Bronchial Rheoplasty for Chronic Bronchitis: Results from a Canadian Feasibility Study with RheOx®.

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 FEV1 ≥ 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.

Retreatment of symptomatic chronic bronchitis with bronchial rheoplasty.

A man in his early 70s with a long-standing history of chronic bronchitis presented to our department 3 years ago with debilitating chronic cough and excessive sputum production. He had no previous diagnosis of chronic obstructive pulmonary disease and without evidence of severe respiratory tract infections. Due to his symptom burden and impairments in daily activities, the patient was considered to be an appropriate candidate for bronchial rheoplasty, a novel endoscopic treatment for patients with chronic bronchitis. The patient responded well to bilateral treatment but then experienced symptom recurrence roughly 14 months after completing the initial treatment. In the absence of an alternative explanation for the return of these symptoms, he then underwent uneventful retreatment. The patient, again, reported significant symptom improvement and no adverse effects since retreatment. While further studies are necessary to assess the safety and efficacy of retreatment, the findings from this case are encouraging.

Bronchial rheoplasty for chronic bronchitis: 2-year results from a US feasibility study with RheOx.

INTRODUCTION: Chronic bronchitis (CB), a phenotype of chronic obstructive pulmonary disease (COPD) characterised by persistent cough and mucus hypersecretion, is associated with poor outcomes despite guideline-based treatment. Bronchial rheoplasty (BR) with the RheOx system delivers non-thermal pulsed electric fields to the lower airway epithelium and submucosa to reduce mucus producing cells. Early phase clinical trials including 1-year follow-up have demonstrated reduction in airway goblet cell hyperplasia and improvement in CB symptoms. METHODS: The current multicentre observational BR study enrolled 21 patients with CB at six centres in the USA, with bilateral treatment and 2-year follow-up. Entry criteria included elevated cough and sputum scores from COPD Assessment Test (CAT) and forced expiratory volume in one second<80% predicted. Safety was assessed by serious adverse event (SAE) incidence through 24 months. Clinical utility was evaluated using changes in the CAT, the St. George's Respiratory Questionnaire (SGRQ) and by comparing exacerbation rates before and following intervention. RESULTS: No procedure-related or device-related SAEs occurred. Mean (SD) changes from baseline in CAT at 12 and 24 months were -9.0 (6.7) (p<0.0001) and -5.6 (7.1) (p<0.0047) and in SGRQ were -16.6 (13.2) (p<0.0001) and -11.8 (19.2) (p<0.0227), respectively. There was a 34% reduction in moderate and a 64% reduction in severe COPD exacerbation events compared with the year prior to treatment. CONCLUSIONS: This study extends the findings from previous feasibility studies, demonstrating that BR can be performed safely and may significantly improve symptoms and health-related quality of life for patients with CB through 24 months. TRAIL REGISTRATION NUMBER: NCT03631472.