Mobile cone-beam computed tomography complementing shape-sensing robotic-assisted bronchoscopy in the small pulmonary nodule sampling: A multicentre experience.

BACKGROUND AND OBJECTIVE: Shape-sensing robotic-assisted bronchoscopy (ssRAB) has expanded as an important diagnostic tool for peripheral pulmonary nodules (PPNs), with diagnostic yields ranging from 60% to 88%. However, sampling and diagnosing PPN less than 2 cm in size has historically been challenging. Mobile cone-beam computed tomography (mCBCT) has been recently integrated into ssRAB to improve diagnostic accuracy, but its added value remains uncertain. We aim to describe the role of mCBCT and determine if it provides any diagnostic advantage. METHODS: A multicentre, retrospective study on the use of ssRAB and mCBCT in two tertiary care institutions: Mayo Clinic Florida and Massachusetts General Hospital. The primary outcome was diagnostic yield and sensitivity for malignancy of ssRAB complemented with mCBCT, compared to ssRAB with the standard 2D fluoroscopy. RESULTS: A total of 192 nodules were biopsied from 173 patients. mCBCT was used in 117 (60.9%) nodules. The overall diagnostic yield was 85.4%. Diagnostic yield between subgroups with and without mCBCT was 83.8% and 88% (p = 0.417), respectively. The mCBCT group had fewer solid nodules (65.8% vs. 81.3%, p = 0.020) and a higher number of ground-glass nodules (10.3% vs. 1.3%, p = 0.016). CONCLUSION: Overall, diagnostic yield between subgroups with and without mCBCT was similar. The complementary use of mCBCT to ssRAB allows proceduralists to target more complex and subsolid PPNs with a diagnostic yield comparable to simple solid PPNs while maintaining an excellent safety profile.

Early Pneumatocele Identification Post-Robotic Assisted Bronchoscopy Cryobiopsy: A Case Series Experience.

INTRODUCTION: The use of cryobiopsy in conjunction with robotic assisted bronchoscopy is on the rise due to the safety and increased diagnostic yield of cryobiopsy. The incorporation of 3D fluoroscopy in the procedure improves the workflow and helps confirm the accuracy of sampling of peripheral pulmonary nodules. METHODS: We describe an observational series of 12 patients comprising 14 nodules where cryobiopsy was performed during shape-sensing robot-assisted bronchoscopy cryobiopsy under general anesthesia. 3D fluoroscopy was used to confirm accurate placement of the cryoprobe. All these patients underwent a second spin with the 3D fluoroscopy either to sample a second lesion intraoperatively or to investigate suspected pneumothorax. RESULTS: The development of a pneumatocele was noted after cryobiopsy in each of the cases. The majority of these were in the upper lobe with the median size of a sampled nodule being 14 mm. The majority of patients were asymptomatic with 1 patient developing mild hemoptysis and 4 patients developing chest tightness or dyspnea. None of the patients required an intervention for the pneumatocele. CONCLUSION: The development of pneumatoceles appears to be a fairly frequent and benign occurrence following cryobiopsy, likely due to increased tissue destruction. The increased use of intraoperative 3D fluoroscopy is likely to highlight changes to the pulmonary parenchyma that were previously not known. The occurrence of pneumatoceles does not appear to adversely impact the safety or tolerability profile of cryobiopsy.

Shape-Sensing Robotic-Assisted Bronchoscopy in the Multiple Pulmonary Nodule Diagnosis during a Single Anesthetic Event.

INTRODUCTION: The widespread use of computed tomography as a screening tool for early lung cancer has increased detection of pulmonary lesions. It is common to encounter patients with more than one peripheral pulmonary nodule (PPN) of uncertain etiology. Shape-sensing robotic-assisted bronchoscopy (ssRAB) emerges as a potential alternative to biopsy multiple PPN, in addition to mediastinal staging in single anesthetic procedure. METHODS: This is a single-center, retrospective review of 22 patients who underwent ssRAB for evaluation of two or more PPN, between November 2021 and April 2023 at Mayo Clinic, FL, USA. RESULTS: A total of 46 PPNs were biopsied in 22 patients. All lesions were ≤2 cm with a median minimum and maximum cross-sectional lesion size of 1.40 cm and 1.05 cm, respectively. Diagnostic yield was 86.9% (n = 40), and target reach was 91.3% (n = 42). Most lesions were in the upper lobes, a solid pattern was found in 78.3% (n = 36), bronchus sign was present in 82.6% of cases (n = 38), 54.4% (n = 25) were malignant nodules, and 32.6% (n = 15) were benign. Fourteen patients had at least one malignant lesion out of two or more nodules sampled, and 10 patients had a malignant diagnosis for all sampled lesions. The complication rate was 9% (n = 2) with one case of bleeding and one of pneumothorax. CONCLUSION: This study is, to our knowledge, the first to assess the use and safety of ssRAB for diagnosis of multiple PPN in a single anesthetic event. This procedure will mainly impact management decisions and subsequently shorten the time from diagnosis to treatment.

Shape-Sensing Robotic-Assisted Bronchoscopy versus Computed Tomography-Guided Transthoracic Biopsy for the Evaluation of Subsolid Pulmonary Nodules.

INTRODUCTION: Lung cancer remains the leading cause of cancer death worldwide. Subsolid nodules (SSN), including ground-glass nodules (GGNs) and part-solid nodules (PSNs), are slow-growing but have a higher risk for malignancy. Therefore, timely diagnosis is imperative. Shape-sensing robotic-assisted bronchoscopy (ssRAB) has emerged as reliable diagnostic procedure, but data on SSN and how ssRAB compares to other diagnostic interventions such as CT-guided transthoracic biopsy (CTTB) are scarce. In this study, we compared diagnostic yield of ssRAB versus CTTB for evaluating SSN. METHODS: A retrospective study of consecutive patients who underwent either ssRAB or CTTB for evaluating GGN and PSN with a solid component less than 6 mm from February 2020 to April 2023 at Mayo Clinic Florida and Rochester. Clinicodemographic information, nodule characteristics, diagnostic yield, and complications were compared between ssRAB and CTTB. RESULTS: A total of 66 nodules from 65 patients were evaluated: 37 PSN and 29 GGN. Median size of PSN solid component was 5 mm (IQR: 4.5, 6). Patients were divided into two groups: 27 in the ssRAB group and 38 in the CTTB group. Diagnostic yield was 85.7% for ssRAB and 89.5% for CTTB (p = 0.646). Sensitivity for malignancy was similar between ssRAB and CTTB (86.4% vs. 88.5%; p = 0.828), with no statistical difference. Complications were more frequent in CTTB with no significant difference (8 vs. 2; p = 0.135). CONCLUSION: Diagnostic yield for SSN was similarly high for ssRAB and CTTB, with ssRAB presenting less complications and allowing mediastinal staging within the same procedure.

Robotic-assisted bronchoscopy versus CT-guided transthoracic biopsy for diagnosis of pulmonary nodules.

BACKGROUND AND OBJECTIVE: Currently, computed tomography-guided transthoracic biopsy (CTTB) is the most accurate diagnostic approach for pulmonary nodules suspected of malignancy. Traditional bronchoscopy has shown suboptimal diagnostic sensitivity, but the emergence of robotic-assisted bronchoscopy (RAB) has the potential to improve diagnostic accuracy, maximize diagnostic yield and complete mediastinal and hilar staging in a single procedure. We aim to assess the efficacy and diagnostic performance of RAB compared to CTTB for diagnosing pulmonary nodules suspected of lung cancer. METHODS: A multicenter retrospective review of consecutive patients who underwent RAB and CTTB for evaluating pulmonary nodules from January 2019 to March 2021 at Mayo Clinic Florida and Mayo Clinic Rochester, United States. Clinical and demographic information, nodule characteristics, outcomes and complications were compared between RAB and CTTB. RESULTS: A total of 225 patients were included: 113 in the RAB group and 112 in the CTTB group. Overall diagnostic yield was 87.6% for RAB and 88.4% for CTTB. For malignant disease, RAB had a sensitivity of 82.1% and a specificity of 100%, CTTB had a sensitivity of 88.5% and a specificity of 100%. Complication rate was significantly higher for CTTB compared to RAB (17% vs. 4.4%; p = 0.002). CONCLUSION: RAB, when available, can be as accurate as CTTB for sampling pulmonary nodules with similar or reduced complications and should be considered as a means for nodule biopsy, particularly when mediastinal staging is also clinically warranted.

Robotic-Assisted Bronchoscopy Integrated with Three-Dimensional Fluoroscopy for Sampling Bilateral Pulmonary Nodules in a Single Procedure.

Bronchoscopic biopsy of peripheral pulmonary nodules has evolved in recent years with the emergence of new technologies such as shape-sensing robotic-assisted bronchoscopy. The use of three-dimensional (3D) fluoroscopy for intraoperative visualization of the biopsy tool in relation to the target nodule aims to overcome computed tomography-to-body divergence encountered during the procedure and allows for more accurate sampling to improve adequacy and diagnostic performance. Until recently, the robotic-assisted navigation plan and 3D imaging function as separate systems. We present a case where intraoperative 3D fluoroscopy images were integrated to the robotic bronchoscopy navigation system, resulting in a single, dynamic, real-time 3D virtual plan showing readjusted paths toward the lesion displayed in the robotic bronchoscopy navigation system, allowing in this case, biopsying two bilateral pulmonary nodules, resulting in different diagnosis within the same endoscopic procedure.

Diagnostic Yield of Shape-Sensing Robotic-Assisted Bronchoscopy for Ground-Glass Nodules and Subsolid Nodules with a Solid Component Less than 6 mm.

BACKGROUND: Ground-glass pulmonary nodules (GGNs) are most commonly sampled by percutaneous transthoracic biopsy. Diagnostic yield for ground-glass nodules using robotic-assisted bronchoscopy has been scarcely described, with a reported yield of 70.6%. OBJECTIVES: The aim of this study is to assess diagnostic yield for GGNs using shape-sensing robotic-assisted bronchoscopy (ssRAB). METHOD: A retrospective study of patients who underwent ssRAB for evaluation of GGNs, from September 2021 to April 2023. Primary outcome was diagnostic yield of ssRAB for GGNs, secondary outcomes were sensitivity for malignancy, and complications that required admission or intervention. RESULTS: A total of 23 nodules were biopsied from 22 patients. Median age was 71 years (IQR 66-81), 63.6% were female, and 40.9% had a previous history of cancer. Forty-three percent of nodules were in the right upper lobes, and the median lesion size was 1.8 × 1.21. Twelve were subsolid nodules (SSNs), and 11 were pure GGNs. Overall diagnostic yield was 87%, with a sensitivity for malignancy of 88.9%. Adenocarcinoma was the most common malignancy diagnosed (70%). No procedure-related complications were reported. CONCLUSION: The use of ssRAB shows a high diagnostic yield for diagnosing GGN and SSN with less than 6 mm solid component with a low risk for complications.

Nonmalignant Central Airway Obstruction: Options for Challenging Cases.

Benign central airway obstruction is commonly referred as nonmalignant central airway obstruction (NMCAO). This is in part related to its lack of benign nature and significant life-quality impairment in patients. It is a pathologic entity with various etiologies and therefore a wide range of therapeutic options are available. Evidence regarding the optimal management that could provide a sustained restoration of airway patency is lacking. The lack of a common pathophysiologic pathway translating into a nonspecific symptom presenting as NMCAO has complicated treatment standardization and subsequently limited solid research to favor of one approach over another one. Our intent is to describe the limited evidence of the most utilized nonsurgical treatment for NMCAO as well as some upcoming promising therapeutic options such as mitomycin C injection, microdebrider, biodegradable stents, radiotherapy, Hybrid Knife, and endoluminal spray cryotherapy. Our goal with this manuscript is to motivate other authors to venture into prospective, multicenter, open-label trials aimed to describe long-term outcomes in patients with NMCAO.

Argon Plasma Coagulation: Elucidation of the Mechanism of Gas Embolism.

BACKGROUND: Argon plasma coagulation (APC) is a tool used in the management of tracheobronchial obstruction or bleeding. Complications include gas embolism which can cause devastating effects including hemodynamic instability, cardiac arrest, and stroke. Multiple theories as to how gas embolism occurs with APC have been postulated; however, none have identified the exact mechanism. OBJECTIVES: To identify the mechanism by which APC causes gas embolism in the tracheobronchial tree. METHODS: Using an explanted porcine tracheobronchial tree with lung parenchyma, the APC catheter was applied through noncontact and direct contact to the endobronchial airway mucosa via flexible bronchoscopy. This was done at multiple gas flow settings and pulse durations. Visual changes in the mucosa were photographed, videoed, and described. RESULTS: Gross evidence of submucosal gas transfer occurred when the APC catheter was in direct contact with the mucosa at all gas flow settings in all applications, despite using shorter pulse durations. Whenever the catheter was not in contact with the mucosa, there was no transfer of gas at any gas flow setting or pulse duration. CONCLUSIONS: Direct mucosal contact with the APC probe leads to submucosal gas deposition and is a likely mechanism for gas entry into the intravascular space. In reported cases of APC-associated gas embolism, presence of a vascularized endobronchial tumor may have increased the risk of gas tracking into the intravascular space. Care should be taken when applying APC during brisk bleeding or limited vision, as inadvertent mucosal contact may occur and could increase the risk of gas embolism.

Management of Significant Airway Bleeding during Robotic Assisted Bronchoscopy: A Tailored Approach.

Robotic assisted bronchoscopy represents a major turning point in bronchoscopic history. The management strategies to address significant airway bleeding in this "robotic era" are not well documented, and further guidance is required. We present a case report that exemplifies our approach and management strategy using a combined and simultaneous flexible/robotic bronchoscopy if this complication is encountered.

Cone-Beam Computed Tomography-Guided Electromagnetic Navigation for Peripheral Lung Nodules.

BACKGROUND: Electromagnetic navigation bronchoscopy (ENB) is a minimally invasive technology for the diagnosis of peripheral pulmonary nodules. However, ENB is limited by the lack of real-time confirmation of various biopsy devices. Cone-beam computed tomography (CBCT) could increase diagnostic yield by allowing real-time confirmation to overcome the inherent divergence of nodule location. OBJECTIVES: The aim of this study was to assess the diagnostic yield of ENB plus CBCT as compared with ENB alone for biopsy of peripheral lung nodules. METHOD: We conducted a retrospective study of patients undergoing ENB before and after the implementation of CBCT. Data from 62 consecutive patients with lung nodules located in the outer two-thirds of the lung who underwent ENB and combined ENB-CBCT were collected. Radial endobronchial ultrasound was used during all procedures as well. Diagnostic yield was defined as the presence of malignancy or benign histological findings that lead to a specific diagnosis. RESULTS: Thirty-one patients had ENB-CBCT, and 31 patients had only ENB for peripheral lung lesions. The median size of the lesion for the ENB-CBCT group was 16 (interquartile range (IQR) 12.6-25.5) mm as compared to 21.5 (IQR 16-27) mm in the ENB group (p = 0.2). In the univariate analysis, the diagnostic yield of ENB-CBCT was 74.2% and ENB 51.6% (p = 0.05). Following multivariate regression analysis adjusting for the size of the lesion, distance from the pleura, and presence of bronchus sign, the odds ratio for the diagnostic yield was 3.4 (95% CI 1.03-11.26, p = 0.04) in the ENB-CBCT group as compared with ENB alone. The median time for the procedure was shorter in patients in the ENB-CBCT group (74 min) than in those in the ENB group (90 min) (p = 0.02). The rate of adverse events was similar in both groups (6.5%, p = 0.7). CONCLUSIONS: The use of CBCT might increase the diagnostic yield in ENB-guided peripheral lung nodule biopsies. Future randomized clinical trials are needed to confirm such findings.

Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial.

Rationale: Chronic bronchitis (CB) is characterized by productive cough with excessive mucus production, resulting in quality-of-life impairment and increased exacerbation risk. Bronchial rheoplasty uses an endobronchial catheter to apply nonthermal pulsed electrical fields to the airways. Preclinical studies have demonstrated epithelial ablation followed by regeneration of normalized epithelium.Objectives: To evaluate the feasibility, safety, and initial outcomes of bronchial rheoplasty in patients with CB.Methods: Pooled analysis of two separate studies enrolling 30 patients undergoing bilateral bronchial rheoplasty was conducted. Follow-up through 6 months (primary outcome) and 12 months included assessment of adverse events, airway histology, and changes in symptoms using the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test and St. George's Respiratory Questionnaire (SGRQ).Measurements and Main Results: Bronchial rheoplasty was performed in all 30 patients (63% male; mean [SD] age, 67 [7.4]; mean [SD] postbronchodilator FEV1, 65% [21%]; mean [SD] COPD Assessment Test score 25.6 [7.1]; mean [SD] SGRQ score, 59.6 [15.3]). There were no device-related and four procedure-related serious adverse events through 6 months, and there were none thereafter through 12 months. The most frequent nonserious, device- and/or procedure-related event through 6 months was mild hemoptysis in 47% (14 of 30) patients. Histologically, the mean goblet cell hyperplasia score was reduced by a statistically significant amount (P < 0.001). Significant changes from baseline to 6 months in COPD Assessment Test (mean, -7.9; median, -8.0; P = 0.0002) and SGRQ (mean, -14.6; median, -7.2; P = 0.0002) scores were observed, with similar observations through 12 months.Conclusions: This study provides the first clinical evidence of the feasibility, safety, and initial outcomes of bronchial rheoplasty in symptomatic patients with CB.Clinical trial registered with www.anzctr.org.au (ACTRN 12617000330347) and clinicaltrials.gov (NCT03107494).

Interventional Bronchoscopy.

For over 150 years, bronchoscopy, especially flexible bronchoscopy, has been a mainstay for airway inspection, the diagnosis of airway lesions, therapeutic aspiration of airway secretions, and transbronchial biopsy to diagnose parenchymal lung disorders. Its utility for the diagnosis of peripheral pulmonary nodules and therapeutic treatments besides aspiration of airway secretions, however, has been limited. Challenges to the wider use of flexible bronchoscopy have included difficulty in navigating to the lung periphery, the avoidance of vasculature structures when performing diagnostic biopsies, and the ability to biopsy a lesion under direct visualization. The last 10-15 years have seen major advances in thoracic imaging, navigational platforms to direct the bronchoscopist to lung lesions, and the ability to visualize lesions during biopsy. Moreover, multiple new techniques have either become recently available or are currently being investigated to treat a broad range of airway and lung parenchymal diseases, such as asthma, emphysema, and chronic bronchitis, or to alleviate recurrent exacerbations. New bronchoscopic therapies are also being investigated to not only diagnose, but possibly treat, malignant peripheral lung nodules. As a result, flexible bronchoscopy is now able to provide a new and expanding armamentarium of diagnostic and therapeutic tools to treat patients with a variety of lung diseases. This State-of-the-Art review succinctly reviews these techniques and provides clinicians an organized approach to their role in the diagnosis and treatment of a range of lung diseases.

Shape-sensing robotic-assisted bronchoscopy for pulmonary nodules: initial multicenter experience using the Ion™ Endoluminal System.

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.

Endoscopic Lung Volume Reduction in Relation to Body Mass Index in Patients with Severe Heterogeneous Emphysema.

BACKGROUND: In chronic obstructive pulmonary disease (COPD), body mass index (BMI) is significantly lower in the emphysema-dominant type. Endoscopic lung volume reduction (ELVR) is an innovative way of treating severe emphysema. However, the specific associations of low BMI values and outcomes of ELVR is not well-studied. OBJECTIVES: We evaluated associations between initial BMI and changes in major outcomes after endobronchial valve (EBV) placement in patients with heterogeneous severe emphysema. METHODS: In a retrospective cohort study, patients were divided into 2 groups based on their baseline BMI (higher BMI ≥21 kg/m2 [n = 18] and lower BMI <21 kg/m2 [n = 63]). Demographics, procedure data, pulmonary function test and 6-min-walk test (6MWT), dyspnea score (according to the modified Medical Research Council [mMRC] scale), BODE (BMI, airflow obstruction, dyspnea, exercise capacity) index, and complications were recorded. After 6 months, changes in variables (dWeight and dBMI) were recorded. RESULTS: Comparing the 2 groups, we found the following: a dWeight of -2.34 kg and +3.39 kg (p value <0.01) and a dBMI of -0.74 and +1.99 kg/m2, in the higher BMI and lower BMI group, respectively (p value <0.01). Changes in forced expiratory volume <1 s (FEV1), 6MWT, mMRC score, and BODE index were not statistically significant. The most common complication was pneumothorax. The lower BMI group experienced more complications than the higher BMI group (40 vs. 24%). CONCLUSION: Baseline BMI is relevant when selecting candidates for ELVR. Our results show that the COPD patients with a lower BMI gained a significant amount of weight, thus increasing their BMI after the procedure. The rate of complications was higher in the lower BMI group. These findings should alert physicians and encourage nutritional assessment in this population.

Performing Bronchoscopy in Times of the COVID-19 Pandemic: Practice Statement from an International Expert Panel.

These recommendations for physicians who perform bronchoscopy will help to protect those patients (un)-affected by the current COVID-19 pandemic, minimize the risk of transmission, and maintain clinical care for all patients.

Safety and Efficacy of the Tracheobronchial Bonastent: A Single-Center Case Series.

BACKGROUND: Tracheobronchial stents are widely used devices in interventional pulmonology; however, the current literature on the effectiveness and complication rates of the different types of stents is limited. OBJECTIVE: We report the largest case series of airway Bonastent placement and describe the efficacy and early (<30 days) and late (≥30 days) complication rates. METHODS: We performed a retrospective review of our prospectively collected database of patients who underwent therapeutic bronchoscopy with stent placement. All adult patients who had a tracheal/bronchial Bona-stent placed between July 1, 2017, and July 30, 2019, for any indication at our institution were included. The efficacy as well as intraoperative and short- and long-term complications of Bonastent placement were evaluated. RESULTS: Sixty Bonastents were placed in 50 patients. The etiology was malignant in 90% of the cases, while 2 patients had a tracheoesophageal fistula. All procedures were performed via rigid bronchoscopy. The most common location for stent placement was the bronchus intermedius, followed by the trachea, in 32 and 30% of the cases, respectively. Seventy percent of the patients (35/50) had improvement of respiratory symptoms within 30 days. Twenty-eight stents (48%) were removed at a mean of 74 days. Seventeen patients (34%) died within 30 days of stent placement. The overall complication rate was 54% (27/50 patients) at a mean follow-up of 111 days. The stent-related complication rate was 23.3% (14/60 cases) within <30 days and 53% (18/34 cases) at ≥30 days. CONCLUSIONS: The tracheobronchial Bonastent is effective for the treatment of patients with central airway obstruction and tracheoesophageal fistulae with an acceptable safety profile.

Efficacy of the Spiration Valve System in Patients with Severe Heterogeneous Emphysema: A Systematic Review and Meta-Analysis.

BACKGROUND: Spiration Valve System (SVS) is an alternative for patients with severe heterogeneous emphysema; however, data about efficacy from randomized controlled trials (RCT) are unclear. OBJECTIVES: To explore both efficacy and safety of SVS in patients with severe emphysema and hyperinflation. METHODS: We included PubMed, EMBASE, Coch-rane database. All searches were performed until August 2019. Only RCTs were included for analysis. Risk of bias was assessed using Cochrane risk of bias tool. A meta-analysis evaluated change in forced expiratory volume in 1 s (FEV1), 6-min walking test (6MWT), residual volume, modified medical research council (mMRC) and Saint George respiratory questionnaire (SGRQ), all-cause mortality, risk of pneumothorax, and risk of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Quality of the evidence was rated using GRADE approach. RESULTS: Four RCTs including 629 subjects were included. SVS showed an overall change of 0.03 L (-0.07 to 0.13, I2 = 90%) in the in FEV1 (L) and a 2.03% (-2.50 to 6.57, I2 = 96%) in the predicted FEV1 (%) compared to baseline; however, studies without collateral ventilation (CV) showed an improvement of 0.12 L (95% CI 0.09-0.015, I2 = 0%), This subgroup also reported better results in SGRQ -12.27 points (95% CI -15.84 to -8.70, I2 = 0%) and mMRC -0.54 (95% CI -0.74 to -0.33, I2 = 0%). We found no benefit in 6MWT mean difference = 4.56 m (95% CI -21.88 to 31.00, I2 = 73%). Relative risk of mortality was 2.54 (95% CI 0.81-7.96, I2 = 0%), for pneumothorax 3.3 (95% CI 0.61-18.12, I2 = 0%) and AECOPD 1.68 (95% CI 1.04-2.70, I2 = 0%). CONCLUSION: In patients with severe heterogeneous emphysema and hyperinflation without CV, SVS is an alternative that showed an improvement in pulmonary function, quality of life, and dyspnea score with an acceptable risk profile.

[How to interpret systematic reviews with multiple comparisons or network meta-analysis]. / Como interpretar una revisión sistemática con comparaciones múltiples o network metaanálisis.

Systematic reviews evaluating multiple interventions can be useful in different clinical situations. However, some concerns arise when more than two interventions are compared and there is a paucity of good quality randomized clinical trials. A novel statistical method based on indirect comparisons, called network meta-analysis (NMA), can be a useful approach to find a clinical answer when multiple interventions are evaluated for the same outcome or comparator. The aim of this review is to describe the main characteristics and provide a user guide for a critical analysis of NMA focusing on its three main domains, namely homogeneity, transitivity and consistency.

[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.