists at the end of each bronchoscopy. The variables were described with absolute and relative frequencies, measures of central tendency and dispersion depending on their nature. The existence of learning curves was evaluated by CUSUM analysis. RESULTS: The most frequent indications in 300 included bronchoscopies was bronchial aspiration in 69.3% and the median duration of these was 9.1 min. The route of entry was nasal in 47.2% and oral in 34.1%. The average score for ease of use, image, and aspiration quality was 80/100. All the planned techniques were performed in 94.9% and the bronchoscopist was satisfied in 96.6% of the bronchoscopies. They highlighted the portability and immediacy of the aScope4TM to start the procedure in 99.3%, the possibility of taking and storing images in 99.3%. The CUSUM analysis showed average scores > 70/100 from the first procedure and from the 9th procedure more than 80% of the scores exceeded the 80/100 score. CONCLUSIONS: The aScope4™ scored well for ease of use, imaging, and aspiration. We found a learning curve with excellent scores from the 9th procedure. Bronchoscopists highlighted its portability, immediacy of use and the possibility of taking and storing images.

[Recommendations for performing interventions during the COVID-19 pandemic]. / Recomendaciones para la realización de intervenciones pulmonares durante la pandemia COVID-19.

Coronavirus infection (SARS-CoV-2), is a pandemic disease declared by the World Health Organization (WHO). This disease reports a high risk of contagion, especially by the transmission of aerosols in health care workers. In this scenario, aerosol exposure is increased in various procedures related to the airway, lungs, and pleural space. For this reason, it is important to have recommendations that reduce the risk of exposure and infection with COVID-19. In this document, a team of international specialists in interventional pulmonology elaborated a series of recommendations, based on the available evidence to define the risk stratification, diagnostic methods and technical considerations on procedures such as bronchoscopy, tracheostomy, and pleural procedures among others. As well as the precautions to reduce the risk of contagion when carrying out pulmonary interventions.

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.

A Prospective Randomized Study Comparing Manual and Wall Suction in the Performance of Bronchoalveolar Lavage.

BACKGROUND: Bronchoalveolar lavage (BAL) may be performed using a hand-held syringe or wall suction. OBJECTIVES: The aim was to study BAL volume and diagnostic yields based on BAL technique. METHODS: A total of 220 consecutive patients undergoing BAL at our center were included. Manual aspiration was performed in 115 patients (group 1), and wall suction (<50 mm Hg of negative pressure) was used in 105 patients (group 2). All bronchoscopies were performed under conscious sedation applying topical anesthesia with lidocaine. Three 50-ml sterile saline aliquots were instilled in all patients. RESULTS: The mean total amount of fluid recovered was 67 ± 20 ml in group 1 and 55 ± 22 ml in group 2 (p < 0.001). More patients in the manual aspiration group met American Thoracic Society criteria (recovery of ≥30% of instilled fluid) for an optimal BAL (81 vs. 59%; p < 0.001). The quantity of recovered fluid was also related to BAL location (p < 0.001) and radiologic findings (p = 0.002). Forty-eight (22%) BALs were diagnostic (23 in group 1 and 25 in group 2), including 37 positive bacterial cultures, 6 positive stains for Pneumocystis, and 5 cases of malignancy. No statistically significant difference in diagnostic yield was observed between the two groups. A BAL diagnosis was more likely in patients with certain radiologic (p = 0.033) and endoscopic findings (p = 0.001). When taking into account all bronchoscopic techniques performed during the procedure (e.g. biopsies, brushing, etc.), bronchoscopy was diagnostic in 37% of patients. CONCLUSIONS: Manual aspiration is superior to wall suction during BAL yielding a larger quantity of aspirate. Diagnostic yields are similar for both techniques.

A randomised trial of lung sealant versus medical therapy for advanced emphysema.

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 3 months; 34 (21 treatment and 13 control) at 6 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 6 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.

Learning curves and association of pathologist's performance with the diagnostic accuracy of linear endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA): a cohort study in a tertiary care reference centre.

OBJECTIVES: We aimed to assess the learning curves and the influence of the pathologist's performance on the endobronchial ultrasound transbronchial needle aspiration's (EBUS-TBNA's) diagnostic accuracy in a real-world study. DESIGN/SETTING: Cohort study conducted in a tertiary care university hospital (single centre) with patients referred for EBUS-TBNA. PARTICIPANTS/INTERVENTION: We initially evaluated 376 patients (673 lymph nodes), 368 (660 lymph nodes) of whom were recruited. The inclusion criterion was EBUS-TBNA indicated for the study of mediastinal or hilar lesions. The exclusion criteria were the absence of mediastinal and hilar lesions during EBUS confirmed by a normal mediastinum and hilum on chest CT (except in cases of mediastinal staging of cancer) and lost to follow-up. PRIMARY AND SECONDARY OUTCOME MEASURES: Diagnostic accuracy and related outcomes. METHODS: We included patients from a prospectively constructed database. We performed a logistic regression multivariate analysis to adjust for potential confounders of the association between pathologist performance and EBUS-TBNA accuracy. The Cumulative Summation (CUSUM) analysis was used to assess pathologists' performance and learning curves. RESULTS: Most indications for EBUS were suspicion of malignancy, including intrathoracic tumours (68.3%), extrathoracic tumours (9.8%) and cancer staging (7.0%). The patients' mean age was 63.7 years, and 71.5% were male. Overall EBUS-TBNA accuracy was 80.8%. In the multivariate logistic regression model, the factors independently associated with EBUS-TBNA accuracy included certain pathologists (ORs ranging from 0.16 to 0.41; p<0.017), a lymph node short-axis diameter <1 cm (OR: 0.36; 95% CI 0.21 to 0.62; p<0.001), and the aetiology of lymph node enlargement (ORs ranging from 7 to 37; p<0.001). CUSUM analysis revealed four different learning curve patterns, ranging from almost immediate learning to a prolonged learning phase, as well as a pattern consistent with performance attrition. CONCLUSIONS: Pathologists' proficiency conditioned EBUS-TBNA accuracy. This human factor is a potential source of error independent of factors conditioning tissue sample adequacy.

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.

Metoprolol in Critically Ill Patients With COVID-19.

BACKGROUND: Severe coronavirus disease-2019 (COVID-19) can progress to an acute respiratory distress syndrome (ARDS), which involves alveolar infiltration by activated neutrophils. The beta-blocker metoprolol has been shown to ameliorate exacerbated inflammation in the myocardial infarction setting. OBJECTIVES: The purpose of this study was to evaluate the effects of metoprolol on alveolar inflammation and on respiratory function in patients with COVID-19-associated ARDS. METHODS: A total of 20 COVID-19 patients with ARDS on invasive mechanical ventilation were randomized to metoprolol (15 mg daily for 3 days) or control (no treatment). All patients underwent bronchoalveolar lavage (BAL) before and after metoprolol/control. The safety of metoprolol administration was evaluated by invasive hemodynamic and electrocardiogram monitoring and echocardiography. RESULTS: Metoprolol administration was without side effects. At baseline, neutrophil content in BAL did not differ between groups. Conversely, patients randomized to metoprolol had significantly fewer neutrophils in BAL on day 4 (median: 14.3 neutrophils/µl [Q1, Q3: 4.63, 265 neutrophils/µl] vs median: 397 neutrophils/µl [Q1, Q3: 222, 1,346 neutrophils/µl] in the metoprolol and control groups, respectively; P = 0.016). Metoprolol also reduced neutrophil extracellular traps content and other markers of lung inflammation. Oxygenation (PaO2:FiO2) significantly improved after 3 days of metoprolol treatment (median: 130 [Q1, Q3: 110, 162] vs median: 267 [Q1, Q3: 199, 298] at baseline and day 4, respectively; P = 0.003), whereas it remained unchanged in control subjects. Metoprolol-treated patients spent fewer days on invasive mechanical ventilation than those in the control group (15.5 ± 7.6 vs 21.9 ± 12.6 days; P = 0.17). CONCLUSIONS: In this pilot trial, intravenous metoprolol administration to patients with COVID-19-associated ARDS was safe, reduced exacerbated lung inflammation, and improved oxygenation. Repurposing metoprolol for COVID-19-associated ARDS appears to be a safe and inexpensive strategy that can alleviate the burden of the COVID-19 pandemic.

Bronchial Thermoplasty Global Registry (BTGR): 2-year results.

OBJECTIVES: Bronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this procedure. DESIGN: The BTGR is an all-comer, prospective, open-label, multicentre study enrolling adult subjects indicated for and treated with BT. SETTING: Eighteen centres in Spain, Italy, Germany, the UK, the Netherlands, the Czech Republic, South Africa and Australia PARTICIPANTS: One hundred fifty-seven subjects aged 18 years and older who were scheduled to undergo BT treatment for asthma. Subjects diagnosed with other medical conditions which, in the investigator's opinion, made them inappropriate for BT treatment were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: Baseline characteristics collected included demographics, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (ACT), medication usage, forced expiratory volume in one second and forced vital capacity, medical history, comorbidities and 12-month baseline recall data (severe exacerbations (SE) and healthcare utilisation). SE incidence and healthcare utilisation were summarised at 1 and 2 years post-BT. RESULTS: Subjects' baseline characteristics were representative of persons with severe asthma. A comparison of the proportion of subjects experiencing events during the 12 months prior to BT to the 2-year follow-up showed a reduction in SE (90.3% vs 56.1%, p<0.0001), emergency room visits (53.8% vs 25.5%, p<0.0001) and hospitalisations (42.9% vs 23.5 %, p=0.0019). Reductions in asthma maintenance medication dosage were also observed. AQLQ and ACT scores improved from 3.26 and 11.18 at baseline to 4.39 and 15.54 at 2 years, respectively (p<0.0001 for both AQLQ and ACT). CONCLUSIONS: The BTGR demonstrates sustained improvement in clinical outcomes and reduction in asthma medication usage 2 years after BT in a real-world population. This is consistent with results from other BT randomised controlled trials and registries and further supports improvement in asthma control after BT. TRIAL REGISTRATION NUMBER: NCT02104856.

The role of bronchoscopy in patients with SARS-CoV-2 pneumonia.

BACKGROUND: The role of bronchoscopy in coronavirus disease 2019 (COVID-19) is a matter of debate. PATIENTS AND METHODS: This observational multicentre study aimed to analyse the prognostic impact of bronchoscopic findings in a consecutive cohort of patients with suspected or confirmed COVID-19. Patients were enrolled at 17 hospitals from February to June 2020. Predictors of in-hospital mortality were assessed by multivariate logistic regression. RESULTS: A total of 1027 bronchoscopies were performed in 515 patients (age 61.5±11.2 years; 73% men), stratified into a clinical suspicion cohort (n=30) and a COVID-19 confirmed cohort (n=485). In the clinical suspicion cohort, the diagnostic yield was 36.7%. In the COVID-19 confirmed cohort, bronchoscopies were predominantly performed in the intensive care unit (n=961; 96.4%) and major indications were: difficult mechanical ventilation (43.7%), mucus plugs (39%) and persistence of radiological infiltrates (23.4%). 147 bronchoscopies were performed to rule out superinfection, and diagnostic yield was 42.9%. There were abnormalities in 91.6% of bronchoscopies, the most frequent being mucus secretions (82.4%), haematic secretions (17.7%), mucus plugs (17.6%), and diffuse mucosal hyperaemia (11.4%). The independent predictors of in-hospital mortality were: older age (OR 1.06; p<0.001), mucus plugs as indication for bronchoscopy (OR 1.60; p=0.041), absence of mucosal hyperaemia (OR 0.49; p=0.041) and the presence of haematic secretions (OR 1.79; p=0.032). CONCLUSION: Bronchoscopy may be indicated in carefully selected patients with COVID-19 to rule out superinfection and solve complications related to mechanical ventilation. The presence of haematic secretions in the distal bronchial tract may be considered a poor prognostic feature in COVID-19.

Transbronchial biopsy results according to diffuse interstitial lung disease classification. Cryobiopsy versus forceps: MULTICRIO study.

BACKGROUND: In recent years, transbronchial cryobiopsy (TBCB) has come to be increasingly used in interventional pulmonology units as it obtains larger and better-quality samples than conventional transbronchial lung biopsy (TBLB) with forceps. No multicenter studies have been performed, however, that analyse and compare TBCB and TBLB safety and yield according to the interstitial lung disease (ILD) classification. OBJECTIVES: We compared the diagnostic yield and safety of TBCB with cryoprobe sampling versus conventional TBLB forceps sampling in the same patient. METHOD: Prospective multicenter clinical study of patients with ILD indicated for lung biopsy. Airway management with orotracheal tube, laryngeal mask and rigid bronchoscope was according to the protocol of each centre. All procedures were performed using fluoroscopy and an occlusion balloon. TBLB was followed by TBCB. Complications were recorded after both TBLB and TBCB. RESULTS: Included were 124 patients from 10 hospitals. Airway management was orotracheal intubation in 74% of cases. Diagnostic yield according to multidisciplinary committee results for TBCB was 47.6% and for TBLB was 19.4% (p<0.0001). Diagnostic yield was higher for TBCB compared to TBLB for two groups: idiopathic interstitial pneumonias (IIPs) and ILD of known cause or association (OR 2.5; 95% CI: 1.4-4.2 and OR 5.8; 95% CI: 2.3-14.3, respectively). Grade 3 (moderate) bleeding after TBCB occurred in 6.5% of patients compared to 0.8% after conventional TBLB. CONCLUSIONS: Diagnostic yield for TBCB was higher than for TBLB, especially for two disease groups: IIPs and ILD of known cause or association. The increased risk of bleeding associated with TBCB confirms the need for safe airway management and prophylactic occlusion-balloon use. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT02464592.

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.

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.

Bronchoscopic Lung Volume Reduction.

Since the publication of the National Emphysema Treatment Trial study, lung volume reduction (LVR) has been considered a therapeutic alternative for patients with advanced obstructive lung disease. The high complication rate of surgical LVR has led to the development of bronchoscopic LVR (BLVR). Of the currently available BLVR alternatives, coils and unidirectional endobronchial valves lead the list. The choice of each device depends on emphysema characteristics and presence of collateral ventilation. Evaluation of these patients at centers with expertise in interventional pulmonology and management of BLVR is strongly recommended.

A comparison of the I-Gel supraglottic device with endotracheal intubation for bronchoscopic lung volume reduction coil treatment.

STUDY OBJECTIVE: To compare the use of the I-gel airway with orotracheal intubation (OTI) for bronchoscopic lung volume reduction (BLVR) coil treatment in patients with severe chronic obstructive pulmonary disease (COPD) with heterogeneous emphysema, since it has been proved that supraglottic airways have lower incidence of postoperative respiratory complaints compared to OTI. DESIGN: A comparative, prospective observational study was designed to assess the use of the I-gel airway compared with the OTI. SETTING: Bronchoscopy room at the University Hospital Fundación Jimenez Diaz, Madrid. Tertiary care center. PATIENTS: Thirty-three procedures were carried out in 22 patients diagnosed with COPD with severe heterogeneous emphysema undergoing BLVR coil treatment under general anaesthesia. INTERVENTION: Seventeen procedures were carried out with I-gel and 16 with endotracheal tube. Airway device choice was left to the attendant anesthesiologist. MEASUREMENTS: Tidal volume, peak pressure, and the presence of gas leaks were compared. Adverse events during the procedure and within the first 3 hours later were also recorded. MAIN RESULTS: Ventilation parameters obtained showed no significant differences. Mean tidal volume was 466.6 ± 28.2 mL and 478.7 ± 34.0 mL (P > .05), mean peak pressure was 17.9 ± 2.5 cmH2O and 19.4 ± 2.4 cmH2O (P > .05) and mean gas leaks was 71 ± 17.6 mL and 79 ± 15.5 mL (P > .05) for I-gel group (IgelG) and endotracheal tube group respectively. No serious complications were reported. One case of pneumothorax was reported in the endotracheal tube group, which was resolved with a chest drainage tube without further complications. CONCLUSION: The I-gel airway ensures appropriate ventilation and makes the use of the flexible fiberoptic bronchoscope quite easy. Therefore, we consider that the I-gel device is an effective and safe alternative to classical OTI for airway management in COPD patients with severe heterogeneous emphysema undergoing BLVR coil treatment.

Recomendaciones para la realización de intervenciones pulmonares durante la pandemia COVID-19 / Recommendations for performing interventions during the COVID-19 pandemic

Coronavirus infection (SARS-CoV-2), is a pandemic disease declared by the World Health Organization (WHO). This disease reports a high risk of contagion, especially by the transmission of aerosols in health care workers. In this scenario, aerosol exposure is increased in various procedures related to the airway, lungs, and pleural space. For this reason, it is important to have recommendations that reduce the risk of exposure and infection with COVID-19. In this document, a team of international specialists in interventional pulmonology elaborated a series of recommendations, based on the available evidence to define the risk stratification, diagnostic methods and technical considerations on procedures such as bronchoscopy, tracheostomy, and pleural procedures among others. As well as the precautions to reduce the risk of contagion when carrying out pulmonary interventions.