ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Long-Term Follow-up of Severe Emphysema Patients Treated with Zephyr Valves in the Multicenter, Randomized TRANSFORM Study
Session Title
A6 - A006 HOT TAKES FROM CLINICAL TRIALS IN LUNG DISEASE
Abstract
A1023 - Long-Term Follow-up of Severe Emphysema Patients Treated with Zephyr Valves in the Multicenter, Randomized TRANSFORM Study
Author Block: D. Slebos1, M. Kornaszewska2, S. Kemp3, A. Kirk4, K. Carron5, H. mal6, C. Pison7, N. Downer8, K. Darwiche9, J. Rao10, R. Hubner11, V. Trosini-Desert12, R. Eberhardt13, E. Derom14, C. Marquette15, N. S. Shargill16, P. L. Shah17; 1Pulmonary Diseases, University Medical Center Groningen, Groningen, Netherlands, 2Pulmonary Diseases, University Hospital of Wales, Cardiff, United Kingdom, 3Respiratory Medicine, Royal Brompton Hospital, London, United Kingdom, 4Pulmonary Diseases, West of Scotland Regional Heart & Lung Centre, Clydebank, United Kingdom, 5Pulmonary Diseases, AZ Delta, Menen, Belgium, 6Pulmonary Diseases, Hôpital Bichat, Paris, France, 7Pôle Thorax et Vaisseaux, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France, 8Pulmonary Diseases, King’s Mill Hospital, Sutton-in-Ashfield, United Kingdom, 9Ruhrlandklinik Westdeutches Lungenzentrum, Essen, Germany, 10Pulmonary Diseases, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom, 11Berlin-Charité Charité Campus Virchow-Klinikum, Berlin, Germany, 12Pulmonary Diseases, Unité d'Endoscopie bronchique Groupe Hospitalier Pitié Salpétrière, Paris, France, 13Pulmonary Diseases, Thoraxklinik am Universitäts klinikum Heidelberg, Heidelberg, Germany, 14Univ Hosp Ghent, Ghent, Belgium, 15Pulmonary Diseases, Hospitalier Universitaire Service de Pneumologie Hôpital Pasteur, Nice, France, 16Pulmonx Corporation, Redwood City, CA, United States, 17Royal Brompton Hospital, London, United Kingdom.
Background: Six-month outcomes in the TRANSFORM Study, the first multicenter RCT evaluating the effectiveness of Zephyr Valves in patients with heterogeneous emphysema and prospectively identified for absence of collateral ventilation in target lobe have been reported1. Zephyr valve treated patients were followed out to 24-months.
Aims and Objectives: Determine the long-term clinical outcomes and safety profile of Zephyr Valve treated patients out to 24-months and long-term results have not been previously reported.
Methods: 97 patients (58Male/39Female; mean age, 64.3±7.4yrs) with hyperinflation and severe heterogeneous emphysema confirmed by quantitative HRCT and FEV1, 30.5±8.9 % pred., RV, 246.6±48.5% pred.; and TLC, 138.4±17.0 % pred. were randomized (2:1) to Zephyr Valve treatment plus optimal medical management (n=65) or optimal medical management alone (n=32) after confirmation of absence of collateral ventilation using Chartis. Control group patients exited the study after the 6-month evaluation (data previously reported1), and Zephyr Valve treated patients were followed out to 24-months.
Results: Patients with complete data (no imputations) at 12-months (n=48), 18-months (n=40), and 24-months (n=39) were included in the analysis. Clinically and statistically significant improvements over Baseline were maintained out to 18 months for FEV1, SGRQ, 6MWD, RV and BODE Index, and for FEV1 (percent change), SGRQ, and RV at 24-months (see table below). During the period beyond 6-months out to 24-months the most common adverse event was COPD exacerbation. There were 8 deaths during the 6- to 24-month period that were all deemed to be “Not related” to the Zephyr Valves (cardiac arrest, 3; myocardial infarction, 1; pneumonia, 2; end stage respiratory disease, 1; and hemoptysis in contralateral lung, 1).
Conclusions: Zephyr Valve treatment in patients with severe heterogenous emphysema provides durable reduction in hyperinflation out to at least 24-months with resultant improvements in lung function, quality of life and exercise capacity out to at least 18-months, and for lung function and quality of life out to at least 24-months with an acceptable safety profile. These improvements in clinical outcomes are contrasted by an expected decrease in these measures over 24 months given the degenerative nature of this disease.
Reference: Kemp S et al. Am J Respir Crit Care Med. 2017; 196(12): 1535-1543.
Author Block: D. Slebos1, M. Kornaszewska2, S. Kemp3, A. Kirk4, K. Carron5, H. mal6, C. Pison7, N. Downer8, K. Darwiche9, J. Rao10, R. Hubner11, V. Trosini-Desert12, R. Eberhardt13, E. Derom14, C. Marquette15, N. S. Shargill16, P. L. Shah17; 1Pulmonary Diseases, University Medical Center Groningen, Groningen, Netherlands, 2Pulmonary Diseases, University Hospital of Wales, Cardiff, United Kingdom, 3Respiratory Medicine, Royal Brompton Hospital, London, United Kingdom, 4Pulmonary Diseases, West of Scotland Regional Heart & Lung Centre, Clydebank, United Kingdom, 5Pulmonary Diseases, AZ Delta, Menen, Belgium, 6Pulmonary Diseases, Hôpital Bichat, Paris, France, 7Pôle Thorax et Vaisseaux, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France, 8Pulmonary Diseases, King’s Mill Hospital, Sutton-in-Ashfield, United Kingdom, 9Ruhrlandklinik Westdeutches Lungenzentrum, Essen, Germany, 10Pulmonary Diseases, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom, 11Berlin-Charité Charité Campus Virchow-Klinikum, Berlin, Germany, 12Pulmonary Diseases, Unité d'Endoscopie bronchique Groupe Hospitalier Pitié Salpétrière, Paris, France, 13Pulmonary Diseases, Thoraxklinik am Universitäts klinikum Heidelberg, Heidelberg, Germany, 14Univ Hosp Ghent, Ghent, Belgium, 15Pulmonary Diseases, Hospitalier Universitaire Service de Pneumologie Hôpital Pasteur, Nice, France, 16Pulmonx Corporation, Redwood City, CA, United States, 17Royal Brompton Hospital, London, United Kingdom.
Background: Six-month outcomes in the TRANSFORM Study, the first multicenter RCT evaluating the effectiveness of Zephyr Valves in patients with heterogeneous emphysema and prospectively identified for absence of collateral ventilation in target lobe have been reported1. Zephyr valve treated patients were followed out to 24-months.
Aims and Objectives: Determine the long-term clinical outcomes and safety profile of Zephyr Valve treated patients out to 24-months and long-term results have not been previously reported.
Methods: 97 patients (58Male/39Female; mean age, 64.3±7.4yrs) with hyperinflation and severe heterogeneous emphysema confirmed by quantitative HRCT and FEV1, 30.5±8.9 % pred., RV, 246.6±48.5% pred.; and TLC, 138.4±17.0 % pred. were randomized (2:1) to Zephyr Valve treatment plus optimal medical management (n=65) or optimal medical management alone (n=32) after confirmation of absence of collateral ventilation using Chartis. Control group patients exited the study after the 6-month evaluation (data previously reported1), and Zephyr Valve treated patients were followed out to 24-months.
Results: Patients with complete data (no imputations) at 12-months (n=48), 18-months (n=40), and 24-months (n=39) were included in the analysis. Clinically and statistically significant improvements over Baseline were maintained out to 18 months for FEV1, SGRQ, 6MWD, RV and BODE Index, and for FEV1 (percent change), SGRQ, and RV at 24-months (see table below). During the period beyond 6-months out to 24-months the most common adverse event was COPD exacerbation. There were 8 deaths during the 6- to 24-month period that were all deemed to be “Not related” to the Zephyr Valves (cardiac arrest, 3; myocardial infarction, 1; pneumonia, 2; end stage respiratory disease, 1; and hemoptysis in contralateral lung, 1).
Conclusions: Zephyr Valve treatment in patients with severe heterogenous emphysema provides durable reduction in hyperinflation out to at least 24-months with resultant improvements in lung function, quality of life and exercise capacity out to at least 18-months, and for lung function and quality of life out to at least 24-months with an acceptable safety profile. These improvements in clinical outcomes are contrasted by an expected decrease in these measures over 24 months given the degenerative nature of this disease.
Reference: Kemp S et al. Am J Respir Crit Care Med. 2017; 196(12): 1535-1543.
