Nathaniel Marchetti1, Theresa Kaufman1, Divay Chandra2, Felix J Herth3, Pallav L Shah4, Dirk-Jan Slebos5, Chandra Dass1, Stephen Bicknell6, Stefan H Blaas7, Michael Pfeifer7, Franz Stanzell8, Christian Witt9, Gaetan Deslee10, Wolfgang Gesierich11, Martin Hetzel12, Romain Kessler13, Sylvie Leroy14, Juergen Hetzel15, Frank C Sciurba2, Gerard J Criner1. 1. Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania. 2. University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 3. Thoraxklinik, University of Heidelberg, Heidelberg, Germany. 4. The National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, United Kingdom. 5. University Medical Center Groningen, University of Groningen, The Netherlands. 6. Gartnaval General Hospital, Glasgow, Scotland. 7. Klinikum Donaustauf, Donaustauf, Germany. 8. Lungenklinik, Hemer, Germany. 9. Campus Charité Mitte, Berlin, Germany. 10. Service de Pneumologie Hôpital Maison Blanche, INSERM 903, Reims, France. 11. Asklepios-Fachkliniken, Muenchen-Gauting, Germany. 12. Krankenhaus von Roten Kreuz, Stuttgart, Germany. 13. CHU de Strasbourg - NHC, Strasbourg, France. 14. FHU OncoAge Côte d'Azur University, Nice, France. 15. Department of Internal Medicine II-Pneumology, University Hospital, Teubingen, Germany.
Abstract
Rationale: Bronchoscopic lung volume reduction utilizing shape-memory nitinol endobronchial coils (EBC) may be safer and more effective in severely hyperinflated homogeneous emphysema compared to medical therapy or lung volume reduction surgery (LVRS). Methods: The effect of bilateral EBC in patients with homogeneous emphysema on spirometry, lung volumes and survival was compared to patients with homogeneous emphysema randomized in the National Emphysema Treatment Trial (NETT) to LVRS or medical therapy. NETT participants were selected to match EBC participants in age, baseline spirometry, and gender. Outcomes were compared from baseline, at 6 and 12 months. Results: There were no significant baseline differences in gender in the EBC, NETT-LVRS or medical treatment patients. At baseline no differences existed between EBC and NETT-LVRS patients in forced expiratory volume in 1 second ( FEV1) or total lung capacity (TLC) %-predicted; residual volume (RV) and diffusing capacity of the lung for carbon monoxide (DLco) %-predicted were higher in the EBC group compared to NETT-LVRS (p < 0.001). Compared to the medical treatment group, EBC produced greater improvements in FEV1 and RV but not TLC at 6 months. FEV1 and RV in the EBC group remained significantly improved at 12-months compared to the medical treatment group. While all 3 therapies improved quality of life, survival at 12 months with EBC or medical therapy was greater than NETT-LVRS. Conclusion:EBC may be a potential therapeutic option in patients with severe homogeneous emphysema and hyperinflation who are already receiving optimal medical treatment.
RCT Entities:
Rationale: Bronchoscopic lung volume reduction utilizing shape-memory nitinol endobronchial coils (EBC) may be safer and more effective in severely hyperinflated homogeneous emphysema compared to medical therapy or lung volume reduction surgery (LVRS). Methods: The effect of bilateral EBC in patients with homogeneous emphysema on spirometry, lung volumes and survival was compared to patients with homogeneous emphysema randomized in the National Emphysema Treatment Trial (NETT) to LVRS or medical therapy. NETT participants were selected to match EBCparticipants in age, baseline spirometry, and gender. Outcomes were compared from baseline, at 6 and 12 months. Results: There were no significant baseline differences in gender in the EBC, NETT-LVRS or medical treatment patients. At baseline no differences existed between EBC and NETT-LVRS patients in forced expiratory volume in 1 second ( FEV1) or total lung capacity (TLC) %-predicted; residual volume (RV) and diffusing capacity of the lung for carbon monoxide (DLco) %-predicted were higher in the EBC group compared to NETT-LVRS (p < 0.001). Compared to the medical treatment group, EBC produced greater improvements in FEV1 and RV but not TLC at 6 months. FEV1 and RV in the EBC group remained significantly improved at 12-months compared to the medical treatment group. While all 3 therapies improved quality of life, survival at 12 months with EBC or medical therapy was greater than NETT-LVRS. Conclusion:EBC may be a potential therapeutic option in patients with severe homogeneous emphysema and hyperinflation who are already receiving optimal medical treatment.
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