Dirk-Jan Slebos1, Joseph Cicenia2, Frank C Sciurba3, Gerard J Criner4, Jorine E Hartman5, Justin Garner6, Gaëtan Deslée7, Antoine Delage8, Michael Jantz9, Charles-Hugo Marquette10, Charlie Strange11, Umur Hatipoglu2, Atul C Mehta2, Adam S LaPrad12, Gerald Schmid-Bindert13, Felix J F Herth14, Pallav L Shah15. 1. Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. Electronic address: d.j.slebos@umcg.nl. 2. Cleveland Clinic Foundation, Cleveland, OH. 3. University of Pittsburgh School of Medicine, Pittsburgh, PA. 4. Lewis Katz School of Medicine at Temple University, Philadelphia, PA. 5. Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 6. Royal Brompton Hospital and Chelsea and Westminster Hospital, London, UK. 7. University Hospital of Reims, INSERM U1250, Reims, France. 8. Quebec Heart and Lung Institute, Quebec City, QC, Canada. 9. University of Florida, Gainesville, FL. 10. Universite Cote d'Azur, IRCAN, ONCOAGE, Nice, France. 11. Medical University of South Carolina, Charleston, SC. 12. PneumRx, Inc., a BTG International group company, Santa Clara, CA. 13. PneumRx GmbH, a BTG International group company, Düsseldorf, Germany; Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany. 14. Thoraxklinik and Translational Lung Research Center, University of Heidelberg, Heidelberg, Germany. 15. Royal Brompton Hospital and Chelsea and Westminster Hospital, London, UK; National Heart and Lung Institute, Imperial College London, London, UK.
Abstract
BACKGROUND: The Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) trial reported improvements in quality of life, pulmonary function, and exercise performance following endobronchial coil treatment. OBJECTIVES: The purpose of this post hoc analysis was to identify baseline predictors, including quantitative CT measures, that identify patients most likely to significantly benefit from endobronchial coil therapy. METHODS: Quantitative CT analysis by an independent radiology laboratory and a qualitative evaluation by five blinded experts of the baseline thoracic CT imaging were performed. Univariate and multivariate logistic regression analyses were performed to elucidate characteristics associated with clinical response. RESULTS: In total, 125 patients underwent coil treatment and had evaluable 12-month follow-up results. Of these, 78 patients received treatment of lobes with the highest emphysematous destruction determined by quantitative CT analysis (quantitative visual match [QVM]+), and 47 received treatment in at least one lobe that was not the most destroyed (QVM-). From the 78 patients with QVM+ treatment, a subgroup of 50 patients (64%) was identified with baseline residual volume > 200% predicted, emphysema score > 20% low attenuation area, and absence of airway disease. In this subgroup, greater lobar residual volume reduction in the treated lobes was achieved, which was associated with significant mean ± SE improvement in FEV1 (15.2 ± 3.1%), St. George's Respiratory Questionnaire (-12 ± 2 points), and residual volume (-0.57 ± 0.13 L). DISCUSSION: This post hoc analysis found that both significant hyperinflation (residual volume ≥ 200% predicted) and CT analysis are critical for patient selection and treatment planning for endobronchial coil therapy. Quantitative CT analysis is important to identify optimal lobar treatment and to exclude patients with insufficient emphysema (< 20% low attenuation area), whereas visual assessment identifies patients with signs of airway disease associated with worse outcomes. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01608490; URL: www.clinicaltrials.gov.
RCT Entities:
BACKGROUND: The Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) trial reported improvements in quality of life, pulmonary function, and exercise performance following endobronchial coil treatment. OBJECTIVES: The purpose of this post hoc analysis was to identify baseline predictors, including quantitative CT measures, that identify patients most likely to significantly benefit from endobronchial coil therapy. METHODS: Quantitative CT analysis by an independent radiology laboratory and a qualitative evaluation by five blinded experts of the baseline thoracic CT imaging were performed. Univariate and multivariate logistic regression analyses were performed to elucidate characteristics associated with clinical response. RESULTS: In total, 125 patients underwent coil treatment and had evaluable 12-month follow-up results. Of these, 78 patients received treatment of lobes with the highest emphysematous destruction determined by quantitative CT analysis (quantitative visual match [QVM]+), and 47 received treatment in at least one lobe that was not the most destroyed (QVM-). From the 78 patients with QVM+ treatment, a subgroup of 50 patients (64%) was identified with baseline residual volume > 200% predicted, emphysema score > 20% low attenuation area, and absence of airway disease. In this subgroup, greater lobar residual volume reduction in the treated lobes was achieved, which was associated with significant mean ± SE improvement in FEV1 (15.2 ± 3.1%), St. George's Respiratory Questionnaire (-12 ± 2 points), and residual volume (-0.57 ± 0.13 L). DISCUSSION: This post hoc analysis found that both significant hyperinflation (residual volume ≥ 200% predicted) and CT analysis are critical for patient selection and treatment planning for endobronchial coil therapy. Quantitative CT analysis is important to identify optimal lobar treatment and to exclude patients with insufficient emphysema (< 20% low attenuation area), whereas visual assessment identifies patients with signs of airway disease associated with worse outcomes. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01608490; URL: www.clinicaltrials.gov.
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: Jorine E Hartman; Karin Klooster; Sonja W S Augustijn; Wouter H van Geffen; Justin L Garner; Pallav L Shah; Nick H T Ten Hacken; Dirk-Jan Slebos Journal: Respiration Date: 2021-03-19 Impact factor: 3.580
Authors: Sebastian Mang; Niklas Huss; Hans-Joachim Schäfers; Holger Wehrfritz; Alexander Massmann; Christian Lensch; Frank Langer; Frederik Seiler; Robert Bals; Philipp M Lepper Journal: Interact Cardiovasc Thorac Surg Date: 2021-08-18
Authors: Jorrit B A Welling; Jorine E Hartman; Sonja W S Augustijn; Huib A M Kerstjens; Lowie E G W Vanfleteren; Karin Klooster; Dirk-Jan Slebos Journal: Int J Chron Obstruct Pulmon Dis Date: 2020-04-23
Authors: Marlies van Dijk; Jorine E Hartman; Sonja W S Augustijn; Nick H T Ten Hacken; Karin Klooster; Dirk-Jan Slebos Journal: Lung Date: 2021-03-09 Impact factor: 2.584
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