A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM).

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Abstract

Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter study evaluating this treatment approach.

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Most cited references 30

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A randomized study of endobronchial valves for advanced emphysema.

Kevin L Kovitz, Geoffrey McLennan, … (2010)

Endobronchial valves that allow air to escape from a pulmonary lobe but not enter it can induce a reduction in lobar volume that may thereby improve lung function and exercise tolerance in patients with pulmonary hyperinflation related to advanced emphysema. We compared the safety and efficacy of endobronchial-valve therapy in patients with heterogeneous emphysema versus standard medical care. Efficacy end points were percent changes in the forced expiratory volume in 1 second (FEV1) and the 6-minute walk test on intention-to-treat analysis. We assessed safety on the basis of the rate of a composite of six major complications. Of 321 enrolled patients, 220 were randomly assigned to receive endobronchial valves (EBV group) and 101 to receive standard medical care (control group). At 6 months, there was an increase of 4.3% in the FEV1 in the EBV group (an increase of 1.0 percentage point in the percent of the predicted value), as compared with a decrease of 2.5% in the control group (a decrease of 0.9 percentage point in the percent of the predicted value). Thus, there was a mean between-group difference of 6.8% in the FEV1 (P=0.005). Roughly similar between-group differences were observed for the 6-minute walk test. At 12 months, the rate of the complications composite was 10.3% in the EBV group versus 4.6% in the control group (P=0.17). At 90 days, in the EBV group, as compared with the control group, there were increased rates of exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization (7.9% vs. 1.1%, P=0.03) and hemoptysis (6.1% vs. 0%, P=0.01). The rate of pneumonia in the target lobe in the EBV group was 4.2% at 12 months. Greater radiographic evidence of emphysema heterogeneity and fissure completeness was associated with an enhanced response to treatment. Endobronchial-valve treatment for advanced heterogeneous emphysema induced modest improvements in lung function, exercise tolerance, and symptoms at the cost of more frequent exacerbations of COPD, pneumonia, and hemoptysis after implantation. (Funded by Pulmonx; ClinicalTrials.gov number, NCT00129584.)

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Interpreting thresholds for a clinically significant change in health status in asthma and COPD.

Simon P. Jones (2002)

Health status (or Health-Related Quality of Life) measurement is an established method for assessing the overall efficacy of treatments for asthma and chronic obstructive pulmonary disease (COPD). Such measurements can indicate the potential clinical significance of a treatment's effect. This paper is concerned with methods of estimating the threshold of clinical significance for three widely used health status questionnaires for asthma and COPD: the Asthma Quality of Life Questionnaire, Chronic Respiratory Questionnaire and St George's Respiratory Questionnaire. It discusses the methodology used to obtain such estimates and shows that the estimates appear to be fairly reliable; ie. for a given questionnaire, similar estimates may be obtained in different studies. These empirically derived thresholds are all mean estimates with confidence intervals around them. The presence of these confidence intervals affects the way in which the thresholds may be used to draw inferences concerning the clinical relevance of clinical trial results. A new system of judging the magnitude of clinically significant results is proposed. Finally, an attempt is made to translate these thresholds into scenarios that illustrate what a clinically significant change with treatment may mean to an individual patient.

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The minimal important difference of exercise tests in severe COPD.

M.A. Puhan, D Chandra, Z Mosenifar … (2011)

Our aim was to determine the minimal important difference (MID) for 6-min walk distance (6MWD) and maximal cycle exercise capacity (MCEC) in patients with severe chronic obstructive pulmonary disease (COPD). 1,218 patients enrolled in the National Emphysema Treatment Trial completed exercise tests before and after 4-6 weeks of pre-trial rehabilitation, and 6 months after randomisation to surgery or medical care. The St George's Respiratory Questionnaire (domain and total scores) and University of California San Diego Shortness of Breath Questionnaire (total score) served as anchors for anchor-based MID estimates. In order to calculate distribution-based estimates, we used the standard error of measurement, Cohen's effect size and the empirical rule effect size. Anchor-based estimates for the 6MWD were 18.9 m (95% CI 18.1-20.1 m), 24.2 m (95% CI 23.4-25.4 m), 24.6 m (95% CI 23.4-25.7 m) and 26.4 m (95% CI 25.4-27.4 m), which were similar to distribution-based MID estimates of 25.7, 26.8 and 30.6 m. For MCEC, anchor-based estimates for the MID were 2.2 W (95% CI 2.0-2.4 W), 3.2 W (95% CI 3.0-3.4 W), 3.2 W (95% CI 3.0-3.4 W) and 3.3 W (95% CI 3.0-3.5 W), while distribution-based estimates were 5.3 and 5.5 W. We suggest a MID of 26 ± 2 m for 6MWD and 4 ± 1 W for MCEC for patients with severe COPD.

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Author and article information

Journal

Journal ID (iso-abbrev): Am. J. Respir. Crit. Care Med.

Title: American journal of respiratory and critical care medicine

Publisher: American Thoracic Society

ISSN (Electronic): 1535-4970

ISSN (Print): 1073-449X

Publication date (Electronic): December 15 2017

Volume: 196

Issue: 12

Affiliations

[1 ] 1 Royal Brompton Hospital and Imperial College London, London, United Kingdom.

[2 ] 2 Sherwood Forest Hospitals, NHS Foundation Trust, Nottinghamshire, United Kingdom.

[3 ] 3 Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.

[4 ] 4 Department of Thoracic Surgery, West of Scotland Regional Heart & Lung Centre, Golden Jubilee National Hospital, West Dunbartonshire, Scotland, United Kingdom.

[5 ] 5 Department of Cardiothoracic Surgery, University Hospital of Wales, Cardiff, United Kingdom.

[6 ] 6 Department of Pulmonology, AZ Delta, Menen, Belgium.

[7 ] 7 Department of Pulmonary Diseases, Skane University Hospital, Lund, Sweden.

[8 ] 8 Department of Pulmonary Diseases, Uppsala University Hospital, Uppsala, Sweden.

[9 ] 9 Service de Pneumologie A, Hôpital Bichat, Paris, France.

[10 ] 10 Clinique Universitaire de Pneumologie, Pôle Thorax et Vaisseaux, CHU Grenoble Alpes, Grenoble, France.

[11 ] 11 Department of Interventional Pneumology, Ruhrlandklinik, West German Lung Center, University Clinic Essen, Essen, Germany.

[12 ] 12 Sheffield Teaching Hospitals, NHS Foundation Trust, Sheffield, United Kingdom.

[13 ] 13 Charité Universitätsmedizin Berlin, Medizinische Klinik m. Schw. Infektiologie und Pneumologie, Campus Virchow, Berlin, Germany.

[14 ] 14 Service de Pneumologie et Réanimation, Unité d'Endoscopie Bronchique, Groupe Hospitalier Pitié Salpétrière, Paris, France.

[15 ] 15 Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg, Heidelberg, Germany.

[16 ] 16 Department of Pulmonary Diseases, Ghent University Hospital, Ghent, Belgium; and.

[17 ] 17 Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, FHU OncoAge, Service de Pneumologie, Nice, France.

Article

DOI: 10.1164/rccm.201707-1327OC

PubMed ID: 28885054

SO-VID: f9bced51-662b-4aff-9556-7a599d6687e7

History

Keywords: hyperinflation,lung volume reduction,chronic obstructive pulmonary disease,collateral ventilation,endobronchial valves

Data availability:

Keywords: hyperinflation, lung volume reduction, chronic obstructive pulmonary disease, collateral ventilation, endobronchial valves

A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM).

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Abstract

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Biomarkers for Inflammatory Lung Disease

Most cited references 30

A randomized study of endobronchial valves for advanced emphysema.

Interpreting thresholds for a clinically significant change in health status in asthma and COPD.

The minimal important difference of exercise tests in severe COPD.

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