Karin Klooster1, Arschang Valipour2, Charles-Hugo Marquette3, Jacques Boutros3, Hervé Mal4, Armelle Marceau4, Pallav L Shah5, Francesca Conway5, Gaëtan Deslée6, Arnaud Bourdin7, Christophe Pison8, Christian Grah9, Martin Hetzel10, Christian Schumann11, Romain Kessler12, Ralf-Harto Huebner13, Dirk Skowasch14, Kaid Darwiche15, Peter Hammerl16, Franz Stanzel17, Michaela Bezzi18, Hervé Dutau19, Felix J F Herth20, Dirk-Jan Slebos1. 1. Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 2. Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Floridsdorf, Austria. 3. Université Côte d'Azur, FHU OncoAge, CHU de Nice, Nice, France. 4. Hôpital Bichat - Claude Bernard, Paris, France. 5. Department of Respiratory Medicine, Royal Brompton Hospital, London, United Kingdom. 6. CHU de Reims, Reims, France. 7. CHU de Montpellier, Montpellier, France. 8. CHU de Grenoble, Grenoble, France. 9. Gemeinschaftskrankenhaus Havelhöhe GmbH, Berlin, Germany. 10. Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH, Stuttgart, Germany. 11. Klinikverbund Allgäu, Immenstadt, Immenstadt, Germany. 12. Nouvel Hôpital Civil, Strasbourg, France. 13. Charité Berlin, Berlin, Germany. 14. Universitätsklinkum Bonn, Bonn, Germany. 15. Department for Interventional Pneumology, Ruhrlandklinik - University Medicine Essen, Essen, Germany. 16. Lungenfachklinik Immenhausen, Immenhausen, Germany. 17. Lungenklinik Hemer, Hemer, Germany. 18. ASST Spedali Civili di Brescia, Brescia, Italy. 19. Hôpital Nord - APHM, Marseille, France. 20. Department of Internal Medicine, Pulmonary and Critical Care Medicine Thoraxklinik and Translational Lung Research Center Heidelberg University Heidelberg, Heidelberg, Germany.
Abstract
BACKGROUND: Bronchoscopic lung volume reduction using endobronchial coils is a new treatment for patients with severe emphysema. To date, the benefits have been modest and have been suggested to be much larger in patients with severe hyperinflation and nonmulti-comorbidity. OBJECTIVE: We aimed to evaluate the efficacy and safety of endobronchial coil treatment in a randomized multicenter clinical trial using optimized patient selection. METHOD: Patients with severe emphysema on HRCT scan with severe hyperinflation (residual volume [RV] ≥200% predicted and RV/total lung capacity [TLC] >55%) were randomized to coil treatment or control. Primary outcome measures were differences in the forced expiratory volume in 1 s (FEV1) and St George's Respiratory Questionnaire (SGRQ) total score at 6 months. RESULTS: Due to premature study termination, a total of 120 patients (age 63 ± 7 years, FEV1 29 ± 7% predicted, RV 251 ± 41% predicted, RV/TLC 67 ± 6%, and SGRQ 58 ± 13 points), instead of 210 patients, were randomized. At study termination, 91 patients (57 coil and 34 control) had 6-month results available. Analyses showed significantly greater improvements in favor of the coil group. The increase in FEV1 was greater in the coil group than that in the control group by + 10.3 [+4.7 to +16.0] % and in SGRQ by -10.6 [-15.9 to -5.4] points. At study termination, there were 5 (6.8%) deaths in the coil cohort reported. CONCLUSION: Despite early study termination, coil treatment compared to control results in a significant improvement in the lung function and quality of life benefits for up to 6 months in patients with emphysema and severe hyperinflation. These improvements were of clinical importance but were associated with a higher likelihood of serious adverse events.
BACKGROUND: Bronchoscopic lung volume reduction using endobronchial coils is a new treatment for patients with severe emphysema. To date, the benefits have been modest and have been suggested to be much larger in patients with severe hyperinflation and nonmulti-comorbidity. OBJECTIVE: We aimed to evaluate the efficacy and safety of endobronchial coil treatment in a randomized multicenter clinical trial using optimized patient selection. METHOD: Patients with severe emphysema on HRCT scan with severe hyperinflation (residual volume [RV] ≥200% predicted and RV/total lung capacity [TLC] >55%) were randomized to coil treatment or control. Primary outcome measures were differences in the forced expiratory volume in 1 s (FEV1) and St George's Respiratory Questionnaire (SGRQ) total score at 6 months. RESULTS: Due to premature study termination, a total of 120 patients (age 63 ± 7 years, FEV1 29 ± 7% predicted, RV 251 ± 41% predicted, RV/TLC 67 ± 6%, and SGRQ 58 ± 13 points), instead of 210 patients, were randomized. At study termination, 91 patients (57 coil and 34 control) had 6-month results available. Analyses showed significantly greater improvements in favor of the coil group. The increase in FEV1 was greater in the coil group than that in the control group by + 10.3 [+4.7 to +16.0] % and in SGRQ by -10.6 [-15.9 to -5.4] points. At study termination, there were 5 (6.8%) deaths in the coil cohort reported. CONCLUSION: Despite early study termination, coil treatment compared to control results in a significant improvement in the lung function and quality of life benefits for up to 6 months in patients with emphysema and severe hyperinflation. These improvements were of clinical importance but were associated with a higher likelihood of serious adverse events.
Authors: Jorine E Hartman; Nick H T Ten Hacken; Karin Klooster; H Marike Boezen; Mathieu H G de Greef; Dirk-Jan Slebos Journal: Eur Respir J Date: 2012-03-22 Impact factor: 16.671
Authors: Karin Klooster; Nick H T Ten Hacken; Ina Franz; Huib A M Kerstjens; Eva M van Rikxoort; Dirk-Jan Slebos Journal: Respiration Date: 2014-05-28 Impact factor: 3.580
Authors: Frank C Sciurba; Gerard J Criner; Charlie Strange; Pallav L Shah; Gaetane Michaud; Timothy A Connolly; Gaëtan Deslée; William P Tillis; Antoine Delage; Charles-Hugo Marquette; Ganesh Krishna; Ravi Kalhan; J Scott Ferguson; Michael Jantz; Fabien Maldonado; Robert McKenna; Adnan Majid; Navdeep Rai; Steven Gay; Mark T Dransfield; Luis Angel; Roger Maxfield; Felix J F Herth; Momen M Wahidi; Atul Mehta; Dirk-Jan Slebos Journal: JAMA Date: 2016 May 24-31 Impact factor: 56.272
Authors: Dirk-Jan Slebos; Joseph Cicenia; Frank C Sciurba; Gerard J Criner; Jorine E Hartman; Justin Garner; Gaëtan Deslée; Antoine Delage; Michael Jantz; Charles-Hugo Marquette; Charlie Strange; Umur Hatipoglu; Atul C Mehta; Adam S LaPrad; Gerald Schmid-Bindert; Felix J F Herth; Pallav L Shah Journal: Chest Date: 2019-02-21 Impact factor: 9.410
Authors: Dirk-Jan Slebos; Jorine E Hartman; Karin Klooster; Stefan Blaas; Gaetan Deslee; Wolfgang Gesierich; Juergen Hetzel; Martin Hetzel; William McNulty; Samuel V Kemp; Romain Kessler; Sylvie Leroy; Franz Stanzel; Christian Witt; Zaid Zoumot; Felix J F Herth; Pallav L Shah Journal: Respiration Date: 2015-06-25 Impact factor: 3.580
Authors: Felix J F Herth; Dirk-Jan Slebos; Gerard J Criner; Arschang Valipour; Frank Sciurba; Pallav L Shah Journal: Respiration Date: 2019-03-05 Impact factor: 3.580
Authors: Felix J F Herth; Dirk-Jan Slebos; Pallav L Shah; Martin Hetzel; Gerald Schmid-Bindert; Adam S LaPrad; Gaëtan Deslée; Arschang Valipour Journal: Respiration Date: 2019-11-19 Impact factor: 3.580
Authors: Jorrit B A Welling; Jorine E Hartman; Nick H T Ten Hacken; Karin Klooster; Dirk-Jan Slebos Journal: Eur Respir J Date: 2015-10-22 Impact factor: 16.671
Authors: Sharyn A Roodenburg; Jorine E Hartman; Gaëtan Deslée; Felix J F Herth; Karin Klooster; Frank C Sciurba; Pallav L Shah; Arschang Valipour; Zaid Zoumot; Dirk-Jan Slebos Journal: Respiration Date: 2022-04-11 Impact factor: 3.966
Authors: C F N Koegelenberg; R N van Zyl-Smit; K Dheda; B W Allwood; M J Vorster; D Plekker; D-J Slebos; K Klooster; P L Shah; F J F Herth Journal: Afr J Thorac Crit Care Med Date: 2022-06-20