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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Bronchial Rheoplasty for Chronic Bronchitis: Results from a US Feasibility Study with RheOxTM
Session Title
TP40 - TP040 COPD CLINICAL TRIALS AND THERAPIES
Abstract
A2263 - Bronchial Rheoplasty for Chronic Bronchitis: Results from a US Feasibility Study with RheOxTM
Author Block: F. C. Sciurba1, A. P. Comellas2, A. Majid3, D. K. Hogarth4, N. Marchetti5, V. Kim6, G. J. Criner7, M. T. Dransfield8; 1Univ of Pittsburgh Med Ctr, Pittsburgh, PA, United States, 2Internal Medicine/Pulmonary, University of Iowa, Iowa City, IA, United States, 3Beth Israel Deaconess Med Ctr, Boston, MA, United States, 4Univ of Chicago, Chicago, IL, United States, 5Pulm Div/ Parkinson Pavillion, Temple Univ Hosp, Philadelphia, PA, United States, 6Thoracic Medicine and Surgery, Temple Lung Center, Philadelphia, PA, United States, 7Pulm & Crit Care Med, Temple Univ Hosp, Philadelphia, PA, United States, 8Univ of Alabama Birmingham & Birmingham VA Med Ctr, Birmingham, AL, United States.
Rationale: Chronic bronchitis, a form of COPD, defined by persistent cough and mucus hypersecretion is associated with poor quality of life, exacerbations, and lung function impairment. Despite pharmacotherapy, patients often remain highly symptomatic. Bronchial Rheoplasty (BR) uses the RheOXTM system to deliver non-thermal pulsed electric fields to airway epithelium and submucosa from the carina to approximately all 5th order bronchi. Preliminary studies have demonstrated. a reduction in airway goblet cell hyperplasia associated with improved symptoms. This U.S. multi-center, prospective single-arm observational study evaluated the safety and clinical utility of BR in chronic bronchitis patients.
Methods: 21 patients with chronic bronchitis were enrolled at 6 centers in the United States and 17 have been followed to 12 months. Inclusion criteria included sum of CAT Q1 and Q2 (cough and mucous score) ≥ 7 out of a possible 10, FEV1/FVC< 0.7, FEV1< 80% predicted. All patients underwent bilateral BR procedures under general anesthesia. Right-sided airways were treated first; left-sided airways were treated one month later. Safety was assessed by the incidence of serious adverse events through 12 months. Clinical utility was evaluated using the St. George’s Respiratory Questionnaire (SGRQ), the COPD Assessment Test (CAT), and by tabulating exacerbations. Spirometry was also measured.
Results: BR was successfully performed in all 21 patients (mean age 66 + 5.3, 57.1% male, post-BD FEV1 53.3 + 15.7, FEV1/FVC 51.2 + 14.3, SGRQ 60.1 + 15.5, CAT 26.9 + 4.9). 52.4% of patients were Global Initiative for Obstructive Lung Disease (GOLD) stage II and 47.6% were GOLD stage III. Most patients received Beta2-agonist and/or long-acting muscarinic agonist treatment (85.7%)
in combination with an inhaled corticosteroid (81%). There were no device or procedure related serious adverse events through 12 months. One severe COPD exacerbation occurred during the 12-month follow-up 218 days following completion of treatment. Mean changes in CAT (MCID 2) at 6 and 12 months were -7.6 + 5.1 (p<0.0001) and -7.8 + 5.6 (p<0.0001), and in SGRQ (MCID 4) -13.3 + 11.9 (p<0.0001) and -16.5 + 13.0 (p<0.0001) . There were no significant changes in spirometric measures.
Conclusion: This study demonstrates that Bronchial Rheoplasty is safe and well-tolerated. BR results in a clinically meaningful reduction in symptoms and health related quality of life for chronic bronchitis patients through 12 months. A prospective randomized clinical trial is warranted to confirm these findings.
Author Block: F. C. Sciurba1, A. P. Comellas2, A. Majid3, D. K. Hogarth4, N. Marchetti5, V. Kim6, G. J. Criner7, M. T. Dransfield8; 1Univ of Pittsburgh Med Ctr, Pittsburgh, PA, United States, 2Internal Medicine/Pulmonary, University of Iowa, Iowa City, IA, United States, 3Beth Israel Deaconess Med Ctr, Boston, MA, United States, 4Univ of Chicago, Chicago, IL, United States, 5Pulm Div/ Parkinson Pavillion, Temple Univ Hosp, Philadelphia, PA, United States, 6Thoracic Medicine and Surgery, Temple Lung Center, Philadelphia, PA, United States, 7Pulm & Crit Care Med, Temple Univ Hosp, Philadelphia, PA, United States, 8Univ of Alabama Birmingham & Birmingham VA Med Ctr, Birmingham, AL, United States.
Rationale: Chronic bronchitis, a form of COPD, defined by persistent cough and mucus hypersecretion is associated with poor quality of life, exacerbations, and lung function impairment. Despite pharmacotherapy, patients often remain highly symptomatic. Bronchial Rheoplasty (BR) uses the RheOXTM system to deliver non-thermal pulsed electric fields to airway epithelium and submucosa from the carina to approximately all 5th order bronchi. Preliminary studies have demonstrated. a reduction in airway goblet cell hyperplasia associated with improved symptoms. This U.S. multi-center, prospective single-arm observational study evaluated the safety and clinical utility of BR in chronic bronchitis patients.
Methods: 21 patients with chronic bronchitis were enrolled at 6 centers in the United States and 17 have been followed to 12 months. Inclusion criteria included sum of CAT Q1 and Q2 (cough and mucous score) ≥ 7 out of a possible 10, FEV1/FVC< 0.7, FEV1< 80% predicted. All patients underwent bilateral BR procedures under general anesthesia. Right-sided airways were treated first; left-sided airways were treated one month later. Safety was assessed by the incidence of serious adverse events through 12 months. Clinical utility was evaluated using the St. George’s Respiratory Questionnaire (SGRQ), the COPD Assessment Test (CAT), and by tabulating exacerbations. Spirometry was also measured.
Results: BR was successfully performed in all 21 patients (mean age 66 + 5.3, 57.1% male, post-BD FEV1 53.3 + 15.7, FEV1/FVC 51.2 + 14.3, SGRQ 60.1 + 15.5, CAT 26.9 + 4.9). 52.4% of patients were Global Initiative for Obstructive Lung Disease (GOLD) stage II and 47.6% were GOLD stage III. Most patients received Beta2-agonist and/or long-acting muscarinic agonist treatment (85.7%)
in combination with an inhaled corticosteroid (81%). There were no device or procedure related serious adverse events through 12 months. One severe COPD exacerbation occurred during the 12-month follow-up 218 days following completion of treatment. Mean changes in CAT (MCID 2) at 6 and 12 months were -7.6 + 5.1 (p<0.0001) and -7.8 + 5.6 (p<0.0001), and in SGRQ (MCID 4) -13.3 + 11.9 (p<0.0001) and -16.5 + 13.0 (p<0.0001) . There were no significant changes in spirometric measures.
Conclusion: This study demonstrates that Bronchial Rheoplasty is safe and well-tolerated. BR results in a clinically meaningful reduction in symptoms and health related quality of life for chronic bronchitis patients through 12 months. A prospective randomized clinical trial is warranted to confirm these findings.
