Lung Volume Reduction Coil Treatment in Chronic Obstructive Pulmonary Disease Patients with Homogeneous Emphysema: A Prospective Feasibility Trial

Background: In patients with heterogeneous emphysema, surgical and bronchoscopic lung volume reduction (LVR) treatments are available. However, for patients with homogeneous emphysema these treatments are hardly investigated and seem less effective. Bronchoscopic LVR coil treatment has been shown to be effective in patients with heterogeneous emphysema, but this treatment has not been exclusively investigated in homogeneous emphysema. Objectives: The aim of this study was to investigate the safety and efficacy of LVR coil treatment in patients with homogeneous emphysema. Methods: In this single-arm, open-label study, patients received a maximum of 12 LVR coils (PneumRx Inc., Mountain View, Calif., USA) in each upper lobe in two sequential procedures. Tests were performed at baseline and at 6 months. The primary endpoint was the improvement from baseline in 6-min walking distance (6MWD) after treatment. Results: Ten patients with severe airway obstruction and hyperinflation were treated. A median of 11 (range 10-12) coils were placed in each lung. Two chronic obstructive pulmonary disease exacerbations and one small pneumothorax were recorded as serious adverse events. At 6 months, 6MWD had improved from 289 to 350 m (p = 0.005); forced vital capacity from 2.17 to 2.55 liters (p = 0.047); residual volume from 5.04 to 4.44 liters (p = 0.007) and St. George's Respiratory Questionnaire from 63 to 48 points (p = 0.028). Conclusion: LVR coil treatment in homogeneous patients improves hyperinflation, airway resistance, exercise capacity and quality of life with an acceptable safety profile. The benefit of LVR coil treatment is not limited to patients with heterogeneous emphysema, and patients with homogenous emphysema can benefit as well.

[1]  P. Jones,et al.  The St George's Respiratory Questionnaire. , 1991, Respiratory medicine.

[2]  P. Jones,et al.  A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. , 1992, The American review of respiratory disease.

[3]  J. Stocks,et al.  Reference values for residual volume, functional residual capacity and total lung capacity. ATS Workshop on Lung Volume Measurements. Official Statement of The European Respiratory Society. , 1995, The European respiratory journal.

[4]  P. Jones,et al.  Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease , 1999, Thorax.

[5]  ATS statement: guidelines for the six-minute walk test. , 2002, American journal of respiratory and critical care medicine.

[6]  Steven Piantadosi,et al.  A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. , 2003, The New England journal of medicine.

[7]  W T Ulmer,et al.  New insights into physiology and pathophysiology by resistance-volume recordings. , 2004, Journal of physiology and pharmacology : an official journal of the Polish Physiological Society.

[8]  J. Hankinson,et al.  General considerations for lung function testing , 2005, European Respiratory Journal.

[9]  J. Hankinson,et al.  Standardisation of spirometry , 2005, European Respiratory Journal.

[10]  P. Jones.  St. George's Respiratory Questionnaire: MCID , 2005, COPD.

[11]  Cynthia D. Brown,et al.  Minimal Clinically Important Differences in the Six-Minute Walk Test and the Incremental Shuttle Walking Test , 2005, COPD.

[12]  T. Molen,et al.  Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire , 2006, Respiratory research.

[13]  E. Ingenito,et al.  Physiologic basis for improved pulmonary function after lung volume reduction. , 2008, Proceedings of the American Thoracic Society.

[14]  Bram van Ginneken,et al.  Robust Segmentation and Anatomical Labeling of the Airway Tree from Thoracic CT Scans , 2008, MICCAI.

[15]  B. van Ginneken,et al.  Automatic lung segmentation from thoracic computed tomography scans using a hybrid approach with error detection. , 2009, Medical physics.

[16]  M. Wahidi,et al.  Interventional Pulmonology a Multicenter Pilot Study of a Bronchial Valve for the Treatment of Severe Emphysema for Editorial Comment See P. 191 Severe Emphysema Treated with Bronchial Valves , 2022 .

[17]  F. Herth,et al.  Bronchoscopic lung volume reduction with a dedicated coil: a clinical pilot study , 2010, Therapeutic advances in respiratory disease.

[18]  B. Make,et al.  The minimal important difference of exercise tests in severe COPD , 2010, European Respiratory Journal.

[19]  A. Holland,et al.  Updating the minimal important difference for six-minute walk distance in patients with chronic obstructive pulmonary disease. , 2010, Archives of physical medicine and rehabilitation.

[20]  Max A. Viergever,et al.  Automatic Segmentation of Pulmonary Lobes Robust Against Incomplete Fissures , 2010, IEEE Transactions on Medical Imaging.

[21]  G. McLennan,et al.  A randomized study of endobronchial valves for advanced emphysema. , 2010, The New England journal of medicine.

[22]  E. Ingenito,et al.  Assessment of a novel lung sealant for performing endoscopic volume reduction therapy in patients with advanced emphysema , 2011, Expert review of medical devices.

[23]  Laura J. Smith.  Endobronchial valves for advanced emphysema , 2011, Thorax.

[24]  D. Slebos,et al.  Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial , 2011, The Lancet.

[25]  F. Herth,et al.  Bronchoscopic thermal vapour ablation therapy in the management of heterogeneous emphysema , 2011, European Respiratory Journal.

[26]  M. Saetta,et al.  Pathophysiology of the Small Airways in Chronic Obstructive Pulmonary Disease , 2012, Respiration.

[27]  E. Ingenito,et al.  Physiological Modeling of Responses to Upper Versus Lower Lobe Lung Volume Reduction in Homogeneous Emphysema , 2012, Front. Physio..

[28]  J. Gaughan,et al.  Total lung capacity by plethysmography and high-resolution computed tomography in COPD , 2012, International journal of chronic obstructive pulmonary disease.

[29]  F. Herth,et al.  Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema. , 2012, Chest.

[30]  H. Boezen,et al.  The minimal important difference for residual volume in patients with severe emphysema , 2012, European Respiratory Journal.

[31]  F. Herth,et al.  Radiological and clinical outcomes of using Chartis™ to plan endobronchial valve treatment , 2012, European Respiratory Journal.

[32]  S. Bicknell,et al.  Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. , 2013, The Lancet. Respiratory medicine.

[33]  F. Martinez,et al.  Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. , 2007, American journal of respiratory and critical care medicine.