1. Bronchial Rheoplasty for Chronic Bronchitis: Results from a Canadian Feasibility Study with RheOx ® .
- Author
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Fortin M, Dorscheid DR, Liberman M, Martel S, and Shaipanich T
- Subjects
- Humans, Male, Female, Aged, Treatment Outcome, Middle Aged, Forced Expiratory Volume, Time Factors, Canada, Recovery of Function, Quality of Life, Electric Stimulation Therapy adverse effects, Electric Stimulation Therapy instrumentation, Electric Stimulation Therapy methods, Bronchi physiopathology, Bronchi surgery, Surveys and Questionnaires, Prospective Studies, Feasibility Studies, Bronchitis, Chronic physiopathology, Bronchitis, Chronic surgery, Bronchitis, Chronic therapy, Lung physiopathology, Lung surgery, Lung drug effects
- Abstract
Purpose: Chronic bronchitis (CB), a chronic obstructive pulmonary disease (COPD) phenotype defined by persistent mucus hypersecretion and cough, is associated with poor quality of life, exacerbations, and lung function impairment. Bronchial Rheoplasty (BR) delivers non-thermal pulsed electric fields to airway epithelium and submucosa. Preliminary studies demonstrated reduced airway goblet cell hyperplasia and symptom improvement in response to BR. This study aimed to further assess the safety and clinical feasibility of BR in the setting of CB., Patients and Methods: This 3-center, single-arm study evaluated the safety and feasibility of BR in Canadian patients. The major inclusion criteria were the sum of CAT first 2 questions (cough and mucus) ≥ 7 out of 10 and FEV
1 ≥ 30% predicted. Right-sided airways were treated first; left, 1 month later. Serious adverse events (SAEs) were tabulated through 12 months. Outcomes were evaluated using the SGRQ and CAT., Results: Ten patients with CB were enrolled and followed for 12 months. The BR procedure was successful in all patients (mean age 69 ± 5.8 years, post-BD FEV1 77.1 ± 28.3, SGRQ 56.2 ± 8.8, CAT 25.4 ± 4.7). Only one SAE, a COPD exacerbation 13 days following the BR procedure, was considered device related. No additional SAEs occurred through 12 months, and 90% of the patients were CAT responders (≥ 2-point improvement) at 3 and 6 months. Similar results were observed in SGRQ., Conclusion: BR was safe and well-tolerated. Meaningful symptom improvement was observed through 12 months, suggesting BR may be a viable treatment option for patients with CB., Competing Interests: Dr Simon Martel reports fee to his institution for patient recruited and treated to cover all the hospital charges from IUCPQ. The authors report no other conflicts of interest in this work., (© 2024 Fortin et al.)- Published
- 2024
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