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

Asma; Broncoscòpia; Termoplàstia bronquialAsma; Broncoscopia; Termoplastia bronquialAsthma; Bronchoscopy; Bronchial ThermoplastyObjectives: 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.This study was sponsored by Boston Scientific Corporation, Marlborough, MA, USA

Espectrometría de impedancia eléctrica en tejido pulmonar

Las biopsias de pulmón son necesarias para el estudio de diversas enfermedades pulmonares. Este es un procedimiento agresivo y tiene la dificultad añadida de conocer la ubicación exacta de la toma de muestras. El método de detección de tejido mediante bioimpedancia eléctrica podría suponer un sistema guía más fiable dado que es capaz de identificar regiones con diferentes propiedades histológicas. Se evalúa la efectividad de este sistema obteniendo datos de impedancia en distintas localizaciones de pulmones en pacientes, mediante el procedimiento de broncoscopia. Por medio de un posterior procesado de señales se obtienen diferencias significativas entre distintos grupos de tejidos.Postprint (published version

Minimally invasive lung tissue differentiation using electrical impedance spectroscopy: a comparison of the 3- and 4-electrode methods

Multiple imaging techniques are used for the diagnosis of lung diseases. The choice of a technique depends on the suspected diagnosis. Computed tomography (CT) of the thorax and positron emission tomography (PET) are imaging techniques used for the detection, characterization, staging and follow-up of lung cancer, and these techniques use ionizing radiation and are radiologist-dependent. Electrical impedance spectroscopy (EIS) performed through a bronchoscopic process could serve as a minimally invasive non-ionizing method complementary to CT and PET to characterize lung tissue. The aim of this study was to analyse the feasibility and ability of minimally invasive EIS bioimpedance measures to differentiate among healthy lung, bronchial and neoplastic lung tissues through bronchoscopy using the 3- and 4-electrode methods. Tissue differentiation was performed in 13 patients using the 4-electrode method (13 healthy lung, 12 bronchial and 3 neoplastic lung tissues) and the 3-electrode method (9 healthy lung, 10 bronchial and 2 neoplastic lung tissues). One-way analysis of variance (ANOVA) showed a statistically significant difference (P < 0.001) between bronchial and healthy lung tissues for both the 3- and 4-electrode methods. The 3-electrode method seemed to differentiate cancer types through changes in the cellular structures of the tissues by both the reactance (Xc) and the resistance (R). Minimally invasive measurements obtained using the 3-electrode method seem to be most suitable for differentiating between healthy and bronchial lung tissues. In the future, EIS using the 3-electrode method could be a method complementary to PET/CT and biopsy in lung pathology diagnosis.Peer ReviewedPostprint (author's final draft

Using temporal electrical impedance spectroscopy measures to differentiate lung pathologies with the 3-electrode method

Minimally invasive lung bioimpedance measurements could serve in the future diagnosis of lung pathologies complementing biopsies and imaging techniques. Through the electrical impedance spectroscopy (EIS) technique using the 3-electrode method, distinction of lung pathologies could be possible depending on the state of the tissue. Since now, only averaged information has been used for the analysis of bioimpedance data in lungs. The aim of this study is to use temporal information to evaluate changes in the impedance signal due to the mechanism of ventilation and perfusion produced by the lungs. Preliminary results show: 1) correlation between ventilation and perfusion with the bioimpedance signal and 2) changes in the amplitude of the bioimpedance time signal depending on the pathology. As conclusion, together with cycled averaged data, temporal data could be useful for lung pathologies distinction.Postprint (published version

Differentiation using minimally-invasive bioimpedance measurements of healthy and pathological lung tissue through bronchoscopy

Purpose: To use minimally-invasive transcatheter electrical impedance spectroscopy measurements for tissue differentiation among healthy lung tissue and pathologic lung tissue from patients with different respiratory diseases (neoplasm, fibrosis, pneumonia and emphysema) to complement the diagnosis at real time during bronchoscopic procedures. Methods: Multi-frequency bioimpedance measurements were performed in 102 patients. The two most discriminative frequencies for impedance modulus (|Z|), phase angle (PA), resistance (R) and reactance (Xc) were selected based on the maximum mean pair-wise Euclidean distances between paired groups. One-way ANOVA for parametric variables and Kruskal–Wallis for non-parametric data tests have been performed with post-hoc tests. Discriminant analysis has also been performed to find a linear combination of features to separate among tissue groups. Results: We found statistically significant differences for all the parameters between: neoplasm and pneumonia (p¿¿0.05) are found between neoplasm and fibrosis; fibrosis and pneumonia; and between healthy lung tissue and emphysema. Conclusion: The application of minimally-invasive electrical impedance spectroscopy measurements in lung tissue have proven to be useful for tissue differentiation between those pathologies that leads increased tissue and inflammatory cells and those ones that contain more air and destruction of alveolar septa, which could help clinicians to improve diagnosis.Peer ReviewedPostprint (published version

Effect of calibration for tissue differentiation between healthy and neoplasm lung using minimally invasive electrical impedance spectroscopy

his study proposes a calibration method and analyses the effect of this calibration in lung measures, using minimally invasive electrical impedance spectroscopy with the 3-electrode method, for tissue differentiation between healthy and neoplasm lung tissue. Tissue measurements were performed in 99 patients [54 healthy tissue and 15 neoplastic tissue samples obtained] with an indicated bronchoscopy. Statistically significant difference (P < 0.001) were found between healthy lung tissue and neoplasm lung tissue in bioimpedance parameters. The calibration of the bioimpedance measures with respect to a measure performed in bronchi reduces the inter-patient dispersion, increasing the sensitivity, decreasing the specificity and increasing the area below the ROC curve for three out of four impedance-derived estimators. Results also show that there are no significant differences between healthy lung tissue among smoker, non-smoker and ex-smoker samples, which was initially stated as a possible cause of EIS measurement dispersion in lungs.Peer ReviewedPostprint (published version

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

Mixed Th2 and non-Th2 inflammatory pattern in the asthma-COPD overlap : a network approach

Altres ajuts: The authors are grateful to all the patients who participated in the study. A number of investigators contributed to the study logistics and they are listed in the Supplementary materials. The project was endorsed by the COPD and Asthma Research Board (PII de EPOC y asma) of the Spanish Society of Pneumology and Thoracic Surgery (SEPAR).The asthma-chronic obstructive pulmonary disease (COPD) overlap (ACO) is a clinical condition that combines features of those two diseases, and that is difficult to define due to the lack of understanding of the underlying mechanisms. Determining systemic mediators may help clarify the nature of inflammation in patients with ACO. We aimed at investigating the role and interaction of common markers of systemic inflammation (IL-6, IL-8, and tumor necrosis factor-α), Th2-related markers (periostin, IL-5, and IL-13), and IL-17 in asthma, COPD, and ACO. This is a cross-sectional study of patients aged ≥40 years with a post-bronchodilator forced expiratory volume in the first second/forced vital capacity 10 pack-years in a patient with a previous diagnosis of asthma or by the presence of eosinophilia in a patient with a previous diagnosis of COPD. Clinical, functional, and inflammatory parameters were compared between categories using discriminant and network analysis. In total, 109 ACO, 89 COPD, and 94 asthma patients were included. Serum levels (median [interquartile range]) of IL-5 were higher in asthma patients than in COPD patients (2.09 [0.61-3.57] vs 1.11 [0.12-2.42] pg/mL, respectively; p =0.03), and IL-8 levels (median [interquartile range]) were higher in COPD patients than in asthma patients (9.45 [6.61-13.12] vs 7.03 [4.69-10.44] pg/mL, respectively; p <0.001). Their values in ACO were intermediate between those in asthma and in COPD. Principal component and network analysis showed a mixed inflammatory pattern in ACO in between asthma and COPD. IL-13 was the most connected node in the network, with different weights among the three conditions. Asthma and COPD are two different inflammatory conditions that may overlap in some patients, leading to a mixed inflammatory pattern. IL-13 could be central to the regulation of inflammation in these conditions

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

Funding This study was sponsored by Boston Scientific Corporation, Marlborough, MA, USA.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

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 cen‑ tral 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 satisfed 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 frst procedure and from the 9th procedure more than 80% of the scores exceeded the 80/100 score