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

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          Abstract

          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 FEV 1, 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 (NCT 03107494).

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          Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function.

          Prescott Woodruff, R. Barr, Eugene G. Bleecker … (2016)
          Currently, the diagnosis of chronic obstructive pulmonary disease (COPD) requires a ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) of less than 0.70 as assessed by spirometry after bronchodilator use. However, many smokers who do not meet this definition have respiratory symptoms.
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            Chronic bronchitis and chronic obstructive pulmonary disease.

            Victor Kim, Gerard J. Criner (2013)
            Chronic bronchitis (CB) is a common but variable phenomenon in chronic obstructive pulmonary disease (COPD). It has numerous clinical consequences, including an accelerated decline in lung function, greater risk of the development of airflow obstruction in smokers, a predisposition to lower respiratory tract infection, higher exacerbation frequency, and worse overall mortality. CB is caused by overproduction and hypersecretion of mucus by goblet cells, which leads to worsening airflow obstruction by luminal obstruction of small airways, epithelial remodeling, and alteration of airway surface tension predisposing to collapse. Despite its clinical sequelae, little is known about the pathophysiology of CB and goblet cell hyperplasia in COPD, and treatment options are limited. In addition, it is becoming increasingly apparent that in the classic COPD spectrum, with emphysema on one end and CB on the other, most patients lie somewhere in the middle. It is known now that many patients with severe emphysema can develop CB, and small airway pathology has been linked to worse clinical outcomes, such as increased mortality and lesser improvement in lung function after lung volume reduction surgery. However, in recent years, a greater understanding of the importance of CB as a phenotype to identify patients with a beneficial response to therapy has been described. Herein we review the epidemiology of CB, the evidence behind its clinical consequences, the current understanding of the pathophysiology of goblet cell hyperplasia in COPD, and current therapies for CB.
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              Incidence of chronic obstructive pulmonary disease in a cohort of young adults according to the presence of chronic cough and phlegm.

              Isa Cerveri, Benedicte Leynaert, Josep M. Antó … (2007)
              The few prospective studies aimed at assessing the incidence of chronic obstructive pulmonary disease (COPD) in relation to the presence of chronic cough/phlegm have produced contrasting results. To assess the incidence of COPD in a cohort of young adults and to test whether chronic cough/phlegm and dyspnea are independent predictors of COPD. An international cohort of 5,002 subjects without asthma (ages 20-44 yr) with normal lung function (FEV(1)/FVC ratio >/= 70%) from 12 countries was followed from 1991-2002 in the frame of the European Community Respiratory Health Survey II. Incident cases of COPD were those who had an FEV(1)/FVC ratio less than 70% at the end of the follow-up, but did not report having had a doctor diagnose asthma during the follow-up. The incidence rate of COPD was 2.8 cases/1,000/yr (95% confidence interval [CI], 2.3-3.3). Chronic cough/phlegm was an independent and statistically significant predictor of COPD (incidence rate ratio [IRR], 1.85; 95% CI, 1.17-2.93) after adjusting for smoking habits and other potential confounders, whereas dyspnea was not associated with the disease (IRR = 0.98; 95% CI, 0.64-1.50). Subjects who reported chronic cough/phlegm both at baseline and at the follow-up had a nearly threefold-increased risk of developing COPD with respect to asymptomatic subjects (IRR = 2.88; 95% CI, 1.44-5.79). The incidence of COPD is substantial even in young adults. The presence of chronic cough/phlegm identifies a subgroup of subjects with a high risk of developing COPD, independently of smoking habits.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Am J Respir Crit Care Med
                Journal ID (iso-abbrev): Am. J. Respir. Crit. Care Med
                Journal ID (publisher-id): ajrccm
                Title: American Journal of Respiratory and Critical Care Medicine
                Publisher: American Thoracic Society
                ISSN (Print): 1073-449X
                ISSN (Electronic): 1535-4970
                Publication date (Print and electronic): 1 September 2020
                Publication date (Electronic): 1 September 2020
                Publication date (Print): 1 September 2020
                Publication date PMC-release: 1 September 2020
                Volume: 202
                Issue: 5
                Pages: 681-689
                Affiliations
                [ 1 ]Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Vienna, Austria
                [ 2 ]Division of Pulmonary Medicine, German Clinic of Santiago, Chile
                [ 3 ]Department of Pulmonary Medicine, Mayo Clinic, Jacksonville, Florida
                [ 4 ]MQ Health, Macquarie University Hospital, Sydney, New South Wales, Australia
                [ 5 ]Department of Medicine, University of Melbourne, Parkville, Victoria, Australia
                [ 6 ]Department of Respiratory Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia
                [ 7 ]Department of Respiratory Medicine, Alfred Hospital, Melbourne, Australia
                [ 8 ]Medstar Franklin Square Medical Center, Baltimore, Maryland; and
                [ 9 ]Gala Therapeutics, Menlo Park, California
                Author notes
                Correspondence and requests for reprints should be addressed to Arschang Valipour, M.D., Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Clinic Floridsdorf, Brünnerstrasse 68, 1210 Wien, Vienna, Austria. E-mail: arschang.valipour@ 123456wienkav.at .
                Article
                Publisher-manuscript ID: 201908-1546OC
                DOI: 10.1164/rccm.201908-1546OC
                PMC ID: 7462406
                PubMed ID: 32407638
                SO-VID: 4af20692-9e65-4008-b06f-089547782a29
                Copyright © Copyright © 2020 by the American Thoracic Society
                License:

                This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 ( http://creativecommons.org/licenses/by-nc-nd/4.0/). For commercial usage and reprints, please contact Diane Gern ( dgern@ 123456thoracic.org ).

                History
                Date received : 08 August 2019
                Date accepted : 13 May 2020
                Related
                Page count
                Figures: 4, Tables: 4, Pages: 9
                Categories
                Subject: Original Articles
                Subject: Chronic Obstructive Pulmonary Disease

                Keywords: chronic obstructive pulmonary disease; obstructive, lung diseases,respiratory tract diseases,bronchial diseases,pulsed electric field
                Data availability:
                Keywords: chronic obstructive pulmonary disease; obstructive, lung diseases, respiratory tract diseases, bronchial diseases, pulsed electric field

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